cGMP-Manufactured Amino Acid for Critical Pharma Applications
Purity: ≥99.5% (HPLC)
Compliance: USP-NF, EP 10.0, BP 2023
Endotoxins: <0.5 EU/mg (Tested by LAL)
Glycine serves as a critical buffer agent in injectable formulations (e.g. IV bags), and as an excipient in orally disintegrating tablets (ODTs)...
Pharmaceutical Grade Glycine (C₂H₅NO₂)
Ultra-Pure Glycine Conforming to USP, EP, BP & FCC Standards for Pharmaceutical, Nutraceutical and Cosmetic Applications.
2. Core selling points
- ✅ **≥99.5% Purity** (HPLC Verified)
- ✅ **Fully Compliant** with USP-NF, EP, BP, JP & FCC
3. Detailed technical parameter table
Parameter | Specification (USP/EP Grade) | Test Method |
Appearance | White crystalline powder | Visual |
Assay (Anhydrous Basis) | 98.5–101.5% | USP Titrimetry |
pH (1% Solution) | 5.5–6.5 | USP <791> |
Heavy Metals (as Pb) | ≤10 ppm | USP <231> / EP 2.4.8 |
Endotoxins | ≤0.5 EU/mg (for Injectable) | USP <85> |
Residual Solvents | Complies with ICH Q3C | GC |
Microbial Limits | TAMC ≤1000 CFU/g, TYMC ≤100 CFU/g | USP <61> |
4. Application Scenarios：
**Injectable Formulations**: Buffer agent in IV solutions.
- **Oral Solid Dosage**: Excipient for tablets/capsules (USP/EP compliant).
- **Sports Nutrition**: Key ingredient in protein supplements (FCC grade).
- **Cosmeceuticals**: Moisturizer & pH stabilizer in anti-aging creams.
5.certifications Section
*"Manufactured in cGMP-compliant facilities (ISO 13485:2016). All batches undergo rigorous QA/QC testing."*
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