Description

Mikafen Sodium Sodium Related Substances 4 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the accuracy and reliability of pharmaceutical impurity profiling and method validation. It is primarily utilized by research institutions, quality assurance laboratories, and manufacturers in the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of related substances in active pharmaceutical ingredients (APIs).
• Analytical Method Development & Validation: Used as a standard to calibrate equipment and validate analytical methods such as HPLC and LC-MS.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and final product release to ensure compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to monitor degradation products and assess the shelf-life of pharmaceutical formulations.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs) and regulatory filings with agencies like the FDA and EMA.
• Research & Development: Supports synthetic chemistry research and the development of new pharmaceutical compounds.

Basic Information

Product Name	Mikafen Sodium Sodium Related Substances 4
CAS No.	1392514-06-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mikafen Sodium Impurity 4; Sodium Mikafen Related Compound 4; Mikafen Sodium Related Substance 4; 1392514-06-5; Mikafen Sodium Analog; Mikafen Sodium Process Impurity; Mikafen Sodium Degradant; Sodium Salt of Mikafen Impurity
EINECS	Contact for details

Quality Control

Our Mikafen Sodium Sodium Related Substances 4 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity and identity confirmation, to ensure it meets the high standards required for reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profiles is provided with every shipment.

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). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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