USP Content Uniformity Calculator

USP <905> Acceptance Value Calculator

Calculate the Acceptance Value (AV) for Uniformity of Dosage Units according to USP <905>.

Common Parameters

Standard Potency (%) Conc. of Standard (mg/mL) Conc. of Sample (mg/mL)

Replicate Standard Values

Replicate	Standard Value	Action
1
2

L1 Stage – Dosage Unit Sample Values (10 Units)

Unit	Sample Value (% LC)	Individual Result (% LC)
1		-
2		-
3		-
4		-
5		-
6		-
7		-
8		-
9		-
10		-

L1 stage must have exactly 10 units.

L2 Stage – Additional Dosage Unit Sample Values (20 Units)

Unit (Additional)	Sample Value (% LC)	Individual Result (% LC)
1		-
2		-
3		-
4		-
5		-
6		-
7		-
8		-
9		-
10		-
11		-
12		-
13		-
14		-
15		-
16		-
17		-
18		-
19		-
20		-

L2 additional table must have exactly 20 rows. (Overall, L2 stage uses 10 from L1 + these 20 = 30 units.)

Calculation Case

Select Case:

Overall Results

L1 Stage (10 Units)

Total Units:

Mean Individual Result: %

Standard Deviation (s):

Reference Value (M): %

Acceptance Value (AV):

L2 Stage (30 Units: 10 from L1 + 20 Additional)

Total Units:

Mean Individual Result: %

Standard Deviation (s):

Reference Value (M): %

Acceptance Value (AV):

Calculation Details:

Individual Result (% LC) = (Sample Value ÷ Average(Standard Replicates)) × (Conc. of Standard ÷ Conc. of Sample) × Standard Potency

AV = |M – Mean| + k × s
For Case 1 (T ≤ 101.5):
• If 98.5% ≤ Mean ≤ 101.5%, then M = Mean (AV = k × s)
• If Mean < 98.5%, then M = 98.5 (AV = (98.5 – Mean) + k × s)
• If Mean > 101.5%, then M = 101.5 (AV = (Mean – 101.5) + k × s)

For Case 2 (T > 101.5):
• If 98.5% ≤ Mean ≤ T, then M = Mean (AV = k × s)
• If Mean < 98.5%, then M = 98.5 (AV = (98.5 – Mean) + k × s)
• If Mean > T, then M = T (AV = (Mean – T) + k × s)

USP <905> requires AV ≤ 15.0 for L1 and AV ≤ 25.0 for L2.
Note: k = 2.4 for a 10-unit test (L1) and k = 2.0 for a 30-unit test (L2).
Additionally, for L2, each dosage unit result must lie between [1 – (0.01×L2)]M and [1 + (0.01×L2)]M. With L2 = 25.0, this is [0.75×M, 1.25×M].