Spectinomycin dihydrochloride EP Impurity D CAS CATO-C4X-22162

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-22162
Molecular FormulaC14H26N2O8
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Spectinomycin dihydrochloride EP Impurity D CAS CATO-C4X-22162 chemical structure

Description

CATO supplies Spectinomycin dihydrochloride EP Impurity D (CAS CATO-C4X-22162), a pharmacopoeial impurity reference standard (molecular formula C14H26N2O8HCl, MW 386.83 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Spectinomycin dihydrochloride EP Impurity D is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 386.83 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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), Spectinomycin dihydrochloride EP Impurity D 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 FormulaC14H26N2O8 2*HCl
Molecular Weight386.83 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)2.0
Halogen ContentCl-containing
Nitrogen Atoms2

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