Lysine Impurity 12 CAS 44978-39-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.44978-39-4
Molecular FormulaC7H13NO3
Molecular Weight159.18 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lysine Impurity 12 CAS 44978-39-4 chemical structure

Description

As a certified reference material (CRM), Lysine Impurity 12 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.

As a process- or degradation-related impurity, Lysine Impurity 12 (CAS 44978-39-4, C7H13NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Lysine Impurity 12 (C7H13NO3) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

Physical & Chemical Properties

Molecular FormulaC7H13NO3
Molecular Weight159.18 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1969
Nitrogen Atoms1

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