Contents of the Supplementary Chapters
SUPPLEMENTARY CHAPTER I
Basis of Pharmacopoeial Requirements
A. Control of Impurities
B. Polymorphism
C. Bacterial Endotoxin Testing
D. Excipients
E. Dissolution Testing of Solid Oral Dosage Forms
F. Declaration of Content
G. Labelling
H. Biological Assays and Tests
J. Efficacy of Antimicrobial Preservation
K. Stereochemistry
L. Microbiological Assay of Antibiotics
M. Microbial Contamination
N. Particulate Contamination
O. Inhaled Products
SUPPLEMENTARY CHAPTER II
Names of Medicinal Substances and Preparations
A. Changes in Monograph Titles
B. Monograph Titles for Formulated Preparations
C. Structures and Nomenclature of Substances of Natural or Semi-synthetic Origin
SUPPLEMENTARY CHAPTER III
Pharmacopoeial Organisation
A1. Contact Points
A2. Expert Advisory Groups
B. Monograph Development: Mechanism
C. Monograph Development: Guidance to Manufacturers
D. Monograph Development: Methods of Analysis
E. British Pharmacopoeia Chemical Reference Substances (BPCRS)
F. Validation of Analytical Procedures
SUPPLEMENTARY CHAPTER IV
European Pharmacopoeia
A. Membership of the European Pharmacopoeia Commission
B. Dates of Implementation
C. Certification Scheme
D. Residual Solvents
E. Alcoholimetric Tables
F. Pharmacopoeial Harmonisation
H. Materials Used in Chromatographic Tests
I. Chromatograms for Information (Transferred to BP website www.pharmacopoeia.com)
J. Control of Impurities in Substances for Pharmaceutical Use
K. Characters Section in Monographs
L. Alternative Methods for Control of Microbiological Quality
M. Reference Standards
N. Gene Transfer Medicinal Products for Human Use
O. Functionality-related Characteristics of Excipients
P. Guidelines for Using the Test for Sterility
Q. Elemental Impurities
R. Chemometric Methods Applied to Analytical Data
S. Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
SUPPLEMENTARY CHAPTER V
Unlicensed Medicines
A. Monograph Selection: Unlicensed Medicines
B. Preservative-free Unlicensed Medicines
C. Bioequivalence of Oral Liquids
D. Storage and Stability of Unlicensed Medicines
E. Extemporaneous Preparations
F. Aseptic Preparations of Unlicensed Medicines
SUPPLEMENTARY CHAPTER VI
Pharmacopoeial Quantitative Analysis
A. Pharmacopoeial Calculations
B. Titrimetric Analysis
C. Indicator Colour Changes
SUPPLEMENTARY CHAPTER VII
A. Traditional Herbal Medicines
B. Names of Herbal Drugs Used in Traditional Chinese Medicine
C. Monographs on Herbal Drug Extracts
D. DNA Barcoding as a Tool for Identification of Herbal Drugs
SUPPLEMENTARY CHAPTER VIII
Materials for use in the Manufacture of Homoeopathic Preparations
SUPPLEMENTARY CHAPTER IX
Similar Biological Medicinal Products