pharmacopoeial standards


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this is description abt advanced pharmacopoeial standards

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pharmacopoeial standards

  1. 1. pharamacopoeial standards<br />RAGHAVA REDDY.K<br />RATNAM INSTIUTE OF PHARMACY<br />NELLOR E<br />ANDHRA PRADESH<br />12/30/2010<br />1<br />
  2. 2. Why we need standards ?<br />How we can frame the standards ?<br />What is pharmacopoeia ?<br />12/30/2010<br />2<br />
  3. 3. Scientific body<br />Subject experts<br />Representatives of CDSCO<br />State regulatory authorities<br />Specialist from industries<br />Associations ,councils...<br />12/30/2010<br />3<br />
  4. 4. Pharmacopoeiain its modern technical sense, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.<br />12/30/2010<br />4<br />
  5. 5. OBJECTIVE<br />The overall objective has been the creation of a compilation of standards that reflect the state of the industry in the country and the production and testing capabilities of units varying in size from the small to the very big.<br />12/30/2010<br />5<br />
  6. 6. Priority given to monographs of drugs included in the National Essential Drugs List and their dosage forms.<br /> Regular upgradation of monographs but consistent with the level and degree of sophistication acceptable to the majority of manufacturers.<br /> Harmonization of IP standards with international acceptance criteria for drug quality. <br />12/30/2010<br />6<br />
  7. 7. QUALITY STANDARDS<br />A compromise between the desirable and the achievable<br />Retention of simple tests where complicated methods offer no advantage<br />No compromise on limitation of toxic impurities<br />Gradual tightening of standards over the years<br />12/30/2010<br />7<br />
  8. 8. Pharmacopoeial standards are the minimum ones<br />Acceptable levels of change <br />Strong compliance between GMP and pharmacopoeial standards<br />12/30/2010<br />8<br />
  9. 9. The primary focus of the pharmacopoeia has been provision of standards for licensed products<br />Prescribing standards for labeling and packaging<br />Considerable support must be given to the traditional medicines<br />12/30/2010<br />9<br />
  10. 10. NORMAL FORMATE<br />Description: Physical form of the material, whether hygroscopic, odour, and indication of polymorphism, if applicable<br />Identification Tests usually including infrared spectrometry, if appropriate<br />Non-specific purity tests, such as light absorption, optical rotation, sulphated ash etc<br />12/30/2010<br />10<br />
  11. 11. Impurities may result from manufacturing process or by degradation of product during storage<br />Impurities other than related substances that may require control such as heavy metals, inorganic impurities, residues of solvents and reagents used during synthesis and purification<br />12/30/2010<br />11<br />
  12. 12. Storage guidelines considering different geographical atmosphere<br />Other tests such as loss on drying <br />Assay and limits for purity calculated on the anhydrous, dried or solvent-free basis, as appropriate <br />12/30/2010<br />12<br />
  13. 13. The requirements given in the monographs are not framed to provide against all possible impurities, contaminants or adulterants; they provide appropriate limitation of potential impurities only.<br />12/30/2010<br />13<br />
  14. 14. Identification tests based on those for the parent drug substance, where applicable, with suitable details for isolation of the active ingredient from the excipients.<br />Impurities as in the case of drug substances but additionally including those arising on manufacture or storage of the dosage form.<br />12/30/2010<br />14<br />
  15. 15. TEST METHODS<br />Pharmacopoeial methods usually prescribe the use of testing equipment available to most manufacturers and public testing laboratories.<br />Test methods are described in a clear language and in sufficient detail that they can be followed in any laboratory by a trained analyst. <br />12/30/2010<br />15<br />
  16. 16. Decision making capacity : which monograph we have to introduce[include] or exclude.<br />Based on the adverse effects ,<br /> indications, prevalence of the disease.<br />12/30/2010<br />16<br />
  17. 17. THALIDOMIDE-cons<br />12/30/2010<br />17<br />
  18. 18. ANTI-CANCER DRUGS-pros<br />They have serious adverse effects but because of their indications we have to<br /> continue in the treatment……….<br />They have serious adverse effects like<br /> alopecia<br /> neurotoxicity<br /> nephrotoxicity<br />cardiotoxicity<br /> HERE PROS &CONS MEANS POSITIVE & NEGATIVE<br />12/30/2010<br />18<br />
  19. 19. Expression of terms used in pharmacopoeia should be clear…..<br /> Ex: negligible<br /> freshly prepared<br />cold<br /> freezing temperature<br />12/30/2010<br />19<br />
  20. 20. HISTORY OF IP<br />Process started in the year 1944 under COL sri R.N CHOPRA<br />First publication in the year 1946<br />First edition in the year 1955<br /> 1966<br /> 1985<br /> 1996<br /> 2007<br /> 2010<br />12/30/2010<br />20<br />
  21. 21. TITLE INN<br />Chemical formula<br /> A.W&M.W<br />CATEGORY<br />description<br /> DOSE <br />usual strength<br />IDENTIFICATION<br />assay<br /> SOLUBILITY<br />structure<br />12/30/2010<br />21<br />