利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.933180023178193174153173133173083175710.11
210.013187913189813188860.05
单位质量响应值RSD%判断
31980.9731856.740.28数据可信
供试品溶液-JPS7638批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1241847-24184767.92067.440.7667.9267.440.76
2240040-24004067.41267.41
3239353-23935367.21967.22
4242636-24263668.14168.14
5237707-23770766.75766.76
6239171-23917167.16867.17
10min1300387-30038784.36082.471.3284.4782.581.31
2290464-29046481.57381.69
3289903-28990381.41681.53
4294416-29441682.68382.80
5291970-29197081.99682.11
6294709-29470982.76682.88
15min1322470-32247090.56288.521.2690.8288.771.26
2312012-31201287.62587.87
3311383-31138387.44887.70
4315049-31504988.47888.73
5314902-31490288.43788.68
6315379-31537988.57088.82
20min1333665-33366593.70691.731.2794.1192.131.27
2323088-32308890.73591.13
3322785-32278590.65091.04
4326361-32636191.65592.05
5324955-32495591.26091.66
6328997-32899792.39592.79
30min1347646-34764697.63295.071.5098.1995.621.50
2334148-33414893.84294.39
3334516-33451693.94594.49
4338351-33835195.02295.57
5336054-33605494.37794.92
6340390-34039095.59596.15
45min1355180-35518099.74897.021.60100.4797.731.59
2341231-34123195.83196.53
3341027-34102795.77396.47
4344528-34452896.75797.47
5342420-34242096.16596.87
6348461-34846197.86198.57
60min1358352-358352100.63997.801.63101.5398.681.63
2343860-34386096.56997.43
3342648-34264896.22997.09
4348262-34826297.80598.68
5346215-34621597.23098.10
6350186-35018698.34699.22
极限1359002-359002100.82197.961.69101.8899.001.69
2344505-34450596.75097.77
3343475-34347596.46197.48
4349503-34950398.15499.19
5345004-34500496.89097.92
6351427-35142798.69499.73
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.933183173179513179433179863175713179540.09
210.013182423188473185440.14
单位质量响应值RSD%判断
32019.5431822.580.44数据可信
供试品溶液-JPS7638批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1247532-24753269.51269.140.6369.5169.140.63
2244201-24420168.57768.58
3247655-24765569.54769.55
4246573-24657369.24369.24
5244343-24434368.61768.62
6246882-24688269.33069.33
10min1295205-29520582.90083.250.8883.0283.370.88
2296668-29666883.31083.42
3295393-29539382.95283.07
4300453-30045384.37384.49
5293000-29300082.28082.39
6298096-29809683.71183.83
15min1316513-31651388.88388.870.8089.1489.130.80
2316287-31628788.82089.07
3315924-31592488.71888.97
4320256-32025689.93490.19
5312468-31246887.74788.00
6317443-31744389.14489.40
20min1324701-32470191.18391.880.8691.5892.280.86
2325736-32573691.47391.87
3326970-32697091.82092.22
4331401-33140193.06493.47
5324601-32460191.15591.55
6329719-32971992.59293.00
30min1337026-33702694.64495.330.9195.2095.890.90
2338123-33812394.95295.51
3339305-33930595.28495.84
4344415-34441596.71997.28
5336328-33632894.44895.00
6341603-34160395.92996.49
45min1343985-34398596.59897.400.9897.3198.120.97
2345226-34522696.94797.66
3346783-34678397.38498.10
4352207-35220798.90799.63
5343538-34353896.47297.18
6349358-34935898.10798.82
60min1345445-34544597.00898.161.0897.8899.041.08
2347830-34783097.67898.55
3349110-34911098.03798.91
4355232-35523299.756100.64
5346809-34680997.39198.26
6352927-35292799.10999.99
极限1345535-34553597.03398.301.1998.0799.341.19
2348139-34813997.76598.80
3350182-35018298.33899.38
4356192-356192100.026101.08
5346678-34667897.35498.38
6353632-35363299.307100.35
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