盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.185209365209375209205213365211625210580.04
212.145218305220495219400.03
单位质量响应值RSD%判断
42779.8042993.410.36数据可信
供试品溶液-2022042701批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1291820-29182054.67665.1812.5954.6865.1812.59
2399097-39909774.77674.78
3361134-36113467.66367.66
4356248-35624866.74866.75
5380955-38095571.37771.38
6298138-29813855.86055.86
10min1521424-52142497.69598.913.0598.3099.643.07
2558091-558091104.565105.40
3511664-51166495.86796.62
4519224-51922497.28398.02
5528553-52855399.03199.82
6528569-52856999.03499.65
15min1514478-51447896.39499.072.0398.09100.902.09
2544137-544137101.951103.94
3527170-52717098.772100.59
4522845-52284597.96299.78
5538020-538020100.805102.70
6526032-52603298.559100.28
20min1511809-51180995.89498.581.9798.66101.502.00
2541993-541993101.549104.67
3520652-52065297.551100.47
4528920-52892099.100102.01
5522279-52227997.856100.87
6531252-53125299.537102.35
30min1503929-50392994.41798.403.1098.25102.423.09
2546509-546509102.395106.65
3507634-50763495.11299.11
4531966-53196699.671103.68
5529274-52927499.166103.27
6531734-53173499.627103.55
盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.185210815212215211225213785212455212090.03
212.145231415232395231900.02
单位质量响应值RSD%判断
42792.2043096.380.51数据可信
供试品溶液-2022042701批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1369259-36925969.09365.3911.7769.0965.3911.77
2276559-27655951.74851.75
3324954-32495460.80360.80
4367896-36789668.83868.84
5383973-38397371.84671.85
6374127-37412770.00470.00
10min1528371-52837198.86598.322.4399.6399.042.46
2515869-51586996.52597.10
3511382-51138295.68696.36
4547487-547487102.441103.21
5528261-52826198.84499.64
6521266-52126697.53598.31
15min1525336-52533698.29798.581.72100.16100.391.73
2520688-52068897.42799.07
3526772-52677298.565100.30
4535643-535643100.225102.13
5538270-538270100.717102.61
6514280-51428096.22898.09
20min1530840-53084099.32797.551.29102.29100.471.23
2525936-52593698.409101.14
3520202-52020297.336100.17
4517477-51747796.82699.84
5522156-52215697.702100.72
6511554-51155495.71898.65
30min1530694-53069499.29997.722.60103.36101.722.54
2528928-52892898.969102.79
3506421-50642194.75898.67
4535223-535223100.147104.24
5528493-52849398.887102.99
6503740-50374094.25698.25
盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.185245625251055247475243345237535245000.10
212.145231555232715232130.02
单位质量响应值RSD%判断
43062.4043098.270.06数据可信
供试品溶液-2022042801批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1375684-37568470.07272.926.8970.0772.926.89
2347975-34797564.90464.90
3420418-42041878.41678.42
4390011-39001172.74472.74
5416470-41647077.68077.68
6395158-39515873.70473.70
10min1536885-536885100.139101.811.48100.92102.621.52
2535461-53546199.874100.59
3556058-556058103.715104.59
4550817-550817102.738103.55
5547764-547764102.168103.03
6548198-548198102.249103.07
15min1549254-549254102.446102.321.34104.34104.261.32
2543706-543706101.411103.24
3536816-536816100.126102.15
4556229-556229103.747105.70
5549960-549960102.578104.58
6555413-555413103.595105.55
20min1534850-53485099.760101.091.69102.79104.171.69
2530517-53051798.951101.91
3542292-542292101.148104.28
4555015-555015103.521106.62
5539605-539605100.647103.78
6549733-549733102.536105.64
30min1536734-536734100.111100.671.10104.25104.881.13
2530652-53065298.977103.03
3537288-537288100.214104.47
4546711-546711101.972106.22
5543817-543817101.432105.69
6543326-543326101.341105.59
盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.185210735216225218075217985223625217320.09
212.145238005232335235160.08
单位质量响应值RSD%判断
42835.1443123.230.48数据可信
供试品溶液-2022042801批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1423685-42368579.21273.766.9279.2173.766.92
2388047-38804772.54972.55
3419666-41966678.46178.46
4381550-38155071.33571.33
5350452-35045265.52065.52
6403757-40375775.48675.49
10min1525341-52534198.21898.581.9699.1099.401.94
2509836-50983695.31996.13
3538712-538712100.718101.59
4527122-52712298.55199.34
5536895-536895100.378101.11
6525899-52589998.32299.16
15min1523366-52336697.84898.140.9699.82100.050.94
2518694-51869496.97598.84
3528360-52836098.782100.77
4523856-52385697.94099.83
5532901-53290199.631101.47
6522236-52223697.63799.57
20min1530897-53089799.25698.321.51102.32101.331.50
2513064-51306495.92298.87
3532090-53209099.480102.57
4519308-51930897.090100.07
5531771-53177199.420102.37
6528343-52834398.779101.80
30min1524728-52472898.10396.921.40102.26101.021.41
2510197-51019795.38699.39
3526757-52675798.482102.68
4509460-50946095.24999.30
5520898-52089897.387101.44
6518516-51851696.942101.06
盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.185230645237845241215243855243505239410.11
212.145236485238295237380.03
单位质量响应值RSD%判断
43016.5043141.520.21数据可信
供试品溶液-2022050701批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1321738-32173860.01266.2018.9960.0166.2018.99
2431147-43114780.42080.42
3400945-40094574.78674.79
4239684-23968444.70744.71
5372965-37296569.56769.57
6362888-36288867.68867.69
10min1504904-50490494.17794.832.1794.8495.572.28
2511502-51150295.40896.30
3522982-52298297.54998.38
4491283-49128391.63792.13
5503778-50377893.96794.74
6516056-51605696.25797.01
15min1511628-51162895.43196.050.6997.1497.840.82
2517940-51794096.60998.56
3515796-51579696.20998.12
4510113-51011395.14996.66
5519300-51930096.86298.68
6514991-51499196.05997.88
20min1510433-51043395.20995.901.7197.9898.751.82
2522518-52251897.463100.49
3521613-52161397.294100.28
4498952-49895293.06795.64
5513455-51345595.77298.67
6517710-51771096.56699.45
30min1507124-50712494.59195.741.0898.4299.661.19
2515612-51561296.175100.28
3519142-51914296.833100.90
4506238-50623894.42698.03
5518182-51818296.654100.61
6513508-51350895.78299.74
盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.185239555244665245555242455243585243160.05
212.145268785273885271330.07
单位质量响应值RSD%判断
43047.2943421.170.62数据可信
供试品溶液-2022050701批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1357692-35769266.48069.673.7666.4869.673.76
2387598-38759872.03872.04
3364270-36427067.70367.70
4381378-38137870.88270.88
5366058-36605868.03568.03
6392158-39215872.88672.89
10min1494704-49470491.94595.172.2392.6895.942.23
2508749-50874994.55595.36
3520768-52076896.78997.54
4506777-50677794.18994.98
5514157-51415795.56096.32
6527167-52716797.97898.79
15min1488089-48808990.71594.502.4792.4896.332.46
2507328-50732894.29196.14
3510385-51038594.85996.69
4504441-50444193.75595.59
5514223-51422395.57397.39
6526152-52615297.79099.69
20min1491696-49169691.38694.412.5394.1597.292.51
2495378-49537892.07094.97
3511088-51108894.99097.87
4507952-50795294.40797.28
5515668-51566895.84198.72
6526132-52613297.786100.77
30min1488705-48870590.83093.151.7294.6197.081.73
2506079-50607994.05997.98
3500928-50092893.10297.04
4493285-49328591.68195.61
5507492-50749294.32298.27
6510577-51057794.89598.97
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