Description

Folinic Acid Impurity G is a high-purity reference standard and chemical intermediate critical for pharmaceutical quality control and research. This compound is essential for the accurate identification, quantification, and monitoring of related substances in Leucovorin (Folinic Acid) drug substances and finished products. It is primarily utilized by analytical laboratories, quality assurance departments, and R&D teams within the pharmaceutical and biotechnology sectors to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for method development, validation, and routine quality control testing of Leucovorin API and formulations.
• Analytical Research: Serves as a critical component in HPLC, UPLC, and LC-MS studies for impurity profiling and stability-indicating assays.
• Process Chemistry: Employed as a marker to optimize synthesis and purification processes, helping to minimize impurity levels in the final Active Pharmaceutical Ingredient (API).
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for drug master files and submission packages.
• Metabolite Studies: Used in research investigating the metabolic pathways and pharmacokinetics of folate-based drugs.

Basic Information

Product Name	Folinic Acid Impurity G
CAS No.	6810-75-9
Molecular Formula	C20H23N7O7
Molecular Weight	473.44 g/mol
Synonyms	N-[4-[[(2-Amino-5-formyl-4-oxo-1,6,7,8-tetrahydro-6-pteridinyl)methyl]amino]benzoyl]-L-glutamic Acid; (6S)-5,6,7,8-Tetrahydrofolic Acid; 5,6,7,8-Tetrahydrofolate; 5-Formyl-5,6,7,8-tetrahydrofolic Acid; Leucovorin Impurity G; 5-CHO-THF; Tetrahydrofolinic Acid
EINECS	Contact for details

Quality Control

Our Folinic Acid Impurity G is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to support your quality and regulatory needs.

Storage

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

Specification

Item	Specification
Appearance	Off-white to light yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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