Lysine Impurity 11 HCl CAS 39994-75-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.39994-75-7
Molecular FormulaC5H11NO3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lysine Impurity 11 HCl CAS 39994-75-7 chemical structure

Description

Lysine Impurity 11 HCl (C5H11NO3HCl) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; 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.

As a process- or degradation-related impurity, Lysine Impurity 11 HCl (CAS 39994-75-7, C5H11NO3HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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), Lysine Impurity 11 HCl 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 FormulaC5H11NO3 HCl
Molecular Weight169.60 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)0.0
CAS Registry Year (est.)1968
Halogen ContentCl-containing
Nitrogen Atoms1

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