多替诺雷片项目信息
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对照品来源工作对照品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%
110.446717867173674886696366885671370.35
210.536730867265672860.05
单位质量响应值RSD%判断
6430.756389.930.46数据可信
供试品溶液-J049F批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124834-2483434.75934.832.2634.7634.832.26
225126-2512635.16735.17
324223-2422333.90433.90
425520-2552035.71935.72
524225-2422533.90633.91
625374-2537435.51535.51
10min140869-4086957.20256.111.5057.2656.171.50
240430-4043056.58856.65
339608-3960855.43755.49
439867-3986755.80055.86
539284-3928454.98455.04
640467-4046756.63956.70
15min148718-4871868.18867.101.2668.3467.251.26
248616-4861668.04568.20
347798-4779866.90067.05
447338-4733866.25666.41
547343-4734366.26366.41
647829-4782966.94467.10
20min153225-5322574.49673.281.1274.7673.551.12
252782-5278273.87674.14
351872-5187272.60272.86
451639-5163972.27672.54
552392-5239273.33073.59
652243-5224373.12273.39
30min157693-5769380.75080.430.7181.1480.820.71
258034-5803481.22781.62
357207-5720780.06980.45
456860-5686079.58479.97
557540-5754080.53580.92
657466-5746680.43280.82
45min161085-6108585.49785.420.6986.0285.940.69
261724-6172486.39286.92
360404-6040484.54485.06
461020-6102085.40685.92
560970-6097085.33685.85
660967-6096785.33285.85
60min162832-6283287.94287.840.3088.6188.500.30
262999-6299988.17688.84
362650-6265087.68888.34
462607-6260787.62788.29
562531-6253187.52188.18
662913-6291388.05688.72
90min163544-6354488.93989.981.1089.7590.791.09
264188-6418889.84090.66
364226-6422689.89490.70
463921-6392189.46790.27
564235-6423589.90690.71
665619-6561991.84392.65
120min163721-6372189.18790.880.9890.1591.830.97
265071-6507191.07692.04
365051-6505191.04892.00
465631-6563191.86092.81
565021-6502191.00691.96
665071-6507191.07692.04
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165860-6586092.18192.350.3793.2993.460.37
265750-6575092.02793.14
365963-6596392.32593.43
466289-6628992.78193.89
565752-6575292.02993.13
666255-6625592.73393.85
多替诺雷片项目信息
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对照品来源工作对照品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%
110.446884169117693576875568875689890.36
210.536931369490694020.19
单位质量响应值RSD%判断
6608.146590.880.19数据可信
供试品溶液-J049F批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124230-2423032.94131.064.4532.9431.064.45
221715-2171529.52229.52
321882-2188229.74929.75
423324-2332431.70931.71
522348-2234830.38230.38
623598-2359832.08232.08
10min140879-4087955.57551.974.7055.6352.024.70
239951-3995154.31454.36
337105-3710550.44550.49
437893-3789351.51651.57
536256-3625649.29049.34
637299-3729950.70850.76
15min149888-4988867.82362.924.8967.9763.064.88
248184-4818465.50765.65
345732-4573262.17362.31
445076-4507661.28161.42
544291-4429160.21460.35
644504-4450460.50460.64
20min154665-5466574.31869.644.2174.5869.884.21
252607-5260771.52071.77
351483-5148369.99270.23
450217-5021768.27168.51
549308-4930867.03567.27
649050-4905066.68466.92
30min160285-6028581.95877.624.6082.3477.984.60
260028-6002881.60981.98
357548-5754878.23778.59
455692-5569275.71476.07
554862-5486274.58674.93
654171-5417173.64674.00
45min164468-6446887.64583.183.1688.1783.673.16
261006-6100682.93883.44
362360-6236084.77985.26
459943-5994381.49381.97
559305-5930580.62681.10
660020-6002081.59882.07
60min167940-6794092.36586.044.3393.0386.674.32
262687-6268785.22485.87
364678-6467887.93188.56
462518-6251884.99485.61
561950-6195084.22284.83
659947-5994781.49982.11
90min167869-6786992.26987.683.6393.0988.453.63
263287-6328786.03986.82
366588-6658890.52791.30
464480-6448087.66188.42
563150-6315085.85386.60
661602-6160283.74984.49
120min168396-6839692.98588.853.7493.9689.763.73
264159-6415987.22588.15
367863-6786392.26193.18
465295-6529588.76989.67
564533-6453387.73388.62
661867-6186784.10984.99
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169020-6902093.83490.502.6894.9691.572.69
266526-6652690.44391.52
368201-6820192.72093.80
465919-6591989.61890.67
565608-6560889.19590.23
664142-6414287.20288.23
多替诺雷片项目信息
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对照品来源工作对照品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%
110.446793467813678616790267560678140.22
210.536886268868688650.01
单位质量响应值RSD%判断
6495.596539.890.49数据可信
供试品溶液-J050F批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122997-2299731.65734.785.8931.6634.785.89
224584-2458433.84233.84
327290-2729037.56737.57
425776-2577635.48335.48
526182-2618236.04236.04
624771-2477134.09934.10
10min138746-3874653.33756.564.8353.3956.624.83
238381-3838152.83552.89
342676-4267658.74758.81
442709-4270958.79258.85
541984-4198457.79457.85
642023-4202357.84857.90
15min147746-4774665.72668.894.7765.8769.054.77
246745-4674564.34864.49
351072-5107270.30570.47
453047-5304773.02473.18
550134-5013469.01469.17
651535-5153570.94271.10
20min153468-5346873.60376.214.6673.8576.474.65
251683-5168371.14671.40
356185-5618577.34377.62
458502-5850280.53380.81
554704-5470475.30575.58
657614-5761479.31079.58
30min158691-5869180.79383.874.4981.1784.274.48
256930-5693078.36978.74
362329-6232985.80186.21
463714-6371487.70888.12
560462-6046283.23183.63
663444-6344487.33687.74
45min163640-6364087.60689.602.9288.1190.132.93
262755-6275586.38786.89
366245-6624591.19291.74
466689-6668991.80392.36
563850-6385087.89588.43
667335-6733592.69293.24
60min164911-6491189.35591.572.7590.0192.252.76
264063-6406388.18888.83
367765-6776593.28493.99
467677-6767793.16393.88
565974-6597490.81991.50
668721-6872194.60095.30
90min166910-6691092.10793.582.1892.9194.412.19
266132-6613291.03691.83
369039-6903995.03895.89
468697-6869794.56795.43
567106-6710692.37793.21
669977-6997796.32997.19
120min167531-6753192.96294.192.2693.9295.182.27
266303-6630391.27292.22
369677-6967795.91696.93
468704-6870494.57795.60
567773-6777393.29594.28
670557-7055797.12798.15
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167748-6774893.26194.702.0494.3795.852.05
267163-6716392.45593.55
370023-7002396.39297.57
468957-6895794.92596.11
568085-6808593.72594.87
670787-7078797.44498.63
多替诺雷片项目信息
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对照品来源工作对照品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%
110.446861768750685866867368764686780.12
210.537073470677707060.06
单位质量响应值RSD%判断
6578.356714.721.46数据可信
供试品溶液-J050F批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121729-2172929.33532.306.8329.3332.306.83
221963-2196329.65129.65
324802-2480233.48433.48
424884-2488433.59433.59
524712-2471233.36233.36
625460-2546034.37234.37
10min138500-3850051.97653.473.9552.0353.523.94
237159-3715950.16650.22
339739-3973953.64953.70
440566-4056654.76554.82
540137-4013754.18654.24
641545-4154556.08756.14
15min145821-4582161.86065.304.2662.0065.444.26
246276-4627662.47462.61
347920-4792064.69464.84
450534-5053468.22368.37
549034-4903466.19866.34
650609-5060968.32468.47
20min151469-5146969.48572.623.2969.7272.873.29
252028-5202870.24070.48
353513-5351372.24472.50
455135-5513574.43474.70
554731-5473173.88974.14
655869-5586975.42575.69
30min157908-5790878.17880.172.5978.5380.542.59
257637-5763777.81278.17
358775-5877579.34879.72
460427-6042781.57881.96
560010-6001081.01581.39
661546-6154683.08983.48
45min161456-6145682.96885.862.8683.4586.362.86
261973-6197383.66684.15
362868-6286884.87485.38
465253-6525388.09488.61
564037-6403786.45286.97
665998-6599889.09989.63
60min163912-6391286.28388.432.1786.9189.082.18
264373-6437386.90687.53
365133-6513387.93288.58
466559-6655989.85790.52
565308-6530888.16888.83
667735-6773591.44492.12
90min165670-6567088.65790.521.9789.4291.321.98
265847-6584788.89689.66
366661-6666189.99590.79
468190-6819092.05992.88
566911-6691190.33291.14
669013-6901393.17094.00
120min167256-6725690.79891.611.6691.7192.561.66
267486-6748691.10892.02
367573-6757391.22692.17
468650-6865092.68093.65
566514-6651489.79690.75
669665-6966594.05095.04
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166679-6667990.01991.811.5691.0892.911.57
267849-6784991.59892.67
367821-6782191.56192.66
468927-6892793.05494.18
567228-6722890.76091.87
669533-6953393.87295.01
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