Applications
Elamipretide (SS-31) is widely used in cosmetic and skincare formulations for premium product development.
Elamipretide (SS-31) — Nutrition Peptide API
High-purity peptide API for nutritional supplements and health formulations
Product Overview
Elamipretide (SS-31) is Mitochondrial protective peptide for cellular energy. It is widely used in premium nutritional supplements, functional foods, and health products.
Zhaoke Biotech produces Elamipretide (SS-31) via advanced solid-phase peptide synthesis (SPPS) with stringent quality control. Each batch is verified by HPLC, LC-MS, and comprehensive analytical testing to ensure ≥99% purity and consistency for nutrition industry standards.
Product Identification and Specifications
| Product Name | Elamipretide (SS-31) |
| CAS Number | 736992-21-5 |
| Molecular Formula | Contact for details |
| Molecular Weight | Contact for details |
| Sequence | Contact for details |
| Sequence Length | Contact for details |
| Key Modification | N/A |
| Solubility | Soluble in water and aqueous buffers |
| Pharmacological Class | Nutrition peptide API |
| Indications | Anti-aging supplements, Cellular rejuvenation, Longevity support, Mitochondrial health |
| Appearance | White to off-white powder |
| Purity | ≥99% |
| Grade | Nutrition Grade / RUO |
Mechanism of Action
Elamipretide (SS-31) acts through specific molecular pathways to support its target physiological functions. Detailed mechanism of action documentation available upon request.
Key Features and Benefits
| Feature | Description | Benefit | |
|---|---|---|---|
| ≥99% Purity Verified | ≥99% purity confirmed by HPLC and LC-MS with full batch COA | Ensures consistent efficacy in nutritional formulations | |
| Nutrition Grade Quality | Manufactured for supplement and functional food applications | Suitable for direct use in health product manufacturing | |
| Full QC Documentation | Complete COA with 12+ test parameters per batch | Supports quality assurance and regulatory compliance | |
| Global Compliance | Documentation supports FDA, EFSA, and global nutrition regulations | Enables rapid market entry worldwide | |
| Flexible Packaging | Available from 50mg samples to bulk kg quantities | Supports R&D through commercial production | |
| 3-5 Day Lead Time | In-stock items ship within 3-5 business days | Minimizes inventory costs and accelerates development |
Applications and Formulations
Quality Standards and COA Specifications
| Test Item | Specification | Method |
|---|---|---|
| Appearance | White to off-white powder | Visual Inspection |
| Identity (HPLC) | Retention time matches reference | RP-HPLC |
| Identity (MS) | Molecular weight matches theoretical | LC-MS/ESI-MS |
| Peptide Purity (HPLC) | ≥99.0% | RP-HPLC |
| Single Impurity | ≤0.5% | RP-HPLC |
| Total Impurities | ≤1.0% | RP-HPLC |
| Water Content | ≤5.0% | Karl Fischer |
| Heavy Metals (Pb) | ≤10 ppm | ICP-MS |
| Microbial Limits | TAMC ≤100 CFU/g; TYMC ≤50 CFU/g | USP <61> |
| Endotoxin | <10 EU/g | LAL Test |
| Residual Solvents | Compliant with ICH Q3C | GC-HS |
Full batch-specific COA provided with each shipment. Contact us for historical COA requests.
Packaging and Storage
Packaging Details
Storage and Handling
Regulatory Documentation Support
Certificate of Analysis (COA)
Full batch-specific COA with HPLC, MS, and microbial test results
Material Safety Data Sheet (MSDS)
Comprehensive safety documentation for handling and storage
FDA Food Facility Registration
Manufacturing facility registered with FDA for nutrition ingredient production
ISO 9001 Quality Certificate
Quality management system certified to ISO 9001:2015
Stability Data
Real-time and accelerated stability data available
GRAS Documentation
Generally Recognized As Safe documentation where applicable
Global Export Capabilities
| Region | Capabilities | Documentation |
|---|---|---|
North America (USA, Canada) | FDA-compliant documentation, direct shipment | FDA COA, commercial invoice, MSDS |
Europe (EU, UK) | EFSA-compliant, REACH documentation | REACH statement, COA, MSDS |
Asia-Pacific (Japan, Australia) | Regional logistics, local language support | Translated COA, regulatory packages |
Latin America | MOH registration support | Spanish/Portuguese translations |
Middle East | GCC registration, halal available | SFDA documentation, halal certificate |
One-Stop Supply Chain Services
| Service | Description | Value |
|---|---|---|
| API Sourcing | Direct access to audited GMP manufacturing facilities | Consistent quality and traceability |
| Quality Assurance | Independent batch release testing with full COA | Reduced quality risk |
| Regulatory Support | CMC documentation and filing assistance | Accelerated market entry |
| Technical Consultation | Formulation development and stability guidance | Expert support throughout development |
| Logistics Management | Cold chain logistics with temperature monitoring | Product integrity guaranteed |
Frequently Asked Questions
Looking for a Complete Peptide Production Solution?
Beyond raw peptide supply, Zhaoke Biotech offers end-to-end production solutions — from custom synthesis and process development to scale-up manufacturing, QC testing, and regulatory documentation. Partner with us for a seamless peptide supply chain experience.
Ready to Source High-Purity Elamipretide (SS-31)?
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