Ceftriaxone Impurity 39 CAS 139-33-3(Anhydrate CAS)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.139-33-3(Anhydrate CAS)
Molecular FormulaC10H14N2O8
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ceftriaxone Impurity 39 CAS 139-33-3(Anhydrate CAS) chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ceftriaxone Impurity 39.

Ceftriaxone Impurity 39 (CAS 139-33-3(Anhydrate CAS)) is a certified pharmaceutical impurity reference standard with the molecular formula C10H14N2O8NaH2O and a molecular weight of 331.23 g/mol.

Ceftriaxone Impurity 39 (C10H14N2O8NaH2O) contains a carbohydrate-derived structure, an amide group. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 FormulaC10H14N2O8 2*Na 2*H2O
Molecular Weight331.23 g/mol
AppearanceOff-white 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 methanol, ethanol, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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