Description

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, an important anti-diabetic drug, ensuring pharmaceutical products meet stringent regulatory purity requirements. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, impurity profiling, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of the D-Fructose related impurity in Acarbose active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for Acarbose analysis.
• Quality Control (QC) & Quality Assurance (QA): Essential for in-process testing and release testing of Acarbose batches to ensure compliance with pharmacopeial standards (USP, EP, JP).
• Stability Studies: Employed to monitor the formation of this specific degradation product in Acarbose under various stress conditions (thermal, humidity, light).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in metabolic studies and research aimed at understanding the synthesis pathways and degradation mechanisms of Acarbose.

Basic Information

Product Name	Acarbose D-Fructose Impurity
CAS No.	1013621-79-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	D-Fructose Impurity of Acarbose; Acarbose Related Compound D; Acarbose Impurity D (D-Fructose); Acarbose EP Impurity D; Acarbose USP Related Compound; 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 derivative; Glucobay Impurity; Precose Impurity
EINECS	Contact for details

Quality Control

Our Acarbose D-Fructose Impurity is manufactured and tested under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity, ensuring it meets the requirements for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards.

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 Certificate of Analysis. The material may be hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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