Calcium Folinate EP Impurity A CAS 4271-30-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.4271-30-1
Molecular FormulaC12H14N2O5
Molecular Weight266.25 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Calcium Folinate EP Impurity A CAS 4271-30-1 chemical structure

Description

Calcium Folinate EP Impurity A (CAS 4271-30-1) is a certified pharmaceutical impurity reference standard with the molecular formula C12H14N2O5 and a molecular weight of 266.25 g/mol.

The molecular framework of Calcium Folinate EP Impurity A (C12H14N2O5) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

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 FormulaC12H14N2O5
Molecular Weight266.25 g/mol
AppearanceOff-white to pale yellow crystalline powder
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)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958
Nitrogen Atoms2

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