Description

Plecanatide Acetate is a synthetic, 16-amino acid peptide analog of uroguanylin, designed as a guanylate cyclase-C (GC-C) agonist for targeted gastrointestinal therapeutics. It delivers high specificity and potency in modulating fluid secretion and intestinal motility, supporting robust clinical and preclinical development pathways. This compound is essential for pharmaceutical R&D, formulation development, and reference standard applications in global drug manufacturing and regulatory testing. Plecanatide Acetate CAS NO 1075732-84-1 is supplied under stringent quality controls to meet the demands of biopharmaceutical innovators and contract development organizations.

Application

• Active pharmaceutical ingredient (API) development for chronic constipation and irritable bowel syndrome with constipation (IBS-C)
• Reference standard in HPLC, LC-MS, and dissolution method validation for pharmacopeial compliance (USP, EP)
• Preclinical toxicology and pharmacokinetic (PK/PD) studies in rodent and non-rodent models
• Stability-indicating assay development and forced degradation studies
• Formulation excipient compatibility testing in oral solid dosage forms
• GMP-compliant process intermediate for peptide synthesis scale-up
• Calibration standard for quantitative bioanalysis in plasma and tissue matrices
• Research tool for GC-C receptor binding and signaling pathway characterization

Basic Information

Product Name	Plecanatide Acetate
CAS No.	1075732-84-1
Molecular Formula	C74H113N21O22S2 · C2H4O2
Molecular Weight	1725.94 g/mol (free base); 1786.02 g/mol (acetate salt)
Synonyms	Plecanatide acetate; TRULANCE® acetate; SP-333 acetate; [Cys1,Cys6]-plecanatide acetate; Nα-Acetyl-L-tyrosyl-L-cysteinyl-L-glutaminyl-L-aspartyl-L-cysteinyl-L-threonyl-L-phenylalanyl-L-threonyl-L-lysyl-L-leucyl-L-valyl-L-arginyl-L-prolyl-L-arginyl-L-cysteinyl-L-cysteine acetate; Ac-Tyr-Cys-Gln-Asp-Cys-Thr-Phe-Thr-Lys-Leu-Val-Arg-Pro-Arg-Cys-Cys-OH · CH3COOH; Plecanatide (acetate salt); SP-333 (acetate form)
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. Testing includes identity confirmation (IR, HPLC, MS), assay (HPLC), related substances (HPLC), residual solvents (GC), water content (Karl Fischer), and heavy metals (ICP-MS). All batches conform to USP & EP monograph requirements for peptide APIs, and are manufactured under cGMP-aligned quality systems compliant with FDA, EMA, and ICH guidelines.

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. Due to its hygroscopic nature, maintain relative humidity below 30% during handling and storage. Avoid repeated exposure to ambient conditions.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	ESI-MS m/z 1725.9 ± 0.5 [M+H]+ (free base)
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)	MeOH ≤ 3000 ppm; Acetonitrile ≤ 410 ppm; Ethyl acetate ≤ 5000 ppm
Heavy Metals	≤ 10 ppm
Microbial Limits	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.