Vaccines, Blood & Biologics
Final Review Memo (12/17/2008) - RiaSTAP
MEMORANDUM
| From: | Alfred Del Grosso 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) |
| To: | Laura Wood HFM-340 LH, DH, OBRR and Pending License File STN 125317/0 |
| Through: | William McCormick HFM-407, 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 |
|---|---|---|---|
| 00168111 | 1 | 0.76 | 12/04/08 |
| 00268111 | 1 | 0.83 | 12/04/08 |
| 00368111 | 1 | 0.85 | 12/04/08 |
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 | CBER Result pH | CBER Test Date |
|---|---|---|---|
| 00168111 | 7.3 | 7.1 | 12/15/08 |
| 00268111 | 7.4 | 7.1 | 12/15/08 |
| 00368111 | 7.2 | 7.1 | 12/15/08 |
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
