Description

Macamide Impurity 11 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 pharmaceutical products and related research materials. It is primarily utilized by professionals in pharmaceutical development, quality control laboratories, and academic research institutions for method validation, impurity profiling, and quantitative analysis.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of impurities in Macamide-related Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods, such as HPLC and UPLC, ensuring accurate and reliable results.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor batch-to-batch consistency and confirm that impurity levels are within specified regulatory limits.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of pharmaceutical substances.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Academic and Contract Research: Supports fundamental research in medicinal chemistry, pharmacology, and analytical science within universities and CROs (Contract Research Organizations).

Basic Information

Product Name	Macamide Impurity 11
CAS No.	405906-95-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Macamide Related Compound 11; Macamide Impurity Standard 11; N-(2-Hydroxyethyl)-9Z-octadecenamide Impurity; 9-Octadecenamide, N-(2-hydroxyethyl)-, (9Z)- (related impurity); Oleoylethanolamide Impurity; OEA Impurity; Fatty Acid Amide Impurity; Analytical Reference Standard 405906-95-8
EINECS	Contact for details

Quality Control

Every batch of Macamide Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and impurity content.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on dried basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	< 20 ppm

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