Description

Milbemycin Impurity 1 is a specified impurity of the macrocyclic lactone acaricide and insecticide, Milbemycin. This compound is critical for analytical reference standards and quality control in the development and manufacturing of veterinary and agricultural products. It is primarily required by pharmaceutical and agrochemical R&D laboratories, quality assurance departments, and manufacturers for method validation, impurity profiling, and regulatory compliance.

Application

• Primary use as a Certified Reference Standard (CRS) for analytical method development and validation.
• Critical component for impurity profiling and identification in Milbemycin active pharmaceutical ingredient (API) batches.
• Essential for quality control and assurance (QC/QA) in the manufacture of veterinary parasiticide formulations.
• Used in stability studies to monitor degradation pathways of Milbemycin-based products.
• Serves as a key impurity marker for regulatory submissions to agencies like the FDA and EMA.
• Utilized in research and development of new agrochemical and pharmaceutical actives within the macrocyclic lactone class.

Basic Information

Product Name	Milbemycin Impurity 1
CAS No.	93074-02-3
Molecular Formula	C₃₂H₄₆O₇
Molecular Weight	542.71 g/mol
Synonyms	(10E,14E,16E)-(1R,4S,5'S,6R,6'R,8R,13R,20R,21R,24S)-6'-Ethyl-21,24-dihydroxy-5',11,13,22-tetramethyl-3,7,19-trioxaspiro[2.15]hexacosa-10,14,16,22-tetraene-2,6,8,20-tetrone; 5-O-Demethyl-28-deoxy-6,28-epoxy-25-(1-methylpropyl)milbemycin β3; Milbemycin A4 5-O-Demethyl Derivative; 13-Deoxy-5-O-demethylmilbemycin A4; Milbemycin β3 Isomer; Milbemycin Impurity A; Milbemycin Related Compound A
EINECS	Contact for details

Quality Control

Every batch of Milbemycin Impurity 1 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and impurity testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial and internal standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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 %)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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