Description

Riboflavin Impurity 1 CAS NO 64480-68-8 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of riboflavin (Vitamin B2) in pharmaceutical and nutraceutical products. It is primarily required by quality control laboratories, research institutions, and manufacturers involved in the development and production of vitamins and related APIs. The availability of this well-characterized impurity standard is essential for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Quality Control: Used as a certified reference material (CRM) for the identification and quantification of impurities in riboflavin active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or other chromatographic methods for riboflavin analysis.
• Stability Studies: Employed to monitor the formation of degradation products in riboflavin under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require detailed impurity profiles and control strategies.
• Research & Development: Used in academic and industrial R&D to study the metabolism, degradation pathways, and chemical behavior of riboflavin.
• Nutraceutical & Food Supplement Analysis: Applied in the quality assurance of vitamin B2-fortified foods, dietary supplements, and infant formula.

Basic Information

Product Name	Riboflavin Impurity 1
CAS No.	64480-68-8
Molecular Formula	C17H20N4O6
Molecular Weight	376.37 g/mol
Synonyms	Lumichrome; 7,8-Dimethylalloxazine; 7,8-Dimethylbenzo[g]pteridine-2,4(1H,3H)-dione; Alloxazine, 7,8-dimethyl-; Riboflavin Impurity A; Riboflavin Related Compound A; Vitamin B2 Impurity 1; 1H-Benzo[g]pteridine-2,4(3H,10H)-dione, 7,8-dimethyl-
EINECS	Contact for details

Quality Control

Every batch of Riboflavin Impurity 1 is manufactured and analyzed under strict quality management systems. The product is characterized using advanced analytical techniques including HPLC, MS, and NMR to confirm identity and purity, ensuring it meets the stringent requirements for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment. Our quality commitment aligns with cGMP principles where applicable, supporting your regulatory and research needs.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	Yellow to orange crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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