Saxagliptin Impurity 1 CAS 1564265-95-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1564265-95-7
Molecular FormulaC18H25N3O2
Molecular Weight315.41 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Saxagliptin Impurity 1 CAS 1564265-95-7 chemical structure

Description

CATO supplies Saxagliptin Impurity 1 (CAS 1564265-95-7), a pharmacopoeial impurity reference standard (molecular formula C18H25N3O2, MW 315.41 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Saxagliptin Impurity 1 (C18H25N3O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 315.41 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 certified reference material (CRM), Saxagliptin Impurity 1 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
Molecular Weight315.41 g/mol
AppearancePale yellow to yellow crystalline powder
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
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1993
Nitrogen Atoms3

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