Lactitol EP Impurity B CAS 53796-37-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.53796-37-5
Molecular FormulaC12H24O11
Molecular Weight344.31 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lactitol EP Impurity B CAS 53796-37-5 chemical structure

Description

The occurrence of Lactitol EP Impurity B is closely related to a carbohydrate-derived structure in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Lactitol EP Impurity B (CAS 53796-37-5, C12H24O11) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a carbohydrate-derived structure, Lactitol EP Impurity B is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 344.31 g/mol — guide the selection of appropriate sample preparation and analytical techniques.

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.

CATO manufactures Lactitol EP Impurity B under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC12H24O11
Molecular Weight344.31 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1972

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