Report
The finished report, ready for your assessment.
We take on the evaluation and deliver the reviewed report. From EUR 1,490 net, typically within 5 working days once your data is complete.
| Peak | t (min) | Area % |
|---|---|---|
| V1 | 2.1 | 0.09 |
| V2 | 3.4 | 0.24 |
| API | 6.2 | 99.15 |
| V3 | 7.8 | 0.38 |
| V4 | 9.1 | 0.14 |
Three sizes, one process
From EUR 1,490 net. Which size your case needs and what it costs is stated in the written quote after the intro call.
S: one question, one data set
For example an unknown peak in the chromatogram, a structure confirmation from NMR and MS or a solubility estimate for one molecule.
M: several samples or methods
For example an impurity profile across several batches, a stability evaluation with shelf life or a DoE with evaluation and recommendation.
L: a full package
For example a nitrosamine risk assessment across a portfolio, a method development with robustness testing or a data package for submission.
How you get your report
Intro call
30 minutes on Microsoft Teams about the question, the data and your deadline.
Quote
In writing, with size, price and delivery date.
Evaluation
Typically within 5 working days once your data is complete, typically within 3 working days with a rush surcharge.
Report
Technically reviewed, for assessment and release in your quality system.
What you get
- The result with its reasoning, clear for the lab, QA and management.
- Input data, calculation path and its version, traceable for any audit.
- Limits of the result: what the report says and what an experiment has to settle.
- The next steps, when the result calls for a decision.
Cases we often evaluate
Spectra interpretation for NMR, MS, IR and UV/Vis
The spectra have been sitting on the desk for days, and nobody has time to assign them properly.
See solutionIdentify an unknown impurity by LC-MS
A peak has appeared above the identification threshold, and we do not know what it is.
See solutionHPLC method development with fewer scouting runs
We need a new HPLC method, and scouting is eating up weeks of instrument time.
See solutionAnalytical method transfer and validation for HPLC
The method runs at the sponsor's site, but in our lab the peaks no longer separate, and the original column is discontinued.
See solutionExtractables and leachables assessment: identification to toxicology
The extractables study produced a long peak list, and for most peaks we have neither a name nor an assessment.
See solutionForced degradation study: degradation products and mass balance
The mass balance in our stress study doesn't close, and we don't know where the missing part went.
See solutionNitrosamine risk assessment: identify and justify NDSRIs
The authority wants to see our nitrosamine risk assessment, and we don't know whether our API can form an NDSRI.
See solutionStability data evaluation: detect OOT and estimate shelf life
One result in our stability study looks different from the earlier ones, and we don't know whether it's a trend or just scatter.
See solutionClose OOS investigations faster and with full traceability
We have an OOS result, the batch is on hold, and the investigation hasn't reached a conclusion for weeks.
See solutionClear the batch release backlog: review release data
Batches pile up before release because reviewing the data takes days every time.
See solutionSolve a solubility problem before you run out of material
Our API won't dissolve properly, and we have been trying solvents for weeks.
See solutionCrystallization process design: cooling or antisolvent
Our crystallization yield is too low, and we don't know whether to cool or use an antisolvent.
See solutionDesign of experiments (DoE): from design to analysis
We have too many factors and too little material, and nobody on the team is sure which design fits.
See solutionProcess optimization and process capability (Cpk, Ppk)
Our Cpk is too tight, and we don't know which parameter drives the variation.
See solutionSynthesis route planning: retrosynthesis and route scouting
We have the target structure, but no route we want to rely on yet.
See solution
Frequently asked questions
What does a report cost?
From EUR 1,490 net. You get the exact quote in writing after the intro call.
Can it be faster?
Yes. With a rush surcharge, typically within 3 working days once your data is complete. The quote states the surcharge and the binding date.
What do I need to provide?
The raw data or exports from your instrument (for example FID, mzML, CSV or a PDF of the chromatogram), the structure or molecular formula if known, and two or three sentences on the question. We confirm in writing after the intro call exactly what your case needs.
Where is my data kept?
Hosted at Hetzner in Nuremberg, data kept in the EU. Your data used only for the agreed purpose. Deletion on request within 30 days, backups included.
Can I use the report in a GMP environment?
Yes, as the basis for your assessment. On request we sign a quality agreement, answer your supplier questionnaire and accommodate a supplier audit. Assessment stays with your QA, batch release with your QP.
Do you set anything up at our site?
No. You get the finished report, nothing is installed at your site.
Next step
Which data is waiting for evaluation at your site?
30 minutes on Microsoft Teams with the CovaSyn team. If it is not a fit, we will say so.