Qualification of the impurities is the process of acquiring and evaluating data
that establishes biological safety of an individual monograph or dug Substance.
Impurity standards thus revealing the need and scope of Impurity profiling of drugs
in Pharmaceutical Research
We have subject matter experts, who are engaged in the synthesis of impurities and
metabolites of active pharmaceutical ingredients which include antibiotics, steroids,
chiral, achiral drugs and deuterated compounds. The subject matter experts possess
core skills in reaction design, complex synthesis, purification, analysis and characterization.
Identification and synthesis of New Degradants and Impurities
In addition to its wide range of existing standards, Pharmaffiliates has considerable
expertise in the identification and synthesis of new and challenging degradants
and impurities. Pharmaffiliates can provide expert advice on the mechanism of degradant
formation and advise on modifications to formulations to reduce their levels. We
can synthesise multigram quantities of degradants for toxicity testing and assist
with your product development.
Quality & Reliability
Pharmaffiliates understands the needs of industry. Our certified standards are shipped
with a Certificate of Analysis, MSDS and all the required documentation to ensure
statutory domestic and international reputations. Our standards are of high purity,
scientifically characterized. Our laboratory and quality systems have successfully
passed audits by major pharmaceutical companies, four largest manufacturers among
We have over 8500 standards available in ready stock. Each Impurity Standard,working
standard is provided with its Certificate of Analysis, Chromatographic purity, Infra-red
spectra, NMR spectra etc with interpretation.