Mianserin Impurity 56 CAS 68998-54-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.68998-54-9
Molecular FormulaC7H17NO3
Molecular Weight163.21 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mianserin Impurity 56 CAS 68998-54-9 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 Mianserin Impurity 56.

As a process- or degradation-related impurity, Mianserin Impurity 56 (CAS 68998-54-9, C7H17NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Mianserin Impurity 56 (C7H17NO3) contains an amino-acid-derived structure, an amide 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. 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC7H17NO3
Molecular Weight163.21 g/mol
Purity97%+
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)0.0
CAS Registry Year (est.)1976
Nitrogen Atoms1

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