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%
19.853057233050073049043050773050333051490.11
29.843071123069443070280.04
单位质量响应值RSD%判断
30979.5931202.030.51数据可信
供试品溶液-2024051421批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1328016-32801696.08298.181.7896.0898.181.78
2340472-34047299.73199.73
3330884-33088496.92296.92
4343387-343387100.585100.58
5332049-33204997.26497.26
6336317-33631798.51498.51
10min1346102-346102101.380102.231.96101.91102.781.95
2348005-348005101.938102.49
3355604-355604104.163104.70
4354455-354455103.827104.39
5352646-352646103.297103.84
6337268-33726898.79299.34
15min1335035-33503598.138101.982.6799.24103.092.65
2350396-350396102.638103.76
3355314-355314104.078105.20
4360412-360412105.572106.71
5346396-346396101.466102.58
6341282-34128299.968101.06
20min1338785-33878599.237101.442.71100.88103.122.68
2351386-351386102.928104.62
3339984-33998499.588101.28
4361708-361708105.951107.67
5337671-33767198.911100.59
6348306-348306102.026103.68
极限1335617-33561798.309100.932.07100.50103.172.06
2348934-348934102.210104.47
3345864-345864101.310103.56
4355121-355121104.022106.33
5343618-343618100.652102.88
6338223-33822399.072101.29
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%
19.853050173051743050133052123051463051120.04
29.843049633055443052540.14
单位质量响应值RSD%判断
30975.8431021.750.11数据可信
供试品溶液-2024051421批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1343914-343914101.03796.183.18101.0496.183.18
2324930-32493095.46095.46
3324812-32481295.42595.43
4325384-32538495.59395.59
5312523-31252391.81591.81
6332704-33270497.74497.74
10min1342105-342105100.50699.092.51101.0799.622.51
2339148-33914899.637100.17
3342014-342014100.479101.01
4333859-33385998.08398.61
5321794-32179494.53895.05
6344729-344729101.276101.82
15min1339239-33923999.66499.381.81100.78100.461.80
2347649-347649102.134103.22
3337105-33710599.037100.12
4330317-33031797.04298.12
5333705-33370598.03899.07
6341618-341618100.362101.47
20min1332047-33204797.55198.881.4299.22100.511.42
2342003-342003100.476102.13
3340142-34014299.929101.57
4335386-33538698.532100.15
5330178-33017897.00298.58
6339590-33959099.767101.43
极限1340297-34029799.97498.461.31102.19100.651.30
2332299-33229997.62599.83
3341112-341112100.214102.41
4333369-33336997.939100.10
5332888-33288897.79899.92
6330947-33094797.22799.44
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%
19.853049533049523048153046523045533047850.06
29.843068773071513070140.07
单位质量响应值RSD%判断
30942.6431200.610.59数据可信
供试品溶液-2024051621批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1324451-32445195.09795.743.6695.1095.743.66
2344220-344220100.892100.89
3326924-32692495.82295.82
4312647-31264791.63791.64
5315788-31578892.55892.56
6335892-33589298.45198.45
10min1335457-33545798.32399.532.6798.85100.062.67
2351882-351882103.137103.70
3339053-33905399.37799.91
4341955-341955100.228100.74
5324918-32491895.23495.75
6344199-344199100.885101.43
15min1342061-342061100.259100.082.08101.33101.172.08
2353743-353743103.683104.82
3338473-33847399.207100.29
4339363-33936399.468100.53
5332320-33232097.40498.45
6342777-342777100.469101.58
20min1333748-33374897.82298.672.1999.45100.312.19
2349343-349343102.393104.10
3335581-33558198.359100.00
4329982-32998296.71898.34
5330484-33048496.86698.45
6340692-34069299.857101.52
极限1340526-34052699.80998.125.57101.98100.315.49
2348850-348850102.249104.53
3331873-33187397.27399.45
4333820-33382097.843100.00
5300617-30061788.11190.23
6352883-352883103.431105.65
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%
19.853048043048253048713048583049483048610.02
29.843044913042633043770.06
单位质量响应值RSD%判断
30950.3630932.620.05数据可信
供试品溶液-2024051621批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1343849-343849101.20597.243.67101.2097.243.67
2336623-33662399.07899.08
3334755-33475598.52898.53
4336238-33623898.96598.96
5312934-31293492.10692.11
6317869-31786993.55893.56
10min1340783-340783100.30399.171.31100.8699.711.31
2342318-342318100.754101.30
3335859-33585998.85399.40
4337486-33748699.33299.88
5335177-33517798.65399.16
6330010-33001097.13297.65
15min1339529-33952999.93399.991.05101.05101.081.05
2340939-340939100.348101.46
3337646-33764699.379100.48
4346187-346187101.893102.99
5337691-33769199.392100.45
6336396-33639699.011100.07
20min1337404-33740499.30899.431.61100.98101.081.58
2340355-340355100.177101.84
3334454-33445498.440100.09
4333967-33396798.29699.96
5347492-347492102.277103.89
6333222-33322298.07799.69
极限1335610-33561098.78098.871.51101.01101.071.49
2345520-345520101.697103.92
3332634-33263497.904100.10
4332776-33277697.946100.16
5336802-33680299.131101.31
6332119-33211997.75299.91
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%
19.853059553059223057653060283059693059280.04
29.843048613050953049780.06
单位质量响应值RSD%判断
31058.6830993.700.15数据可信
供试品溶液-2024051721批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1340468-34046899.936100.844.3599.94100.854.35
2362615-362615106.437106.44
3345314-345314101.359101.36
4353219-353219103.679103.68
5341532-341532100.249100.25
6318217-31821793.40593.41
10min1354464-354464104.045105.061.48104.60105.621.50
2366780-366780107.660108.25
3356404-356404104.614105.18
4360311-360311105.761106.34
5358119-358119105.117105.67
6351475-351475103.167103.69
15min1351997-351997103.320103.831.11104.45104.981.12
2356391-356391104.610105.80
3348488-348488102.290103.43
4357622-357622104.972106.14
5357359-357359104.894106.04
6350542-350542102.893103.99
20min1351928-351928103.300103.811.12105.01105.531.12
2358273-358273105.163106.93
3347818-347818102.094103.81
4354283-354283103.991105.74
5357711-357711104.998106.72
6351899-351899103.292104.96
极限1343878-343878100.937103.001.37103.22105.291.35
2352886-352886103.581105.94
3347546-347546102.014104.29
4350459-350459102.869105.19
5357699-357699104.994107.30
6352902-352902103.586105.82
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%
19.853057803065553066563057213064793062380.15
29.843036843036583036710.01
单位质量响应值RSD%判断
31090.1530860.870.53数据可信
供试品溶液-2024051721批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1348002-348002102.31697.194.48102.3297.184.48
2338706-33870699.58399.58
3343981-343981101.134101.13
4313486-31348692.16892.17
5317227-31722793.26893.27
6321901-32190194.64294.64
10min1348387-348387102.429101.621.74103.00102.161.75
2352521-352521103.645104.20
3350650-350650103.095103.66
4336616-33661698.96999.48
5343865-343865101.100101.62
6341807-341807100.495101.02
15min1343777-343777101.074100.270.71102.21101.380.73
2341767-341767100.483101.61
3343266-343266100.924102.06
4340906-340906100.230101.29
5337575-33757599.251100.33
6338999-33899999.669100.75
20min1341563-341563100.423100.061.78102.12101.721.78
2351832-351832103.442105.13
3339367-33936799.777101.47
4337270-33727099.161100.78
5336409-33640998.908100.54
6335477-33547798.634100.27
极限1337836-33783699.32799.220.89101.58101.440.90
2340997-340997100.257102.52
3340643-340643100.153102.40
4336436-33643698.916101.09
5335555-33555598.657100.84
6333322-33332298.000100.19
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