BP 2018 (9.3 Update)
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Preliminaries
- British Pharmacopoeia 2018
- Foreword
- Contents
- Notices
- Preface
- British Pharmacopoeia Commission
- Expert Advisory Groups, Panels of Experts and Working Parties
- Code of Practice
- Membership of the British Pharmacopoeia Commission
- Membership of Expert Advisory Groups, Panels of Experts and Working Parties
- Current British Pharmacopoeia Staff
- Current British Pharmacopoeia Laboratory Staff
- Current Staff of the Publisher of the British Pharmacopoeia
- Introduction
- General Notices
- Monographs: Medicinal and Pharmaceutical Substances
- Formulated Preparations: General Monographs
- Formulated Preparations: Specific Monographs
- Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products
- Materials for use in the Manufacture of Homoeopathic Preparations
- Blood-related Products
- Immunological Products
- Radiopharmaceutical Preparations
- Surgical Materials
- Infrared Reference Spectra
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Appendices
- Introduction
- Contents of the Appendices
- European Pharmacopoeia Equivalent Texts
- Appendix I
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Appendix II
- Appendix II A. Infrared Spectrophotometry
- Appendix II B. Ultraviolet and Visible Absorption Spectrophotometry
- Appendix II C. Nuclear Magnetic Resonance Spectrometry
- Appendix II D. Atomic Spectrophotometry: Emission and Absorption
- Appendix II E. Fluorescence Spectrophotometry [Fluorimetry]
- Appendix II F. X-Ray Fluorescence Spectrometry
- Appendix II G. Mass Spectrometry
- Appendix II G1. Inductively Coupled Plasma-Mass Spectrometry
- Appendix II H. Raman Spectroscopy
- Appendix II J. Flow Cytometry
- Appendix II K. Peptide Identification by Nuclear Magnetic Resonance Spectrometry
- Appendix II L. Chemical Imaging
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Appendix III
- Appendix III Chromatographic Separation Techniques
- Appendix III A. Thin-layer Chromatography
- Appendix III B. Gas Chromatography
- Appendix III C. Size-exclusion Chromatography
- Appendix III D. Liquid Chromatography
- Appendix III E. Paper Chromatography
- Appendix III F. Electrophoresis
- Appendix III G. Capillary Electrophoresis
- Appendix III H. Supercritical Fluid Chromatography
- Appendix III J. Isoelectric Focusing
- Appendix III K. Peptide Mapping
- Appendix III L. Amino Acid Analysis
- Appendix III M. Glycan Analysis of Glycoproteins
- Appendix IV
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Appendix V
- Appendix V A. Determination of Melting Point
- Appendix V B. Determination of Freezing Point
- Appendix V C. Determination of Distillation Range
- Appendix V D. Determination of Boiling Point
- Appendix V E. Determination of Refractive Index
- Appendix V F. Determination of Optical Rotation and Specific Optical Rotation
- Appendix V G. Determination of Weight per Millilitre, Density, Relative Density and Apparent Density
- Appendix V H. Viscosity
- Appendix V J. Circular Dichroism
- Appendix V K. Approximate pH of Solutions
- Appendix V L. Determination of pH Values
- Appendix V M. Thermal Analysis
- Appendix V N. Osmolality
- Appendix V O. Conductivity
- Appendix V P. Total Organic Carbon in Water for Pharmaceutical Use
- Appendix V Q. Density of Solids
- Appendix V R. Detection and Measurement of Radioactivity
- Appendix VI Qualitative Reactions and Tests
- Appendix VII Limit Tests
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Appendix VIII
- Appendix VIII A. Non-aqueous Titration
- Appendix VIII B. Amperometric, Potentiometric and Voltametric Titrations
- Appendix VIII C. Oxygen-flask Combustion
- Appendix VIII D. Complexometric Titrations
- Appendix VIII E. Potentiometric Determination of Ionic Concentration Using Ion-selective Electrodes
- Appendix VIII F. Determination of Ethanol
- Appendix VIII G. Determination of Methanol and Propan-2-ol
- Appendix VIII H. Determination of Nitrogen
- Appendix VIII J. Tetrazolium Assay of Steroids
- Appendix VIII K. Ethylene Glycol and Diethylene Glycol in Ethoxylated Substances
- Appendix VIII L. Residual Solvents
- Appendix VIII M. Residual Ethylene Oxide and Dioxan
- Appendix VIII N. N,N-Dimethylaniline
- Appendix VIII O. 2-Ethylhexanoic Acid
- Appendix VIII P. Total Protein
- Appendix VIII Q. Acetic Acid in Synthetic Peptides
- Appendix VIII R. Nickel in Hydrogenated Vegetable Oils
- Appendix VIII S. Methyl, Ethyl and Isopropyl Methanesulfonate in Methanesulfonic Acid
- Appendix VIII T. Methyl, Ethyl and Isopropyl Methanesulfonate in Active Substances
- Appendix VIII V. Methanesulfonyl Chloride in Methanesulfonic Acid
- Appendix VIII W. Determination of Elemental Impurities
- Appendix VIII X. Methyl, Ethyl and Isopropyl Toluenesulfonate in Active Substances
- Appendix VIII Y. Methyl, Ethyl and Isopropyl Benzenesulfonate in Active Substances
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Appendix IX
- Appendix IX A. Determination of Sulfated Ash
- Appendix IX B. Determination of Sulfur Dioxide
- Appendix IX C. Determination of Water
- Appendix IX D. Determination of Loss on Drying
- Appendix IX E. Limit Test for Carbon Monoxide in Medicinal Gases
- Appendix IX F. Determination of Carbon Dioxide in Medicinal Gases
- Appendix IX G. Determination of Nitrogen Monoxide and Nitrogen Dioxide in Medicinal Gases
- Appendix IX H. Determination of Oxygen in Medicinal Gases
- Appendix IX J. Determination of Water in Medicinal Gases
- Appendix IX K. Gas Detector Tubes
- Appendix IX L. Determination of Nitrous Oxide in Gases
- Appendix IX M. Water-Solid Interactions: Determination of Sorption-Desorption Isotherms and of Water Activity
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Appendix X
- Appendix X A. Acetyl Value
- Appendix X B. Acid Value
- Appendix X C. Ester Value
- Appendix X D. Hydroxyl Value
- Appendix X E. Iodine Value
- Appendix X F. Peroxide Value
- Appendix X G. Saponification Value
- Appendix X H. Unsaponifiable Matter
- Appendix X J. Determination of Cineole
- Appendix X K. Determination of Aldehydes
- Appendix X L. Oxidising Substances
- Appendix X M. Essential Oils
- Appendix X N. Fixed Oils
- Appendix X O. Anisidine Value
- Appendix X P. Oils Rich in Omega-3-acids
- Appendix X Q. Sterols in Fatty Oils
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Appendix XI
- Appendix XI A. Total Solids
- Appendix XI B1. Ethanol-soluble Extractive
- Appendix XI B2. Water-soluble Extractive
- Appendix XI C. Swelling Index
- Appendix XI D. Foreign Matter
- Appendix XI E. Essential Oils in Herbal Drugs
- Appendix XI F. Continuous Extraction of Drugs
- Appendix XI G. Complete Extraction of Alkaloids
- Appendix XI H. Stomata
- Appendix XI J. Ash
- Appendix XI K. Acid-insoluble Ash
- Appendix XI L. Pesticide Residues
- Appendix XI M. Tannins in Herbal Drugs
- Appendix XI N. Bitterness Value
- Appendix XI P. Dry Residue of Extracts
- Appendix XI Q. Loss on Drying of Extracts
- Appendix XI R. Test for Aristolochic Acids in Herbal Drugs
- Appendix XI S. Determination of Mycotoxins in Herbal Drugs
- Appendix XI T. Herbal Drugs: Sampling and Sample Preparation
- Appendix XI U. Microscopic Examination of Herbal Drugs
- Appendix XI V. Deoxyribonucleic Acid (DNA) Based Identification Techniques for Herbal Drugs
- Appendix XI W. High-Performance Thin-Layer Chromatography of Herbal Drugs and Herbal Drug Preparations
- Appendix XII
- Appendix XIII
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Appendix XIV
- Appendix XIV Biological Assays and Tests
- Appendix XIV A. Microbiological Assay of Antibiotics
- Appendix XIV B. Immunochemical Methods
- Appendix XIV C. Test for Bacterial Endotoxins (LAL Test)
- Appendix XIV D. Test for Pyrogens
- Appendix XIV E. Test for Abnormal Toxicity
- Appendix XIV F. Test for Depressor Substances
- Appendix XIV G. Test for Histamine
- Appendix XIV H. Monocyte-Activation Test
- Appendix XIV I. Assay of Pancreatin
- Appendix XIV J. Blood and Related Products
- Appendix XIV K. Immunological Products
- Appendix XIV L. Nucleic Acid Amplification Techniques
- Appendix XIV M. Assay of Interferons
- Appendix XIV N1. Numeration of CD34/CD45+ Cells in Haematopoietic Products
- Appendix XIV N2. Colony-forming Cell Assay for Human Haematopoietic Progenitor Cells
- Appendix XIV N3. Nucleated Cell Count and Viability
- Appendix XIV O. Host-cell Protein Assays
- Appendix XIV P. Determination of Bactericidal, Fungicidal or Yeasticidal Activity of Antiseptic Medicinal Products
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Appendix XV
- Appendix XV A. Terminology used in Monographs on Biological Products
- Appendix XV B. Aluminium in Adsorbed Vaccines
- Appendix XV C. Calcium in Adsorbed Vaccines
- Appendix XV D. Free Formaldehyde
- Appendix XV E. Phenol in Immunosera (Antisera) and Vaccines
- Appendix XV F. Neurovirulence
- Appendix XV G. Composition of Polysaccharide Vaccines
- Appendix XV H. Chicken Flocks Free from Specified Pathogens for the Production and Quality Control of Vaccines
- Appendix XV J. Cell Substrates for the Production of Vaccines for Human Use
- Appendix XV K. Carrier Proteins for the Production of Conjugated Polysaccharide Vaccines for Human Use
- Appendix XV L. Immunonephelometry for Vaccine Component Assay
- Appendix XV M. Substitution of in Vivo Method(s) by in Vitro Method(s) for the Quality Control of Vaccines
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Appendix XVI
- Appendix XVI A. Test for Sterility
- Appendix XVI B. Microbiological Examination of Non-sterile Products
- Appendix XVI C. Efficacy of Antimicrobial Preservation
- Appendix XVI D. Microbiological Quality of Non-sterile Pharmaceutical Preparations and Substances for Pharmaceutical Use
- Appendix XVI E. Microbiological Examination of Cell-based Preparations
- Appendix XVI F. Microbiological Examination of Herbal Medicinal Products for Oral Use and Extracts used in their Preparation
- Appendix XVI G. Microbiological Quality of Herbal Medicinal Products for Oral Use and Extracts Used in their Preparation
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Appendix XVII
- Appendix XVII A. Particle Size of Powders
- Appendix XVII B. Sieves and Filters
- Appendix XVII C. Specific Surface Area by Air Permeability
- Appendix XVII E. Flowability
- Appendix XVII F. Measurement of Consistency and Texture Analysis
- Appendix XVII G. Friability
- Appendix XVII H. Resistance to Crushing of Tablets
- Appendix XVII J. Softening Time Determination of Lipophilic Suppositories
- Appendix XVII K. Pycnometric Density of Solids
- Appendix XVII M. Specific Surface Area by Gas Adsorption
- Appendix XVII N. Powder Flow
- Appendix XVII O. Optical microscopy
- Appendix XVII P. Particle Size Analysis by Laser Light Diffraction
- Appendix XVII Q. Characterisation of Crystalline and Partially Crystalline Solids by X-ray Powder Diffraction (XRPD)
- Appendix XVII R. Porosity and Pore-size Distribution of Solids by Mercury Porosimetry
- Appendix XVII S. Bulk Density and Tapped Density of Powders
- Appendix XVII T. Wettability of Porous Solids Including Powders
- Appendix XVII U. Crystallinity
- Appendix XVII V. Characterisation of Crystalline Solids by Microcalorimetry and Solution Calorimetry
- Appendix XVIII Methods of Sterilisation
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Appendix XIX
- Appendix XIX A. Containers Introduction
- Appendix XIX B. Glass Containers for Pharmaceutical Use
- Appendix XIX C. Plastic Containers and Closures
- Appendix XIX D. Containers for Blood and Blood Components
- Appendix XIX E. Rubber Closures for Containers for Aqueous Parenteral Preparations
- Appendix XIX F. Sets for the Transfusion of Blood and Blood Components
- Appendix XIX G. Sterile Single-use Plastic Syringes
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Appendix XX
- Appendix XX Materials Used for the Manufacture of Containers
- Appendix XX A. Materials for Containers for Human Blood and Blood Components
- Appendix XX B. Polyolefins
- Appendix XX C. Polyethylene
- Appendix XX D. Polypropylene for Containers and Closures for Parenteral Preparations and Ophthalmic Preparations
- Appendix XX E. Poly(Ethylene - Vinyl Acetate) for Containers and Tubing for Total Parenteral Nutrition Preparations
- Appendix XX F. Silicone
- Appendix XX G. Plastic Additives
- Appendix XX H. Polyethylene Terephthalate for Containers for Preparations not for Parenteral Use
- Appendix XXI
- Appendix XXII
- Appendix XXIII B. Conversion Tables for Commonly Used Units
- Appendix XXIV Abbreviations
- Appendix XXV Names, Symbols and Atomic Weights of Elements
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Supplementary Chapters
- Introduction
- Contents of the Supplementary Chapters
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SC I Basis of Pharmacopoeial Requirements
- SC I Basis of Pharmacopoeial Requirements
- SC I A. Control of Impurities
- SC I B. Polymorphism
- SC I C. Bacterial Endotoxin Testing
- SC I Guidelines for using the test for bacterial endotoxins
- SC I D. Excipients
- SC I E. Dissolution Testing of Solid Oral Dosage Forms
- SC I F. Declaration of Content
- SC I G. Labelling
- SC I H. Biological Assays and Tests
- SC I J. Efficacy of Antimicrobial Preservation
- SC I K. Stereochemistry
- SC I L. Microbiological Assay of Antibiotics
- SC I M. Microbial Contamination
- SC I N. Particulate Contamination
- SC I O. Inhaled Products
- SC II Names of Medicinal Substances and Preparations
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SC III Pharmacopoeial Organisation
- SC III Pharmacopoeial Organisation
- SC III A1. Contact Points
- SC III A2. Expert Advisory Groups
- SC III B. Monograph Development: Mechanism
- SC III C. Monograph Development: Guidance to Manufacturers
- SC III D. Monograph Development: Methods of Analysis
- SC III E. British Pharmacopoeia Chemical Reference Substances (BPCRS)
- SC III F. Validation of Analytical Procedures
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SC IV European Pharmacopoeia
- SC IV European Pharmacopoeia
- SC IV A. Membership of the European Pharmacopoeia Commission
- SC IV B. Dates of Implementation
- SC IV C. Certification Scheme
- SC IV D. Residual Solvents
- SC IV E. Alcoholimetric Tables
- SC IV F. Pharmacopoeial Harmonisation
- SC IV G. Statistical Analysis of Results of Biological Assays and Tests
- SC IV H. Materials Used in Chromatographic Tests
- SC IV J. Control of Impurities in Substances for Pharmaceutical Use
- SC IV K. Characters Section in Monographs
- SC IV L. Alternative Methods for Control of Microbiological Quality
- SC IV M. Reference Standards
- SC IV N. Gene Transfer Medicinal Products for Human Use
- SC IV O. Functionality-related Characteristics of Excipients
- SC IV P. Guidelines for Using the Test for Sterility
- SC IV Q. Elemental Impurities
- SC IV R. Chemometric Methods Applied to Analytical Data
- SC IV S. Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
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SC V Unlicensed Medicines
- SC V Unlicensed Medicines
- SC V A. Monograph Selection: Unlicensed Medicines
- SC V B. Preservative-free Unlicensed Medicines
- SC V C. Bioequivalence of Oral Liquids
- SC V D. Storage and Stability of Unlicensed Medicines
- SC V E. Extemporaneous Preparations
- SC V F. Aseptic Preparation of Unlicensed Medicines
- SC VI Pharmacopoeial Quantitative Analysis
- SC VII Traditional Herbal Medicines
- SC VIII Materials for use in the Manufacture of Homoeopathic Preparations
- SC IX Similar Biological Medicinal Products
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British Pharmacopoeia (Veterinary)
- British Pharmacopoeia (Veterinary) 2018
- Contents
- Notices
- Preface
- British Pharmacopoeia Commission
- Expert Advisory Groups, Panels of Experts and Working Parties
- Code of Practice
- Membership of the British Pharmacopoeia Commission
- Membership of Expert Advisory Groups, Panels of Experts and Working Parties
- Current British Pharmacopoeia Staff
- Current British Pharmacopoeia Laboratory Staff
- Current Staff of the Publisher of the British Pharmacopoeia
- Introduction
- General Notices
- Medicinal and Pharmaceutical Substances
- Formulated Preparations: General Monographs
- Formulated Preparations: Specific Monographs
- Immunological Products
- Surgical Materials (Sutures)
- Infrared Reference Spectra
-
Appendices
- Contents of the Appendices
- European Pharmacopoeia Equivalent Texts
- Appendix XV A (Vet). Terminology used in Monographs on Biological Products
- Appendix XV H (Vet). Chicken Flocks Free from Specified Pathogens for the Production and Quality Control of Vaccines
- Appendix XV H (Vet) 1. Healthy Chicken Flocks for the Production of Inactivated Vaccines for Veterinary Use
- Appendix XV J (Vet) 1. Cell Cultures for the Production of Veterinary Vaccines
- Appendix XV J (Vet) 2. Substances of Animal Origin for the Production of Immunological Veterinary Medicinal Products
- Appendix XV K (Vet) 1. Evaluation of Safety of Veterinary Vaccines and Immunosera
- Appendix XV K (Vet) 2. Evaluation of Efficacy of Veterinary Vaccines and Immunosera
- Appendix XV K (Vet) 3. Evaluation of Safety of each Batch of Immunosera for Veterinary Use
- Appendix XVI B (Vet) 3. Test for Absence of Mycoplasmas
- Appendix XVI B (Vet) 4. Avian Viral Vaccines: Tests for Extraneous Agents in Seed Lots
- Appendix XVI B (Vet) 5. Avian Live Virus Vaccines: Tests for Extraneous Agents in Batches of Finished Product
- Appendix XXI B (Vet). Approved Synonyms
- Supplementary Chapters