Description

Fumaric Acid Impurity 11 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity and safety profile of pharmaceutical-grade fumaric acid and its related drug substances. It is primarily utilized by research and development laboratories, quality assurance departments, and regulatory bodies involved in pharmaceutical manufacturing. The precise characterization of this impurity is essential for method validation, stability studies, and meeting stringent regulatory compliance standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in fumaric acid API and related pharmaceutical formulations.
• Analytical Method Development & Validation (HPLC/GC): Serves as a critical component in developing and validating chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in-house by manufacturers to monitor batch-to-batch consistency and ensure impurity levels remain within specified limits (ICH guidelines).
• Stability Studies: Employed to track the formation and growth of specific degradation products in fumaric acid under various stress conditions.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Academic & Contract Research: Supports chemical and pharmaceutical research in universities and CROs (Contract Research Organizations) focusing on organic synthesis, metabolism, and impurity isolation.

Basic Information

Product Name	Fumaric Acid Impurity 11
CAS No.	4749-70-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fumaric Acid Related Compound; Fumaric Acid Specified Impurity; Fumaric Acid EP Impurity; Fumaric Acid USP Impurity; (2E)-But-2-enedioic acid impurity; Allomaleic acid impurity; trans-1,2-Ethylenedicarboxylic acid impurity; Boletic acid impurity
EINECS	Contact for details

Quality Control

Every batch of Fumaric Acid Impurity 11 is manufactured and controlled under a strict quality management system. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, and NMR to ensure it meets the high standards required for a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment. Our quality systems are designed to support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area. Due to its hygroscopic nature, the container must be kept tightly sealed in a controlled low-humidity environment to prevent moisture absorption and degradation. Recommended long-term storage temperature is 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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