Part 452—macrolide Antibiotic Drugs

(ii) Samples required: (a) The mitomycin used in making the batch: Five packages, each containing approximately 100 milligrams. (b) The batch: (1) For all tests except sterility: A minimum of 25 immediate containers. (2) For sterility testing: 20 immediate containers, collected at regular intervals throughout each filling operation. (b) Tests and methods of assay—(1) Potency. Proceed as directed in § 436.105 of this chapter, preparing the sample for assay as follows: Reconstitute as directed in the labeling. Using a suitable hypodermic needle and syringe, remove all of the withdrawable contents from each container if it is represented as a single dose container; or if the labeling specifies the amount of potency in a given volume of the resultant preparation, remove an accurately measured representative portion from each container. Dilute the solution thus obtained with sufficient 1 percent potassium phosphate buffer, pH 6.0 (solution 1), to give a stock solution of convenient concentration. Further dilute the stock solution with solution 1 to the reference concentration of 1 microgram of mitomycin per milliliter (estimated). (2) Sterility. Proceed as directed in § 436.20 of this chapter, using the method described in paragraph (e)(1) of that section. (3) Pyrogens. Proceed as directed in § 436.32(a) of this chapter, using a solution containing 0.5 milligram of mitomycin per milliliter. (4) [Reserved] (5) Depressor substances. Proceed as directed in § 436.35 of this chapter. (6) Moisture. Proceed as directed in § 436.201 of this chapter. (7) pH. Proceed as directed in § 436.202 of this chapter using the drug reconstituted as directed in the labeling. (8) Identity. Proceed as directed in § 436.310 of this chapter.