Terbutaline Impurity 18 CAS CATO-C4X-118318

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-118318
Molecular FormulaC8H7BrO3
Molecular Weight231.04 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Terbutaline Impurity 18 CAS CATO-C4X-118318 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 Terbutaline Impurity 18.

As a process- or degradation-related impurity, Terbutaline Impurity 18 (CAS CATO-C4X-118318, C8H7BrO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Terbutaline Impurity 18 (C8H7BrO3) contains a carboxylic acid group, a hydroxyl group, an ether linkage, bromine substitution, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 231.04 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 FormulaC8H7BrO3
Molecular Weight231.04 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore in a cool place (≤25°C), keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentBr-containing

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