Description

Linaclotide is a synthetic, 14-amino acid peptide that functions as a guanylate cyclase-C (GC-C) agonist. This compound is of significant commercial and therapeutic importance as the active pharmaceutical ingredient (API) in medications for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C). It is primarily required by pharmaceutical manufacturers and research organizations engaged in the development and production of gastrointestinal therapeutics.

Application

• Active Pharmaceutical Ingredient (API): Core component in the formulation of prescription drugs for chronic constipation disorders.
• Pharmaceutical Research & Development: Used in preclinical and clinical studies for investigating GC-C receptor agonists and gastrointestinal motility.
• Reference Standard: Serves as a high-purity analytical standard for quality control and method validation in pharmaceutical laboratories.
• Formulation Development: Employed in the development of solid oral dosage forms, such as capsules, requiring precise API integration.
• Biochemical Research: A tool compound for studying intracellular cyclic GMP signaling pathways in intestinal epithelial cells.

Basic Information

Item	Details
Product Name	Linaclotide
CAS No.	851199-59-2
Molecular Formula	C59H79N15O21S6
Molecular Weight	1526.8 g/mol
Synonyms	MD-1100; Linaclotide acetate; Guanylate cyclase-C agonist; [4-12]-linaclotide; Constella (brand name); Linzess (brand name); (2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-Amino-3-carboxypropanoyl]amino]-3-hydroxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-3-methylbutanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-3-(1H-imidazol-4-yl)propanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-5-carbamimidamidopentanoic acid
EINECS	Contact for details

Quality Control

Our Linaclotide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, peptide mapping for sequence confirmation, and tests for residual solvents and related substances to ensure compliance with ICH guidelines and customer-specific requirements. A comprehensive Certificate of Analysis (COA) documenting identity, purity, potency, and safety parameters is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. The product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC/MS)	Conforms to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 97.0% (Total related substances ≤ 3.0%)
Peptide Content	≥ 80.0% (by weight)
Water Content (KF)	≤ 8.0%
Residual Solvents (GC)	Meets ICH Q3C limits
Bacterial Endotoxins	< 10 EU/mg
Microbial Enumeration	Meets Ph. Eur. 2.6.12/ USP <61>

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.