Loperamide EP Impurity H HCl salt CAS 61299-42-1(Free Base)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.61299-42-1(Free Base)
Molecular FormulaC29H31ClN2O
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Loperamide EP Impurity H HCl salt CAS 61299-42-1(Free Base) 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 Loperamide EP Impurity H HCl salt.

As a process- or degradation-related impurity, Loperamide EP Impurity H HCl salt (CAS 61299-42-1(Free Base), C29H31ClN2OHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Loperamide EP Impurity H HCl salt (C29H31ClN2OHCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 14.0, corresponding to approximately 14 ring(s) or double-bond equivalent(s). With a molecular weight of 495.49 g/mol, it falls into the moderately-high-molecular-weight range. 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC29H31ClN2O HCl
Molecular Weight495.49 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms2

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