• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Final Review Memo (12/17/2008) - RiaSTAP

MEMORANDUM

From:

Alfred Del Grosso HFM-406, PQLS, DPQ, OVRR
Hsiaoling Wang HFM-406, PQLS, DPQ, OVRR

Subject:

 Test Results for Residual Moisture, pH, Solubility and Appearance for Three (3) Lots of Human Fibrinogen Concentrate, Pasteurized, CSL Behring GmbH, (license #1765)
STN: 125317/0
Lots 00168111, 00268111, 00368111

To:Laura Wood HFM-340 LH, DH, OBRR and Pending License File STN 125317/0
Through:

William McCormick HFM-407, DPQ, OVRR
Rajesh GuptaHFM-407 PQLS, DPQ, OVRR

Determination of residual moisture content was performed by CBER using Karl Fischer coulometric titration with methanol extraction of the lyophilized sample. The reported results are the average of measurements performed on methanol extractions of the contents of two separate vials of each lot. Test results are as follows:

Lot #Mfr Result
% Moisture
CBER Result
% Moisture
CBER
Test Date
0016811110.7612/04/08
0026811110.8312/04/08
0036811110.8512/04/08

CSL Behring GmbH has specified a limit for residual moisture of -(b)(4)- for this product. Both CBER”s and the manufacturer’s test results for these lots meet this specification.

Testing for pH, solubility and appearance were requested by Laura Wood, DH, OBRR.

pH was performed as described in DPQ test method Doc. ID 000482, “pH Determination”. Solubility and appearance were evaluated after reconstitution with 50 ml of Type 1 reagent grade water. pH, solubility and appearance evaluations were performed on single vials of reconstituted product for each lot submitted.

Lot #

Mfr Result
pH

CBER Result
pH
CBER
Test Date
001681117.37.112/15/08
002681117.47.112/15/08
003681117.27.112/15/08

The allowable range for pH in the license application submitted for this product is -(b)(4)-. Results obtained by both CBER and the manufacturer meet this specification.

Acceptance criterion for solubility is that dissolution time with slight swirling be not more than ---(b)(4)---. Appearance is described as “should be almost colorless, clear to slightly opalescent” and “---------------------(b)(4)---------------------- minutes after dissolution at --(b)(4)-- degrees C”. The submitted samples of these lots were evaluated as meeting these criteria.

cc: Karen Campbell