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Identification and quantification of impurities is a crucial task in pharmaceutical process development for quality and safety. Related components are the impurities in pharmaceuticals which are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during stability testing, or develop during formulation or upon aging of both API and formulated APIs to medicines. The presence of these unwanted chemicals even in small amounts may influence the efficacy and safety of the pharmaceutical products. Various analytical methodologies are employed for the…mehr

Produktbeschreibung
Identification and quantification of impurities is a crucial task in pharmaceutical process development for quality and safety. Related components are the impurities in pharmaceuticals which are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during stability testing, or develop during formulation or upon aging of both API and formulated APIs to medicines. The presence of these unwanted chemicals even in small amounts may influence the efficacy and safety of the pharmaceutical products. Various analytical methodologies are employed for the determination of related components in pharmaceuticals. There is a great need for development of new analytical methods for quality evaluation of new emerging drugs. The ICH guideline which deals with "Stability Testing of new Drug Substances and Products" plays a vital role in establishing the stability of bulk drugs as well as the pharmaceutical formulations. The present work aimed at developing RP-HPLC method for Almotriptan and to carry out stability studies at different stress conditions.
Autorenporträt
Lipsa Samal completed her UG & PG (Pharmacy) from RCPHS, Odisha. She is having 3 years of teaching experience. She is the university gold medalist & also qualified GPAT. Total she is having 11 no. of Journal & 6 no. of book publications. Currently, she is working as Asst. Prof. at Centurion university of technology and management, Odisha, India.