Clomifene Citrate EP Impurity A CAS CATO-C4X-151216

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-151216
Molecular Formula2*C26H29NO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clomifene Citrate EP Impurity A CAS CATO-C4X-151216 chemical structure

Description

As a process- or degradation-related impurity, Clomifene Citrate EP Impurity A (CAS CATO-C4X-151216, C26H29NOHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Clomifene Citrate EP Impurity A (C26H29NOHCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

As a certified reference material (CRM), Clomifene Citrate EP Impurity A 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 Formula2*C26H29NO 2*HCl
Molecular Weight407.98 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity≥95%
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

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