氢溴酸伏硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301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(%)99.9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%
114.111798411797131800001797391797641798110.07
214.131796151795591795870.03
单位质量响应值RSD%判断
12743.5212709.620.19数据可信
供试品溶液-2816279批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min128881-2888116.05213.8815.2416.0513.8815.25
222251-2225112.36712.37
328477-2847715.82715.83
420448-2044811.36511.36
521963-2196312.20712.21
627776-2777615.43715.44
5min152705-5270529.29330.9610.0429.2930.9610.04
246481-4648125.83325.83
360955-6095533.87833.88
454641-5464130.36930.37
559062-5906232.82632.83
660408-6040833.57433.57
10min174965-7496541.66445.2913.7741.6645.2913.76
262955-6295534.98934.99
393119-9311951.75451.75
482555-8255545.88345.88
583813-8381346.58246.58
691535-9153550.87450.87
15min191739-9173950.98753.0712.6050.9953.0712.60
276323-7632342.41942.42
3113715-11371563.20163.20
496048-9604853.38253.38
596942-9694253.87953.88
698124-9812454.53654.54
20min1103969-10396957.78458.8712.1957.7858.8712.19
285334-8533447.42747.43
3124514-12451469.20369.20
4101219-10121956.25656.26
5109754-10975461.00061.00
6110723-11072361.53861.54
30min1115740-11574064.32763.9310.9064.3363.9310.90
296946-9694653.88153.88
3135212-13521275.14975.15
4108770-10877060.45360.45
5115133-11513363.98963.99
6118398-11839865.80465.80
45min1135319-13531975.20871.759.9875.2171.749.98
2108450-10845060.27560.27
3145690-14569080.97280.97
4122182-12218267.90767.91
5127546-12754670.88870.89
6135346-13534675.22375.22
60min1148256-14825682.39875.2910.3682.4075.2910.36
2115779-11577964.34864.35
3149717-14971783.21083.21
4128738-12873871.55171.55
5125545-12554569.77669.78
6144785-14478580.46980.47
90min1157292-15729287.42078.929.5287.4278.929.51
2121697-12169767.63767.64
3152619-15261984.82384.82
4133940-13394074.44274.44
5136665-13666575.95675.96
6149730-14973083.21883.22
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1161712-16171289.87781.428.2289.8881.428.23
2129860-12986072.17472.17
3153924-15392485.54985.55
4138355-13835576.89676.90
5140739-14073978.22178.22
6154380-15438085.80285.80
极限1161450-16145089.73187.203.3689.7387.203.37
2151974-15197484.46584.46
3163959-16395991.12691.13
4158954-15895488.34488.34
5153512-15351285.32085.32
6151571-15157184.24184.24
氢溴酸伏硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301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(%)99.9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%
114.111803541801371798941801181800411801090.10
214.131787491792081789780.19
单位质量响应值RSD%判断
12764.6412666.530.55数据可信
供试品溶液-2816279批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min116957-169579.43310.6219.309.4310.6219.29
216792-167929.3419.34
322674-2267412.61312.61
416678-166789.2789.28
524863-2486313.83113.83
616620-166209.2459.25
5min142503-4250323.64325.5915.3923.6425.5915.40
242551-4255123.67023.67
355144-5514430.67530.68
443438-4343824.16324.16
537954-3795421.11321.11
654457-5445730.29330.29
10min163200-6320035.15642.2710.9435.1642.2710.94
279003-7900343.94743.95
382282-8228245.77145.77
473013-7301340.61540.62
572023-7202340.06440.06
686393-8639348.05848.06
15min175989-7598942.27150.5810.1542.2750.5810.15
294746-9474652.70552.70
398868-9886854.99855.00
487811-8781148.84748.85
587190-8719048.50148.50
6100978-10097856.17156.17
20min189788-8978849.94756.557.8149.9556.567.80
2105691-10569158.79358.79
3106887-10688759.45859.46
497695-9769554.34554.35
598172-9817254.61054.61
6111769-11176962.17462.17
30min1101434-10143456.42564.777.9956.4264.778.00
2120111-12011166.81466.81
3123547-12354768.72668.73
4112887-11288762.79662.80
5113202-11320262.97162.97
6127404-12740470.87170.87
45min1114745-11474563.82973.346.9763.8373.346.97
2137019-13701976.22076.22
3139062-13906277.35677.36
4132951-13295173.95773.96
5129011-12901171.76571.77
6138221-13822176.88976.89
60min1134491-13449174.81479.123.0574.8179.123.05
2146497-14649781.49281.49
3142848-14284879.46279.46
4144743-14474380.51780.52
5140274-14027478.03178.03
6144508-14450880.38680.39
90min1150631-15063183.79284.571.7883.7984.571.78
2155851-15585186.69686.70
3153662-15366285.47885.48
4153358-15335885.30985.31
5148730-14873082.73482.73
6149912-14991283.39283.39
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1151994-15199484.55085.523.2284.5585.523.22
2158169-15816987.98587.99
3157867-15786787.81787.82
4156977-15697787.32287.32
5145472-14547280.92280.92
6151920-15192084.50984.51
极限1150870-15087083.92587.763.6383.9287.763.64
2157787-15778787.77387.77
3159162-15916288.53788.54
4151772-15177284.42784.43
5160958-16095889.53689.54
6166032-16603292.35992.36
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