多替诺雷非布司他片项目信息
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ZZ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%
111.047253272479722397257172491724620.18
211.097407073895739820.17
单位质量响应值RSD%判断
6563.596671.061.15数据可信
供试品溶液-6052601批-多替诺雷-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min119301-1930126.17123.2715.8426.1723.2615.85
215749-1574921.35521.35
312526-1252616.98516.98
417276-1727623.42523.43
518120-1812024.57024.57
619977-1997727.08827.09
10min138729-3872952.51451.195.3552.5651.235.36
235964-3596448.76548.80
334644-3464446.97547.00
439428-3942853.46253.50
538113-3811351.67951.72
639647-3964753.75953.80
15min148283-4828365.46965.012.6165.6065.132.62
247746-4774664.74164.86
345693-4569361.95762.06
448741-4874166.09066.22
547867-4786764.90565.03
649338-4933866.89967.03
20min152918-5291871.75471.771.4771.9972.001.48
253386-5338672.38872.61
351461-5146169.77869.99
453099-5309971.99972.24
552985-5298571.84472.08
653722-5372272.84473.09
30min157870-5787078.46878.631.0578.8378.981.06
258722-5872279.62479.97
357337-5733777.74678.07
457425-5742577.86578.22
557842-5784278.43078.79
658719-5871979.61979.99
45min161265-6126583.07283.361.0983.5683.841.09
262256-6225684.41584.89
361184-6118482.96283.42
460446-6044681.96182.45
561586-6158683.50783.99
662133-6213384.24984.75
60min163524-6352486.13585.880.9386.7686.500.92
263914-6391486.66487.28
363024-6302485.45786.05
462371-6237184.57185.20
563294-6329485.82386.45
663890-6389086.63187.27
极限164036-6403686.82987.391.4487.6088.161.43
265908-6590889.36790.13
364367-6436787.27888.01
463074-6307485.52586.29
564600-6460087.59488.36
664716-6471687.75188.54
多替诺雷非布司他片项目信息
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101278-202405对照品来源中检所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%
111.135516565511445499125512715523475512660.17
211.155612205607605609900.06
单位质量响应值RSD%判断
49529.7450313.001.11数据可信
供试品溶液-6052601批-非布司他-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1174351-17435131.40328.1316.2431.4028.1316.23
2141694-14169425.52125.52
3113180-11318020.38520.39
4160736-16073628.95128.95
5163575-16357529.46229.46
6183577-18357733.06533.06
10min1308284-30828455.52654.714.0355.5854.764.05
2297695-29769553.61953.66
3283048-28304850.98151.01
4312951-31295156.36756.42
5303427-30342754.65254.70
6317096-31709657.11457.17
15min1362800-36280065.34565.092.1665.4965.232.17
2354768-35476863.89964.03
3351369-35136963.28763.41
4364656-36465665.68065.82
5361189-36118965.05565.20
6373539-37353967.28067.43
20min1389178-38917870.09770.221.3370.3570.461.34
2386075-38607569.53869.78
3383473-38347369.06969.29
4390223-39022370.28570.54
5391642-39164270.54070.79
6398468-39846871.77072.03
30min1420093-42009375.66576.030.9576.0476.390.95
2418288-41828875.34075.69
3420562-42056275.74976.09
4419962-41996275.64176.01
5424712-42471276.49776.86
6428964-42896477.26377.64
45min1444362-44436280.03680.730.7580.5381.220.75
2445478-44547880.23780.72
3448111-44811180.71181.18
4447344-44734480.57381.07
5450797-45079781.19581.69
6453262-45326281.63982.15
60min1458660-45866082.61183.650.7883.2484.280.78
2463812-46381283.53984.15
3465130-46513083.77784.38
4463295-46329583.44684.08
5466181-46618183.96684.59
6469511-46951184.56685.21
极限1482040-48204086.82286.350.8987.5987.120.89
2485445-48544587.43688.19
3477022-47702285.91886.66
4473468-47346885.27886.05
5477458-47745885.99786.77
6481060-48106086.64687.43
多替诺雷非布司他片项目信息
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ZZ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%
111.047336673311733107361673354733910.18
211.097342173357733890.07
单位质量响应值RSD%判断
6647.746617.580.33数据可信
供试品溶液-6052602批-多替诺雷-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min118332-1833224.79825.2510.9324.8025.2410.93
220673-2067327.96527.96
318956-1895625.64225.64
414840-1484020.07420.07
519275-1927526.07426.07
619909-1990926.93126.93
10min138201-3820151.67553.186.1151.7253.226.11
239623-3962353.59953.65
339765-3976553.79153.83
435678-3567848.26248.30
543052-4305258.23758.28
639543-3954353.49153.54
15min147592-4759264.37966.252.9964.5166.382.99
249254-4925466.62766.76
349547-4954767.02367.16
446938-4693863.49463.61
550929-5092968.89369.03
649599-4959967.09467.23
20min152142-5214270.53472.702.2770.7772.942.28
254022-5402273.07773.32
354472-5447273.68573.93
452687-5268771.27171.49
555508-5550875.08775.34
653650-5365072.57472.82
30min158392-5839278.98879.721.1179.3480.091.12
258849-5884979.60679.98
359059-5905979.89080.26
458937-5893779.72580.06
560107-6010781.30881.69
658277-5827778.83379.20
45min160729-6072982.14984.111.4182.6384.601.41
262241-6224184.19584.70
362607-6260784.69085.19
462532-6253284.58885.06
563252-6325285.56286.08
661689-6168983.44883.95
60min162405-6240584.41785.871.4985.0486.511.49
263369-6336985.72186.36
363897-6389786.43587.08
463816-6381686.32586.94
564900-6490087.79288.45
662509-6250984.55785.19
极限163735-6373586.21687.681.4286.9888.461.42
264969-6496987.88588.67
365041-6504187.98288.77
465404-6540488.47389.23
566032-6603289.32390.13
663737-6373786.21887.00
多替诺雷非布司他片项目信息
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101278-202405对照品来源中检所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%
111.135576055571035588905592585593975584510.19
211.155609525625625617570.21
单位质量响应值RSD%判断
50175.2950381.790.30数据可信
供试品溶液-6052602批-非布司他-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1169917-16991730.38530.1410.2230.3930.1410.22
2186436-18643633.33933.34
3168103-16810330.06130.06
4135929-13592924.30724.31
5175433-17543331.37231.37
6175617-17561731.40531.40
10min1305063-30506354.55355.885.8154.6055.925.81
2312687-31268755.91655.97
3315618-31561856.44056.49
4286994-28699451.32251.36
5342976-34297661.33361.38
6311457-31145755.69655.75
15min1358491-35849164.10765.552.3264.2565.702.33
2367320-36732065.68665.83
3372440-37244066.60166.75
4356405-35640563.73463.86
5379067-37906767.78667.94
6365800-36580065.41465.56
20min1385797-38579768.99070.451.8869.2470.711.88
2392750-39275070.23370.49
3399456-39945671.43371.69
4391147-39114769.94770.18
5405803-40580372.56872.84
6388952-38895269.55469.81
30min1416127-41612774.41476.001.5874.7876.371.57
2423217-42321775.68276.06
3428514-42851476.62977.00
4427411-42741176.43276.78
5434819-43481977.75678.14
6419874-41987475.08475.45
45min1442177-44217779.07280.611.5479.5681.111.54
2448411-44841180.18780.69
3455528-45552881.46081.96
4453647-45364781.12381.60
5460281-46028182.31082.83
6444660-44466079.51680.01
60min1456789-45678981.68583.241.5782.3083.871.57
2463449-46344982.87683.51
3469962-46996284.04184.68
4470143-47014384.07384.68
5474724-47472484.89285.55
6457829-45782981.87182.50
极限1468593-46859383.79685.321.6384.5586.091.63
2473206-47320684.62185.39
3482277-48227786.24387.02
4482195-48219586.22886.98
5487164-48716487.11787.91
6469334-46933483.92884.69
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