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Linaclotide Acetate

Product Name: Linaclotide Acetate
INCI Name: Linaclotide Acetate
CAS No.: 851199-60-5
Molecular Formula: C₅₉H₇₉N₁₅O₂₁S₆
Molecular Weight: 1526.8 g/mol
Appearance: White to Off-white Amorphous Powder
Grade: Medical Grade / Peptide Research Grade
Shelf Life: 2 Years (Sealed & Proper Storage)
Storage Condition: Sealed, Store at -20℃, Keep Away from Moisture & Light

Description

 

Products Description

 

 

Linaclotide Acetate is a cyclic tetradecapeptide made by chemical synthesis, structurally analogous to endogenous guanylin and uroguanylin within human gastrointestinal tissue. This peptide compound acts as a highly selective Guanylate Cyclase‑C (GC‑C) agonist that delivers pharmacological benefits locally inside intestinal lumen with negligible systemic uptake after oral exposure.

Once linaclotide acetate contacts intestinal epithelial luminal receptors, both parent peptide and its biologically‑active metabolite bind specifically to GC‑C sites. Such receptor activation raises cGMP concentration on both intracellular and extracellular sides of epithelium. Elevated intracellular cGMP triggers CFTR ion‑channel opening, promoting chloride and bicarbonate efflux into gut cavity. Extra intestinal fluid softens stool and accelerates whole gastrointestinal transit. Meanwhile, extracellular cGMP suppresses visceral nociceptive nerve signaling to ease abdominal bloating and gut‑related discomfort.

Because almost no ingredient enters blood circulation, linaclotide acetate exerts gut‑restricted pharmacology and avoids widespread off‑target systemic effects. Our supplied material is white‑to‑off‑white amorphous peptide powder, offered in medical‑grade and peptide‑research‑grade batches for API development and laboratory investigation only. Sealed cold storage at ‑20℃ away from light and moisture guarantees full 2‑year shelf‑life of finished powder lots.

 

Applications

Linaclotide Acetate HPLC Purity Test Report COA Certificate

Linaclotide effectiveness

1.effective symptom relief: linaclotide works locally in the intestines to reduce pain and discomfort while promoting regular bowel movements.

2.dual action mechanism: it increases fluid secretion in the intestines and accelerates transit time, addressing both constipation and abdominal pain.

3.minimal systemic absorption: linaclotide acts primarily in the gut, ensuring targeted treatment with fewer systemic side effects.

4.clinically proven: extensive studies have demonstrated linaclotide's effectiveness in improving bowel habits and reducing abdominal pain in IBS-C and CIC patients.

 

Linaclotide uses and application areas

1.irritable bowel syndrome with constipation (IBS-C): reduces abdominal pain, bloating, and constipation.

2.chronic idiopathic constipation (CIC): promotes regular bowel movements in patients with persistent constipation of unknown cause.

Synthetic Peptide Linaclotide Acetate Raw Material For Gastrointestinal Drug API

Technical Specification

 

Test Item Specification Standard
Appearance White to Off-white Amorphous Powder
Molecular Weight 1526.8 ±1 Da
Purity (HPLC) ≥98.0%
Total Related Impurities (HPLC) ≤2.0%
Maximum Single Impurity (HPLC) ≤1.0%
Moisture Content (Karl Fischer) ≤8.0%
Acetonitrile Residue ≤410 ppm
Acetate Content (HPLC) 4.5%-5.5%
Host Cell Protein Residue ≤0.01%
Host Cell DNA Residue ≤10.0 ng/mg
Endotoxin <1.0 EU/μg
Solubility Slightly soluble in water, soluble in DMSO and methanol under slight heating

 

Safety Profile

 

  1. Absorption Characteristics: Minimal systemic absorption after oral intake; undetectable in blood circulation within 3-5 hours, low systemic side effect risk.
  2. Adverse Reaction Profile: The most common mild adverse reaction is slight diarrhea (incidence ≤20%), usually occurring within 2 weeks of administration, dose-dependent and self-relieving. Occasional rare reactions include mild nausea and flatulence, no severe organ toxicity reported.
  3. Contraindications: Strictly prohibited for children under 2 years old; avoid use in 2-18 years old group due to dehydration risk. Not recommended for pregnant and lactating women without clinical safety data support.
  4. Toxicity Level: Classified as WGK 3 in Germany; oral acute toxicity Class 4, non-highly toxic raw material.
  5. Stability & Safety: Stable under sealed -20℃ storage; no degradation or harmful substance precipitation within 2-year shelf life.

 

Why Choose Us

 

  • Rigorous Batch‑wise Quality Assurance Every production lot undergoes complete HPLC profiling. We strictly enforce ≥98% purity baseline. Each shipment comes with full COA, HPLC chromatogram spectrum and related testing documentation for your lab record or registration submission.
  • Flexible Pack‑size Supply Chain We cover small lab sample quantity (100mg,1g), pilot‑test batch (100g), up to commercial bulk kilogram orders. Custom impurity‑profile requirements are acceptable for pharma clients.
  • Global Multi‑mode Logistics Support DHL / UPS / FedEx air courier, sea freight and air‑cargo options available. Goods get dispatched within 24 working hours once payment confirmed, covering door‑to‑door and port‑to‑port delivery solutions worldwide.
  • Complete Compliance Document Kit MSDS, third‑party independent lab test reports and customs‑oriented certificates are ready to assist cross‑border clearance and your product registration workflows.
  • Specialized Peptide Technical Assistance Our in‑house peptide R&D team offers mechanism consultation, solubility guidance, storage handling tips and after‑sales technical follow‑up for biotech and pharmaceutical partners.
  • Stable Long‑term Bulk Inventory Large on‑site raw‑material stock maintains consistent delivery rhythm. Long‑term framework supply contracts can be signed for global biotech and pharma enterprises.

 

OEM Service

 

We deliver one‑stop OEM & custom service tailored to linaclotide acetate peptide project requirements for research institutes and pharma customers:

  • Custom Synthesis & Purification Adjustment Support fine‑tuning purification process for higher purity demand, custom salt‑form processing, custom impurity‑control threshold according to your project protocol.
  • Customized Packaging Service Custom inner/outer labeling, custom unit‑pack specifications from mg‑level sample vial, aluminium foil bag to 1kg / 25kg drum bulk packaging. Custom label text compliant with export regulation.
  • Batch‑specific Document Customization Adjust COA format, generate project‑targeted test‑report versions to satisfy internal lab management or regulatory submission requirements.
  • Scale‑up Manufacturing Service Support technology transfer from lab gram‑scale trial to pilot‑plant kilogram‑level production. We assist process optimization for your future commercial API development.
  • Confidentiality Commitment Strict non‑disclosure agreement for all OEM / custom projects; customer project data and formula information will never be shared with third‑party organizations.

OEM Service

 

delivery and shipping service

1. `Bulk linaclotide acetate peptide raw material warehouse stacked package for global pharmaceutical export shipment` 2.

 

01.Packaging and service

Storage: Store in a dry, cool, and well-ventilated place.

Packaging: 1 kg/bag, 25 kg/drum

Delivery Time: 7 days after order placement

02.Delivery Methods

1.Express Delivery
3-5 days for shipments under 100 kg
Door-to-door service

2.Ocean Freight
Over 300 kg: Approximately 30 days. Port-to-port service requires a professional customs clearance agent.

3.Air Freight
100kg-1000kg, 5-7 days
Airport-to-airport service, requires a professional customs clearance agent

1. `Bulk linaclotide acetate peptide raw material warehouse stacked package for global pharmaceutical export shipment` 2.

Frequently Asked Questions

Q1: What is the minimum order quantity for Linaclotide Acetate?

A: Our minimal sample order starts at 100 mg for lab evaluation. Larger batches including 1g,100g,1kg and bulk drum quantity are available for pilot and commercial projects.

Q2: Could you offer free trial samples of this GC‑C agonist peptide?

A: We can provide small‑quantity trial samples; customers need to cover sample freight cost. Please send your inquiry with your lab project background for sample application review.

Q3: What risk should we pay attention to when handling linaclotide acetate powder in lab?

A: Wear lab gloves, eye‑protection and dust‑proof mask during powder manipulation. Avoid direct skin contact and inhalation of fine peptide dust. Store opened aliquot under sealed ‑20℃ dry and dark environment, do not expose to room‑temperature atmosphere for long time.

Q4: How long will goods be shipped once we complete payment?

A: Stock‑available orders are arranged shipment within 24 working hours. For custom‑OEM or non‑stock customized batches, manufacturing cycle depends on order scale; our sales team will inform you exact lead‑time in quotation.

Q5: What documents can you supply for customs clearance and lab registration?

A: We provide COA, HPLC spectrum file, MSDS safety datasheet, commercial invoice, packing list. Third‑party independent inspection reports can be supplied upon special request.

Q6: Can linaclotide acetate be dissolved in pure water for in‑vitro cell assay directly?

A: It shows slight water‑solubility. For cell experiment preparation, we recommend pre‑dissolving stock solution in DMSO or heated methanol then further dilution into aqueous medium, do note solvent final concentration limits for your cell model.

Q7: What is the difference between medical grade and peptide‑research‑grade linaclotide acetate you supply?

A: Medical grade implements stricter control for host‑cell residue and endotoxin indicator, oriented for pre‑clinical API development. Research grade meets basic HPLC purity standard for academic lab mechanism research, not suitable for animal / pre‑clinical drug candidate study.

Q8: What will happen if the powder is stored out of recommended ‑20℃ sealed condition?

A: Prolonged exposure at room temperature, moisture or strong light may trigger peptide degradation, increase related‑impurity content and reduce actual potency. Once original seal broken, aliquot powder and freeze quickly to extend usable period.

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