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%
110.056448564523646916437664222644590.28
210.066459064932647610.38
单位质量响应值RSD%判断
6413.836437.480.27数据可信
供试品溶液-2025072421批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158720-5872081.99174.147.6581.9974.147.65
255756-5575677.85277.85
350511-5051170.52870.53
447019-4701965.65365.65
553207-5320774.29374.29
653376-5337674.52974.53
10min165657-6565791.67787.833.6591.8187.953.65
263670-6367088.90289.03
364457-6445790.00190.12
459518-5951883.10583.21
560874-6087484.99885.12
663234-6323488.29488.42
15min166912-6691293.42991.922.1193.7292.192.11
267146-6714693.75694.03
366848-6684893.34093.61
463959-6395989.30689.55
564370-6437089.88090.15
665763-6576391.82592.10
20min167037-6703793.60492.961.9194.0593.381.91
268173-6817395.19095.62
367135-6713593.74194.16
464549-6454990.13090.53
565694-6569491.72892.14
666847-6684793.33893.76
30min167335-6733594.02094.041.9494.6294.621.94
269498-6949897.04097.63
367785-6778594.64895.23
465815-6581591.89792.44
566209-6620992.44893.02
667472-6747294.21194.79
45min167519-6751994.27794.311.5795.0395.051.57
268920-6892096.23396.99
367650-6765094.46095.20
466391-6639192.70293.40
566324-6632492.60893.33
668462-6846295.59396.33
60min167654-6765494.46594.651.2995.3895.541.30
269080-6908096.45697.37
367797-6779794.66595.56
467243-6724393.89194.75
566572-6657292.95493.83
668381-6838195.48096.38
90min169646-6964697.24797.070.7798.3298.120.75
269181-6918196.59797.67
368707-6870795.93596.99
469715-6971597.34398.35
570272-7027298.12199.15
669614-6961497.20298.26
120min1-0.0000.00-1.231.212.05
2-0.0001.24
3-0.0001.21
4-0.0001.17
5-0.0001.20
6-0.0001.22
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1-0.0000.00-1.231.212.05
2-0.0001.24
3-0.0001.21
4-0.0001.17
5-0.0001.20
6-0.0001.22
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%
110.056472564947645896479364591647290.24
210.066506165179651200.13
单位质量响应值RSD%判断
6440.706473.160.36数据可信
供试品溶液-2025072421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%
5min132047-3204744.53141.805.7544.5341.805.76
231209-3120943.36643.37
327012-2701237.53437.53
430536-3053642.43142.43
529652-2965241.20341.20
630048-3004841.75341.75
10min146933-4693365.21562.514.1065.2962.584.10
245332-4533262.99163.06
341695-4169557.93758.00
445985-4598563.89863.97
544196-4419661.41261.48
645781-4578163.61563.68
15min153416-5341674.22472.451.6274.4172.621.63
252463-5246372.89973.08
351040-5104070.92271.08
452470-5247072.90973.09
551438-5143871.47571.65
652006-5200672.26472.44
20min157120-5712079.37077.821.7279.6878.121.71
255298-5529876.83977.14
355968-5596877.77078.05
457192-5719279.47179.77
555556-5555677.19777.49
654893-5489376.27676.57
30min160941-6094184.68082.992.0285.1283.412.02
258428-5842881.18881.61
360013-6001383.39083.80
461229-6122985.08085.51
559230-5923082.30282.72
658500-5850081.28881.71
45min162827-6282787.30185.942.2887.8886.502.27
260772-6077284.44585.01
362513-6251386.86487.41
463814-6381488.67289.25
560210-6021083.66484.22
660957-6095784.70285.26
60min164557-6455789.70487.392.7090.4388.092.69
260748-6074884.41285.11
363166-6316687.77288.46
465043-6504390.38091.10
562340-6234086.62487.32
661475-6147585.42286.12
90min165205-6520590.60588.772.5891.4889.622.57
262151-6215186.36187.20
364618-6461889.78990.63
466062-6606291.79692.67
563045-6304587.60488.44
662228-6222886.46887.31
120min164672-6467289.86489.052.2990.8990.052.28
262355-6235586.64587.63
365210-6521090.61291.60
466101-6610191.85092.87
563248-6324887.88688.87
662937-6293787.45388.44
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165510-6551091.02990.301.2592.2091.451.25
264156-6415689.14790.28
364941-6494190.23891.38
466278-6627892.09693.27
564828-6482890.08191.21
664214-6421489.22890.36
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%
110.056533365715653476535865462654430.25
210.066549565389654420.12
单位质量响应值RSD%判断
6511.746505.170.08数据可信
供试品溶液-2025072421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%
5min19289-928912.80513.239.7312.8113.239.71
210585-1058514.59214.59
39752-975213.44313.44
47985-798511.00811.01
510412-1041214.35314.35
69575-957513.19913.20
10min116237-1623722.38323.687.4922.4023.707.49
218566-1856625.59425.62
318281-1828125.20125.22
415191-1519120.94120.96
517703-1770324.40424.43
617071-1707123.53323.55
15min121793-2179330.04230.394.5630.1030.454.56
223244-2324432.04332.11
322630-2263031.19631.26
420300-2030027.98428.04
522394-2239430.87130.94
621897-2189730.18630.25
20min125063-2506334.55035.763.4534.6635.873.46
226359-2635936.33736.46
326382-2638236.36836.48
424591-2459133.89934.00
526850-2685037.01437.13
626399-2639936.39236.50
30min130041-3004141.41242.212.9441.5842.382.94
231024-3102442.76842.95
331241-3124143.06743.24
429111-2911140.13040.29
530752-3075242.39342.57
631549-3154943.49143.66
45min134507-3450747.56948.541.5547.8048.781.56
235567-3556749.03049.28
335414-3541448.81949.07
434524-3452447.59247.82
535586-3558649.05649.30
635658-3565849.15649.40
60min137990-3799052.37052.991.0952.6853.311.10
238655-3865553.28753.62
338641-3864153.26853.60
437909-3790952.25952.56
538458-3845853.01653.35
638985-3898553.74254.07
90min139298-3929854.17357.503.0154.5857.922.99
241855-4185557.69858.12
342515-4251558.60859.03
441570-4157057.30657.70
542402-4240258.45258.87
642637-4263758.77659.19
120min144460-4446061.28961.810.5961.7862.320.61
244896-4489661.89062.41
344866-4486661.84962.37
444656-4465661.56062.04
544910-4491061.91062.43
645241-4524162.36662.88
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145074-4507462.13663.661.2562.7364.271.26
246339-4633963.88064.50
346525-4652564.13664.76
446223-4622363.72064.31
546191-4619163.67664.29
646716-4671664.39965.02
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%
110.056496165326647476503165200650530.35
210.066494164854648980.10
单位质量响应值RSD%判断
6472.946451.090.24数据可信
供试品溶液-2025072421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%
5min114079-1407919.54819.499.2819.5519.489.29
214125-1412519.61219.61
312737-1273717.68517.68
412367-1236717.17117.17
515452-1545221.45421.45
615448-1544821.44921.45
10min123819-2381933.07133.854.1233.1033.884.12
224664-2466434.24534.28
323054-2305432.00932.04
423766-2376632.99833.03
525687-2568735.66535.70
625272-2527235.08935.12
15min130640-3064042.54243.072.8742.6343.162.87
231257-3125743.39843.49
329909-2990941.52741.61
430345-3034542.13242.22
532280-3228044.81944.91
631705-3170544.02144.11
20min135475-3547549.25549.751.0349.4149.911.04
236287-3628750.38250.54
335571-3557149.38849.54
435632-3563249.47349.63
536300-3630050.40050.57
635714-3571449.58749.75
30min141200-4120057.20457.681.0057.4457.920.99
242248-4224858.65958.90
341735-4173557.94758.18
441602-4160257.76258.00
541183-4118357.18057.43
641280-4128057.31557.57
45min146724-4672464.87465.661.7365.2166.001.72
248515-4851567.36067.70
347605-4760566.09766.43
447433-4743365.85866.19
547359-4735965.75566.10
646113-4611364.02564.37
60min148452-4845267.27369.162.2267.7269.622.21
251333-5133371.27371.73
350845-5084570.59571.04
449446-4944668.65369.10
549846-4984669.20869.67
648967-4896767.98868.44
90min152211-5221172.49275.563.7073.0576.123.67
255028-5502876.40376.98
357983-5798380.50681.06
453703-5370374.56375.12
554505-5450575.67776.25
653090-5309073.71274.28
120min155903-5590377.61877.741.4178.3078.431.40
256803-5680378.86879.57
356949-5694979.07079.76
456032-5603277.79778.48
555109-5510976.51677.22
655143-5514376.56377.25
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157810-5781080.26680.311.2581.0781.131.24
258285-5828580.92581.76
358311-5831180.96181.79
458542-5854281.28282.09
557546-5754679.89980.73
656570-5657078.54479.36
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