Pharmacopoeia of Eurasian Economic Union – Ph. EAEU

Pharmacopoeia of Eurasian Economic Union – Ph. EAEU

EAEU Pharmacopoeia

Volume I

Contents

  1. General notices

1.1. General statements

1.2. Other provisions applying to general chapters and monographs

1.5. Abbreviations and Symbols

1.6. Units of the international system (SI) used in the pharmacopoeia

 

  1. Methods of Analysis

2.1. Apparatus

2.1.1. Droppers

2.1.2. Comparative table of porosity of sintered-glass filters

2.1.3. Ultraviolet ray lamps for analytical purposes

2.1.4. Sieves

2.1.5. Tubes for comparative tests

2.1.6. Gas detector tubes

 

2.2. Physical and physicochemical methods

2.2.1. Clarity and degree of opalescence of liquids

2.2.2. Degree of coloration of liquids

2.2.3. Potentiometric determination of pH

2.2.4. Approximate pH of solution

2.2.5. Relative density

2.2.6. Refractive index

2.2.7. Optical rotation

2.2.8. Viscosity

2.2.9. Capillary viscometer method

2.2.10. Viscosity – Rotating viscometer method

2.2.11. Distillation range

2.2.12. Boiling point

2.2.13. Determination of water by distillation

2.2.14. Melting point – capillary method

2.2.15. Melting point – open capillary method

2.2.16. Melting point – instantaneous method

2.2.18. Freezing point

2.2.19. Amperometric titration

2.2.20. Potentiometric titration

2.2.21. Fluorimetry

2.2.22. Atomic emission spectrometry

2.2.23. Atomic absorption spectrometry

2.2.24. Absorption spectrophotometry, infrared

2.2.25. Absorption spectrophotometry, ultraviolet and visible

2.2.27. Thin-layer chromatography

2.2.28. Gas chromatography

2.2.29. Liquid chromatography

2.2.30. Size-exclusion chromatography

2.2.31. Electrophoresis

2.2.32. Loss on drying

2.2.35. Osmolality

2.2.38. Conductivity

2.2.40. Near-infrared spectroscopy

2.2.44. Total organic carbon in water for pharmaceutical use

2.2.46. Chromatographic separation techniques

2.2.47. Capillary electrophoresis

2.2.54. Isoelectric focusing

2.2.55. Peptide mapping

2.2.56. Amino acid analysis

2.2.57. Inductively coupled plasma-atomic emission spectrometry

2.2.60. Melting point – instrumental method

2.2.66. Detection and measurement of radioactivity

 

2.3. Identification

2.3.1. Identification reactions of ions and functional group

2.3.4. Odour

 

2.4. Limit tests

2.4.1. Ammonium salts

2.4.2. Arsenic

2.4.3. Calcium

2.4.4. Chlorides

2.4.5. Fluorides

2.4.6. Magnesium

2.4.7. Magnesium and alkaline-earth metals

2.4.8. Heavy metals

2.4.9. Iron

2.4.10. Lead in sugars

2.4.11. Phosphates

2.4.12. Potassium

2.4.13. Sulfates

2.4.14. Sulfated ash

2.4.15. Nickel in polyols

2.4.16. Total ash

2.4.17. Aluminum

2.4.18. Free formaldehyde

2.4.24. Identification and control of residual solvents

2.4.26. N,N-Dimethylaniline

2.4.27. Heavy metals in herbal drugs and herbal drug preparations

2.4.28. 2-Ethylhexanoic acid

 

2.5. Assay

2.5.1. Acid value

2.5.2. Ester value

2.5.3. Hydroxyl value

2.5.4. Iodine value

2.5.5. Peroxide value

2.5.6. Saponification value

2.5.7. Unsaponifiable matter

2.5.8. Determination of primary aromatic amino-nitrogen

2.5.9. Determination of nitrogen by sulfuric acid digestion

2.5.10. Oxygen-flask method

2.5.11. Complexometric titration

2.5.12. Water: semi-micro determination

2.5.32. Water: micro determination

2.5.33. Total protein

2.5.36. Anisidine value

 

2.6. Biological tests

2.6.1 Sterility

2.6.8. Pyrogens

2.6.12. Microbiological examination of non-sterile products: microbial enumeration tests

2.6.13. Microbiological examination of non-sterile products: test for specified micro-organisms

2.6.14. Bacterial endotoxins

2.6.31. Microbiological examination of herbal medicinal products for oral use and extracts used in their preparation

 

2.8. Methods in pharmacognosy

2.8.1. Ash insoluble in hydrochloric acid

2.8.2. Foreign matter

2.8.3. Stomata and stomatal index

2.8.4. Swelling index

2.8.5. Water in essential oils

2.8.6. Foreign esters in essential oils

2.8.7. Fatty oils and resinified essential oils in essential oils

2.8.8. Odour and taste of essential oils

2.8.9. Residue on evaporation of essential oils

2.8.10. Solubility in alcohol of essential oils

2.8.11. Assay of 1,8-cineole in essential oils

2.8.12. Essential oils in herbal drugs

2.8.14. Tannins in herbal drugs

2.8.15. Bitterness value

2.8.16. Dry residue of extracts

2.8.17. Loss on drying of extracts

2.8.23. Microscopic examination of herbal drugs

 

2.9. Pharmaceutical technical procedures

2.9.1. Disintegration of tablets and capsules

2.9.2. Disintegration of suppositories and pessaries

2.9.3. Dissolution test for solid dosage form

2.9.4. Dissolution test for transdermal patches

2.9.5. Uniformity of mass of single-dose preparation

2.9.7. Friability of uncoated tablets

2.9.8. Resistance to crushing of tablets

2.9.10. Ethanol content

2.9.17. Test for extractable volume of parenteral preparation

2.9.19. Particulate contamination: sub-visible particles

2.9.22.Softening time determination of lipophilic suppositories

2.9.27. Uniformity of mass of delivered doses from multidose containers

2.9.37. Optical microscopy

2.9.40. Uniformity of dosage units

2.9.42. Dissolution test for lipophilic solid dosage forms

2.9.91. Extractable volume for liquid dosage forms for internal use

2.9.92. Mass (volume) of the package’s contents

 

  1. Reagents

4.1.1. Reagents

4.1.2. Standard solutions for limit tests

4.1.3. Buffer solutions

4.2.2. Volumetric solutions

 

5.4. Residual solvents

5.5 Alcoholometric tables

5.9. Polymorphism

5.10. Control of impurities in substances for pharmaceutical use

5.11. Characters section in monographs

5.15. Functionality-related characteristics of excipients

5.16. Crystallinity

5.17.1. Recommendations on dissolution testing

 

1433 Herbal drugs

1483 Products with risk of transmitting agents of animal spongiform encephalopathy

1808 Veterinary liquid preparations for cutaneous applicationnal use

 

2034 Substances for Pharmaceutical Use