Impurities in pharmaceuticals are the unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon aging of both API and formulated API’s to medicines .The presence of these unwanted chemicals even in small amounts may influence the efficacy and safety of the pharmaceutical products. Impurity profiling is the common name of a group of analytical activities, the aim of which is the detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities as well as residual solvents in bulk drugs and pharmaceutical formulations
The different pharmacopoeias, such as the British Pharmacopoeia (BP) and the United States Pharmacopoeia(USP) are slowly incorporating limits to allowable levels of impurities present in the API’s or formulations.Various regulatory authorities like ICH, USFDA, Canadian Drug and Health Agency are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredient’s (API’s). Qualification of the impurities is the process of acquiring and evaluating data that establishes biological safety of an individual impurity thus, revealing the need and scope of impurity profiling of drugs in pharmaceutical research .
International Conference on Harmonization (ICH) has published guidelines which define what investigations and documentation should be made in investigating impurities and degradation products seen in stability studies at recommended storage conditions.
International Conference on Harmonization (ICH) has published guidelines which define what investigations and documentation should be made in investigating impurities and degradation products seen in stability studies at recommended storage conditions.
ANALYSIS OF IMPURITIES:
In pharmaceutical research and development, IP is often decided by using high performance liquid chromatography (HPLC), mass spectrometry (MS) and nuclear magnetic resonance (NMR) spectrometry. There are different methods for detecting and characterizing impurities with TLC, HPLC, HPTLC, AAS etc.
About SynThink:
There is a good significant demand for the impurity-reference standards along with the API reference standards from both regulatory authorities and pharmaceutical companies.
There is a good significant demand for the impurity-reference standards along with the API reference standards from both regulatory authorities and pharmaceutical companies.
Synthink Research Chemicals offers services in custom synthesis from milligram to kilo scale.
We also offer reference standards of drug intermediates, like APIs, impurities and metabolites, building blocks, medchem compounds etc.
SynThink supply products to pharmaceutical, biotech companies as well as R&D labs at various research institutes and organizations. Read more >
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Synthink Research Chemicals
Sr. No. 80, Near JSPM Shahu College,
Pune - Mumbai Bypass,
Tathawade, Pune.
India-411033
Mob: (+91) 7066038398
Email : sales@synthinkchemicals.com
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