氢溴酸伏硫西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.151798021799601797311797101797241797850.06
214.181796901798171797540.05
单位质量响应值RSD%判断
12705.6512676.590.17数据可信
供试品溶液-2757904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%
2min175074-7507441.81231.8925.7041.8131.8925.69
255319-5531930.81030.81
367992-6799237.86837.87
443480-4348024.21624.22
564504-6450435.92535.93
637178-3717820.70620.71
5min1171569-17156995.55592.702.5395.5592.702.53
2168911-16891194.07494.07
3165577-16557792.21892.22
4164072-16407291.37991.38
5168759-16875993.99093.99
6159803-15980389.00289.00
10min1182672-182672101.738100.401.03101.74100.401.03
2180950-180950100.779100.78
3177723-17772398.98298.98
4181498-181498101.085101.08
5180184-180184100.353100.35
6178550-17855099.44399.44
15min1182786-182786101.802100.841.94101.80100.841.94
2181928-181928101.324101.32
3179311-17931199.86799.87
4185753-185753103.454103.45
5175352-17535297.66297.66
6181223-181223100.931100.93
20min1184326-184326102.660101.280.96102.66101.280.96
2182320-182320101.542101.54
3180558-180558100.561100.56
4179807-179807100.143100.14
5180888-180888100.745100.74
6183204-183204102.035102.03
30min1184833-184833102.942102.461.13102.94102.461.13
2184364-184364102.681102.68
3180720-180720100.651100.65
4186882-186882104.083104.08
5182787-182787101.803101.80
6184222-184222102.602102.60
45min1185086-185086103.083102.400.68103.08102.400.68
2184249-184249102.617102.62
3181648-181648101.168101.17
4184836-184836102.944102.94
5183421-183421102.156102.16
6183901-183901102.423102.42
60min1185072-185072103.075102.251.10103.08102.251.10
2183678-183678102.299102.30
3180883-180883100.742100.74
4186486-186486103.863103.86
5182091-182091101.415101.41
6183369-183369102.127102.13
极限1181209-181209100.924102.051.40100.92102.051.40
2181976-181976101.351101.35
3180051-180051100.279100.28
4185696-185696103.423103.42
5186386-186386103.807103.81
6184034-184034102.497102.50
氢溴酸伏硫西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.151799131799651800251799751797551799270.06
214.181798821798941798880.01
单位质量响应值RSD%判断
12715.6912686.040.17数据可信
供试品溶液-2757904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%
2min147642-4764226.51427.2120.2726.5127.2120.27
233356-3335618.56318.56
362266-6226634.65234.65
454267-5426730.20130.20
552303-5230329.10829.11
643558-4355824.24124.24
5min1129617-12961772.13470.7815.0572.1370.7815.04
2145894-14589481.19381.19
394423-9442352.54852.55
4143214-14321479.70179.70
5116795-11679564.99965.00
6133144-13314474.09774.10
10min1168179-16817993.59594.424.7493.5994.424.74
2174058-17405896.86796.87
3155079-15507986.30486.30
4178862-17886299.54099.54
5171239-17123995.29895.30
6170523-17052394.89994.90
15min1176910-17691098.45499.182.4898.4599.182.48
2180666-180666100.544100.54
3172024-17202495.73595.73
4183748-183748102.259102.26
5181162-181162100.820100.82
6174748-17474897.25197.25
20min1179857-179857100.094100.461.47100.09100.461.47
2184447-184447102.648102.65
3178649-17864999.42299.42
4183065-183065101.879101.88
5179333-17933399.80299.80
6177767-17776798.93198.93
30min1179364-17936499.819101.031.7199.82101.031.71
2183493-183493102.117102.12
3180278-180278100.328100.33
4186145-186145103.593103.59
5182391-182391101.504101.50
6177587-17758798.83198.83
45min1182931-182931101.805101.721.77101.80101.721.77
2184212-184212102.518102.52
3181035-181035100.749100.75
4185412-185412103.185103.19
5185811-185811103.407103.41
6177232-17723298.63398.63
60min1184312-184312102.573101.502.16102.57101.502.17
2183296-183296102.008102.01
3180650-180650100.535100.54
4188667-188667104.997105.00
5179937-179937100.138100.14
6177428-17742898.74298.74
极限1185579-185579103.278101.801.87103.28101.801.87
2184760-184760102.822102.82
3181293-181293100.893100.89
4185632-185632103.308103.31
5183489-183489102.115102.12
6176827-17682798.40898.41
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