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Isophane Insulin Human Suspension

Type of Posting: Revision Bulletin

Posting Date: 29–Jun–2012

Official Date: 01–Jul–2012

Expert Committee: Monographs—Biologics & Biotechnology 1

Reason for Revision: Compliance

In accordance with section 7.05 (c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the Monographs—Biologics & Biotechnology 1 Expert Committee has revised the Isophane Insulin Human Suspension monograph based on comments received:

Currently official test for Sterility<71> text reads as follows:

Sterility <71>—It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined, the Suspension being filtered immediately after it has been reduced to a clear solution by the addition of a freshly prepared 1 in 100 solution of ascorbic acid in Fluid A.

USP has received comments from manufacturers that the use of an acid in the diluent is inhibitory in this test. Based on these comments the wording was revised to the following in PF 36(6):

Sterility Tests <71>—It meets the requirements, when tested as directed for Test for Sterility of the Product to Be Examined, Membrane Filtration, and the Suspension being filtered immediately after it has been reduced to a clear solution by the addition of a freshly prepared solution (1 in 100) of ascorbic acid in Fluid A

^ and the Suspension being filtered immediately after it has been reduced to a clear solution by the addition of a suitable solvent, such as Heparin Sodium Injection

USP received comments from the FDA that a specific solvent should not be mentioned in the monograph. USP has revised the wording to meet the FDA’s request to the following wording which is acceptable to the FDA, manufacturers, and the MonographsBiologics & Biotechnology 1 Expert Committee:

Sterility Tests <71>—It meets the requirements, when tested as directed for Test for Sterility of the Product to Be Examined, Membrane Filtration, and the Suspension being filtered immediately after it has been put into solution using a validated suitable solvent.

This Isophane Insulin Human Suspension Revision Bulletin supersedes the currently official USP Isophane Insulin Human Suspension monograph. The Revision Bulletin will be incorporated in USP 36–NF 31.

Should you have any questions, please contact Kevin Carrick (301-230-6349 or klc@usp.org).