Tetracaine EP Impurity C CAS 71839-12-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.71839-12-8
Molecular FormulaC12H17NO2
Molecular Weight207.27 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tetracaine EP Impurity C CAS 71839-12-8 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 Tetracaine EP Impurity C.

Tetracaine EP Impurity C (CAS 71839-12-8) is a certified pharmaceutical impurity reference standard with the molecular formula C12H17NO2 and a molecular weight of 207.27 g/mol.

Tetracaine EP Impurity C (C12H17NO2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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), Tetracaine EP Impurity C 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 FormulaC12H17NO2
Molecular Weight207.27 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1977
Nitrogen Atoms1

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