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Pharmaceutical Chemistry
L-Cysteine Hydrochloride Monohydrate
Formula:
HSCH₂CH(NH₂)COOH·HCl·H₂O
GOST/CAS:
CAS 7048-04-6
L-Cysteine Hydrochloride Monohydrate (Highly Purified Pharmaceutical Substance) is a non-essential sulfur-containing amino acid in the form of a crystalline salt, playing a key role in the biosynthesis of proteins, glutathione, and vital coenzymes. The product is a white crystalline powder, highly soluble in water. Due to its powerful antioxidant properties, ability to stimulate tissue regeneration, and active involvement in metabolic processes, L-Cysteine HCl is indispensable in the production of pharmaceuticals, infusion solutions, dietary supplements, specialized nutrition, and premium cosmetics.
Applications
Pharmaceutical Manufacturing: Used as an Active Pharmaceutical Ingredient (API) for the synthesis of mucolytic drugs (e.g., Acetylcysteine), ophthalmic treatments (for cataracts), as well as medications aimed at liver function recovery and body detoxification.
Infusion Therapy and Parenteral Nutrition: Acts as a mandatory component in complex amino acid solutions for intravenous administration, used to restore protein balance in patients during post-operative periods or critical conditions.
Pharmaceutical Cosmeceuticals: Incorporated into therapeutic formulations for hair, skin, and nails. It stimulates the production of collagen and keratin, slows down aging processes, and promotes the healing of skin damage and strengthening of hair follicles.
Biotechnology and Cell Cultures: Applied as an essential nutrient substrate in media for cultivating microorganisms and cell lines during the production of vaccines, monoclonal antibodies, and other biotechnological products.
Key Advantages
Pharmaceutical Quality and High Purity: Manufactured in strict accordance with GMP standards and compliant with the rigorous requirements of leading pharmacopoeias (Ph. Eur., USP, BP), guaranteeing the absence of dangerous impurities and a stable safety profile.
High Bioavailability and Solubility: Due to its hydrochloride form and monohydrate structure, the substance features excellent water solubility, is rapidly absorbed by the body, and easily integrates into both liquid and solid dosage forms.
Pronounced Antioxidant Effect: Effectively neutralizes free radicals, protects cells from oxidative stress, and serves as a key precursor to glutathione—the body's master endogenous antioxidant.
Stability of Technological Properties: The product fully retains its chemical stability within complex multi-component blends, dry powders, capsules, and tablets when standard storage conditions are maintained.
Storage & Transportation
- Store in dry, clean, light-protected, and well-ventilated warehouses in tightly closed original packaging.
- Recommended storage temperature range is from +5°C to +25°C. Avoid exposure to moisture and direct sunlight, as the product is sensitive to oxidation.
- Keep away from strong oxidizing agents, alkalis, and heat sources.
- Transportation is permitted by all types of covered transport in accordance with the freight regulations applicable to each mode of transport. The material is classified as non-hazardous for transport.
- Shelf life is 3 years from the date of manufacture (provided the original factory packaging remains hermetically sealed).
Technical Specifications
Appearance
White crystalline powder or colorless crystals
Molecular Weight
175.64 g/mol
Assay (on dry basis)
99.0% – 101.0%
Specific Optical Rotation
+5.5° to +7.0°
pH (2.5% aqueous solution)
1.5 – 2.0
Loss on Drying
8.5% – 12.0%
Sulfated Ash
≤ 0.1%
Heavy Metals (as Pb)
≤ 10 ppm
Supply info
- Hermetic fiber drums of 25 kg net weight, equipped with a double inner polyethylene liner to ensure full protection against moisture and light.
- Availability of test samples and small batches for laboratory trials, formulation testing, and manufacturing process validation.