Description

Pyrantel Impurity A is a designated impurity standard used in the quality control and analytical profiling of the anthelmintic drug Pyrantel. This compound is critical for ensuring the purity, safety, and efficacy of Pyrantel-based pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Pyrantel Impurity A in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurities during stability studies.
• Quality Control & Batch Release: Used in routine QC testing to ensure Pyrantel drug substances and products meet pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, CTA) by providing impurity profiles and demonstrating control strategies for drug substances.
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Research & Development: Utilized in R&D to understand the degradation pathways of Pyrantel and to synthesize purer batches of the API.

Basic Information

Product Name	Pyrantel Impurity A
CAS No.	36700-38-6
Molecular Formula	C11H14N2S
Molecular Weight	206.31 g/mol
Synonyms	1-Methyl-2-[(E)-2-(thiophen-2-yl)ethenyl]-1,4,5,6-tetrahydropyrimidine; (E)-1-Methyl-2-(2-(2-thienyl)vinyl)-1,4,5,6-tetrahydropyrimidine; trans-1-Methyl-2-(2-(2-thienyl)vinyl)-1,4,5,6-tetrahydropyrimidine; Pyrantel Related Compound A; Pyrantel EP Impurity A; Pyrantel USP Impurity A
EINECS	Contact for details

Quality Control

Our Pyrantel Impurity A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR), to ensure it meets high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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