Stability is defined as the capacity of drug to remain within established specification limits to maintain its identity, strength, quality and purity throughout the retest or expiration dating period.
It is the ability of formulations to retain its physical, chemical, microbiological and toxicological parameters same that time of manufacturer.
Regulatory requirement for setting herbal drug industryRAGHAV DOGRA
The World Health Organization (WHO) estimates that 80 percent of the population of some Asian and African countries presently use herbal medicine for some aspect of primary health care.Pharmaceuticals are prohibitively expensive for most of the world's population, half of whom lived on less than $2 U.S. per day in 2002. In comparison, herbal medicines can be grown from seed or gathered from nature for little or no cost
patent (/ˈpætənt/ or /ˈpeɪtənt/) is a set of exclusive rights granted by a sovereign state to an inventor or assignee for a limited period of time in exchange for detailed public disclosure of an invention. An invention is a solution to a specific technological problem and is a product or a process. Patents are a form of intellectual property.
What is Efficacy
Why Efficacy is required for Herbal products
How Efficacy of Herbal products ensured
What are the various avenues of determining efficacy
Regulatory requirement for setting herbal drug industryRAGHAV DOGRA
The World Health Organization (WHO) estimates that 80 percent of the population of some Asian and African countries presently use herbal medicine for some aspect of primary health care.Pharmaceuticals are prohibitively expensive for most of the world's population, half of whom lived on less than $2 U.S. per day in 2002. In comparison, herbal medicines can be grown from seed or gathered from nature for little or no cost
patent (/ˈpætənt/ or /ˈpeɪtənt/) is a set of exclusive rights granted by a sovereign state to an inventor or assignee for a limited period of time in exchange for detailed public disclosure of an invention. An invention is a solution to a specific technological problem and is a product or a process. Patents are a form of intellectual property.
What is Efficacy
Why Efficacy is required for Herbal products
How Efficacy of Herbal products ensured
What are the various avenues of determining efficacy
In this slide contains Introductionnof Indian pharmacopeia, ayurvedic, unani pharmacopeia and monographs of herbal drugs.
Presented by: P.SUDHEER KUMAR (Department of pharmaceutical analysis ).RIPER, anantapur
Adulteration is the debasement of Genuine materials3.
It may be deliberated or accidentally done.
In crude drugs, this practice includes the substitution of the original crude drug, fully or partially with sub-stranded substances.
Sub-stranded substances include- Inferiority and spoilage.
Inferiority- Natural sub-stranded condition whose natural constituent is below the minimum standard.
Spoilage- sub-stranded condition produced by microbial or pest infestation.
Herbal remedies are plants used as medicine.
People use herbal remedies to help prevent or cure disease.
They use them to get relief from symptoms, boost energy, relax, or lose weight.
Herbal remedies are a type of dietary supplement. They are not medicines.
Herbals are not regulated like medicines.
Herbals do not need to be rigidly tested before they are sold.
Herbals may not work as claimed.
Labels do not need to be approved.
It may not list the correct amount of an ingredient.
Herbal drugs are usually considered safe but when taken along with other drugs of chemical origin (allopathic drugs), they do interact with them and cause Bio-drug interaction
In this slide contains Monographs of herbal drugs: Siddha and Unani pharmacopeia
Presented by: P. VENKATESH (Department of pharmaceutical analysis).RIPER, anantapur
INDIAN AND INTERNATIONAL PATENT LAW AS APPLICABLE TO HERBAL AND NATURAL PRODUCTSTejaswini Chandra
ITS A USEFUL TOPIS FOR LAW STUDNETS REGARDING THE HERBAL DRUGS AND NATURAL PRODUCTS .
ALSO USEFUL FOR THE MPHARM STUDENTS OF ALL DOMAIN TO STUDY REGARDING THE PATENT LAW
HOPE YOU ALL MAKE USE OF IT TO FULLEST AND SUCCEED.
Unit 2. Regulatory requirements for setting herbal drug industry:
Content: Global marketing management.
Indian and International patent law as applicable herbal drugs and natural products.
Export - Import (EXIM) policy, TRIPS.
Quality assurance in herbal/natural drug products.
Concepts of TQM, GMP, GLP, ISO-9000.
Stability testing protocol for herbal products in a detailed review.It’s the ability of formulation to retain its physical, chemical, microbiological and toxicological parameter same as that time of manufacture .
Drug product remains within specifications established to ensure its identity, strength, quality and purity.
Stability – Chemical and Physical integrity of herbal medicinal products.
Over a given time period and under the influence of environmental factors including temperature, humidity and light.
To provide evidence on how the quality of active substance varies with time and environmental factors
To establish re- test period for active substance
To establish shelf life of finished products.
To recommend storage conditions.
To evaluate the efficacy of drug.
To develop suitable packing information for drug product
To submit stability information for regulatory agencies.
1.Physical stability study:-
The original physical properties namely appearance, uniformity, palatability, dissolution, and suspend ability are maintained.
Chemical stability study:-
Each and every active ingredient retains its chemical integrity as well as potency specified on label, within the specified limits.
It involves drug assay and determination of drug degradation.
In this slide contains Introductionnof Indian pharmacopeia, ayurvedic, unani pharmacopeia and monographs of herbal drugs.
Presented by: P.SUDHEER KUMAR (Department of pharmaceutical analysis ).RIPER, anantapur
Adulteration is the debasement of Genuine materials3.
It may be deliberated or accidentally done.
In crude drugs, this practice includes the substitution of the original crude drug, fully or partially with sub-stranded substances.
Sub-stranded substances include- Inferiority and spoilage.
Inferiority- Natural sub-stranded condition whose natural constituent is below the minimum standard.
Spoilage- sub-stranded condition produced by microbial or pest infestation.
Herbal remedies are plants used as medicine.
People use herbal remedies to help prevent or cure disease.
They use them to get relief from symptoms, boost energy, relax, or lose weight.
Herbal remedies are a type of dietary supplement. They are not medicines.
Herbals are not regulated like medicines.
Herbals do not need to be rigidly tested before they are sold.
Herbals may not work as claimed.
Labels do not need to be approved.
It may not list the correct amount of an ingredient.
Herbal drugs are usually considered safe but when taken along with other drugs of chemical origin (allopathic drugs), they do interact with them and cause Bio-drug interaction
In this slide contains Monographs of herbal drugs: Siddha and Unani pharmacopeia
Presented by: P. VENKATESH (Department of pharmaceutical analysis).RIPER, anantapur
INDIAN AND INTERNATIONAL PATENT LAW AS APPLICABLE TO HERBAL AND NATURAL PRODUCTSTejaswini Chandra
ITS A USEFUL TOPIS FOR LAW STUDNETS REGARDING THE HERBAL DRUGS AND NATURAL PRODUCTS .
ALSO USEFUL FOR THE MPHARM STUDENTS OF ALL DOMAIN TO STUDY REGARDING THE PATENT LAW
HOPE YOU ALL MAKE USE OF IT TO FULLEST AND SUCCEED.
Unit 2. Regulatory requirements for setting herbal drug industry:
Content: Global marketing management.
Indian and International patent law as applicable herbal drugs and natural products.
Export - Import (EXIM) policy, TRIPS.
Quality assurance in herbal/natural drug products.
Concepts of TQM, GMP, GLP, ISO-9000.
Stability testing protocol for herbal products in a detailed review.It’s the ability of formulation to retain its physical, chemical, microbiological and toxicological parameter same as that time of manufacture .
Drug product remains within specifications established to ensure its identity, strength, quality and purity.
Stability – Chemical and Physical integrity of herbal medicinal products.
Over a given time period and under the influence of environmental factors including temperature, humidity and light.
To provide evidence on how the quality of active substance varies with time and environmental factors
To establish re- test period for active substance
To establish shelf life of finished products.
To recommend storage conditions.
To evaluate the efficacy of drug.
To develop suitable packing information for drug product
To submit stability information for regulatory agencies.
1.Physical stability study:-
The original physical properties namely appearance, uniformity, palatability, dissolution, and suspend ability are maintained.
Chemical stability study:-
Each and every active ingredient retains its chemical integrity as well as potency specified on label, within the specified limits.
It involves drug assay and determination of drug degradation.
Stability Testing.pptx ,M.PHARM,1ST year ,1st semesterManshiRana2
Stability testing of dosage forms is an important aspect of pharmaceutical development and manufacturing. It involves evaluating the physical, chemical, and microbiological attributes of a dosage form over a specific period of time under various storage conditions.
The purpose of stability testing is to ensure the efficacy, quality and safety of the drug throughout its shelf life.
.
SCOPE OF STABILITY TESTING Provide evidence as to how the quality of drug product varies with time.
Determine recommended storage conditions.
Establish shelf life for the drug product.
Establish quality of a drug product or substance .
Determine container and closure system suitability .
That presentation is about the stability of the drug, why it's necessary?? What is the shelf life of a drug? Purpose of stability testing and its importance.Also a review article of Sanjay Bajaj et al published in Journal of applied pharmaceutical sciences.
stability testing of phytopharmaceuticals.pdfKGNithyaLakshmi
Stability testing is necessary to ensure the product is of acceptablequality throughout its entire storage period.
An important part of quality control of herbal products is theevaluation of the chemical stability of a finished product during thestorage period.
Stability testing of herbal products is a challenging task because theentire herb or herbal product is regarded as the active substance,regardless of whether constituents with defined therapeutic activityare known.With the help of modern analytical techniques like HPLC,HPTLC and by employing proper guidelines it is possible toestablish sound stability data for herbal products and predicttheir shelf life which will help in global acceptabilityof herbalproducts.
INTRODUCTION
FACTORS EFFECTING STABILITY
OBJECTIVE
TYPES OF STABILITY
TYPES OF STABILITY THAT MUST BE CONSIDERED FOR ANY DRUG
REGULATORY REQUIREMENTS
STABILITY STUDIES FOR PHARMACEUTICAL PRODUCTS
DEGRADATIVE PATHWAYS
Stability studies are performed in life sciences, chemical, and food and beverage industries to determine the effects of environmental conditions on product quality. Environmental conditions can impact product shelf life, and the viability of product formulation.
DEFINATION
The capacity of a drug or product to remain within established specifications of identity, quality, purity in a specific period of time.
The capacity or the capability of a particular formulation in a specific container to remain with in particular chemical, microbiological, therapeutically, and toxicological specifications.
USP defines stability of pharmaceutical product as, "extent to which a product retains with in specified limits and throughout its period of storage and use (i.e. shelf life).
The capacity or the capability of a particular formulation in a specific container to remain with in particular chemical, microbiological, therapeutically, and toxicological specifications.
USP defines stability of pharmaceutical product as, "extent to which a product retains with in specified limits and throughout its period of storage and use (i.e. shelf life).
The primary factors effecting stability:
PH, Temperature, Moisture, humidity, light, Storage closure and containers Oxygen.
The major factors effecting drug stability are:
Particle size (suspension and emulsion), PH, additives and molecular binding and diffusion of drugs and excipients.
The ability of a pharmaceutical product to retain its chemical, physical, microbiological and biopharmaceutical properties within specified limits throughout its shelf-life.
The stability testing of herbal products check the quality of herbal products which varies with the time under the influence of environmental factors, such as temperature, humidity, light, oxygen, moisture, other ingredient or excipient in the dosage form.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
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MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
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Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
1. MPG 104 T. INDUSTRIAL PHARMACOGNOSTICAL
TECHNOLOGY
M.pharm 1st
semester
UNIT-4 TESTING OF NATURAL PRODUCTS:
STABILITY TESTING OF NATURAL PRODUCTS
INTRODUCTION:
Stability is defined as the capacity of drug to remain within established
specification limits to maintain its identity, strength, quality and purity
throughoutthe retest or expiration dating period.
Itis the ability of formulations to retain its physical, chemical, microbiological and
toxicological parameters samethat time of manufacturer.
PURPOSE OF STABILITY TESTING :
The purposeof stability testing is to provideevidence on how the quality of drug
substancevaries with time under various environmentalchanges.
The four climatic zones-
The design of the stability testing programmeshould take into account the
climatic condition in the area in which the drug products will be used.
I. Zone I – temperate
II. Zone II –Sub tropical with high possibility of humidity
III. Zone III –hot/dry
IV. Zone IV – hot /humid
Advantages:
Help in determination of shelf life and storageconditions.
2. Help in selection of suitable formulation, excipients and container closure
systems for a product.
Well being of the patient and manufacture by ensuring the good product
quality.
Enhance patient confidence in herbal drugs and improvecompliance.
Objectives:
To provideevidence on how the quality of active substancevaries with time
and environmentfactors.
To establish re-test period for active substance.
To establish shelf life of finished products.
To evaluate the efficacy of drug.
To develop suitable packing information for drug product.
To submit stability information for regulatory agencies.
Factors affecting stability testing:
There are various factors that affects the stability testing of natural products.
Temperature- chemical changes increase with increasein temperature.
Light – many chemical changes due to exposureto light .
Eg. Auto oxidation of volatile oils.
Moisturecontent- absorption of moistureon solid surfaceincreases
decomposition.
Oxidation – additional of oxygen, radical formation and degradation of
compound.
Hydrolysis- reduction with water leads to degradation of compound.
Geometric isomerism- trans and cis form, one formmay be more
therapeutically active.
Drug interaction- reaction of two or more drugs or between a drug.
3. Role of markers:
Markers arechemically known compound, which may or may not have
therapeutic effect, used to calculate the quality of herbal medicinal ingredients in
herbal medicinal products (HMPs).
Typical sources for finding markers are –
1. Monograph and drafts
2. Experience, transfer fromplants/ constituents
3. Literature research
4. Scientific research
Analytical method:
A systemic approach should be adopted to the presentation and evaluation
of stability information, which should include, as necessary, physical,
chemical, biological and microbiology test characteristics.
All productcharacteristics likely to be affected by storage.
E.g. assay valueor potency, content of products of decomposition,
physicochemicalproperties should be determined. For solid or semi-solid
oral dosageforms, dissolution tests should be carried out.
The analysis of preparation is mostly done by chromatography technique
like hplc, GC, TLC and spectroscopic technique like uv-visiblespectroscopy
or by the combination of chromatographic and spectroscopic technique
such as LC-MS, GC-MS
Analytical methods should be validated or verified, and accuracy as well as
the precision should be recorded.
Types of stability study:
Different types of stability study according to the condition to be maintained
throughoutthe shelf life of drug.
1. Physicalstability study.
2. Chemical stability study.
4. 3. Microbiological stability study.
4. Therapeutic stability study.
5. Toxicology stability study.
1.Physical stability study-
The original physicalproperties, namely, appearance, uniformity,
dissolution and suspendability are maintained.
2.Chemical stability-
Each and every active ingredient retains its chemical integrity as well as
potency specified on label, within the specified limits. Itinvolves drug assay
and determination of drug degradation.
Material used for stability studies-
I. Active pharmaceutical ingredient ( API)
II. Finished pharmaceutical products.
Stages in stability testing-
I. Pre formulation.
II. Final product.
III. Postmarketing.
3.Microbiology stability study-
Sterility or resistanceto microbial growth is maintained as per the specified
requirements.
4.Therapeutic stability study-
The therapeutic effect remains unaltered.
5.Toxicology stability study-
No valid increase in toxicity should occurs.
5. STABILITY TESTING:
Itis recommended that in case of a herbal medicinal productcontaining a
natural product or a herbal drug preparation with constituents of known
therapeutic.
Shelf life- The period of time during which a product, if stored correctly, is
expected to comply with the specification as determined by the stability studies
on a no. Of batches of the product. The shelf life is used to establish the expiry
date of each batch.
The determination of shelf life of herbal medicinal drug is sameas chemically
defined APIs, butspecial nature of herbal productshould be taken into
consideration.
Expiry date- The date after which something is no longer in effect. Itis
established for each batch by adding the shelf-life period to the date of
manufacture.
Methods of stability testing:
1. Stress testing.
2. Accelerated stability testing.
3. Intermediate testing.
4. Forced degradation testing.
5. Long term stability testing products or real time testing.
6. Stress testing-
Stress testing help to identify the degradation product, which can help to
establish the degradation pathway. Stress tests areusually considered
unnecessary for herbaldrug and its preparation.
Nature of stress testing depends on the individual drug substanceand the
type of drug productinvolved.
Generally conducted on a single batch of the drug substance.
The testing should also evaluate the susceptibility of the drug to hydrolysis
across a wide range of pH values when in solution or suspension.
Performphytochemicalanalysis for constituents in given sample of herbal
medicinal products (HMPs) by HPLC, HPTLC.
Acceleratedstability testing-
The substanceor medicinal product is challenged by a controlled
exaggerated stress (storageconditions) over a shorttime , so that the rate
of degradation reaction is enhanced.
In shortperiod of time, stability data can be obtained (3-6 months)
Samples are stored at 40°C ± 2°±; 75% ± 5 % relative humidity (RH) for a
period of 6 months.
Procedure-
1) Note down description, identification, pH, viscosity, assay,heavy metals
and microbial purity.
2) Aboveparameter should match those specified in monographs or label.
3) Transfer HMPs
Pet bottle with Al-cap, containing rubber cork.
Glass bottle with Al-cap, containing rubber cork.
4) 1st
set- 25°C ± 2°C/ 60% RH ± 5% ----- under controlled condition.
5) 2nd
set- 40°C ± 2°C / 75% RH±5% -----accelerated condition.
6) Carry out sampling at various intervals (0,1,2,3,4,5……months)
7. 7) Performphytochemicalanalysis for constituents in given sample of HMPs
by HPLC, HPTLC.
Intermediate testing-
Conducted when accelerated studies fail. At 25°Cfor longer duration of
time.
Forced degradationtesting-
Performed to provideintrinsic stability assessmentof drug.
Long termstability testing or real time testing-
Evaluation of the physical, chemical and microbiological characteristics of a
drug productover the expected duration of shelf-life under recommended
storageconditions and in the proposed container/closuresystem. The
results are used to establish the shelf-life, to confirmthe projected shelf
life, and to recommend storageconditions.
Derived storage condition for Real time testing is below.
Climatic
zone
Storagetemperature (◦C) Relative humidity(%RH)
I 21 45
II 25 50
III 30 35
IV 30 70
Challenges in stability testing of herbal medicinal products (HMPs):
Stability testing of herbal products is a challenge because-
The whole herbal productis regarded as the active matter, regardless of
active constituents with defined therapeutic activity.
HMPs are complex in nature due to their high no. of constituents.
Constituents sometimes have very low concentrations in the finished
product.
8. Different requirements for the different types of extracts.
Steps to overcome challenges:
i. Use of markers for HMPs.
Marker concentration should be within ±5%
When marker concentration is less in finished product then variation of
±10%
ii. Use of fingerprintchromatograms.
iii. Use of GC-MS, HPLC, HPTLC and spectroscopic technique.
Stability testing storage conditions for drugs as per ICH & WHO:
Storage of stability samples:-
Intended
storage
conditions
Stability test
method
Temperature and
humidity as per ICH
Temperature and humidity
as per WHO
Room
temperature
Long term 25±2°C/60±5%RH 25-30±2°C/60-75±5%RH
Intermediate 30±2°C/65±5%RH 30±2°C/65±5%RH
Accelerated 40±2°C/75±5%RH 40±2°C/75±5%RH
Refrigerator Long term 5°C ambient 5±3°C
Accelerated 25±2°C/605%RH 25±2°C/60±5%RH or
30±2°C/65±5%RH
Freezer Long term -20°C/ambient (12) -20°C±5°C
9. Test schedule for stability of new products
Methodand climatic
zone
Environmental Frequency of testing
Long term for climatic
zones I and IV
25°C/60%RH 3,6,9,12,18,24,36months
Long term for climatic
zones III
30°C/35%RH 3,6,9,12,18,24,36months
Long term for climatic
zones Iva/intermediate
for zones I and II
30°C/65%RH 3,6,9,12,18,24,36months
Long term for climatic
zone IVb/intermediate
for zones I and II
30°C/75%RH 3,6,9,12,18,24,36months
Accelerated condition
for all zones
40°C/75%RH 3,6 months
F
PROTOCOL FOR STABILITY TESTING :
Protocolis a document describing the basic components of a well-controlled
stability study.
A well-controlled stability protocol should contain the following information:-
Selection of batches and samples
Test selection
Analytical procedures
Acceptance criteria
Storageconditions
storageperiod
Testing frequency
Sampling plan
10. Container closuresystem
Evaluation
Statement labelling
1. Selectionof batches and samples
In general , this selection should constitute a random sample from
pilot or production batches that may involve a single batch or 2-3
batche.
2. Test selection
The test that monitor the quality , potency , purity ,and identity that are
expected to vary upon storage are chosen as stability tests.
3. Analytical procedures
Procedures given in the official compendia should be followed and if alternate
methods are to be used they need to be duly validated.
4. Acceptance criteria
This should be fixed beforehand in formof statistical limits for the results
manifested in computable terms and pass or fail for qualitative tests.
5. Storage conditions
After the stability of the producthas been evaluated, following conditions are
recommended for storage.
Store under normal storageconditions.
Store between 2 and 8 ◦C ( under refrigeration, no freezing.)
Store below 8 ◦C ( under refrigeration)
Store between -5 and -20 ◦C ( in a freezer)
Store below -18 ◦C( in a deep freezer)
These are based upon the marketing climatic zone of the drug.
Storagecondition such that thermal stability as well sensitivity to moisturecan
be tested.
6. Storage period
11. Itgenerally extend fromminimum of 3-6 months in accelerated and
stress testing and upto 12,18 or 60 months in ongoing ot follow-up
stability testing.
7. Testing frequency
Itshould be sufficientto establish the stability profile of the drug test
schedules for different types of stability testing.
8. Sampling plan
Itinvolves devising for the no. of samples to be placed in the stability
chambers and taking out of the charged batch so as to cover the
entire study.
9. Container closure system
The testing in actual containers as well as closures scheduled for
marketing, are to be tested separately with proper orientation of
storageof containers.
10.Evaluation
The data on attribute is analysed to determine the time duration at
which 95% one-sideconfides limit for the mean curveintersects the
acceptance criterion.
11.Statement labelling
A storagestatement , retest period, and re test date based on the
stability evaluation of the drug substanceshould be established for
the labelling