Quality control

The injectables plant’s quality control laboratory offers a large variety of analytical methods for both raw materials and finished products.

 

Our analytical methods include:

Size-exclusion chromatography (GPC)

High-performance liquid chromatography (HPLC and UPLC)

Gas chromatography (GC)

UV/Vis chromatography

Anticoagulant activity for low-molecular-weight heparins (LMWH) and unfractionated heparins (UFH)

Moisture analysis by Karl Fischer titration

Total organic carbon (TOC) test

All of these analytical methods comply with the latest United States Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.) requirements.

Microbiology

The microbiology laboratory at the injectables plant offers a large variety of microbiological tests, which are available for testing raw materials or finished products.

 

Our microbiological tests include:

Sterility testing using Sterility Test Isolators

Endotoxin testing using the Gel-Clot or chromogenic method

Bioburden testing

Microbial identification

Environmental control testing

Liquid particle testing

Positive and negative controls for media fill testing (MFT)

All our microbiological tests comply with the latest United States Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.) requirements.

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