Tofacitinib Impurity 38 CAS 1092578-45-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1092578-45-4
Molecular FormulaC20H25N5
Molecular Weight335.45 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tofacitinib Impurity 38 CAS 1092578-45-4 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 Tofacitinib Impurity 38.

CATO supplies Tofacitinib Impurity 38 (CAS 1092578-45-4), a pharmacopoeial impurity reference standard (molecular formula C20H25N5, MW 335.45 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Tofacitinib Impurity 38 (C20H25N5) contains a nitrogen-containing heterocyclic scaffold, a nitrile group. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 335.45 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).

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.

CATO manufactures Tofacitinib Impurity 38 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC20H25N5
Molecular Weight335.45 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1989
Nitrogen Atoms5

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