Table 3.
Samples | S1 ±SD | BP Vol 5, 2017 Limit for S1 in % |
S2: An average of 12 units (S1+S2) ± SD | BP Vol 5, 2017 Limit for S2 in % |
---|---|---|---|---|
P001 | 98.65 ± 3.55 | NLT 80 | ||
P002 | 97.72 ± 2.28 | NLT 80 | ||
P003 | 97.03 ± 1.68 | NLT 80 | ||
P004 | 102.34 ± 1.63 | NLT 80 | ||
P005 | 102.06 ± 4.38 | NLT 80 | ||
P006 | 82.95 ± 1.23 | NLT 80 | ||
P007 | 94.80 ± 3.57 | NLT 80 | ||
P008 | 91.31 ± 2.02 | NLT 80 | ||
P009 | 86.80 ± 3.75 | NLT 80 | ||
P010 | 85.18 ± 0.84 | NLT 80 | ||
P011 | 96.20 ± 1.05 | NLT 80 | ||
P012 | 19.22 ± 0.85 | NLT 80 | 21.22 ± 5.76 | Average of 12 units ≥ 75, and each unit NLT 60 |
P013 | 95.45 ± 3.26 | NLT 80 | ||
P014 | 65.97 ± 1.43 | NLT 80 | 62.77 ± 9.53 | Average of 12 units ≥ 75, and each unit NLT 60 |
P015 | 98.09 ± 0.94 | NLT 80 |
Value 1: S1 (Average percentage drug released in %); Value 2: S2 (Average percentage drug released in % done when sample fails stage 1). NLT: Not less than.