Description

Carbazochrome Sodium Sulfonate Impurit D is a specific impurity reference standard used in the pharmaceutical quality control process. This compound is critical for ensuring the purity and safety of the active pharmaceutical ingredient, Carbazochrome Sodium Sulfonate. It is primarily required by analytical laboratories and pharmaceutical manufacturers for method development, validation, and routine batch testing to comply with stringent regulatory standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Impurity D in Carbazochrome Sodium Sulfonate drug substance and finished products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopoeial specifications (e.g., USP, EP, JP).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions.

Basic Information

Product Name	Carbazochrome Sodium Sulfonate Impurit D
CAS No.	1464-48-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carbazochrome Sodium Sulfonate Related Compound D; Carbazochrome Impurity D; Adrenochrome monosemicarbazone sodium sulfonate impurity D; 1-Methyl-1,2,3,9-tetrahydro-9-oxo-4-carbazolepropanoic acid derivative; ADONA Impurity D
EINECS	Contact for details

Quality Control

Every batch of Carbazochrome Sodium Sulfonate Impurit D is manufactured and analyzed under strict quality management systems. The material is characterized using advanced spectroscopic and chromatographic techniques to ensure high purity and correct identity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, purity, and identification tests. Our quality standards are designed to meet the requirements for use in pharmaceutical analysis and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. After opening, ensure the container is resealed tightly under anhydrous conditions if necessary.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Assay	Contact for details
Water Content	≤ 5.0%
Residual Solvents	Complies with ICH guidelines

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