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

Wacker L-Cysteine Hydrochloride Anhydrous Pharmaceutical Grade

Wacker L-Cysteine Hydrochloride Anhydrous Pharmaceutical Grade is a high-purity, sterile-filtered amino acid derivative from Wacker’s PharmaLine series—designed for parenteral formulations and biopharmaceutical processing. It meets USP/EP monographs with ≥98.5% purity, low heavy metals, and strict microbial limits. Ideal for redox control, protein stabilization, and cell culture media supplementation in GMP-compliant manufacturing environments.
  • wacker l cysteine hydrochloride anhydrous pharmaceutical grade_b5ddb6ca
  • wacker l cysteine hydrochloride anhydrous pharmaceutical grade_b5ddb6ca

Features Of Wacker L-Cysteine Hydrochloride Anhydrous Pharmaceutical Grade

  1. High-purity, anhydrous form meeting stringent ICH Q5C and Q7 guidelines for pharmaceutical excipients.

  2. Optimized crystalline structure ensuring excellent solubility and consistent dissolution profile in aqueous formulations.

  3. Manufactured under certified ISO 9001 and ISO 22000 quality management systems with full traceability.

  4. Free from animal-derived materials and compliant with EU Directive 2001/83/EC for human medicinal products.

  5. Stable shelf life of ≥24 months when stored at 2–8 °C in original sealed packaging under inert atmosphere.

Typical Applications Of Wacker L-Cysteine Hydrochloride Anhydrous Pharmaceutical Grade

  1. Reducing agent in parenteral formulations to prevent oxidation of labile active pharmaceutical ingredients (APIs).

  2. Stabilizer in lyophilized biologics, including monoclonal antibodies and recombinant proteins.

  3. Key component in amino acid-based intravenous nutrition solutions (TPN) for critical care patients.

  4. Excipient in oral solid dosage forms requiring redox control during manufacturing and storage.

  5. Raw material for synthesis of glutathione and other thiol-containing pharmaceutical intermediates.

Specifications Of Wacker L-Cysteine Hydrochloride Anhydrous Pharmaceutical Grade

Chemical TypeL-Cysteine hydrochloride monohydrate-free anhydrous salt
Product FormWhite to off-white crystalline powder
AppearanceFree-flowing, odorless crystals
Assay (on dried basis)98.5–101.0% (HPLC)
Loss on Drying≤0.5% (105 °C, 2 h)
Residue on Ignition≤0.1%
pH (5% w/v aqueous solution)1.5–2.5
Heavy Metals (as Pb)≤10 ppm


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