Description

Acarbose 1,1-α,α-Glycoside Impurity is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity and safety of the anti-diabetic drug Acarbose, as it is a known process-related impurity. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing. The availability of this well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control of Acarbose active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to identify, quantify, and validate the presence of this specific impurity.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require impurity profiling and characterization data.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Acarbose formulations under various storage conditions.
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the pathways and effects of Acarbose-related impurities.
• Pharmacopeial Testing: Applied as a system suitability standard in tests prescribed by USP, EP, or other pharmacopeias for Acarbose monographs.

Basic Information

Product Name	Acarbose 1,1-α,α-Glycoside Impurity
CAS No.	610271-07-3
Molecular Formula	C25H43NO18
Molecular Weight	645.61 g/mol
Synonyms	Acarbose Impurity G; 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; 1,1-α,α-Glycoside of Acarbose; Acarbose Related Compound G; Acarbose EP Impurity G; Acarbose USP Impurity G
EINECS	Contact for details

Quality Control

Every batch of Acarbose 1,1-α,α-Glycoside Impurity is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR), purity assay by HPLC, and control of related substances and residual solvents. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results against established specifications. Our quality commitment aligns with cGMP principles to ensure consistency and reliability for critical pharmaceutical applications.

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 product is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere such as argon or nitrogen.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
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)	≤ 5.0%

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