European Pharmacopoeia Equivalent Texts
In monographs reproduced from the European Pharmacopoeia the analytical methods, tests and other supporting texts are invoked by means of the reference number of the text in the General Chapters of the European Pharmacopoeia.
The table below lists the contents of the General Chapters of the European Pharmacopoeia and gives the British Pharmacopoeia or British Pharmacopoeia (Veterinary) equivalents. It is provided for information but it is emphasised that, for texts of the European Pharmacopoeia, in cases of doubt or dispute the text published by the Council of Europe is authoritative. Appendices of the British Pharmacopoeia (Veterinary) are identified by inclusion of ‘(Vet)’ after the Appendix letter, for example, Appendix XV J (Vet)1.
Ph. Eur. | Subject of text | British Pharmacopoeia reference |
1 | General Notices | (1) |
2.1.1 | Droppers | |
2.1.2 | Sintered-glass Filters | Appendix XVII B2 |
2.1.3 | ||
2.1.4 | ||
2.1.5 | ||
2.1.6 | ||
2.2.1 | Clarity and Degree of Opalescence of Liquids | |
2.2.2 | ||
2.2.3 | ||
2.2.4 | Approximate pH of Solutions | |
2.2.5 | ||
2.2.6 | ||
2.2.7 | ||
2.2.8 | ||
2.2.9 | Capillary Viscometer Method | Appendix V H, Method II |
2.2.10 | Rotating Viscometer Method | Appendix V H, Method III |
2.2.11 | ||
2.2.12 | ||
2.2.13 | ||
2.2.14 | ||
2.2.15 | ||
2.2.16 | ||
2.2.17 | Drop Point | |
2.2.18 | ||
2.2.19 | Amperometric Titration | |
2.2.20 | ||
2.2.21 | Fluorimetry | |
2.2.22 | ||
2.2.23 | Atomic Absorption Spectrometry | |
2.2.24 | ||
2.2.25 | ||
2.2.26 | ||
2.2.27 | ||
2.2.28 | ||
2.2.29 | ||
2.2.30 | ||
2.2.31 | ||
2.2.32 | Loss on Drying | |
2.2.33 | ||
2.2.34 | Thermogravimetry | |
2.2.35 | ||
2.2.36 | ||
2.2.37 | X-ray Fluorescent Spectrophotometry | |
2.2.38 | ||
2.2.39 | ||
2.2.40 | Near-Infrared Spectroscopy | |
2.2.41 | ||
2.2.42 | ||
2.2.43 | ||
2.2.44 | Total Organic Carbon in Water | |
2.2.45 | ||
2.2.46 | ||
2.2.47 | Capillary Electrophoresis | |
2.2.48 | Raman Spectroscopy | |
2.2.49 | Falling Ball Viscometer Method | Appendix V H, Method IV |
2.2.54 | Isoelectric Focussing | |
2.2.55 | Peptide Mapping | |
2.2.56 | Amino Acid Analysis | |
2.2.57 | ||
2.2.58 | Inductively Coupled Plasma-Mass Spectrometry | Appendix II G1 |
2.2.59 | Glycan Analysis of Glycoproteins | |
2.2.60 | Vacant | |
2.2.61 | Characterisation of Crystalline Solids by Microcalorimetry and Solution Calorimetry | |
2.2.64 | Peptide Identification by Nuclear Magnetic Resonance Spectrometry | |
2.2.65 | Voltametric Titration | |
2.2.66 | Detection and Measurement of Radioactivity | |
2.3.1 | Identification Reactions | |
2.3.2 | ||
2.3.3 | Identification of Phenothiazines by TLC | |
2.3.4 | ||
Limit test for: | ||
2.4.1 | – Ammonium | |
2.4.2 | ||
2.4.3 | ||
2.4.4 | ||
2.4.5 | ||
2.4.6 | ||
2.4.7 | ||
2.4.8 | ||
2.4.9 | ||
2.4.10 | ||
2.4.11 | ||
2.4.12 | ||
2.4.13 | – Sulfate | |
2.4.14 | Sulfated Ash | |
2.4.15 | Limit test for Nickel in Polyols | |
2.4.16 | Total Ash | |
2.4.17 | Limit test for Aluminium | |
2.4.18 | ||
2.4.19 | ||
2.4.20 | Determination of Metal Catalyst or Metal Reagent Residues | |
2.4.21 | ||
2.4.22 | ||
2.4.23 | ||
2.4.24 | ||
2.4.25 | Residual Ethylene Oxide and Dioxan | |
2.4.26 | N,N-Dimethylaniline | |
2.4.27 | Heavy Metals in Herbal Drugs and Fatty Oils | |
2.4.28 | ||
2.4.29 | ||
2.4.30 | ||
2.4.31 | ||
2.4.32 | Total Cholesterol in Oils Rich in Omega-3 Acids | |
2.5.1 | ||
2.5.2 | ||
2.5.3 | ||
2.5.4 | ||
2.5.5 | ||
2.5.6 | Saponification Value | |
2.5.7 | Unsaponifiable Matter | |
2.5.8 | Assay of Primary Aromatic Amino Nitrogen | |
2.5.9 | ||
2.5.10 | ||
2.5.11 | ||
2.5.12 | Semi-micro Determination of Water | Appendix IX C, Method I |
2.5.13 | ||
2.5.14 | ||
2.5.15 | Phenol in Immunosera and Vaccines | |
Polysaccharide Vaccines: | ||
2.5.16 | ||
2.5.17 | ||
2.5.18 | ||
2.5.19 | – O-acetyl | |
2.5.20 | ||
2.5.21 | ||
2.5.22 | ||
2.5.23 | ||
2.5.24 | ||
2.5.25 | ||
2.5.26 | Nitrogen Monoxide and Nitrogen Dioxide in Medicinal Gases | |
2.5.27 | ||
2.5.28 | Water in Medicinal Gases | |
2.5.29 | Sulfur Dioxide | |
2.5.30 | Oxidising Substances | |
2.5.31 | ||
2.5.32 | Micro Determination of Water | Appendix IX C, Method III |
2.5.33 | ||
2.5.34 | ||
2.5.35 | ||
2.5.36 | ||
2.5.37 | Methyl, Ethyl and Isopropyl Methanesulfonate in Methanesulfonic Acid | |
2.5.38 | Methyl, Ethyl and Isopropyl Methanesulfonate in Active Substances | |
2.5.39 | Methanesulfonyl Chloride in Methanesulfonic Acid | |
2.5.40 | Methyl, Ethyl and Isopropyl Toluenesulfonate in Active Substances | |
2.5.41 | Methyl, Ethyl and Isopropyl Benzenesulfonate in Active Substances | |
2.6.1 | ||
2.6.2 | Mycobacteria | Appendix XVI B4 |
2.6.3 | Vacant | |
2.6.4 | Vacant | |
2.6.5 | Vacant | |
2.6.6 | Vacant | |
2.6.7 | Mycoplasmas | |
2.6.8 | ||
2.6.9 | ||
2.6.10 | ||
2.6.11 | ||
2.6.12 | Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests | Appendix XVI B2 |
2.6.13 | Appendix XVI B1 | |
2.6.14 | Bacterial Endotoxins | |
2.6.15 | ||
2.6.16 | Extraneous Agents in Viral Vaccines | |
2.6.17 | Anticomplementary Activity of Immunoglobulins | |
2.6.18 | ||
2.6.19 | Neurovirulence of Poliomyelitis Vaccine (Oral) | |
2.6.20 | Anti-A and Anti-B Haemagglutinins | |
2.6.21 | ||
2.6.22 | Activated Coagulation Factors | |
2.6.24 | Avian Viral Vaccines: Tests for Extraneous Agents in Seed Lots | |
2.6.25 | Avian Live Virus Vaccines: Tests for Extraneous Agents in Batches of Finished Product | |
2.6.26 | Test for Anti-D Antibodies in Human Immunoglobulin | |
2.6.27 | Microbiological Control of Cellular Products | |
2.6.30 | Monocyte-Activation Test | |
2.6.31 | Microbiological Examination of Herbal Medicinal Products for Oral Use and Extracts used in their Preparations | |
2.6.33 | Residual Pertussis Toxin and Irreversibility of Pertussis Toxoid | |
2.6.34 | ||
2.7.1 | ||
2.7.2 | Microbiological Assay of Antibiotics | |
2.7.3 | Vacant | |
2.7.4 | Assay of Coagulation Factor VIII | |
2.7.5 | Assay of Heparin | |
2.7.6 | ||
2.7.7 | Assay of Pertussis Vaccine (Whole Cell) | |
2.7.8 | Assay of Tetanus Vaccine (Adsorbed) | |
2.7.9 | Fc Function of Immunoglobulins | |
2.7.10 | Assay of Human Coagulation Factor VII | |
2.7.11 | Assay of Coagulation Factor IX | |
2.7.12 | Assay of Heparin in Coagulation Factors | |
2.7.13 | Assay of Anti-D Immunoglobulin | |
2.7.14 | ||
2.7.15 | Assay of Hepatitis B (rDNA) Vaccine | |
2.7.16 | ||
2.7.17 | Assay of Human Antithrombin III | |
2.7.18 | Assay of Human Coagulation Factor II | |
2.7.19 | Assay of Human Coagulation Factor X | |
2.7.20 | In vivo Assay of Poliomyelitis Vaccine (Inactivated) | Appendix XIV K7 |
2.7.21 | Assay of Human von Willebrand factor | |
2.7.22 | Assay of Human Coagulation Factor XI | |
2.7.23 | Numeration of CD34/CD45+ Cells in Haematopoietic Products | |
2.7.24 | ||
2.7.25 | Assay of Human Plasmin Inhibitor | |
2.7.27 | Flocculation Value (Lf) of Diphtheria and Tetanus Toxins and Toxoids (Ramon Assay) | Appendix XIV K8 |
2.7.28 | Colony-forming Cell Assay for Human Haematopoietic Progenitor Cells | Appendix XIV N2 |
2.7.29 | Nucleated Cell Count and Viability | Appendix XIV N3 |
2.7.30 | Assay of Human Protein C | |
2.7.31 | Assay of Human Protein S | |
2.7.32 | Assay of Human α-1-Proteinase Inhibitor | |
2.7.34 | Assay of Human C1-esterase Inhibitor | |
2.7.35 | Immunonephelometry for Vaccine Component Assay | |
2.8.1 | ||
2.8.2 | ||
2.8.3 | ||
2.8.4 | ||
2.8.5 | Water in Essential Oils | |
2.8.6 | Foreign Esters | |
2.8.7 | ||
2.8.8 | Odour and Taste of Volatile Oils | |
2.8.9 | Residue on Evaporation | |
2.8.10 | Solubility in Ethanol (Volatile Oils) | |
2.8.11 | ||
2.8.12 | Essential Oils in Herbal Drugs | |
2.8.13 | ||
2.8.14 | Tannins in Herbal Drugs | |
2.8.15 | ||
2.8.16 | ||
2.8.17 | ||
2.8.18 | Determination of Aflatoxin B1 in Herbal Drugs | |
2.8.20 | ||
2.8.21 | Test for Aristolochic Acids in Herbal Drugs | Appendix XI R1 |
2.8.22 | Determination of Ochratoxin A in Herbal Drugs | |
2.8.23 | Microscopic Examination of Herbal Drugs | |
2.8.24 | Vacant | |
2.8.25 | High-performance Thin-Layer Chromatography of Herbal Drugs and Herbal Drug Preparations | |
2.9.1 | Appendix XII A1 | |
2.9.2 | Disintegration of Suppositories and Pessaries | |
2.9.3 | ||
2.9.4 | Dissolution Test for Transdermal Patches | Appendix XII B2 |
2.9.5 | ||
2.9.6 | Uniformity of Content | |
2.9.7 | Appendix XVII G1 | |
2.9.8 | ||
2.9.9 | Measurement of Consistency by Penetrometry | |
2.9.10 | Ethanol Content | |
2.9.11 | ||
2.9.12 | Appendix XVII A1 | |
2.9.13 | Vacant | |
2.9.14 | Specific Surface Area by Gas Permeability | |
2.9.15 | Vacant | |
2.9.16 | ||
2.9.17 | Extractable Volume of Parenteral Preparations | Appendix XII C5 |
2.9.18 | Aerodynamic Assessment of Fine Particles | Appendix XII C7 |
2.9.19 | Particulate Contamination: Sub-visible Particles | |
2.9.20 | ||
2.9.21 | Vacant | |
2.9.22 | ||
2.9.23 | ||
2.9.24 | Vacant | |
2.9.25 | Dissolution Test for Medicated Chewing Gums | Appendix XII B4 |
2.9.26 | Specific Surface Area By Gas Adsorption | |
2.9.27 | Uniformity of Mass of Delivered Doses from Multidose Containers | |
2.9.28 | Vacant | |
2.9.29 | Intrinsic Dissolution | Appendix XII B5 |
2.9.31 | ||
2.9.32 | ||
2.9.33 | Characterisation of Crystalline and Partially Crystalline Solids by X-ray Powder Diffraction (XRPD) | |
2.9.34 | ||
2.9.35 | Powder Fineness | |
2.9.36 | Powder Flow | |
2.9.37 | Optical Microscopy | |
2.9.38 | Particle-size Distribution Estimation by Analytical Sieving | |
2.9.39 | Water-Solid Interactions: Determination of Sorption-Desorption Isotherms and of Water Activity | |
2.9.40 | Uniformity of Dosage Units | Appendix XII C4 |
2.9.41 | Friability of Granules and Spheroids | Appendix XVII G2 |
2.9.42 | Dissolution Test for Lipophilic Solid Dosage Forms | Appendix XII B3 |
2.9.43 | Apparent Dissolution | Appendix XII B6 |
2.9.44 | Preparations for Nebulisation: Characterisation | Appendix XII C8 |
2.9.45 | ||
2.9.46 | Vacant | |
2.9.47 | Demonstration of Uniformity of Dosage Units Using Larger Sample Sizes | Appendix XII C9 |
3.1.1 | ||
3.1.1.1 | ||
3.1.1.2 | ||
3.1.3 | Polyolefins | |
3.1.4 | Polyethylene – Without Additives | Appendix XX C1 |
3.1.5 | Polyethylene – With Additives | Appendix XX C2 |
3.1.6 | ||
3.1.7 | Poly(ethylene–vinyl acetate) | |
3.1.8 | Silicone Oil Used as a Lubricant | |
3.1.9 | Silicone Elastomer for Closures and Tubing | Appendix XX F2 |
3.1.10 | ||
3.1.11 | ||
3.1.12 | Vacant | |
3.1.13 | ||
3.1.14 | Materials Based on Plasticised Poly(vinyl chloride) for Containers for Aqueous Solutions for Intravenous Infusion | Appendix XX A5 |
3.1.15 | Polyethylene Terephthalate for Containers for Preparations Not for Parenteral Use | |
3.2 | Containers | |
3.2.1 | Glass Containers for Pharmaceutical Use | |
3.2.2 | ||
3.2.2.1 | Plastic Containers for Aqueous Solutions for Parenteral Infusions | Appendix XIX C1 |
3.2.3 | ||
3.2.4 | ||
3.2.5 | Sterile Plastic Containers with Anticoagulant for Blood and Blood Components | Appendix XIX D3 |
3.2.6 | ||
3.2.7 | Vacant | |
3.2.8 | ||
3.2.9 | ||
4.1.1 | Reagents | |
4.1.2 | ||
4.1.3 | ||
4.2.1 | ||
4.2.2 | ||
5.1.1 | ||
5.1.2 | ||
5.1.3 | ||
5.1.4 | Microbiological Quality of Non-sterile Pharmaceutical Preparations and Substances for Pharmaceutical Use | |
5.1.5 | F0 Concept (sterilisation) | |
5.1.6 | ||
5.1.7 | ||
5.1.8 | Microbiological Quality of Herbal Medicinal Products for Oral Use and Extracts used in their Preparation | |
5.1.9 | ||
5.1.10 | Supplementary Chapter I C | |
5.1.11 | Determination of Bactericidal, Fungicidal or Yeasticidal Activity of Antiseptic Medicinal Products | |
5.2.1 | Terminology: Vaccines | |
5.2.2 | SPF Chicken Flocks | |
5.2.3 | ||
5.2.4 | Cell Cultures (Veterinary Vaccine Production) | |
5.2.5 | Substances of Animal Origin for the Production of Immunological Veterinary Medicinal Products | |
5.2.6 | Safety: Veterinary Vaccines | |
5.2.7 | Efficacy: Veterinary Vaccines | |
5.2.8 | ||
5.2.9 | Evaluation of Safety of Each Batch of Immunosera for Veterinary Use | |
5.2.11 | Carrier Proteins for the Production of Conjugated Polysaccharide Vaccines for Human Use | |
5.2.12 | Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products | Supplementary Chapter IV S |
5.2.13 | Healthy Chicken Flocks for the Production of Inactivated Vaccines for Veterinary Use | Appendix XV(Vet)1 |
5.3 | Statistical Analysis of Biological Assays and Tests | Supplementary Chapter IV G |
5.4 | ||
5.5 | ||
5.6 | ||
5.7 | Physical Characteristics of Radionuclides | |
5.8 | ||
5.9 | ||
5.10 | ||
5.11 | ||
5.12 | ||
5.14 | ||
5.16 | ||
5.17.1 | Recommendations on dissolution testing | |
5.19 | Extemporaneous Preparation of Radiopharmaceuticals | |
5.20 | Metal Catalyst or Metal Reagent Residues | |
5.21 | Chemometric Methods Applied to Analytical Data | |
5.22 | Names of Herbal Drugs Used in Traditional Chinese Medicine | |
5.23 | Monographs on Herbal Drug Extracts (Information Chapter) |
(1) Reproduced in full as Part III of the General Notices of the British Pharmacopoeia and British Pharmacopoeia (Veterinary).