托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
1 16.482016192011982011922012882014312013460.09
2 16.552010662009922010290.03
单位质量响应值RSD%判断
12217.6012146.770.42数据可信
供试品溶液-2批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
15min131128-3112815.33113.1114.8415.3313.1114.83
224892-2489212.26012.26
323816-2381611.73011.73
5min126629-2662913.11514.297.1513.1414.327.12
230163-3016314.85614.88
330275-3027514.91114.93
10min151310-5131025.27223.786.5925.3223.826.57
248535-4853523.90523.95
344974-4497422.15122.20
20min145223-4522322.27422.671.5522.3622.751.54
246589-4658922.94623.03
346265-4626522.78722.87
30min169467-6946734.21433.432.8934.3433.552.89
268453-6845333.71533.84
365680-6568032.34932.47
45min166014-6601432.51432.650.3632.7032.830.34
266395-6639532.70132.88
366444-6644432.72532.90
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
1 16.484044514048704044854038494038154042940.12
2 16.554067854074234071040.12
单位质量响应值RSD%判断
24532.4024598.430.20数据可信
供试品溶液-2批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
15min145073-4507311.00911.735.5711.0111.735.55
248660-4866011.88511.89
350294-5029412.28412.28
5min149159-4915912.00712.322.6112.0312.352.60
251794-5179412.65012.67
350419-5041912.31512.34
10min188146-8814621.52922.194.2921.5722.234.27
295319-9531923.28123.32
389121-8912121.76721.81
20min191159-9115922.26521.901.5222.3421.981.50
288519-8851921.62021.70
389316-8931621.81521.89
30min1127049-12704931.03131.332.2931.1431.452.30
2131628-13162832.15032.27
3126172-12617230.81730.93
45min1128424-12842431.36731.220.4231.5331.380.42
2127472-12747231.13531.30
3127520-12752031.14631.31
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
1 16.484031134025914025894021834020904025130.11
2 16.554083954078564081260.10
单位质量响应值RSD%判断
24424.3324660.180.68数据可信
供试品溶液批-mnpH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
15min1298111-29811172.88371.391.8372.8871.391.83
2289567-28956770.79470.79
3288311-28831170.48770.49
5min1300879-30087973.55974.231.4573.6874.351.45
2301332-30133273.67073.79
3308694-30869475.47075.59
10min195103-9510323.25123.390.7723.5023.640.73
296504-9650423.59323.83
395444-9544423.33423.58
20min1111160-11116027.17727.230.7927.4627.510.79
2112356-11235627.46927.75
3110646-11064627.05127.33
30min1121248-12124829.64329.781.2329.9730.111.22
2123492-12349230.19230.52
3120675-12067529.50329.83
45min1141716-14171634.64734.870.5835.0235.240.58
2143323-14332335.04035.42
3142802-14280234.91335.29
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
1 16.484037634039624035214034884030964035660.09
2 16.554130794133234132010.05
单位质量响应值RSD%判断
24488.2324966.831.37数据可信
供试品溶液批-mnpH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
15min1335208-33520881.34478.053.6781.3478.053.67
2315867-31586776.65176.65
3313824-31382476.15576.15
5min1324897-32489778.84277.462.9178.9877.592.91
2324196-32419678.67278.80
3308513-30851374.86674.99
10min1117721-11772128.56727.433.7928.8327.693.78
2112088-11208827.20027.46
3109333-10933326.53226.78
20min1114373-11437327.75527.991.0328.0728.301.02
2116676-11667628.31328.62
3115008-11500827.90928.20
30min1147926-14792635.89734.713.1236.2635.063.11
2141942-14194234.44534.80
3139222-13922233.78534.13
45min1147273-14727335.73835.520.6036.1635.930.62
2146239-14623935.48735.90
3145553-14555335.32135.72
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