多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
110.243252732456327863272532256325500.66
210.323226132316322880.13
单位质量响应值RSD%判断
3178.713128.681.13数据可信
供试品溶液-H139P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%
5min112651-1265135.99433.924.9135.9933.924.91
211193-1119331.84531.85
312374-1237435.20635.21
411780-1178033.51633.52
511331-1133132.23832.24
612195-1219534.69634.70
10min120275-2027557.68554.983.0457.7455.043.04
218956-1895653.93253.99
319664-1966455.94756.01
418834-1883453.58553.64
518766-1876653.39253.45
619443-1944355.31855.38
15min124107-2410768.58765.692.7268.7465.842.72
223201-2320166.01066.15
323388-2338866.54266.69
422525-2252564.08664.23
522399-2239963.72863.87
622916-2291665.19965.35
20min126320-2632074.88471.982.3075.1572.242.30
225421-2542172.32672.58
325425-2542572.33772.60
425084-2508471.36771.62
524682-2468270.22370.47
624873-2487370.76771.03
30min128929-2892982.30779.462.4682.7079.842.46
228570-2857081.28581.66
327838-2783879.20379.59
427564-2756478.42378.79
527120-2712077.16077.53
627542-2754278.36078.74
45min130564-3056486.95884.081.9187.4984.591.91
229810-2981084.81385.32
329257-2925783.24083.76
429246-2924683.20983.71
529004-2900482.52083.01
629439-2943983.75884.26
60min130956-3095688.07486.611.5388.7587.261.53
230750-3075087.48888.14
330607-3060787.08187.73
429903-2990385.07885.72
530602-3060287.06787.70
629828-2982884.86485.51
90min131998-3199891.03888.112.1291.8688.912.11
231429-3142989.41990.22
330729-3072987.42888.23
430989-3098988.16888.95
530438-3043886.60087.38
630238-3023886.03186.82
120min131662-3166290.08287.961.8291.0688.901.82
231507-3150789.64190.59
330942-3094288.03488.98
430535-3053586.87687.80
530571-3057186.97887.90
630274-3027486.13387.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限132631-3263192.83991.251.2793.9792.341.27
232491-3249192.44193.54
331923-3192390.82591.92
431812-3181290.50991.58
531589-3158989.87590.94
631991-3199191.01892.09
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
110.243296232693328583244132503326910.69
210.323313133216331740.19
单位质量响应值RSD%判断
3192.483214.530.49数据可信
供试品溶液-H139P批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13488-34889.7699.325.179.779.325.18
23540-35409.9159.91
33403-34039.5319.53
43207-32078.9828.98
53196-31968.9518.95
63129-31298.7648.76
10min17243-724320.28619.684.8020.3019.704.80
27074-707419.81219.83
37507-750721.02521.04
46963-696319.50219.52
56522-652218.26618.28
66859-685919.21019.22
15min19300-930026.04727.073.7226.1027.123.72
210023-1002328.07228.12
310197-1019728.55928.61
49527-952726.68326.73
59530-953026.69126.74
69411-941126.35826.40
20min111437-1143732.03232.701.6432.1332.801.63
211691-1169132.74432.84
311688-1168832.73532.83
411580-1158032.43332.52
512016-1201633.65433.74
611649-1164932.62632.72
30min114162-1416239.66440.892.1639.8141.042.15
214726-1472641.24441.39
315107-1510742.31142.46
414436-1443640.43240.58
514628-1462840.96941.12
614548-1454840.74540.89
45min117334-1733448.54849.112.0148.7649.322.01
217815-1781549.89550.11
318038-1803850.52050.74
417046-1704647.74147.95
517446-1744648.86249.08
617524-1752449.08049.29
60min119480-1948054.55955.461.1554.8555.751.15
220034-2003456.11056.41
320011-2001156.04656.35
419901-1990155.73856.03
519586-1958654.85555.15
619792-1979255.43255.73
90min122605-2260563.31163.461.4763.7063.851.46
223118-2311864.74865.14
323000-2300064.41764.82
422533-2253363.10963.50
522350-2235062.59762.98
622333-2233362.54962.94
120min124326-2432668.13168.861.4168.6269.361.41
224914-2491469.77870.28
325039-2503970.12870.64
424479-2447968.55969.05
524135-2413567.59668.09
624624-2462468.96669.46
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限125376-2537671.07270.741.3871.6871.351.38
225355-2535571.01371.63
325801-2580172.26272.89
425245-2524570.70571.31
524829-2482969.54070.14
624938-2493869.84570.45
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
110.243285632924328723310833100329720.38
210.323344833320333840.28
单位质量响应值RSD%判断
3219.923234.880.33数据可信
供试品溶液-H139P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%
5min15222-522214.51713.533.7914.5213.533.80
24848-484813.47713.48
34872-487213.54413.54
44789-478913.31313.31
54719-471913.11913.12
64743-474313.18513.19
10min110135-1013528.17527.063.9528.2027.083.96
210027-1002727.87527.90
39656-965626.84426.87
49238-923825.68225.70
510011-1001127.83027.85
69331-933125.94025.96
15min113670-1367038.00237.301.7138.0737.371.71
213610-1361037.83637.90
313453-1345337.39937.47
413209-1320936.72136.79
513485-1348537.48837.56
613083-1308336.37136.44
20min116247-1624745.16744.931.7945.3045.061.79
216399-1639945.58945.72
316513-1651345.90646.04
415793-1579343.90444.03
516152-1615244.90245.03
615860-1586044.09144.22
30min119909-1990955.34755.041.7255.5655.241.72
220214-2021456.19556.40
320076-2007655.81156.02
419527-1952754.28554.48
519743-1974354.88555.09
619313-1931353.69053.89
45min123629-2362965.68865.231.4865.9965.531.49
223833-2383366.25666.56
323806-2380666.18066.48
423136-2313664.31864.61
523382-2338265.00265.30
623009-2300963.96564.25
60min125350-2535070.47371.521.5270.8871.921.52
226239-2623972.94473.36
326004-2600472.29172.70
425496-2549670.87971.28
525958-2595872.16372.57
625308-2530870.35670.75
90min128465-2846579.13279.661.2979.6680.181.29
228981-2898180.56781.10
328997-2899780.61181.14
428588-2858879.47479.99
528846-2884680.19280.72
628044-2804477.96278.47
120min129825-2982582.91383.951.1383.5784.611.13
230345-3034584.35985.03
330400-3040084.51285.18
430392-3039284.48985.14
530515-3051584.83185.49
629707-2970782.58583.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限130914-3091485.94185.591.5486.7486.381.54
231363-3136387.18988.00
331121-3112186.51687.32
430319-3031984.28785.07
530873-3087385.82786.63
630131-3013183.76484.54
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