Description

Milbemycin Impurity 3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of milbemycin-based pharmaceutical and veterinary products. It is primarily utilized by quality control laboratories, research institutions, and manufacturers in the pharmaceutical and agrochemical sectors for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in milbemycin active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate high-performance liquid chromatography (HPLC), LC-MS, and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in GMP environments to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of milbemycin compounds.
• Research & Development: Used in chemical and metabolic research to study the properties, behavior, and synthesis pathways of milbemycin-related compounds.

Basic Information

Product Name	Milbemycin Impurity 3
CAS No.	1025877-03-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Milbemycin Related Compound 3; Milbemycin A4 Impurity; 5-O-DemyI-13β,25-Didesoxy-25-[(1R)-1-methylpropyl]-5-oxomilbemycin β; (6R,7S,8E,10E,14R,16S,17S,18S,19S,20R,21R,24S)-21,24-Dihydroxy-6-[(1R)-1-methylpropyl]-3,4,5,6,7,8,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24-tetracosahydro-14,19-epoxy-4,7-methano-7H-cyclopenta[a]cycloocten-17-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside
EINECS	Contact for details

Quality Control

Our Milbemycin Impurity 3 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, NMR, and MS. We adhere to quality management principles suitable for use in regulated environments.

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 must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if prolonged exposure is anticipated.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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