Technical2026-09-15 · 5 min read

By PathGene Biotech · Technically reviewed by Alex Huang

PathGene Citicoline: 99.91% Purity and Four Heavy Metals Not Detected

PathGene Citicoline: 99.91% Purity and Four Heavy Metals Not Detected

99.91% purity; lead, arsenic, cadmium and mercury not detected; aerobic plate count and moulds and yeasts each below 10 CFU/g. These are the third-party test results for PathGene citicoline (CDP-choline) sample PGCDP-260530. Together, they give buyers evaluating high-purity citicoline raw material a concrete view of chemical purity, elemental impurities and microbiological results.

Nanjing PathGene Biotech Co., Ltd. presents the sample identification, methods and results so procurement and quality teams can assess the evidence directly. For supply specifications and sample enquiries, visit our citicoline powder product page.

PathGene citicoline test results at a glance

Quality measureSubmitted sample result
Purity99.91%
Lead, arsenic, cadmium and mercuryAll four not detected; individual detection limits below
Aerobic plate count<10 CFU/g
Moulds and yeasts<10 CFU/g
Coliforms<0.3 MPN/g
Salmonella and Staphylococcus aureusBoth not detected /25 g

Client sample code: PGCDP-260530. Analysis dates: 7–13 September 2026. Report issue date: 14 September 2026. All results above refer to the same submitted sample.

99.91% purity: a measured result for high-purity CDP-choline sourcing

The submitted citicoline sample returned a purity result of 99.91%. For buyers using 99.9% purity as a screening consideration, this provides a specific sample result to review alongside the method and purchasing requirements.

Purity was tested using customer method ESX-ED-05176. The report identifies the test as purity, rather than an assay on a dried basis. The 99.91% result should therefore retain that description; it is not presented as a dried-basis assay, full pharmacopoeial compliance or a guaranteed minimum for every supplied batch.

Four heavy metals not detected, with detection limits disclosed

Beyond purity, the sample returned results below the respective detection limits for lead, arsenic, cadmium and mercury. Listing each detection limit makes these results more informative for supplier evaluation than a general statement about heavy-metal compliance.

ElementResultLOD (mg/kg)LOQ (mg/kg)
Lead (Pb)Not detected0.020.05
Arsenic (As)Not detected0.010.03
Cadmium (Cd)Not detected0.0020.005
Mercury (Hg)Not detected0.0010.003

All four elements were tested using GB 5009.268-2025, Chapter One, first method. For mercury, the detection limit was 0.001 mg/kg. “Not detected” means a result below that method detection limit, rather than absolute absence. LOD and LOQ describe method capability; they are not product acceptance limits.

Low microbial counts: aerobic plate count and moulds and yeasts below 10 CFU/g

The sample also showed aerobic plate count below 10 CFU/g, moulds and yeasts below 10 CFU/g, and coliforms below 0.3 MPN/g. Salmonella and Staphylococcus aureus were not detected in the specified 25 g test portions.

TestResultMethod
Aerobic plate count<10 CFU/gGB 4789.2-2022
Moulds and yeasts<10 CFU/gGB 4789.15-2016, first method
Coliforms<0.3 MPN/gGB 4789.3-2025, first method
SalmonellaNot detected /25 gGB 4789.4-2024
Staphylococcus aureusNot detected /25 gGB 4789.10-2016, first method

These results add microbiological information that a purity percentage alone cannot provide. Low counts and non-detection of specified organisms are distinct findings; neither should be described as sterility or non-detection of all microorganisms.

Three quality dimensions for evaluating PathGene citicoline

The strength of this sample profile is the combination: 99.91% purity, four heavy metals not detected and low microbial counts. It gives citicoline buyers several measurable points for technical review, from the purity method to individual element detection limits and microbiological endpoints.

Use these sample results to inform evaluation, then confirm the specification, COA and any additional testing requirements for the intended delivery batch. Our quality control and documentation page provides a starting point for discussing the documents required for your project.

Discuss bulk citicoline powder and sample requirements

If you are sourcing high-purity Citicoline / CDP-Choline raw material, share your target specification, expected volume and priority tests with PathGene to discuss sample evaluation and quality documentation.

View citicoline specifications and request a sample · Contact PathGene for a quotation

Test source and scope

Source: report AR-26-ZL-016891-01-ZH / EN, issued by Eurofins Testing & Inspection (Xiamen) Co., Ltd.; laboratory sample code 787-2026-00036066; sample described as Citicoline; client sample code PGCDP-260530. Results apply only to the submitted sample. The purity test/method is outside the CNAS accreditation scope. The report states that it is intended only for scientific research, teaching or internal quality control and shall not be used as proof to the public. This article describes sample test information; it is not a product certification, an all-batch guarantee or a conclusion of full pharmacopoeial compliance.

Frequently Asked Questions

What purity was measured for this PathGene citicoline sample?+

Sample PGCDP-260530 returned 99.91% purity using customer method ESX-ED-05176. This is a sample-specific purity result, not a dried-basis assay.

Which heavy metals were not detected in the citicoline sample?+

Lead, arsenic, cadmium and mercury were not detected at respective detection limits of 0.02, 0.01, 0.002 and 0.001 mg/kg. Not detected means below the method detection limit, not zero.

Were all microbiological tests reported as not detected?+

No. Aerobic plate count and moulds and yeasts were each below 10 CFU/g; coliforms were below 0.3 MPN/g. Salmonella and Staphylococcus aureus were not detected /25 g.

How can I enquire about PathGene CDP-choline raw material?+

Use the citicoline product page or website contact form to share your target specification, volume and priority tests, and discuss samples, pricing and documents for the intended delivery batch.

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