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)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.23206700
206700+0
206485
206485+0
206408
206408+0
206331
206331+0
206156
206156+0
2064160.10
219.28206402
206402+0
206913
206913+0
2066580.18
单位质量响应值RSD%判断
10734.0610718.780.11数据可信
中间条件12月-供试品溶液-2023082121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%
5min185906.4
80540+6708*0.8
-85906.441.96743.463.1541.9743.463.14
288011.6
80946+8832*0.8
-88011.642.99643.00
391581.6
85732+7312*0.8
-91581.644.74044.74
491335.8
84259+8846*0.8
-91335.844.62044.62
585665
78857+8510*0.8
-8566541.84941.85
691284.8
84304+8726*0.8
-91284.844.59544.59
10min1142307
133351+11195*0.8
-14230769.52168.911.0269.9969.401.02
2141808.2
131337+13089*0.8
-141808.269.27769.75
3142495
133067+11785*0.8
-14249569.61270.11
4140793.6
130272+13152*0.8
-140793.668.78169.28
5138728
128388+12925*0.8
-13872867.77268.24
6140263.6
130110+12692*0.8
-140263.668.52269.02
15min1165237.6
153688+14437*0.8
-165237.680.72381.131.0181.9682.381.02
2166927.8
153675+16566*0.8
-166927.881.54882.80
3168244
155920+15405*0.8
-16824482.19183.46
4167188.4
153982+16508*0.8
-167188.481.67682.94
5163627.4
150677+16188*0.8
-163627.479.93681.15
6165236.4
152182+16318*0.8
-165236.480.72281.98
20min1179247.8
164987+17826*0.8
-179247.887.56786.791.1189.7088.941.11
2176916.8
161208+19636*0.8
-176916.886.42888.58
3180734.4
165988+18433*0.8
-180734.488.29390.48
4176199.6
160626+19467*0.8
-176199.686.07888.25
5175499.2
160120+19224*0.8
-175499.285.73687.84
6177349.8
161953+19246*0.8
-177349.886.64088.79
30min1183904.2
161109+28494*0.8
-183904.289.84290.271.2692.9593.381.23
2181781.4
158199+29478*0.8
-181781.488.80591.92
3184635.6
161930+28382*0.8
-184635.690.19993.36
4186665.6
162708+29947*0.8
-186665.691.19194.31
5183439.8
160051+29236*0.8
-183439.889.61592.67
6188235.6
164402+29792*0.8
-188235.691.95895.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1182752.2
147913+43549*0.8
-182752.289.27989.660.7493.3993.780.69
2182746.2
146699+45059*0.8
-182746.289.27693.38
3182607.8
147851+43446*0.8
-182607.889.20893.38
4185227
149199+45035*0.8
-18522790.48894.63
5185325
149509+44770*0.8
-18532590.53694.59
6182550.2
147495+43819*0.8
-182550.289.18093.32
60min1185575.6
143654+52402*0.8
-185575.690.65888.931.8695.7694.051.74
2182289
139521+53460*0.8
-18228989.05394.15
3177220.2
136809+50514*0.8
-177220.286.57691.73
4183253
140741+53140*0.8
-18325389.52494.67
5185125.2
142598+53159*0.8
-185125.290.43895.50
6178809.8
137577+51541*0.8
-178809.887.35392.48
极限1185784.6
140811+56217*0.8
-185784.690.76089.321.0296.8795.420.95
2181512.2
135557+57444*0.8
-181512.288.67394.76
3180359.4
135125+56543*0.8
-180359.488.11094.23
4183527.8
137479+57561*0.8
-183527.889.65895.80
5182986.4
137052+57418*0.8
-182986.489.39395.46
6182850.6
137009+57302*0.8
-182850.689.32795.43
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)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.23206240
206240+0
205534
205534+0
205866
205866+0
205996
205996+0
206159
206159+0
2059590.14
219.28208034
208034+0
208874
208874+0
2084540.29
单位质量响应值RSD%判断
10710.3010811.930.67数据可信
中间条件12月-供试品溶液-2023082221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min188901.2
81582+9149*0.8
-88901.243.29141.375.2743.2941.375.27
284621.6
77600+8777*0.8
-84621.641.20741.21
387521.2
80322+8999*0.8
-87521.242.61942.62
487973.2
80410+9454*0.8
-87973.242.83942.84
583956.6
76943+8767*0.8
-83956.640.88440.88
676730
69970+8450*0.8
-7673037.36437.36
10min1142725
131325+14250*0.8
-14272569.50169.232.1469.9869.682.15
2138751.8
127835+13646*0.8
-138751.867.56768.02
3143234
131770+14330*0.8
-14323469.74970.22
4146998.2
135255+14679*0.8
-146998.271.58272.06
5142191.8
130767+14281*0.8
-142191.869.24269.70
6139051.4
127837+14018*0.8
-139051.467.71368.13
15min1167791.8
153531+17826*0.8
-167791.881.70882.352.2582.9683.582.24
2169784.6
155043+18427*0.8
-169784.682.67883.89
3166872.4
152570+17878*0.8
-166872.481.26082.51
4176260.6
161059+19002*0.8
-176260.685.83287.10
5165405.2
151454+17439*0.8
-165405.280.54681.77
6168555
154043+18140*0.8
-16855582.08083.25
20min1176785.4
160159+20783*0.8
-176785.486.08788.061.6988.2590.211.68
2180665.4
163723+21178*0.8
-180665.487.97790.10
3179568
162448+21400*0.8
-17956887.44389.59
4185712.4
168266+21808*0.8
-185712.490.43592.66
5182672.6
165499+21467*0.8
-182672.688.95491.07
6179666.4
162856+21013*0.8
-179666.487.49089.57
30min1178119.2
151752+32959*0.8
-178119.286.73789.422.4789.8592.542.41
2178946.2
152195+33439*0.8
-178946.287.14090.24
3182391.8
155191+34001*0.8
-182391.888.81891.94
4189300.4
161050+35313*0.8
-189300.492.18295.41
5186304.8
158712+34491*0.8
-186304.890.72393.83
6186735.4
159093+34553*0.8
-186735.490.93393.98
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1186133.2
151418+43394*0.8
-186133.290.64090.291.3194.7294.401.29
2182564.6
148151+43017*0.8
-182564.688.90292.97
3182604.6
148199+43007*0.8
-182604.688.92193.03
4187838.2
152455+44229*0.8
-187838.291.47095.72
5185310.4
150604+43383*0.8
-185310.490.23994.35
6188066.6
153117+43687*0.8
-188066.691.58195.64
60min1178438.6
138469+49962*0.8
-178438.686.89388.611.8191.9893.731.77
2179339.6
138982+50447*0.8
-179339.687.33192.39
3179659.8
139051+50761*0.8
-179659.887.48792.59
4186168.4
144014+52693*0.8
-186168.490.65795.93
5183028.8
142020+51261*0.8
-183028.889.12894.25
6185193.2
144002+51489*0.8
-185193.290.18295.26
极限1174658
129546+56390*0.8
-17465885.05286.841.7691.1192.951.70
2179625.8
133837+57236*0.8
-179625.887.47193.50
3174476.8
129664+56016*0.8
-174476.884.96391.03
4181877.8
135217+58326*0.8
-181877.888.56794.85
5178508.8
132816+57116*0.8
-178508.886.92793.03
6180872.4
134830+57553*0.8
-180872.488.07894.16
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)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.23204895
204895+0
207525
207525+0
207175
207175+0
206854
206854+0
206861
206861+0
2066620.50
219.28211403
211403+0
211731
211731+0
2115670.11
单位质量响应值RSD%判断
10746.8510973.391.48数据可信
中间条件12月-供试品溶液-2023082221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186314.8
78982+9166*0.8
-86314.841.65240.213.1241.6540.213.11
283126.2
76059+8834*0.8
-83126.240.11440.11
380130.8
73654+8096*0.8
-80130.838.66838.67
482273.6
75568+8382*0.8
-82273.639.70239.70
581599.2
74916+8354*0.8
-81599.239.37739.38
686537.4
79691+8558*0.8
-86537.441.76041.76
10min1144017.8
133093+13656*0.8
-144017.869.49868.591.4769.9669.031.46
2144289.2
132894+14244*0.8
-144289.269.62970.07
3141809
130617+13990*0.8
-14180968.43268.86
4143160.6
132119+13802*0.8
-143160.669.08469.53
5140434.2
129547+13609*0.8
-140434.267.76868.21
6139053
128737+12895*0.8
-13905367.10267.57
15min1170824.8
156336+18111*0.8
-170824.882.43480.741.4783.6781.951.46
2167538.6
153493+17557*0.8
-167538.680.84882.07
3168250
154134+17645*0.8
-16825081.19182.38
4168269
154205+17580*0.8
-16826981.20082.41
5164610.2
151183+16784*0.8
-164610.279.43580.63
6164404.2
150905+16874*0.8
-164404.279.33580.54
20min1181175.6
164442+20917*0.8
-181175.687.42986.581.4389.5888.681.41
2180979.8
164127+21066*0.8
-180979.887.33489.45
3181479.4
165029+20563*0.8
-181479.487.57589.67
4180469.6
164028+20552*0.8
-180469.687.08889.20
5176739.4
160753+19983*0.8
-176739.485.28887.36
6175618.8
159798+19776*0.8
-175618.884.74786.84
30min1183280.6
156227+33817*0.8
-183280.688.44488.751.4791.5791.821.42
2183848
157092+33445*0.8
-18384888.71891.81
3188731.8
161595+33921*0.8
-188731.891.07594.14
4182703.6
156214+33112*0.8
-182703.688.16691.24
5184327.2
158072+32819*0.8
-184327.288.94991.97
6180592
154836+32195*0.8
-18059287.14790.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1184969.8
150421+43186*0.8
-184969.889.26088.691.1093.3692.741.08
2184099.4
149789+42888*0.8
-184099.488.83992.91
3186732
152460+42840*0.8
-18673290.11094.19
4181909.4
148583+41658*0.8
-181909.487.78391.84
5183803.8
150499+41631*0.8
-183803.888.69792.71
6181216.4
148218+41248*0.8
-181216.487.44891.45
60min1180284.6
136763+54402*0.8
-180284.686.99986.621.3492.1091.661.30
2181150.6
137537+54517*0.8
-181150.687.41792.48
3182929.4
139583+54183*0.8
-182929.488.27593.35
4176751.6
134870+52352*0.8
-176751.685.29490.33
5177271.8
135435+52296*0.8
-177271.885.54590.54
6178562.6
136861+52127*0.8
-178562.686.16891.14
极限1178925.4
131299+59533*0.8
-178925.486.34386.171.2392.4192.171.20
2177282.2
130015+59084*0.8
-177282.285.55091.58
3182655
134263+60490*0.8
-18265588.14294.20
4178505.6
131908+58247*0.8
-178505.686.14092.12
5177528.8
131336+57741*0.8
-177528.885.66991.61
6176458.8
130866+56991*0.8
-176458.885.15291.08
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