Ranitidine Hydrochloride EP Impurity B CAS 91224-69-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.91224-69-0
Molecular FormulaC10H18N2OS
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ranitidine Hydrochloride EP Impurity B CAS 91224-69-0 chemical structure

Description

The occurrence of Ranitidine Hydrochloride EP Impurity B is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Ranitidine Hydrochloride EP Impurity B (CAS 91224-69-0, C10H18N2OSC4H4O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Ranitidine Hydrochloride EP Impurity B (C10H18N2OSC4H4O4) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 FormulaC10H18N2OS C4H4O4
Molecular Weight330.40 g/mol
Purity97%+
StorageStore at 2-8°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
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1983
Nitrogen Atoms2
Sulfur Atoms1

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