This document discusses quality control tests for pharmaceutical capsules that are performed during the manufacturing process (IPQC tests) and on finished products (FPQC tests). It provides details on various physical parameters tested by IPQC like temperature, humidity, weight variation. FPQC tests include assays, dissolution testing, stability testing, and ensuring uniform drug content between capsules. The document outlines specific test methods and acceptance criteria from pharmacopeias for tests like disintegration, dissolution and content uniformity. It emphasizes that quality testing helps ensure capsules meet regulatory standards and provides maximum safety for human health.
This document discusses capsules as a dosage form of medication. It provides an introduction to capsules, describing them as solid dosage forms that contain one or more ingredients enclosed in a gelatin shell. The document outlines the advantages of capsules, such as masking unpleasant tastes and being easy to swallow. Disadvantages include some drugs or solutions being unsuitable for capsules. The document also describes various quality control tests for capsules, such as appearance, size, disintegration testing, weight variation, and content uniformity testing. It provides details on procedures for several of these tests.
IPQC Tests for capsules As per IP, BP & USPPramod Ramane
IPQC- In Process Quality Control Tests for Capsules are
1. Uniformity Of Content
2. Disintigration Test
3. Weight Variation Test
4. Dissolution Test
The tests are with Acceptance limits/Criteria as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) & United States Pharmacopoeia (USP)
Hardness, friability, thickness, disintegration, weight variation, content uniformity, and dissolution are important quality control tests conducted on tablets. Hardness ensures tablets can withstand handling and processing, while friability measures how well tablets withstand abrasion. Disintegration tests how long it takes for tablets to break down, and weight variation and content uniformity ensure all tablets contain the intended amount of active drug. Dissolution testing determines how quickly the drug is released from the tablet in the body. Documentation of all quality control test results is necessary.
IPQC?
Its Need
In-Process Quality Control tests for Tablets
Hardness
Friability
Thickness
Disintegration Time
Weight variation
Content uniformity
Dissolution test
Leakage testing for strip and blister packaging
This document discusses in process quality control (IPQC) and finished product quality control (FPQC) tests for tablets. It begins with introducing the concepts of quality, quality control, IPQC and FPQC. It then lists and describes common tests conducted for tablets, including tests for size and shape, colour and odour, hardness, friability, content uniformity and dissolution. Standard acceptance criteria for many of the tests are also provided. The document emphasizes that IPQC and FPQC are important to control quality, identify errors, and ensure product specifications are met.
This document discusses in-process quality control tests for liquid dosage forms, including sterile and non-sterile formulations. For sterile dosage forms like parenterals and ophthalmics, it describes tests for drug content, clarity, pyrogens, sterility, stability, leakage, and dye penetration. For non-sterile syrups and suspensions, it outlines testing drug content, active ingredient assays, pH, weight per ml, and particle size. The document provides details on procedures for each test and references for further information.
Capsules are solid dosage forms that contain a drug or mixture of drugs enclosed within a shell. The shell is typically made of gelatin but can also be other materials. Capsules are intended for oral administration and provide rapid release of contents unless they are modified or enteric release capsules. Capsules can be filled using various methods like auger, dosator, or dosing disc systems. Tests are conducted to ensure uniformity of contents, weight, and dissolution based on pharmacopeial standards.
This document discusses quality control tests for pharmaceutical powders. It describes 7 key tests:
1) Particle size and shape determination which affects properties like weight variation and flowability. Methods include sieving and microscopy.
2) Density measurements including bulk density, tapped density and granular density which influence compressibility.
3) Granule strength and friability testing which affects changes in particle size and compressibility.
4) Flow property tests like angle of repose, compressibility index and Hausner’s ratio which indicate flow rates for uniform tablet production.
5) Moisture content testing using a moisture or IR balance to measure 2% optimal moisture for compression.
6) Percent fines testing
This document discusses capsules as a dosage form of medication. It provides an introduction to capsules, describing them as solid dosage forms that contain one or more ingredients enclosed in a gelatin shell. The document outlines the advantages of capsules, such as masking unpleasant tastes and being easy to swallow. Disadvantages include some drugs or solutions being unsuitable for capsules. The document also describes various quality control tests for capsules, such as appearance, size, disintegration testing, weight variation, and content uniformity testing. It provides details on procedures for several of these tests.
IPQC Tests for capsules As per IP, BP & USPPramod Ramane
IPQC- In Process Quality Control Tests for Capsules are
1. Uniformity Of Content
2. Disintigration Test
3. Weight Variation Test
4. Dissolution Test
The tests are with Acceptance limits/Criteria as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) & United States Pharmacopoeia (USP)
Hardness, friability, thickness, disintegration, weight variation, content uniformity, and dissolution are important quality control tests conducted on tablets. Hardness ensures tablets can withstand handling and processing, while friability measures how well tablets withstand abrasion. Disintegration tests how long it takes for tablets to break down, and weight variation and content uniformity ensure all tablets contain the intended amount of active drug. Dissolution testing determines how quickly the drug is released from the tablet in the body. Documentation of all quality control test results is necessary.
IPQC?
Its Need
In-Process Quality Control tests for Tablets
Hardness
Friability
Thickness
Disintegration Time
Weight variation
Content uniformity
Dissolution test
Leakage testing for strip and blister packaging
This document discusses in process quality control (IPQC) and finished product quality control (FPQC) tests for tablets. It begins with introducing the concepts of quality, quality control, IPQC and FPQC. It then lists and describes common tests conducted for tablets, including tests for size and shape, colour and odour, hardness, friability, content uniformity and dissolution. Standard acceptance criteria for many of the tests are also provided. The document emphasizes that IPQC and FPQC are important to control quality, identify errors, and ensure product specifications are met.
This document discusses in-process quality control tests for liquid dosage forms, including sterile and non-sterile formulations. For sterile dosage forms like parenterals and ophthalmics, it describes tests for drug content, clarity, pyrogens, sterility, stability, leakage, and dye penetration. For non-sterile syrups and suspensions, it outlines testing drug content, active ingredient assays, pH, weight per ml, and particle size. The document provides details on procedures for each test and references for further information.
Capsules are solid dosage forms that contain a drug or mixture of drugs enclosed within a shell. The shell is typically made of gelatin but can also be other materials. Capsules are intended for oral administration and provide rapid release of contents unless they are modified or enteric release capsules. Capsules can be filled using various methods like auger, dosator, or dosing disc systems. Tests are conducted to ensure uniformity of contents, weight, and dissolution based on pharmacopeial standards.
This document discusses quality control tests for pharmaceutical powders. It describes 7 key tests:
1) Particle size and shape determination which affects properties like weight variation and flowability. Methods include sieving and microscopy.
2) Density measurements including bulk density, tapped density and granular density which influence compressibility.
3) Granule strength and friability testing which affects changes in particle size and compressibility.
4) Flow property tests like angle of repose, compressibility index and Hausner’s ratio which indicate flow rates for uniform tablet production.
5) Moisture content testing using a moisture or IR balance to measure 2% optimal moisture for compression.
6) Percent fines testing
This document summarizes the standards and testing methods for different types of tablets according to the Indian Pharmacopoeia. It describes 10 types of tablets and the standards that apply to all tablets, including content uniformity, weight variation, disintegration, friability, and dissolution testing. The document provides details on the acceptance criteria and testing procedures for each of these standards.
Capsules come in both hard and soft gelatin shells that enclose solid or liquid medications. Quality control tests are conducted on empty capsules and finished capsules to ensure uniformity of weight, content of active ingredients, and dissolution. Key tests include uniformity of weight, content of active ingredients, and uniformity of content. Acceptance criteria vary slightly between pharmacopeias but generally require less than 10% deviation from the average weight and 90-110% of the average active content. In-process quality checks are also important to monitor production and identify defects.
The document discusses in-process and finished product quality control tests for parenterals. It defines parenterals as sterile preparations intended for administration by injection, infusion, or implantation. It describes various types of parenterals including small volume parenterals like ampoules and vials, as well as large volume parenterals. The document then outlines several important in-process quality control tests that are conducted on parenterals to ensure safety, identity, strength, quality and purity. These include tests like content uniformity, leakage, sterility, bacterial endotoxins and clarity. Specific test methods, acceptance criteria and significance are provided for key tests according to compendial standards.
Friability testing involves placing a sample of tablets into a drum that rotates at 25 rpm for 100 revolutions. The tablets are weighed before and after the test to determine any weight loss due to mechanical stress. An acceptable friability is less than 1% weight loss, as this ensures tablets can withstand forces during manufacturing, distribution, and handling by customers. The test is run using either a single or double drum friabilator, following procedures for sample size, rotation speed, and calculation of percentage weight loss specified in pharmacopeia.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with "Quality control of packaging materials."
Thank you for reading.
we hope it was helpful to you.
UIPS,PU team
In Process Quality Control Tests (IPQC) for Solid Dosage FromSagar Savale
This document discusses in-process quality control tests that are performed during the manufacturing of solid oral dosage forms such as tablets and capsules. It provides details about common tests like weight variation, hardness, friability, disintegration and dissolution. The tests help to identify any issues during production so that corrective actions can be taken. Specific test methods, acceptance criteria and instruments used for tests are outlined for various types of oral dosage forms including immediate release tablets, sustained release tablets, capsules and suppositories. Maintaining quality during manufacturing is important to deliver consistent drug levels in patients.
IPQC and FPQC tests are important quality control steps for creams from raw materials to finished product. Creams are topical semisolid preparations used to deliver drugs to the skin. They can be oil-in-water or water-in-oil emulsions. Evaluation of creams includes tests for physical properties, pH, viscosity, spreadability, irritancy, microbial growth, and preservative efficacy. Creams are packaged in jars or tubes and stored properly to ensure stability.
This document describes several key pieces of equipment used in the pharmaceutical manufacturing process. It discusses the Rapid Mixer Granulator, which performs fast mixing and wet granulation in a single step. It then describes the fluidized bed dryer, which dries granules using hot air in a fluidized bed. Tablet compression machines are also summarized, explaining how they compress granules into tablets using dies and punches. Finally, the document discusses coating machines, which apply coatings to tablets through a spraying process while tumbling and drying them using heated air.
This document discusses stability testing of pharmaceutical packaging. Stability testing ensures that packaging maintains the quality of drugs over time under various environmental conditions like temperature, humidity and light. It involves testing packaging for leakage, strength, impact of distribution processes, and compatibility with drugs. The document outlines guidelines for conducting stability tests, including storage conditions, timepoints for sampling, and parameters to evaluate like appearance, assay and degradation. The goal is to determine shelf life and ensure patient safety.
Quality Control Tests Of Capsules dosage form.
1. Weight Variation Test
2. Content Uniformity Test
3. Dissolution Test
4. Disintegration Test
5. Leak Test
Control including pharmaceutical aspects, physical stability and packing of capsules. Capsules provide advantages such as masking taste and odor, ease of swallowing, and economical production. Quality control tests include physical tests like disintegration, weight variation and chemical tests like dissolution and content uniformity. Capsules are packaged in containers like plastic bottles or blister packs to protect from moisture and ensure stability. Pharmaceutical aspects of capsules include improved dissolution and bioavailability over tablets due to liquid fill formulations, as well as reduced gastric irritation potential.
The document provides information on quality control testing for pharmaceutical tablets. It defines quality control as the process of monitoring quality during manufacturing to ensure standards are met. It describes several important quality control tests conducted on tablets, including weight variation, thickness, hardness, friability, disintegration, dissolution, and content uniformity tests. These tests are essential to ensure tablets are safe, effective, and meet specifications for attributes like drug content, stability and patient acceptability. The document provides details on procedures, equipment and acceptance criteria for each quality control test.
Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
This document evaluates different tests performed on capsules, including stability, invariability, disintegration, dissolution, and moisture permeation tests. Stability tests evaluate the integrity of the capsule shell and determine shelf life by testing shell integrity and storage conditions. Invariability tests ensure uniform weight and drug content across capsules using weight variation and content uniformity tests. Disintegration and dissolution tests measure how quickly the capsule shell breaks down and releases its drug in water or simulated gastric fluid. Moisture permeation testing verifies the suitability of packaging for preventing moisture from affecting capsules.
Photostability testing is performed to evaluate the stability of drug substances and products when exposed to light. It aims to identify necessary precautions to prevent unacceptable changes during manufacturing, formulation, or shelf life. The document discusses factors influencing photostability and provides examples. It outlines the process for photostability testing of both drug substances and products according to ICH guidelines, including presentation of samples, analysis, and judgement of results. Challenges in testing and solutions to ensure accurate light measurements and tight environmental control are also reviewed.
Glass as a packaging material in pharmaceutical packagingShweta Shelke
This presentation gives a brief idea about the types of glasses used in pharmaceutical industry and its intended use. Different tests used for assuring its quality for intended use.
1. The document discusses quality control tests for tablets, including tests for tablet characteristics before and after compression. It describes tests for properties like hardness, friability, thickness, weight variation, drug content uniformity, and dissolution.
2. Official tests discussed include weight variation, disintegration, dissolution, and drug content/assay. Non-official tests include hardness and friability. Test conditions and acceptance criteria are provided for many of the tests.
3. The purpose of the quality control tests is to ensure tablets include the correct dose of drug, the drug is released in a controlled and reproducible manner, and the tablets have sufficient mechanical strength.
This document discusses various dissolution apparatus used to test the dissolution of pharmaceutical dosage forms. It describes the 7 main types of apparatus specified in pharmacopeias like USP including basket, paddle, flow-through cell and reciprocating cylinder apparatuses. Each type of apparatus has a specific design and is used to test different dosage forms like tablets, capsules, transdermal patches based on simulating their dissolution environment in the body. Dissolution testing provides critical information for quality control and drug development.
1. The document discusses in-process quality control (IPQC) and finished product quality control (FPQC) tests for pharmaceutical capsules according to various pharmacopoeias. It describes 12 key tests including appearance, size, assay, content uniformity, dissolution, and stability testing.
2. The tests evaluate physical parameters like temperature, humidity, weight, and disintegration time. They also assess the content of active ingredients and whether capsules meet specifications for content uniformity, dissolution rate, and stability over time.
3. Ensuring quality through comprehensive testing during and after production is important for regulatory compliance and producing safe, effective pharmaceuticals. The various pharmacopoeias have different standards and requirements but collectively
This document summarizes the standards and testing methods for different types of tablets according to the Indian Pharmacopoeia. It describes 10 types of tablets and the standards that apply to all tablets, including content uniformity, weight variation, disintegration, friability, and dissolution testing. The document provides details on the acceptance criteria and testing procedures for each of these standards.
Capsules come in both hard and soft gelatin shells that enclose solid or liquid medications. Quality control tests are conducted on empty capsules and finished capsules to ensure uniformity of weight, content of active ingredients, and dissolution. Key tests include uniformity of weight, content of active ingredients, and uniformity of content. Acceptance criteria vary slightly between pharmacopeias but generally require less than 10% deviation from the average weight and 90-110% of the average active content. In-process quality checks are also important to monitor production and identify defects.
The document discusses in-process and finished product quality control tests for parenterals. It defines parenterals as sterile preparations intended for administration by injection, infusion, or implantation. It describes various types of parenterals including small volume parenterals like ampoules and vials, as well as large volume parenterals. The document then outlines several important in-process quality control tests that are conducted on parenterals to ensure safety, identity, strength, quality and purity. These include tests like content uniformity, leakage, sterility, bacterial endotoxins and clarity. Specific test methods, acceptance criteria and significance are provided for key tests according to compendial standards.
Friability testing involves placing a sample of tablets into a drum that rotates at 25 rpm for 100 revolutions. The tablets are weighed before and after the test to determine any weight loss due to mechanical stress. An acceptable friability is less than 1% weight loss, as this ensures tablets can withstand forces during manufacturing, distribution, and handling by customers. The test is run using either a single or double drum friabilator, following procedures for sample size, rotation speed, and calculation of percentage weight loss specified in pharmacopeia.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with "Quality control of packaging materials."
Thank you for reading.
we hope it was helpful to you.
UIPS,PU team
In Process Quality Control Tests (IPQC) for Solid Dosage FromSagar Savale
This document discusses in-process quality control tests that are performed during the manufacturing of solid oral dosage forms such as tablets and capsules. It provides details about common tests like weight variation, hardness, friability, disintegration and dissolution. The tests help to identify any issues during production so that corrective actions can be taken. Specific test methods, acceptance criteria and instruments used for tests are outlined for various types of oral dosage forms including immediate release tablets, sustained release tablets, capsules and suppositories. Maintaining quality during manufacturing is important to deliver consistent drug levels in patients.
IPQC and FPQC tests are important quality control steps for creams from raw materials to finished product. Creams are topical semisolid preparations used to deliver drugs to the skin. They can be oil-in-water or water-in-oil emulsions. Evaluation of creams includes tests for physical properties, pH, viscosity, spreadability, irritancy, microbial growth, and preservative efficacy. Creams are packaged in jars or tubes and stored properly to ensure stability.
This document describes several key pieces of equipment used in the pharmaceutical manufacturing process. It discusses the Rapid Mixer Granulator, which performs fast mixing and wet granulation in a single step. It then describes the fluidized bed dryer, which dries granules using hot air in a fluidized bed. Tablet compression machines are also summarized, explaining how they compress granules into tablets using dies and punches. Finally, the document discusses coating machines, which apply coatings to tablets through a spraying process while tumbling and drying them using heated air.
This document discusses stability testing of pharmaceutical packaging. Stability testing ensures that packaging maintains the quality of drugs over time under various environmental conditions like temperature, humidity and light. It involves testing packaging for leakage, strength, impact of distribution processes, and compatibility with drugs. The document outlines guidelines for conducting stability tests, including storage conditions, timepoints for sampling, and parameters to evaluate like appearance, assay and degradation. The goal is to determine shelf life and ensure patient safety.
Quality Control Tests Of Capsules dosage form.
1. Weight Variation Test
2. Content Uniformity Test
3. Dissolution Test
4. Disintegration Test
5. Leak Test
Control including pharmaceutical aspects, physical stability and packing of capsules. Capsules provide advantages such as masking taste and odor, ease of swallowing, and economical production. Quality control tests include physical tests like disintegration, weight variation and chemical tests like dissolution and content uniformity. Capsules are packaged in containers like plastic bottles or blister packs to protect from moisture and ensure stability. Pharmaceutical aspects of capsules include improved dissolution and bioavailability over tablets due to liquid fill formulations, as well as reduced gastric irritation potential.
The document provides information on quality control testing for pharmaceutical tablets. It defines quality control as the process of monitoring quality during manufacturing to ensure standards are met. It describes several important quality control tests conducted on tablets, including weight variation, thickness, hardness, friability, disintegration, dissolution, and content uniformity tests. These tests are essential to ensure tablets are safe, effective, and meet specifications for attributes like drug content, stability and patient acceptability. The document provides details on procedures, equipment and acceptance criteria for each quality control test.
Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
This document evaluates different tests performed on capsules, including stability, invariability, disintegration, dissolution, and moisture permeation tests. Stability tests evaluate the integrity of the capsule shell and determine shelf life by testing shell integrity and storage conditions. Invariability tests ensure uniform weight and drug content across capsules using weight variation and content uniformity tests. Disintegration and dissolution tests measure how quickly the capsule shell breaks down and releases its drug in water or simulated gastric fluid. Moisture permeation testing verifies the suitability of packaging for preventing moisture from affecting capsules.
Photostability testing is performed to evaluate the stability of drug substances and products when exposed to light. It aims to identify necessary precautions to prevent unacceptable changes during manufacturing, formulation, or shelf life. The document discusses factors influencing photostability and provides examples. It outlines the process for photostability testing of both drug substances and products according to ICH guidelines, including presentation of samples, analysis, and judgement of results. Challenges in testing and solutions to ensure accurate light measurements and tight environmental control are also reviewed.
Glass as a packaging material in pharmaceutical packagingShweta Shelke
This presentation gives a brief idea about the types of glasses used in pharmaceutical industry and its intended use. Different tests used for assuring its quality for intended use.
1. The document discusses quality control tests for tablets, including tests for tablet characteristics before and after compression. It describes tests for properties like hardness, friability, thickness, weight variation, drug content uniformity, and dissolution.
2. Official tests discussed include weight variation, disintegration, dissolution, and drug content/assay. Non-official tests include hardness and friability. Test conditions and acceptance criteria are provided for many of the tests.
3. The purpose of the quality control tests is to ensure tablets include the correct dose of drug, the drug is released in a controlled and reproducible manner, and the tablets have sufficient mechanical strength.
This document discusses various dissolution apparatus used to test the dissolution of pharmaceutical dosage forms. It describes the 7 main types of apparatus specified in pharmacopeias like USP including basket, paddle, flow-through cell and reciprocating cylinder apparatuses. Each type of apparatus has a specific design and is used to test different dosage forms like tablets, capsules, transdermal patches based on simulating their dissolution environment in the body. Dissolution testing provides critical information for quality control and drug development.
1. The document discusses in-process quality control (IPQC) and finished product quality control (FPQC) tests for pharmaceutical capsules according to various pharmacopoeias. It describes 12 key tests including appearance, size, assay, content uniformity, dissolution, and stability testing.
2. The tests evaluate physical parameters like temperature, humidity, weight, and disintegration time. They also assess the content of active ingredients and whether capsules meet specifications for content uniformity, dissolution rate, and stability over time.
3. Ensuring quality through comprehensive testing during and after production is important for regulatory compliance and producing safe, effective pharmaceuticals. The various pharmacopoeias have different standards and requirements but collectively
In Process Quality Control Tests For Capsules [Autosaved].pptxSurendra Chowdary
This document discusses in-process quality control tests for capsules. It describes 7 types of tests: 1) Stability tests like shell integrity and shelf life determination, 2) Purity tests of the capsule shell, 3) Invariability tests like weight variation and content uniformity, 4) Disintegration testing, 5) Dissolution testing, 6) Moisture permeation testing of packaging, and 7) Batch release tests. The document provides details on the procedures and acceptance criteria for each of these quality control tests performed on capsules during manufacturing.
Non sterile manufacturing process technologyPRANJAY PATIL
This document provides an overview of in-process quality control (IPQC) tests for non-sterile pharmaceutical tablets and capsules. It discusses the importance of IPQC in minimizing errors and enforcing manufacturing standards. Common IPQC tests described for tablets include weight variation, content uniformity, hardness, thickness, friability, dissolution, disintegration, and moisture content. For capsules, discussed tests include content of active ingredients, weight variation, content uniformity, disintegration, and dissolution. A variety of apparatus used in conducting these tests are also outlined.
Non sterile manufacturing process technologyPRANJAY PATIL
This document provides an overview of in-process quality control (IPQC) tests for tablets and capsules during the manufacturing process. It discusses the importance and scope of IPQC, as well as general IPQC tests such as identity, quality, purity, and potency tests. Specific IPQC tests covered for tablets include weight variation, content uniformity, hardness, thickness, friability, dissolution, disintegration, and moisture content. For capsules, content of active ingredients, weight variation, content uniformity, disintegration, dissolution, and moisture permeation are discussed. Various apparatus used to perform these tests are also described.
This document evaluates various properties of tablets including size, shape, thickness, friability, weight variation, disintegration, and dissolution. It describes common tests used to analyze these properties, including friability testing to measure how easily tablets crumble, weight variation testing to check consistency of tablet weights, disintegration testing using glass tubes in fluid, and dissolution testing using apparatus 1 (basket type) or apparatus 2 (paddle type) to measure how quickly drugs dissolve. The document provides details on procedures, equipment, and standards used for these pharmaceutical quality control tests.
In process stability control test for capsuleJinendra Jain
This document discusses quality control testing for capsules. It describes physical tests like disintegration testing, weight variation testing, and chemical tests like dissolution testing and content uniformity testing. Disintegration testing ensures capsules break down within a specified time in liquid. Weight variation testing checks that capsule weights are consistent. Dissolution testing measures how quickly the active drug is released. Content uniformity testing confirms the amount of drug in each capsule is consistent. These quality control tests are important to ensure capsules meet specifications and perform as intended.
This document provides information about tablets, including their definition, categories, in-process tests, and testing methods. Tablets are solid oral dosage forms containing medicaments. There are several categories including uncoated, film coated, sugar coated, and modified release tablets. In-process tests include uniformity of contents, weight, dissolution, and disintegration. Dissolution and disintegration tests are described for different tablet types using specified apparatus, media, and time/acceptance criteria. Modified and prolonged release tablets have additional dissolution testing methods and criteria for acid and buffer stages.
Quality control test for capsule and finish product of capsule are
■ weight variation test
■ Dissolution test
■ Disintegration test
■ moisture permeation test
■ contents uniformity test
■ blooms gelatin strength .
IPQC checks are carried out during the manufacturing process to monitor critical variables that can impact product quality. In-process materials are tested for identity, strength, and purity, and any rejected materials are quarantined. The objectives are quality control, process control, and ensuring final product quality through continuous monitoring and implementation of good manufacturing practices. IPQC involves establishing and documenting controls to ensure output falls within acceptable standard ranges.
This document provides information on the manufacturing process, flowcharts, and in-process quality control (IPQC) tests for non-sterile capsule dosage forms. It describes the manufacturing of hard and soft gelatin capsule shells using plate and rotary die processes. Key steps include dipping pins in gelatin solution, drying, stripping, and trimming shells. Capsules are filled and quality tests conducted including appearance, size, disintegration time, weight variation, moisture permeation, content uniformity, and dissolution. The document aims to provide an overview of capsule manufacturing and quality assurance.
This document discusses important quality control tests that are conducted on tablets during production. It outlines tests for hardness, friability, thickness, disintegration, weight variation, content uniformity, dissolution, and leak testing of packaging. Specific procedures and acceptance criteria are provided for each test to ensure the tablets meet standards for quality, stability, and ability to deliver the intended dose of medication. Routine quality control testing plays a key role in pharmaceutical manufacturing.
Quality control tests are important to ensure tablets meet standards for safety, efficacy and patient acceptability. Key tests include weight variation, hardness, friability, disintegration and dissolution. Weight variation tests if individual tablet weights match the average weight. Hardness ensures tablets can withstand manufacturing and handling stresses. Friability tests surface strength and disintegration confirms how quickly tablets break down in fluid. Dissolution determines the rate of drug release.
1. Capsules are solid dosage forms that enclose one or more active ingredients in a soluble gelatin shell for oral administration. Hard capsules use gelatin and contain dry powders, while soft capsules contain oils or liquids dissolved in oils.
2. Capsules are manufactured through rotary die or reciprocating die processes that form, fill, seal and cut the gelatin shells. The gelatin used is type A or B derived from animal collagen.
3. Finished capsules are tested for attributes like size, shape, weight uniformity, content uniformity, and dissolution. Soft gelatin capsules provide benefits like protecting unstable ingredients and increasing bioavailability but have certain material limitations.
Industrial Pharmacy, Quality control of tablets.pdfAlishaKhatun4
This document discusses quality control testing for tablets. It begins by defining quality control as procedures taken during manufacturing to ensure a product meets requirements and is reproducible. It then describes various types of quality control tests for tablets, including weight variation, drug content, disintegration, dissolution, thickness, hardness, friability, and organoleptic characteristics. The document provides details on testing procedures and equipment for these analyses. It concludes that quality control of tablets requires various tests to be performed during production and after to ensure product standards are met.
This document discusses in-process quality control (IPQC) for various dosage forms including tablets, capsules, liquids, ointments, and parenterals. It provides details on common IPQC tests for each dosage form, such as hardness testing, friability testing, weight variation, disintegration, and dissolution for tablets. Specific steps in sterility testing and leak testing are also outlined for ensuring the quality of sterile parenteral products during manufacturing. The document emphasizes that IPQC is important to monitor processes, make adjustments to ensure product quality meets specifications, and avoid wasted efforts from non-compliant batches.
a) Tablet Weight Variation Test.
b) Tablet hardness Test.
c) Tablet friability Test.
d) Tablet disintegration Test.
e) Tablet dissolution Test.
f) Leakage test of Packaging of tablets / capsules.
g) Capsule weight variation test
h) Determination of Binding Sites and Association constant.
This document summarizes various quality control tests performed on tablets during the manufacturing process, known as in-process quality control (IPQC). It describes tests of tablet thickness, weight variation, hardness, friability, drug content, disintegration time, and dissolution. Acceptance criteria are provided for each test according to pharmacopeial standards. The purpose of IPQC testing is to ensure tablets meet specifications for identity, strength, quality and purity before the manufacturing process is complete.
IPQC tests are important quality control checks performed during the manufacturing of tablets, capsules, and ointments. For tablets, key tests include weight variation, disintegration, dissolution, drug content, hardness, and friability. Tests for capsules include uniformity of content, disintegration, weight variation, and dissolution. Common tests for ointments are not described. IPQC aims to detect errors, minimize human error, and ensure quality at each stage of production according to established procedures.
Similar to In process & finished products quality control test of capsule (20)
This document provides an introduction to various pharmaceutical concepts and processes. It discusses classification of dosage forms and delivery systems. It also covers topics like metrology, packaging, size reduction, mixing, filtration, extraction techniques, distillation, drying, sterilization, aseptic processing, and the production of tablets and capsules. The goal is to familiarize students with key elements of pharmaceutics including equipment, calculations, quality standards, and manufacturing steps for different drug formulations.
Pharmaceutical chemistry is the branch of chemistry that deals with the chemical, biochemical, and pharmacological aspects of drugs. It includes the synthesis, isolation, identification, and structural modification of drugs, as well as studying their chemical characteristics, biochemical changes after administration, and pharmacological effects. Pharmaceutical chemists work in the healthcare industry to develop and evaluate new and improved drugs through activities like drug discovery, metabolism studies, and quality control testing of drugs.
Auditing of vendors and production departmentArpitSuralkar
This document outlines procedures for auditing vendors that produce capsules and sterile products. It discusses the benefits of vendor audits such as cost savings, process improvements, and risk reduction. The document describes the vendor selection process and provides a checklist for auditing vendors, which includes evaluating their premises, personnel, documentation, validation procedures, samples, stability studies, and drug recall processes. The goal of vendor audits is to inspect vendors' quality management systems and ensure they meet requirements for producing capsules and sterile medical products.
An audit of a microbiology laboratory involves independently reviewing the laboratory's records, operations, and procedures to evaluate efficiency, effectiveness, compliance, and risk mitigation. The objectives are to determine the quality systems in place, the knowledge and capabilities of audited staff, and whether continuous improvement is part of the culture. Principles of efficient auditing include proper preparation, documentation, adherence to methods and standard operating procedures, and staff proficiency demonstrations. Types of audits include those of contract manufacturers, contract laboratories, ingredient suppliers, and internal audits. A micro audit works backwards or forwards from samples to comprehensively evaluate microbiological control. The auditing process consists of planning, on-site information gathering, report preparation, exit meeting,
This document discusses amperometric titration, which is an electrochemical titration method that measures current under a constant applied voltage. It explains the principle that the current passing through an indicator electrode is measured during titration as the concentration of electroreducible ions changes. The document outlines the conditions, apparatus used including dropping mercury and rotating platinum microelectrodes, types of amperometric titrations, advantages such as ability to analyze reducible and non-reducible ions, applications including HPLC detection, and disadvantages like inaccurate results from foreign substances.
The document discusses validation of critical utility systems used in pharmaceutical manufacturing facilities. It focuses on validation of HVAC, water, and steam systems. For HVAC validation, it provides details on DQ, IQ, OQ, and PQ protocols including objectives, responsibilities, tests performed. It discusses user requirements, specifications for HVAC control and monitoring. For water system validation, it discusses purification methods, grade of water, and protocols for IQ, OQ and PQ. It also discusses two types of steam systems - house steam and clean steam - and validation considerations for each.
This document discusses plant layout for pharmaceutical manufacturing. It describes the objectives of plant layout being to integrate machinery, materials, and personnel for efficient production. The main types of layouts are process/functional and product/straight line. Key factors that influence layout include the type of process, space available, operational convenience, and health/safety considerations. Special provisions for pharmaceutical plants include preventing mixing of substances and permitting hygienic production. Storage areas for raw materials and finished goods are also discussed.
This document discusses various natural sweetening agents. It begins by explaining that sugar is the most widely used natural sweetening agent due to its quick and short-lived sweet taste. It then categorizes sweeteners as nutritive (such as sugar alcohols) or non-nutritive (such as artificial sweeteners). The document provides details on numerous natural sweeteners including their source, properties, uses, and methods of extraction. It focuses on sweeteners derived from plants such as stevia, licorice, citrus fruits, and others.
The document discusses validation regulatory requirements from various authorities like the FDA, EU, WHO, and PIC/S. It outlines the objectives, historical background, and regulations for validation from these bodies. The three main stages of process validation are described as process design, process qualification, and continued process verification. Types of validation like prospective, concurrent, and retrospective are also defined.
This document describes quality control tests performed on suppositories, including weight variation testing to ensure suppositories are uniformly sized, hardness testing to evaluate structural integrity, disintegration testing to assess dissolution rate, and drug content testing to verify active ingredient levels. Dissolution testing was also conducted using a basket apparatus to analyze drug release over time in vitro. Finally, short term stability studies were performed on promising formulations by storing samples at room temperature and refrigeration for 6 weeks and testing for drug content and dissolution profile.
Ipqc and fpqc test for pharmaceuticals semi solidsArpitSuralkar
This document discusses quality control tests for semisolid dosage forms like creams, pastes, jellies and ointments. It outlines 11 tests: appearance, spreadability, pH, rate of absorption, irritancy, rate of penetration, consistency, sensitivity, drug content, rheology/viscosity, and rate of release of the active medication. These tests evaluate various physical properties and ensure safety, stability and appropriate release of the drug.
The document discusses the importance of in-process quality control (IPQC) testing for pharmaceuticals. IPQC aims to monitor and control the manufacturing process at various stages to ensure quality products. It involves physical, chemical, biological and microbiological testing of raw materials and samples taken during production. Tests are done before, during and after manufacturing to check identity, purity, potency and meet specifications. IPQC is essential for tablets and involves tests such as hardness, friability, disintegration and dissolution to evaluate quality.
Thermogravimetric analysis is a technique that measures how the mass of a substance changes as it is heated. It involves heating a sample and measuring the weight changes that occur as temperature changes. This allows one to see how the sample's chemical or physical properties change as it is heated or cooled.
Infrared spectroscopy is a technique used to identify chemicals. It works by exposing a sample to infrared light, which causes the bonds between atoms to vibrate at characteristic frequencies. These vibrations are detected and plotted on a graph called an infrared spectrum, which acts as a molecular "fingerprint" to help identify unknown materials.
Electrogravimetry is a method used to separate and quantify ions of a substance, usually a metal, through electrolysis. The analyte solution is electrolyzed, causing the analyte to deposit on the cathode. The cathode is weighed before and after the experiment, and the mass difference is used to calculate the amount of analyte originally present. There are two types of electrogravimetry - constant current electrolysis, where the current is kept constant, and constant potential electrolysis, where the potential is kept constant. In both cases, the deposited analyte on the cathode is measured through changes in mass to determine the concentration in the original solution.
Potentiometry is a method of electroanalytical chemistry used to measure electric potential. It involves measuring the potential of electrochemical cells under zero current conditions. Potentiometric titrations determine the endpoint potentiometrically by measuring changes in potential caused by the addition of a titrant. Common applications include acid-base, redox, precipitation, and complexometric titrations. Commercial potentiometers have advantages over simple potentiometers like temperature control and internal calibration.
Intellectual property rights establish minimum standards of protection for intellectual creations of the mind such as inventions, artistic works, symbols, names and images. They usually give the creator exclusive rights over use of the creation for a certain period of time. The main purpose is to encourage creation of a variety of intellectual goods. There are two main forms - literary and artistic works protected by copyright, and industrial property like patented inventions protected by patents, trademarks, industrial designs, trade secrets and geographical indications. World Intellectual Property Organization promotes IP protection globally.
Refraction is the change in direction of a wave passing between different media. Refractometry uses refractometers to measure the refractive index of substances, which indicates their composition and purity. There are several types of refractometers including Abbe, traditional handheld, and digital handheld refractometers. Abbe refractometers provide high-precision laboratory measurement of refractive index using prisms and a telescope. Traditional handheld refractometers use prisms and a reticle viewed through a magnifying eyepiece. Digital handheld refractometers operate similarly but use an LED light source and photodiodes connected to a digital display. Refractometers are used in industries such as chemistry, food, and medicine to analyze sample composition.
Differential thermal analysis (DTA) is a thermal analysis technique that monitors the temperature difference between a sample and an inert reference material as both are subjected to a controlled temperature program. It detects endothermic or exothermic physical or chemical changes in the sample that cause temperature differences compared to the reference. A DTA instrument consists of sample and reference holders connected to thermocouples, a furnace, temperature programmer, and recording system to plot the differential temperature curve against time or temperature. DTA provides both qualitative and quantitative information about materials and is widely used in industries like pharmaceuticals, polymers, minerals, and cement.
Differential scanning calorimetry (DSC) is a technique used to analyze thermal transitions in materials. There are two main types of DSC instruments: heat-flux DSC and power-compensated DSC. Heat-flux DSC measures the difference in heat flow into the sample and reference, while power-compensated DSC maintains the sample and reference at equal temperatures while measuring the power difference required. DSC can be used to analyze properties such as glass transitions, melting points, crystallization kinetics, and heat of reactions. It has applications in fields such as materials science, polymers, and pharmaceuticals.
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
In process & finished products quality control test of capsule
1. In process & finished products
quality control test for
pharmaceuticals (Capsules)
Prepared by
Arpit rajaram suralkar
M pharmacy in quality Assuarance
First year.
2. IPQC AND FPQC TESTS FOR PHARMACEUTICAL
CAPSULES
• Physical parameters of pharmaceutical capsules that are controlled by
IPQC tests are temperature, pressure, relative humidity, particle size, color,
fill weight, shell weight, softgel ribbon thickness, softgel seal thickness,
softgel shell moisture level, softgel hardness, disintegration time etc. FPQC
test for pharmaceutical capsules are assay, fill weight, uniformity of
content, uniformity of mass, mass variation, microbiological test,
disintegration test, dissolution test, stability test etc. IPQC and FPQC test
for pharmaceutical capsules according to pharmacopoeias are listed below
3. • Appearance
Capsules produced on a small or a large scale should be uniform in appearance.
Visual or electronic inspection should be undertaken to detect any flaws in the
integrity and appearance of the capsule. Evidence of physical instability is
demonstrated by gross changes in appearance, including hardening or softening,
cracking, swelling, mottling, printing mistake or discoloration of the shell.
Defective capsules should be rejected.
• Size and Shape
Hard capsules are made in a range of sizes, the standard industrial ones in
use today for human medicines range from size from 000 (the largest, 1.40 ml)
to 5 (the smallest, 0.13 ml) are commercially available. Soft gel capsules are
available in variety of shapes such as spherical (0.05–5 ml), ovoid (0.05–7 ml),
cylindrical (0.15– 25 ml), tubes (0.5–0 ml), pear (0.3–5 ml) etc .
4. • Unique Identification Markings
Capsule surfaces may bear symbols or other unique
identification markings for better identification
• Assay
In a capsule an active ingredient is present which is called API.
So to prepare the capsule assay has to be done by using
suitable analytical method to produce good finished product.
5. • Content of Active Ingredients
• For this test a sample of the contents is assayed as
described in individual monographs and calculates the
amount of active ingredient in each capsule. According
to IP the range for the content of active ingredient
stated in the monograph is based on the requirement
that 20 capsules, or such other number as may be
indicated in the monograph, are used in the assay. In
the circumstances where 20 capsules cannot be
obtained, a smaller number, which must not be less
than 5.
• The requirements of the Table 1 apply when the stated
limits are between 90 and 110 percent. For limits other
than 90 to 110 percent, proportionately smaller or
larger allowances should be made.
6. • Content Uniformity Test
• For this test according to BP determine the content of the active ingredient in each of 10
capsules (hard or soft) taken at random using the method given in the monograph or by any
other suitable analytical method of equivalent accuracy and precision. Calculate the
acceptance value (AV) using the following formula:
• │M – X │ + KS
• Where,
• M = Reference value.
• X = Mean of individual content (x1, x2,..., xn) expressed as percentage of the label claim.
• K = Acceptability constant.
• S = Sample standard deviation.
• As per BP capsules comply with the test if not more than one of the individual values thus
obtained is outside the limits 85 to 115 percent of the average value and none is outside the
limits 75 to 125 percent. The capsules fails to comply with the test if more than 3 individual
contents are outside the limits of 85 percent to 115 percent of the average content or if one
or more individual contents are outside the limits of 75 percent to 125 per cent of the
average content. If 2 or 3 individual values are outside the limits 85 to 115 percent of the
average values, repeat the determination using another 20 capsules. The capsules comply
with the test if in the total sample of 30 capsules not more than 3 individual values are
outside the limits 85 to 115 percent and none is outside the limits 75 to 125 percent of the
average value. As stated by IP, BP, USP and PhEur limits for content uniformity (CU) and mass
variation (MV) tests of capsules. According to IP this test is not applicable for capsules
containing multivitamins and trace elements
7. • Uniformity of Mass
• For this test weigh an intact capsule. Open the capsule without losing any
part of the shell and remove the contents as completely as possible. To
remove the contents of a soft capsule the shell may be washed with ether
or other suitable solvent and the shell allowed to stand until the odor of
the solvent is no longer perceptible. Weigh the shell. The weight of the
contents is the difference between the weighing. Repeat the procedure
with a further 19 capsules. Determine the average mass. According to IP,
BP, PhEur and PhInt capsules not more than 2 of the individual masses
deviate from the average mass by more than the percentage deviation
shown in the Table 3 and Table 4 respectively and none deviates by more
than twice that percentage
8. • Mass Variation Test
• For hard capsules according to BP accurately weigh 10 capsules individually, taking care to preserve
the identity of each capsule. Remove the contents of each capsule by suitable means. Accurately
weigh the emptied shells individually, and calculate for each capsule the net mass of its contents by
subtracting the mass of the shell from the respective gross mass. Calculate the active substance
content in each capsule from the mass of product removed from the individual capsules and the
result of the assay. Calculate the AV using the following formula:
• Xi = Wi × A/W
• Where,
• x1, x2,..., xn = Individual estimated contents of the dosage units tested.
• w1, w2,..., wn = Individual masses of the dosage units tested.
• A = Content of active substance (percentage of label claim) obtained using an appropriate analytical
method (assay).
• W = Mean of individual weights (w1, w2,..., wn)
• For soft capsules consistent with BP accurately weigh 10 intact capsules individually to obtain their
gross masses, taking care to preserve the identity of each capsule. Then cut open the capsules by
means of a suitable clean, dry cutting instrument such as scissors or a sharp open blade, and
remove the contents by washing with a suitable solvent. Allow the occluded solvent to evaporate
from the shells at room temperature over a period of about 30 min, taking precautions to avoid
uptake or loss of moisture. Weigh the individual shells, and calculate the net contents. Calculate the
active substance content in each capsule from the mass of product removed from the individual
capsules and the result of the assay. Calculate the AV using the following formula given above.
• According to BP and USP, the requirement is met if the acceptance value of 10 capsules is less than
or equal to 15 percent. If acceptance value is greater than 15 percent, test the next 20 capsule and
calculate the acceptance value. The requirements are met if the final acceptance value of the 30
capsule is less than or equal to 15 percent and no individual content of the capsule is less than (1 –
25 × 0.01) M or more than (1 + 25 × 0.01)M in calculation of acceptance value under mass variation
or content uniformity.
9. • Disintegration Test
• The USP disintegration apparatus consist of 6 glass tubes that are 3 inches long, open at the
top, and held against a 10-mesh screen at the bottom end of the basket rack assembly. To
test for disintegration time, one capsule is placed in each tube and the basket rack is
positioned in specified medium at 37±2ºC such that capsule remains 2.5 cm below the
surface of the liquid on their upward movement and descend not closer than 2.5 cm from the
bottom of the beaker. A standard motor driven device is used to move the basket assembly
containing the capsules up and down through distance of 5 to 6 cm at a frequency of 28 to 32
cycles per minute. Perforated plastic discs may also be used in the test. These are placed on
the top of capsules and impart an abrasive action to the capsules. The discs may or may not
be meaningful or impart more sensitivity to the test, but they are useful for capsules that
float. Operate the apparatus for the specified time. The capsule complies with the test, if the
capsules
10. • Dissolution Test
• The BP or USP dissolution apparatus (Basket apparatus) consist of a
cylindrical vessel with a hemispherical bottom, which may be covered,
made of glass or other inert, transparent material; a motor; a metallic
drive shaft; and a cylindrical basket. The vessel is partially immersed in a
suitable water bath of any convenient size or heated by a suitable device
such as a heating jacket. The water bath or heating device permits holding
the temperature inside the vessel at 37±0.5°C during the test and keeping
the bath fluid in constant, smooth motion. For this test as per BP and
PhEur place the stated volume of the dissolution medium (±1%) in the
vessel of the specified apparatus. Assemble the apparatus, equilibrate the
dissolution medium to 37±0.5°C. Place 1 capsules in the apparatus, taking
care to exclude air bubbles from the surface of the capsules. Operate the
apparatus at the specified rate. Within the time interval specified, or at
each of the times stated, withdraw a specimen from a zone midway
between the surface of the dissolution medium and the top of the
rotating basket or blade, not less than 1 cm from the vessel wall. Where
multiple sampling times are specified, replace the aliquots withdrawn for
analysis with equal volumes of fresh dissolution medium at 37°C or, where
it can be shown that replacement of the medium is not necessary, correct
for the volume change in the calculation. Keep the vessel covered for the
duration of the test and verify the temperature of the medium at suitable
times
11. Perform the analysis using a suitable assay method as directed in the individual
monograph. Repeat the test with additional capsules. According to BP, USP, PhEur,
PhInt and JP unless otherwise specified in the individual monograph, the requirements
are met if the quantities of active ingredient dissolved from the capsules tested
conform to the following acceptance criteria. Continue testing through the 3 stages
unless the results conform at either S1 or S2. The quantity Q, is the specified amount
of dissolved active substance, expressed as a percentage of the labeled content; the 5
percent, 15 percent, and 25 percent values in the capsule are percentages of the
labeled content so that these values and Q are in the same terms.
12. • Moisture Permeation Test
The USP requires determination of the moisture permeation
characteristics of single-unit and unitdose containers to ensure their
suitability for packaging capsules. The degree and rate of moisture
penetration are determined by packaging the dosage unit together with a
colorrevealing desiccant pellet, exposing the packaged unit to known
relative humidity over a specified time, observing the desiccant pellet for
color change. Any change in color indicates absorption of moisture. By
measuring pretest weight and protest weight of pellet, amount can be
calculated .
13. • Stability Test
The capsule manufacturers routinely conduct accelerated physical
stability tests on all new capsule products as an integral part of the
product development program. The following tests have proved
adequate for determining the effect of the capsule shell content on
the gelatin shell. The tests are strictly relevant to the integrity of the
gelatin shell and should not be confused as stability tests for the
active ingredients in the capsule content. The results of such tests
are used as a guide for the reformulation of the capsule content or
the capsule shell, or for the selection of the proper retail package.
The test conditions for such accelerated stability tests are shown in
above, Table 8. The capsules at these stations are observed
periodically for 2 weeks. Both gross and subtle effects of the
storage conditions on the capsule shell are noted and recorded. The
control capsule should not be affected except at the 80 percent RH
(relative humidity) station, where the capsule would react as
described under the effects of high humidity.
14. • CONCLUSION
• To ensure the quality of pharmaceuticals regulatory
bodies are continually developing their requirements
toward pharmaceutical companies. In pharmaceutical
industry the maximum quality of pharmaceuticals,
depends on the tests performed during manufacturing
and after manufacturing of the pharmaceuticals as per
specifications of the respective pharmacopoeias and
the regulatory requirements of the particular
countries. From the present study it is clearly revealed
though various pharmacopoeias suggest different
types of IPQC and FPQC tests for pharmaceutical
capsules with different specifications and standards but
the main function of the all pharmacopoeias is to
assure the maximum quality of pharmaceuticals for
human health