Test method for the absence of active clotting factors in dried human blood coagulation factor IX complex.
Adverse effects possibly due to the active clotting factors are sometimes reported upon administration of some preparations of Factor IX complex having conformed to the specifications in the Japanese Minimum Requirements for Biological Products. The author, therefore, proposed the revision of the test method for the absence of active clotting factors in the Minimum Requirements by introducing calcium ion into the test medium.
D002118:Calcium; D005164:Factor IX / Q000032:analysis* / Q000592:standards; D005170:Factor X / Q000032:analysis; D006801:Humans; D007477:Ions; D008722:Methods; D013917:Thrombin / Q000032:analysis*; D013997:Time Factors
D007477:Ions; D005164:Factor IX; D005170:Factor X; D013917:Thrombin; D002118:Calcium