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High-purity crystalline amino acid meeting strict ICH Q5, Q7, and USP-NF/EP pharmacopoeial requirements.
Manufactured under cGMP-compliant conditions in a dedicated pharmaceutical facility with full traceability.
Consistent batch-to-batch quality supported by comprehensive Certificates of Analysis and Compliance.
Optimized solubility and stability profile for reliable performance in oral solid dosage forms and parenteral formulations.
Free from specified allergens, BSE/TSE agents, and residual solvents—validated per ICH Q3C and Q5D guidelines.
Active pharmaceutical ingredient (API) in antioxidant and hepatoprotective drug formulations.
Stabilizing excipient in lyophilized biologics and peptide-based therapeutics.
Key component in medical nutrition products for patients with cystinuria or metabolic disorders.
Raw material for synthesis of glutathione and other redox-active pharmaceutical intermediates.
Functional ingredient in high-end nutraceutical capsules and effervescent tablets targeting immune support.
| Chemical Type | L-Cystine (L-3,3'-dithiobis(2-aminopropanoic acid)) |
| Product Form | Fine white crystalline powder |
| Appearance | White to almost white, odorless crystalline powder |
| Assay (on dried basis) | 98.5–101.5% (USP-NF) |
| Heavy Metals (as Pb) | ≤10 ppm |
| Residue on Ignition | ≤0.1% |
| Water Content | 0.5–1.5% (Karl Fischer) |
| Microbial Limits | Total aerobic count ≤100 CFU/g; absence of E. coli, Salmonella, and S. aureus |
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E-mail: wangxingqiang@ericwchem.com
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Building A1, Jiete Industrial Park, Huangpu District, Guangzhou City, Guangdong Province, China
