Description

Isosorbide Impurity 4 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 required by analytical laboratories and quality control units within the pharmaceutical and biotechnology industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in isosorbide-based Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, ensuring accurate impurity detection.
• Quality Control and Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor impurity levels against strict pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: Employed in forced degradation and long-term stability studies of isosorbide drugs to track the formation and behavior of this specific impurity over time.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research and Development: Used in academic and industrial R&D to study the metabolism, synthesis pathways, and chemical behavior of isosorbide-related compounds.

Basic Information

Product Name	Isosorbide Impurity 4
CAS No.	39698-15-2
Molecular Formula	C6H10O4
Molecular Weight	146.14 g/mol
Synonyms	1,4:3,6-Dianhydro-D-glucitol Impurity 4; Isosorbide Related Compound 4; 1,4-Anhydro-D-glucitol; D-Isosorbide Impurity D; (3R,3aR,6S,6aR)-Hexahydrofuro[3,2-b]furan-3,6-diol; Dianhydro-D-glucitol Impurity; Isosorbide EP Impurity D
EINECS	Contact for details

Quality Control

Every batch of Isosorbide Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for parameters such as assay, 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. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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