Dissolution Testing — USP <711>

Dissolution Stage Testing Calculator

Evaluate individual unit dissolution results against the USP <711> three-stage acceptance criteria (S1, S2, S3).

How Stage Testing Works

USP <711> defines a progressive three-stage acceptance table for single-point dissolution testing (Acceptance Table 1). Testing proceeds to the next stage only if the previous stage fails, using additional units each time.

Stage	Units Tested (Cumulative)	Acceptance Criteria
S1	6	Each unit ≥ Q + 5%
S2	12 (6 + 6 more)	Average of 12 ≥ Q, and no unit < Q − 15%
S3	24 (12 + 12 more)	Average of 24 ≥ Q; no more than 2 units < Q − 15%; no unit < Q − 25%

Q is the amount of dissolved active ingredient specified in the individual product monograph, expressed as a percentage of the labeled content.

Interactive Calculator

Q Value (%)

Stage 1 (S1) — 6 Units

Individual Unit Results (% dissolved) 85, 88, 82, 90, 84, 87

Comma or newline separated, 6 values

Enter Stage 1 data

Stage 2 (S2) — 6 Additional Units (only if S1 fails)

Additional Unit Results (% dissolved) 79, 83, 81, 86, 80, 84

Enter Stage 1 data first

Stage 3 (S3) — 12 Additional Units (only if S2 fails)

Additional Unit Results (% dissolved) 78, 82, 80, 85, 79, 83, 77, 81, 84, 80, 79, 82

Enter Stage 2 data first

This calculator applies USP <711> Acceptance Table 1 logic for educational and preliminary assessment purposes. Confirm the correct Q value from the applicable product monograph, and follow your approved laboratory procedure for formal batch disposition — this tool does not replace validated LIMS or manual calculation review.

Physical Testing — USP <1216>

Tablet Friability Calculator

Calculate percent friability loss from a friabilator test and compare against the standard acceptance criterion.

What Friability Testing Measures

Friability testing assesses a tablet's resistance to chipping, abrasion, and breakage during handling, packaging, and shipping, by tumbling a sample in a rotating friabilator drum for a defined number of revolutions and comparing weight before and after.

% Friability = [(Initial Weight − Final Weight) / Initial Weight] × 100

Standard Test Conditions and Acceptance

Parameter	Typical Requirement
Sample size	Whole tablets corresponding to ~6.5 g, or 10 tablets if unit weight exceeds 0.65 g
Drum speed	25 rpm
Duration	100 revolutions (4 minutes)
Acceptance criterion	Maximum mean weight loss of 1.0% is generally considered acceptable
Chipped/cracked/broken tablets	Not acceptable regardless of overall % loss

Interactive Calculator

Initial Sample Weight (g)

Final Sample Weight (g)

% Friability

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This calculator applies the standard USP <1216> friability formula for educational and preliminary assessment purposes. Always visually inspect tablets for capping, chipping, or cracking after testing — any such defect typically fails the test regardless of the calculated percentage — and confirm your product-specific acceptance criterion and test conditions.

Cleaning Validation — Recovery Study

Swab Recovery Calculator

Calculate percent recovery from a swab recovery study and use it to adjust your cleaning validation acceptance limit for real-world sampling efficiency.

Why Recovery Studies Matter

Swabbing rarely recovers 100% of the residue actually present on a surface — some is left behind due to surface texture, swab material, or technique. A recovery study spikes a known amount of analyte onto coupons of the actual (or representative) surface material, swabs them using the routine method, and measures how much is recovered.

% Recovery = (Amount Recovered / Amount Spiked) × 100 Recovery-Adjusted Limit = Original Swab Limit / (% Recovery / 100)

Typical Acceptance

Recovery Range	Interpretation
≥ 70%	Generally good recovery; adjustment optional depending on site procedure
50% – 70%	Acceptable in many programs, but requires recovery correction factor applied to the limit
< 50%	Often considered inadequate — review swab material, technique, or surface/analyte combination

Regardless of the exact site-specific threshold, most cleaning validation programs apply a recovery-adjusted (tighter) acceptance limit whenever recovery is below 100%, to ensure the true residue level cannot exceed the actual MACO-derived limit.

Interactive Calculator

Surface / Coupon	Amount Spiked (µg)	Amount Recovered (µg)	% Recovery

Mean % Recovery

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Min % Recovery

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Max % Recovery

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Original Swab Limit (µg/swab)

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This tool illustrates the recovery calculation and limit adjustment concept for educational purposes. Formal recovery studies should follow a validated protocol across multiple spike levels, surface materials, and analysts, per your site's cleaning validation program.