Contents of the Appendices

european pharmacopoeia equivalent texts

appendix i

A. General Reagents

B. Volumetric Reagents and Solutions

C. Standard Solutions

D. Buffer Solutions

E. Reference Materials

F. Polymorphism

appendix ii

A. Infrared Spectrophotometry

B. Ultraviolet and Visible Absorption Spectrophotometry

C. Nuclear Magnetic Resonance Spectrometry

D. Atomic Spectrophotometry: Emission and Absorption

E. Fluorescence Spectrophotometry [Fluorimetry]

F. X-Ray Fluorescence Spectrometry

G. Mass Spectometry

1. Inductively Coupled Plasma-Mass Spectrometry

H. Raman Spectrometry

J. Flow Cytometry

K. Peptide Identification by Nuclear Magnetic Resonance Spectrometry

L. Chemical Imaging

appendix iii

Chromatographic Separation Techniques

A. Thin-layer Chromatography

B. Gas Chromatography

C. Size-exclusion Chromatography

D. Liquid Chromatography

E. Paper Chromatography

F. Electrophoresis

G. Capillary Electrophoresis

H. Supercritical Fluid Chromatography

J. Isoelectric Focusing

K. Peptide Mapping

L. Amino Acid Analysis

M. Glycan Analysis of Glycoproteins

appendix iv

A. Clarity of Solution

B. Colour of Solution

appendix v

Determination of:

A. Melting Point

B. Freezing Point

C. Distillation Range

D. Boiling Point

E. Refractive Index

F. Optical Rotation and Specific Optical Rotation

G. Weight per Millilitre, Density, Relative Density and Apparent Density

H. Viscosity

J. Circular Dichroism

K. Approximate pH of Solutions

L. Determination of pH Values

M. Thermal Analysis

N. Osmolality

O. Conductivity

P. Total Organic Carbon in Water for Pharmaceutical Use

Q. Density of Solids

R. Detection and Measurement of Radioactivity

appendix vi

Qualitative Reactions and Tests

appendix vii

Nessler Cylinders

Tubes for Comparative Tests

Limit Test for:

Aluminium

Ammonium

Arsenic

Calcium

Chlorides

Fluorides

Heavy Metals

Iron

Lead in Sugars

Magnesium

Magnesium and Alkaline-earth Metals

Heavy Metals in Herbal Drugs and Herbal Drug Preparations

Nickel in Polyols

Phosphates

Potassium

Sulfates

appendix viii

A. Non-aqueous Titration

B. Amperometric, Potentiometric and Voltametric Titrations

C. Oxygen-flask Combustion

D. Complexometric Titrations

E. Potentiometric Determination of Ionic Concentration using Ion-selective Electrodes

F. Determination of Ethanol

G. Determination of Methanol and Propan-2-ol

H. Determination of Nitrogen

J. Tetrazolium Assay of Steroids

K. Ethylene Glycol and Diethylene Glycol in Ethoxylated Substances

L. Residual Solvents

M. Residual Ethylene Oxide and Dioxan

N. N,N-Dimethylaniline

O. 2-Ethylhexanoic Acid

P. Total Protein

Q. Acetic Acid in Synthetic Peptides

R. Nickel in Hydrogenated Vegetable Oils

S. Methyl, Ethyl and Isopropyl Methanesulfonate in Methanesulfonic Acid

T. Methyl, Ethyl and Isopropyl Methanesulfonate in Active Substances

V. Methanesulfonyl Chloride in Methanesulfonic Acid

W. Determination of Elemental Impurities

X. Methyl, Ethyl and Isopropyl Toluenesulfonate in Active Substances

Y. Methyl, Ethyl and Isopropyl Benzenesulfonate in Active Substances

appendix ix

Determination of:

A. Sulfated Ash

B. Sulfur Dioxide

C. Water

D. Loss on Drying

E. Limit Test for Carbon Monoxide in Medicinal Gases

F. Carbon Dioxide in Medicinal Gases

G. Nitrogen Monoxide and Nitrogen Dioxide in Medicinal Gases

H. Oxygen in Medicinal Gases

J. Water in Medicinal Gases

K. Gas Detector Tubes

L. Nitrous Oxide in Gases

M. Water-Solid Interactions: Determination of Sorption-Desorption Isotherms and of Water Activity

appendix x

A. Acetyl Value

B. Acid Value

C. Ester Value

D. Hydroxyl Value

E. Iodine Value

F. Peroxide Value

G. Saponification Value

H. Unsaponifiable Matter

J. Determination of Cineole

K. Determination of Aldehydes

L. Oxidising Substances

M. Essential Oils

N. Fixed Oils

O. Anisidine Value

P. Oils Rich in Omega-3-acids

1. Composition of Fatty Acids

2. Total Cholesterol in Oils Rich in Omega-3-Acids

Q Sterols in Fatty Oils

appendix xi

A. Total Solids

B1. Ethanol-soluble Extractive

B2. Water-soluble Extractive

C. Swelling Index

D. Foreign Matter

E. Essential Oils in Herbal Drugs

F. Continuous Extraction of Drugs

G. Complete Extraction of Alkaloids

H. Stomata

J. Ash

K. Acid-insoluble Ash

L. Pesticide Residues

M. Tannins in Herbal Drugs

N. Bitterness Value

O. Vacant

P. Dry Residue of Extracts

Q. Loss on Drying of Extracts

R. Test for Aristolochic Acids in Herbal Drugs

1. Test for Aristolochic Acids in Herbal Drugs

2. Test for Aristolochic Acids I and II in Herbal Drugs

S. Determination of Mycotoxins in Herbal Drugs

1. Determination of Aflatoxin B₁ in Herbal Drugs

2. Determination of Ochratoxin A in Herbal Drugs

T. Herbal Drugs: Sampling and Sample Preparation

U. Microscopic Examination of Herbal Drugs

V. Deoxyribonucleic acid (DNA) Based Identification Techniques for Herbal Drugs

W. High-performance Thin-Layer Chromatography of Herbal Drugs and Herbal Drug Preparations

appendix xii

A. Disintegration

1. Disintegration Test for Tablets and Capsules

2. Disintegration Test for Suppositories and Pessaries

B. Dissolution

1. Dissolution Test for Tablets and Capsules (Dissolution Test for Solid Dosage Forms)

2. Dissolution Test for Transdermal Patches

3. Dissolution Test for Lipophilic Solid Dosage Forms

4. Drug Release from Medicated Chewing Gum

5. Intrinsic Dissolution

6. Apparent Dissolution

C. Consistency of Formulated Preparations

1. Uniformity of Weight (Mass)

2. Uniformity of Weight (Mass) of Delivered Doses from Multidose Containers

3. Uniformity of Content

4. Uniformity of Dosage Units

5. Extractable Volume of Parenteral Preparations

6. Vacant

7. Aerodynamic Assessment of Fine Particles – Fine Particle Dose and Particle Size Distribution

8. Preparations for Nebulisation: Characterisation

9. Demonstration of Uniformity of Dosage Units Using Larger Sample Sizes

appendix xiii

Particulate Contamination

A. Sub-visible Particles

B. Visible Particles

appendix xiv

Biological Assays and Tests

A. Microbiological Assay of Antibiotics

B. Immunochemical Methods

C. Test for Bacterial Endotoxins

D. Test for Pyrogens

E. Test for Abnormal Toxicity

F. Test for Depressor Substances

G. Test for Histamine

H. Monocyte-Activation Test

I. Assay of Pancreatin

J. Blood and Related Products

Coagulants

A1. Assay of Human Coagulation Factor II

A2. Assay of Factor VII Fraction

A3. Assay of Factor VIII Fraction

A4. Assay of Factor IX Fraction

A5. Assay of Human Coagulation Factor X

A6. Assay of Human Coagulation Factor XI

A7. Activated Coagulation Factors

A8. Assay of Human von Willebrand factor

A9. Test for Prekallikrein Activator

A10. Assay of Human Plasmin Inhibitor

Anticoagulants

B1. Assay of Heparin in Coagulation Factors

B2. Assay of Heparin

B3. Assay of Human Antithrombin III

B4. Assay of Human Protein C

B5. Assay of Human Protein S

Immunoglobulins

C1. Test for Fc Function of Immunoglobulins

C2. Test for Anticomplementary Activity of Immunoglobulin

C3. Assay of Human anti-D Immunoglobulin

C4. Test for anti-D Antibodies in Human Immunoglobulin

C5. Anti-A and anti-B Haemagglutinins

Other blood-related components

D1. Assay of Human α-1-Proteinase Inhibitor

D2. Assay of Human C1-Esterase Inhibitor

K. Immunological Products

1. Assay of Diphtheria Vaccine (Adsorbed)

2. Assay of Pertussis Vaccine (Whole Cell)

3. Assay of Tetanus Vaccine (Adsorbed)

4. Assay of Hepatitis A Vaccine

5. Assay of Hepatitis B Vaccine (rDNA)

6. Assay of Pertussis Vaccine (Acellular)

7. In vivo Assay of Poliomyelitis Vaccine (Inactivated)

8. Flocculation Value (Lf) of Diphtheria and Tetanus Toxins and Toxoids (Ramon Assay)

9. Residual Pertussis Toxin and Irreversibility of Pertussis

L. Nucleic Acid Amplification Techniques

M. Assay of Interferons

N1. Numeration of CD34/CD45+ Cells in Haematopoietic Products

N2. Colony-forming Cell Assay for Human Haematopoietic Progenitor Cells

N3. Nucleated Cell Count and Viability

O. Host-cell Protein Assays

P. Determination of Bactericidal, Fungicidal or Yeasticidal Activity of Antiseptic Medicinal Products

appendix xv

Production and Testing of Vaccines

A. Terminology used in Monographs on Biological Products

B. Aluminium in Adsorbed Vaccines

C. Calcium in Adsorbed Vaccines

D. Free Formaldehyde

E. Phenol in Immunosera (Antisera) and Vaccines

F. Neurovirulence

1. Test for Neurovirulence of Live Virus Vaccines

2. Test for Neurovirulence of Poliomyelitis Vaccine (Oral)

G. Composition of Polysaccharide Vaccines

H. Chicken Flocks Free From Specified Pathogens for the Production and Quality Control of Vaccines

J. Cell Substrates for the Production of Vaccines for Human Use

K. Carrier Proteins for the Production of Conjugated Polysaccharide Vaccines for Human Use

L. Immunonephelometry for Vaccine Component Assay

M. Substitution of in Vivo Method(s) by in Vitro Method(s) for the Quality Control of Vaccines

appendix xvi

A. Test for Sterility

B. Microbiological Examination of Non-sterile Products

1. Test for Specified Micro-organisms

2. Microbial Enumeration Tests

3. Test for Absence of Mycoplasmas

4. Mycobacteria

5. Extraneous Agents in Viral Vaccines

C. Efficacy of Antimicrobial Preservation

D. Microbiological Quality of Non-sterile Pharmaceutical Preparations and Substances for Pharmaceutical Use

E. Microbiological Examination of Cell-Based Preparations

F. Microbiological Examination of Herbal Medicinal Products for Oral Use and Extracts used in their Preparation

G. Microbiological Quality of Herbal Medicinal Products for Oral Use and Extracts used in their Preparation

appendix xvii

A. Particle Size of Powders

1. Particle Size Classification of Powders

2. Powder Fineness

B. Sieves and Filters

1. Sieves

2. Filters

3. Particle-size Distribution Estimation by Analytical Sieving

C. Specific Surface Area by Air Permeability

D. Vacant

E. Flowability

F. Measurement of Consistency and Texture Analysis

1. Measurement of Consistency by Penetrometry

2. Texture Analysis of Semi-solids or Gels

G. Friability

1. Friability of Uncoated Tablets

2. Friability of Granules and Spheroids

H. Resistance to Crushing of Tablets

J. Softening Time Determination of Lipophilic Suppositories

K. Pycnometric Density of Solids

L. Vacant

M. Specific Surface Area by Gas Adsorption

N. Powder Flow

O. Optical Microscopy

P. Particle Size Analysis by Laser Light Diffraction

Q. Characterisation of Crystalline and Partially Crystalline Solids by X-ray Powder Diffraction (XRPD)

R. Porosity and Pore-size Distribution of Solids by Mercury Porosimetry

S. Bulk Density and Tapped Density of Powders

T. Wettability of Porous Solids Including Powders

U. Crystallinity

V. Characterisation of Crystalline Solids by Microcalorimetry and Solution Calorimetry

appendix xviii

Methods of Sterilisation

appendix xix

Containers

A. Introduction

B. Glass Containers for Pharmaceutical Use

C. Plastic Containers and Closures

1. Plastic Containers for Aqueous Solutions for Parenteral Infusions

D. Containers for Blood and Blood Components

1. Sterile Plastic Containers for Blood and Blood Components

2. Empty Sterile Containers of Plasticised Poly(Vinyl Chloride) for Human Blood and Blood Components

3. Sterile Containers of Plasticised Poly(Vinyl Chloride) for Human Blood Containing Anticoagulant Solution

E. Rubber Closures for Containers for Aqueous Parenteral Preparations

F. Sets for the Transfusion of Blood and Blood Components

G. Sterile Single-use Plastic Syringes

appendix xx

Materials Used for the Manufacture of Containers

A. Materials for Containers for Human Blood and Blood Components

1. Materials Based on Plasticised Poly(Vinyl Chloride) for Containers for Human Blood and Blood Components

2. Materials Based on Plasticised Poly(Vinyl Chloride) for Tubing Used in Sets for the Transfusion of Blood and Blood Components

3. Materials Based on Non-plasticised Poly(Vinyl Chloride) for Containers for Non-injectable, Aqueous Solutions

4. Materials Based on Non-plasticised Poly(Vinyl Chloride) for Containers for Solid Dosage forms for Oral Administration

5. Materials Based on Plasticised Poly(Vinyl Chloride) for Containers for Aqueous Solutions for Intravenous Infusion

B. Polyolefins

C. Polyethylene

1. Polyethylene Without Additives for Containers for Parenteral Preparations and for Ophthalmic Preparations

2. Polyethylene With Additives for Containers for Parenteral and for Ophthalmic Preparations

D. Polypropylene for Containers and Closures for Parenteral Preparations and Ophthalmic Preparations

E. Poly(ethylene - vinyl acetate) for Containers and Tubing for Total Parenteral Nutrition Preparations

F. Silicone

1. Silicone Oil Used as a Lubricant

2. Silicone Elastomer for Closures and Tubing

G. Plastic Additives

H. Polyethylene Terephthalate for Containers for Preparations not for Parenteral Use

appendix xxi

A. Abbreviated Titles

B. Approved Synonyms

C. Codes for Eye Drops in Single-dose Containers

appendix xxii

A. Viral Safety

B. Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products

appendix xxiii

Weights and Measures

B. Conversion Tables for Commonly Used Units

appendix xxiv

Abbreviations

appendix xxv

Names, Symbols and Atomic Weights of Elements