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STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE

  • US 20200222448A1
  • Filed: 01/27/2020
  • Published: 07/16/2020
  • Est. Priority Date: 01/15/2019
  • Status: Active Grant
First Claim
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1. A solution of L-cysteine comprising,a pharmaceutically acceptable carrier,about 50 mg/mL of L-cysteine hydrochloride monohydrate, or equivalent amount of a pharmaceutically acceptable L-cysteine or a salt or hydrate thereof,a pharmaceutically acceptable amount of cystine for at least about 12 months from the time of manufacture of the solution,less than about 150 ppb of aluminum for at least about 12 months from the time of manufacture of the solution,a pH from about 1.0 to about 2.5, andwherein the solution is enclosed in a single-use vial.

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