L-Methionine USP EP BP JP
Premium L-Methionine HCl for Critical Pharma & Nutraceutical Formulations
Premium L-Methionine HCl for Critical Pharma & Nutraceutical Formulations
Blue Eyes Bio delivers high-purity L-Methionine (CAS 63-68-3) manufactured under strict GMP guidelines, fully compliant with USP-NF, Ph.Eur., and JP standards. Essential for parenteral nutrition, detoxification therapies, and premium nutraceuticals.
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2. Technical Parameters (Key Trust Factors)
Parameter | Specification | Test Method |
Appearance | White crystalline powder | Visual |
Assay (Anhydrous) | 98.5% - 101.0% | USP Titration |
Specific Rotation | -7.7° to -8.7° | USP/EP |
pH (1% Solution) | 5.0 - 6.5 | USP |
Loss on Drying | ≤ 0.5% | EP 2.2.32 |
Heavy Metals (Pb) | ≤ 10 ppm | USP <231> |
Sulfate Ash | ≤ 0.1% | EP 2.4.14 |
Related Substances | ≤ 0.5% (Total Impurities) | HPLC, USP |
Endotoxins | < 0.5 EU/mg (Inj. Grade) | USP <85> |
Residual Solvents | Complies ICH Q3C | GC |
3. Application scenarios (solving customer pain points)
Pharmaceutical field
✓ Parenteral nutrition preparations: essential amino acids for patients with liver disease/postoperatively
✓ Detoxification therapy: antidote for acetaminophen poisoning (N-acetylcysteine precursor)
✓ Oral solid preparations: core ingredients of amino acid supplements
Health care products field
✓ Liver health products (glutathione synthesis promoter)
✓ Sports nutrition products (protein synthesis and anti-oxidation)
✓ Pet nutrition enhancers (essential amino acids for dogs)
Scientific research applications
✓ Key components of cell culture media ✓ Drug delivery system research
4. Quality compliance (core concerns of European and American customers)
Certification system
▶︎ GMP Manufacturing (ISO 9001 Certified)
▶︎ USP/EP/JP Monograph Compliance
▶︎ Batch-Specific COA & MSDS
▶︎ Regulatory Support (DMF/CEP filing support)
Quality control
▶︎ Triple quality control: raw material screening → process control → finished product full inspection
▶︎ Stability study: 36 months shelf life (25°C, avoid humidity)
5. Differentiation (strengthening competitiveness)
✅ **Ultra-high purity guarantee**
Pharmaceutical grade purity >99% (HPLC), heavy metal residues lower than EP standards
✅ **Injection-grade solutions**
Customized low-endotoxin products (<0.25 EU/mg)
✅ **Global supply chain resilience**
✅ **Technical collaboration support**
6. Packaging and logistics
✅ Standard packaging
25kg cardboard drum (lined with double-layer PE bag), or customized specifications
✅ Special requirements
Nitrogen protection packaging (anti-oxidation)｜Temperature-controlled transportation (2-8°C)
✅ Global delivery
DDP terms support｜
Compliance & Support
