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241101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%
110.907112871044709907107871094710670.08
211.107215372318722360.17
单位质量响应值RSD%判断
6519.916507.750.14数据可信
供试品溶液-6051501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%
5min115676-1567621.59224.647.1321.5924.647.14
219268-1926826.54026.54
318658-1865825.69925.70
417485-1748524.08424.08
517648-1764824.30824.31
618609-1860925.63225.63
10min137062-3706251.04952.401.9051.0852.441.90
238802-3880253.44653.49
338816-3881653.46553.51
438307-3830752.76452.80
537801-3780152.06752.11
637464-3746451.60351.65
15min146290-4629063.76063.930.8763.8864.060.87
246520-4652064.07664.21
346847-4684764.52764.66
446871-4687164.56064.69
546042-4604263.41863.55
645929-4592963.26263.39
20min150835-5083570.02069.600.5170.2569.840.51
250557-5055769.63769.88
350424-5042469.45469.69
450773-5077369.93470.17
550472-5047269.52069.75
650136-5013669.05769.29
30min156197-5619777.40576.170.9677.7576.520.95
255037-5503775.80876.16
355355-5535576.24676.60
455553-5555376.51876.87
554907-5490775.62975.98
654759-5475975.42575.77
45min159018-5901881.29180.520.7181.7681.000.70
258327-5832780.33980.82
358228-5822880.20380.69
458643-5864380.77581.25
558685-5868580.83281.31
657840-5784079.66880.14
60min160579-6057983.44182.520.7384.0583.140.73
259593-5959382.08382.70
359950-5995082.57583.19
460265-6026583.00983.62
559500-5950081.95582.56
659596-5959682.08782.69
极限162567-6256786.17984.860.9486.9385.610.93
261766-6176685.07685.83
361198-6119884.29485.05
461872-6187285.22285.97
561067-6106784.11384.86
661180-6118084.26985.01
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%
110.935370115366465360455362995359665363930.09
211.095434915441875438390.10
单位质量响应值RSD%判断
49075.3049038.680.06数据可信
供试品溶液-6051501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%
5min1217098-21709839.78944.696.2739.7944.696.27
2259643-25964347.58747.59
3254517-25451746.64746.65
4241087-24108744.18644.19
5239189-23918943.83843.84
6251437-25143746.08346.08
10min1413472-41347275.78077.301.9375.8577.381.94
2428570-42857078.54778.63
3433462-43346279.44379.52
4423761-42376177.66577.74
5416508-41650876.33676.41
6414857-41485776.03476.11
15min1474285-47428586.92586.620.8287.1286.830.82
2473573-47357386.79587.01
3476410-47641087.31587.52
4475584-47558487.16387.37
5466654-46665485.52785.73
6469257-46925786.00486.21
20min1495276-49527690.77390.340.4891.1190.690.48
2493180-49318090.38890.74
3494757-49475790.67791.03
4494310-49431090.59590.94
5490072-49007289.81990.16
6489959-48995989.79890.14
30min1518903-51890395.10394.060.8395.5994.560.83
2512184-51218493.87194.38
3514361-51436194.27094.78
4515922-51592294.55695.06
5511239-51123993.69894.19
6506588-50658892.84693.34
45min1532080-53208097.51896.680.7398.1797.330.73
2527615-52761596.70097.36
3526927-52692796.57397.24
4528407-52840796.84597.50
5529293-52929397.00797.66
6520591-52059195.41296.06
60min1539298-53929898.84197.830.9899.6598.640.97
2532699-53269997.63198.45
3539275-53927598.83799.66
4535573-53557398.15898.98
5528404-52840496.84497.65
6527390-52739096.65897.47
极限1547222-547222100.29398.321.14101.2799.301.13
2539716-53971698.91799.90
3532909-53290997.67098.66
4535419-53541998.13099.11
5532625-53262597.61898.59
6530944-53094497.31098.28
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241101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%
110.907287672707726937263672664727150.13
211.107479774866748320.07
单位质量响应值RSD%判断
6671.106741.620.75数据可信
供试品溶液-6051502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%
5min112401-1240116.59121.9613.1016.5921.9613.11
215793-1579321.12921.13
318320-1832024.51024.51
417674-1767423.64623.65
516735-1673522.39022.39
617547-1754723.47623.48
10min129950-2995040.07043.113.9340.1043.153.94
231667-3166742.36742.40
333520-3352044.84644.89
432924-3292444.04944.09
532545-3254543.54243.58
632738-3273843.80043.84
15min137861-3786150.65452.542.1150.7552.652.12
238776-3877651.87851.98
340046-4004653.57753.69
439965-3996553.46953.58
539543-3954352.90453.01
639445-3944552.77352.89
20min142221-4222156.48758.031.4856.6758.231.49
243141-4314157.71857.91
343749-4374958.53158.74
443919-4391958.75958.96
543837-4383758.64958.85
643377-4337758.03358.23
30min147613-4761363.70163.840.6763.9764.140.67
247147-4714763.07763.37
347815-4781563.97164.27
448029-4802964.25764.56
547770-4777063.91164.21
647949-4794964.15064.45
45min151711-5171169.18368.090.9069.5668.480.88
250345-5034567.35667.75
350777-5077767.93468.34
451003-5100368.23668.64
550796-5079667.95968.36
650719-5071967.85668.26
60min153181-5318171.15070.050.9571.6470.560.94
251965-5196569.52370.03
352477-5247770.20870.73
452567-5256770.32970.85
552118-5211869.72870.24
651824-5182469.33569.85
极限155166-5516673.80673.010.8574.4273.640.84
254352-5435272.71773.34
354726-5472673.21773.86
454973-5497373.54874.19
554172-5417272.47673.11
654017-5401772.26972.90
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%
110.935509975498235495015487835485675495340.18
211.095670145676545673340.08
单位质量响应值RSD%判断
50277.5851157.261.23数据可信
供试品溶液-6051502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%
5min1149673-14967326.53534.3712.3026.5434.3712.29
2184837-18483732.77032.77
3213306-21330637.81737.82
4208892-20889237.03437.03
5199513-19951335.37235.37
6206823-20682336.66836.67
10min1325471-32547157.70360.842.9457.7560.902.95
2337434-33743459.82459.88
3352599-35259962.51262.58
4349910-34991062.03562.10
5347542-34754261.61661.67
6346144-34614461.36861.43
15min1391494-39149469.40871.101.4669.5571.261.47
2397523-39752370.47770.63
3407212-40721272.19472.36
4405297-40529771.85572.02
5404296-40429671.67871.84
6400575-40057571.01871.18
20min1425486-42548675.43477.001.0775.6977.281.07
2436311-43631177.35377.63
3436824-43682477.44477.73
4434901-43490177.10377.39
5438513-43851377.74478.02
6434016-43401676.94777.23
30min1464859-46485982.41582.770.6182.8083.170.61
2463068-46306882.09782.50
3469650-46965083.26483.68
4467786-46778682.93483.35
5470153-47015383.35383.76
6465571-46557182.54182.95
45min1496389-49638988.00587.280.6288.5287.820.61
2488388-48838886.58687.12
3492763-49276387.36287.92
4492680-49268087.34787.90
5494381-49438187.64988.20
6489201-48920186.73087.28
60min1505040-50504089.53889.400.5090.2090.090.50
2501131-50113188.84589.53
3505045-50504589.53990.24
4506401-50640189.78090.48
5506733-50673389.83990.53
6501147-50114788.84889.54
极限1513008-51300890.95190.860.7191.7791.700.70
2511220-51122090.63491.46
3513020-51302090.95391.80
4518757-51875791.97092.82
5511164-51116490.62491.47
6507842-50784290.03590.88
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