Lactitol Impurity 2 CAS CATO-C4X-29472

Purity >85%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-29472
Molecular FormulaC9H14O7
Molecular Weight234.20 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lactitol Impurity 2 CAS CATO-C4X-29472 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 Lactitol Impurity 2.

Lactitol Impurity 2 (CAS CATO-C4X-29472) is a certified pharmaceutical impurity reference standard with the molecular formula C9H14O7 and a molecular weight of 234.20 g/mol.

Lactitol Impurity 2 (C9H14O7) contains a carboxylic acid group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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), Lactitol Impurity 2 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 FormulaC9H14O7
Molecular Weight234.20 g/mol
Purity>85%
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing

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