Clindamycin Phosphate EP Impurity I CAS 1309048-48-3

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.1309048-48-3
Molecular FormulaC18H35ClN2O11P2S
Molecular Weight584.94 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clindamycin Phosphate EP Impurity I CAS 1309048-48-3 chemical structure

Description

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.

As a process- or degradation-related impurity, Clindamycin Phosphate EP Impurity I (CAS 1309048-48-3, C18H35ClN2O11P2S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to an amide group, a sulfone group, a phosphate ester group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Clindamycin Phosphate EP Impurity I is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 584.94 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

Physical & Chemical Properties

Molecular FormulaC18H35ClN2O11P2S
Molecular Weight584.94 g/mol
Purity>90%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1990
Halogen ContentCl-containing
Nitrogen Atoms2
Sulfur Atoms1

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