Description

α-D-Glucosyl Acarbose Impurity is a specified impurity of the anti-diabetic drug acarbose, a critical reference standard for pharmaceutical analysis. This compound is essential for ensuring the purity, safety, and efficacy of acarbose formulations through rigorous quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in acarbose active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC and LC-MS, to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure analytical procedures are performing as intended for impurity profiling.
• Stability Studies: Employed in forced degradation and long-term stability studies of acarbose to identify and track potential degradation products.
• Regulatory Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Research and Development: Used in pharmacokinetic and metabolic studies to understand the fate of related substances in biological systems.

Basic Information

Product Name	α-D-Glucosyl Acarbose Impurity
CAS No.	83116-09-0
Molecular Formula	C25H43NO18
Molecular Weight	645.61 g/mol
Synonyms	Acarbose Impurity G; 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; O-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; α-D-Glucosylacarbose; Acarbose Related Compound G
EINECS	Contact for details

Quality Control

Every batch of α-D-Glucosyl Acarbose Impurity is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR) and purity determination by validated chromatographic methods (HPLC). A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications tailored for use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Avoid repeated or prolonged exposure to the atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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