Lysine Impurity 22 Trihydrochloride CAS 164262-23-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.164262-23-1
Molecular FormulaC12H26N4O3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lysine Impurity 22 Trihydrochloride CAS 164262-23-1 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 Lysine Impurity 22 Trihydrochloride.

As a process- or degradation-related impurity, Lysine Impurity 22 Trihydrochloride (CAS 164262-23-1, C12H26N4O3HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Lysine Impurity 22 Trihydrochloride is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 310.82 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 22 Trihydrochloride 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 FormulaC12H26N4O3 3*HCl
Molecular Weight310.82 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)2003
Halogen ContentCl-containing
Nitrogen Atoms4

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