(R)-Cetirizine EP Impurity G DiHCl CAS 728948-88-7

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.728948-88-7
Molecular FormulaC19H23ClN2O
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

(R)-Cetirizine EP Impurity G DiHCl CAS 728948-88-7 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 (R)-Cetirizine EP Impurity G DiHCl.

CATO supplies (R)-Cetirizine EP Impurity G DiHCl (CAS 728948-88-7), a pharmacopoeial impurity reference standard (molecular formula C19H23ClN2OHCl, MW 367.31 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, (R)-Cetirizine EP Impurity G DiHCl (C19H23ClN2OHCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 367.31 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

As a certified reference material (CRM), (R)-Cetirizine EP Impurity G DiHCl meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC19H23ClN2O 2*HCl
Molecular Weight367.31 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1986
Halogen ContentCl-containing
Nitrogen Atoms2

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