Mitiglinide Calcium Impurity 17 CAS 70925-10-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.70925-10-9
Molecular FormulaC8H14N2O2
Molecular Weight170.21 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mitiglinide Calcium Impurity 17 CAS 70925-10-9 chemical structure

Description

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.

CATO supplies Mitiglinide Calcium Impurity 17 (CAS 70925-10-9), a pharmacopoeial impurity reference standard (molecular formula C8H14N2O2, MW 170.21 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Mitiglinide Calcium Impurity 17 (C8H14N2O2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 170.21 g/mol, it falls into the medium-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.

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 FormulaC8H14N2O2
Molecular Weight170.21 g/mol
AppearanceWhite to pale yellow crystalline powder. (faint amine-like odor)
Purity>95%
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)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1977
Nitrogen Atoms2

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