磷酸奥司他韦干混悬剂项目信息
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100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.861508850150797915088081506485150789815080040.07
29.931508757150547615071160.16
单位质量响应值RSD%判断
152941.58151774.020.55数据可信
供试品溶液-2024111821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%
5min11674100-167410099.968100.410.4499.97100.410.43
21671750-167175099.82899.83
31680489-1680489100.350100.35
41688578-1688578100.833100.83
51687067-1687067100.743100.74
61686981-1686981100.738100.74
10min11680123-1680123100.32899.881.24101.44101.001.22
21666874-166687499.537100.65
31670363-167036399.745100.86
41696204-1696204101.288102.41
51636429-163642997.71998.84
61685473-1685473100.647101.77
15min11663999-166399999.36598.811.06101.59101.031.05
21648455-164845598.437100.65
31651968-165196898.647100.87
41674947-1674947100.019102.26
51624674-162467497.01799.22
61664187-166418799.376101.61
20min11649799-164979998.51797.801.28101.85101.121.26
21630256-163025697.350100.66
31635942-163594297.690101.01
41661335-166133599.206102.56
51601382-160138295.62698.91
61647737-164773798.394101.74
30min11631396-163139697.41896.741.18101.84101.151.17
21614101-161410196.386100.78
31615919-161591996.494100.90
41641066-164106697.996102.46
51587280-158728094.78499.13
61630598-163059897.371101.81
极限11616106-161610696.50595.551.32102.01101.031.30
21592739-159273995.110100.57
31596172-159617295.315100.79
41622937-162293796.913102.46
51564181-156418193.40598.80
61608178-160817896.032101.55
磷酸奥司他韦干混悬剂项目信息
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100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.861507623150806215087501508451150765415081080.04
29.931507314150767515074940.02
单位质量响应值RSD%判断
152952.13151812.080.53数据可信
供试品溶液-2024112021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%
5min11659867-165986799.10399.963.9899.1099.963.98
21754633-1754633104.761104.76
31718417-1718417102.598102.60
41716870-1716870102.506102.51
51597020-159702095.35095.35
61598188-159818895.42095.42
10min11690467-1690467100.930101.112.92102.03102.222.93
21756357-1756357104.863106.03
31734407-1734407103.553104.69
41704764-1704764101.783102.92
51629349-162934997.28098.34
61645586-164558698.25099.31
15min11683943-1683943100.540100.512.88102.76102.742.90
21742011-1742011104.007106.34
31726349-1726349103.072105.36
41692761-1692761101.066103.34
51617934-161793496.59998.74
61637577-163757797.77299.92
20min11668515-166851599.61999.803.41102.96103.153.41
21756261-1756261104.858108.34
31709920-1709920102.091105.53
41673022-167302299.888103.28
51601334-160133495.60898.82
61620099-162009996.72899.97
30min11652989-165298998.69298.822.35103.14103.282.39
21703543-1703543101.710106.36
31691446-1691446100.988105.56
41656757-165675798.917103.42
51627115-162711597.147101.42
61599445-159944595.49599.81
极限11636490-163649097.70797.352.90103.25102.912.91
21686401-1686401100.687106.47
31671763-167176399.813105.51
41637798-163779897.785103.39
51567406-156740693.58298.94
61582927-158292794.50999.88
磷酸奥司他韦干混悬剂项目信息
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100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.861506248150519615075841506383150721515065250.07
29.931503804150486615043350.05
单位质量响应值RSD%判断
152791.58151493.960.61数据可信
供试品溶液-2024112021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%
5min11659391-165939199.23099.554.5199.2399.554.51
21758492-1758492105.157105.16
31750987-1750987104.708104.71
41608100-160810096.16396.16
51576768-157676894.29094.29
61634929-163492997.76897.77
10min11733459-1733459103.660101.215.02104.76102.325.01
21790707-1790707107.083108.25
31772675-1772675106.005107.17
41616486-161648696.66597.73
51587986-158798694.96096.01
61653761-165376198.89499.98
15min11681746-1681746100.56799.874.88102.82102.104.88
21776995-1776995106.263108.62
31747542-1747542104.502106.84
41604914-160491495.97398.12
51566900-156690093.69995.80
61642808-164280898.239100.42
20min11649180-164918098.62098.905.24101.99102.255.23
21760581-1760581105.281108.82
31753823-1753823104.877108.38
41584774-158477494.76897.98
51551550-155155092.78295.93
61623760-162376097.100100.38
30min11630432-163043297.49997.845.27101.97102.285.25
21744581-1744581104.325109.03
31733668-1733668103.672108.34
41568563-156856393.79998.06
51535013-153501391.79395.97
61604879-160487995.971100.33
极限11612166-161216696.40696.715.21101.96102.245.20
21722052-1722052102.977108.85
31713766-1713766102.482108.30
41549386-154938692.65297.96
51519149-151914990.84496.04
61586973-158697394.900100.32
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