Buprenorphine EP Impurity C CAS 16614-60-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.16614-60-1
Molecular FormulaC27H36N2O4
Molecular Weight452.59 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Buprenorphine EP Impurity C CAS 16614-60-1 chemical structure

Description

The occurrence of Buprenorphine EP Impurity C is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Buprenorphine EP Impurity C (CAS 16614-60-1) is a certified pharmaceutical impurity reference standard with the molecular formula C27H36N2O4 and a molecular weight of 452.59 g/mol.

The molecular framework of Buprenorphine EP Impurity C (C27H36N2O4) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

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 FormulaC27H36N2O4
Molecular Weight452.59 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
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
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1961
Nitrogen Atoms2

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