美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.07203568
203568+0		203841
203841+0		203866
203866+0		204488
204488+0		204157
204157+0		2039840.18
219.07203597
203597+0		203555
203555+0		2035760.02
单位质量响应值RSD%判断
10696.5910675.200.15数据可信
供试品溶液-12460835批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min176701.8
73437+4081*0.8		-76701.837.61339.897.8837.6139.897.88
289460.8
85516+4931*0.8		-89460.843.87043.87
380068.2
76805+4079*0.8		-80068.239.26439.26
472207
69123+3855*0.8		-7220735.40935.41
586872.8
83172+4626*0.8		-86872.842.60042.60
682741.6
79244+4372*0.8		-82741.640.57540.57
10min1142499.4
135589+8638*0.8		-142499.469.87969.001.5470.3069.441.51
2139120.2
132513+8259*0.8		-139120.268.22168.71
3138448.4
131862+8233*0.8		-138448.467.89268.33
4141418.4
134660+8448*0.8		-141418.469.34869.74
5138979
132419+8200*0.8		-13897968.15268.63
6143726.2
136887+8549*0.8		-143726.270.48070.93
15min1168612.2
158917+12119*0.8		-168612.282.68482.961.3183.8884.171.28
2167531.4
158137+11743*0.8		-167531.482.15483.40
3168505.6
158928+11972*0.8		-168505.682.63183.82
4171269.8
161629+12051*0.8		-171269.883.98785.15
5166709.4
157259+11813*0.8		-166709.481.75182.98
6172392.8
162236+12696*0.8		-172392.884.53885.77
20min1179222.2
164503+18399*0.8		-179222.287.88787.460.7290.0089.600.71
2177792.4
163106+18358*0.8		-177792.487.18589.34
3177294.4
162568+18408*0.8		-177294.486.94189.05
4176841.4
162483+17948*0.8		-176841.486.71988.82
5180187.8
165635+18191*0.8		-180187.888.36090.50
6178834.2
164203+18289*0.8		-178834.287.69689.87
30min1186421.8
166485+24921*0.8		-186421.891.41792.740.8094.5195.840.78
2188956.4
168542+25518*0.8		-188956.492.66095.79
3189313
168933+25475*0.8		-18931392.83595.91
4190551
169871+25850*0.8		-19055193.44296.50
5188935
168491+25555*0.8		-18893592.65095.77
6190530.4
169984+25683*0.8		-190530.493.43296.58
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1189421.6
158340+38852*0.8		-189421.692.88892.320.8096.9996.450.77
2189991.4
158781+39013*0.8		-189991.493.16897.32
3188590.4
157564+38783*0.8		-188590.492.48196.59
4185847.6
155382+38082*0.8		-185847.691.13695.23
5188434
157286+38935*0.8		-18843492.40496.55
6187265.4
156831+38043*0.8		-187265.491.83196.02
60min1187176.8
148428+48436*0.8		-187176.891.78791.380.3496.9296.540.31
2185782
147026+48445*0.8		-18578291.10396.30
3185551.6
146602+48687*0.8		-185551.690.99096.12
4186489.8
147889+48251*0.8		-186489.891.45096.56
5186835.6
148246+48237*0.8		-186835.691.62096.80
6186193.2
147474+48399*0.8		-186193.291.30596.51
极限1185155.2
141248+54884*0.8		-185155.290.79690.310.6396.9596.480.61
2185096.8
141948+53936*0.8		-185096.890.76796.97
3182291.2
139480+53514*0.8		-182291.289.39295.54
4183729.6
140032+54622*0.8		-183729.690.09796.22
5185062.6
142013+53812*0.8		-185062.690.75196.95
6183634.2
140659+53719*0.8		-183634.290.05096.27
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.07203385
203385+0		203618
203618+0		203261
203261+0		203574
203574+0		203007
203007+0		2033690.13
219.07201159
201159+0		201648
201648+0		2014040.18
单位质量响应值RSD%判断
10664.3410561.300.69数据可信
供试品溶液-12460835批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min180969
77661+4135*0.8		-8096939.98039.828.4539.9839.828.45
269274.2
66447+3534*0.8		-69274.234.20534.21
377858.4
74568+4113*0.8		-77858.438.44438.44
486858.8
83150+4636*0.8		-86858.842.88842.89
588133.6
84352+4727*0.8		-88133.643.51743.52
680719.4
77401+4148*0.8		-80719.439.85639.86
10min1142840.4
135866+8718*0.8		-142840.470.53069.011.4770.9769.461.48
2138088.8
131576+8141*0.8		-138088.868.18368.56
3139719
133111+8260*0.8		-13971968.98869.42
4138842.6
132169+8342*0.8		-138842.668.55669.03
5141523.2
134676+8559*0.8		-141523.269.87970.36
6137608.2
130977+8289*0.8		-137608.267.94668.39
15min1165332.6
156027+11632*0.8		-165332.681.63680.982.1382.8682.182.14
2157938.4
149020+11148*0.8		-157938.477.98579.12
3166811.8
157327+11856*0.8		-166811.882.36683.56
4166309
156753+11945*0.8		-16630982.11883.36
5165876
156368+11885*0.8		-16587681.90483.16
6161700.2
152365+11669*0.8		-161700.279.84281.04
20min1175301.8
160813+18111*0.8		-175301.886.55887.381.5088.6989.481.43
2180710.6
165865+18557*0.8		-180710.689.22991.23
3178978.8
164270+18386*0.8		-178978.888.37490.48
4176360.8
161660+18376*0.8		-176360.887.08189.23
5177142.2
162663+18099*0.8		-177142.287.46789.64
6173280.2
159217+17579*0.8		-173280.285.56087.64
30min1193265.2
172322+26179*0.8		-193265.295.42893.901.1698.5296.981.15
2189859.8
169435+25531*0.8		-189859.893.74696.74
3190180.2
169621+25699*0.8		-190180.293.90497.00
4188777.2
168098+25849*0.8		-188777.293.21296.33
5191856
171060+25995*0.8		-19185694.73297.87
6187065
166817+25310*0.8		-18706592.36695.40
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1188906.6
157537+39212*0.8		-188906.693.27692.901.7997.4397.021.74
2188981.4
158111+38588*0.8		-188981.493.31297.35
3184556.4
154054+38128*0.8		-184556.491.12895.26
4192275.2
160624+39564*0.8		-192275.294.93999.09
5190458.6
159377+38852*0.8		-190458.694.04298.24
6183715.8
153903+37266*0.8		-183715.890.71294.77
60min1188672.6
149571+48877*0.8		-188672.693.16092.411.6198.3597.561.54
2191336
151636+49625*0.8		-19133694.47599.55
3183378
145366+47515*0.8		-18337890.54695.69
4187343.4
148349+48743*0.8		-187343.492.50497.71
5188227.2
148300+49909*0.8		-188227.292.94098.18
6183977
145949+47535*0.8		-18397790.84195.91
极限1183348
138844+55630*0.8		-18334890.53192.211.4896.7698.391.38
2190307.8
146019+55361*0.8		-190307.893.967100.09
3184648.4
141362+54108*0.8		-184648.491.17397.33
4185952.4
142622+54163*0.8		-185952.491.81798.05
5189671.2
145180+55614*0.8		-189671.293.65399.93
6186576
143360+54020*0.8		-18657692.12598.20
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