Analytical quality and documentation

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Articles in this topic

Analytical carryover in a sample sequence

Analytical carryover in a sample sequence. Carryover concerns a signal remaining from an earlier sample or analytical step.

Matrix effects in bioanalytical measurement

Matrix effects in bioanalytical measurement. A biological sample contains more than the target analyte.

Dilution integrity in analytical assays

Dilution integrity in analytical assays. A diluted analytical sample needs a justified method for recovering the reported value.

Internal standards in bioanalytical assays

Internal standards in bioanalytical assays. An internal standard is used within an analytical procedure to support measurement.

Extraction recovery in sample analysis

Extraction recovery in sample analysis. Recovery describes an aspect of how material is measured through a procedure.

Recovery and trueness in analytical measurement

Recovery and trueness in analytical measurement. A recovery experiment can inform method evaluation, but its meaning depends on how it was performed.

Recovery correction and reporting results

Recovery correction and reporting results. Applying a recovery correction changes the reported result and requires an explicit rationale.

Chromatographic retention time and identity

Chromatographic retention time and identity. Retention time belongs to a defined chromatographic procedure.

Peak height versus peak area

Peak height versus peak area. Peak height and integrated area describe different features of a chromatographic signal.

Chromatographic resolution and peak width

Chromatographic resolution and peak width. Resolution concerns the separation of chromatographic peaks, including their widths.

Detector response factors and analyte amount

Detector response factors and analyte amount. Different components can produce different responses in a measurement system.

Co-elution and chromatographic specificity

Co-elution and chromatographic specificity. A single displayed peak need not settle every question about overlapping components.

Separation factor versus resolution

Separation factor versus resolution. A separation factor and peak resolution describe related but distinct chromatographic properties.

Gradient versus isocratic chromatographic methods

Gradient versus isocratic chromatographic methods. A chromatographic method is more than a technique label.

System suitability and sample testing

System suitability and sample testing. System suitability checks address whether the analytical system meets defined conditions for a procedure.

Analytical blank types and their purpose

Analytical blank types and their purpose. Different blank preparations can investigate different sources of signal.

Calibration weighting and model performance

Calibration weighting and model performance. A calibration model includes choices about fitting and error structure.

Back-calculated calibration standards

Back-calculated calibration standards. Back-calculation compares model-derived values with assigned calibration values.

Independent analytical quality controls

Independent analytical quality controls. Control samples help evaluate performance beyond the arithmetic fit of calibration points.

Instrument drift across an analytical run

Instrument drift across an analytical run. A signal may change over time during an analytical sequence.

Reference bracketing in sample sequences

Reference bracketing in sample sequences. References placed at defined points in a run provide information about those observations and the chosen monitoring strategy.

Analytical method robustness

Analytical method robustness. Robustness evaluation investigates how a procedure responds to selected variations.

Sample preparation versus injection replicates

Sample preparation versus injection replicates. An analytical result depends on the complete procedure, not only the detector.

UV detection wavelength and chromatographic response

UV detection wavelength and chromatographic response. A UV response depends on measurement conditions and the absorbing material.

Detector saturation and quantitative range

Detector saturation and quantitative range. A measurement system has an operating range.

Reporting thresholds in impurity analysis

Reporting thresholds in impurity analysis. A report may use defined rules for which findings are listed.

Forced degradation versus shelf-life studies

Forced degradation versus shelf-life studies. Stress investigations and studies supporting storage claims have different purposes.

Photostability testing and packaging

Photostability testing and packaging. Light-related stability findings depend on how the material was exposed and protected.

Water content and dry-basis reporting

Water content and dry-basis reporting. A result can depend on the basis used to express it.

Counterions in peptide documentation

Counterions in peptide documentation. Chemical form can be part of the material description.

Parts per million: ppm reporting basis

Parts per million: ppm reporting basis. Parts per million expresses a ratio, but the basis must be clear.

Elemental impurity panel scope

Elemental impurity panel scope. An elemental report covers the analytes and procedures actually included.

Reference purity assignment and certificates

Reference purity assignment and certificates. An assigned reference value needs a documented basis and appropriate use.