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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.