Description

Moxidectin Ep Impurity K 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 the active pharmaceutical ingredient Moxidectin. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling in veterinary and pharmaceutical products.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Moxidectin API and finished drug products.
• Analytical Method Development: Used as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization.
• Stability Studies: Employed as a marker to monitor degradation pathways and establish shelf-life specifications for Moxidectin-based formulations.
• Research & Development: Used in chemical and pharmacological research to study the metabolism, synthesis pathways, and degradation products of Moxidectin.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch testing to ensure product purity and consistency.

Basic Information

Product Name	Moxidectin Ep Impurity K
CAS No.	174756-99-1
Molecular Formula	C₃₇H₅₃NO₈
Molecular Weight	639.82 g/mol
Synonyms	23-O-Methyl-5-O-demethyl-28-deoxy-25-(1,3-dimethyl-1-butenyl)-6,28-epoxy-23-(methoxyimino)milbemycin B; Moxidectin EP Impurity K; Moxidectin Related Compound K; (5R,6S,23E,25S)-5,6,23,25-Tetrahydro-5-hydroxy-6-methyl-23-(methoxyimino)-25-(1,3-dimethyl-1-buten-1-yl)-22H,26H-6,28-epoxypyrano[4,3-d][1]oxacyclooctadecin-13,19-dione; Moxidectin Impurity K
EINECS	Contact for details

Quality Control

Every batch of Moxidectin Ep Impurity K is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial 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) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment 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)	≥ 98.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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