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BN080041-InterSol Platlet Additive Solution CMC Mid Cycle Review Memo - Intersol
BN080041-InterSol Platelet Additive Solution
CMC Mid-Cycle Review Memo
InterSol solution is an isotonic solution designed to replace a proportion of the plasma used in the storage of platelets. It is intended for the storage of apheresis platelets collected using the AMICUS separator and stored for up to 5 days in a PL 2410 (non-PVC) plastic storage container.
The drug substance consists of the various USP salts used to prepare the solution. There is no new drug substance. InterSol solution will be supplied in a 500 mL PL 2411 plastic container with a nominal solution fill volume of -(b)(4)- mL.
Each 100 mL contains:
Dibasic Sodium Phosphate, Anhydrous, USP 305 mg
Monobasic Sodium Phosphate, Monohydrate, USP 93 mg
Sodium Citrate, Dihydrate, USP 318 mg
Sodium Acetate, Trihydrate, USP 442 mg
Sodium Chloride, USP 452 mg
Water for Injection, USP qs
No approvability related CMC issue at this point.