Pharmaceutical companies develop, produce, and market drugs or pharmaceuticals licensed for use as medications, using chemical processes. They are subject to a variety of laws and regulations regarding the patenting, testing and ensuring safety and efficacy and marketing of drugs. For Pharmaceutical Testing Butterworth Laboratories Limited routinely assist such companies with:
Raw Material Testing
Much of our renown as an analytical chemistry laboratory derives from our Raw Material testing expertise where we have decades of experience in testing both active pharmaceutical ingredients (APIs) and inactive ingredients (excipients).
The various Pharmacopoeias provide monographs for the testing of the most commonly used raw materials in the pharmaceutical industry, and where there is no applicable method our Projects Team have the capability to develop and validate one to your requirements, or alternatively we can use your own.
Pharmacopoeias frequently used at Butterworth include:
- European Pharmacopoeia – Ph. Eur.
- United States Pharmacopoeia – USP
- British Pharmacopoeia – BP
- Japanese Pharmacopoeia – JP
- Chinese Pharmacopoeia – ChP
Finished Product Testing
Licenced and registered medicines in their finished dosage form must be tested to demonstrate that they comply with their specification to ensure patient safety and for those looking to outsource this testing, choosing a capable and qualified analytical partner is crucial.
Our MHRA and FDA-approved laboratory works to pharmacopoeias that provide monographs, not only for the chemical analysis of the API but also for the Phys/Chem characteristics such as dissolution and disintegration.
QC Release Testing
We routinely undertake QC testing of both raw materials and finished products, including Schedule I-V controlled drugs. We can also provide expertise in developing and validating suitably robust methods where none are available.
Explore some of the techniques we commonly use for the testing of pharmaceutical materials:
