Description

Ivermectin Ep Impurity I is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of Ivermectin-based drug products by enabling the accurate identification and quantification of this specific impurity. It is an essential material for research laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and fine chemical industries.

Application

• Primary use as a certified reference standard for analytical method development and validation.
• Critical component in impurity profiling and stability studies of Ivermectin Active Pharmaceutical Ingredients (APIs).
• Used for quality control testing to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., USP, EP).
• Essential for regulatory submissions (e.g., ANDA, NDA) to demonstrate thorough impurity characterization.
• Supports research and development of Ivermectin synthesis pathways and purification processes.
• Employed in calibration of analytical equipment such as High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS).

Basic Information

Product Name	Ivermectin Ep Impurity I
CAS No.	1135339-49-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ivermectin EP Impurity I; Ivermectin Related Compound I; (5-O-Demethyl-22,23-dihydroavermectin A1a)-(E)-8,9-epoxide; 22,23-Dihydroavermectin B1a 5-O-demethyl-8,9-epoxide; Ivermectin Impurity E; Ivermectin EP Impurity E; Ivermectin Related Substance I
EINECS	Contact for details

Quality Control

Our Ivermectin Ep Impurity I is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods, to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile 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 product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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