In the German magazin pharmind (ECV Editio Cantor Verlag), BioChem points to its expertise in the independent quality control of pharmaceutical water. Water is one of the most frequently used raw materials for the production of pharmaceutical preparations. For the different water qualities, individual quality control requirements are specified in the pharmacopoeias.
Whether as an in-process control or for the qualification of water systems within the scope of a (new) construction project: as a GMP-certified quality control laboratory, BioChem offers you all the necessary analyses of pharmaceutical water and helps you to exclude possible impurities or to determine them precisely:
Microbiological testing (excerpt):
- testing for sterility acc. to Ph. Eur. 2.6.1 and USP <71>
- testing for bacterial endotoxins by LAL test acc. to Ph. Eur. 2.6.14/5.1.10 and USP <85>
rFC test acc. to Ph. Eur. 2.6.32 - microbiological examination (total aerobic count/bioburden) according to Ph. Eur. 2.6.12/2.6.13 and USP <61>/<62>
- identification of grown colonies by MALDI TOF
Physical-chemical analyses (excerpt):
- TOC (total organic carbon) and TN (total nitrogen)
- determination of conductivity
- aluminium, ammonium, calcium, chloride, magnesium, nitrate, sulphate
- oxidable substances
- acid/alkaline reacting substances
- heavy metals
- evaporation residues
- visible and non-visible particles
Click here to get the advertisement in pharmind (ECV Editio Cantor Verlag, in German).
Contact the experts of our microbiological department
The experts in our microbiological department will be pleased to provide you with advice and support in planning and carrying out microbiological tests for your products or projects. We will be pleased to prepare an offer tailored to your current issues.
Please use our contact form for your enquiry.
Contact the experts of our analytical department
The experts in our analytical department will be pleased to provide you with advice and support in planning and carrying out analytical tests for your products or projects. We will be pleased to prepare an offer tailored to your current issues.
Please use our contact form for your enquiry.