Description

Carbazochrome Impurity 9 is a specified impurity of the hemostatic agent Carbazochrome, identified by CAS NO 856783-37-4. This compound is critical for pharmaceutical research and development, serving as a key reference standard for ensuring drug purity, safety, and regulatory compliance. It is primarily required by analytical laboratories, quality control units, and R&D departments within the pharmaceutical and fine chemical industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Carbazochrome Impurity 9 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development & Validation: Essential for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques, to monitor impurity levels.
• Quality Control & Assurance: Employed in routine quality control testing to ensure Carbazochrome drug substances and products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation and increase of this specific degradation product during forced degradation and long-term stability studies of Carbazochrome formulations.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation pathways and stability profile of Carbazochrome.

Basic Information

Product Name	Carbazochrome Impurity 9
CAS No.	856783-37-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carbazochrome Related Compound 9; Carbazochrome Impurity C; 1,2,3,4-Tetrahydro-1-methyl-6-quinolinol 5,6-dione derivative; Adrenochrome monosemicarbazone impurity; Adrenochrome semicarbazone impurity 9; Carbazochrome EP Impurity C; Carbazochrome System Suitability Mixture Component
EINECS	Contact for details

Quality Control

Every batch of Carbazochrome Impurity 9 is manufactured and handled under strict quality management systems. The product undergoes rigorous identity confirmation and purity analysis using advanced techniques such as HPLC, NMR, and Mass Spectrometry to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Complies with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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