托吡司特多替诺雷片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TOP-20231101对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.121289708128974512904171291387128931512901140.07
210.101292303128869112904970.20
单位质量响应值RSD%判断
127481.62127771.980.17数据可信
供试品溶液-25110601批-托吡司特-shui(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1325739-32573922.90222.7112.1322.9022.7112.13
2320740-32074022.55022.55
3388365-38836527.30527.30
4333989-33398923.48223.48
5271738-27173819.10519.10
6297833-29783320.94020.94
10min1509529-50952935.82335.903.2435.9536.033.26
2500412-50041235.18235.31
3542365-54236538.13238.28
4512223-51222336.01336.14
5498114-49811435.02135.13
6501090-50109035.23035.35
15min1561640-56164039.48739.521.2739.8139.851.31
2556729-55672939.14239.46
3575992-57599240.49640.86
4561817-56181739.49939.83
5559076-55907639.30739.61
6557577-55757739.20139.51
20min1580181-58018140.79140.770.9741.3441.321.01
2578945-57894540.70441.24
3590353-59035341.50642.09
4579923-57992340.77241.32
5575605-57560540.46940.99
6574516-57451640.39240.92
30min1597238-59723841.99042.211.1042.7642.981.12
2597281-59728141.99342.76
3611900-61190043.02143.84
4592859-59285941.68242.46
5599870-59987042.17542.92
6603282-60328242.41543.17
45min1610650-61065042.93342.910.4343.9443.920.47
2609420-60942042.84643.84
3613806-61380643.15544.21
4611976-61197643.02644.03
5610092-61009242.89443.87
6606113-60611342.61443.60
60min1611650-61165043.00343.170.3544.2544.410.38
2613963-61396343.16644.40
3617623-61762343.42344.72
4612488-61248843.06244.31
5613158-61315843.10944.33
6614930-61493043.23444.46
90min1614067-61406743.17343.340.4444.6644.820.37
2615905-61590543.30244.78
3613834-61383443.15744.70
4615173-61517343.25144.74
5620232-62023243.60645.06
6619066-61906643.52444.99
120min1603398-60339842.42342.871.5644.1544.601.51
2613783-61378343.15344.87
3615326-61532643.26245.04
4614695-61469543.21744.94
5618198-61819843.46345.16
6593358-59335841.71743.43
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1610909-61090942.95143.380.5244.9145.340.51
2616313-61631343.33145.29
3619293-61929343.54045.56
4619074-61907443.52545.49
5618340-61834043.47345.41
6618201-61820143.46445.40
托吡司特多替诺雷片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号241101对照品来源原料药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%
110.273247432595325103265532628325720.24
210.253262132626326240.02
单位质量响应值RSD%判断
3171.573182.830.26数据可信
供试品溶液-25110601批-多替诺雷-shui(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110325-1032529.21830.1615.7629.2230.1615.76
210575-1057529.92629.93
313602-1360238.49238.49
411184-1118431.64931.65
58704-870424.63124.63
69557-955727.04527.04
10min122306-2230663.12362.855.7863.2963.025.80
221493-2149360.82260.99
324607-2460769.63469.85
422360-2236063.27663.45
521073-2107359.63459.77
621410-2141060.58760.74
15min126924-2692476.19175.792.6076.7076.302.63
226777-2677775.77576.28
328062-2806279.41280.01
426353-2635374.57575.10
526484-2648474.94675.41
626091-2609173.83474.32
20min129090-2909082.32181.422.2583.2682.362.28
229006-2900682.08383.01
329794-2979484.31385.35
428092-2809279.49680.44
528465-2846580.55281.44
628192-2819279.77980.68
30min130839-3083987.27086.642.4488.6688.032.45
230745-3074587.00488.39
331729-3172989.78991.30
429421-2942183.25784.64
530437-3043786.13287.46
630531-3053186.39887.74
45min131854-3185490.14289.151.9492.0291.021.96
231855-3185590.14592.01
332311-3231191.43693.44
430703-3070386.88588.73
531340-3134088.68890.50
630958-3095887.60789.43
60min132034-3203490.65289.871.7993.0392.241.80
231929-3192990.35592.72
332389-3238991.65694.17
430742-3074286.99689.32
531910-3191090.30192.60
631550-3155089.28291.59
90min131447-3144788.99189.111.3591.8791.971.35
231852-3185290.13793.00
331782-3178289.93992.96
430687-3068786.84089.65
531505-3150589.15591.96
631663-3166389.60292.40
120min131953-3195390.42388.771.7893.8092.131.78
231453-3145389.00892.38
331840-3184090.10393.63
430583-3058386.54689.84
531581-3158189.37092.67
630804-3080487.17190.47
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132326-3232691.47891.311.1395.3695.161.18
232490-3249091.94295.80
332831-3283192.90796.93
431820-3182090.04693.82
532129-3212990.92194.72
632006-3200690.57394.36
托吡司特多替诺雷片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TOP-20231101对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.121308026131103613127651307357130962513097620.17
210.101329669133060213301360.05
单位质量响应值RSD%判断
129423.12131696.631.24数据可信
供试品溶液-25110601批-托吡司特-shui(内含1.0%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1226080-22608015.53920.0116.3415.5420.0116.34
2334775-33477523.01023.01
3340206-34020623.38323.38
4263974-26397418.14418.14
5258966-25896617.79917.80
6322609-32260922.17422.17
10min1530848-53084836.48638.604.1336.5738.714.17
2586678-58667840.32440.45
3585253-58525340.22640.36
4554768-55476838.13038.23
5541245-54124537.20137.30
6570965-57096539.24439.37
15min1622546-62254642.78943.822.1343.0844.142.17
2649705-64970544.65645.01
3651805-65180544.80045.15
4639966-63996643.98644.30
5619568-61956842.58442.89
6641321-64132144.07944.42
20min1664172-66417245.65046.311.8646.1846.881.87
2678768-67876846.65347.25
3677447-67744746.56247.16
4693716-69371647.68148.24
5658163-65816345.23745.78
6670580-67058046.09146.68
30min1702933-70293348.31448.560.6749.0949.380.73
2711526-71152648.90549.76
3710606-71060648.84249.70
4704687-70468748.43549.26
5699769-69976948.09748.89
6709322-70932248.75349.60
45min1726728-72672849.95050.140.5151.0051.240.55
2736128-73612850.59651.73
3729635-72963550.14951.28
4729219-72921950.12151.21
5725587-72558749.87150.93
6729540-72954050.14351.26
60min1733198-73319850.39450.640.3851.7252.010.43
2740192-74019250.87552.29
3738501-73850150.75952.17
4738410-73841050.75352.12
5734160-73416050.46151.80
6735917-73591750.58151.97
90min1750210-75021051.56451.401.5353.1753.061.52
2760957-76095752.30254.00
3751909-75190951.68053.37
4748666-74866651.45853.11
5726563-72656349.93851.56
6748864-74886451.47153.14
120min1751794-75179451.67351.571.0953.5753.521.10
2755733-75573351.94353.93
3751279-75127951.63753.62
4754569-75456951.86353.80
5734135-73413550.45952.35
6754706-75470651.87353.83
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1757522-75752252.06651.960.9054.2554.180.92
2764032-76403252.51454.79
3756616-75661652.00454.27
4757361-75736152.05554.28
5743440-74344051.09853.27
6756491-75649151.99554.24
托吡司特多替诺雷片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号241101对照品来源原料药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%
110.273324933131333033323133345332520.25
210.253357933584335820.02
单位质量响应值RSD%判断
3237.783276.290.84数据可信
供试品溶液-25110601批-多替诺雷-shui(内含1.0%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17242-724219.99225.8516.1119.9925.8516.12
210917-1091730.13730.14
310788-1078829.78129.78
48609-860923.76623.77
58350-835023.05123.05
610279-1027928.37628.38
10min120787-2078757.38462.095.3857.5062.245.40
223854-2385465.85166.02
323664-2366465.32665.49
422546-2254662.24062.37
521428-2142859.15459.28
622677-2267762.60262.76
15min126221-2622172.38575.082.6572.8275.572.67
227654-2765476.34176.87
327855-2785576.89677.42
427772-2777276.66777.14
526392-2639272.85773.31
627290-2729075.33675.84
20min128911-2891179.81181.665.0880.6482.565.04
229412-2941281.19482.15
329227-2922780.68481.64
432558-3255889.87990.78
528357-2835778.28279.14
629018-2901880.10781.03
30min130717-3071784.79785.600.7086.0786.950.71
231032-3103285.66687.07
330944-3094485.42386.83
431272-3127286.32987.73
531221-3122186.18887.48
630851-3085185.16786.54
45min131663-3166387.40887.980.9989.1589.821.01
231709-3170987.53589.42
332032-3203288.42790.31
432445-3244589.56791.45
531718-3171887.56089.34
631663-3166387.40889.25
60min131761-3176187.67987.981.0989.9190.301.08
231692-3169287.48889.86
331831-3183187.87290.24
432418-3241889.49391.87
532094-3209488.59890.86
631415-3141586.72489.05
90min131807-3180787.80687.601.2790.5390.421.25
231843-3184387.90590.76
331645-3164587.35990.22
432347-3234789.29792.17
531654-3165487.38390.14
631103-3110385.86288.67
120min131513-3151386.99487.171.5590.2090.461.52
231493-3149386.93990.28
331265-3126586.31089.65
432467-3246789.62893.00
531669-3166987.42590.66
631043-3104385.69788.98
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132233-3223388.98289.070.9892.6792.860.99
232333-3233389.25893.09
332148-3214888.74792.57
432852-3285290.69194.56
532055-3205588.49092.22
631972-3197288.26192.02
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