Grade-specific quality control and technical documentation for pharmaceutical, nutraceutical and cosmetic development.
Source L-Glutathione Reduced with grade-specific quality control and the technical documentation needed for supplier qualification.
Ureda supplies L-Glutathione Reduced for pharmaceutical, nutraceutical and cosmetic product development. USP-NF, EP and food-grade options are available, supported by batch-specific Certificates of Analysis, controlled impurity profiles, microbiological testing and long-term stability documentation.
Whether you are qualifying a pharmaceutical raw material, developing a dietary supplement or sourcing a cosmetic formulation ingredient, our team can help you select the appropriate grade and prepare the corresponding documentation package.
*Product highlights*
- USP-NF, EP and food-grade options
- Assay specification of 98.0%-102.0% on the dried basis
- Enzymatic manufacturing technology
- Batch-specific COA and grade-specific specification
- 36-month long-term stability data available for referenced EP-grade batches
- Standard 25 kg drum packing, with additional packing options subject to confirmation
- Sample, technical document and quotation support
*Request a batch COA, sample or quotation for your target application.*
L-Glutathione Reduced at a Glance
L-Glutathione Reduced, also known as Reduced Glutathione or GSH, is a tripeptide composed of glutamic acid, cysteine and glycine. For industrial buyers, however, product identity alone is not enough. Grade selection, impurity control, microbiological quality, stability and documentation must all match the intended formulation and destination market.
| Product item | Information |
|---|---|
| Product name | L-Glutathione Reduced |
| Common names | Reduced Glutathione, Glutathione, GSH |
| CAS number | 70-18-8 |
| Molecular formula | C10H17N3O6S |
| Molecular weight | 307.32 |
| Appearance | White crystalline powder or white crystals |
| Solubility | Freely soluble in water; very slightly soluble in ethanol and methylene chloride |
| Available grades | USP-NF, EP and food grade |
| Assay specification | 98.0%-102.0% on the dried basis |
| Standard packing | 25 kg/drum |
| Available documents | Specification, batch COA, TDS, SDS and stability data, as applicable |
Choose the Right Glutathione Grade for Your Application
The correct grade should be selected according to the finished-product category, dosage form, route of administration, destination market and the customer’s internal qualification requirements. A pharmacopoeial name should never be treated as a substitute for reviewing the current specification and batch COA.
USP-NF L-Glutathione Reduced
USP-NF grade is designed for customers requiring a United States Pharmacopeia-National Formulary specification and a detailed pharmaceutical quality profile.
The representative USP-NF COA includes:
- Chemical, HPLC and infrared identification
- Specific optical rotation
- Assay on the dried basis
- Oxidized Glutathione and other specified related substances
- Total impurities
- Methanol and ethanol residual-solvent testing
- Loss on drying and residue on ignition
- Chloride, sulfate, ammonium, iron and arsenic controls
- Microbiological limits
- Bacterial endotoxin testing for the referenced batch
In the representative batch, the assay result was 98.8%, oxidized Glutathione was 0.29%, and total impurities were 0.42%. These figures are representative batch results rather than guaranteed values for every shipment. The applicable release decision is always based on the current batch-specific COA.
USP-NF product documentation specifies storage in a tightly sealed container, protected from light, at a temperature not exceeding 30°C.
EP L-Glutathione Reduced
EP grade is intended for pharmaceutical customers evaluating material against European Pharmacopoeia requirements. The referenced EP 11.0 specification covers identity, assay, optical rotation, clarity and color of solution, related substances, microbiological quality and bacterial endotoxins.
The representative EP-grade batch reported:
- Assay: 99.1% on the dried basis
- Total impurities: 0.76%
- Bacterial endotoxins: below 0.10 EU/mg
- Compliance with the applicable EP 11.0 specification
EP grade is a suitable starting point for pharmaceutical formulation and supplier qualification. Final suitability must still be assessed against the intended dosage form, route of administration, regulatory pathway and the customer’s internal quality requirements.
Food-Grade L-Glutathione Reduced
Food-grade L-Glutathione Reduced is intended for customers developing dietary supplements, nutraceutical products and permitted functional formulations.
The food-grade quality profile includes:
- Assay and identity
- Specific optical rotation
- Loss on drying and residue on ignition
- Oxidized Glutathione and total related substances
- Heavy metals, arsenic, lead, mercury and cadmium
- Total aerobic microbial count
- Coliforms, yeast and mold
- Salmonella and Staphylococcus aureus controls
The representative food-grade batch reported an assay of 99.4%, loss on drying of 0.2%, oxidized-related material of 0.41% and total related substances of 0.53%.
Customers should confirm permitted use, dosage, labeling and finished-product requirements in each destination market before commercialization.
Grade Comparison
| Procurement requirement | Food grade | EP grade | USP-NF grade |
|---|---|---|---|
| Primary positioning | Nutraceutical and food-formulation evaluation | Pharmaceutical development | Pharmaceutical development |
| Applicable quality basis | Internal food-grade specification | EP 11.0 | USP-NF |
| Assay specification | 98.0%-102.0% | 98.0%-102.0% | 98.0%-102.0% |
| Related-substance testing | Yes | EP impurity profile | USP-NF impurity profile |
| Microbiological testing | Yes | Yes | Yes |
| Bacterial endotoxin result in referenced COA | Not listed | <0.10 EU/mg | <0.10 EU/mg |
| Representative assay result | 99.4% | 99.1% | 98.8% |
Representative COA values describe the tested batches only. Request the current specification and batch-specific COA before placing or releasing an order.
Enzymatic Manufacturing and Quality Control
The manufacturing source uses enzymatic technology to produce the Glutathione series. Enzymatic processing provides a controlled route for commercial-scale production and supports consistent quality when combined with validated process controls and grade-specific release testing.
Quality evaluation is matched to the selected grade and may include:
- Identity testing: infrared, chromatographic or chemical identification, depending on the specification.
- Assay: quantitative determination of L-Glutathione Reduced on the dried basis.
- Related substances: control of oxidized Glutathione and other process- or degradation-related impurities.
- Physical properties: appearance, solution clarity, color, solubility and specific optical rotation.
- General chemical controls: loss on drying, residue on ignition, chloride, sulfate, ammonium and iron.
- Elemental impurities: grade-specific heavy-metal and individual element testing.
- Residual solvents: methanol and ethanol testing under the referenced USP-NF specification.
- Microbiological quality: total count and specified-organism controls.
- Bacterial endotoxins: available where included in the applicable grade specification or customer requirement.
The manufacturing source lists Glutathione specifications including USP, EP, JP and CP, as well as 1 kg, 5 kg, 10 kg and 25 kg packaging options. Kosher, Halal, FSSC 22000, DML and KDMF documentation is also listed for Glutathione. Availability and applicability should be confirmed for the requested grade, manufacturing site and shipment before these documents are included in a customer qualification package.
Supported by 36-Month Long-Term Stability Data
Stability is a critical sourcing consideration because Reduced Glutathione can be affected by oxidation and storage conditions. Product evaluation should therefore extend beyond the initial assay result.
Long-term studies were conducted on three EP-grade production batches packed in 25 kg drums and stored at 25 ± 2°C and 60 ± 5% relative humidity. Appearance, identification, specific optical rotation, loss on drying, related substances, bacterial endotoxins and assay were monitored through 36 months.
At the 36-month interval:
- Batch 5001-2212004 reported an assay of 99.3%
- Batch 5001-2212005 reported an assay of 98.9%
- Batch 5001-2212006 reported an assay of 99.1%
All three batches remained within the applicable assay acceptance range, and the study reports no significant change in the tested quality attributes through 36 months.
This study supports the stability of the referenced EP-grade batches under the stated packaging and storage conditions. It should not be interpreted as a universal shelf-life declaration for every Glutathione grade. Assigned shelf life or retest period depends on the product grade, packaging configuration and applicable batch documentation.
Applications of Bulk L-Glutathione Reduced Powder
Pharmaceutical Formulation
USP-NF and EP grades are available for pharmaceutical development and raw-material qualification. Pharmaceutical buyers typically evaluate identity, impurity profile, residual solvents, microbiological quality, bacterial endotoxins, stability and change-control documentation in addition to assay.
The material’s suitability for a particular dosage form or route of administration must be determined by the finished-product manufacturer. The presence of an endotoxin test does not by itself establish approval or suitability for injectable use.
Nutraceutical and Dietary Supplement Formulation
Food-grade Reduced Glutathione may be evaluated for capsules, tablets, powder blends, sachets and other permitted nutraceutical formats. Buyers commonly request information on assay, oxidized Glutathione, heavy metals, microbiological quality, solubility, packing and shelf life before approving a source.
Product developers should conduct formulation compatibility and finished-product stability studies under their actual processing, packaging and storage conditions.
Cosmetic and Personal-Care Formulation
L-Glutathione Reduced is also evaluated as a cosmetic raw material for serums, creams, masks and other personal-care formulations. Cosmetic developers should assess solubility, pH compatibility, oxidation control, packaging interactions and stability within the finished formulation.
Any cosmetic efficacy, safety or marketing claim must be supported by the finished-product evidence and comply with the regulations of the target market.
Documentation for Supplier Qualification
Different customers require different levels of documentation. A practical qualification package may include:
- Current grade-specific specification
- Batch-specific Certificate of Analysis
- Technical Data Sheet and Safety Data Sheet
- Stability data, where applicable
- Impurity and residual-solvent information
- Microbiological and endotoxin results, where applicable
- Packaging and storage information
- Manufacturing and quality certificates applicable to the requested product
- Regulatory or market-support documents, subject to product scope and confidentiality requirements
Send us your intended application, destination market and required standard so that we can prepare the most relevant document package instead of sending a generic file set.
Supply Experience for the U.S. Market
Ureda has experience supplying Glutathione products for the U.S. market. Supporting regulatory and shipment documentation can be made available for qualified customer review, subject to document scope and confidentiality requirements.
Where an NDC listing is relevant to a specific listed product, the exact product, labeler and listing status should be reviewed separately. An NDC number or FDA establishment registration does not mean that a raw material, finished product or manufacturing facility is FDA approved.
Packaging, Storage and Ordering
The standard packing shown in the referenced batch documentation is 25 kg per drum. Additional 1 kg, 5 kg and 10 kg packaging options are listed by the manufacturing source and should be confirmed when requesting a quotation.
To protect product quality:
- Keep the container tightly sealed.
- Protect the material from light.
- Follow the storage temperature stated in the applicable grade documentation.
- Avoid unnecessary exposure to moisture, heat and air during sampling and handling.
- Use the assigned expiry or retest date shown in the shipment documents.
For an accurate quotation, please provide the required grade, destination country, estimated order quantity, annual demand, packaging requirement and target delivery date.
Frequently Asked Questions
What is the difference between Reduced Glutathione and oxidized Glutathione?
Reduced Glutathione is commonly abbreviated as GSH. Oxidized Glutathione is generally treated as a related substance or degradation-related parameter in Reduced Glutathione specifications. The applicable limit depends on the selected grade.
What is the assay specification for L-Glutathione Reduced?
The referenced USP-NF, EP and food-grade documents specify an assay range of 98.0%-102.0% on the dried basis. Actual results vary by batch and are reported on the batch-specific COA.
Can you provide a Glutathione COA before ordering?
Yes. A representative COA can be provided for technical evaluation. The final shipment should be evaluated using the COA issued for the supplied batch.
Is 36-month stability data available?
Yes. Long-term stability data through 36 months is available for three referenced EP-grade batches stored in 25 kg drums at 25 ± 2°C and 60 ± 5% relative humidity. Grade-specific shelf life or retest period should be confirmed from the applicable product documents.
Is bacterial endotoxin testing available?
The referenced EP and USP-NF COAs include bacterial endotoxin results below 0.10 EU/mg. This test result does not independently establish suitability or regulatory approval for injectable use.
Which grade should I choose for supplements?
Food grade is generally the primary option for nutraceutical and dietary-supplement evaluation. Final selection depends on destination-market regulations, formulation requirements and the customer’s internal quality standard.
Which grade should I choose for pharmaceutical development?
USP-NF or EP grade may be selected according to the applicable market, dossier strategy and customer specification. Route of administration and finished-product requirements must also be considered.
What is the standard Glutathione packaging?
The referenced batch documents use 25 kg drums. Smaller packaging options may be available and should be confirmed during quotation.
Is an NDC number the same as FDA approval?
No. An NDC is a product identifier used in drug listing. Assignment or publication of an NDC does not mean that FDA has approved the product or verified all submitted information.
Can I request a sample?
Sample availability depends on the required grade, quantity, destination and intended evaluation. Include these details in your request so the correct sample and supporting documents can be prepared.
Request a Grade Recommendation, Sample or Quotation
Tell us what you are developing and what your quality team needs to review.
Please include:
- Intended application
- Required grade or pharmacopoeial standard
- Destination country
- Estimated trial and commercial quantity
- Annual demand
- Preferred packaging
- Required technical and regulatory documents
*Contact Ureda to request the current L-Glutathione Reduced specification, representative COA, sample availability and bulk quotation.*
Request a Grade Recommendation, Sample or Quotation
Send your application, required standard, destination country, estimated demand and documentation requirements. Our team will recommend the appropriate grade and prepare the relevant qualification package.
