Description

Sucralose Ep Impurity D 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 and safety of sucralose in compliance with stringent pharmacopeial guidelines, such as those from the European Pharmacopoeia (EP). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and food ingredient suppliers engaged in research, method development, and regulatory compliance testing for sucralose-based products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Impurity D in sucralose active pharmaceutical ingredient (API) according to EP and other pharmacopeial monographs.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) or Liquid Chromatography-Mass Spectrometry (LC-MS) methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and ensure impurity levels are within specified limits.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs) and marketing authorization applications.
• Food & Beverage Ingredient Analysis: Employed in the quality assessment of food-grade sucralose to verify the absence of undesired process-related impurities.
• Research & Development: Utilized in stability studies and degradation pathway elucidation to understand the formation and control of this specific impurity.

Basic Information

Product Name	Sucralose Ep Impurity D
CAS No.	64644-65-1
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'-Trichloro-4,1',6'-trideoxygalactosucrose Impurity D; Sucralose Related Compound D; Sucralose Impurity D (EP); 4-Chloro-4-deoxy-α-D-galactopyranosyl 1,6-dichloro-1,6-dideoxy-β-D-fructofuranoside; Trichlorogalactosucrose Impurity D
EINECS	Contact for details

Quality Control

Every batch of Sucralose Ep Impurity D is manufactured and analyzed under strict quality management systems. The material undergoes rigorous identity confirmation, purity assay, and impurity profiling using validated chromatographic methods (e.g., HPLC) to ensure it meets the exacting standards required for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results, including purity, chromatographic data, and storage conditions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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