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%
116.709684396807967889682196734967990.05
216.669676496736967500.03
单位质量响应值RSD%判断
5796.355807.320.14数据可信
供试品溶液-24060501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%
5min117322-1732217.87818.413.4317.8818.413.42
217003-1700317.54917.55
317913-1791318.48818.49
417849-1784918.42218.42
518230-1823018.81518.81
618702-1870219.30219.30
10min129293-2929330.23330.363.9730.3330.473.97
227940-2794028.83728.93
328367-2836729.27729.38
431165-3116532.16532.27
529985-2998530.94731.05
629774-2977430.72930.84
15min136156-3615637.31636.741.0137.5837.001.01
235158-3515836.28636.54
335351-3535136.48536.75
435616-3561636.75937.04
535459-3545936.59736.87
635824-3582436.97437.25
20min140655-4065541.96042.142.3542.4342.612.34
239187-3918740.44440.90
340433-4043341.73042.20
441431-4143142.76043.25
541490-4149042.82143.30
641769-4176943.10943.59
30min147647-4764749.17648.212.1649.8848.922.15
245447-4544746.90547.59
345537-4553746.99847.70
447728-4772849.26049.98
547153-4715348.66649.38
646750-4675048.25048.97
45min152398-5239854.07954.612.2355.0655.592.22
250969-5096952.60553.55
353188-5318854.89555.86
454542-5454256.29257.29
553180-5318054.88655.87
653221-5322154.92955.92
60min156485-5648558.29759.042.4859.5860.322.45
256307-5630758.11459.35
357410-5741059.25260.52
459555-5955561.46662.78
557896-5789659.75461.05
655566-5556657.34958.65
90min164028-6402866.08364.832.6267.6966.442.58
260637-6063762.58364.14
364475-6447566.54468.14
464269-6426966.33167.98
561664-6166463.64365.27
661790-6179063.77365.39
120min166077-6607768.19768.331.6170.1770.301.57
265036-6503667.12369.03
367834-6783470.01171.98
465086-6508667.17469.19
566456-6645668.58870.57
666721-6672168.86270.83
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169933-6993372.17772.532.4774.5374.882.43
268237-6823770.42772.71
370672-7067272.94075.29
473406-7340675.76178.15
569499-6949971.72974.09
669908-6990872.15174.50
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%
116.709678396723967129672696792967470.04
216.669779597722977580.06
单位质量响应值RSD%判断
5793.235867.830.91数据可信
供试品溶液-24060502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%
5min115391-1539115.80716.222.3315.8116.222.34
215545-1554515.96515.97
316071-1607116.50616.51
416353-1635316.79516.80
515552-1555215.97315.97
615822-1582216.25016.25
10min126872-2687227.59927.841.2527.6927.941.24
227455-2745528.19828.29
327525-2752528.27028.36
427203-2720327.93928.03
526910-2691027.63827.73
626700-2670027.42227.51
15min134679-3467935.61735.291.1635.8635.531.15
233623-3362334.53234.78
334447-3444735.37935.63
434657-3465735.59435.84
534220-3422035.14635.39
634513-3451335.44735.69
20min139202-3920240.26240.682.4640.7041.122.44
240298-4029841.38841.83
340716-4071641.81742.26
438420-3842039.45939.91
538654-3865439.70040.14
640354-4035441.44641.89
30min146099-4609947.34649.487.4548.0150.157.36
247465-4746548.74949.42
347451-4745148.73549.41
447416-4741648.69949.36
545359-4535946.58647.24
655281-5528156.77657.45
45min152578-5257854.00054.760.9354.9355.700.91
253363-5336354.80655.74
353237-5323754.67755.63
453345-5334554.78855.72
554128-5412855.59256.51
653231-5323154.67155.66
60min158205-5820559.77960.631.3261.0161.871.32
259316-5931660.92062.16
359581-5958161.19362.44
458771-5877160.36161.60
558203-5820359.77761.00
660119-6011961.74563.03
90min162177-6217763.85966.723.2865.4268.303.22
267378-6737869.20170.78
362791-6279164.48966.08
466014-6601467.80069.38
564690-6469066.44068.00
666725-6672568.53070.16
120min156650-5665058.18267.227.0960.0969.176.94
268383-6838370.23372.20
365466-6546667.23769.19
467112-6711268.92770.88
565301-6530167.06768.99
669778-6977871.66573.68
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172134-7213474.08574.202.0876.3276.522.05
274217-7421776.22578.58
372027-7202773.97576.30
472799-7279974.76877.10
569639-6963971.52373.82
672646-7264674.61177.02
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%
116.709681296807968519687896805968310.04
216.669753797492975140.04
单位质量响应值RSD%判断
5798.265853.180.67数据可信
供试品溶液-24053001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%
5min112811-1281113.16813.577.6413.1713.577.64
213096-1309613.46113.46
312565-1256512.91512.92
412564-1256412.91412.91
515212-1521215.63615.64
612964-1296413.32513.33
10min120585-2058521.15921.753.1721.2321.823.16
220183-2018320.74620.82
321690-2169022.29522.37
421945-2194522.55722.63
521398-2139821.99522.08
621152-2115221.74221.82
15min127510-2751028.27727.622.3028.4727.822.29
226622-2662227.36427.55
325815-2581526.53526.73
427399-2739928.16328.36
526817-2681727.56527.77
627076-2707627.83128.03
20min132292-3229233.19232.273.2033.5432.623.17
231476-3147632.35332.70
330094-3009430.93331.28
432593-3259333.50233.86
530361-3036131.20731.57
631554-3155432.43432.78
30min136852-3685237.87938.602.3438.4139.132.30
238031-3803139.09139.61
337700-3770038.75139.27
438962-3896240.04840.59
536554-3655437.57338.11
637230-3723038.26838.80
45min144542-4454245.78445.631.8846.5346.381.87
243984-4398445.21045.95
343617-4361744.83345.56
445418-4541846.68447.45
543499-4349944.71245.46
645301-4530146.56447.31
60min149276-4927650.65050.322.8851.6551.322.84
248216-4821649.56050.55
349097-4909750.46651.44
450409-5040951.81452.84
546570-4657047.86848.86
650148-5014851.54652.55
90min157261-5726158.85758.211.3060.1459.481.30
256583-5658358.16059.43
356237-5623757.80559.06
457737-5773759.34760.66
555849-5584957.40658.66
656094-5609457.65858.95
120min162069-6206963.79963.322.1365.4064.922.09
262848-6284864.60066.19
362041-6204163.77165.35
462607-6260764.35265.99
559482-5948261.14062.72
660540-6054062.22863.84
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164526-6452666.32566.641.4968.2868.591.48
264750-6475066.55568.50
364909-6490966.71968.65
466601-6660168.45870.45
563700-6370065.47667.39
664529-6452966.32868.28
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