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.
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.
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.
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Contact Us:
Synthink Research Chemicals
Sr. No. 80, Near JSPM Shahu College,
Pune - Mumbai Bypass,
Tathawade, Pune.
India-411033
Mob: (+91) 7066038398
Email : info@synthinkchemicals.com
Website: http://www.synthinkchemicals.com
