Chlortetracycline EP Impurity A CAS 14297-93-9

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.14297-93-9
Molecular FormulaC22H23ClN2O8
Molecular Weight478.88 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Chlortetracycline EP Impurity A CAS 14297-93-9 chemical structure

Description

The occurrence of Chlortetracycline EP Impurity A is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Chlortetracycline EP Impurity A (CAS 14297-93-9) is a certified pharmaceutical impurity reference standard with the molecular formula C22H23ClN2O8 and a molecular weight of 478.88 g/mol.

Based on its molecular formula C22H23ClN2O8, Chlortetracycline EP Impurity A contains a flavonoid core, 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 478.88 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC22H23ClN2O8
Molecular Weight478.88 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>90%
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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1961
Halogen ContentCl-containing
Nitrogen Atoms2

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