International Journal of Pharmaceutical and Chemical Sciences
نویسندگان
چکیده
The control of impurities in Formulated products and Active Pharmaceutical ingredient’s were regulated by various regulatory authorities like US-FDA,ICH,MHRA,TGA etc.As per International Conference on Harmonization guidelines, the Impurity may be defined as any component of new drug product that is not the drug substance or an excipient in drug product. Nowadays apart from purity profile there was an increasing essentiality of impurity profile by regulatory agencies. Hence the Qualification of impurities which is essential for establishing the biological safety of an individual impurity. Thus it reveals the need and scope of impurity profiling of drugs in Pharmaceutical research.
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Pharma Science Monitor an International Journal of Pharmaceutical Sciences a Review: Chemical Penetration Enhancers
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