Pharma Lab Calculators
20 calculators and 3 lab simulators for routine QC, dissolution, method validation, CMC and cleaning validation. Paste your raw data from Excel and get the result, the pass/fail verdict, every calculation step and a printable report.
- Free, no sign-up
- ICH, USP and Ph. Eur. based
- Every step shown
- Data stays in your browser
Run a reversed-phase separation, watch the bands separate inside the column and get the system suitability verdict.
- Simulator
- Chromatogram
- 8 faults
- USP <621>
Replicate %RSD, retention time, tailing, plates, resolution and S/N with automatic pass/fail.
- %RSD
- Tailing
- Plates
- USP <621>
Agreement of two independently weighed standards, corrected for weight and dilution.
- Std 1 vs Std 2
- %RSD
- 98–102%
Multi-step dilution schemes, final concentrations and the assay factor.
- Multi-step
- Concentration
- Assay factor
mg/unit and % label claim per sample, mean and repeatability %RSD.
- % LC
- Repeatability
- mg/unit
Run a six-vessel USP apparatus, introduce real bench faults and see the profile and stage verdict change.
- Simulator
- Apparatus 1 & 2
- 8 faults
- Training
% dissolved per unit with the USP <711> S1, S2 and S3 verdict.
- USP <711>
- Stages
- Q value
Multi-point profiles corrected for medium withdrawn at each pull.
- Profile
- Volume correction
Comparative dissolution with f2 and f1 under FDA or EMA rules.
- f2
- f1
- FDA
- EMA
Regression, r, R², residuals and y-intercept with a chart.
- r / R²
- Slope
- Residuals
% recovery per preparation, per level and overall.
- % Recovery
- 3 levels
- %RSD
Two analysts, days or labs: set %RSD, combined %RSD, difference.
- Combined %RSD
- Ruggedness
LOD and LOQ from the calibration curve, plus S/N.
- 3.3σ/S
- 10σ/S
- S/N
How long standard and sample solutions stay within limits.
- % Difference
- Hours
Deliberate method variations against the nominal result.
- Flow
- Temperature
- pH
Interference from blank, placebo and impurities, and resolution.
- Blank
- Placebo
- Resolution
% degradation and mass balance for each stress condition.
- Stress
- Mass balance
ICH Q3A/Q3B thresholds and classification of batch results.
- Q3A
- Q3B
- Specification
Store batches at ICH conditions, test the packaging, and get the significant change assessment and the Q1E shelf life.
- Simulator
- ICH Q1A
- Q1E
- 6 faults
Batch poolability, regression with 95% bounds and the Q1E extrapolation limit.
- Q1E
- ANCOVA
- Extrapolation
ICH Q3D PDEs, permitted concentrations and the 30% control threshold.
- Q3D
- PDE
- 24 elements
CPCA potency category, acceptable intake and ppm limit for NDSRIs.
- CPCA
- NDSRI
- AI
- ppm
MACO by HBEL, dose and 10 ppm, with swab and rinse limits.
- MACO
- HBEL
- Swab
- Rinse
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Built for the bench and the audit
Copy a block of cells and paste it into any table. Rows are added for you.
Each result comes with the formula and the numbers used, so you can check it or copy it into your notebook.
Set your own acceptance criteria, or keep the common defaults from ICH, USP and Ph. Eur.
Add product, batch and analyst, then print or save a clean PDF report.
These calculators are decision support for orientation and training. They are not validated GMP software, and results must be checked against your approved method, SOP and the current pharmacopoeia or guideline before use in GMP records. Your data is processed in your browser and is not sent to Molgenium.