Bictegravir Impurity 7 CAS 1284248-73-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1284248-73-2
Molecular FormulaC5H11NO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bictegravir Impurity 7 CAS 1284248-73-2 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 Bictegravir Impurity 7.

Bictegravir Impurity 7 (CAS 1284248-73-2) is a certified pharmaceutical impurity reference standard with the molecular formula C5H11NOHCl and a molecular weight of 137.61 g/mol.

The molecular framework of Bictegravir Impurity 7 (C5H11NOHCl) is characterized by an amide group, a hydroxyl group, an ether linkage, chlorine 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.

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 FormulaC5H11NO HCl
Molecular Weight137.61 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)0.0
CAS Registry Year (est.)1990
Halogen ContentCl-containing
Nitrogen Atoms1

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