Hydrochlorothiazide Impurity N8 CAS 4140-83-4

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.4140-83-4
Molecular FormulaC6H7ClN2O2
Molecular Weight206.65 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Hydrochlorothiazide Impurity N8 CAS 4140-83-4 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 Hydrochlorothiazide Impurity N8.

Hydrochlorothiazide Impurity N8 (CAS 4140-83-4) is a certified pharmaceutical impurity reference standard with the molecular formula C6H7ClN2O2 and a molecular weight of 206.65 g/mol.

Structurally, Hydrochlorothiazide Impurity N8 (C6H7ClN2O2) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 206.65 g/mol, it falls into the medium-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC6H7ClN2O2
Molecular Weight206.65 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation
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.)1958
Halogen ContentCl-containing
Nitrogen Atoms2

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