Description

28-Oxo Ivermectin B1A (Impurity) is a key oxidative degradation product and impurity of the broad-spectrum antiparasitic agent Ivermectin. This compound is of critical importance for pharmaceutical research and development, serving as a certified reference standard for analytical method development, stability studies, and quality control testing. It is primarily needed by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies to ensure the purity, safety, and efficacy of Ivermectin-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of 28-Oxo Ivermectin B1A in Ivermectin active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor degradation pathways.
• Forced Degradation Studies: Employed in stability testing to understand the oxidative degradation profile of Ivermectin under various stress conditions.
• Quality Control & Batch Release: Critical for setting impurity limits and ensuring batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., USP, EP).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research on Degradation Mechanisms: Used in academic and industrial research to study the metabolic and environmental degradation pathways of avermectin compounds.

Basic Information

Product Name	28-Oxo Ivermectin B1A (Impurity)
CAS No.	102190-55-6
Molecular Formula	C₄₈H₇₂O₁₅
Molecular Weight	889.1 g/mol
Synonyms	28-Oxoabamectin B1a; 5-O-Demethyl-28-oxoabamectin; 28-Keto Ivermectin B1a; 28-Oxo-22,23-dihydroavermectin B1a; Ivermectin Impurity F (EP); Ivermectin Related Compound F (USP); 4″-Deoxy-4″-oxo-22,23-dihydroavermectin B1a; 5-O-Demethyl-28-oxo-22,23-dihydroavermectin B1a
EINECS	Contact for details

Quality Control

Our 28-Oxo Ivermectin B1A (Impurity) is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards (USP, EP). 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 a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single 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.