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| Product Information |
Product name | L-Glutathione Reduced; GSH; Glutathione |
Molecular Formula | C20H32N6O12S2 |
Molecular Weight | 612.63 |
CAS No. | 70-18-8 |
Assay | 99% up by HPLC |
Appearance | White or almost white crystalline powder |
| COA Of L-Glutathione Reduced |
Item | Specification | Result | Test Method |
Physical Properties | — | — | — |
Appearance | White or almost white crystalline powder | White crystalline powder | Visual Inspection |
Appearance of solution (10% w/v in water) | Clear and colorless | Complies | Visual (UV-Vis Spectrophotometry) |
Bulk Density | ≥0.20 g/ml | 0.25 g/ml | Volumetric Measurement |
Tapped Density | ≥0.40 g/ml | 0.542 g/ml | Tapped Density Analyzer |
Mesh Size | 100% through mesh 80 | Complies | Sieve Analysis (USP<786>) |
Chemical Analysis | — | — | — |
Identification (S.O.R.) | -15.5° ~ -17.5° | -15.6° | Specific Optical Rotation |
Identification (Infrared) | Positive | Positive | FTIR Spectroscopy |
Related Substances | |||
- L-glutathione oxidized | ≤1.5% | 0.3% | HPLC |
- Total impurities | ≤2.0% | 1.6% | HPLC |
Assay (dry basis) | 98.0% to 101.0% | 100.3% | HPLC |
Loss on drying (3 h at 105°C) | ≤0.5% | 0.2% | Gravimetric Analysis |
Residue on ignition | ≤0.1% | Complies | USP<281> Gravimetric Analysis |
Inorganic Impurities | — | — | — |
Ammonium | ≤200 ppm | Complies | Ion Chromatography |
Chloride | ≤200 ppm | Complies | Ion Chromatography |
Sulfate | ≤300 ppm | Complies | Turbidimetric Method |
Iron | ≤10 ppm | Complies | ICP-OES |
Heavy Metals | — | — | — |
Arsenic | ≤1 ppm | Complies | ICP-MS |
Cadmium | ≤1 ppm | Complies | ICP-MS |
Lead | ≤1 ppm | Complies | AAS |
Mercury | ≤1 ppm | Complies | Cold Vapor Atomic Absorption (CVAAS) |
Heavy metals (Total) | ≤10 ppm | Complies | ICP-MS |
Microbiology | — | — | — |
Total Aerobic Viable Count | ≤1000 cfu/g | Complies | AOAC 990.12 |
Yeast and Mold | ≤100 cfu/g | Complies | AOAC 997.02 |
Enterobacteriaceae | Negative/g | Complies | ISO 21528 |
E. Coli | Negative/10g | Complies | ISO 16654 |
Salmonella | Negative/10g | Complies | ISO 6579 |
Staphylococcus Aureus | Negative/10g | Complies | USP<62> |
Conclusion | Complies with USP 43 standards | — |
L-Glutathione Reduced (GSH) — Technological Breakthroughs in Antioxidant Processing and Multidimensional Applications |
L-Glutathione Reduced (L-Glutathione Reduced, CAS 70-18-8), as a core intracellular antioxidant, plays a vital role in maintaining redox balance and cellular detoxification. Innovations in its production process directly impact its bioactivity and market competitiveness. This article explores GSH industrial solutions across pharmaceuticals, nutraceuticals, and cosmetics from the perspectives of high-purity fermentation, stability-enhancing technologies, and dosage form innovation, with a focus on CDMO service integration.
Core Technologies: Bio-Fermentation and Targeted Purification |
1. High-Density Fermentation Technology
Strain Optimization: Engineered Saccharomyces cerevisiae strains are used to enhance intracellular GSH accumulation to 15%–20% of dry weight—significantly higher than traditional strains.
Fed-Batch Fermentation: Dynamic regulation of glucose and cysteine feeding shortens fermentation time to 48 hours and triples production capacity.
Green Extraction: High-pressure homogenization combined with ultrafiltration achieves ≥90% yield without solvent residues, supporting eco-friendly processing.
2. Multistage Purification System
Ion Exchange Chromatography: DEAE-cellulose columns with gradient elution effectively separate GSH from peptide impurities, achieving ≥99% purity (HPLC verified).
Crystallization: Low-temperature ethanol crystallization produces white crystalline powder conforming to Glutathione CAS 70-18-8 pharmacopeial standards.
Stability Enhancement: Vacuum freeze-drying combined with inert gas packaging extends shelf life to 24 months at room temperature.
Process Advantages: Efficient Conversion from Raw Material to End Product |
1. Efficacy and Safety Assurance
Antioxidant Potency: Verified via DTNB assay, GSH exhibits ≥98% reduction capacity, suitable for GSH supplements for liver health and immune-modulating drug development.
Impurity Control: LC-MS/MS analysis ensures heavy metals (Pb < 0.1 ppm) and endotoxins (<0.25 EU/mg) meet pharmaceutical-grade standards for injectables.
2. Innovative Dosage Forms & Enhanced Absorption
Transdermal Delivery Systems: Liposomal encapsulation significantly improves dermal absorption—up to 5x—for glutathione skin whitening effects in cosmetic formulations.
Oral Fast-Release Tablets: Multi-layer pellet coating protects GSH from gastric degradation, enabling targeted release in the small intestine and improving bioavailability by 40%.
CDMO End-to-End Service: Compliance & Customization |
1. Global Compliance Framework
Certifications: Complies with USP, EP, and JP pharmacopeia standards. FDA DMF registered, ISO 9001 and 13485 certified.
Regulatory Dossiers: Full documentation including ICH Q1A stability data, ICH M7 genotoxicity reports, and comprehensive L-Glutathione Reduced benefits efficacy data are provided for regulatory submissions.
2. Custom Formulation Development
Flexible Dosage Design: Based on How to take L-Glutathione Reduced studies, customizable doses from 50–1000 mg are available in tablets, lyophilized powder, or injectable formats.
Synergistic Formulations: Combined with Vitamin C and alpha-lipoic acid, next-generation products are developed to meet Best Glutathione Supplement 2025 market trends.
Application Scenarios: Cross-Sector Health Solutions |
1. Pharmaceutical Applications
Liver Protection: Clinical-grade injectable GSH (99.9% purity) reduces hepatic damage risk from chemotherapy agents.
Neuroprotection: Liposomal GSH capable of crossing the blood-brain barrier is used in adjunct therapy for Parkinson’s disease.
2. Functional Cosmetics
Anti-Photoaging Serums: GSH is combined with ergothioneine and astaxanthin to inhibit UV-induced collagen degradation.
Oral Beauty Supplements: GSH with collagen peptides improves skin radiance and elasticity from within.
| Product Information |
Product name | L-Glutathione Reduced; GSH; Glutathione |
Molecular Formula | C20H32N6O12S2 |
Molecular Weight | 612.63 |
CAS No. | 70-18-8 |
Assay | 99% up by HPLC |
Appearance | White or almost white crystalline powder |
| COA Of L-Glutathione Reduced |
Item | Specification | Result | Test Method |
Physical Properties | — | — | — |
Appearance | White or almost white crystalline powder | White crystalline powder | Visual Inspection |
Appearance of solution (10% w/v in water) | Clear and colorless | Complies | Visual (UV-Vis Spectrophotometry) |
Bulk Density | ≥0.20 g/ml | 0.25 g/ml | Volumetric Measurement |
Tapped Density | ≥0.40 g/ml | 0.542 g/ml | Tapped Density Analyzer |
Mesh Size | 100% through mesh 80 | Complies | Sieve Analysis (USP<786>) |
Chemical Analysis | — | — | — |
Identification (S.O.R.) | -15.5° ~ -17.5° | -15.6° | Specific Optical Rotation |
Identification (Infrared) | Positive | Positive | FTIR Spectroscopy |
Related Substances | |||
- L-glutathione oxidized | ≤1.5% | 0.3% | HPLC |
- Total impurities | ≤2.0% | 1.6% | HPLC |
Assay (dry basis) | 98.0% to 101.0% | 100.3% | HPLC |
Loss on drying (3 h at 105°C) | ≤0.5% | 0.2% | Gravimetric Analysis |
Residue on ignition | ≤0.1% | Complies | USP<281> Gravimetric Analysis |
Inorganic Impurities | — | — | — |
Ammonium | ≤200 ppm | Complies | Ion Chromatography |
Chloride | ≤200 ppm | Complies | Ion Chromatography |
Sulfate | ≤300 ppm | Complies | Turbidimetric Method |
Iron | ≤10 ppm | Complies | ICP-OES |
Heavy Metals | — | — | — |
Arsenic | ≤1 ppm | Complies | ICP-MS |
Cadmium | ≤1 ppm | Complies | ICP-MS |
Lead | ≤1 ppm | Complies | AAS |
Mercury | ≤1 ppm | Complies | Cold Vapor Atomic Absorption (CVAAS) |
Heavy metals (Total) | ≤10 ppm | Complies | ICP-MS |
Microbiology | — | — | — |
Total Aerobic Viable Count | ≤1000 cfu/g | Complies | AOAC 990.12 |
Yeast and Mold | ≤100 cfu/g | Complies | AOAC 997.02 |
Enterobacteriaceae | Negative/g | Complies | ISO 21528 |
E. Coli | Negative/10g | Complies | ISO 16654 |
Salmonella | Negative/10g | Complies | ISO 6579 |
Staphylococcus Aureus | Negative/10g | Complies | USP<62> |
Conclusion | Complies with USP 43 standards | — |
L-Glutathione Reduced (GSH) — Technological Breakthroughs in Antioxidant Processing and Multidimensional Applications |
L-Glutathione Reduced (L-Glutathione Reduced, CAS 70-18-8), as a core intracellular antioxidant, plays a vital role in maintaining redox balance and cellular detoxification. Innovations in its production process directly impact its bioactivity and market competitiveness. This article explores GSH industrial solutions across pharmaceuticals, nutraceuticals, and cosmetics from the perspectives of high-purity fermentation, stability-enhancing technologies, and dosage form innovation, with a focus on CDMO service integration.
Core Technologies: Bio-Fermentation and Targeted Purification |
1. High-Density Fermentation Technology
Strain Optimization: Engineered Saccharomyces cerevisiae strains are used to enhance intracellular GSH accumulation to 15%–20% of dry weight—significantly higher than traditional strains.
Fed-Batch Fermentation: Dynamic regulation of glucose and cysteine feeding shortens fermentation time to 48 hours and triples production capacity.
Green Extraction: High-pressure homogenization combined with ultrafiltration achieves ≥90% yield without solvent residues, supporting eco-friendly processing.
2. Multistage Purification System
Ion Exchange Chromatography: DEAE-cellulose columns with gradient elution effectively separate GSH from peptide impurities, achieving ≥99% purity (HPLC verified).
Crystallization: Low-temperature ethanol crystallization produces white crystalline powder conforming to Glutathione CAS 70-18-8 pharmacopeial standards.
Stability Enhancement: Vacuum freeze-drying combined with inert gas packaging extends shelf life to 24 months at room temperature.
Process Advantages: Efficient Conversion from Raw Material to End Product |
1. Efficacy and Safety Assurance
Antioxidant Potency: Verified via DTNB assay, GSH exhibits ≥98% reduction capacity, suitable for GSH supplements for liver health and immune-modulating drug development.
Impurity Control: LC-MS/MS analysis ensures heavy metals (Pb < 0.1 ppm) and endotoxins (<0.25 EU/mg) meet pharmaceutical-grade standards for injectables.
2. Innovative Dosage Forms & Enhanced Absorption
Transdermal Delivery Systems: Liposomal encapsulation significantly improves dermal absorption—up to 5x—for glutathione skin whitening effects in cosmetic formulations.
Oral Fast-Release Tablets: Multi-layer pellet coating protects GSH from gastric degradation, enabling targeted release in the small intestine and improving bioavailability by 40%.
CDMO End-to-End Service: Compliance & Customization |
1. Global Compliance Framework
Certifications: Complies with USP, EP, and JP pharmacopeia standards. FDA DMF registered, ISO 9001 and 13485 certified.
Regulatory Dossiers: Full documentation including ICH Q1A stability data, ICH M7 genotoxicity reports, and comprehensive L-Glutathione Reduced benefits efficacy data are provided for regulatory submissions.
2. Custom Formulation Development
Flexible Dosage Design: Based on How to take L-Glutathione Reduced studies, customizable doses from 50–1000 mg are available in tablets, lyophilized powder, or injectable formats.
Synergistic Formulations: Combined with Vitamin C and alpha-lipoic acid, next-generation products are developed to meet Best Glutathione Supplement 2025 market trends.
Application Scenarios: Cross-Sector Health Solutions |
1. Pharmaceutical Applications
Liver Protection: Clinical-grade injectable GSH (99.9% purity) reduces hepatic damage risk from chemotherapy agents.
Neuroprotection: Liposomal GSH capable of crossing the blood-brain barrier is used in adjunct therapy for Parkinson’s disease.
2. Functional Cosmetics
Anti-Photoaging Serums: GSH is combined with ergothioneine and astaxanthin to inhibit UV-induced collagen degradation.
Oral Beauty Supplements: GSH with collagen peptides improves skin radiance and elasticity from within.
