Description

Levamisole Ep Impurity E (Mixture Of Diastereomers) is a defined chemical reference standard used in the analytical profiling of the active pharmaceutical ingredient, Levamisole HCl. This compound is critical for pharmaceutical quality control and regulatory compliance, serving as a key marker for process-related impurities. It is primarily required by analytical laboratories, quality assurance departments, and research institutions within the pharmaceutical and biotechnology sectors to ensure product purity, safety, and adherence to pharmacopeial monographs such as the European Pharmacopoeia (EP).

Application

• Primary use as a certified reference standard (CRS) for system suitability and method validation in HPLC and LC-MS analysis.
• Identification and quantification of process impurities during the quality control (QC) of Levamisole hydrochloride active pharmaceutical ingredient (API).
• Essential component in stability studies and forced degradation studies to monitor impurity profiles over time.
• Calibration standard for ensuring analytical method compliance with pharmacopeial specifications (EP, USP) and ICH guidelines.
• Use in research and development for impurity synthesis pathway investigation and control strategy development.
• Supporting documentation for regulatory filings (EDMF, CMC, DMF) by providing characterized impurity samples.

Basic Information

Product Name	Levamisole Ep Impurity E (Mixture Of Diastereomers)
CAS No.	32190-36-6
Molecular Formula	C11H12N2S
Molecular Weight	204.29 g/mol
Synonyms	(2S,3S,5S)- and (2R,3R,5R)-2,3,5,6-Tetrahydro-6-phenylimidazo[2,1-b]thiazole; Levamisole Impurity E (EP); (-)-Tetramisole Related Compound E; (6S)-2,3,5,6-Tetrahydro-6-phenylimidazo[2,1-b][1,3]thiazole (and enantiomer); Levamisole Diastereomeric Impurity; Tetramisole Impurity E; 6-Phenyl-2,3,5,6-tetrahydroimidazo[2,1-b]thiazole
EINECS	Contact for details

Quality Control

Every batch of Levamisole Ep Impurity E is manufactured and controlled to meet the stringent requirements for pharmaceutical reference standards. Our quality system ensures identity, purity, and stability are rigorously verified. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results from advanced chromatographic and spectroscopic analyses. We support compliance with cGMP and relevant ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which could affect stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0% (sum of diastereomers)
Individual Diastereomer Ratio	Specified on COA
Related Substances (HPLC)	Report individual impurities ≥ 0.1%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.