Laboratory Test Request Details

Biopharmaceuticals Test Request


Request: 18-01619

Status: Closed


Title:

European Pharmacopoeia Sterile Pharmaceutical Release Testing

Description:

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
90-111%
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


Interested in this Biopharmaceuticals Request?

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.

Create FREE Account


Other biopharmaceuticals laboratory services.

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:

Learn more about biopharmaceuticals testing and research

Biologics,Biopharmaceuticals,Immunotherapy and Immunotherapeutics,Pharmaceuticals ,Proteins and Peptides,

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.

Submit Laboratory Request

Test Request: 19-01226

Eastern Europe Genetics Laboratory needed for Food genetically modified organism GMO testing of soyabeans and corn. view


Test Request: 19-01225

Small Business importing hats needs Textiles Laboratory for confirmatory testing of fabric composition. view


Test Request: 19-01224

Canada Laboratory needed for testing iridium platinum gold and ozium in ppm view