Tacrolimus EP Impurity I CAS 104987-16-8

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.104987-16-8
Molecular FormulaC44H67NO11
Molecular Weight786.00 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tacrolimus EP Impurity I CAS 104987-16-8 chemical structure

Description

The occurrence of Tacrolimus EP Impurity I is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Tacrolimus EP Impurity I (CAS 104987-16-8) is a certified pharmaceutical impurity reference standard with the molecular formula C44H67NO11 and a molecular weight of 786.00 g/mol.

Based on its molecular formula C44H67NO11, Tacrolimus EP Impurity I contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 786.00 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 manufactures Tacrolimus EP Impurity I under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC44H67NO11
Molecular Weight786.00 g/mol
Purity>90%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1986
Nitrogen Atoms1

Related Tacrolimus Standards

Recommended Standards

Why CATO?