(1S,3S)-Tryptophan EP Impurity I CAS 40678-46-4

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.40678-46-4
Molecular FormulaC13H14N2O2
Molecular Weight230.26 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

(1S,3S)-Tryptophan EP Impurity I CAS 40678-46-4 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 (1S,3S)-Tryptophan EP Impurity I.

As a process- or degradation-related impurity, (1S,3S)-Tryptophan EP Impurity I (CAS 40678-46-4, C13H14N2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

(1S,3S)-Tryptophan EP Impurity I (C13H14N2O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, 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).

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.

As a certified reference material (CRM), (1S,3S)-Tryptophan EP Impurity I 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 FormulaC13H14N2O2
Molecular Weight230.26 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1968
Nitrogen Atoms2

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