Description

Macamide Impurity 5 CAS NO 847361-96-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a benchmark in impurity profiling and method validation. It is primarily utilized by researchers, analytical chemists, and quality control professionals in the pharmaceutical and biotechnology industries for drug development and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Macamide-related active pharmaceutical ingredients (APIs).
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods.
• Quality Control and Assurance (QC/QA): Essential for in-process testing and final release testing of pharmaceutical batches to meet pharmacopeial standards (e.g., USP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control.
• Academic and Contract Research: Supports chemical and pharmacological research in academic institutions and CROs (Contract Research Organizations).

Basic Information

Product Name	Macamide Impurity 5
CAS No.	847361-96-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Macamide Related Compound 5; Macamide EP Impurity 5; Macamide USP Impurity 5; Macamide Impurity 5 (847361-96-0); (E)-N-(2-Hydroxyethyl)octadec-9-enamide; 9-Octadecenamide, N-(2-hydroxyethyl)-, (9E)-; N-(2-Hydroxyethyl)oleamide
EINECS	Contact for details

Quality Control

Every batch of Macamide Impurity 5 is manufactured under strict quality management systems and undergoes comprehensive analytical testing to ensure identity, purity, and consistency. Our quality protocols are designed to meet the stringent requirements of pharmaceutical reference standards, aligning with ICH guidelines. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming specifications for assay, related substances, and residual solvents.

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 COA. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual 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.