Description

Plecanatide is a synthetic 16-amino acid peptide analog of human uroguanylin, designed as a guanylate cyclase-C (GC-C) agonist for targeted gastrointestinal pharmacology. It delivers clinically validated efficacy in chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C), offering a mechanism-based therapeutic approach with minimal systemic absorption. Pharmaceutical manufacturers, contract development and manufacturing organizations (CDMOs), and clinical research suppliers rely on high-purity Plecanatide CAS NO 467426-54-6 for formulation development, analytical reference standards, and Phase III–IV clinical trial material.

Application

• Active pharmaceutical ingredient (API) for oral solid dosage forms (tablets) targeting CIC and IBS-C
• Reference standard in HPLC, LC-MS, and dissolution method validation for regulatory submissions (FDA, EMA, PMDA)
• Raw material for stability-indicating assay development and forced degradation studies
• Key component in bioequivalence and comparative dissolution testing of generic plecanatide products
• Research tool for GC-C receptor binding and signaling pathway characterization in preclinical models
• Formulation excipient compatibility testing (especially with moisture-sensitive or acidic co-components)

Basic Information

Product Name	Plecanatide
CAS No.	467426-54-6
Molecular Formula	C78H122N22O23S4
Molecular Weight	1751.14 g/mol
Synonyms	Trulance® (brand name); SP-333; [Cys1,Cys16]-plecanatide; Cyclo[Asp1-Pro2-Val3-Ser4-Tyr5-Cys6-Leu7-Gly8-Thr9-Arg10-Leu11-Cys12-Ala13-Ile14-Val15-Cys16]; Uroguanylin analog; GC-C agonist; Guanylate cyclase-C activator
EINECS	Not listed (no EINECS number assigned)

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. All batches conform to USP-NF monograph requirements where applicable and meet ICH Q5, Q6A, and Q7 guidelines for biotechnological/biological APIs. Testing includes identity (HPLC retention time, IR, amino acid analysis), assay, related substances (HPLC), residual solvents (GC), water content (Karl Fischer), and microbiological limits per USP <61> and <62>.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8°C under inert atmosphere (nitrogen or argon) to prevent oxidation and moisture uptake. Maintain relative humidity below 30% during handling and storage due to hygroscopic nature. Avoid repeated exposure to ambient conditions.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	FT-IR spectrum conforms to reference
Assay (HPLC)	98.0–102.0%
Related Substances (HPLC)	Single impurity ≤ 0.5%; Total impurities ≤ 2.0%
Water Content (KF)	≤ 8.0%
Residual Solvents (GC)	Meets ICH Q3C limits
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Total aerobic count ≤ 100 CFU/g; Absence of E. coli, S. aureus, P. aeruginosa, S. typhimurium

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