Description

α-D-Glucosyl Acarbose D-Fructose Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and method development of acarbose, a widely used α-glucosidase inhibitor medication. It serves as a key impurity standard for pharmaceutical manufacturers and analytical laboratories to ensure drug purity, safety, and regulatory compliance. Precise identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards in the production of anti-diabetic drugs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Acarbose Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) and LC-MS/MS methods in quality control laboratories.
• Pharmacopeial Testing: Used to comply with impurity profiling requirements specified in monographs from the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other international pharmacopeias.
• Stability Studies: Employed as a marker to monitor degradation pathways and establish shelf-life for acarbose-based drug products under various storage conditions.
• Process Chemistry & R&D: Aids in the research and development of improved synthetic routes for acarbose and in monitoring impurity formation during manufacturing.
• Regulatory Submissions: Provides necessary data on impurity identity and levels for regulatory filings with agencies like the FDA and EMA.

Basic Information

Product Name	α-D-Glucosyl Acarbose D-Fructose Impurity
CAS No.	1220983-28-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acarbose Impurity F; Acarbose Related Compound F; 4,6-Dideoxy-4-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1-yl]amino]-α-D-glucopyranosyl-(1→4)-O-α-D-glucopyranosyl-(1→4)-D-glucopyranose; Glucosyl Acarbose Fructose; α-D-Glucosylacarbose D-Fructose; Acarbose Analog; Acarbose Derivative
EINECS	Contact for details

Quality Control

This high-grade reference material is produced under strict quality management systems. Each batch is subjected to comprehensive analytical characterization using techniques including HPLC, LC-MS, and NMR to confirm identity and purity. We provide a comprehensive Certificate of Analysis (CoA) with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards expected for pharmaceutical impurities and reference standards, supporting compliance with GMP, ICH Q3A/B, and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or CoA. This material is hygroscopic (moisture-sensitive); ensure the container is sealed in a dry environment after each use to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH limits

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