Description

Sucralose Ep Impurity G is a specified impurity reference standard used in the analytical profiling and quality control of sucralose, a high-intensity artificial sweetener. This compound is critical for ensuring the purity, safety, and regulatory compliance of sucralose products intended for pharmaceutical and food applications. It is primarily required by analytical laboratories, quality assurance departments, and manufacturers within the pharmaceutical, food ingredient, and fine chemical industries for method validation and impurity quantification.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Impurity G in sucralose active pharmaceutical ingredient (API) according to pharmacopeial monographs (EP, USP).
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and related chromatographic methods for sucralose purity analysis.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in routine QC testing to monitor and control impurity levels in sucralose batches, ensuring they meet strict specification limits.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and control strategies for sucralose manufacturing processes.
• Stability Studies: Employed in forced degradation and long-term stability studies of sucralose to identify and track the formation of this specific impurity over time and under various conditions.
• Research & Development (R&D): Used in chemical research to study the degradation pathways, synthesis by-products, and metabolic profiles related to sucralose.

Basic Information

Product Name	Sucralose Ep Impurity G
CAS No.	105066-20-4
Molecular Formula	C12H19Cl3O8
Molecular Weight	397.63 g/mol
Synonyms	1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl 4-chloro-4-deoxy-α-D-galactopyranoside; 4,1',6'-Trichlorogalactosucrose Impurity G; Sucralose Related Compound G; 1',4,6'-Trichlorosucrose Impurity G; Sucralose Impurity G (EP); Sucralose Process Impurity G
EINECS	Contact for details

Quality Control

Every batch of Sucralose Ep Impurity G is manufactured and analyzed under strict quality systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using validated analytical methods such as HPLC, NMR, and mass spectrometry to ensure it meets the exacting standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines (EP/USP) for impurity standards.

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, keep the container under inert atmosphere to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines
Water Content (KF)	≤ 1.0%

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