Ampicillin EP Impurity I CAS 10001-82-8

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.10001-82-8
Molecular FormulaC24H26N4O5S
Molecular Weight482.55 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ampicillin EP Impurity I CAS 10001-82-8 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.

Ampicillin EP Impurity I (CAS 10001-82-8) is a certified pharmaceutical impurity reference standard with the molecular formula C24H26N4O5S and a molecular weight of 482.55 g/mol.

Owing to a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, Ampicillin EP Impurity I is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 482.55 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

Physical & Chemical Properties

Molecular FormulaC24H26N4O5S
Molecular Weight482.55 g/mol
Purity>90%
StorageStore in a cool place (≤25°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)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1959
Nitrogen Atoms4
Sulfur Atoms1

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