Description

Folic Acid Impurity C is a specified impurity used as a critical reference standard in the pharmaceutical industry. Its primary value lies in ensuring the quality, safety, and efficacy of folic acid (Vitamin B9) and its related pharmaceutical formulations. This compound is essential for analytical laboratories and manufacturers involved in the research, development, and quality control of vitamins and active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in pharmacopeial testing (e.g., USP, EP).
• Method Development and Validation: Critical for developing, validating, and verifying analytical procedures for folic acid purity and stability studies.
• Quality Control & Assurance (QC/QA): Used for system suitability testing, peak identification, and quantifying impurity levels in folic acid API and finished drug products.
• Stability Indicating Studies: Employed to monitor and characterize degradation products in folic acid under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive identification and control of specified impurities.
• Research & Development: Serves as a key material in metabolic pathway studies and the synthesis of novel folic acid analogs.

Basic Information

Product Name	Folic Acid Impurity C
CAS No.	47707-78-8
Molecular Formula	C19H19N7O6
Molecular Weight	441.40 g/mol
Synonyms	N-[4-[[(2-Amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-L-glutamic Acid; L-Glutamic Acid, N-[4-[[(2-amino-1,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-; (2S)-2-[[4-[[(2-Amino-4-oxo-1,4-dihydro-6-pteridinyl)methyl]amino]benzoyl]amino]pentanedioic Acid; Pteroic Acid; Folic Acid Related Compound C; Vitamin B9 Impurity C
EINECS	Contact for details

Quality Control

Our Folic Acid Impurity C is manufactured and tested under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques to ensure identity, purity, and suitability for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and identification tests performed in compliance with current pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.