Clindamycin Phosphas EP Impurity L CAS 620181-05-7

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.620181-05-7
Molecular FormulaC18H34ClN2O8PS
Molecular Weight504.96 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clindamycin Phosphas EP Impurity L CAS 620181-05-7 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 Clindamycin Phosphas EP Impurity L.

Clindamycin Phosphas EP Impurity L (CAS 620181-05-7) is a certified pharmaceutical impurity reference standard with the molecular formula C18H34ClN2O8PS and a molecular weight of 504.96 g/mol.

Based on its molecular formula C18H34ClN2O8PS, Clindamycin Phosphas EP Impurity L contains an amide group, a sulfone group, a phosphate ester group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 504.96 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

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 FormulaC18H34ClN2O8PS
Molecular Weight504.96 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)2.5
CAS Registry Year (est.)1985
Halogen ContentCl-containing
Nitrogen Atoms2
Sulfur Atoms1

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