Larotrectinib Impurity 1 CAS 1223404-68-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1223404-68-9
Molecular FormulaC21H22F2N6O2
Molecular Weight428.44 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Larotrectinib Impurity 1 CAS 1223404-68-9 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 Larotrectinib Impurity 1.

Larotrectinib Impurity 1 (CAS 1223404-68-9) is a certified pharmaceutical impurity reference standard with the molecular formula C21H22F2N6O2 and a molecular weight of 428.44 g/mol.

The molecular framework of Larotrectinib Impurity 1 (C21H22F2N6O2) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 Larotrectinib Impurity 1 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 FormulaC21H22F2N6O2
Molecular Weight428.44 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore in a cool place (≤25°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)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1990
Halogen ContentF-containing
Nitrogen Atoms6

Related Larotrectinib Standards

Recommended Standards

Why CATO?