In order to meet these challenges one needs to adopt novel approaches in pharmaceutical research. Both molecular biology and genetic engineering will be exploited duly in opening up new routes. Genetic engineering may be explored in the development of new drugs, besides, being used as a research to investigate the molecular causes of severe and dreadful diseases. It is earnestly believed that towards the beginning of the keeping in view the tremendous global technological competition, one is left with no other choice than to internationalize research and development of pharmaceutical drugs to achieve the common objective better drugs for a better world. It is, however, pertinent to mention here that pharmaceutical chemicals must maintain a very high degree of chemical purity. It is quite obvious that a state of absolute purity may not be achievable, but a sincere effort must be exercised to obtain the maximum freedom from foreign substances. Bearing in mind the exorbitant operational costs to attain the ‘highest standards’ of purity, perhaps some of these processes are not economically viable. Therefore, a compromise has got to be made to strike a balance between the purity of a substance at a reasonably viable cost and at the same time its purity e.g.being fully acceptable for all pharmaceutical usages. In short, a host of impurities in pharmaceutical chemicals do occur that may be partially responsible for toxicity, chemical interference and general instability. In this chapter, the purity and management of pharmaceutical chemicals would be discussed briefly so as to take adequate cognizance of the importance of standardization of these substances, in addition to their management by Official Methods.

The standardization of pharmaceutical chemicals and the dosage forms prepared therefrom 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,  Broad-based highest attainable standard,  Biological response versus chemical purity, and  Offical standards versus manufacturing standards. Medical scientists mainly rely on the measurement of bioavailability of a drug as a positive indicator of therapeutic equivalence, because clinical efficacy for orally administered drugs depends on the degree of absorption and the presence of the active ingredient in the blood stream. Technical information based on in vivo standards and specifications are generally incorporated in various official compendia. Hence, in order to record a legitimate assessment of bioavailability, in vivo test is an absolute necessity and the relative data obtained therefrom should form an integral part of the standard specifications in the offcial standard. Any dosage-form can produce adverse drug reactions. Hence, a regular feedback of relevant information on such adverse reactions from the medical practitioners to the appropriate regulatory authorities and the concerned manufacturers would not only help to intensify better safety measures but also widen the scope to improve drug-design by meticulous research scientists all over the world.

Best Regards,
Nancy Ella
Associate Managing Editor
Drug Designing: Open Access