Linaclotide Impurity 27 CAS CATO-C4X-210627

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-210627
Molecular FormulaC59H79N15O21S6
Molecular Weight1526.73 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Linaclotide Impurity 27 CAS CATO-C4X-210627 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Linaclotide Impurity 27.

As a process- or degradation-related impurity, Linaclotide Impurity 27 (CAS CATO-C4X-210627, C59H79N15O21S6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Linaclotide Impurity 27 (C59H79N15O21S6) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 28.0, corresponding to approximately 28 ring(s) or double-bond equivalent(s). With a molecular weight of 1526.73 g/mol, it falls into the high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC59H79N15O21S6
Molecular Weight1526.73 g/mol
Purity≥95%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)28.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms15
Sulfur Atoms6

Related Linaclotide Standards

Recommended Standards

Why CATO?