European Pharmacopoeia Sterile Pharmaceutical Release Testing
Pharmaceutical Laboratory needed for sterile biopharmaceutical release testing according to European Pharmacopeia to the following parameters and methods:
Test parameter Test Method Specification
Appearance Ph.Eur 2.2.1 White to yellowish-white lyophilizate
Uniformity of mass Ph.Eur 2.9.40 Complies to Ph.Eur
Solubility Soluble in water within 2 min without visible particles (2ml/amp)
Identification Ph.Eur Monograph Positive
Particle contamination: sub-visible particles Ph.Eur 2.9.19 = 6000 particles/container (particles = 10µm)
= 600 particles/container (particles = 25µm)
Particle contamination: visible particles Ph.Eur 2.9.20 Complies
Moisture Ph.Eur 2.2.32 =5%
Assay Ph.Eur Monograph 1350-1665 I.U./ amp
pH Ph.Eur 2.2.3 4.5-7.5 (1ml/amp)
Bacterial endotoxins Ph.Eur 2.6.14 ? 0.2 EE/I.U.
Sterility Ph.Eur 2.6.1 Sterile
Members of our Laboratory Outsourcing Network can use our online platform to communicate with the Lab Requestor, submit responses with quotes and have access to more information such as budget, location required, etc.
Contract Laboratory can help you with all your Biopharmaceuticals testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs including:
Need Biopharmaceuticals Testing or Scientific Research?
Save time and money searching. Simply, submit a Biopharmaceuticals request to find the laboratories or lab suppliers that best meet your needs.
Eastern Europe Genetics Laboratory needed for Food genetically modified organism GMO testing of soyabeans and corn. view
Small Business importing hats needs Textiles Laboratory for confirmatory testing of fabric composition. view