Citicoline (CDP-Choline)
Citicoline (CDP-Choline)
Key Specifications
| CAS Number | 987-78-0 |
| Purity | ≥99.8% |
| Molecular Formula | C₁₄H₂₆N₄O₁₁P₂ |
| Molecular Weight | 488.32 g/mol |
| Appearance | White crystalline powder |
| Solubility | Freely soluble in water |
| Storage | Room temperature, dry |
| Shelf Life | 24 months |
CAS 987-78-0
What Is Citicoline (CDP-Choline)?
Citicoline (cytidine 5'-diphosphocholine, CDP-choline; CAS 987-78-0) is a nucleotide-choline conjugate with molecular formula C14H26N4O11P2 and molecular weight 488.32 g/mol. It occurs endogenously as a key intermediate in the Kennedy pathway, the biochemical route mammalian cells use to build phosphatidylcholine, a major membrane phospholipid — but it is not commercially extracted from biological tissue. Essentially all citicoline supplied to the pharmaceutical and nutraceutical industries today is produced biotechnologically: an engineered microbial strain expressing choline-phosphate cytidylyltransferase is fermented to generate the enzyme and nucleotide precursor, which is then used to catalyze the coupling of cytidine triphosphate with phosphocholine, followed by purification and crystallization. This enzymatic route has largely replaced older multi-step chemical synthesis, giving tighter, more consistent control over purity and impurity profile. Commercial bulk material is typically supplied as a white crystalline powder that is freely soluble in water.
Other Names
Key Features
USP/EP Dual-Pharmacopoeia Purity
Manufactured to ≥99.8% purity and certified to both USP and EP monographs — a combination held by very few domestic producers — supporting both pharmaceutical-grade and premium supplement formulations.
Controlled Enzymatic Biosynthesis Platform
Produced via a proprietary enzymatic/fermentation route using engineered production strains, giving batch-to-batch consistency in impurity profile compared to legacy multi-step chemical synthesis.
Consistent Crystalline Form
Supplied as a free-flowing white crystalline powder with controlled particle size, suitable for direct compression, capsule filling, and solution/injection formulations.
Comprehensive Contaminant Screening
Every batch is tested for heavy metals (Pb, Hg, Cd, As), residual solvents, and microbial limits, with full COA and third-party test reports available on request.
Flexible Bulk & OEM Supply
Available in flexible bulk packaging with customizable particle size, blending, and private-label/OEM formulation support for pharmaceutical, nutraceutical, and medical nutrition brands.
| Molecular Formula | C₁₄H₂₆N₄O₁₁P₂ |
| Molecular Weight | 488.32 g/mol |
| Appearance | White crystalline powder |
| Solubility | Freely soluble in water |
| Storage Condition | Room temperature, dry |
| Shelf Life | 24 months |
| Grade 1 | Pharmaceutical Grade (USP/EP) · ≥99.8% · USP/EP |
| Grade 2 | Food Grade · ≥98.0% · Food Safety |
End-Product Applications
Overview
CDP-Choline (Citicoline) is a neuroprotective agent and choline precursor. PathGene is among very few Chinese manufacturers to hold both USP and EP pharmacopeia certification at ≥99.8% purity.
Mechanism & Benefits
provides choline for acetylcholine synthesis and phosphatidylcholine membrane repair; demonstrated efficacy in cerebral circulation improvement and cognitive recovery. Typical pharma dosage: 500–1000 mg/day (oral or IV). Supplement dosage: 250–500 mg/serving
Compatible Formulations
oral tablet/capsule, IV injection solution (pharma grade), effervescent tablet, powder
Target Market
pharmaceutical manufacturers (CNS drugs, stroke rehabilitation), premium cognitive health supplement brands, medical nutrition companies
Packaging Options
1 kg 5 kg 25 kg
Lead Time
3–5 business days
Minimum Order
25 kg
Custom Packaging
Custom packaging (foil bags, HDPE drums), GMP labeling, and export documentation are available. Contact us for specifics.Certifications
USP
US Pharmacopoeia
EP
European Pharmacopoeia
ISO
ISO
ISO9001
ISO 9001
Manufacturing Process
Production Strain Engineering & Seed Culture
An engineered microbial strain expressing choline-phosphate cytidylyltransferase (CCT) is recovered from cryopreserved stock and expanded through seed culture stages under strict aseptic and genetic-stability controls.
Fermentation for Enzyme & Nucleotide Precursor Production
The seed culture is transferred to production fermenters where controlled temperature, pH, dissolved oxygen, and feeding strategy drive high-density cell growth and accumulation of the CCT enzyme and CTP precursor.
Enzymatic Bioconversion
Cell lysate or whole-cell biocatalyst is used to catalyze coupling of cytidine triphosphate (CTP) with phosphocholine, forming CDP-choline (citicoline) and releasing inorganic pyrophosphate as a by-product.
Biomass Removal & Clarification
The reaction broth is centrifuged and/or membrane-filtered to remove residual cell mass and insoluble debris, then treated with activated carbon to reduce color bodies and trace pyrogens.
Chromatographic Purification
Ion-exchange and/or preparative chromatography separates citicoline from unreacted precursors, salts, and reaction by-products to reach the purity required for pharmaceutical-grade material.
Concentration & Crystallization
The purified solution is vacuum-concentrated, and controlled cooling/anti-solvent crystallization is used to precipitate citicoline in a defined, reproducible crystal form.
Drying & Micronization
Wet crystals are vacuum- or fluid-bed dried under low-temperature conditions to protect the hygroscopic nucleotide structure, then milled and sieved to the target particle size.
Quality Control & Packaging
Each batch is tested by HPLC assay, related-substance profiling, heavy metal and microbial limit testing before being packed in moisture-protective bulk containers under GMP-aligned conditions.
Quality Specifications
| Test Item | Specification | Result |
|---|---|---|
| Appearance | White to off-white crystalline powder | Conforms, white crystalline powder |
| Odor & color | Odorless, white, free-flowing | Conforms |
| Assay (HPLC, on dried basis) | ≥99.8% | 99.85% |
| Crystal form / particle size | Fine crystalline powder, 100% through 80 mesh | Conforms, 100% through 80 mesh |
| Loss on drying | ≤5.0% | 2.8% |
| Lead (Pb) | ≤10 ppm | <5 ppm |
| Mercury (Hg) | ≤1 ppm | <0.5 ppm |
| Cadmium (Cd) | ≤1 ppm | <0.5 ppm |
| Arsenic (As) | ≤2 ppm | <1 ppm |
| Total aerobic plate count | ≤1000 CFU/g | <100 CFU/g |
| Yeast & mold | ≤100 CFU/g | <10 CFU/g |
| E. coli | Negative/25 g | Negative |
| Salmonella | Negative/25 g | Negative |
Purity & Assay Method
Purity is determined by reversed-phase HPLC with UV detection, quantified against a characterized citicoline reference standard and reported on a dried-basis percentage, consistent with USP/EP-style monograph methodology. Because citicoline is a nucleotide salt sensitive to moisture and trace ionic impurities, buyers should always request the batch-specific Certificate of Analysis and, where regulatory use requires it, an independent third-party HPLC verification rather than relying on a generic specification sheet alone.
Solubility & Formulation
Citicoline is freely soluble in water, forming clear, essentially colorless solutions across a wide concentration range, which supports its use in oral solutions, effervescent tablets, and sterile injectable formulations. For solid dosage forms (tablets, capsules, powder sachets), its hygroscopic nature calls for moisture-controlled processing, desiccant packaging, and, where needed, a moisture barrier coating; for aqueous/injectable formulations, pH adjustment and sterile filtration (rather than terminal heat sterilization) are typically used to preserve the integrity of the nucleotide structure.
Available Product Forms
Bulk Citicoline (CDP-Choline) Powder
High-purity raw powder for supplement factories, research organizations, ingredient distributors, and contract manufacturers.
Citicoline (CDP-Choline) Capsules
Custom capsule strength, shell material, bottle count, excipients, and label design for private-label brands.
Citicoline (CDP-Choline) Tablets
Tablet formulation, granulation, compression, coating, bottle packaging, and custom labeling support.
Citicoline (CDP-Choline) Powder Blends
Citicoline (CDP-Choline) can be blended with complementary actives (antioxidants, other longevity ingredients, vitamins, minerals) per customer formula.
How is the ≥99.8% purity confirmed, and can I get a batch-specific COA?+
Purity is verified by HPLC against a reference standard for every production batch. A full Certificate of Analysis covering assay, related substances, heavy metals, and microbial limits is provided with each shipment, and pre-shipment samples can be tested independently if required.
How is your citicoline actually produced — fermentation, enzymatic conversion, or chemical synthesis?+
Our citicoline is produced via an enzymatic bioconversion route: an engineered microbial strain is fermented to generate the key enzyme and nucleotide precursor, which then catalyzes formation of CDP-choline, followed by purification and crystallization. This biotechnological route provides more consistent impurity control than older multi-step chemical synthesis.
How soluble is citicoline, and does that affect which dosage forms it suits?+
Citicoline is freely soluble in water, which makes it well suited to oral solutions, effervescent tablets, and injectable formulations, as well as standard tablets, capsules, and powder blends provided moisture is properly controlled during processing and packaging.
Can we request a free sample before placing a bulk order?+
Yes, small evaluation samples are available on request for formulation and quality testing purposes. Please contact our team with your intended application and required quantity so we can arrange the appropriate sample and documentation.
Do you support third-party or independent laboratory testing?+
Yes. In addition to our internal QC reports, customers are welcome to send samples to their own accredited laboratory for independent verification of assay, purity, and safety parameters before or after purchase.
Do you offer OEM or private-label formulation support?+
Yes, we support OEM and private-label programs, including custom particle size, blending with complementary ingredients, and formulation guidance for finished dosage forms such as tablets, capsules, and effervescent products.
What packaging options are available, and how should the product be stored?+
Citicoline is typically packed in moisture-protective bulk drums or foil-lined bags (e.g., 1 kg, 5 kg, 25 kg), with custom packaging available on request. It should be stored in a cool, dry place, tightly sealed and protected from moisture and direct light.
What is the minimum order quantity (MOQ) and how do we get a quotation?+
MOQ varies by packaging format and intended use (pharmaceutical vs. nutraceutical grade); please contact our sales team with your target quantity, application, and destination market so we can provide an accurate quotation and lead time.
Why Choose PathGene
- Direct China manufacturer supply — factory pricing, no middleman
- Batch-specific COA & full traceability on every shipment
- In-house R&D + synthetic biology / enzymatic production platform
- Free sample for qualified B2B buyers before commercial order
- Flexible MOQ — from lab-scale trial to ton-scale commercial supply
- One-stop OEM/private-label support for finished dosage forms
- Worldwide shipping by courier, air freight, and sea freight
OEM & Private-Label Services
- ·Custom capsule manufacturing
- ·Custom tablet manufacturing
- ·Powder blending & custom formulation
- ·Private-label bottles, pouches & labels
- ·Small trial orders
- ·Bulk commercial production
- ·Export documentation
- ·Third-party laboratory testing
Documents Available
- ·Certificate of Analysis (COA)
- ·Product specification sheet
- ·Material Safety Data Sheet (MSDS)
- ·Manufacturing flow chart
- ·HPLC test report
- ·Heavy-metal test report
- ·Microbiological test report
- ·Non-GMO / allergen statement
- ·Country-of-origin documentation
- ·Packing list & commercial invoice
Certificate availability should be confirmed with our sales team before ordering.
Sample Certificate of Analysis
PathGene Biotech Co., Ltd.
南京派琪生物科技有限公司
CERTIFICATE OF ANALYSIS
Layout example — not an issued batch record
Product Name
Citicoline (CDP-Choline)
CAS No.
987-78-0
Batch No.
PG-SAMPLE-000000
Packaging
Issued upon order confirmation
| Test Item | Specification | Result |
|---|---|---|
| Appearance | White to off-white crystalline powder | Conforms, white crystalline powder |
| Odor & color | Odorless, white, free-flowing | Conforms |
| Assay (HPLC, on dried basis) | ≥99.8% | 99.85% |
| Crystal form / particle size | Fine crystalline powder, 100% through 80 mesh | Conforms, 100% through 80 mesh |
| Loss on drying | ≤5.0% | 2.8% |
| Lead (Pb) | ≤10 ppm | <5 ppm |
| Mercury (Hg) | ≤1 ppm | <0.5 ppm |
| Cadmium (Cd) | ≤1 ppm | <0.5 ppm |
| Arsenic (As) | ≤2 ppm | <1 ppm |
| Total aerobic plate count | ≤1000 CFU/g | <100 CFU/g |
| Yeast & mold | ≤100 CFU/g | <10 CFU/g |
| E. coli | Negative/25 g | Negative |
| Salmonella | Negative/25 g | Negative |
Conclusion: Conforms to internal quality specifications
The COA issued with your order will carry the actual batch number, manufacture/test dates, and QC signature.
Related Products
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