Prompt Insulin Zinc Suspension
» Prompt Insulin Zinc Suspension is a sterile suspension of Insulin in buffered Water for Injection, modified by the addition of a suitable zinc salt in a manner such that the solid phase of the suspension is amorphous. Its potency, based on the sum of its insulin and desamido insulin components, is not less than 95.0 percent and not more than 105.0 percent of the potency stated on the label, expressed in USP Insulin Units per mL.
Packaging and storage
Preserve in the unopened multiple-dose container provided by the manufacturer. Do not repackage. Store in a refrigerator, protect from sunlight, and avoid freezing.
Labeling
Label it to indicate the one or more animal species to which it is related, as porcine, as bovine, or as a mixture of porcine and bovine. Where it is purified, label it as such. Its container label states that the Suspension is to be shaken carefully before use. The label states the potency in USP Insulin Units per mL. Label it to state that it is to be stored in a refrigerator and that freezing is to be avoided.
Bacterial endotoxins 85
It contains not more than 80 USP Endotoxin Units per 100 USP Insulin Units.
pH 791:
between 7.0 and 7.8, determined potentiometrically.
Insulin not extracted by buffered acetone solution
Centrifuge 15 mL (40-Unit), 8 mL (80-Unit), or 6 mL (100-Unit) of Suspension, and discard the supernatant. Suspend the residue in 8.4 mL of water, quickly add 16.6 mL of buffered acetone TS, shake or stir vigorously, and centrifuge within 3 minutes after the addition of the buffered acetone TS. Discard the supernatant, repeat the treatment with water and buffered acetone TS, centrifuge, and discard the supernatant: no crystalline residue remains.
Limit of high molecular weight proteins
Proceed as directed in the test for Limit of high molecular weight proteins under Insulin Injection: not more than 1.5% is found.
Other requirements
It meets the requirements in the tests for Sterility and Insulin in the supernatant under Isophane Insulin Suspension and for Zinc content and Zinc in the supernatant under Insulin Zinc Suspension.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 2647
Pharmacopeial Forum: Volume No. 27(2) Page 2170
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