Clarithromycin EP Impurity J(Roxithromycin EP Impurity C) HCl CAS 145645-54-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.145645-54-1
Molecular FormulaC37H68N2O13
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clarithromycin EP Impurity J(Roxithromycin EP Impurity C) HCl CAS 145645-54-1 chemical structure

Description

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.

Clarithromycin EP Impurity J(Roxithromycin EP Impurity C) HCl (CAS 145645-54-1) is a certified pharmaceutical impurity reference standard with the molecular formula C37H68N2O13HCl and a molecular weight of 785.41 g/mol.

Based on its molecular formula C37H68N2O13HCl, Clarithromycin EP Impurity J(Roxithromycin EP Impurity C) HCl contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 785.41 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.

CATO manufactures Clarithromycin EP Impurity J(Roxithromycin EP Impurity C) HCl under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC37H68N2O13 HCl
Molecular Weight785.41 g/mol
Purity97%+
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1998
Halogen ContentCl-containing
Nitrogen Atoms2

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