SPDS SET 2: ASH-01
Table-62: ERH-46: Weight of sample: 4071mg - 100ml with methanol Actual quantity in the weight taken Marker Actual
Weight of sample (mg)
Quanti ty added (mg) 0.164
Total Quantity (mg)
Calculated Values (%w/w)
Observed Value (%w/w)
Recovery (%w/w)
content (% w/w)
Purity
100 ml
1 ml
0.155
6.3
0.063
90
0.211
0.506
0.515
101.82
W-IV
0.151
6.1
0.061
0.056
90
0.112
0.268
0.272
101.21
W-V
WF-A
0.130
5.3
0.053
0.230
99
0.281
0.674
0.678
100.71
4071
12-D
0.037
1.5
0.015
0.190
95
0.196
0.469
0.477
101.64
W –A
0.039
1.6
0.016
0.160
99
0.174
0.418
0.416
99.57
W –B
0.010
0.4
0.004
0.156
99
0.159
0.380
0.283
74.31
4.5.6) Conclusion:
Table-63:
12-Deoxy withastramonolide
Withanolide A
Withanolide B
Batch No.
Withanoside IV
Withanoside V
Withaferin A
WS/06Lot08
100.6
99.8
99.9
100.9
97.3
75.0
WS/06Lot10
94.6
97.4
95.9
93.4
97.2
99.3
WS/05Lot20
101.5
100.1
99.6
101.0
98.4
73.7
WS/05Lot21
96.5
96.5
99.2
93.7
93.7
106.5
RD/1170
95.9
95.8
97.3
97.2
96.4
98.1
RD/1045
99.8
100.3
100.3
101.4
96.3
74.9
RD/1162 RM
99.0
95.3
98.8
91.2
94.5
97.5
ERH-46 RM
101.8
101.2
100.7
101.6
99.6
74.3
Spike recovery of Total withanolides is within the acceptance criteria indicating the method is
accurate.
Enclosure-11: Sample chromatograms (8 Pages).
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3DJH RI
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