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AN OVERVIEW OFAPI, AFI, AND
OTHER INTERNATIONAL
PHARMACOPOEIAS
By – Dr Ajith kumar
Final Year P.G Scholar
Dept. of Rasashastra and Bhaishajya kalpana
Under the guidance of : Dr P.G Jadar M.D Ayu PhD
Professor and Dean
Dept of PG Studies in Rasashastra and bhaishajya kalpana
Topics covered
Introduction
Need for pharmacopoeia in Ayurveda
The APC
General introduction to pharmacopoeia
A brief overview of API
Formulary and AFI
Other International pharmacopoeias
Summary
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 2
Introduction
Drug and Cosmetic Act 1940 – regulation of import, manufacture,
and distribution of drugs in India
Primary objective of the act – ensure safety, efficacy, and quality
standards of drugs and cosmetics sold in India.
Amended in 1964 to include Ayurvedic and Unani drugs
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 3
Need for a pharmacopoeia in Ayurveda?
Controversy and confusion in identification of drugs.
Widespread geography of the country – multiple botanical sources of a drug.
Commercial substitution.
Foreign invasions, discouragement and negative attitude towards the system – Ayurvedic drugs
were wrongly published as crude, poisonous, and potentially dangerous.
Government had no control over manufacturing and marketing. Hence no control over quality
of these products.
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 4
The Ayurvedic Pharmacopoeia Committee (APC)
Constituted by Govt of India on 20th September 1962
First functional unit of ministry of AYUSH
Purpose – to establish safety and toxicity profiles and standardize drugs and
formulations mentioned in our classics.
From 2006 it’s under CCRAS
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 5
As a result…
Unavailable laboratory data to feed monographs – PLIM ( Pharmacopoeia Laboratory of Indian
Medicine) was established in 1970 in Ghaziabad.
3 publications : AFI, API, and Atlas of Ayurvedic Pharmacopoeia drugs
AFI was published first in 1978, under Col. R N Chopra Committee which would provide
sufficient basis to enforce Drug and Cosmetic Act and also would be precursor to publish API
API was then published in 1986
ATLAS – 2009 (TLC) and 2011 (microscopy and macroscopy)
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 6
Pharmacopoeia
Derived from Greek, the word meaning is “drug-making”
What? – A legally binding collection for medicines used in a region
Who? – Prepared by national or regional authority
Why? – To state standards and quality specifications for medicines
Hence it can be defined as “It is a legally binding collection, prepared by a
national or regional authority of standards and quality specifications for
medicines used in that country or region.”
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 7
Role of pharmacopoeia
The role of a pharmacopoeia is to furnish quality specifications for active
pharmaceutical ingredients (APIs), finished pharmaceutical products (FPPs), and
general requirements, e.g. for dosage forms.
Quality specification :
It includes a set of tests that will help determine :
1. Quality and purity of a product
2. Ascertain the strength and amount of active ingredients in a product
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 8
API – THE AYURVEDIC PHARMACOPOEIA OF INDIA
- The API is a legal document of standards for the quality of
ayurvedic drugs
- It provides us some uniformity in the ayurvedic medicines
marketed, so far as their identity, purity and strength are
concerned.
- It is the book of reference for implementation of the drugs
and cosmetics act (1940).
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 9
Division of content
• API – PART 1
• Total 9 volumes
• 645 monographs on single drugs
• Vol.7 deals with metal and mineral origin
drugs
2/2/2023 10
volume Year of publication No of monographs
I 1990 80
II 1999 78
III 2001 100
IV 2004 68
V 2006 92
VI 2008 101
VII 2008 21(metals and
minerals)
VIII 2011 60 (aqueous and
hydroalcoholic
extracts)
IX 2016 45
•API part II
•3 volumes have been published
101 monographs.
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 11
volume Year of publication No of monographs
I 2007 50 (formulations)
II 2008 51
III 2010 51
TLC Atlas of Ayurvedic Pharmacopoeial Drugs – Part 1, Vol. 1 – 2009 – 80
monographs
Microscopy and Macroscopy Atlas of API Drugs – Part 1, Vol. 1 – 2011 – 80
monographs
Microscopy and Macroscopy Atlas of API Drugs – Part 1, Vol. 5 – 2009 – 92
monographs
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 12
Contents of API
Preface
Introduction
Legal notices
General notices - for guidance of the analysts, the pharmaceutical suppliers, manufacturers
and the research workers engaged in this field.
Monographs
Appendices- details about the apparatus, reagents and solutions, tests, methods of preparations
of specimen for microscopic examinations have been given.
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 13
MONOGRAPHS
• Title
• Definition - giving its identification in scientific nomenclature and very brief information
about its source, occurrence, distribution and precautions in collection if any etc, are mentioned
• Synonyms- in Sanskrit and also other Indian regional languages
• Description : Macroscopic – morphological characteristics and
Microscopic- its microscopic structure, the individual elements,
deposition of crystals etc. each having a pharmacognostic value in
identification.
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 14
• Identity, purity and strength – gives norms and limits like tolerance of
foreign matter alcohol soluble extract
total ash water soluble extract
acid insoluble ash moisture content
• Constituents
• Properties and action- rasa panchakas
• Important formulations
• Therapeutic uses
• Dose
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 15
Formulary
It is a list of prescription drugs/medicines.
Contains collection of formulas for the compounding and testing of
medication.
Depending on individual formularies, some may also contain additional
clinical information such as side effects, contraindications, and doses.
156 countries – national or provincial essential medicine lists
135 countries – national treatment guidelines/formulary manuals
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 16
AFI – THE AYURVEDIC FORMULARY OF INDIA
Huge number of formulations scattered all over was
compiled.
List of single drugs of animal, mineral, and plant origin was
prepared on basis of names appearing in formulations, along
with official names and English equivalents.
Plant origin drugs have been edited according to botanical
names of plants appearing in formulations for convenience of
users.
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 17
Other features
Ayurvedic terms of therapeutic indications and their appropriate English
equivalent has been mentioned.
The original shloka of reference from where the shloka has been derived has also
been included
Keeping in mind the non-availability of roots and barks and regulating laws of
the country, alternative parts of the plants have been indicated for the
formulations
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 18
Division of content
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 19
2/2/2023 20
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 21
Contents of AFI
Foreword
- Legal notice
- General notices
- Transliteration symbols
- Abbreviations for parts of plants
- Preface
- Introduction
- Formulary—compound formulations:
- Formulary—single drugs:
1. List of single drugs of animal origin.
2. List of single drugs of mineral origin.
3. List of single drugs of plant origin:
- Appendices:
2/2/2023 22
Formulary – compound formulations
Name of formulation in samskrit
Reference
Shloka
Name of drugs mentioned in shloka along with their : basonym (if synonym is given in shloka),
part used, quantity
Dose
Important therapeutic uses
Special method of preparation is mentioned only for some formulations
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 23
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 24
2/2/2023 25
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 26
Formulary – single drugs of animal origin - 114
2/2/2023 27
Formulary – single drugs of mineral origin - 179
2/2/2023 28
Formulary – single drugs of plant origin - 1048
2/2/2023 29
Appendicies
Appendices:
1. Paribhasa (Glossary of technical terms).
2. Sodhana (Process of detoxication).
3. Therapeutic indices:
(a). Formula wise.
(b). Disease wise.
4. List of diseases/technical terms and their approximate English
equivalents.
5. Metric equivalents of classical weights and measures.
6. Bibliography.
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 30
Paribhasha
2/2/2023 31
Shodhana
2/2/2023 32
Therapeutic indices
(formula wise)
2/2/2023 33
Therapeutic indices
(disease wise)
2/2/2023 34
Dosage forms and doses mentioned in AFI
Sl. No Dosage form General dose
1 Asava and Arista 12 to 24 ml
2 Arka 12 to 24 ml
3 Avaleha and Paka 6 to 12 gm
4 Kwatha churna 48 gm
5 Guggulu 3 gm
6 Ghrita 12 gm
7 Churna 1 to 6 gm
8 Taila 6 to 12 gm
for internal use
9 Dravaka 5 drops
10 Lavana kshara 1 to 2 gm
125 – 250 mg
2/2/2023 35
Sl.
No
Dosage form General dose
11 Lepa --
12 Vati and gutika 125 mg to 2 gm
13 Varti, Netrbindu, Anjana --
14 Sattva 1 gm
15 Kupipakva rasayana 62.5 to 125 mg
16 Parpati 125 to 250 mg
17 Pishti 62 to 125 mg (few
upto 500mg)
18 Bhasma upto 250 mg
19 Mandura 1 gm
20 Rasa yoga 125- 250 mg
21 Lauha 250 mg to 2 gm
Dose- general guidelines
Doses : Doses mentioned in the Formulary are intended merely for general
guidance
Represent, unless otherwise stated, the average range of quantities per dose which
are generally regarded as suitable for adults when administered orally.
It is not to be regarded as binding upon the prescribers.
It is to be noted that the relation between the doses in metric and Ayurvedic
Systems set forth in the text is of only approximate equivalence, and are for the
convenience of the prescriber and are sufficiently accurate for pharmaceutical or
other purposes.
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 36
Different parts of plants to be used mentioned in API - 66
37
38
39
Other International Pharmacopoeias
WHO lists 30+ pharmacopoeias from 149 independent countries
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 41
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 42
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 43
Topics
To summarize…
Pharmacopoeias and formularies - Guidelines for approved
pharmaceutical standards – necessary for manufacture and
prescription of these formulations
Ensure quality control methods
An important component of the drug safety system
An instrument for patient and consumer protection
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 44
API, AFI – AN OVERVIEW BY DR AJITH KUMAR

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API, AFI – AN OVERVIEW BY DR AJITH KUMAR

  • 1. AN OVERVIEW OFAPI, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS By – Dr Ajith kumar Final Year P.G Scholar Dept. of Rasashastra and Bhaishajya kalpana Under the guidance of : Dr P.G Jadar M.D Ayu PhD Professor and Dean Dept of PG Studies in Rasashastra and bhaishajya kalpana
  • 2. Topics covered Introduction Need for pharmacopoeia in Ayurveda The APC General introduction to pharmacopoeia A brief overview of API Formulary and AFI Other International pharmacopoeias Summary 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 2
  • 3. Introduction Drug and Cosmetic Act 1940 – regulation of import, manufacture, and distribution of drugs in India Primary objective of the act – ensure safety, efficacy, and quality standards of drugs and cosmetics sold in India. Amended in 1964 to include Ayurvedic and Unani drugs 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 3
  • 4. Need for a pharmacopoeia in Ayurveda? Controversy and confusion in identification of drugs. Widespread geography of the country – multiple botanical sources of a drug. Commercial substitution. Foreign invasions, discouragement and negative attitude towards the system – Ayurvedic drugs were wrongly published as crude, poisonous, and potentially dangerous. Government had no control over manufacturing and marketing. Hence no control over quality of these products. 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 4
  • 5. The Ayurvedic Pharmacopoeia Committee (APC) Constituted by Govt of India on 20th September 1962 First functional unit of ministry of AYUSH Purpose – to establish safety and toxicity profiles and standardize drugs and formulations mentioned in our classics. From 2006 it’s under CCRAS 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 5
  • 6. As a result… Unavailable laboratory data to feed monographs – PLIM ( Pharmacopoeia Laboratory of Indian Medicine) was established in 1970 in Ghaziabad. 3 publications : AFI, API, and Atlas of Ayurvedic Pharmacopoeia drugs AFI was published first in 1978, under Col. R N Chopra Committee which would provide sufficient basis to enforce Drug and Cosmetic Act and also would be precursor to publish API API was then published in 1986 ATLAS – 2009 (TLC) and 2011 (microscopy and macroscopy) 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 6
  • 7. Pharmacopoeia Derived from Greek, the word meaning is “drug-making” What? – A legally binding collection for medicines used in a region Who? – Prepared by national or regional authority Why? – To state standards and quality specifications for medicines Hence it can be defined as “It is a legally binding collection, prepared by a national or regional authority of standards and quality specifications for medicines used in that country or region.” 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 7
  • 8. Role of pharmacopoeia The role of a pharmacopoeia is to furnish quality specifications for active pharmaceutical ingredients (APIs), finished pharmaceutical products (FPPs), and general requirements, e.g. for dosage forms. Quality specification : It includes a set of tests that will help determine : 1. Quality and purity of a product 2. Ascertain the strength and amount of active ingredients in a product 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 8
  • 9. API – THE AYURVEDIC PHARMACOPOEIA OF INDIA - The API is a legal document of standards for the quality of ayurvedic drugs - It provides us some uniformity in the ayurvedic medicines marketed, so far as their identity, purity and strength are concerned. - It is the book of reference for implementation of the drugs and cosmetics act (1940). 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 9
  • 10. Division of content • API – PART 1 • Total 9 volumes • 645 monographs on single drugs • Vol.7 deals with metal and mineral origin drugs 2/2/2023 10 volume Year of publication No of monographs I 1990 80 II 1999 78 III 2001 100 IV 2004 68 V 2006 92 VI 2008 101 VII 2008 21(metals and minerals) VIII 2011 60 (aqueous and hydroalcoholic extracts) IX 2016 45
  • 11. •API part II •3 volumes have been published 101 monographs. 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 11 volume Year of publication No of monographs I 2007 50 (formulations) II 2008 51 III 2010 51
  • 12. TLC Atlas of Ayurvedic Pharmacopoeial Drugs – Part 1, Vol. 1 – 2009 – 80 monographs Microscopy and Macroscopy Atlas of API Drugs – Part 1, Vol. 1 – 2011 – 80 monographs Microscopy and Macroscopy Atlas of API Drugs – Part 1, Vol. 5 – 2009 – 92 monographs 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 12
  • 13. Contents of API Preface Introduction Legal notices General notices - for guidance of the analysts, the pharmaceutical suppliers, manufacturers and the research workers engaged in this field. Monographs Appendices- details about the apparatus, reagents and solutions, tests, methods of preparations of specimen for microscopic examinations have been given. 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 13
  • 14. MONOGRAPHS • Title • Definition - giving its identification in scientific nomenclature and very brief information about its source, occurrence, distribution and precautions in collection if any etc, are mentioned • Synonyms- in Sanskrit and also other Indian regional languages • Description : Macroscopic – morphological characteristics and Microscopic- its microscopic structure, the individual elements, deposition of crystals etc. each having a pharmacognostic value in identification. 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 14
  • 15. • Identity, purity and strength – gives norms and limits like tolerance of foreign matter alcohol soluble extract total ash water soluble extract acid insoluble ash moisture content • Constituents • Properties and action- rasa panchakas • Important formulations • Therapeutic uses • Dose 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 15
  • 16. Formulary It is a list of prescription drugs/medicines. Contains collection of formulas for the compounding and testing of medication. Depending on individual formularies, some may also contain additional clinical information such as side effects, contraindications, and doses. 156 countries – national or provincial essential medicine lists 135 countries – national treatment guidelines/formulary manuals 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 16
  • 17. AFI – THE AYURVEDIC FORMULARY OF INDIA Huge number of formulations scattered all over was compiled. List of single drugs of animal, mineral, and plant origin was prepared on basis of names appearing in formulations, along with official names and English equivalents. Plant origin drugs have been edited according to botanical names of plants appearing in formulations for convenience of users. 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 17
  • 18. Other features Ayurvedic terms of therapeutic indications and their appropriate English equivalent has been mentioned. The original shloka of reference from where the shloka has been derived has also been included Keeping in mind the non-availability of roots and barks and regulating laws of the country, alternative parts of the plants have been indicated for the formulations 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 18
  • 19. Division of content 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 19
  • 21. 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 21
  • 22. Contents of AFI Foreword - Legal notice - General notices - Transliteration symbols - Abbreviations for parts of plants - Preface - Introduction - Formulary—compound formulations: - Formulary—single drugs: 1. List of single drugs of animal origin. 2. List of single drugs of mineral origin. 3. List of single drugs of plant origin: - Appendices: 2/2/2023 22
  • 23. Formulary – compound formulations Name of formulation in samskrit Reference Shloka Name of drugs mentioned in shloka along with their : basonym (if synonym is given in shloka), part used, quantity Dose Important therapeutic uses Special method of preparation is mentioned only for some formulations 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 23
  • 24. 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 24
  • 26. 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 26
  • 27. Formulary – single drugs of animal origin - 114 2/2/2023 27
  • 28. Formulary – single drugs of mineral origin - 179 2/2/2023 28
  • 29. Formulary – single drugs of plant origin - 1048 2/2/2023 29
  • 30. Appendicies Appendices: 1. Paribhasa (Glossary of technical terms). 2. Sodhana (Process of detoxication). 3. Therapeutic indices: (a). Formula wise. (b). Disease wise. 4. List of diseases/technical terms and their approximate English equivalents. 5. Metric equivalents of classical weights and measures. 6. Bibliography. 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 30
  • 35. Dosage forms and doses mentioned in AFI Sl. No Dosage form General dose 1 Asava and Arista 12 to 24 ml 2 Arka 12 to 24 ml 3 Avaleha and Paka 6 to 12 gm 4 Kwatha churna 48 gm 5 Guggulu 3 gm 6 Ghrita 12 gm 7 Churna 1 to 6 gm 8 Taila 6 to 12 gm for internal use 9 Dravaka 5 drops 10 Lavana kshara 1 to 2 gm 125 – 250 mg 2/2/2023 35 Sl. No Dosage form General dose 11 Lepa -- 12 Vati and gutika 125 mg to 2 gm 13 Varti, Netrbindu, Anjana -- 14 Sattva 1 gm 15 Kupipakva rasayana 62.5 to 125 mg 16 Parpati 125 to 250 mg 17 Pishti 62 to 125 mg (few upto 500mg) 18 Bhasma upto 250 mg 19 Mandura 1 gm 20 Rasa yoga 125- 250 mg 21 Lauha 250 mg to 2 gm
  • 36. Dose- general guidelines Doses : Doses mentioned in the Formulary are intended merely for general guidance Represent, unless otherwise stated, the average range of quantities per dose which are generally regarded as suitable for adults when administered orally. It is not to be regarded as binding upon the prescribers. It is to be noted that the relation between the doses in metric and Ayurvedic Systems set forth in the text is of only approximate equivalence, and are for the convenience of the prescriber and are sufficiently accurate for pharmaceutical or other purposes. 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 36
  • 37. Different parts of plants to be used mentioned in API - 66 37
  • 38. 38
  • 39. 39
  • 40. Other International Pharmacopoeias WHO lists 30+ pharmacopoeias from 149 independent countries
  • 41. 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 41
  • 42. 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 42
  • 43. 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 43 Topics
  • 44. To summarize… Pharmacopoeias and formularies - Guidelines for approved pharmaceutical standards – necessary for manufacture and prescription of these formulations Ensure quality control methods An important component of the drug safety system An instrument for patient and consumer protection 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 44