Organic solvents are widely used in the pharmaceutical industry for synthesizing active pharmaceutical ingredients, in formulations, and for cleaning equipment. Residual solvents may remain in final drug products and different analytical techniques like gas chromatography are used to test levels. Solvents are classified into four classes based on toxicity, with class 1 being human carcinogens and class 4 having insufficient toxicity data. Regulatory limits are set for each class to ensure solvent levels do not exceed acceptable toxicological thresholds.
This is a ppt on Medicinal chemistry, just made to help out and give the students of CLASS XI studying in CBSE about what Medicinal Chemistry is >>Please do feedback in the comments part
Bio pharmaceutical classification System [BCS]Sagar Savale
The Biopharmaceutical Classification System was first developed by in 1995, by Amidon et al & his colleagues.
Definition:
“The Biopharmaceutical Classification System is a scientific framework for classifying a drug substance based on its aqueous solubility & intestinal permeability & dissolution rate”.
To saved time fast screening is required so drug substances are classified on basis of solubility and permeability. This classification is called Biopharmaceutical Classification System
This is a ppt on Medicinal chemistry, just made to help out and give the students of CLASS XI studying in CBSE about what Medicinal Chemistry is >>Please do feedback in the comments part
Bio pharmaceutical classification System [BCS]Sagar Savale
The Biopharmaceutical Classification System was first developed by in 1995, by Amidon et al & his colleagues.
Definition:
“The Biopharmaceutical Classification System is a scientific framework for classifying a drug substance based on its aqueous solubility & intestinal permeability & dissolution rate”.
To saved time fast screening is required so drug substances are classified on basis of solubility and permeability. This classification is called Biopharmaceutical Classification System
Most important questions of Pharmacognosy 2Payaamvohra1
This video gives an idea about frequently and most asked questions of B pharmacy Sem 5 Pharmacognosy
#Industrial Pharmacy# SEm5 #PCI syllabus #Third year B pharmacy
Cold cream , vanishing cream , IDEAL PROPERTIES OF VANISHING CREAMS , MAJOR INGREDIENTS USED FOR THE PRODUCTION OF VANISHING CREAMS , FORMULATION OF VANISHING CREAM , IDEAL CHARACTERISTICS OF COLD CREAM , INGREDIENTS USED FOR PREPARATION OF COLD CREAM , FORMULATION OF COLD CREAM
Solvent plays a crucial role in the reaction. So we should smartly work with solvent. This presentation tries to summarizes the role as well as the effects of the solvent on the different reactions.
Most important questions of Pharmacognosy 2Payaamvohra1
This video gives an idea about frequently and most asked questions of B pharmacy Sem 5 Pharmacognosy
#Industrial Pharmacy# SEm5 #PCI syllabus #Third year B pharmacy
Cold cream , vanishing cream , IDEAL PROPERTIES OF VANISHING CREAMS , MAJOR INGREDIENTS USED FOR THE PRODUCTION OF VANISHING CREAMS , FORMULATION OF VANISHING CREAM , IDEAL CHARACTERISTICS OF COLD CREAM , INGREDIENTS USED FOR PREPARATION OF COLD CREAM , FORMULATION OF COLD CREAM
Solvent plays a crucial role in the reaction. So we should smartly work with solvent. This presentation tries to summarizes the role as well as the effects of the solvent on the different reactions.
Residual solvents
USP <467>
ICH Q3C
Classification of Residual Solvents by Risk Assessment
Options for Determining Levels of Class 2 Residual Solvents
Methods For Establishing Exposure Limits
Analytical Procedures
Residual Solvents, Their Limits and PDE A Reviewijtsrd
The objective of this Review Paper is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The Review Paper recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents. Residual solvents in pharmaceuticals are defined here as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. The solvents are not completely removed by practical manufacturing techniques. Nitin Thorat | Prof. Santosh Waghmare | Dr. Hemant Kamble "Residual Solvents, Their Limits and PDE: A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-5 , August 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50465.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/50465/residual-solvents-their-limits-and-pde-a-review/nitin-thorat
To recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.
The guideline applies to all dosage forms and routes of administration.
This guidelines does not address all possible solvents, only those identified in drugs at that time, neither address solvents intentionally used as excipients nor solvates.
The maximum acceptable intake per day of residual solvent in pharmaceutical products is defined as “permitted daily exposure” (PDE)
Previously, another terms were used like “Tolerable daily intake” (TDI) & “Acceptable daily intake” (ADI) by different organization & authorities, but now usually this new term “PDE” is used
Setting Specification Limits for Impurities in Active Pharmaceutical Ingredient (API’s).
Setting Specification Limits for Impurities in Active Pharmaceutical Ingredient (API’s)
Setting Specification Limits for Impurities in Active Pharmaceutical Ingredient (API’s)
ETORICOXIB AND PREGABALIN OF METHOD DEVLOPMENT IN RPHPLC BY UPEXA BAVADIYAUpexaBavadiya
Development and Validation for Simultaneous Estimation of Etoricoxib and Pregabalin in Bulk and Tablet Dosage Form by RP-HPLC 2K21 GTU MASTER IN PHARMACY BY UPEXA BAVADIYA
A REVIEW ON ETORICOXIB AND PREGABALIN IN METHOD VALIDATION BY RP-HPLCUpexaBavadiya
Development and Validation for Simultaneous Estimation of Etoricoxib and Pregabalin in Bulk and Tablet Dosage Form by RP-HPLC 2K20,GTU,MASTER IN PHARMACY IN QA
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay.
The impurities in pharmaceuticals are unwanted chemicals that remain with the active pharmaceutical ingredients
(APIs) or develop during formulation or upon aging of both API and formulation.
THE PRESENTATIONS DESCRIBES THE ICH GUIDELINE FOR RESIDUAL SOLVENTS i.e Q3C.
IT contains the basic of ICH and the complete description about the ICH guideline Q3C and its classification,limits,acceptance criteria in Pharma industries and the standards.
#Pharmaceuticalguideline
#medicine
#healthandmedicine
DEVELOPMENT AND VALIDATION OF SPECTROSCOPIC AND CHROMATOGRAPHIC METHOD FOR D...Dipak Reddy
A simple, precise & accurate UV spectroscopy & HPLC method was developed & validated as per ICH guideline.
In UV spectroscopy 0.1HCL used as diluent & in HPLC Methanol :ortho phosphoric acid (40:60%v/v) used.
Thus based on validation data it is concluded that present method is economical, less time consuming, precise , accurate for estimation of Pioglitazone in bulk drug & formulations.
This method can be used to determine the purity of the drug available from various sources by detecting the related impurities.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
Safalta Digital marketing institute in Noida, provide complete applications that encompass a huge range of virtual advertising and marketing additives, which includes search engine optimization, virtual communication advertising, pay-per-click on marketing, content material advertising, internet analytics, and greater. These university courses are designed for students who possess a comprehensive understanding of virtual marketing strategies and attributes.Safalta Digital Marketing Institute in Noida is a first choice for young individuals or students who are looking to start their careers in the field of digital advertising. The institute gives specialized courses designed and certification.
for beginners, providing thorough training in areas such as SEO, digital communication marketing, and PPC training in Noida. After finishing the program, students receive the certifications recognised by top different universitie, setting a strong foundation for a successful career in digital marketing.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
2. • Organic solvents are very widely used in
the pharmaceutical industry.
Used in the
1) synthesis of active pharmaceutical
ingredient.
2)In formulation
3)Cleaning the equipment..
O.Priyanka, M.Pharmacy,GPRCP,
7/28/2012 Department of Pharmaceutics 2
3. • Steps involved in chemical synthesis of
API
• 1)Reaction
• 2)Separation or extraction
• 3)Purification
• 4)Drying
• Organic solvents are used widely in
synthesis API
O.Priyanka, M.Pharmacy,GPRCP,
7/28/2012 Department of Pharmaceutics 3
4. • Used in formulation of either
1)liquid pharmaceuticals or
2)solid dosage forms
New solvents-SUPER CRITICAL FLUIDS or
IONIC LIQUIDS are developed.
And usually some small amount of solvents
may remain in the final product.They are
called as residual solvents(RS) or organic
volatile impurities.
7/28/2012 O.Priyanka, M.Pharmacy,GPRCP, 4
Department of Pharmaceutics
5. • As residual solvents are not desirable
substances in a final product, different
methods for their removal may be used,
provided they fulfill safety criteria.
• After the drying process, analysis should
be done to check that amount of solvents
used at any step of the production do not
exceed acceptable limits. (taken from ICH
Guideline or from pharmacopoeias).
7/28/2012 O.Priyanka, M.Pharmacy,GPRCP, 5
Department of Pharmaceutics
6. METHODOLOGIES FOR ANALYSIS OF RS
Gas chromatography (GC) is a very useful
technique for analysis of residual solvents.
• HS-GC, GC-MS, HS-GC-MS,SPME-GC,
SDME-GC are excellent tools to determine
OVI.
• When only class 3 impurities are present
loss of weight method is
used.TGA,DTA,DSC may also be used
Various other techniques like
• IR and NMR have been applied to
7/28/2012 O.Priyanka, M.Pharmacy,GPRCP, 6
Department of Pharmaceutics
determine RS.
7. • Special directions published in
pharmacopeias and ICH guidelines
determine maximum allowable amounts of
RS in pharmaceutical products.
• If amounts of RS are below the limits the
analyzed product is cleared for sale.
7/28/2012 O.Priyanka, M.Pharmacy,GPRCP,
Department of Pharmaceutics 7
8. WHY DO WE NEED CERTAIN REGULATIONS
TO LIMIT THE USE OF SOLVENTS.
• 1)Toxicity
• 2)Odor and taste(obviously not good drug
attributes for both manufacturers n
patients)
• Different associations who set limits for RS
• -USP
• -EU(pharma europa)
• -ICH(Q3 C)
7/28/2012
O.Priyanka, M.Pharmacy,GPRCP, 8
Department of Pharmaceutics
9. CLASSIFICATION OF
SOLVENTS
• According to Q3C guideline solvents are
divided into four groups
• CLASS 1 SOLVENTS: human
carcinogens
• Limits:as absolute parts per million in
material under testing.
• Ex:benzene,carbon
tetrachloride,1,1dichloro ethane,1,2
dichloroethane,1,1,1 trichloro ethane.
7/28/2012
O.Priyanka, M.Pharmacy,GPRCP, 9
Department of Pharmaceutics
10. • CLASS 2 SOLVENTS:solvents ought to be
limited.
• -agents of neurotoxicity r teratogenicity
• Ex:Acetonitrile,Chlorobenzene,Chloroform,
Cyclohexane,1,2Dichloroethene,Dichlorom
ethane,1,2Dimethoxyethane,N,NDimethylf
ormamide,1,4-Dioxane,2-Ethoxyethanol,
Ethyleneglycol,Formamide,Hexane,Metha
nol,2-Methoxyethanol,Methylbutyl
ketone,NMethylpyrrolidone,Nitromethane,
Pyridine,Sulfolane,Tetrahydrofuran,Tetrali
n,Toluene,1,1,2-Trichloroethene,Xylene* 10
7/28/2012
O.Priyanka, M.Pharmacy,GPRCP,
Department of Pharmaceutics
11. • Limits: listed in 2 ways
• 1) Option 1:uses the absolute
• parts per million of solvents contained in
the material being tested and is used in
cases where the daily dose is known or
fixed and is expressed by the formula:
• Concentration (ppm) = (1000 × PDE)/dose
(In grams per day)
• 2)Option 2: the sum of amounts of residual
• solvents present in each component of the
drug product per day, should be less than
7/28/2012 O.Priyanka, M.Pharmacy,GPRCP, 11
given by PDE. Department of Pharmaceutics
12. Component Amount in Acetonitrile daily
formulation content exposure
Drug 0.3 g 800 ppm 0.24 mg
substance
Excipient 1 0.9 g 400 ppm 0.36 mg
Excipient 2 3.8 g 800 ppm 3.04 mg
Drug product 5.0 g 720 ppm 3.64 mg
Permitable daily exposure for acetonitrile is
4.1 mg per day
7/28/2012 O.Priyanka, M.Pharmacy,GPRCP, 12
Department of Pharmaceutics
13. • Class 3 solvents: Solvents with low toxic
potential.
• Limits: they have permissions of daily
exposures of 50 mg (0.5%) or less
• Ex:Acetic acid,Heptane,Acetone Isobutyl
acetate,Anisole Isopropyl acetate,1-
Butanol Methyl acetate,2-Butanol 3-
Methyl-1-butanol,Butyl acetate Methylethyl
ketone,tert-Butylmethyl
ether,Methylisobutyl ketone,Cumene 2-
Methyl-1-propanol.
O.Priyanka, M.Pharmacy,GPRCP,
7/28/2012 Department of Pharmaceutics 13
14. • Class 4 solvents: solvents for which no
adequate toxicological data was found.
• Ex:1,1-Diethoxypropane,Methylisopropyl
ketone,1,1-
Dimethoxymethane,Methyltetrahydrofuran,
• 2,2-Dimethoxypropane,Petroleum ether,
Isooctane,Trichloroacetic acid,Isopropyl
ether Trifluoroacetic acid
O.Priyanka, M.Pharmacy,GPRCP,
7/28/2012 Department of Pharmaceutics 14