Description

Citicoline Impurity 7 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Citicoline, a key pharmaceutical ingredient. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and quality control testing. The availability of a well-characterized impurity standard is essential for maintaining stringent product specifications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Citicoline active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing to ensure impurity levels are within specified limits.
• Stability Studies: Employed to track the formation of degradation products in Citicoline under various stress conditions (e.g., heat, light, humidity) as part of ICH stability protocols.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways of Citicoline and to develop improved purification processes.

Basic Information

Item	Details
Product Name	Citicoline Impurity 7
CAS No.	7084-69-7
Molecular Formula	C14H26N4O11P2
Molecular Weight	488.33 g/mol
Synonyms	Cytidine-5'-diphosphocholine Impurity 7; CDP-Choline Impurity 7; 5'-O-[Hydroxy({[2-(trimethylammonio)ethoxy]hydroxyphosphoryl})phosphoryl]cytidine; Cytidine 5'-(trihydrogen diphosphate) P'→5'-ester with 2-(trimethylammonio)ethyl alcohol; Nicholin Impurity 7
EINECS	Contact for details

Quality Control

Every batch of Citicoline Impurity 7 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis, and identity confirmation (IR, MS) to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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