Dissolution Apparatus Mechanical Calibration Checker (FDA Guidance, ASTM E2503 Parameters)
Every position of a basket or paddle apparatus against both sets of tolerances.
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- Free preview: the method, the limits that apply and the verdict for your input; computed figures stay hidden until the pass.
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Calibration record
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About the Dissolution Apparatus Mechanical Calibration Checker (FDA Guidance, ASTM E2503 Parameters)
Records and checks the mechanical calibration of a USP apparatus 1 (basket) or apparatus 2 (paddle), position by position: shaft wobble and verticality, basket wobble, the shaft’s centering at an upper and a lower position, vessel verticality, the basket or paddle depth, the rotational speed and the temperature, with the medium volume and the vessel’s size where you measured them.
Each measurement is judged against two sets of tolerances side by side: the tighter mechanical calibration tolerances that FDA’s guidance recommended, based on ASTM E2503 (1.0 mm wobble and centering, 0.5° shaft and 1.0° vessel verticality, 25 ± 2 mm depth, ± 2 rpm), and the harmonised pharmacopoeial requirements of the dissolution test (2 mm centering, ± 4 % speed, 37 ± 0.5 °C), choosing which one decides. The free preview shows every measurement’s verdict, the tolerances and the method; the deviations from the targets stay hidden, and the calibration record as PDF, Excel and printout opens with an Ultimate pass.
How to use it
- Choose the apparatus, the tolerances that decide, and enter the target speed, the target temperature and the stated medium volume.
- Paste the measurements, one position per line under a first line that names the columns, or open your calibration sheet as CSV or Excel; leave a cell empty when it was not measured.
- Read the verdict of every position and measurement against both sets of tolerances, and the checks.
- Without a pass the record stays a free preview with its computed figures hidden; the PDF, Excel and Print record unlocks with an Ultimate pass.
Examples
Position 4, centering at the upper position: 1.2 mm
Outside the 1.0 mm of mechanical calibration, within the pharmacopoeias’ 2 mm
Measured 103.5 rpm against a target of 100 rpm
Outside ± 2 rpm (mechanical calibration), within ± 4 % (pharmacopoeias)
26.1 mm
Within 25 ± 2 mm
Common uses
- The periodic mechanical calibration of a dissolution bath, as a signed record.
- Checking an apparatus after a repair, a move or new vessels before it is used again.
- Comparing a bath with both the mechanical calibration tolerances and the pharmacopoeial requirements.
- Finding which positions need adjusting.
Mechanical calibration tolerances
- Shaft wobble: not more than 1.0 mm total runout.
- Shaft verticality: not more than 0.5° from vertical (the bubble within the lines of a bubble level).
- Basket wobble: not more than 1.0 mm total runout.
- Vessel and shaft centering: not more than 1.0 mm from the centre line, measured at an upper and a lower position.
- Vessel verticality: not more than 1.0° from vertical.
- Basket or paddle depth: 25 ± 2 mm.
- Rotational speed: ± 2 rpm of the target.
These are the tolerances FDA recommended for mechanical calibration, based on the ASTM E2503 standard practice, as the FIP position paper tabulates them. Temperature, volume and vessel size take the pharmacopoeial requirements.
Pharmacopoeial requirements
The harmonised dissolution test asks for a shaft whose axis is not more than 2 mm from the vessel’s vertical axis at any point and that rotates smoothly without significant wobble, a basket or paddle 25 ± 2 mm above the inside bottom of the vessel, a speed within ± 4 % of the stated rate, the medium at 37 ± 0.5 °C and within ± 1 % of its stated volume, and a 1-litre vessel 160 to 210 mm high with an inside diameter of 98 to 106 mm. The harmonised specification gives the basket’s runout as ± 1 mm.
Sources
- FDA guidance: The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 — mechanical calibration as an alternative to the apparatus suitability procedure, with controls for dissolved gases, vibration and vessel dimensions
- FIP position paper on qualification of paddle and basket dissolution apparatus — Tables I and II: the harmonised specifications and FDA’s recommendations based on ASTM E2503
- The Japanese Pharmacopoeia, English version — 6.10 Dissolution Test, harmonised with the European Pharmacopoeia and the U.S. Pharmacopeia: the apparatus
Limitations
- Measurements only: the gauges, their calibration and the way you measure are your procedure’s.
- The vessel’s height and diameter are checked against the 1-litre vessel of the harmonised text (160 to 210 mm, 98 to 106 mm): leave them empty for a 2-litre or 4-litre vessel.
- The tolerances follow FDA’s recommendations based on ASTM E2503 as the FIP position paper gives them: check them against the edition of the standard and the procedure your site follows.
- Dissolved gases, vibration and vessel irregularities also affect results; the record names them, it does not measure them.
- Up to 48 positions at a time, checked on your device in a moment.
- MySmartCoPilot is not affiliated with or endorsed by FDA, ASTM International, FIP or the pharmacopoeias. This record compares your measurements with the tolerances of the method you choose; your QA approves the calibration.
Privacy
On this device: nothing is sent
Your measurements stay in this browser and are never sent anywhere. The PDF and Excel files are made on your device.
Frequently asked questions
What do I get without a pass?
Without a pass, Dissolution Apparatus Mechanical Calibration Checker (FDA Guidance, ASTM E2503 Parameters) shows the method, the limits that apply and the verdict for your input; computed figures stay hidden until the pass. Until you unlock it, the result can’t be downloaded or printed. An Ultimate pass, a one-time payment unless you choose automatic renewal, unlocks the full result. The pricing page lists the passes and their prices.
What does the Ultimate pass add here?
This tool in full, and every other Pro, Premium and Ultimate tool, for 7 days, 30 days or a year (a pass bought with PayPal leaves out email-address extractors). The pass is a one-time payment unless you choose automatic renewal.
What is the shaft wobble tolerance?
Not more than 1.0 mm total runout in mechanical calibration. The pharmacopoeias ask only that the shaft rotates smoothly without significant wobble.
How far may the shaft be from the vessel’s centre?
Not more than 1.0 mm from the centre line at an upper and a lower position for mechanical calibration, and not more than 2 mm at any point for the pharmacopoeias.
What speed tolerance applies at 50 rpm?
± 2 rpm in mechanical calibration, and ± 4 % (also ± 2 rpm at 50 rpm) in the pharmacopoeias. At 100 rpm the pharmacopoeias allow ± 4 rpm and mechanical calibration still ± 2 rpm.
Which set decides the verdict?
The one you choose. The record shows each measurement against both, so a position within the pharmacopoeias but outside mechanical calibration is easy to see.