Category
Chlorambucil
Alternate CAS Number
Chlorambucil STD - 305-03-3 : IMP - B - 116505-53-4 : IMP - E - 1988791-13-4 ;
Molecular Formula
Chlorambucil STD - C14H19Cl2NO2 : IMP - B - C12H16ClNO2 : IMP - E - C28H37Cl3N2O4 ;
Molecular Weight
Chlorambucil STD - 304.21 g/mol : IMP - B - 241.71 g/mol : IMP - E - 571.96 g/mol ;
Synonym

Chlorambucil - 4-[p-[Bis(2-chloroethyl)amino]phenyl]butyric Acid; 4-[Bis(2-chloroethyl)amino]benzenebutanoic Acid; 4-[p-[Bis(2-chloroethyl)amino]phenyl]butyric Acid;

Chlorambucil EP Impurity B - 4-[4-[(2-Chloroethyl)amino]phenyl]butanoic Acid ; 4-[(2-Chloroethyl)amino]benzenebutanoic Acid;

Chlorambucil EP Impurity E - 4-(4-((2-((4-(4-(Bis(2-chloroethyl)amino)phenyl)butanoyl)oxy)ethyl)(2-chloroethyl)amino)phenyl)butanoic acid ; 

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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Chlorambucil can be used in system suitability testing (SST) for HPLC or other chromatographic methods as a Certified Reference Standard (CRS). It ensures the system produces consistent retention times, sharp and symmetric peaks, proper resolution, and reproducible peak areas, allowing accurate and reliable analysis of Chlorambucil in pharmaceutical formulations.