Sterility Test for Insulin Isophane Suspension

Which agents I use for Insulin Isophane suspension for filtration method to freely filter those suspension?

Can’t answer that question without knowing what is in your product matrix

Its a inj. insulin isophane 10 ml suspension

yes I get that, but does it contain zinc compounds? Is it filterable through a 0.45 um membrane? if not, perform direct inoculation. If it is, perform membrane filtration, the matrix will probably render the sample turbid, perform secondary inoculation after 14 days according to Ph.Eur.2.1.6

My product are zink free. its contain protamine sulfate and metacresol preservative. If I follow direct inoculation method, after 2 days the medium container becomes turbid.

Have you tried secundary inoculation?

No. Now I use heparin solution to filter tha isophane suspension.


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