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%
119.23203027
203027+0		203424
203424+0		203445
203445+0		203457
203457+0		203303
203303+0		2033310.09
219.28206404
206404+0		205891
205891+0		2061480.18
单位质量响应值RSD%判断
10573.6310692.320.79数据可信
长期12月-供试品溶液-12355772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%
5min175206.8
70418+5986*0.8		-75206.837.06435.534.6537.0635.524.65
267922.2
63399+5654*0.8		-67922.233.47433.47
374831.4
69817+6268*0.8		-74831.436.87936.88
470982.8
66426+5696*0.8		-70982.834.98334.98
568620.4
64122+5623*0.8		-68620.433.81833.82
674939.6
70374+5707*0.8		-74939.636.93336.93
10min1135953.2
127106+11059*0.8		-135953.267.00265.931.6767.4166.321.65
2134790.2
125923+11084*0.8		-134790.266.42966.80
3130950.2
122079+11089*0.8		-130950.264.53764.95
4131212.6
122647+10707*0.8		-131212.664.66665.05
5135883.4
126965+11148*0.8		-135883.466.96867.34
6133855.2
125408+10559*0.8		-133855.265.96866.38
15min1166120
154116+15005*0.8		-16612081.86980.341.5183.0381.461.50
2164731
152651+15100*0.8		-16473181.18582.29
3162442.4
150248+15243*0.8		-162442.480.05781.18
4159228.6
147651+14472*0.8		-159228.678.47379.58
5163917.6
152084+14792*0.8		-163917.680.78481.90
6161626.8
149982+14556*0.8		-161626.879.65580.80
20min1178966.4
164340+18283*0.8		-178966.488.20187.491.6090.2789.521.56
2180337
165501+18545*0.8		-18033788.87690.89
3173225.6
158808+18022*0.8		-173225.685.37187.39
4178338.6
163885+18067*0.8		-178338.687.89189.87
5179448.6
164851+18247*0.8		-179448.688.43890.46
6174860.4
160682+17723*0.8		-174860.486.17788.21
30min1186090.4
159824+32833*0.8		-186090.491.71191.020.9694.7694.020.96
2184537.4
158587+32438*0.8		-184537.490.94693.95
3183500.8
157392+32636*0.8		-183500.890.43593.40
4182092.2
156773+31649*0.8		-182092.289.74192.70
5187002.4
161172+32288*0.8		-187002.492.16195.16
6184942
159482+31825*0.8		-18494291.14694.13
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1185983.6
152554+41787*0.8		-185983.691.65991.831.3195.7295.831.28
2189273.4
153159+45143*0.8		-189273.493.28097.29
3182982.2
149547+41794*0.8		-182982.290.18094.15
4184955.6
152014+41177*0.8		-184955.691.15295.11
5189068.6
155395+42092*0.8		-189068.693.17997.20
6185712.8
152872+41051*0.8		-185712.891.52595.52
60min1182833.8
143129+49631*0.8		-182833.890.10790.611.4695.1995.631.41
2184239.4
144133+50133*0.8		-184239.490.79995.85
3184213.2
143870+50429*0.8		-184213.290.78695.76
4180648.8
141876+48466*0.8		-180648.889.03094.00
5188596.6
148039+50697*0.8		-188596.692.94798.01
6182566.2
143035+49414*0.8		-182566.289.97594.99
极限1177984
134276+54635*0.8		-17798487.71689.002.1393.8095.032.02
2181918
137258+55825*0.8		-18191889.65595.71
3178190.4
134400+54738*0.8		-178190.487.81893.80
4179944.4
136110+54793*0.8		-179944.488.68394.64
5187734.2
142147+56984*0.8		-187734.292.52298.61
6177798.4
134120+54598*0.8		-177798.487.62593.64
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%
119.23204439
204439+0		204878
204878+0		204604
204604+0		204489
204489+0		204368
204368+0		2045560.10
219.28204659
204659+0		204683
204683+0		2046710.01
单位质量响应值RSD%判断
10637.3410615.720.15数据可信
长期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%
5min186107.4
80521+6983*0.8		-86107.442.46150.447.7842.4650.447.78
2106510.4
99700+8513*0.8		-106510.452.52252.52
3104920.2
98281+8299*0.8		-104920.251.73851.74
4105587.2
98976+8264*0.8		-105587.252.06752.07
5105856.4
99142+8393*0.8		-105856.452.20052.20
6104721.2
98094+8284*0.8		-104721.251.64051.64
10min1148693.6
138964+12162*0.8		-148693.673.32377.492.7573.8078.052.79
2157980
147452+13160*0.8		-15798077.90378.49
3158983.4
148273+13388*0.8		-158983.478.39778.97
4160856.8
150284+13216*0.8		-160856.879.32179.90
5159158
148662+13120*0.8		-15915878.48479.06
6157185
146893+12865*0.8		-15718577.51178.08
15min1174099.6
161438+15827*0.8		-174099.685.85287.881.5287.1489.301.56
2178598.4
165112+16858*0.8		-178598.488.07089.52
3179505
165857+17060*0.8		-17950588.51789.96
4181511.8
168059+16816*0.8		-181511.889.50790.97
5179598.4
165904+17118*0.8		-179598.488.56390.02
6175984.4
162950+16293*0.8		-175984.486.78188.22
20min1183193
167417+19720*0.8		-18319390.33691.220.7992.5893.620.83
2184028.2
167617+20514*0.8		-184028.290.74893.18
3185894
169126+20960*0.8		-18589491.66894.10
4185845
169533+20390*0.8		-18584591.64394.10
5186933.6
170396+20672*0.8		-186933.692.18094.62
6183995.4
167773+20278*0.8		-183995.490.73193.13
30min1180387.4
154293+32618*0.8		-180387.488.95289.781.7292.2093.201.69
2184344.8
156980+34206*0.8		-184344.890.90494.34
3177824.2
151393+33039*0.8		-177824.287.68891.14
4182883.4
156197+33358*0.8		-182883.490.18393.66
5186488.8
159352+33921*0.8		-186488.891.96195.42
6180491.8
154403+32611*0.8		-180491.889.00492.41
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1182818
149694+41405*0.8		-18281890.15190.121.3694.3894.521.33
2183083.4
148725+42948*0.8		-183083.490.28294.73
3182510.6
148277+42792*0.8		-182510.689.99994.42
4184459.4
150297+42703*0.8		-184459.490.96095.43
5185404.2
151085+42899*0.8		-185404.291.42695.91
6178210.2
145375+41044*0.8		-178210.287.87992.27
60min1177501.8
134521+53726*0.8		-177501.887.52987.990.7892.7693.400.81
2177438.6
133801+54547*0.8		-177438.687.49892.95
3178751.8
134807+54931*0.8		-178751.888.14693.57
4179733.4
136195+54423*0.8		-179733.488.63094.12
5180281.6
136612+54587*0.8		-180281.688.90094.40
6176865.4
134155+53388*0.8		-176865.487.21592.59
极限1178747
131975+58465*0.8		-17874788.14388.551.2594.3594.941.20
2178704.8
131044+59576*0.8		-178704.888.12294.54
3176064.6
128815+59062*0.8		-176064.686.82193.22
4182241.6
134412+59787*0.8		-182241.689.86696.34
5180214.8
132758+59321*0.8		-180214.888.86795.35
6181479.2
133900+59474*0.8		-181479.289.49195.83
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