Sapropterin Impurity 3 CAS CATO-C4X-27663

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-27663
Molecular FormulaC9H14N4O4
Molecular Weight242.23 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sapropterin Impurity 3 CAS CATO-C4X-27663 chemical structure

Description

The occurrence of Sapropterin Impurity 3 is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Sapropterin Impurity 3 (CAS CATO-C4X-27663) is a certified pharmaceutical impurity reference standard with the molecular formula C9H14N4O4 and a molecular weight of 242.23 g/mol.

Structurally, Sapropterin Impurity 3 (C9H14N4O4) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 242.23 g/mol, it falls into the medium-molecular-weight range. 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.

As a certified reference material (CRM), Sapropterin Impurity 3 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 FormulaC9H14N4O4
Molecular Weight242.23 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)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms4

Related Sapropterin Standards

Recommended Standards

Why CATO?