Lecture 27 Flashcards
(15 cards)
What is the origin of the term ‘Pharmacopoeia’?
Derived from the Greek term for ‘drug-making’
The term reflects the historical roots of drug formulation and regulation.
What is the purpose of a Pharmacopoeia?
Set standards for the quality, identity, and purity of drugs, excipients, and formulated products
It ensures that medicines meet specific criteria for safety and efficacy.
What standardized testing methods are provided by Pharmacopoeias?
- IR
- UV-Vis
- HPLC
These methods help in verifying the quality and consistency of pharmaceutical products.
What are the aims of Pharmacopoeias?
- Verify identity
- Confirm homogeneity
- Determine purity of substances
These aims are crucial for ensuring the safety and effectiveness of pharmaceutical products.
Name some common Pharmacopoeias.
- USP–NF (United States)
- BP (British Pharmacopoeia)
- EP (European Pharmacopoeia)
- JP (Japanese Pharmacopoeia)
- PRC (Chinese Pharmacopoeia)
Each of these pharmacopoeias has specific standards and regulations for their respective regions.
What does the British Pharmacopoeia (BP) include?
- Volumes I & II: Medicinal substances (APIs)
- Volume III: Formulated preparations
- Volume IV: Appendices, reference spectra
- Volume V: Veterinary products
The BP provides a comprehensive resource for various pharmaceutical needs.
What are Monographs in the context of Pharmacopoeias?
Define the quality standards for individual drugs or herbal products
They serve as a detailed guide for the quality control of specific substances.
What tests do Monographs typically include?
- Identification tests (e.g., IR spectroscopy, melting point)
- Tests for homogeneity (e.g., absence of impurities)
- Assays for purity and content (e.g., HPLC, UV-Vis)
These tests ensure the integrity and quality of the drug or herbal product.
What is the British Herbal Pharmacopoeia (BHP)?
Monographs tailored to herbal materials prepared by pharmacognosists
The BHP focuses specifically on the standards for herbal ingredients.
What content is included in BHP Monographs?
- Macroscopical/microscopical characteristics
- Identification using simple techniques (e.g., TLC)
- Quantitative standards (e.g., foreign matter, ash content)
- Description of the material of commerce
- Powdered material characteristics
- Stated actions (e.g., pharmacological effects)
This comprehensive information aids in the evaluation of herbal products.
What are some challenges with Herbal Monographs?
- Identification difficulties
- Variability of herbal products
- Analytical limitations
These challenges complicate the standardization and quality control of herbal medicines.
What is DNA Barcoding used for in herbal products?
- Improves species identification
- Detects adulteration or substitution
- Useful when plant material is scarce or processed
DNA Barcoding enhances the reliability of herbal product identification.
What is a key method for batch consistency and quality control?
Dissolution Testing
It measures how fast a substance dissolves in a liquid medium, which is crucial for ensuring product performance.
True or False: Dissolution testing is required in all regions.
False
While global pharmacopoeias provide guidelines, the requirement for dissolution testing varies by region.
Fill in the blank: A product is considered pharmacopoeial if it meets all ______ requirements.
monograph
Meeting monograph criteria is essential for a product’s recognition in the pharmacopoeia.
