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Questions and Answers
What is the primary purpose of a pharmacopeia?
What is the primary purpose of a pharmacopeia?
Which type of pharmacopeia is published by the Council of Pharmaceutical Society in the UK?
Which type of pharmacopeia is published by the Council of Pharmaceutical Society in the UK?
What is included in a monograph in the context of pharmacopeias?
What is included in a monograph in the context of pharmacopeias?
How often are pharmacopeias published and revised?
How often are pharmacopeias published and revised?
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Which organization oversees the Indian Pharmacopoeia?
Which organization oversees the Indian Pharmacopoeia?
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What kind of drugs does the British Pharmaceutical Codex include?
What kind of drugs does the British Pharmaceutical Codex include?
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What does the Indian Pharmacopoeia specify for drugs imported and manufactured in India?
What does the Indian Pharmacopoeia specify for drugs imported and manufactured in India?
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Which pharmacopeia is not officially recognized by a national authority?
Which pharmacopeia is not officially recognized by a national authority?
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What is the main purpose of compliance with IP standards in the drug manufacturing industry?
What is the main purpose of compliance with IP standards in the drug manufacturing industry?
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Which year marks the publication of the first edition of the Indian Pharmacopoeia?
Which year marks the publication of the first edition of the Indian Pharmacopoeia?
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What major change was introduced in the first edition of the Indian Pharmacopoeia?
What major change was introduced in the first edition of the Indian Pharmacopoeia?
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What notable feature of the Indian Pharmacopoeia was introduced in its seventh edition?
What notable feature of the Indian Pharmacopoeia was introduced in its seventh edition?
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What type of ingredients does the Indian Pharmacopoeia control, besides formulations?
What type of ingredients does the Indian Pharmacopoeia control, besides formulations?
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Which of the following revisions was made in the Indian Pharmacopoeia in 2008?
Which of the following revisions was made in the Indian Pharmacopoeia in 2008?
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What was a common feature across the different editions of the Indian Pharmacopoeia?
What was a common feature across the different editions of the Indian Pharmacopoeia?
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In which edition was the use of descriptive terms for solubility introduced?
In which edition was the use of descriptive terms for solubility introduced?
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Study Notes
Introduction to Pharmacopeia
- Pharmacopeia: A book that directs and requires the preparation of medicine
- Pharmakon: A drug
- Poiein: To make
- Legislation of a country: Sets standard and mandatory quality indices
- Periodic Publication: Published by Pharmaceutical Societies of nations
- Monograph: A comprehensive description of a specific pharmaceutical, including:
- Nomenclature
- Classification
- Physical characteristics
- Dosage
- Purity
- Impurity limits
- Identification
- Assay
- Storage conditions
Pharmacopeias
- Standard reference book: Official book providing information about useful drugs, including:
- Molecular formula
- Structural formula
- Preparation methods
- Actions
- Uses
- Adverse effects
- Published and revised every five years by legal authority of the government
- New manufactured and sold drugs must be confirmed by pharmacopeias
Types of Pharmacopeias
- British Pharmacopoeia (B.P.): Used in the UK, Pakistan, and other countries, published by GMC (the General Medical Council). Dose range for morphine: 10-20mg
- United States Pharmacopeia (U.S.P.)
- European Pharmacopoeia (E.P.)
- International Pharmacopoeia (I.P.)
- British Pharmaceutical Codex (BPC): Published by the Council of Pharmaceutical Society of the UK, including official and non-official drugs
- Extra-Pharmacopoeia (E.P.): Provides detailed information about official and non-official drugs, including trade names, actions, uses, and adverse effects
Indian Pharmacopoeia (I.P.)
- Official book of standards for drugs, based on the Second Schedule to the Drugs and Cosmetics Act, 1940
- Specifies standards of identity, purity, and strength for all drugs imported, manufactured, sold, stocked, or exhibited for sale or distributed in India
- Indian Pharmacopoeia Commission (IPC): An autonomous institution of the Ministry of Health and Family Welfare, sets standards for all drugs
- Reference document for various stakeholders, including enforcement agencies, industries, labs, and academic institutions
- Compliance with I.P. standards assures quality for patients and healthcare professionals
I.P. Timelines
- 1944: Bengal Pharmacopeia
- 1948: First Pharmacopeia committee constituted
- 1955: First edition of I.P.
- Multiple editions and supplements issued through 2022
Salient Features of I.P.
-
First I.P.:
- Covers 986 monographs
- Latin titles
- Metric system for weights and measures
- Doses in both metric and English
- List of preparations per monograph
- Abbreviated titles
- Descriptive solubility terms
-
Seventh I.P.:
- Published 2014
- 2567 monographs and 577 new ones
- 19 radiopharmaceuticals
- Chapters for Antibiotics, Herbal products, Vaccines/sera, insulin products, biotech, and general chapters
-
Eighth I.P.:
- Published 2018
- 2829 monographs and 220 new ones
- Revisions and omissions for 366 monographs
- 170 New Chemical Monographs
-
I.P. 2022:
- New Monographs: 92
- APIs: 27
- Dosage Forms: 33
- Vitamins, Minerals, Amino acids, Fatty Acids: 21
- Herbs & Herbal Products: 02
- Biotechnology Derived Therapeutic Products: 03
- Blood & Blood Related Products: 02
- Vaccines and Immunosera for human use: 04
- General Chapters: 12
Summary
- Pharmacopeia: Official drugs
- Pharma. Codex: Official + non-official drugs
- Extra-Pharmacopeia: Detailed information on official + non-official drugs
- Formulary: Registered drugs for marketing
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Description
This quiz covers the essential concepts of pharmacopeia, including its purpose, types, and key components like monographs and standards for drug preparation. It provides an overview of the British Pharmacopoeia and the importance of regulation in pharmaceutical practices. Test your knowledge about this crucial aspect of pharmaceutical sciences!
