Guangzhou Eric Wei Chemical Co., Ltd.
Guangzhou Eric Wei Chemical Co., Ltd.

Wacker L-Cysteine Hydrochloride Monohydrate Pharmaceutical Grade

Wacker L-Cysteine Hydrochloride Monohydrate Pharmaceutical Grade is a high-purity, GMP-compliant amino acid derivative from Wacker’s PharmaLine series. It serves as a critical excipient and reducing agent in biopharmaceutical formulations, offering exceptional stability, low endotoxin levels, and strict batch-to-batch consistency per EP/USP standards.
  • wacker l cysteine hydrochloride monohydrate pharmaceutical grade_9846a072
  • wacker l cysteine hydrochloride monohydrate pharmaceutical grade_9846a072

Features Of Wacker L-Cysteine Hydrochloride Monohydrate Pharmaceutical Grade

  1. High-purity pharmaceutical-grade material compliant with USP, EP, and JP monographs.

  2. Strictly controlled manufacturing process ensuring batch-to-batch consistency and low endotoxin levels.

  3. Optimized crystalline structure for enhanced solubility and stability in aqueous formulations.

  4. Produced under GMP conditions with full traceability and comprehensive CoA documentation.

  5. Free from heavy metals, residual solvents, and microbial contamination per ICH Q5D and Q7 guidelines.

Typical Applications Of Wacker L-Cysteine Hydrochloride Monohydrate Pharmaceutical Grade

  1. Active pharmaceutical ingredient (API) in mucolytic drugs such as acetylcysteine-based formulations.

  2. Stabilizer and reducing agent in parenteral nutrition solutions and injectable biologics.

  3. Key excipient in lyophilized protein therapeutics to prevent disulfide bond scrambling.

  4. Component in oral rehydration salts and pediatric nutritional supplements requiring redox balance.

  5. Raw material for synthesis of glutathione and other thiol-containing bioactive compounds.

Specifications Of Wacker L-Cysteine Hydrochloride Monohydrate Pharmaceutical Grade

Chemical TypeL-Cysteine hydrochloride monohydrate
Product FormWhite to off-white crystalline powder
AppearanceFree-flowing, odorless crystals
Assay (on dried basis)98.5–101.5%
Loss on Drying7.0–9.0%
pH (5% aqueous solution)1.5–2.5
Heavy Metals (as Pb)≤ 10 ppm
Sulfated Ash≤ 0.1%


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