Lysine Impurity 43 DiHCl CAS 82951-55-1 (free base)

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.82951-55-1 (free base)
Molecular FormulaC11H21N3O5S
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lysine Impurity 43 DiHCl CAS 82951-55-1 (free base) chemical structure

Description

As a process- or degradation-related impurity, Lysine Impurity 43 DiHCl (CAS 82951-55-1 (free base), C11H21N3O5SHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Lysine Impurity 43 DiHCl (C11H21N3O5SHCl) is characterized by an amide group, a sulfone group, a carboxylic acid 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.

As a certified reference material (CRM), Lysine Impurity 43 DiHCl 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 FormulaC11H21N3O5S 2*HCl
Molecular Weight343.82 g/mol
Purity≥95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)2.0
Halogen ContentCl-containing
Nitrogen Atoms3
Sulfur Atoms1

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