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%
19.816195362083616546241861924620060.45
29.916229262529624100.27
单位质量响应值RSD%判断
6320.696297.680.26数据可信
中间条件6月-供试品溶液-2025072121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%
5min127349-2734938.89236.0316.1238.8936.0316.11
222049-2204931.35531.36
325583-2558336.38136.38
418950-1895026.94826.95
529397-2939741.80541.80
628678-2867840.78240.78
10min141012-4101258.32257.438.2558.3957.498.25
237570-3757053.42753.48
339251-3925155.81855.88
436210-3621051.49351.54
544476-4447663.24863.32
643793-4379362.27762.34
15min148065-4806568.35268.786.0668.5168.946.06
245070-4507064.09364.23
346186-4618665.68065.83
447048-4704866.90667.04
551663-5166373.46973.64
652178-5217874.20174.37
20min151426-5142673.13274.405.0573.4174.675.05
249275-4927570.07370.32
349919-4991970.98971.25
452493-5249374.64974.89
555316-5531678.66378.96
655473-5547378.88779.18
30min156530-5653080.39080.884.4880.7981.284.48
253990-5399076.77877.14
353869-5386976.60676.99
458275-5827582.87183.24
558519-5851983.21883.65
660066-6006685.41885.85
45min158736-5873683.52784.743.6484.0685.273.64
256926-5692680.95381.45
357518-5751881.79582.30
461557-6155787.53988.04
560715-6071586.34186.91
662089-6208988.29588.86
60min160894-6089486.59686.833.2887.2787.503.29
258523-5852383.22483.85
358959-5895983.84484.49
462473-6247388.84189.49
561907-6190788.03688.75
663583-6358390.42091.14
90min161486-6148687.43888.142.7888.2588.952.79
259463-5946384.56185.33
360847-6084786.52987.31
463479-6347990.27291.07
562517-6251788.90489.76
664086-6408691.13592.00
120min162192-6219288.44289.032.6789.4089.992.68
260120-6012085.49586.40
361574-6157487.56388.49
464654-6465491.94392.89
563037-6303789.64390.65
664067-6406791.10892.13
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162753-6275389.23990.962.8490.3592.072.85
262092-6209288.29989.35
362185-6218588.43289.51
465674-6567493.39394.50
565026-6502692.47293.63
666039-6603993.91295.08
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%
19.816131061853613836141161845615600.44
29.916148061630615550.18
单位质量响应值RSD%判断
6275.236211.400.73数据可信
中间条件6月-供试品溶液-2025072221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%
5min125543-2554336.70836.0012.8036.7136.0012.80
226433-2643337.98737.99
325485-2548536.62536.62
418880-1888027.13327.13
525670-2567036.89136.89
628298-2829840.66740.67
10min138523-3852355.36256.775.5355.4256.835.53
240196-4019657.76657.83
339032-3903256.09356.15
435961-3596151.68051.73
541209-4120959.22259.28
642085-4208560.48160.55
15min145583-4558365.50867.482.9865.6667.642.99
246838-4683867.31167.47
346400-4640066.68266.84
445686-4568665.65665.79
548181-4818169.24169.40
649065-4906570.51270.68
20min149218-4921870.73273.052.2470.9973.312.24
250811-5081173.02173.29
350194-5019472.13472.40
451169-5116973.53673.78
550927-5092773.18873.46
652647-5264775.66075.95
30min154323-5432378.06879.701.6578.4580.091.65
255473-5547379.72180.11
354445-5444578.24378.63
456239-5623980.82281.18
555734-5573480.09680.49
656540-5654081.25481.67
45min156893-5689381.76283.461.3482.2783.981.34
258105-5810583.50384.03
357564-5756482.72683.24
458809-5880984.51585.01
558095-5809583.48984.02
658973-5897384.75185.30
60min158194-5819483.63184.701.4084.2885.361.40
259117-5911784.95885.62
357732-5773282.96783.62
459433-5943385.41286.05
559178-5917885.04585.72
659958-5995886.16686.86
90min159549-5954985.57886.520.8686.3687.320.86
260316-6031686.68187.49
359685-5968585.77486.57
460949-6094987.59088.37
560301-6030186.65987.47
660426-6042686.83987.67
120min160320-6032086.68787.060.4787.6288.010.47
260793-6079387.36688.32
360470-6047086.90287.84
460816-6081687.39988.33
560216-6021686.53787.49
660868-6086887.47488.45
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161957-6195789.03990.171.2290.1191.261.20
262508-6250889.83190.93
362403-6240389.68090.76
464009-6400991.98893.06
562302-6230289.53590.64
663289-6328990.95392.08
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%
19.816162761430617366157461823616380.25
29.916352863391634600.16
单位质量响应值RSD%判断
6283.186403.631.35数据可信
中间条件6月-供试品溶液-2025072321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%
5min124943-2494335.28331.9117.5235.2831.9117.52
219498-1949827.58027.58
326889-2688938.03538.04
420855-2085529.50029.50
517141-1714124.24624.25
626023-2602336.81036.81
10min139955-3995556.51753.548.5756.5853.608.58
235385-3538550.05350.10
341106-4110658.14558.21
437190-3719052.60652.66
532959-3295946.62146.66
640517-4051757.31257.37
15min147054-4705466.55965.845.0966.7165.995.10
244666-4466663.18163.31
348877-4887769.13869.30
447636-4763667.38267.52
542744-4274460.46260.58
648318-4831868.34768.50
20min150901-5090172.00172.583.0472.2672.833.05
250683-5068371.69271.93
352724-5272474.57974.85
452637-5263774.45674.71
548671-4867168.84669.07
652237-5223773.89174.16
30min154970-5497077.75679.492.2278.1479.862.23
256230-5623079.53979.89
356801-5680180.34680.75
457797-5779781.75582.13
554503-5450377.09677.43
656871-5687180.44580.84
45min158567-5856782.84584.041.7283.3684.551.72
259567-5956784.25984.75
359412-5941284.04084.57
461302-6130286.71387.22
558529-5852982.79183.25
659104-5910483.60484.13
60min159700-5970084.44786.241.6685.1086.891.66
260689-6068985.84686.47
361379-6137986.82287.50
462631-6263188.59389.25
560291-6029185.28385.88
661126-6112686.46487.13
90min161172-6117286.52988.251.4987.3289.041.49
262551-6255188.48089.25
362576-6257688.51589.33
463956-6395690.46791.27
561842-6184287.47788.22
662250-6225088.05488.87
120min161733-6173387.32388.961.2688.2689.901.25
262770-6277088.79089.71
363493-6349389.81290.78
464022-6402290.56191.51
562672-6267288.65189.54
662673-6267388.65389.61
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164328-6432890.99491.420.7392.0892.500.75
264220-6422090.84191.91
365326-6532692.40593.52
465122-6512292.11793.22
564339-6433991.00992.04
664433-6443391.14292.25
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%
19.816330262967632816336863360632560.27
29.916374863687637180.07
单位质量响应值RSD%判断
6448.116429.670.21数据可信
中间条件6月-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%
5min119221-1922126.78328.497.5326.7828.487.53
220903-2090329.12729.13
319248-1924826.82126.82
423239-2323932.38232.38
519506-1950627.18027.18
620538-2053828.61828.62
10min133760-3376047.04248.426.2247.0948.476.22
235325-3532549.22349.27
333403-3340346.54546.59
438900-3890054.20454.26
533803-3380347.10247.15
633305-3330546.40846.46
15min141597-4159757.96259.705.1158.0959.835.11
243569-4356960.71060.84
342145-4214558.72658.85
446966-4696665.44465.59
541625-4162558.00158.13
641157-4115757.34957.47
20min146649-4664965.00266.385.1365.2266.605.13
248243-4824367.22367.45
347170-4717065.72865.95
452165-5216572.68872.94
546464-4646464.74464.96
645119-4511962.87063.09
30min153145-5314574.05474.464.2774.3874.804.28
254408-5440875.81476.16
353061-5306173.93774.27
457284-5728479.82180.20
552202-5220272.74073.07
650521-5052170.39770.72
45min157743-5774380.46180.893.0480.9181.363.05
258523-5852381.54782.02
357703-5770380.40580.86
460930-6093084.90185.41
557981-5798180.79281.24
655444-5544477.25777.70
60min160230-6023083.92683.492.7684.5184.082.77
260838-6083884.77385.38
359900-5990083.46684.05
462208-6220886.68287.33
558936-5893682.12382.71
657378-5737879.95280.52
90min163182-6318288.03986.962.3588.7687.702.36
263058-6305887.86788.61
362323-6232386.84287.57
464214-6421489.47790.27
561699-6169985.97386.69
659969-5996983.56284.27
120min163751-6375188.83287.952.0589.7088.832.06
263823-6382388.93389.83
362698-6269887.36588.24
464765-6476590.24591.19
562602-6260287.23188.10
661059-6105985.08185.93
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164314-6431489.61790.562.1490.6491.592.15
266243-6624392.30593.35
365652-6565291.48192.50
466244-6624492.30693.40
564880-6488090.40591.42
662620-6262087.25688.24
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