Explore Pharmanalyse's three levels of drug analysis services

To meet the diverse needs of laboratories, importers, and healthcare professionals, Pharmanalyse structures its services around three levels of drug analysis. This modular approach allows the company to tailor the analytical effort, turnaround times, and costs to the specific purpose of each quality control test.

From a simple, quick check to an official registration dossier, discover the full range of our laboratory services. All of our analyses are performed using chromatography with high-purity reference standards: the active ingredient of the drug.

The Standard Level (Guaranteed uncertainty of less than 20%)

The Standard level is designed to meet the needs of rapid testing, preliminary screening, or simply confirming the presence of an active ingredient. It prioritizes agility and affordability by optimizing the utilization time of chromatography equipment (HPLC).

Calibration range: 3 calibration points surrounding the target concentration of the sample.

Quality Control (QC): 1 intermediate-level QC sample at the end of the analysis run to confirm and validate the instrument's performance.

Sample: 1 ; the sample is analyzed once.

It's the ideal solution for quickly resolving uncertainties at the best price, while ensuring optimal quality in the test results.

The "Precise" level (Guaranteed uncertainty of less than 10%)

This intermediate level offers the perfect balance between cost and analytical rigor. It is designed for stakeholders seeking reliable quantification to ensure the safety of a batch, verify internal compliance, or validate a formulation step.

Calibration range: 5 calibration points surrounding the target concentration of the sample. The calibration range is analyzed at the beginning of the analytical sequence.

Quality Control (QC): Three QC levels (limit of quantification, medium, high) are included in the sequence. The sample at the limit of quantification (LOQ) for the analytical method is analyzed at the end of the analysis sequence to confirm and validate the instrument's performance.

Sample: 3 ; the sample is analyzed three times using independent preparations, allowing for the calculation of a standard deviation (precision) and ensuring the accuracy of the determined mean value.

A strategic choice that combines budget control with quantitative reliability.

The Regulatory Level (Guaranteed uncertainty of less than 5%)

The Regulatory level meets the most stringent requirements of international pharmaceutical standards (GMP, European Pharmacopoeia, USP). It is essential for the release of imported batches, disputes, or submissions to health authorities. 

Calibration range: 5 points surrounding the target concentration of the sample. The calibration range is analyzed at the beginning and end of the analytical run.

Quality Control (QC): Three QC levels (limit of quantification, medium, high) are included in duplicate using independent preparations inserted into the sequence. The sample at the limit of quantification (LOQ) of the analytical method is analyzed at the end of the analysis sequence, before the second calibration range is analyzed, to confirm and validate the instrument’s performance.

Sample: 6 ; the sample is analyzed six times using independent preparations, allowing for the calculation of a standard deviation (precision), ensuring the accuracy of the determined mean value, and guaranteeing impeccable repeatability.

This level ensures minimal measurement uncertainty and full traceability recognized by regulatory authorities.

With these three levels of pharmaceutical analysis services, Pharmanalyse provides you with customized support that balances scientific rigor, regulatory requirements, and budget management.