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Pharmaceutical Chemicals: Purity and Management

INTRODUCTION   Since the Second World War a rapid development of  pharmaceutical chemicals , and ultimately drugs, has made a quantum progress. Medicinal chemists, pharmacologists, biochemists, analytical chemists and medical professionals have paved the way with their single goal objective to combat the sufferings of human beings. In this integrated effort the role of an analyst  vis-a-vis  the chemical purity of pharmaceutical substances and drugs made therefrom and finally the dosage forms that are usually available for direct patient’s usage, has become not only extremely crucial but also equally important and vital. As on date product safety has to be an integral part of all product research in pharmaceutical substances. However, the risk-beneft-ratio has got to be pegged to a bare minimum level. Therefore, it has become absolutely necessary to lay emphasis on product. safety research and development which is very crucial in all the developmental stages of a new secondary pharmace
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Pharmaceutical Chemicals: Purity

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  PURITY The standardization of ‘ pharmaceutical chemicals ’ and the dosage forms prepared therefrom plays a vital role so that the patient gets the ‘drug’ within the permissible limits of potency and tolerance.   The standards for pharmaceutical chemicals and their respective dosage forms, as laid down in, various   Official Compendia  fulfil broadly the following  three  cardinal objectives, namely :   ( a ) Broad-based highest attainable standard,   ( b ) Biological response  versus  chemical purity, and   ( c ) Offical standards  versus  manufacturing standards.   1. BROAD-BASED HIGHEST ATTAINABLE STANDARD   Keeping in view the various methods of manufacture of a pharmaceutical substance  vis-a-vis  its standards of purity, types of impurity and changing pattern of stability, a broad-based highest attainable standard is always fixed. A few typical examples are stated below :   2. BIOLOGICAL RESPONSE  VS.  CHEMICAL PURITY   Though chemical purity is the topmost priority, yet the bio
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Pharmaceutical Chemicals: Management

  MANAGEMENT Various  Official Compendia  of different countries categorically specify descriptive as well as informa-tive details with regard to the pharmaceutical substances and formulated dosage forms produced therefrom. Hence, all pharmaceutical chemicals and finished products must rigidly conform to the laid-out standards in a particular country and are subjected to various checks at different levels either by Government/State owned drug testing laboratories or by Government/State approved drug testing laboratories.   Official Compendia  for pharmaceutical substances usually include the following parameters, namely :   ·                Description of the Drug or Finished Product   ·                Identification Tests   ·                Physical Constants   ·                Assay of Pharmaceutical Substances   ·                Assay of Principal Active Ingredients in Formulated Dosage Forms   ·                Limit Test   ·                Storage Conditions
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Description of the Drug or Finished Product - Pharmaceutical Chemicals: Management

  DESCRIPTION OF THE DRUG OR FINISHED PRODUCT   The description of a particular drug or finished product may essentially include the following details, namely :   ·                Brand Name of the Product   ·                Name of the Active Ingredient   ·                Strength of Active Igredient in Dosage Form   ·                Lot/Batch Number   ·                Date of Manufacture   ·                Date of Expiry   ·                Storage Conditions (if any)   ·                Separate Dosage for Adults and Children
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Sampling Procedures and Errors - Pharmaceutical Chemicals: Management

  SAMPLING PROCEDURES AND ERRORS   To collect a ‘ representative sample ’ forms a vital aspect of analytical chemistry, because the samples subjected to analysis are assumed to be perfectly homogeneous and truly representative. Thus, sampling may be considered as the most critical aspect of analysis. In other words, the accuracy and significance of measurements may be solely limited by the sampling process. Unless and until the sampling process is performed properly, it may give rise to a possible weak link in the interpretation of the analytical results. For instance, the improper handling of a blood sample both during and after sampling from a patient prior to an operation may not only pose serious complications but also may prove fatal.   A definite instruction with regard to the sampling of given materials have been duly put forward by a number of professional societies, namely :   ·                Association of Official Analytical Chemists (AOAC),   ·                American Soci
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