Description

L-Cysteine Hydrochloride, Monohydrate, USP

L-Cysteine Hydrochloride, Monohydrate, USP is a pharmaceutical-grade amino acid derivative used in injectable nutrition, inhalation therapies, and as a stabilizer in biologics and pharmaceutical manufacturing. As the hydrochloride salt of L-cysteine, this compound offers enhanced solubility and stability while maintaining the critical thiol functionality necessary for redox balance and protein structure. L-Cysteine Hydrochloride

• Is a USP-compliant amino acid derivative with reducing and antioxidant activity
• Is used in parenteral nutrition, mucolytic inhalants, and biologic stabilization
• Enhances disulfide bond formation in proteins and maintains redox potential
• Is suitable for injectable solutions, biologics processing, and excipient systems
• Is manufactured under Good Manufacturing Practice (GMP) conditions
• Is supplied with complete regulatory documentation including Certificate of Analysis (CoA) and supporting technical data

L-Cysteine Hydrochloride, Monohydrate is the crystalline form of L-cysteine hydrochloride containing one molecule of water of hydration. It appears as a white, crystalline powder freely soluble in water, with a slightly acidic pH. Its thiol (-SH) group serves as a critical reducing agent and precursor for glutathione synthesis.

In pharmaceutical and clinical applications, L-Cysteine Hydrochloride, Monohydrate USP is used in:

• Parenteral nutrition (PN) formulations as a source of sulfur-containing amino acids
• Inhalation therapies and mucolytics for chronic respiratory conditions like cystic fibrosis
• Biologic manufacturing to stabilize monoclonal antibodies, proteins, and peptides
• Culture media and fermentation processes in cell-based production systems
• Compounded solutions requiring thiol-based redox buffering or protection from oxidation

The compound supports protein folding and structure, particularly in disulfide-rich biologics, and helps reduce oxidative degradation during formulation, filling, and storage. In neonatology and clinical nutrition, it is often used to meet increased cysteine demands.

CarboMer supplies L-Cysteine Hydrochloride, Monohydrate USP with validated control over optical purity, water content, heavy metals, and microbial limits. Each lot conforms to United States Pharmacopeia (USP) monograph specifications for use in injectable and regulated pharmaceutical applications.

The material is packaged in sealed, light-protective, tamper-evident containers. Available in R&D, clinical, and commercial-scale volumes. Minimum order quantities (MOQ), lead times, and documentation—including CoA and SDS—are available upon request.

Each batch is tested for identity (IR, HPLC), assay (anhydrous basis), loss on drying, pH, specific rotation, chloride content, heavy metals, and microbial purity. Certificates of Analysis (CoA), Safety Data Sheets (SDS), and full traceability documentation accompany every shipment.

As with all CarboMer injectable-grade amino acids and biologic excipients, L-Cysteine Hydrochloride, Monohydrate USP is supported by technical expertise, regulatory guidance, and reliable global supply to ensure the development and delivery of safe, effective pharmaceutical products.