Pharmaceutical raw material analyses according to European Pharmacopoeia monographs

Measurlabs offers a broad range of physico-chemical and microbiological assays to verify that pharmaceutical raw materials (e.g., APIs, excipients, API precursors, process water, and solvents) meet the quality criteria specified in the applicable European Pharmacopoeia (Ph. Eur.) monograph. Some examples of ingredients we have experience analyzing include microcrystalline cellulose (Ph. Eur. 0316), 85% glycerol (Ph. Eur. 0497), gelatin (Ph. Eur. 0330), and potassium sorbate (Ph. Eur. 0618).

Properties that can be determined include:

  • Appearance and identity

  • Solubility, pH, conductivity, and viscosity

  • Microbiological quality (TAMC, TYMC, specified microorganisms)

  • Impurities (e.g., heavy metals, bacterial endotoxins)

  • Particle size distribution and powder flowability characteristics

Testing is conducted in accordance with the Ph. Eur. general chapters referenced in the applicable monograph. We offer methods suitable for R&D as well as GMP-compliant quality control and batch release testing.

We have access to the full set of Ph. Eur. monographs and can offer most tests specified in them. Please contact us using the form below for more information and a quote.

Suitable sample matrices
Pharmaceutical raw materials
Available quality systems
Accredited testing laboratory

Questions? We're happy to help.

Questions? We're happy to help.

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