Human EDTA Plasma for PK Studies & Bioanalytical Method Validation
Blank human plasma in the anticoagulant your study samples use — K2EDTA, K3EDTA or sodium EDTA. Sterile filtered, from EU donors, as pooled plasma or as individual donor lots for selectivity and matrix-effect testing. From 10 mL to bulk, with a CoA for every lot.
Blank Matrix That Matches Your Study Samples
Calibration standards and QC samples in a PK study should be prepared in the same matrix as the study samples — the same species and the same anticoagulant. A mismatch adds an avoidable variable to your method validation.
We supply human EDTA plasma in all common EDTA formats and volumes, so the blank matrix for calibrators, QCs and selectivity testing comes from one documented source for the whole study.
What Bioanalytical Labs Need
- Matching anticoagulant — K2EDTA, K3EDTA or sodium EDTA, plus heparin and citrate.
- Individual donor lots — ICH M10 asks for selectivity testing in blank matrix from at least 6 individual sources for chromatographic methods and at least 10 for ligand-binding assays.
- Hemolyzed and lipemic plasma — to evaluate the effect of hemolysis and lipemia on your method.
- Enough pooled matrix — for calibrators and QCs across the full study, from one lot.
- Documentation — CoA per lot and donor screening report.
Plasma Formats for PK and Bioanalysis
Standard catalogue items and custom collections from defined donors.
Pooled Blank Plasma
Sterile filtered human EDTA plasma pooled from healthy EU donors. 10 mL and 250 mL, bulk volumes on request.
Individual Donor Sets
Single-donor plasma lots for selectivity and matrix-effect testing — for example sets of 6 or 10 individual donors, in your anticoagulant.
Hemolyzed & Lipemic Plasma
Plasma with hemolysis or lipemia for the corresponding validation experiments. Available on request.
Sodium EDTA Plasma
Human plasma collected in sodium EDTA for methods and studies that specify this counter-ion. Available on request.
Other Anticoagulants
Lithium heparin, citrate 3.2 % and 3.8 % and ACD-A are listed under pooled human plasma.
Lot Reservation
Reserve one qualified lot for the whole study, so calibrators and QCs never change matrix mid-programme.
Specifications
| Parameter | Specification |
|---|---|
| Matrix | Human EDTA plasma (K2EDTA, K3EDTA, sodium EDTA on request) |
| Origin | Self-reported healthy EU donors |
| Processing | Sterile filtered (0.2 µm) |
| Donor format | Pooled or single donor |
| Infection markers | HIV-1/2 Ab, HBsAg and HCV Ab non-reactive (CE-marked tests) |
| Microbial count | TAMC + TYMC below 10 CFU/mL |
| Volumes | 10 mL · 250 mL · bulk on request |
| Storage | At or below −18 °C, shipped on dry ice |
| Shelf life | 4 years from manufacture |
Quality & Documentation
- Certificate of Analysis — for every lot.
- Donor screening report — each donation tested individually.
- Ethical sourcing — donations collected in line with the EDQM Guide to the Preparation, Use and Quality Assurance of Blood Components.
- Certified manufacturing — our manufacturing partner works under ISO 9001 and ISO 13485.
- Research use — for in vitro use only, not for administration to humans.
How We Work Together
Tell Us Your Method
Anticoagulant, number of individual donors, volumes and any special matrices such as hemolyzed or lipemic plasma.
Test Sample & Documents
We send a test sample with CoA and donor screening report for your method development.
Reserve Your Lot
Once the matrix works in your method, we reserve the lot for the duration of your study.
Delivery on Dry Ice
Frozen delivery across Germany and the EU, with documentation for every shipment.
Frequently Asked Questions
Which anticoagulant should I use for blank plasma in a PK study?
Use the anticoagulant of your study samples. Most clinical PK studies collect K2EDTA plasma, but some protocols specify K3EDTA or sodium EDTA. We supply all three, plus heparin and citrate plasma.
How many individual donors do I need for method validation?
ICH M10 asks for selectivity testing in blank matrix from at least 6 individual sources for chromatographic methods and at least 10 for ligand-binding assays. We supply individual donor sets in these sizes.
Do you supply hemolyzed and lipemic plasma?
Yes, on request. Tell us the anticoagulant and volume you need for your hemolysis and lipemia experiments.
Is the plasma sterile?
Our pooled EDTA plasma is sterile filtered through 0.2 µm, with a total microbial count below 10 CFU/mL.
How is the plasma tested?
Every donation is tested for HIV-1/2 antibodies, hepatitis B surface antigen and hepatitis C antibodies with CE-marked tests and is non-reactive.
What volumes are available?
10 mL and 250 mL as standard, bulk volumes and individual donor sets on request.
More on plasma and serum for bioanalysis: human serum and plasma for IVD and CRO applications, single donor human plasma and our overview of all biological raw materials.
Get the Right Blank Matrix for Your Next Study
Tell us your anticoagulant, donor numbers and volumes. You receive a quote with CoA and donor documentation — and a test sample on request.
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