Teriparatide Impurity 3 (Teri-Met 8(O)) CAS CATO-C4X-21853

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-21853
Molecular FormulaC181H291N55O52S2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Teriparatide Impurity 3 (Teri-Met 8(O)) CAS CATO-C4X-21853 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 Teriparatide Impurity 3 (Teri-Met 8(O)).

CATO supplies Teriparatide Impurity 3 (Teri-Met 8(O)) (CAS CATO-C4X-21853), a pharmacopoeial impurity reference standard (molecular formula C181H291N55O52S2C2HF3O2, MW 4247.79 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C181H291N55O52S2C2HF3O2, Teriparatide Impurity 3 (Teri-Met 8(O)) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 4247.79 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

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 FormulaC181H291N55O52S2 C2HF3O2
Molecular Weight4247.79 g/mol
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)64.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms55
Sulfur Atoms2

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