Description

Moxidectin Impurity 13 is a designated reference standard used for the analytical profiling and quality control of the antiparasitic veterinary and pharmaceutical agent, Moxidectin. This high-purity impurity standard is critical for ensuring product safety and regulatory compliance by enabling accurate identification and quantification of related substances. It is an essential material for research and development laboratories, quality assurance units, and manufacturers operating within the pharmaceutical and veterinary medicine sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control and release testing of Moxidectin active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities in drug dossiers.
• Stability Studies: Used to monitor the formation and levels of this specific impurity in Moxidectin formulations under various storage conditions over time.
• Research on Degradation Pathways: Aids in studying the chemical stability and degradation mechanisms of Moxidectin to improve formulation strategies.
• Calibration & System Suitability: Employed to calibrate analytical instruments and ensure system suitability for precise impurity analysis in compliance with pharmacopeial guidelines.

Basic Information

Product Name	Moxidectin Impurity 13
CAS No.	112124-81-9
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 Related Compound; Moxidectin EP Impurity; Moxidectin USP Impurity; Milbemycin oxime impurity; LL-F28249 impurity; Nemadectin derivative
EINECS	Contact for details

Quality Control

Every batch of Moxidectin Impurity 13 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of specific impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting compliance with in-house specifications aligned with pharmacopeial standards (USP/EP). Our quality commitment ensures the reliability and traceability required for your critical analytical and regulatory applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. For long-term storage, keep the container in a cool, dry, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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