Specifications include, but are not limited to: SHetA2 capsules consist of 50 mg of lyophilized SHetA2 drug substance, Kolliphor HS 15, and D-(+)-trehalose dihydrate, which are encapsulated into size 0, swedish orange, opaque, hard gelatin capsules and packaged at a current Good Manufacturing Practice (cGMP) manufacturing facility and supplied to the Stephenson Cancer Center Pharmacy. The capsules must meet the following specifications: 1.2.1 Weight variation in the clinical batch should be 100 ± 5% of the total weight of capsule. 1.2.2 Uniformity of drug content should be 100 ± 5% of the labeled dose (161.5 mg to 178.5 mg of NSC 721689. 1.2.3 Disintegration: Capsules should disintegrate (powder) or disperse (semisolid) within 10 minutes when put into water or simulated gastric fluid at 37 °C. 1.2.4 Dissolution: More than 85% of the drug content should dissolve in less than 30 minutes when put into water or simulated gastric fluid at 37 °C.
