依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.553224283223943224623221153223443223490.05
29.583221693221943221820.01
单位质量响应值RSD%判断
33753.8233630.690.26数据可信
长期18月-供试品溶液-2024012321批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1172670-17267051.12154.3017.8651.1254.3017.86
2173653-17365351.41251.41
3145562-14556243.09643.10
4226817-22681767.15267.15
5220207-22020765.19565.20
6161490-16149047.81147.81
10min1272560-27256080.69580.888.0680.8581.048.07
2254473-25447375.34075.49
3251397-25139774.42974.56
4313022-31302292.67492.88
5271760-27176080.45880.65
6275922-27592281.69081.83
15min1296090-29609087.66187.944.3688.0688.354.38
2286164-28616484.72385.10
3290049-29004985.87386.23
4320340-32034094.84195.32
5287135-28713585.01085.45
6302410-30241089.53289.92
20min1305855-30585590.55290.513.0191.2191.183.02
2298727-29872788.44289.08
3303939-30393989.98590.60
4321403-32140395.15695.92
5295164-29516487.38788.08
6309269-30926991.56392.22
30min1309322-30932291.57991.911.9692.5192.851.98
2308098-30809891.21692.12
3311011-31101192.07992.96
4320360-32036094.84795.90
5301704-30170489.32390.28
6312082-31208292.39693.33
45min1311210-31121092.13892.661.0393.3493.881.07
2311807-31180792.31593.49
3313596-31359692.84494.00
4319220-31922094.50995.84
5310889-31088992.04393.26
6311150-31115092.12093.33
60min1312156-31215692.41892.651.1493.9094.141.16
2313406-31340692.78894.24
3314286-31428693.04894.48
4318632-31863294.33595.95
5307931-30793191.16792.67
6311206-31120692.13793.62
极限1332605-33260598.47298.730.43100.23100.500.46
2332667-33266798.490100.22
3332548-33254898.455100.17
4334256-33425698.961100.86
5336081-33608199.501101.27
6332771-33277198.521100.28
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.553220043218623216483215383215453217190.07
29.583214913218583216740.09
单位质量响应值RSD%判断
33687.8533577.660.24数据可信
长期18月-供试品溶液-2024012421批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1194286-19428657.62352.129.6557.6252.129.65
2192541-19254157.10557.11
3151429-15142944.91244.91
4168948-16894850.10850.11
5182585-18258554.15254.15
6164555-16455548.80548.80
10min1284591-28459184.40684.664.7684.5884.824.77
2311671-31167192.43792.61
3277963-27796382.44082.57
4286010-28601084.82784.98
5278122-27812282.48782.65
6274302-27430281.35481.50
15min1304031-30403190.17290.992.1290.6091.402.13
2319096-31909694.64095.09
3302190-30219089.62690.01
4308755-30875591.57391.98
5302364-30236489.67790.09
6304345-30434590.26590.66
20min1307707-30770791.26293.081.3391.9693.771.33
2319213-31921394.67495.41
3310400-31040092.06092.71
4314530-31453093.28593.96
5315030-31503093.43494.11
6316213-31621393.78594.45
30min1311135-31113592.27894.291.3793.2595.261.35
2318496-31849694.46295.48
3315247-31524793.49894.43
4318338-31833894.41595.37
5320785-32078595.14196.10
6323582-32358295.97096.91
45min1313160-31316092.87994.991.3994.1396.231.37
2319771-31977194.84096.14
3317913-31791394.28995.50
4321990-32199095.49896.74
5322822-32282295.74596.99
6325953-32595396.67397.90
60min1314894-31489493.39395.281.3594.9296.811.33
2320627-32062795.09496.68
3318611-31861194.49695.99
4323713-32371396.00997.54
5322179-32217995.55497.09
6327434-32743497.11398.63
极限1327906-32790697.25398.020.4699.0699.840.47
2331867-33186798.427100.30
3329723-32972397.79199.57
4331340-33134098.271100.09
5330550-33055098.03799.86
6331667-33166798.368100.18
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.553217153210213217573216143216753215560.10
29.583209923210733210320.02
单位质量响应值RSD%判断
33670.7933510.650.34数据可信
长期18月-供试品溶液-2025012521批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1204241-20424160.65159.4715.8260.6559.4715.82
2233716-23371669.40469.40
3217380-21738064.55364.55
4141981-14198142.16242.16
5211702-21170262.86762.87
6192659-19265957.21257.21
10min1316733-31673394.05790.315.2394.2490.495.23
2313028-31302892.95693.16
3309556-30955691.92592.12
4299841-29984189.04089.17
5311739-31173992.57492.76
6273824-27382481.31481.49
15min1321949-32194995.60693.933.3396.0794.383.34
2317796-31779694.37294.86
3323135-32313595.95896.43
4321208-32120895.38695.78
5318493-31849394.57995.05
6295222-29522287.66988.08
20min1320693-32069395.23394.232.2595.9894.962.26
2317205-31720594.19794.97
3322915-32291595.89296.65
4321601-32160195.50296.18
5318014-31801494.43795.19
6303440-30344090.10990.79
30min1319675-31967594.93094.191.8195.9795.201.82
2317196-31719694.19495.25
3321783-32178395.55696.60
4321146-32114695.36796.33
5317122-31712294.17295.21
6306187-30618790.92591.87
45min1318542-31854294.59494.061.6395.9295.361.63
2316878-31687894.10095.44
3321330-32133095.42296.75
4320699-32069995.23496.49
5315793-31579393.77795.09
6307192-30719291.22392.45
60min1319027-31902794.73894.011.7296.3495.591.73
2317821-31782194.38096.00
3320095-32009595.05596.67
4320333-32033395.12696.66
5316255-31625593.91595.51
6305946-30594690.85392.35
极限1331317-33131798.38798.770.57100.28100.630.57
2335663-33566399.678101.58
3331595-33159598.470100.37
4334188-33418899.240101.06
5331310-33131098.385100.26
6331513-33151398.446100.21
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