磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.853027503026273025633023773028933026420.07
29.843028353028223028280.01
单位质量响应值RSD%判断
30725.0830775.200.12数据可信
供试品溶液-2024051421批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1347528-347528102.92497.983.35102.9297.983.35
2328816-32881697.38397.38
3332057-33205798.34298.34
4330484-33048497.87797.88
5312916-31291692.67492.67
6333141-33314198.66398.66
10min1352026-352026104.256102.461.42104.83103.011.42
2344490-344490102.025102.57
3352043-352043104.262104.81
4340749-340749100.917101.46
5342420-342420101.412101.93
6344097-344097101.908102.46
15min1353728-353728104.761101.931.92105.91103.041.92
2340522-340522100.849101.96
3351428-351428104.079105.20
4340344-340344100.797101.90
5338550-338550100.265101.34
6340518-340518100.848101.96
20min1350471-350471103.796101.441.99105.53103.121.99
2338418-338418100.226101.89
3351474-351474104.093105.80
4335644-33564499.405101.07
5337884-337884100.068101.70
6341156-341156101.037102.71
极限1349088-349088103.386100.952.07105.70103.202.05
2346705-346705102.681104.91
3342699-342699101.494103.78
4333134-33313498.661100.88
5341747-341747101.212103.40
6331840-33184098.278100.51
磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.853023033025383023403023703020373023180.06
29.843025393023783024580.04
单位质量响应值RSD%判断
30692.1830737.600.11数据可信
供试品溶液-2024051421批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1331128-33112898.18098.553.8598.1898.553.85
2342479-342479101.545101.55
3343002-343002101.700101.70
4337346-337346100.023100.02
5308386-30838691.43791.44
6331853-33185398.39598.39
10min1339606-339606100.694101.261.11101.24101.811.11
2341209-341209101.169101.73
3348918-348918103.455104.02
4339166-339166100.563101.12
5341320-341320101.202101.71
6338917-338917100.489101.04
15min1343483-343483101.843101.421.29102.95102.531.28
2337229-33722999.989101.11
3349959-349959103.763104.90
4340477-340477100.952102.07
5339699-339699100.721101.79
6341452-341452101.241102.35
20min1338056-338056100.234100.790.86101.90102.460.87
2338556-338556100.382102.06
3344457-344457102.132103.85
4342145-342145101.446103.12
5336617-33661799.807101.44
6339734-339734100.732102.40
极限1334473-33447399.17299.691.44101.40101.921.43
2334025-33402599.039101.28
3345804-345804102.531104.81
4334945-33494599.312101.55
5335701-33570199.536101.72
6332399-33239998.557100.78
磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.853025853024433024633023853022953024340.04
29.843026163021403023780.12
单位质量响应值RSD%判断
30703.9630729.470.06数据可信
供试品溶液-2024051621批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1335610-33561099.50399.332.4499.5099.332.44
2336155-33615599.66499.66
3344253-344253102.065102.07
4319708-31970894.78894.79
5336210-33621099.68199.68
6338191-338191100.268100.27
10min1341618-341618101.284101.381.57101.84101.931.57
2336170-33617099.669100.22
3350171-350171103.820104.39
4341091-341091101.128101.65
5336741-33674199.838100.39
6345831-345831102.533103.09
15min1340559-340559100.970100.451.95102.09101.571.94
2336760-33676099.844100.95
3349845-349845103.723104.87
4329801-32980197.78198.87
5339507-339507100.658101.77
6336393-33639399.735100.86
20min1342778-342778101.628100.112.83103.30101.792.81
2331874-33187498.395100.06
3348525-348525103.332105.05
4328597-32859797.42499.06
5327216-32721697.01498.68
6347017-347017102.885104.57
极限1339789-339789100.74299.242.00102.98101.462.00
2329963-32996397.829100.04
3345701-345701102.495104.79
4329844-32984497.79399.97
5329252-32925297.61899.82
6333692-33369298.934101.19
磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.853022663013773025093022143016183019970.16
29.843020783023603022190.07
单位质量响应值RSD%判断
30659.5930713.310.13数据可信
供试品溶液-2024051621批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1340778-340778101.13597.843.47101.1397.843.47
2323409-32340995.98095.98
3335510-33551099.57199.57
4310246-31024692.07492.07
5329551-32955197.80397.80
6338522-338522100.465100.47
10min1346899-346899102.951101.312.15103.51101.852.14
2335834-33583499.667100.20
3334607-33460799.30399.86
4343987-343987102.087102.60
5334910-33491099.39399.94
6351961-351961104.454105.01
15min1342779-342779101.72999.981.92102.86101.081.92
2332075-33207598.55299.64
3338737-338737100.529101.63
4331708-33170898.44399.52
5330338-33033898.03699.13
6345691-345691102.593103.73
20min1338049-338049100.32599.172.54102.02100.832.52
2326065-32606596.76898.40
3341125-341125101.238102.90
4336108-33610899.749101.37
5321468-32146895.40497.04
6342218-342218101.562103.27
极限1331328-33132898.33098.593.14100.59100.803.10
2323805-32380596.09898.27
3331434-33143498.362100.59
4331896-33189698.499100.68
5322966-32296695.84998.02
6351791-351791104.403106.68
磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.852999033002832999303001183005073001480.09
29.843029183026833028000.06
单位质量响应值RSD%判断
30471.8830772.360.70数据可信
供试品溶液-2024051721批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1332704-33270498.948100.521.3398.95100.521.33
2335239-33523999.70299.70
3338478-338478100.666100.67
4335833-33583399.87999.88
5345314-345314102.699102.70
6340338-340338101.219101.22
10min1343727-343727102.227104.121.21102.78104.681.20
2351307-351307104.481105.03
3351510-351510104.541105.10
4354746-354746105.504106.06
5346304-346304102.993103.56
6352991-352991104.982105.54
15min1336880-336880100.190104.152.22101.31105.282.20
2353063-353063105.003106.14
3352374-352374104.798105.94
4356342-356342105.978107.12
5345325-345325102.702103.84
6357132-357132106.213107.36
20min1338423-338423100.649103.511.81102.32105.221.79
2358051-358051106.487108.20
3347687-347687103.404105.13
4349037-349037103.806105.54
5346551-346551103.067104.78
6348444-348444103.630105.37
极限1337704-337704100.435102.551.28102.67104.841.28
2347481-347481103.343105.65
3343731-343731102.228104.52
4345244-345244102.678104.98
5343749-343749102.233104.52
6350893-350893104.358106.67
磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.853030823022553030293030973025143027950.13
29.843018413011683015040.16
单位质量响应值RSD%判断
30740.6130640.650.24数据可信
供试品溶液-2024051721批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1342858-342858101.738102.581.63101.74102.581.64
2336034-33603499.71399.71
3345563-345563102.541102.54
4350568-350568104.026104.03
5350907-350907104.127104.13
6348175-348175103.316103.32
10min1348060-348060103.282104.571.16103.85105.141.16
2353358-353358104.854105.41
3349450-349450103.694104.26
4356241-356241105.710106.29
5357964-357964106.221106.80
6349373-349373103.672104.25
15min1345222-345222102.440104.351.27103.58105.501.26
2351527-351527104.311105.45
3356462-356462105.775106.92
4351989-351989104.448105.61
5356479-356479105.780106.95
6348330-348330103.362104.51
20min1347391-347391103.083103.731.67104.79105.461.65
2354597-354597105.222106.94
3338987-338987100.590102.32
4353217-353217104.812106.56
5353246-353246104.821106.58
6349883-349883103.823105.55
极限1350094-350094103.886102.232.30106.17104.542.26
2349653-349653103.755106.06
3330773-33077398.152100.44
4351666-351666104.352106.68
5344499-344499102.225104.56
6340494-340494101.037103.34
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