他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.681273121272891272951274471269551272600.15
212.671282451284751283600.13
单位质量响应值RSD%判断
10036.2810131.020.67数据可信
供试品溶液-2025091521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%
5min110895-108958.6389.6839.838.649.6839.84
27672-76726.0836.08
315385-1538512.19812.20
413513-1351310.71310.71
519366-1936615.35415.35
66463-64635.1245.12
10min123582-2358218.69618.559.4818.7018.559.48
221418-2141816.98116.98
327470-2747021.77921.78
422742-2274218.03018.03
523637-2363718.74018.74
621519-2151917.06117.06
15min132113-3211325.46024.716.0925.4624.716.09
229045-2904523.02823.03
334253-3425327.15727.16
430250-3025023.98323.98
531597-3159725.05125.05
629739-2973923.57823.58
20min138183-3818330.27229.396.5230.2729.386.52
233815-3381526.80926.81
340707-4070732.27432.27
437196-3719629.49029.49
537413-3741329.66229.66
635079-3507927.81227.81
30min145879-4587936.37436.053.9236.3736.053.93
243178-4317834.23334.23
347878-4787837.95937.96
445719-4571936.24736.25
546572-4657236.92336.92
643630-4363034.59134.59
45min150570-5057040.09341.005.0540.0941.005.05
251461-5146140.80040.80
356731-5673144.97844.98
450701-5070140.19740.20
551659-5165940.95740.96
649166-4916638.98038.98
极限165081-6508151.59851.155.2351.6051.155.23
264093-6409350.81550.81
367726-6772653.69553.69
465647-6564752.04752.05
566424-6642452.66352.66
658112-5811246.07346.07
他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.681286461284491285961285571284011285300.08
212.671285651285881285760.02
单位质量响应值RSD%判断
10136.4410148.070.09数据可信
供试品溶液-2025091522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%
5min15192-51924.0926.2427.124.096.2427.14
25393-53934.2514.25
39017-90177.1077.11
49141-91417.2057.21
58288-82886.5336.53
610439-104398.2288.23
10min121214-2121416.72119.0810.9516.7219.0810.95
220692-2069216.31016.31
324353-2435319.19619.20
426448-2644820.84720.85
526646-2664621.00321.00
625870-2587020.39120.39
15min131278-3127824.65426.186.2324.6526.186.23
230200-3020023.80423.80
333203-3320326.17226.17
434867-3486727.48327.48
535257-3525727.79127.79
634479-3447927.17727.18
20min138515-3851530.35931.184.4330.3631.184.43
236827-3682729.02829.03
339032-3903230.76630.77
441075-4107532.37632.38
541330-4133032.57732.58
640588-4058831.99331.99
30min147339-4733937.31437.802.9037.3137.802.91
245720-4572036.03836.04
347568-4756837.49437.49
448914-4891438.55538.56
549634-4963439.12339.12
648597-4859738.30538.31
45min156562-5656244.58444.902.0144.5844.902.01
255595-5559543.82243.82
356148-5614844.25744.26
457695-5769545.47745.48
558780-5878046.33246.33
657036-5703644.95744.96
极限168253-6825353.79953.761.3453.8053.761.34
267393-6739353.12153.12
367027-6702752.83352.83
468283-6828353.82353.82
569590-6959054.85354.85
668650-6865054.11254.11
他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.681277541280871282241281871284361281380.20
212.671276681280381278530.21
单位质量响应值RSD%判断
10105.5210091.000.11数据可信
供试品溶液-2025091621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%
5min111386-113869.0149.887.329.019.887.32
211796-117969.3389.34
311942-119429.4549.45
413292-1329210.52310.52
513682-1368210.83210.83
612814-1281410.14410.14
10min123383-2338318.51119.354.0118.5119.344.02
223006-2300618.21318.21
324894-2489419.70819.71
424950-2495019.75219.75
525095-2509519.86719.87
625290-2529020.02120.02
15min131130-3113024.64425.913.7824.6425.903.78
231213-3121324.71024.71
333477-3347726.50226.50
433363-3336326.41226.41
533150-3315026.24426.24
634006-3400626.92126.92
20min137517-3751729.70130.883.6929.7030.883.69
237337-3733729.55829.56
339855-3985531.55231.55
439851-3985131.54831.55
538567-3856730.53230.53
640931-4093132.40332.40
30min143184-4318434.18737.314.8834.1937.314.87
245958-4595836.38336.38
348788-4878838.62438.62
448854-4885438.67638.68
546972-4697237.18637.19
649042-4904238.82538.82
45min155068-5506843.59544.472.4543.6044.472.45
255014-5501443.55243.55
357853-5785345.80045.80
455619-5561944.03144.03
555501-5550143.93843.94
657987-5798745.90645.91
极限166342-6634252.52053.811.7552.5253.811.75
267269-6726953.25453.25
369253-6925354.82554.82
468256-6825654.03654.04
567376-6737653.33953.34
669304-6930454.86554.87
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