Description

Tartrazine Impurity 6 is a high-purity chemical reference standard used for the identification and quantification of a specific process-related impurity in Tartrazine (FD&C Yellow 5, E102). This compound is critical for ensuring the quality, safety, and regulatory compliance of synthetic colorants used in the food and pharmaceutical industries. It is an essential material for analytical laboratories, quality control departments, and manufacturers requiring precise impurity profiling for their products.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for method development, validation, and routine quality control testing of Tartrazine used in drug formulations.
• Food & Beverage Colorant Analysis: Serves as a critical standard for monitoring and controlling impurity levels in FD&C Yellow No. 5 (E102) to ensure compliance with food safety regulations (e.g., FDA, EFSA).
• Analytical Method Development: Essential for developing and calibrating HPLC, UPLC, and LC-MS methods for the accurate separation and detection of Tartrazine impurities.
• Regulatory Compliance & Documentation: Provides definitive proof of impurity identity for regulatory submissions (e.g., DMF, CMC) and audits in GMP environments.
• Research & Development: Used in studies investigating the synthesis pathways, stability, and degradation profiles of azo dyes like Tartrazine.
• Quality Assurance Reference Standard: Enables in-house qualification of secondary working standards and ensures the accuracy of impurity assays in commercial Tartrazine batches.

Basic Information

Product Name	Tartrazine Impurity 6
CAS No.	104236-33-1
Molecular Formula	C16H9N4Na3O9S2
Molecular Weight	566.36 g/mol
Synonyms	5-Oxo-1-(4-sulfonatophenyl)-4-[(4-sulfonatophenyl)hydrazono]-3-pyrazolecarboxylic Acid Trisodium Salt; Trisodium 5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-1H-pyrazole-3-carboxylate; FD&C Yellow 5 Impurity 6; E102 Impurity 6; CI 19140 Impurity 6
EINECS	Contact for details

Quality Control

Every batch of Tartrazine Impurity 6 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements of reference standard users. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity assay, identity confirmation (IR, MS), residual solvent analysis, and water content (KF). We support compliance with ICH Q3B, USP, and EP guidelines for impurities.

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 stability, the container should be kept under inert atmosphere if specified. Handle with appropriate laboratory safety practices.

Specification

Item	Specification
Appearance	Orange to red powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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