Difelikefalin 99% Cas No.1024828-77-0

Xi'an Tihealth supplies premium, pharmaceutical-grade Difelikefalin API, manufactured in strict compliance with cGMP quality management systems. As a highly selective synthetic peptide, our Difelikefalin powder guarantees a core purity of ≥ 99.0% (Assay by HPLC), with stringent control over peptide-related impurities and residual solvents. Every batch undergoes comprehensive structural confirmation (MS, NMR) and quality validation to ensure exceptional batch-to-batch consistency. We provide fully documented, reliable active pharmaceutical ingredients to support global pharmaceutical enterprises and research institutions from early-stage formulation development through to commercial-scale manufacturing.

Difelikefalin is a highly selective kappa opioid receptor (KOR) agonist. Unlike traditional centrally-acting opioids, difelikefalin is peripherally restricted. Its unique chemical structure significantly limits its ability to cross the blood-brain barrier (BBB). Consequently, it acts primarily on KORs located in peripheral tissues and the peripheral nervous system, enabling it to exert potent pharmacological effects while effectively circumventing CNS-related adverse events, such as respiratory depression, sedation, or addiction liability.

The therapeutic mechanism involves the specific activation of kappa opioid receptors distributed across peripheral sensory neurons and immune cells. Upon receptor binding, it triggers an intracellular signaling cascade that downregulates the excitability of pruriceptors (itch-sensing neurons). Furthermore, it modulates specific inflammatory pathways and directly inhibits the transmission of pruritic signals from the peripheral nervous system to the spinal cord and brain, thereby neutralizing the sensation of itch at its anatomical source.

The core clinical value of difelikefalin lies in its profound and sustained anti-pruritic efficacy. Extensive clinical data demonstrates its capacity to rapidly alleviate moderate-to-severe chronic itching. It represents a paradigm shift in managing chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis patients, addressing a critical unmet medical need and significantly improving the overall quality of life for affected individuals.

As a high-purity API, Xi'an Tihealth's Difelikefalin is strategically positioned for the following specialized R&D and manufacturing applications:

• Core Formulation Development: The primary active ingredient for intravenous (IV) or oral formulation projects targeting uremic pruritus in hemodialysis settings.
•  
• Expanded Indication Research: A critical molecule for investigating novel therapeutic interventions for other refractory pruritic conditions, including cholestatic pruritus, atopic dermatitis, and neurogenic itch.
•  
• Pharmacological Studies: A reliable, standardized reference material for university research labs and pharmaceutical companies conducting preclinical KOR pathway studies and toxicity evaluations.

Packaging

Delivery

Payment

Q1: What is the purity standard of Xi'an Tihealth's Difelikefalin API?

A: Our pharmaceutical-grade Difelikefalin maintains a strict purity specification of ≥ 99.0% as determined by High-Performance Liquid Chromatography (HPLC). We maintain rigorous control over related substances and single unknown impurities to meet the demanding requirements of drug formulation and regulatory compliance.

Q2: Can you provide the necessary documentation for regulatory submissions?

A: Yes. We provide comprehensive analytical data and technical documentation, including Certificates of Analysis (CoA), HPLC chromatograms, Mass Spectrometry (MS) data, and Route of Synthesis (ROS) summaries, to fully support our clients' IND/NDA filings and process validation needs.

Q3: What supply quantities are available for R&D versus commercial stages?

A: We offer highly flexible supply chain solutions. We can provide milligram to gram quantities packaged in specialized pharmaceutical vials for early-stage laboratory research, seamlessly scaling up to multi-kilogram batches in standardized export drums for clinical trials and commercial manufacturing.

The information provided herein is based on publicly available scientific literature and is intended for informational purposes only. Difelikefalin supplied by Xi'an Tihealth is classified strictly as an Active Pharmaceutical Ingredient (API) or research chemical. It is intended exclusively for use by qualified professionals in laboratory research, formulation development, and authorized pharmaceutical manufacturing. It is strictly prohibited for direct administration to humans, animals, or use as a finished medicinal product. Buyers are responsible for ensuring compliance with all applicable local and international regulations governing the handling and use of this substance.

Hot Tags: difelikefalin 99% cas no.1024828-77-0, China difelikefalin 99% cas no.1024828-77-0 manufacturers, suppliers, factory, hialuronato de sodio hialuronato sodico sodium hyaluronate, , ,