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Control & Standardisation

 

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Control & Standardisation

 

Control

 

Human albumin solutions from a number of manufacturers are received for batch release testing at NIBSC. Such tests include the assay of pre-kallikrein activator (PKA), SE-HPLC for polymers and aggregates, and a visual inspection for particulate contamination.

 

Product Release test(s) including whether PhEur/WHO or in house
Albumin

SE-HPLC for molecular size distribution (PhEur method)
  Appearance - visual inspection for particles (PhEur method)
  PKA assay (PhEur method)

 

 

Standardisation

Code Description
  02/168 2nd International Standard for PKA

 00/488

 PKA control Used in the PKA assay

 

 

 

 



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