Description

Macamide Impurity 2 CAS NO 883715-21-7 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 required by analytical laboratories, quality control units, and research scientists in the pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of related substances in Macamide or similar active pharmaceutical ingredients (APIs).
• Analytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for purity analysis.
• Quality Control & Assurance: Employed in routine QC testing to monitor batch-to-batch consistency and ensure compliance with regulatory specifications (e.g., ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Facilitates metabolic studies, pharmacokinetic research, and the synthesis of related compounds in medicinal chemistry.

Basic Information

Product Name	Macamide Impurity 2
CAS No.	883715-21-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Macamide Related Compound 2; Macamide Impurity B; N-[(2S)-1-Hydroxy-4-methylpentan-2-yl]-5-oxo-5-(phenylamino)pentanamide; 5-Oxo-5-(phenylamino)-N-[(2S)-1-hydroxy-4-methylpentan-2-yl]pentanamide; (2S)-N-(5-Oxo-5-(phenylamino)pentanoyl)-4-methyl-2-aminopentan-1-ol; Macamide Process Impurity; Macamide Degradant
EINECS	Contact for details

Quality Control

Our Macamide Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the high standards required for reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and analytical methods (e.g., HPLC, NMR) is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. 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%
Water Content	≤ 5.0%
Residual Solvents	Complies with ICH Q3C

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