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Plecanatide powder is a guanylate cyclase-C (GC-C) agonist API used for the treatment of gastrointestinal diseases. It has CAS 467426-54-6 as its unique chemical identifier and offers clear clinical advantages and wide application value in the treatment of chronic idiopathic constipation and constipation-predominant irritable bowel syndrome. As a high-end polypeptide API, it differs from traditional laxative ingredients with core advantages including precise action, extremely low systemic absorption, mild adverse reactions, and good long-term tolerance. It can meet the R&D and production needs of various dosage forms such as oral solid preparations and enteric-coated preparations, making it a key raw material for the development of gastrointestinal targeted drugs.
Technical Specifications
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Product Name |
Plecanatide powder |
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Synonyms |
CAS 467426-54-6, Plecanatide API, Plecanatide Raw Material |
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Characteristic |
White to off-white lyophilized powder |
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CAS Number |
467426-54-6 |
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Assay |
≥99% (HPLC, Subject to the COA) |
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Formula |
C65H104N18O26S4 |
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Package |
Technical Package |
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Storage |
Store at -20℃ |
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Structure |
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Product Characteristics
High Purity and Strict Quality Control, Meeting High-End Preparation Standards
Plecanatide API is produced using a combined process of solid-phase synthesis, HPLC purification, and freeze-drying process. Production and packaging are completed in a clean workshop throughout the process to control impurities such as peptide fragments, deamidation products, and organic solvent residues from the source. The main component content is stably ≥99.0%, single maximum impurity ≤0.5%, total impurities ≤1.0%, and key indicators are fully superior to international pharmacopoeia and domestic registration requirements.
Stable Physicochemical Properties, Suitable for Multi-Dosage Form Production
Plecanatide powder is a white or off-white freeze-dried powder, odorless and non-caking, with good water solubility. It dissolves quickly in water for injection and common pharmaceutical excipients, facilitating preparation, formulation screening, and industrial production. The product has uniform crystal form and particle size, stable fluidity, and is compatible with enteric coating, microcapsule, sustained-release and other preparation processes. It is suitable for the development of oral tablets, capsules, powders, and intestinal targeted preparations.
Clear Mechanism of Action and Excellent Clinical Data: Plecanatide API, with CAS 467426-54-6 as its structural basis, specifically activates intestinal GC-C receptors, promotes the secretion of intestinal chloride and bicarbonate ions, increases intraluminal water content, softens feces and promotes intestinal peristalsis. It does not act on the central nervous system and has no risk of addiction. Clinical studies have confirmed that patients with constipation-predominant irritable bowel syndrome who use preparations containing Plecanatide have more than 2 additional complete spontaneous bowel movements per week, and their scores for abdominal pain, bloating, and abdominal discomfort decrease by ≥30%. The overall symptom improvement rate is significantly better than that of traditional laxatives. After oral administration, Plecanatide has extremely low systemic absorption, with plasma concentration below the detection limit. It mainly acts locally on the intestine and has no obvious effects on liver and kidney function, cardiovascular system, or central nervous system. The incidence of adverse reactions such as headache and diarrhea is less than 5%, mostly mild to moderate. No dosage adjustment is required for elderly patients or those with impaired liver and kidney function, showing excellent safety and tolerance for long-term use.
Full-Cycle Quality Control and Stable Quality
Full-Process Traceability Management
We work closely with certified cooperative factories that hold GMP, FDA, and CEP certifications to implement full-chain traceability management for Plecanatide API, covering starting materials, peptide synthesis, cleavage and purification, freeze-drying, crushing and sieving, packaging, and finished product inspection. Each batch of Plecanatide Raw Material is assigned a unique batch number. Production processes are recorded in real time, and data on key process parameters, intermediate testing, and finished product testing are fully retained to achieve enable full traceability, verifiability and re-testability. Delivered products are accompanied by a complete set of quality documents including test results for content, impurities, moisture, microorganisms, endotoxins, etc., ensuring that every batch of Plecanatide powder used by customers is traceable and transparent in quality.
Strict Standard Compliance Assurance
Plecanatide API (CAS 467426-54-6) is manufactured in strict accordance with ICH Q7, USP, EP, and CP standards. A full-dimensional testing plan specific to peptide APIs is implemented, including HPLC purity analysis, LC-MS structure confirmation, amino acid composition analysis, residual solvents, elemental impurities, microbial limits, and bacterial endotoxins. Quality indicators are fully aligned with major international pharmacopoeias, supporting drug registration and declaration in major global markets including the US, Europe, Japan, and China. We provide compliant and stable supply of Plecanatide to pharmaceutical companies and reduce registration and production risks.
Continuous Quality System Optimization
Supported by continuous technological upgrades of cooperative factories, we constantly optimize the synthesis and purification processes of Plecanatide API to improve product purity and yield while reducing production costs and impurity levels. We have established a complete system for deviation handling, change control, stability testing, and annual quality review. Process verification and quality benchmarking are carried out regularly to ensure consistent and stable quality of every batch, providing customers with long-term and reliable raw material supply.
Application Scenarios
Drugs for Constipation-Predominant Irritable Bowel Syndrome
Plecanatide API is the core raw material for the production of drugs for constipation-predominant irritable bowel syndrome. Oral enteric-coated preparations made from it can accurately reach the colon to improve intestinal peristalsis, increase defecation frequency, and relieve abdominal pain and bloating. It is a first-line treatment recommended by guidelines worldwide. Such drugs have mild and long-lasting effects without disturbing normal intestinal flora, thus becoming suitable for long-term management of chronic constipation-predominant irritable bowel syndrome in adults.
Drugs for Chronic Idiopathic Constipation
Plecanatide Raw Material can be used to manufacture preparations for chronic idiopathic constipation. It restores normal defecation patterns by regulating intestinal secretion and motility, offering significant advantages for patients who do not respond well to or cannot tolerate traditional laxatives. Preparations made from it are convenient to take, administered once daily with high patient compliance, and effectively improve core symptoms such as difficult defecation, dry and hard stools, and incomplete evacuation.
R&D of Innovative Drugs Related to Gastrointestinal Disorders
As an active ingredient, Plecanatide can be used in the R&D of innovative drugs such as intestinal targeted preparations, sustained and controlled release preparations, and compound preparations. With its clear mechanism of action and good safety profile, Plecanatide has expansion potential in functional gastrointestinal diseases and adjuvant treatment of inflammatory bowel disease, providing high-quality raw material support for the development of new gastrointestinal drugs.
Packaging and Transportation
Plecanatide API is vacuum-sealed in pharmaceutical-grade low-adsorption peptide-specific bottles or aluminum foil bags with desiccants and light protection inside, and insulated shockproof packaging outside featuring resistance to light, moisture, oxidation, and degradation, which ensures the stability of peptide raw materials. Customized packaging services are also available.
Logistics strictly complies with pharmaceutical and cold-chain transportation standards, with constant low temperature and light protection at 2–8°C throughout the process. Domestic delivery is handled by professional pharmaceutical cold-chain logistics companies. International transportation meets UN regulations and cold-chain requirements, offering air freight and international express options with full temperature monitoring and trackable routes to ensure safe and on-time delivery. We have complete export qualifications, customs clearance documents, and freight forwarding resources to enable efficient and compliant global logistics services.
Our Advantages
High Standard Quality Assurance
Products come from GMP, FDA, and CEP certified cooperative factories with full-process strict quality inspection. Key indicators of Plecanatide API exceed international pharmacopoeia standards, with purity stably ≥99.0% and strict impurity control, providing core assurance for preparation safety, successful R&D, and registration approval.
Mature Export and Global Service
We have mature experience in global exports and a complete system for customs declaration, inspection, logistics, and documentation. Plecanatide API (CAS 467426-54-6) can be legally supplied to Europe, America, Japan, South Korea, Southeast Asia, the Middle East, South America and other regions. We provide multilingual business support, 7×12-hour fast response, and stable replenishment services, making us a reliable long-term partner for customers.
Sample Support and Customization Services
We provide Plecanatide Free Sample for potential R&D customers, suitable for preliminary R&D scenarios such as formulation screening, testing method development, and pharmacological pre-experiments. Sample purity and quality are consistent with bulk goods. We also offer Customized Plecanatide services, with customizable purity, particle size, and packaging specifications, supported by one-on-one technical assistance to meet diverse customer needs.
Full-Process Documentation Support
We provide a complete set of registration documents including COA, HNMR, LC-MS, HPLC chromatograms, residual solvents, elemental impurities, microbiological data, stability data, manufacturing process overview, etc., supporting domestic and international drug registration and reducing customer R&D and registration costs.
FAQ
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