Description

Isosorbide Impurity 6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing isosorbide or its derivatives. It is primarily utilized by analytical chemists and quality control professionals in pharmaceutical development and manufacturing. The availability of a well-characterized impurity standard is essential for method validation and accurate impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Isosorbide Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of isosorbide-based pharmaceuticals.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to identify and track degradation products that may form in isosorbide formulations under various stress conditions.
• Research & Development: Facilitates metabolic and pharmacokinetic studies by helping to distinguish the parent drug compound from its related impurities.

Basic Information

Product Name	Isosorbide Impurity 6
CAS No.	65940-93-4
Molecular Formula	C6H10O4
Molecular Weight	146.14 g/mol
Synonyms	1,4:3,6-Dianhydro-D-glucitol Impurity 6; Isosorbide Related Compound 6; 1,4:3,6-Dianhydro-D-sorbitol Impurity; D-Isosorbide Impurity 6; 1,4-Anhydro-D-glucitol, 3,6-anhydro-; Dianhydrosorbitol Impurity 6; (3R,3aR,6S,6aR)-Hexahydrofuro[3,2-b]furan-3,6-diol (related impurity)
EINECS	Contact for details

Quality Control

Every batch of Isosorbide Impurity 6 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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