Quality & Validation

Our laboratory is not currently accredited to ISO/IEC 17025 by UKAS or another accreditation body. We therefore do not present our test reports as accredited results.

Our internal quality management is guided by the ISO/IEC 17025 requirements relevant to our activities. This includes documented method validation and verification, regular instrument qualification and calibration, defined quality-control acceptance criteria, documented deviation and corrective and preventive action (CAPA) procedures, and full traceability of samples, reference standards and analytical runs.

Formal accreditation for individual analytical procedures or a limited method scope is under consideration. This is not a claim of current accreditation.

Where suitable certified reference materials (CRMs) are available, we preferentially use them or qualified primary standards from established manufacturers. We document the manufacturer, lot number, certificate, assay value, storage conditions and expiry date.

For novel compounds without suitable commercially available reference material, we use qualified in-house reference standards. Identity is confirmed by nuclear magnetic resonance (NMR) spectroscopy and high-resolution mass spectrometry. The quantitative assigned value is determined independently, for example by quantitative NMR (qNMR) and/or an appropriate mass-balance approach.

Where applicable, the assessment accounts for water, residual solvents, counter-ions and inorganic components. Each in-house standard receives a documented assay value with its associated measurement uncertainty and is approved before use in routine analysis.

Measurement traceability concerns the documented connection between a quantitative result, its calibration and the reference values used, including their uncertainty. It is distinct from the chain of custody of a sample and from verification of a PDF record. The applicable reference basis and any limitations depend on the analyte and method.

Our quantitative methods are validated or verified for their intended purpose using current scientific and regulatory principles, including the relevant principles of ICH Q2(R2). We assess specificity or selectivity, the calibration model and working range, accuracy and recovery, repeatability, intermediate precision, and robustness.

Acceptance criteria for each parameter are defined before validation begins. Accuracy is checked using independently prepared samples or spike-recovery studies at multiple concentration levels. Precision is assessed both within an analytical run and across different days, analysts and, where applicable, instruments.

A method is approved for routine samples only after all predefined acceptance criteria have been met. Applying these validation principles does not constitute regulatory approval or laboratory accreditation.

For quantitative assays, measurement uncertainty is evaluated from the significant contributions across the full analytical procedure. These include the reference standard and its assigned value, weighing, volumetric steps, sample preparation, calibration, instrumental repeatability and intermediate precision.

Expanded uncertainty is typically stated with a coverage factor of k = 2, corresponding to approximately 95% coverage where the underlying statistical assumptions are appropriate.

Depending on the analyte and matrix, expanded uncertainty for our routine quantitative HPLC assays is typically in the range of approximately ±2% to ±5%. This is not a universal limit for every method or sample. The method-specific value can be stated in the test report or supplied on request.

Each quantitative analytical sequence includes suitable blanks to monitor carry-over and contamination, a fresh multi-point calibration across the relevant concentration range, and independently prepared QC samples with known target concentrations.

Where technically possible, QC samples are prepared from a separate stock solution or an independent second-source standard, rather than exclusively from the solution used for calibration standards. Both calibration points and QC samples are assessed against acceptance criteria defined in advance.

Additional QC samples are analysed at regular intervals during longer sequences to detect instrument drift or changes in system performance. Results are released only when all system-suitability, calibration and QC criteria have been met.

Suitable commercial proficiency-testing schemes are not currently available for many novel peptides, SARMs and related compounds. Where appropriate schemes are available, we participate where possible.

For analytes without an available proficiency-testing scheme, we conduct documented interlaboratory comparisons. Identical or homogenised blind samples are analysed independently by our laboratory and at least one external laboratory. Results are compared against acceptance criteria defined in advance.

We also use internal blind samples, repeat measurements and, where appropriate, second-analyst checks. Deviations outside the predefined limits are investigated and documented before the method continues in routine use.