Description

Levamisole Ep Impurity B is a critical reference standard and impurity used in the pharmaceutical development and quality control of Levamisole, an anthelmintic and immunomodulatory agent. This compound is essential for ensuring the purity, safety, and efficacy of active pharmaceutical ingredients (APIs) by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Levamisole Ep Impurity B in Levamisole API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC testing of Levamisole to ensure batches meet the specified impurity limits as per EP, USP, or other pharmacopeias.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate control over the manufacturing process.
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of Levamisole.

Basic Information

Product Name	Levamisole Ep Impurity B
CAS No.	37430-07-2
Molecular Formula	C11H12N2S
Molecular Weight	204.29 g/mol
Synonyms	(S)-2,3,5,6-Tetrahydro-6-phenylimidazo[2,1-b]thiazole; Levamisole Related Compound B; Levamisole Impurity B; (-)-Tetramisole Impurity; (S)-(-)-2,3,5,6-Tetrahydro-6-phenylimidazo[2,1-b]thiazole; L-Tetramisole Impurity; 6-Phenyl-2,3,5,6-tetrahydroimidazo[2,1-b]thiazole
EINECS	Contact for details

Quality Control

Every batch of Levamisole Ep Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and impurity profile.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Assay	97.0% - 103.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%

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