Description

Folic Acid Impurity 13 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity and safety of folic acid (vitamin B9) in pharmaceutical formulations and nutritional supplements. It is primarily required by analytical laboratories, pharmaceutical R&D departments, and quality assurance teams involved in the development and manufacturing of folic acid APIs and finished drug products.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of related substances in folic acid active pharmaceutical ingredients (APIs) according to ICH guidelines.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods for folic acid analysis.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control impurity levels in folic acid batches to meet pharmacopeial standards (USP, EP, JP).
• Stability Studies: Used to track the formation of this specific degradation product during forced degradation and long-term stability studies of folic acid drug substances and products.
• Regulatory Compliance and Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research on Folic Acid Metabolism and Synthesis: Acts as a specific intermediate or marker in research studies investigating folic acid synthesis pathways or metabolic byproducts.

Basic Information

Product Name	Folic Acid Impurity 13
CAS No.	70194-49-9
Molecular Formula	C19H19N7O6
Molecular Weight	441.40 g/mol
Synonyms	N-[4-[[(2-Amino-3,4,7,8-tetrahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-L-glutamic acid; L-Glutamic acid, N-[4-[[(2-amino-3,4,7,8-tetrahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-; Tetrahydrofolic acid impurity; 5,6,7,8-Tetrahydrofolic acid related compound; Folate impurity; Vitamin B9 Impurity 13; PreGlu1 impurity.
EINECS	Contact for details

Quality Control

Our Folic Acid Impurity 13 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of residual solvents and moisture. Certificates of Analysis (COA) with detailed chromatograms and batch-specific data are provided to ensure full traceability and compliance with pharmaceutical reference standard requirements.

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 in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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