Octreotide EP Impurity E CAS 1546983-27-0(Free base)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1546983-27-0(Free base)
Molecular FormulaC49H66N10O10S3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Octreotide EP Impurity E CAS 1546983-27-0(Free base) chemical structure

Description

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.

CATO supplies Octreotide EP Impurity E (CAS 1546983-27-0(Free base)), a pharmacopoeial impurity reference standard (molecular formula C49H66N10O10S3C2HF3O2, MW 1165.33 g/mol) used for the identification and quantification of trace impurities in APIs.

Octreotide EP Impurity E (C49H66N10O10S3C2HF3O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC49H66N10O10S3 C2HF3O2
Molecular Weight1165.33 g/mol
Purity>95%
StorageStore in a cool place (≤25°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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)22.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms10
Sulfur Atoms3

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