Content Uniformity Spreadsheet

Sample # Unit Value

1 102.0
2 101.5
3 103.0
4 100.5
5 101.1
6 104.0
7 105.0
8 102.0
9 101.0
10 102.5
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Average 102.3
St Dev 1.4
%RSD 1.4
Min 100.5
Max 105.0
Count 10
Acceptability Constant 2.4

Reference Value, M 101.5

Acceptance Value, AV 4.1
Delta from M for Min (% of LC) 1.0
Delta from M for Max (% of LC) 3.5
All values within 15% of M? Pass
All values within 25% of M? Pass
Acceptance Value < 15%? Pass

Target 100.0
Calculations performed as defined in USP <905>

Uniformity of Dosage Units meets all acceptance criteria