High Purity Citicoline Sodium Raw Material for Pharmaceutical and Supplement Use

English name: Citicoline sodium

CAS No:33818-15-4

Molecular formula: C14H25N4NaO11P2

Molecular weight: 510.31

EINECS Accession number: 251-689-1

Citicoline Sodium, chemically designated as Cytidine 5'-diphosphocholine sodium salt, is a water-soluble nootropic agent and an intermediate in the biosynthesis of cell membrane phospholipids. Its molecular formula is C14H25N4NaO11P2, and it typically possesses a molecular weight of approximately 510.31 g/mol (anhydrous basis). As the sodium salt form of Citicoline, this raw material offers enhanced stability and solubility compared to its free acid counterpart, making it the preferred form for pharmaceutical formulations and dietary supplements.

In clinical and research contexts, Citicoline Sodium is often referred to by its synonyms: CDP-Choline (Cytidine Diphosphate Choline) or Cognizin® (a branded form). It appears as a white to off-white, crystalline or amorphous powder, characterized by its high hygroscopicity, which necessitates strict moisture-controlled handling during manufacturing.

The raw material is highly soluble in water (approximately 250 mg/mL) but practically insoluble in organic solvents such as ethanol, acetone, or dichloromethane. Its pH in a 10% aqueous solution ranges from 6.0 to 8.0. A critical physical attribute is its melting point, which degrades above 200°C without a distinct melting phase. Due to its hygroscopic nature, the raw material readily absorbs atmospheric moisture, which can lead to clumping or hydrolysis if not stored properly. Standard specifications require loss on drying to be less than 5% for the hydrous grade, while anhydrous grades are held to stricter limits.

Unlike synthetic stimulants, Citicoline Sodium functions as a rate-limiting intermediate in the biosynthesis of phosphatidylcholine, a major component of neuronal membranes. Upon administration (orally or intravenously), it hydrolyzes into cytidine and choline. These two metabolites cross the blood-brain barrier (BBB) independently, where they are reassembled into CDP-Choline within the brain. This process provides dual benefits: (1) it supplies choline for the synthesis of acetylcholine, a key neurotransmitter involved in memory and learning, and (2) it provides cytidine, which converts to uridine, supporting the synthesis of membrane phospholipids and reducing free radical damage. Consequently, Citicoline Sodium raw material is valued for neuroprotection, neurorepair, and cognitive enhancement.

High-quality Citicoline Sodium raw material is produced via biocatalytic fermentation or chemical synthesis, followed by rigorous purification steps including recrystallization and lyophilization to achieve purity levels exceeding 98% (typically 98.0–102.0% on anhydrous basis). Reputable manufacturers comply with GMP (Good Manufacturing Practices) and provide Certificates of Analysis (CoA) that test for:

• Assay (HPLC): 98.0% – 102.0%

• Heavy Metals: <20 ppm (lead <3 ppm, arsenic <2 ppm)

• Residual Solvents: Meets USP <467> criteria

• Microbial Limits: Total aerobic count <1,000 CFU/g; absence of E. coli and Salmonella.

• Related Substances: Individual impurity <0.5%; total impurities <1.0%.