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101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6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%
1 10.163080953081623085063082063082003082340.06
2 10.163084303083663083980.02
单位质量响应值RSD%判断
30337.9930354.130.04数据可信
长期12月-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%
5min1315072-31507294.46093.083.7794.4693.093.77
2325931-32593197.71597.72
3313690-31369094.04594.05
4313204-31320493.90093.90
5291582-29158287.41787.42
6303426-30342690.96890.97
10min1336245-336245100.80898.422.25101.3398.942.26
2337771-337771101.265101.81
3328167-32816798.38698.91
4325933-32593397.71698.24
5321166-32116696.28796.77
6320362-32036296.04696.55
15min1340646-340646102.12798.423.38103.2199.493.37
2339865-339865101.893103.00
3325744-32574497.65998.73
4331732-33173299.454100.52
5315743-31574394.66195.68
6316030-31603094.74795.79
20min1330212-33021298.99997.412.03100.6599.022.04
2333908-333908100.107101.78
3326575-32657597.90899.52
4323053-32305396.85298.47
5318184-31818495.39396.94
6317458-31745895.17596.74
极限1324195-32419597.19596.111.1499.4098.261.17
2325132-32513297.47699.70
3319852-31985295.89398.05
4319113-31911395.67197.83
5315172-31517294.49096.57
6319929-31992995.91698.01
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101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6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%
1 10.163082423085533086673086353081753084540.08
2 10.163077573078023077800.02
单位质量响应值RSD%判断
30359.6530293.310.16数据可信
长期12月-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%
5min1323961-32396197.18896.471.3497.1996.471.34
2319953-31995395.98595.99
3316648-31664894.99494.99
4318440-31844095.53195.53
5321755-32175596.52696.53
6328613-32861398.58398.58
10min1340350-340350102.104100.520.95102.64101.060.95
2333342-333342100.002100.54
3332062-33206299.618100.15
4333391-333391100.017100.55
5333824-333824100.146100.68
6337488-337488101.246101.79
15min1340031-340031102.009100.191.35103.12101.291.35
2330534-33053499.159100.25
3327978-32797898.39399.47
4332247-33224799.673100.76
5335983-335983100.794101.89
6337136-337136101.140102.25
20min1339653-339653101.89599.801.45103.57101.451.44
2328179-32817998.453100.09
3326795-32679598.03899.67
4333336-333336100.000101.64
5336084-336084100.824102.48
6331938-33193899.581101.25
极限1332852-33285299.85598.631.76102.09100.841.74
2326311-32631197.893100.08
3320509-32050996.15298.32
4329716-32971698.914101.11
5337020-337020101.105103.32
6326236-32623697.870100.10
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101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6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%
1 10.163072173073803072893074493077473074160.07
2 10.163089143085763087450.08
单位质量响应值RSD%判断
30257.4830388.290.31数据可信
长期12月-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%
5min1295537-29553788.67195.313.9288.6795.313.92
2321100-32110096.34196.34
3321870-32187096.57296.57
4333330-333330100.010100.01
5318970-31897095.70295.70
6315215-31521594.57594.58
10min1321589-32158996.488100.142.2596.98100.672.26
2331067-33106799.33199.87
3340692-340692102.219102.76
4342439-342439102.743103.30
5334196-334196100.270100.80
6332508-33250899.764100.29
15min1329782-32978298.94699.791.2999.97100.881.30
2331050-33105099.326100.41
3337699-337699101.321102.43
4338053-338053101.427102.55
5327737-32773798.33299.42
6331293-33129399.399100.48
20min1329373-32937398.82399.421.28100.40101.061.28
2326199-32619997.87199.51
3332940-33294099.893101.56
4336962-336962101.100102.79
5334803-334803100.452102.09
6327806-32780698.35399.98
极限1328174-32817498.46398.671.40100.59100.861.39
2326735-32673598.032100.21
3336197-336197100.871103.09
4331058-33105899.329101.58
5322387-32238796.72798.92
6328716-32871698.626100.80
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