Analysis lec

• Base on the sample size of analysis

  Ultra-microanalysis - < 1mg

  micro-analysis - 1 mg - 10 mg

  semi- microanalysis - 10 mg - 100mg

  macro-analysis - 100 mg - 1g
• Proximate analysis


  Total amount of a class or a group of active plant principles in a given sample
• Ultimate analysis


  Amount of a specific constituent or a single chemical species present in the sample
• Classical method


  also known as general/ chemical/ wet/ stoichiometric method

  • example : titrimetric analysis, gravimetric analysis
• Instrumental method

  • more accurate
  • based on specific physical or chemical properties of the analyte
  • Examples: spectrometry, polarimetry, chromatography
• Electrochemical method


  Works by measuring the potential (volts) and/or current (amps) in an electrochemical cell containing the analyte
• Optical methods


  based upon the measurement of the interaction of the molecules with electromagnetic radiation
• Chromatography


  It is defined as the process of separation of the individual components of a mixture based on their relative affinities towards stationary and mobile phases
• Thermal method


  Refers to group of techniques in which a physical property of a substance is measured as a function of temperature while the substance is subjected to a controlled temperature program
• Miscellaneous or special method


  Involves the crude drugs and other natural products

  Examples: Acid value, Ash content, Water content
• Based on materials used

  • Chemical = titrimetric method
  • Physical = instruments and special apparata
  • Biological = use of microorganism and animals and parts thereof
• Volumetric Analysis


  It is an analysis involving the measurement of volume of a solution of known concentration required to react with the desired constituent
• Gravimetric Analysis


  It is an analysis involving the accurate measurement of weight of substance being determined which may be isolated in pure form or converted to another substance of known composition by making it react quantitatively with another substance usually a precipitant
• Special Methods


  analysis which require a distinct type of technique such as analysis of crude drugs, assay of fats and fixed oils, assay of volatile oils and assay of alkaloids
• Physico-Chemical Methods


  Analysis based on some specific physical or chemical property or properties of the substance being analyzed with the use of instruments such as: spectrophotometer, chromatograph units, polarographer, polarimeter, flourometer
• Official Compendia


  Approved sources of guidelines for drug quality required by certain practitioners or agencies
• Pharmacopoeia


  the word derives from the ancient Greek φαρμακοποιΐα(pharmakopoiia)

  drug-making
• (pharmako-)


  Drugs
• (poi-)


  Make
• Creation to signing of the first Philippine Pharmacopeia in cooperation with the Japanese Government through the initiatives of Dr. Conrado S Dayrit and Prof Akira Hamada


  1996
• Creation Pharmacopeia Organization for the preparation and publication of the Phil Pharmacopeia thru Department Order no. 216- F


  May 26, 1999
• Exec. Order 302 - Declaring and adopting the Phil Pharmacopeia as the Official book of Standards and Reference for Pharmaceutical Products and Crude plant drugs in the Philippines


  March 29, 2004
• 1864 


  Medical Act of 1858 published the first combined Pharmacopeia (London, Edinburgh and Dublin)

  British pharmacopeia
• 2007


  BP edition included monographs of materials used for Traditional Chinese medicines
• 2008 and thereafter


  revision is annual and is made official every 1st of January each year
• Japanese pharmacopeia


  was first published in 25 June, 1886
• Indian pharmacopeia


  was published in the year 1951 by WHO in cooperation with United Nations
• European pharmacopeia 


  Was published in 1969
• First US Pharmacopeia


  1778 - The first American formulary compiled by Gen William Brown was so called “Lititz Pharmacopeia” published at Lititz, Pensylvania, for use by the Military Hospital of the United States Army
• 1820 


  The first US Pharmacopeia through the efforts of : Dr. Lyman Spalding, Dr. Samuel Mitchill and Dr. Jacob Bigelow (Founders of US Pharmacopeial Convention)
• 1888


  First National Formulary was published by American PharmacistsAssociation (APhA)
• 1906

  President Theodore Roosevelt signed into law the first Federal Pure Food and Drug Act and changed the title to National

  Formulary, designating both USP and NF as establishing legal standards for medical and pharmaceutic substances
• 1975


  USP acquires NF and Drug standards Laboratory from APhA
• 1980 


  First combined USP-NF was published
• 2002


  USP revised and published annually, made official every 1st of May each year
• General Notices Section


  The section which presents the basic assumptions, definitions, and default conditions for the interpretation and application of the United States Pharmacopeia (USP) and the National Formulary (NF)
• General Chapters

  • 1 to 999 – Physical tests and determinations, microbiological tests, Chemical tests and assays, Biological tests and assays
  • 1000 to 1999 – General Information (no mandatory requirement)
  • Above 2000 apply to articles classified as Dietary ingredient or supplements
• Monograph

  • API and FPP
  • provides a specification by way of a name, definition, description, tests, procedures, and acceptance criteria and sometimes packaging and labeling requirements.
  • Sample Raw Material (RM) monograph
• USP–NF


  is a combination of two official compendia: the United States Pharmacopeia (USP) and the National Formulary (NF)
• Monographs


  for drug substances and preparations are featured in the USP