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5000
标示量(mg)2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%
110.446665566950668896698466924668800.20
210.536806668559683120.52
单位质量响应值RSD%判断
6406.136487.370.90数据可信
供试品溶液-J049F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%
5min15974-59748.3147.795.048.317.795.02
25643-56437.8547.85
35478-54787.6247.62
45736-57367.9837.98
55129-51297.1387.14
65626-56267.8307.83
10min111831-1183116.46616.163.6716.4816.183.67
211264-1126415.67715.69
311651-1165116.21616.23
412114-1211416.86016.87
510963-1096315.25815.27
611864-1186416.51216.53
15min116511-1651122.98022.392.3623.0222.432.36
215771-1577121.95021.99
316211-1621122.56222.60
416064-1606422.35822.40
515535-1553521.62121.66
616432-1643222.87022.91
20min120161-2016128.06027.253.0028.1427.333.01
218986-1898626.42426.50
319702-1970227.42127.50
420360-2036028.33728.42
519081-1908126.55726.63
619180-1918026.69426.77
30min124816-2481634.53834.141.5634.6634.261.56
224207-2420733.69133.81
324680-2468034.34934.47
424925-2492534.69034.82
523936-2393633.31433.43
624611-2461134.25334.38
45min129806-2980641.48340.991.1341.6741.171.14
228962-2896240.30940.48
329574-2957441.16041.34
429754-2975441.41141.59
529174-2917440.60440.78
629437-2943740.97041.15
60min133536-3353646.67546.211.2446.9346.461.24
232616-3261645.39445.64
333310-3331046.36046.61
433693-3369346.89347.15
532846-3284645.71445.96
633205-3320546.21446.46
90min138410-3841053.45852.931.4053.7953.261.41
237333-3733351.95952.28
338173-3817353.12853.45
438804-3880454.00754.34
537769-3776952.56652.88
637715-3771552.49152.82
120min142341-4234158.92957.852.0559.3558.262.05
240326-4032656.12556.53
341494-4149457.75158.17
442691-4269159.41659.84
541399-4139957.61858.02
641128-4112857.24157.65
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143546-4354660.60659.381.5661.1259.891.56
241726-4172658.07358.57
342678-4267859.39859.91
443285-4328560.24360.76
542313-4231358.89059.39
642448-4244859.07859.59
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5000
标示量(mg)2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%
110.446809468124679536783667795679600.22
210.536971369851697820.14
单位质量响应值RSD%判断
6509.586626.971.27数据可信
供试品溶液-J049F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%
5min15538-55387.5657.846.287.577.846.24
25275-52757.2067.21
35473-54737.4777.48
45993-59938.1878.19
56188-61888.4538.45
65976-59768.1648.16
10min110809-1080914.76615.703.9314.7815.713.92
211145-1114515.22515.24
311577-1157715.81515.83
411902-1190216.25916.27
511994-1199416.38516.40
611518-1151815.73515.75
15min115558-1555821.25421.661.7221.2921.701.72
215504-1550421.18021.22
315862-1586221.66921.71
416069-1606921.95221.99
516164-1616422.08122.12
615985-1598521.83721.88
20min119046-1904626.01826.321.3226.0926.401.32
219208-1920826.24026.31
319244-1924426.28926.36
419765-1976527.00127.08
519212-1921226.24526.32
619136-1913626.14126.22
30min124255-2425533.13432.851.1833.2532.961.17
224045-2404532.84732.96
324144-2414432.98333.10
424230-2423033.10033.22
524103-2410332.92733.05
623490-2349032.08932.21
45min128989-2898939.60139.641.6039.7739.821.59
229746-2974640.63640.81
329268-2926839.98340.16
429031-2903139.65939.84
528643-2864339.12939.31
628442-2844238.85439.03
60min132540-3254044.45244.751.9244.6944.991.91
233834-3383446.22046.46
332726-3272644.70644.95
433037-3303745.13145.37
532397-3239744.25744.50
632011-3201143.73043.97
90min137311-3731150.97051.380.9551.2851.700.95
237440-3744051.14651.46
337836-3783651.68752.00
437746-3774651.56451.88
538142-3814252.10552.42
637203-3720350.82251.13
120min140839-4083955.79055.952.6556.1956.352.63
240778-4077855.70656.11
343050-4305058.81059.21
440807-4080755.74656.15
540288-4028855.03755.44
639978-3997854.61355.01
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142152-4215257.58357.630.5658.0758.130.56
242153-4215357.58558.08
342601-4260158.19758.70
442011-4201157.39157.89
541942-4194257.29657.79
642275-4227557.75158.24
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5000
标示量(mg)2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%
110.446828867917681846819768181681530.21
210.536881468934688740.13
单位质量响应值RSD%判断
6528.076540.740.14数据可信
供试品溶液-J050F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%
5min16812-68129.3539.004.489.359.004.46
26132-61328.4208.42
36517-65178.9488.95
46580-65809.0359.03
56355-63558.7268.73
66935-69359.5229.52
10min112753-1275317.51117.052.9717.5317.062.99
211886-1188616.32016.33
312542-1254217.22117.24
412827-1282717.61217.63
512101-1210116.61516.63
612389-1238917.01117.03
15min117340-1734023.80923.122.4123.8523.162.40
216555-1655522.73122.77
317148-1714823.54523.59
417091-1709123.46723.51
516361-1636122.46522.51
616523-1652322.68722.73
20min120740-2074028.47727.861.5028.5627.941.50
220140-2014027.65327.73
320084-2008427.57627.66
420168-2016827.69227.78
520612-2061228.30128.38
620014-2001427.48027.56
30min125514-2551435.03234.561.1835.1634.691.18
224740-2474033.96934.09
325440-2544034.93135.06
425276-2527634.70534.84
524971-2497134.28734.41
625077-2507734.43234.56
45min130627-3062742.05341.411.3542.2441.591.34
229536-2953640.55540.74
330302-3030241.60641.79
430498-3049841.87542.06
530084-3008441.30741.49
629889-2988941.03941.22
60min134141-3414146.87846.261.1947.1446.511.19
233252-3325245.65745.91
333821-3382146.43846.69
434143-3414346.88047.14
533397-3339745.85646.11
633375-3337545.82646.08
90min139070-3907053.64553.111.2453.9853.441.24
238086-3808652.29452.62
338774-3877453.23953.57
439359-3935954.04254.38
538398-3839852.72353.05
638374-3837452.69053.02
120min142619-4261958.51857.811.2158.9558.231.21
241515-4151557.00257.42
342239-4223957.99758.42
442644-4264458.55358.98
542088-4208857.78958.21
641495-4149556.97557.39
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144012-4401260.43159.651.4360.9660.161.43
242744-4274458.69059.20
343700-4370060.00360.52
444108-4410860.56361.09
543402-4340259.59360.11
642676-4267658.59759.11
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5000
标示量(mg)2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%
110.446872568466691406896568585687760.41
210.536961870011698140.40
单位质量响应值RSD%判断
6587.746630.010.46数据可信
供试品溶液-J050F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%
5min16907-69079.3779.095.389.389.095.35
26607-66078.9708.97
36818-68189.2569.26
46971-69719.4649.46
56867-68679.3239.32
66007-60078.1558.16
10min112723-1272317.27317.013.9417.2917.023.94
212595-1259517.09917.11
312928-1292817.55117.57
412564-1256417.05717.07
512795-1279517.37017.39
611559-1155915.69215.71
15min117110-1711023.22822.632.2623.2722.672.26
216657-1665722.61422.66
316898-1689822.94122.99
416603-1660322.54022.58
516736-1673622.72122.77
615997-1599721.71721.76
20min120324-2032427.59227.112.2827.6727.192.29
220099-2009927.28627.37
320201-2020127.42527.51
419987-1998727.13427.22
520119-2011927.31427.40
619066-1906625.88425.96
30min124944-2494433.86433.521.5333.9933.641.53
224815-2481533.68933.82
324869-2486933.76233.89
424407-2440733.13533.26
525031-2503133.98234.11
624057-2405732.66032.78
45min129695-2969540.31439.981.4140.5040.161.41
229929-2992940.63240.81
329633-2963340.23040.41
429342-2934239.83540.02
529351-2935139.84740.03
628731-2873139.00539.18
60min133584-3358445.59444.951.5645.8545.201.57
233356-3335645.28445.53
333181-3318145.04645.30
432847-3284744.59344.84
533503-3350345.48445.73
632208-3220843.72643.96
90min138479-3847952.23951.641.8052.5751.961.80
238436-3843652.18152.51
338643-3864352.46252.79
437751-3775151.25151.57
538095-3809551.71852.04
636807-3680749.96950.28
120min142074-4207457.12056.132.0257.5456.542.02
241738-4173856.66357.08
342121-4212157.18357.60
440682-4068255.23055.64
541428-4142856.24356.66
640023-4002354.33554.73
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143252-4325258.71957.911.5259.2358.421.52
243150-4315058.58059.09
343122-4312258.54259.05
442144-4214457.21557.71
542633-4263357.87858.39
641655-4165556.55157.04
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