Description

Acarbose Ep Impurity G is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the anti-diabetic drug Acarbose by serving as a key marker for impurity profiling and control. It is an essential material for pharmaceutical manufacturers, quality control laboratories, and research institutions engaged in method development and validation. The reliable identification and quantification of this impurity are fundamental to meeting stringent pharmacopeial requirements for drug substance and product release.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Acarbose Ep Impurity G in Acarbose Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels, ensuring drug substance and product meet European Pharmacopoeia (EP), United States Pharmacopeia (USP), or other specified monograph specifications.
• Stability Studies: Employed as an analytical marker to track the formation of degradation impurities in Acarbose under various stress conditions (e.g., heat, light, humidity) as part of ICH stability protocols.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., CMC sections of ANDA, NDA, MAAs) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Supports investigative studies into the synthesis pathways, degradation mechanisms, and pharmacokinetic profiles related to Acarbose and its impurities.

Basic Information

Item	Detail
Product Name	Acarbose Ep Impurity G
CAS No.	1013621-73-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acarbose Impurity G; Acarbose Related Compound G; Acarbose EP 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 (related); Acarbose Process Impurity; Acarbose Degradant; Acarbose Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Acarbose Ep Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use as a qualified reference standard for regulatory purposes.

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); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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