Description

Sodium Gualenate Impurity 1 is a specified impurity of the anti-inflammatory drug Sodium Gualenate, identified by the CAS registry number 65757-01-9. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and validation. It is essential for quality control laboratories and manufacturers involved in the synthesis and purification of Sodium Gualenate to ensure the final drug product meets stringent regulatory purity requirements.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Sodium Gualenate Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Crucial for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods to monitor process-related impurities.
• Quality Assurance & Control (QA/QC): Used in-house by API manufacturers to establish impurity profiles, set specifications, and ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability testing of drug substances and products.
• Process Chemistry Research: Aids chemists in optimizing synthesis and purification processes to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Sodium Gualenate Impurity 1
CAS No.	65757-01-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Gualenate Impurity 1; Sodium Gualenate Related Compound 1; 1,7-Dimethyl-4-isopropylazulene-3-sulfonate Impurity; Azulene Sulfonate Derivative Impurity; Sodium 1,4-Dimethyl-7-isopropylazulene-3-sulfonate Impurity; GA Impurity 1
EINECS	Contact for details

Quality Control

Our Sodium Gualenate Impurity 1 is produced under strict quality management systems. Each batch is characterized and tested using advanced analytical techniques such as HPLC, GC, NMR, and Mass Spectrometry to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. We support compliance with ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere if the compound is found to be easily oxidized.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Assay	90.0% - 110.0% (on dried basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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