§ 436.504 - Penicillin-bacitracin ointment.

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(a) Potency—(1) Penicillin content. Proceed as directed in § 540.380a(b)(1) of this chapter, except the last sentence of that paragraph. Its content of penicillin is satisfactory if it contains not less than 85 percent of the number of units it is represented to contain.

(2) Bacitracin content. Proceed as directed in § 448.510a(b)(1) of this chapter, except that sufficient penicillinase is added to the sample under test to completely inactivate the penicillin present. Its content of bacitracin is satisfactory if it contains not less than 85 percent of the number of units it is represented to contain.

(b) Moisture. Proceed as directed in § 436.201.

                    
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