Pharmacopoeial / Raw Material Analysis
GMP testing of raw materials, APIs, excipients and drug products for compliance with appropriate standards, according to pharmacopoeial monographs and client methods
Our scientists have over 10 years’ experience and detailed knowledge of methods in a range of pharmacopeias, including EP, USP, BP and JP which enables us to provide dedicated support for pharmacopoeial testing.
A full suite of analytical equipment allows us to offer chemical and physical analysis covering all pharmacopoeial monographs.
In addition to monograph testing Almac has the ability to develop and validate new methods or transfer existing methods from our clients. We can work with your QC department to provide reliable test results quickly.
Impurities such as N-Nitrosodimethylamine (NDMA) have been highlighted by the US FDA, EMA and other regulatory authorities as an area for concern as they are probable human carcinogens. We have responded to regulatory guidance and offer laboratory drug testing to detect levels of NDMA and related impurities within our mass spectrometry laboratory. Our expert team have successfully performed testing on a number of APIs and Finished Products as per FDA method FY20-006-DPA-S_LCMSMS 10/17/2019 to establish levels of NDMA. Read our paper to find out more.