(3) Pharmacopeia

• Pharmacopoeia


  A legal and official book issued by recognized authorities usually appointed by Government of each country, comprising list of pharmaceutical substances, formulae along with their description and standards
• Monographs


  Descriptions of preparations
• List of Pharmacopoeias


  • British
  • European
  • Indian
  • International
  • United States
• British Pharmacopoeia (BP)


  1. First edition published in 1864

  2. Second edition published in 1867

  3. Fourth edition published in 1898

  4. Fifth edition published in 1914

  5. Eighth edition published in 1953
• British Pharmacopoeia (BP)


  • Titles of drugs & preparations were in English instead of Latin and metric system was used
  • Published annually
• British Pharmacopoeia (BP) 2007-2009

  • Given in Six Volumes
  • Volume I & II contains medicinal substances
  • Volume III contains formulated preparations, blood related products, immunological products, radiopharmaceutical preparations, surgical materials & homoeopathic preparations
  • Volume IV contains supplementary chapters, IR spectra etc.
  • Volume V contains veterinary
  • Volume VI contains CD ROM version
• United States Pharmacopeia (USP)

  1. First edition published on 15th December 1820 in both Latin & English

  2. Published at Ten years intervals from 1820 to 1942

  3. Published at Five years intervals from 1942 to 2000

  4. Published annually from 2002
• European Pharmacopoeia (EP)


  1. 1st edition published in 1967

  2. 2nd edition published in 1980

  3. 3rd edition published in 1997

  4. 4th edition published in 2001, valid from 1 January 2002

  5. 5th edition published in 2004, valid from 1 January 2005

  6. 6th edition published in 2007, valid from 1 January 2008

  7. 7th edition published in 2010, valid from 1 January 2011

  8. 8th edition published in 2013, valid from 1 January 2014
• Monographs


  • Based on the specifications for substances used in medicinal products approved in Member States
  • Interested parties should be invited to participate in the elaboration of the monograph before publication in Pharmeuropa
• Preparation of Monographs


  1. Gather information on the substance's origin, composition, preparation method, crystalline forms, enantiomers, hydrates, etc.

  2. Consult existing monographs on similar substances

  3. Use the International Nonproprietary Name (INN) established by the World Health Organization for the title

  4. Precisely define the chemical structure, empirical formula, relative molecular mass, etc.

  5. Specify the content/assay limits

  6. Describe the appearance, solubility, stability, hygroscopicity, solid-state properties, and behavior in solution

  7. Provide identification tests using physical, chemical, and instrumental methods
• The purpose of the Identification section is to provide confirmation of the identity of the substance
• The Appearance of solution test is used to ascertain the general purity of a substance by detecting insoluble or colored impurities
• The Appearance of solution test is practically always prescribed for substances intended for parenteral preparations
• Pharmacopoeia


  A legal and official book issued by recognized authorities usually appointed by Government of each country, comprising list of pharmaceutical substances, formulae along with their description and standards

  
• Monographs

  Descriptions of pharmaceutical preparations

  
• List of Pharmacopoeias

  • British
  • European
  • Indian
  • International
  • United States
• British Pharmacopoeia (BP)

  • First edition published in 1864
  • Consists of two sections: Part I - Materia Medica, Part II - Preparation & compounds
  • Titles of drugs & preparations in English instead of Latin and metric system from 8th edition published in 1953
  • Published annually
• British Pharmacopoeia (BP) 2007-2009

  • Given in Six Volumes: Volume I & II contains medicinal substances, Volume III contains formulated preparations, blood related products, immunological products, radiopharmaceutical preparations, surgical materials & homoeopathic preparations, Volume IV contains supplementary chapters, IR spectra etc., Volume V contains veterinary, Volume VI contains CD ROM version

  
• United States Pharmacopoeia (USP)

  • First edition published on 15th December 1820 in both Latin & English
  • Published at Ten years intervals from 1820 to 1942
  • Published at Five years intervals from 1942 to 2000
  • Published annually from 2002
• European Pharmacopoeia (EP)

  • European pharmacopeia commission started working since 1964
  • 1st edition published in 1967, 2nd edition in 1980, 3rd edition in 1997, 4th edition in 2001, 5th edition in 2004, 6th edition in 2007, 7th edition in 2010, 8th edition in 2013
• Monographs

  • Based on the specifications for substances used in medicinal products approved in Member States
  • Interested parties should be invited to participate in the elaboration of the monograph before publication
• Preparation of Monographs

  1. Gather information on the substance: origin, whether mixture or single entity, method of preparation, different crystalline forms, enantiomers, hydrates, different entities (acid, base, salt, etc)

  2. Consult existing monographs on similar substances

  3. Use International Nonproprietary Name (INN) established by WHO in the title

  4. Ascertain chemical structure, graphic formula, empirical formula, relative molecular mass, chemical name

  5. Specify content limits taking into account precision of method and acceptable purity
• Characters of Monographs

  • Appearance (color, physical form)
  • Taste (not to be considered)
  • Odour (generally not mentioned)
  • Solubility
  • Stability factors
  • Hygroscopicity
  • Solid-state properties (crystallinity, polymorphism, density, particle size, specific surface area)
  • Melting point, decomposition, optical rotation, radioactive half-life and radiation type
  • Behavior in solution
• Identification in Monographs

  • Provide confirmation of identity using physical and/or chemical tests and reactions
  • Distinguish active substances and excipients with similar structures
  • Methods include spectrophotometric analysis, chromatographic examination, determination of physical constants, chemical reactions
• Tests in Monographs

  • Appearance of solution (clarity, degree of opalescence, degree of coloration)
  • Performed on solution S, usually in water but other solvents may be used
  • Concentration of 50-100 g/L for very pure substances or high dose, 10-20 g/L for less pure substances or small doses