Stable, highly pure L-cysteine compositions for injection and methods of use

摘要: The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: or a pharmaceutically acceptable salt thereof and/or hydrate in an amount from about 10 mg/mL 100 mg/mL; Aluminum 1.0 parts per billion (ppb) 250 ppb; cystine 0.01 wt % 2 relative L-cysteine; pyruvic acid carrier, comprising water; headspace O that less than 1.0%; dissolved oxygen present the carrier million (ppm) 1 ppm, wherein composition enclosed single-use container having volume of mL mL. Also are total parenteral nutrition regimen and methods their use.