Description

Folinic Acid Impurity E is a high-purity chemical reference standard, specifically identified as a key impurity in the synthesis and quality control of Leucovorin (Folinic Acid). This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final active pharmaceutical ingredient (API). It is primarily used by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Folinic Acid Impurity E in Leucovorin API and drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during manufacturing.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B guidelines) for related substances.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Folinic Acid to minimize impurity formation.

Basic Information

Product Name	Folinic Acid Impurity E
CAS No.	944737-05-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(6R)-5,10-Dideazatetrahydrofolic acid; 5,10-Dideaza-5,6,7,8-tetrahydrofolic acid; Dideazatetrahydrofolate; DDATHF derivative; Leucovorin Impurity E; Folinic acid related compound E; (6R)-DDATHF
EINECS	Contact for details

Quality Control

Our Folinic Acid Impurity E is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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