Cilnidipine Impurity 18 CAS 52326-05-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.52326-05-3
Molecular FormulaC9H16O5
Molecular Weight204.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cilnidipine Impurity 18 CAS 52326-05-3 chemical structure

Description

The occurrence of Cilnidipine Impurity 18 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Cilnidipine Impurity 18 (CAS 52326-05-3) is a certified pharmaceutical impurity reference standard with the molecular formula C9H16O5 and a molecular weight of 204.22 g/mol.

Structurally, Cilnidipine Impurity 18 (C9H16O5) contains a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 2.0, corresponding to approximately 2 ring(s) or double-bond equivalent(s). With a molecular weight of 204.22 g/mol, it falls into the medium-molecular-weight range.

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 FormulaC9H16O5
Molecular Weight204.22 g/mol
Purity>95%
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1971

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