Description

Acarbose Ep Impurity B is a specified impurity of the anti-diabetic drug Acarbose, used as a critical reference standard in pharmaceutical quality control and analytical research. This compound is essential for ensuring the purity, safety, and efficacy of Acarbose drug substances and finished products by enabling accurate identification and quantification of this specific impurity. It is primarily required by analytical laboratories, quality assurance departments in pharmaceutical manufacturing, and research institutions focused on method development and validation for regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Acarbose Ep Impurity B in Acarbose Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Crucial for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in compliance with ICH guidelines.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of Acarbose, meeting pharmacopeial specifications (EP, USP).
• Stability Studies: Employed as an analytical marker to track the formation of degradation products in Acarbose under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Acarbose.

Basic Information

Product Name	Acarbose Ep Impurity B
CAS No.	1220983-54-9
Molecular Formula	C25H43NO18
Molecular Weight	645.61 g/mol
Synonyms	Acarbose Related Compound B; Acarbose Impurity B; 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; (2R,3S,4R,5R)-2-(((2R,3S,4R,5R,6R)-6-(((2R,3S,4R,5R,6R)-6-(((1S,4R,5S,6S)-4,5,6-Trihydroxy-3-(hydroxymethyl)cyclohex-2-en-1-yl)amino)-4,5-dihydroxy-2-(hydroxymethyl)tetrahydro-2H-pyran-3-yl)oxy)-4,5-dihydroxy-2-(hydroxymethyl)tetrahydro-2H-pyran-3-yl)oxy)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol
EINECS	Contact for details

Quality Control

Our Acarbose Ep Impurity B is manufactured under strict quality-controlled conditions suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, NMR, and Mass Spectrometry to confirm identity and establish high purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and chromatographic profile. Our quality system is designed to support compliance with cGMP and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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