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Test Results for Residual Moisture - Atryn




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Memorandum

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

Subject: Test Results for Residual Moisture, pH and Solubility for Three (3) 
Lots of Antithrombin alfa (Recombinant) (ATryn) from GTC Biotherapeutics Inc. 
(license #1794)
STN: 125284/0
Lots 06C03-61, 06C10-61, 06C31-61 

To: Roman Drews HFM-392 LH, DH, OBRR and Pending License File STN 125284/0 

Through: William McCormick HFM-407, DPQ, OVRR
 Rajesh Gupta HFM-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 averages of measurements performed on two 
separate vials submitted to our division. Test results are as follows:



    Lot#

    CBER Result
     % Moisture

    CBER
     Test Date


      06C03-610.8301/12/09
      06C10-611.201/12/09
      06C31-611.301/12/09

GTC Biopharmaceuticals Inc. has specified a limit for residual moisture of 
-b(4)- for this product. CBER’s test results for these lots meet this 
specification.

Testing for pH and solubility were requested by Roman Drews, DH, OBRR. pH was 
performed as described in DPQ test method Doc. ID 000482, “pH Determination”. 
Solubility was evaluated after reconstitution with 10 ml of ASTM Type 1 reagent 
grade water. Evaluation for pH and solubility were performed on single vials of 
reconstituted product for each lot submitted.



    Lot#

    CBER Result
     % Moisture

    CBER
     Test Date


      06C03-616.912/15/08
      06C10-616.812/15/08
      06C31-616.812/15/08

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

Acceptance criterion for solubility is that dissolution time with slight 
swirling be not more than --b(4)---. The submitted samples of these lots were 
evaluated as meeting these criteria.
 

   
 


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  Approval History, Letters, Reviews and Related Documents - ATryn	[ARCHIVED] 
  ATryn 
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