Tolperisone Impurity 8 CAS CATO-C4X-20658

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-20658
Molecular FormulaC17H25NO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tolperisone Impurity 8 CAS CATO-C4X-20658 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 Tolperisone Impurity 8.

CATO supplies Tolperisone Impurity 8 (CAS CATO-C4X-20658), a pharmacopoeial impurity reference standard (molecular formula C17H25NOHCl, MW 295.85 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Tolperisone Impurity 8 (C17H25NOHCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. 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 295.85 g/mol, it falls into the medium-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

CATO manufactures Tolperisone Impurity 8 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC17H25NO HCl
Molecular Weight295.85 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

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