Atorvastatin Impurity 136 Pivalic Acid CAS 1363159-14-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1363159-14-1
Molecular FormulaC13H25NO4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Atorvastatin Impurity 136 Pivalic Acid CAS 1363159-14-1 chemical structure

Description

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.

Atorvastatin Impurity 136 Pivalic Acid (CAS 1363159-14-1) is a certified pharmaceutical impurity reference standard with the molecular formula C13H25NO4C5H10O2 and a molecular weight of 361.48 g/mol.

Based on its molecular formula C13H25NO4C5H10O2, Atorvastatin Impurity 136 Pivalic Acid contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 361.48 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

Physical & Chemical Properties

Molecular FormulaC13H25NO4 C5H10O2
Molecular Weight361.48 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1991
Nitrogen Atoms1

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