Linaclotide API

Linaclotide API
Details:
Linaclotide API (CAS 851199-59-2) is a high-purity synthetic cyclic peptide active pharmaceutical ingredient, composed of 14 amino acids and forming stable spatial structure via three pairs of disulfide bonds.
  • CAS Number 851199-59-2
  • Formula C59H79N15O21S6
  • Storage Short-term Storage: Sealed and stored at -20℃
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Description
Technical Parameters

HK Neopharm Limited is one of the most reliable manufacturers and suppliers of linaclotide api in China, featured by quality products and good price. Please rest assured to buy linaclotide api in stock here and get quotation from our factory. Customized orders are welcome.

 

Linaclotide API (CAS 851199-59-2) is a high-purity synthetic cyclic peptide active pharmaceutical ingredient, composed of 14 amino acids and forming stable spatial structure via three pairs of disulfide bonds. Linaclotide Powder is massively manufactured by solid-phase peptide synthesis (SPPS) with high-grade amino acid monomers and synthetic resins, complying with strict GMP management to reach HPLC purity above 99.9%.

As core raw material for gastrointestinal therapeutic drugs, it serves global branded & generic pharmaceutical firms, CDMO institutions and research labs; China Linaclotide manufacturers support stable R&D, production and regulatory approval of finished preparations.

 

Technical Specifications

 

 

Product Name

Linaclotide API

Synonyms

Linaclotide powder, Linaclotide raw material

Characteristics

A white to off-white powder

CAS Number

851199-59-2

Assay

≥98.0% (HPLC, Subject to the COA)

Formula

C59H79N15O21S6

Package

Technical Package

Storage

Long-term Storage: Sealed and stored at -80℃ under inert gas atmosphere, away from moisture, with a shelf life of 2 years; Short-term Storage: Sealed and stored at -20℃, away from moisture, with a shelf life of 1 year; if stored after dissolving in solvent, it can be stored at -80℃ for 6 months and -20℃ for 1 month, all need to be sealed, protected from moisture and avoid repeated freeze-thaw cycles.

Structure

product-513-374

Linaclotide Raw Material acts as a highly selective GC-C agonist, specially applied in manufacturing formulations for IBS-C and chronic idiopathic constipation. It activates intestinal GC-C receptors, regulates cGMP level to promote intestinal secretion and peristalsis without systemic absorption, featuring outstanding safety. Mature fragment synthesis and directional oxidation avoid disulfide mismatch, keeping steady batch quality that meets FDA, EMA and NMPA standards, supplying reliable Bulk Linaclotide worldwide.

 

 
 
Product Features

Linaclotide API

Linaclotide Powder appears as white to off-white amorphous powder. Impurity contents are strictly restricted by HPLC detection, with fine solubility, no peculiar odor and stable physical & chemical properties, fully meeting strict raw material requirements for pharmaceutical formulation production.

Linaclotide API

Adopting standardized solid-phase peptide synthesis, Bulk Linaclotide uses premium medical-grade raw materials under full GMP supervision. Accurate reaction parameter control eliminates disulfide mismatch, achieving tiny batch deviation and excellent product uniformity.

As targeted GC-C agonist, Linaclotide features clear action mechanism, only acting on intestinal epithelial receptors without circulating in human body, with low adverse reaction risk and ideal for constipation-related gastrointestinal pharmaceutical preparations.

Our products comply with global multi-regulatory guidelines, supplying full COA and traceability documents. Customized Linaclotide is available to match R&D and mass production demands of pharmaceutical enterprises and professional CDMO partners.

 

Full-Cycle Quality Control & Consistent Quality

 

 

 

Linaclotide API (CAS 851199-59-2), a high-selective GC-C peptide API, owns stable physicochemical properties and reliable technological process, becoming essential raw material for gastrointestinal drugs and adapting diversified pharmaceutical application scenarios.

 

Linaclotide Raw Material maintains purity over 99.9%. Strict HPLC testing controls impurities within qualified range, with good solubility and stable properties that fully satisfy formulation production specifications.

 

Mass production follows standardized SPPS procedures and GMP regulations. Precise process control prevents abnormal disulfide bonding, ensuring consistent performance and minimal batch-to-batch difference of finished products.

 

With highly targeted pharmacological effect, Linaclotide hardly enters systemic blood circulation, resulting in low side effects and is exclusive high-quality API for IBS-C and chronic idiopathic constipation pharmaceutical preparations.

Products pass international regulatory certification and provide complete quality files, supporting generic drug development and large-scale industrial production for worldwide medical institutions.

 

Application Scenarios

 

 

Linaclotide API (CAS 851199-59-2) boasts definite pharmacological mechanism and stable quality, widely used in gastrointestinal disease medication, fitting original drug, generic drug and scientific research scenarios with balanced clinical effect and economical cost.

Linaclotide Application Scenarios

It is mainly applied in R&D and production of IBS-C formulations. As high-target raw material, it produces safe clinical medicines to relieve abdominal pain and constipation, matching large-scale manufacturing demands of global pharmaceutical factories.

It applies to CIC drug preparation, with more precise efficacy than traditional laxatives. Reasonable Linaclotide cost effectively improves market competitiveness of finished drugs.

It matches customized technical services for pharmaceutical CDMOs. GMP-qualified raw supply shortens formulation development cycle and reduces overall R&D expenditure for customers.

It supports academic research on gastrointestinal pathology and peptide synthesis optimization. Wide clinical expansion makes Linaclotide price suitable for mass application, and Linaclotide made in China gains widespread recognition in global medical research field.

 

Packaging and Transportation

 

 

As high-activity peptide API, Linaclotide API (CAS 851199-59-2) adopts standardized pharmaceutical packaging & logistics. Proper control of Linaclotide cost guarantees full-link quality stability from factory delivery to end use.

 

Double-sealed packaging includes inert-gas-filled sterile aluminum bags and pressure-resistant waterproof drums, isolating moisture and oxygen to prevent degradation, adapting diversified batch specifications and maintaining stable quality during transit.

 

Flexible package specifications cover 1g, 5g, 10g and 25g per drum. Complete label information facilitates traceability, and optimized packaging cost fits reasonable Linaclotide price system well.

 

All goods adopt professional cold chain transport below -20℃, equipped with temperature real-time monitoring, ensuring safe arrival at designated destinations.

 

We abide by international pharmaceutical transport regulations, provide full qualification documents and optimize logistics plans, greatly cutting comprehensive procurement costs for global buyers.

 

 
 
Our Advantages

We own mature large-scale SPPS production lines under full GMP compliance. Precise process management avoids disulfide defects, keeping stable purity of Linaclotide Powder and highly consistent batch quality.

Comprehensive whole-process quality inspection system adopts high-precision testing instruments, providing full traceability files that meet international drug standards for formulation R&D and industrial mass production.

Optimized industrial chain effectively controls Linaclotide cost and provides competitive Linaclotide price, lowering comprehensive expenditure for clients of all purchase scales.

Professional technical team offers thoughtful after-sales service, customized packaging schemes and reliable cold chain logistics. Fast response to orders ensures timely supply, and Buy Linaclotide enjoys convenient one-stop cooperative experience.

 

FAQ

 

Q1: Can you provide quality certificates complying with FDA, EMA, NMPA standards?

A: Yes, we supply full detailed COA covering purity, impurities, physicochemical indexes and microbial limits, supporting registered marketing of finished drugs.

Q2: What is the batch-to-batch difference of mass-produced products?

A: Under GMP standardized production and full-cycle quality monitoring, purity deviation between batches is controlled within ±0.1%, with consistent key indexes.

Q3: Are stability data sufficient for long-term storage and transportation?

A: We have completed long-term, accelerated and transportation stability tests. Under specified conditions, purity and biological activity of Linaclotide Raw Material remain stable, fully supporting long-term cold chain storage and delivery.

Q4: Can you maintain long-term stable supply cooperation?

A: With large production base and complete supply chain, we achieve continuous mass production, and long-term supply agreements ensure steady Linaclotide in stock all year round.

 

Linaclotide API (CAS 851199-59-2) features high purity, excellent stability and strong targeting. Relying on strict quality control and large-scale production capacity, it provides reliable peptide raw materials for global gastrointestinal drug R&D. Adhering to regulatory compliance and product quality, we offer favorable Linaclotide price and professional after-sales service. China Linaclotide suppliers sincerely cooperate with global medical enterprises and research institutes for win-win development, and we provide Linaclotide Free Sample for testing from our China Linaclotide factory.

 

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