SS31 Peptide Purity Specs & Manufacturing Guide

SS31 peptide, also known as elamipretide, is a mitochondrial-targeted tetrapeptide specifically designed for high-purity research applications in cellular bioenergetics and oxidative stress studies. For B2B buyers in the cosmetic raw material and laboratory supply sectors, this compound offers a unique value proposition as a stable, water-soluble molecule that facilitates reproducible preclinical investigations into mitochondrial function. The core commercial advantage lies in its ability to support formulation development for anti-aging and energy metabolism research, with strict purity standards ensuring batch-to-batch consistency for demanding experimental protocols.

Core Molecular Specs & Product Technical Index

SS31 peptide is characterized by a molecular weight of approximately 639.8 Da, with a sequence of D-Arg-Dmt-Lys-Phe-NH2, where Dmt represents dimethyltyrosine. This structure confers exceptional stability against enzymatic degradation, making it suitable for extended in vitro and in vivo studies. The product is supplied as a lyophilized white powder with a purity grade typically exceeding 98% as verified by reversed-phase high-performance liquid chromatography (RP-HPLC) and mass spectrometry (MS). Solubility is optimized in water, phosphate-buffered saline (PBS), or dimethyl sulfoxide (DMSO) at concentrations up to 10 mg/mL, with storage requirements mandating -20°C desiccated conditions to prevent hydrolysis and aggregation. National industry testing standards, including those from the United States Pharmacopeia (USP) and Chinese Pharmacopoeia (ChP), guide the analytical methods for peptide content, counterion content, and residual solvent analysis.

• Purity: ≥98% by HPLC, with individual impurity peaks below 0.5%
• Molecular Weight: 639.8 Da, confirmed by electrospray ionization mass spectrometry (ESI-MS)
• Endotoxin Level: <1.0 EU/mg, suitable for cell culture and animal studies
• Water Content: ≤5% by Karl Fischer titration
• Appearance: White to off-white lyophilized powder, free of visible particulates

According to a 2023 market analysis by Grand View Research, the global peptide synthesis market is projected to reach USD 68.5 billion by 2030, with high-purity research peptides like SS31 accounting for a growing share due to increased demand for mitochondrial-targeted therapeutics in preclinical development.

Manufacturing Flow & Strict Quality Control System

The manufacturing process for SS31 peptide begins with rigorous raw material screening, where all amino acid derivatives and coupling reagents are tested for identity, purity, and absence of racemization. Solid-phase peptide synthesis (SPPS) using Fmoc chemistry is employed, with each coupling step monitored by Kaiser test to ensure >99% reaction efficiency. Following cleavage from the resin, the crude peptide undergoes multi-stage purification via preparative HPLC using a C18 column and a gradient of acetonitrile in water with 0.1% trifluoroacetic acid. The purified peptide is then lyophilized and subjected to third-party testing certification, including amino acid analysis, peptide content determination by UV spectroscopy, and stability studies under accelerated conditions (40°C/75% relative humidity for 4 weeks). Long-term stability tests at -20°C demonstrate a shelf life of at least 24 months with no significant degradation.

Main Certification Standards We Support

• Certificate of Analysis (CoA) with HPLC chromatogram and MS spectrum for each batch
• Good Manufacturing Practice (GMP) compliance documentation for pharmaceutical-grade production
• ISO 9001:2015 quality management system certification
• Material Safety Data Sheet (MSDS) for safe handling and transport
• Third-party endotoxin and bioburden testing reports from accredited laboratories

Main Commercial Application Scenarios

SS31 peptide is primarily utilized in preclinical research settings where mitochondrial function is a key variable. In cosmetic formulation development, it serves as an active ingredient in anti-aging serums and creams, targeting mitochondrial oxidative stress pathways to support skin cell energy metabolism. For laboratory research, it is employed in cell-based assays measuring ATP production, reactive oxygen species (ROS) levels, and mitochondrial membrane potential. In compound raw material wholesale, SS31 is supplied in bulk quantities (1g to 100g) to contract manufacturing organizations (CMOs) and research institutes for large-scale studies.

• Cosmetic Blending: Incorporated into topical formulations at 0.1-1.0% concentration, combined with liposomal delivery systems for enhanced dermal penetration
• Laboratory Research: Used in mitochondrial isolation protocols, Seahorse XF analyzer assays, and fluorescence microscopy studies with MitoTracker dyes
• Compound Raw Material Wholesale: Supplied as lyophilized powder in sealed vials with desiccant, accompanied by batch-specific CoA and stability data

Comparison: ss31 peptide VS Ordinary Low-Grade Peptide Raw Materials

Standard Buyer Selection Guide For Bulk Purchase

When purchasing SS31 peptide in bulk, buyers often encounter pitfalls such as variable purity between suppliers, lack of transparent documentation, and risk of degraded peptide stability during shipping. To mitigate these issues, core screening criteria should include verification of HPLC purity data, confirmation of endotoxin levels, and review of stability studies under recommended storage conditions. Supplier qualification verification methods include requesting a sample for in-house testing, auditing the manufacturing facility for GMP compliance, and checking third-party certifications such as ISO 9001. Additionally, buyers should confirm the supplier's ability to provide custom packaging (e.g., argon-flushed vials) and temperature-controlled shipping for international orders.

Key Inspection Checklist Before Cooperation

• Request batch-specific HPLC chromatogram and MS spectrum for purity verification
• Confirm endotoxin testing method (LAL assay) and acceptable limits
• Review stability data under accelerated and long-term conditions
• Verify supplier's GMP certification and audit history
• Check shipping protocols for cold chain maintenance and dry ice usage

Core Competitive Advantages Of Our ss31 peptide

Our SS31 peptide offers distinct competitive advantages in purity, stability, cost performance, and after-sales technical support. The purity level of ≥98% by HPLC, combined with endotoxin levels below 1.0 EU/mg, ensures minimal interference in sensitive mitochondrial assays. Stability is enhanced through lyophilization with trehalose as a cryoprotectant, maintaining >95% purity after 24 months at -20°C. Cost performance is optimized through direct manufacturing without intermediaries, allowing competitive pricing for bulk orders (1g to 100g). After-sales technical support includes access to application scientists for protocol optimization, custom formulation guidance, and rapid replacement of any defective batches. This comprehensive approach addresses buyer pain points such as variable purity between suppliers, lack of transparent documentation, and risk of degraded peptide stability, enabling researchers to select SS31 peptide with confidence for reproducible experimental outcomes.

Frequently Asked Questions

Q: What is the recommended storage condition for SS31 peptide to maintain its purity over extended periods?

A: SS31 peptide should be stored as a lyophilized powder at -20°C in a desiccated environment, protected from light and moisture. Under these conditions, the peptide maintains ≥98% purity for at least 24 months. Reconstituted solutions in water or PBS should be used immediately or aliquoted and stored at -80°C for up to 3 months, avoiding repeated freeze-thaw cycles.

Q: How does the purity of SS31 peptide affect its performance in mitochondrial membrane potential assays?

A: Higher purity (≥98%) minimizes the presence of truncated or deletion peptides that can interfere with mitochondrial targeting and cause non-specific binding. Impurities at levels above 5% may lead to altered fluorescence signals in assays using JC-1 or TMRM dyes, compromising data accuracy. Our product's low impurity profile ensures consistent results across replicate experiments.

Q: What documentation is provided with bulk orders of SS31 peptide for regulatory compliance?

A: Each bulk order includes a comprehensive Certificate of Analysis (CoA) detailing HPLC purity, MS confirmation, peptide content, endotoxin level, water content, and appearance. Additionally, we provide stability data, MSDS, and GMP compliance documentation upon request. For international shipments, we supply customs-friendly documentation including country of origin certificates and phytosanitary certificates if required.