托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TAAF230001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(%)99.8对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.589751297465974489742697385974470.05
216.489763297582976070.04
单位质量响应值RSD%判断
5877.385922.750.55数据可信
供试品溶液-24062502批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min119043-1904319.32718.996.1919.3319.006.18
217627-1762717.89017.89
320774-2077421.08421.08
417693-1769317.95717.96
518779-1877919.05919.06
618375-1837518.64918.65
10min131499-3149931.96932.583.2632.0832.693.27
231713-3171332.18632.29
333905-3390534.41134.53
431292-3129231.75931.86
532820-3282033.31033.42
631383-3138331.85131.95
15min137272-3727237.82839.103.2438.1139.383.24
238796-3879639.37539.65
340714-4071441.32141.63
438342-3834238.91439.19
538633-3863339.20939.50
637388-3738837.94638.23
20min143976-4397644.63243.464.6645.1343.964.63
239975-3997540.57141.07
345328-4532846.00446.54
440964-4096441.57542.07
543603-4360344.25344.76
643054-4305443.69644.19
30min145781-4578146.46448.353.1047.2149.093.09
246681-4668147.37748.10
350035-5003550.78151.57
447175-4717547.87948.60
548336-4833649.05749.81
647819-4781948.53249.27
45min153541-5354154.34054.363.0655.3455.373.06
252659-5265953.44554.43
356657-5665757.50258.58
452367-5236753.14854.14
553798-5379854.60155.63
652333-5233353.11454.12
60min159088-5908859.97059.014.0161.2760.323.98
256236-5623657.07558.36
362128-6212863.05564.45
455623-5562356.45357.74
557541-5754158.39959.73
658223-5822359.09260.39
90min162502-6250263.43462.914.0965.0764.564.06
259609-5960960.49862.10
365912-6591266.89568.64
459694-5969460.58562.18
560442-6044261.34463.00
663762-6376264.71366.34
120min167704-6770468.71467.574.2870.7069.564.23
265608-6560866.58768.52
371629-7162972.69874.81
464130-6413065.08767.02
563996-6399664.95166.95
666401-6640167.39269.38
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170972-7097272.03169.354.2374.4071.724.18
268303-6830369.32271.63
371941-7194173.01475.54
464082-6408265.03867.33
568226-6822669.24471.60
666433-6643367.42469.79
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TAAF230001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(%)99.8对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.589906699103990659901098896990280.09
216.489715697082971190.06
单位质量响应值RSD%判断
5972.745893.140.95数据可信
供试品溶液-24062503批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min114991-1499115.13114.584.6715.1314.584.67
214805-1480514.94314.94
315059-1505915.19915.20
413750-1375013.87813.88
514610-1461014.74614.75
613466-1346613.59213.59
10min128184-2818428.44728.133.1328.5328.213.13
228138-2813828.40028.48
328255-2825528.51828.60
426270-2627026.51526.59
528782-2878229.05029.13
627592-2759227.84927.92
15min133548-3354833.86133.662.4534.1033.902.46
234240-3424034.55934.80
334109-3410934.42734.67
432060-3206032.35932.58
533293-3329333.60333.85
632843-3284333.14933.38
20min135566-3556635.89836.402.3036.3336.832.30
236425-3642536.76537.20
337497-3749737.84738.28
435105-3510535.43235.84
536030-3603036.36636.80
635786-3578636.12036.53
30min141245-4124541.63041.821.5442.2642.441.54
242213-4221342.60743.24
342151-4215142.54443.19
440905-4090541.28641.89
540663-4066341.04241.67
641400-4140041.78642.40
45min144551-4455144.96645.301.3045.8346.161.31
245714-4571446.14047.01
345485-4548545.90946.79
444236-4423644.64945.48
544655-4465545.07145.93
644628-4462845.04445.89
60min147142-4714247.58247.791.3348.6948.901.29
246464-4646446.89748.03
347400-4740047.84248.98
446964-4696447.40248.48
548023-4802348.47149.58
648083-4808348.53149.63
90min150441-5044150.91152.141.4552.2953.521.40
251402-5140251.88153.27
352479-5247952.96854.37
452392-5239252.88154.22
551557-5155752.03853.42
651676-5167652.15853.52
120min157649-5764958.18756.032.6859.8457.692.61
254730-5473055.24056.92
356695-5669557.22458.92
454970-5497055.48357.12
553474-5347453.97355.64
655548-5554856.06657.72
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159415-5941559.96959.212.2861.9561.182.20
257654-5765458.19260.18
359327-5932759.88061.89
459740-5974060.29762.24
556400-5640056.92658.89
659421-5942159.97561.94
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