Difelikefalin Acetate Salt API CAS 1024828-77-0 | Peptide Manufacturer
Difelikefalin Acetate Salt API CAS 1024828-77-0 | Peptide Manufacturer
Difelikefalin API,CAS 1024828-77-0,Difelikefalin Acetate,Custom Peptide Synthesis,Bulk Peptide Supplier,kappa opioid receptor agonist,non-histaminergic antipruritic,cGMP Peptide Manufacturing
Source high-purity Difelikefalin Acetate peptide API (CAS 1024828-77-0) directly from cGMP manufacturer. Purity ≥99.0% by HPLC. Flexible packaging from mg to bulk kg for pharmaceutical R&D.
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Description
cGMP STANDARD PHARMACEUTICAL PEPTIDE SUPPLIER
Difelikefalin Acetate Salt
CAS No.: 1024828-77-0
Purity (HPLC)≥ 99.0%
Molecular FormulaC36H53N7O6
Molecular Weight679.85 Da
Peptide Content / AcetateCustom / Controlled
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Scientific Overview & High-Quality Custom Peptide Synthesis
We specialize in the advanced chemical synthesis and stable bulk distribution of high-purity Difelikefalin API raw material. Operating under standardized pharmaceutical quality control guidelines, each manufactured batch undergoes extensive structural identification and rigorous High-Performance Liquid Chromatography (HPLC) testing. This ensures consistent active ingredient baselines and strict alignment with global monograph benchmarks.
Our cGMP-compliant peptide synthesis platforms successfully minimize batch-to-batch variation, reliably supporting your entire pipeline from early laboratory process exploration, formulation pilot testing, to commercial-scale industrialization. We offer versatile packaging structures tailored for global clients, covering milligram-level R&D reference standard samples to industrial bulk kilogram lots.
Pharmacological Action & Peripheral Receptor Selectivity
Mechanism of Action (MoA)
Difelikefalin operates as a highly selective, peripherally restricted kappa opioid receptor (KOR) agonist. Meticulously designed using advanced lipophilic and structural blocking methodologies, it exhibits limited blood-brain barrier penetration. It acts specifically on peripheral KOR subtypes distributed across peripheral sensory nerve tissues and inflammatory immune cells. This peripheral restriction successfully bypasses the typical central nervous system adverse effects associated with conventional opioid drugs, neutralizing pathological pruritus conduction at its sensory origin.
Neuro-Inflammatory Signaling Regulation
Upon high-affinity receptor binding, Difelikefalin modulates intracellular cyclic adenosine monophosphate (cAMP) and related downstream signaling pathways. This activity suppresses the excitability and afferent transmission of peripheral itch impulses, while alleviating localized inflammation-mediated nerve irritation, delivering a potent therapeutic index for treating refractory non-histaminergic pruritus pathogenesis.
API Formulation Objectives & Clinical Reference Documentation
When processed into finished commercial injectable formulations or targeted topical delivery systems, this synthetic peptide API delivers highly reproducible clinical reference outcomes:
✔ Modulation of Chronic Kidney Disease-Associated Pruritus (CKD-aP): Validated in clinical trial data to potently relieve moderate-to-severe chronic pruritus in patients undergoing hemodialysis.
✔ Sleep Architecture Optimization: Reduces secondary nocturnal sleep disruptions and systemic physical discomfort driven by intractable uremic itching.
✔ Durable Therapeutic Index: Sustains long-term anti-pruritic response lines with excellent patient tolerance, eliminating risks of standard central opioid addiction lines.
Product Application & Expanded Indication Research
Finished Drug Manufacturing
Utilized as the critical core active ingredient for formulating commercial injectables approved for chronic kidney disease-associated pruritus (CKD-aP) management.
Expanded Indication Protocols
Widely adopted in pre-clinical protocols investigating alternative chronic pruritus vectors, including cholestatic pruritus, hepatic itching, and inflammatory skin conditions like atopic dermatitis.
Basic Medical R&D
Serves as a high-affinity professional tool compound for parsing peripheral opioid receptor signaling networks, mapping neural pathways, and investigating sensory pathogenesis.
Technical Specifications & Logistics Standards
| Product Identity | Difelikefalin (High-Purity Synthetic Polypeptide) |
|---|---|
| Product Characteristics | White to off-white solid powder |
| Test Method & Purity | HPLC Analysis; Assay ≥ 99.0% |
| Flexible Packaging Matrix | • Laboratory Scale: 10–100 mg per protective glass vial • Scaling/Pilot Scale: 1–5 kg per advanced aluminum vacuum foil bag • Bulk Commercial Production: 25 kg inside heavy-duty fiber drums *Fully customizable packaging configurations are available upon request. |
| Storage & Cold-Chain Mandates | Store tightly sealed and dry at frozen conditions -20°C ± 5°C. Protect from direct light and moisture ingress. Avoid repeated freeze-thaw cycles. |
| Shelf Life Reference | 36 months under recommended proper sealed, low-temperature storage conditions. |
Frequently Asked Questions (Regulatory & Procurement)
Can you provide the complete technical package and HPLC data sheets for Difelikefalin?
Yes. Every batch of our Difelikefalin API is released with a comprehensive Certificate of Analysis (COA). We provide full structural verification packages, including HPLC chromatograms verifying a purity profile of ≥99.0%, alongside Mass Spectrometry (MS) and H-NMR data to guarantee sequence authenticity.
Do you accommodate custom packaging options for advanced formulation or microsphere trials?
Absolutely. We fully support custom peptide synthesis pipelines. Beyond our commercial bulk lots, we offer tailored container sizes down to milligram and gram tiers to perfectly fit the process exploration requirements of formulation chemists and R&D teams.
How is product stability secured under sub-zero transport regulations?
To preserve the physicochemical stability of the synthetic peptide, all international air freight is strictly handled via validated cold-chain logistics. The active materials are vacuum-sealed in light-proof aluminum bags and transferred in insulated temperature-controlled containers equipped with integrated temperature loggers.
Is this product available for individual medical injection or patient prescription?
No. This product is a highly purified Active Pharmaceutical Ingredient (API) intended strictly for industrial process development, formulation manufacturing, and institutional scientific research. It cannot be sold or distributed for direct human administration, food additives, or cosmetic applications.
Shaanxi Sunrise Pharmaceutical Co., Ltd.
Senior Independent Site Operations Specialist: Betty
📧 Email: betty@pharma-sunrise.com|💬 WhatsApp: +86 18092760627