Norethindrone Impurity 8 CAS 25796-09-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.25796-09-2
Molecular FormulaC20H30O2
Molecular Weight302.45 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Norethindrone Impurity 8 CAS 25796-09-2 chemical structure

Description

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.

As a process- or degradation-related impurity, Norethindrone Impurity 8 (CAS 25796-09-2, C20H30O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Norethindrone Impurity 8 (C20H30O2) contains a steroid core, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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 FormulaC20H30O2
Molecular Weight302.45 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light
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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1964

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