Saxagliptin Impurity 32 HCl CAS 1564266-00-7 (free base)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1564266-00-7 (free base)
Molecular FormulaC18H25N3O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Saxagliptin Impurity 32 HCl CAS 1564266-00-7 (free base) chemical structure

Description

Saxagliptin Impurity 32 HCl (CAS 1564266-00-7 (free base)) is a certified pharmaceutical impurity reference standard with the molecular formula C18H25N3O2HCl and a molecular weight of 351.88 g/mol.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Saxagliptin Impurity 32 HCl is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 351.88 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

As a certified reference material (CRM), Saxagliptin Impurity 32 HCl meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC18H25N3O2 HCl
Molecular Weight351.88 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms3

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