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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
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