Ethambutol Hydrochloride EP Impurity D CAS 52399-93-6

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.52399-93-6
Molecular FormulaC2H4Cl2
Molecular Weight98.96 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ethambutol Hydrochloride EP Impurity D CAS 52399-93-6 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 Ethambutol Hydrochloride EP Impurity D.

As a process- or degradation-related impurity, Ethambutol Hydrochloride EP Impurity D (CAS 52399-93-6, C2H4Cl2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C2H4Cl2, Ethambutol Hydrochloride EP Impurity D contains chlorine substitution; these features give the compound characteristic molecular-ion distribution patterns in mass spectrometry. The molecular weight of 98.96 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.

As a certified reference material (CRM), Ethambutol Hydrochloride EP Impurity D meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC2H4Cl2
Molecular Weight98.96 g/mol
Purity97%+
StorageStore at 2-8°C, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO
StabilityStable under recommended storage conditions
Degree of Unsaturation (DBE)0.0
CAS Registry Year (est.)1971
Halogen ContentCl-containing

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