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At RSSL, we understand that not every manufacturer has the resources, expertise or equipment available to conduct raw materials testing and interpret the results. Whether applying the pharmacopoeia monographs, transferring in your methods, or developing new methods on your behalf, we can provide GMP QC testing services for your APIs, excipients and drug products.
Our services span chemical, physical, biopharmaceutical and microbiological testing. This includes detecting impurities in the production of raw materials containing amino acids, as outlined in Ph.Eur.2.2.56.
In addition to conducting analyses, we can provide expert consultancy, advice on the best testing approaches and guidance on topics such as harmonisation and upcoming pharmacopeial changes.
Our experienced scientists’ detailed analytical knowledge and extensive equipment capabilities mean that we are able to offer analysis for the majority of pharmacopoeia monographs, including:
We can employ the following techniques to meet your raw materials testing needs:
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