非布司他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%
110.907060370631706657035070419705340.20
210.997113771321712290.19
单位质量响应值RSD%判断
6471.016481.260.12数据可信
供试品溶液-6041601批-多替诺雷-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112579-1257917.42717.475.3817.4317.475.38
213480-1348018.67518.68
312459-1245917.26117.26
411753-1175316.28316.28
513306-1330618.43418.43
612067-1206716.71816.72
10min123994-2399433.24233.161.7233.2733.191.72
224447-2444733.86933.90
324051-2405133.32133.35
423481-2348132.53132.56
524226-2422633.56333.59
623412-2341232.43532.46
15min129726-2972641.18341.040.8441.2741.130.84
230014-3001441.58241.67
329512-2951240.88640.97
429575-2957540.97441.05
529663-2966341.09541.18
629269-2926940.55040.63
20min133429-3342946.31346.420.4946.4746.570.50
233595-3359546.54346.70
333667-3366746.64346.80
433576-3357646.51746.67
533550-3355046.48146.64
633214-3321446.01546.16
30min138107-3810752.79453.090.5153.0253.320.51
238285-3828553.04053.27
338586-3858653.45753.69
438472-3847253.30053.53
538106-3810652.79253.03
638358-3835853.14253.37
45min142760-4276059.24059.550.4959.5659.860.48
243056-4305659.65059.97
343024-4302459.60659.93
443165-4316559.80160.12
542693-4269359.14759.47
643184-4318459.82860.14
60min146095-4609563.86163.820.4664.2864.240.45
246046-4604663.79364.21
346136-4613663.91764.34
446370-4637064.24264.66
545726-4572663.34963.77
646025-4602563.76464.18
90min150138-5013869.46269.410.5269.9969.940.51
250106-5010669.41769.95
350158-5015869.48970.01
450368-5036869.78070.30
549615-4961568.73769.26
650233-5023369.59370.11
120min152676-5267672.97873.020.8673.6273.660.85
252813-5281373.16873.81
352995-5299573.42074.06
452842-5284273.20873.85
551837-5183771.81672.45
653073-5307373.52874.16
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153163-5316373.65373.880.6774.4174.640.67
253247-5324773.76974.54
353600-5360074.25875.02
453612-5361274.27575.04
552729-5272973.05173.81
653624-5362474.29175.05
非布司他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%
110.865290575304075288895292095284865292100.14
211.105411845417435414640.08
单位质量响应值RSD%判断
48730.2048780.540.08数据可信
供试品溶液-6041601批-非布司他-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158399-5839910.76910.793.5910.7710.793.60
262037-6203711.44011.44
357725-5772510.64510.65
456734-5673410.46210.46
559817-5981711.03111.03
656477-5647710.41510.41
10min185684-8568415.80115.731.6215.8215.741.63
287410-8741016.11916.14
385325-8532515.73515.75
484789-8478915.63615.65
585294-8529415.72915.75
683159-8315915.33515.35
15min193466-9346617.23617.271.0117.2817.311.01
294481-9448117.42317.47
394752-9475217.47317.52
493522-9352217.24617.29
593485-9348517.24017.28
692092-9209216.98317.03
20min197322-9732217.94717.960.7718.0218.030.77
298636-9863618.19018.26
397748-9774818.02618.10
496955-9695517.88017.95
597157-9715717.91717.99
696479-9647917.79217.86
30min1100634-10063418.55818.610.8818.6618.720.87
2101771-10177118.76818.87
3101643-10164318.74418.85
4101362-10136218.69218.79
5100830-10083018.59418.70
699391-9939118.32918.43
45min1104342-10434219.24219.061.4519.3819.191.46
2105144-10514419.39019.53
3104487-10448719.26819.40
4101506-10150618.71918.85
5102404-10240418.88419.02
6102180-10218018.84318.97
60min1105731-10573119.49819.451.0219.6619.611.02
2106716-10671619.68019.85
3105065-10506519.37519.54
4106599-10659919.65819.82
5104428-10442819.25819.42
6104234-10423419.22219.38
90min1107424-10742419.81019.681.6320.0119.881.61
2104596-10459619.28919.49
3109230-10923020.14320.34
4107721-10772119.86520.06
5105122-10512219.38619.58
6106244-10624419.59319.79
120min1109550-10955020.20219.841.8720.4320.081.83
2104178-10417819.21219.45
3109375-10937520.17020.40
4107862-10786219.89120.12
5108114-10811419.93720.17
6106565-10656519.65219.88
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1108568-10856820.02119.860.9520.2920.130.95
2108293-10829319.97020.24
3107434-10743419.81220.08
4108904-10890420.08320.35
5106587-10658719.65619.92
6106547-10654719.64819.91
非布司他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%
110.906999770178702066992370035700680.18
210.997046370308703860.16
单位质量响应值RSD%判断
6428.266404.550.27数据可信
供试品溶液-6042201批-多替诺雷-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112406-1240617.34715.6821.3217.3515.6821.33
211461-1146116.02616.03
312997-1299718.17418.17
48448-844811.81311.81
513821-1382119.32619.33
68140-814011.38211.38
10min123877-2387733.38731.648.6433.4231.668.65
223030-2303032.20332.23
323710-2371033.15433.18
420190-2019028.23228.25
524727-2472734.57634.61
620210-2021028.26028.28
15min129869-2986941.76640.544.7241.8540.614.74
229213-2921340.84940.93
329758-2975841.61141.70
427438-2743838.36738.43
530479-3047942.61942.71
627174-2717437.99838.06
20min133658-3365847.06446.292.6047.2246.432.62
233305-3330546.57146.72
333504-3350446.84947.00
432064-3206444.83544.97
534060-3406047.62647.79
632019-3201944.77344.90
30min138803-3880354.25953.791.0754.4954.011.09
238461-3846153.78054.01
338607-3860753.98554.22
437883-3788352.97253.18
538947-3894754.46054.70
638093-3809353.26653.47
45min143325-4332560.58260.600.6360.9060.910.63
243235-4323560.45660.77
343315-4331560.56860.89
442905-4290559.99560.29
543557-4355760.90661.24
643677-4367761.07461.37
60min146219-4621964.62964.880.6765.0565.300.65
246258-4625864.68365.10
346057-4605764.40264.83
446358-4635864.82365.22
546590-4659065.14765.58
646912-4691265.59865.99
90min150206-5020670.20470.390.6970.7470.920.67
249992-4999269.90470.43
350086-5008670.03670.57
450479-5047970.58571.09
550341-5034170.39270.93
650948-5094871.24171.75
120min152805-5280573.83874.010.8574.4974.650.83
252522-5252273.44274.08
352815-5281573.85274.50
452905-5290573.97874.60
552731-5273173.73474.39
653803-5380375.23375.86
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153688-5368875.07375.090.8275.8475.850.81
253231-5323174.43475.20
353366-5336674.62275.39
453727-5372775.12775.87
553697-5369775.08575.87
654495-5449576.20176.95
非布司他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%
110.865242795260345254375256385238745250520.18
211.105293635286045289840.11
单位质量响应值RSD%判断
48347.3347656.221.02数据可信
供试品溶液-6042201批-非布司他-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158177-5817710.89710.2214.6410.9010.2214.62
255788-5578810.45010.45
361613-6161311.54111.54
445139-451398.4558.46
562407-6240711.69011.69
644349-443498.3078.31
10min182313-8231315.41815.105.0115.4415.125.04
282586-8258615.47015.49
383422-8342215.62615.65
476400-7640014.31114.32
584239-8423915.77915.80
674623-7462313.97813.99
15min188803-8880316.63416.812.4616.6816.852.48
290912-9091217.02917.07
392332-9233217.29517.34
487742-8774216.43516.47
591631-9163117.16417.21
686945-8694516.28616.32
20min194385-9438517.68017.651.5517.7517.721.57
295473-9547317.88417.96
396164-9616418.01318.09
493896-9389617.58817.65
593370-9337017.49017.56
692123-9212317.25617.32
30min199801-9980118.69418.551.6918.8018.651.70
2100858-10085818.89218.99
3100665-10066518.85618.96
498329-9832918.41918.51
597619-9761918.28618.39
696814-9681418.13518.23
45min1103410-10341019.37019.120.8519.5019.260.85
2102524-10252419.20419.34
3101945-10194519.09619.23
4102350-10235019.17219.30
5101203-10120318.95719.09
6101145-10114518.94619.07
60min1103036-10303619.30019.461.4619.4619.631.46
2106460-10646019.94220.11
3104549-10454919.58419.75
4103697-10369719.42419.58
5101982-10198219.10319.27
6103730-10373019.43019.59
90min1106306-10630619.91319.711.5220.1119.901.50
2106501-10650119.94920.15
3105552-10555219.77219.97
4105141-10514119.69519.88
5102121-10212119.12919.33
6105680-10568019.79519.98
120min1108076-10807620.24419.921.3320.4720.151.32
2105003-10500319.66919.90
3107235-10723520.08720.32
4105762-10576219.81120.03
5107369-10736920.11220.34
6104619-10461919.59719.82
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1107492-10749220.13519.315.3320.4019.575.25
294614-9461417.72317.99
3106079-10607919.87020.14
4106809-10680920.00720.26
597643-9764318.29018.55
6105774-10577419.81320.07
非布司他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%
110.907034970058702816997370187701700.23
210.997032270169702460.16
单位质量响应值RSD%判断
6437.616391.810.51数据可信
供试品溶液-6042401批-多替诺雷-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115850-1585022.16919.5114.3622.1719.5114.37
214705-1470520.56820.57
314628-1462820.46020.46
414751-1475120.63220.63
513644-1364419.08419.08
610120-1012014.15514.15
10min125790-2579036.07234.675.1936.1134.705.20
225203-2520335.25135.29
325515-2551535.68835.72
425153-2515335.18135.22
524796-2479634.68234.71
622253-2225331.12531.15
15min130966-3096643.31242.432.8843.4142.522.89
230283-3028342.35742.45
331028-3102843.39943.49
430704-3070442.94543.04
530347-3034742.44642.54
628666-2866640.09540.17
20min134324-3432448.00947.192.6548.1847.362.66
233751-3375147.20747.37
334544-3454448.31648.48
434530-3453048.29748.46
532663-3266345.68645.85
632633-3263345.64445.79
30min138985-3898554.52854.211.4754.7854.451.48
238325-3832553.60553.85
339138-3913854.74254.99
439394-3939455.10055.35
538846-3884654.33454.57
637859-3785952.95353.17
45min143244-4324460.48560.450.8760.8360.780.87
242916-4291660.02660.36
343673-4367361.08561.42
443660-4366061.06761.40
543004-4300460.14960.48
642826-4282659.90060.21
60min146123-4612364.51264.321.0264.9564.751.03
245779-4577964.03164.46
346401-4640164.90165.34
446540-4654065.09565.53
545802-4580264.06364.49
645270-4527063.31963.73
90min149740-4974069.57169.630.8970.1270.170.90
249273-4927368.91869.46
350213-5021370.23370.78
450383-5038370.47071.02
549685-4968569.49470.03
649388-4938869.07969.59
120min152425-5242573.32673.080.8873.9973.730.89
251815-5181572.47373.13
352704-5270473.71774.38
452810-5281073.86574.53
551858-5185872.53373.18
651866-5186672.54573.17
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153034-5303474.17874.071.0174.9674.851.00
252238-5223873.06573.84
353653-5365375.04475.83
453432-5343274.73575.52
552566-5256673.52474.29
652826-5282673.88774.64
非布司他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%
110.865258025252525259395256435256165256500.05
211.105267185257455262320.14
单位质量响应值RSD%判断
48402.3947408.291.47数据可信
供试品溶液-6042401批-非布司他-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167440-6744012.65911.6410.5912.6611.6410.57
263995-6399512.01212.01
364058-6405812.02412.02
466599-6659912.50112.50
560504-6050411.35711.36
649585-495859.3079.31
10min187906-8790616.50015.693.1216.5215.713.13
282319-8231915.45215.47
384951-8495115.94615.97
482801-8280115.54215.56
583258-8325815.62815.65
680269-8026915.06715.08
15min195247-9524717.87816.992.7317.9317.042.74
288074-8807416.53216.58
390811-9081117.04517.09
489621-8962116.82216.87
589689-8968916.83516.88
689785-8978516.85316.89
20min191524-9152417.17917.432.8017.2617.512.79
294351-9435117.71017.78
395018-9501817.83517.91
494271-9427117.69517.77
593930-9393017.63117.70
688184-8818416.55216.62
30min198096-9809618.41317.944.6618.5218.044.61
299736-9973618.72118.82
392180-9218017.30217.41
488125-8812516.54116.65
597614-9761418.32218.42
697564-9756418.31318.41
45min1103840-10384019.49119.204.3619.6319.344.33
2103569-10356919.44019.57
397710-9771018.34018.47
4109536-10953620.56020.69
5101528-10152819.05719.19
697715-9771518.34118.47
60min1101238-10123819.00318.663.3119.1718.823.29
297269-9726918.25818.42
394642-9464217.76517.93
4102815-10281519.29919.46
5102518-10251819.24319.41
697949-9794918.38518.54
90min199817-9981718.73618.319.1118.9418.519.02
2103800-10380019.48419.68
388491-8849116.61016.80
484385-8438515.83916.04
5104579-10457919.63019.83
6104303-10430319.57819.77
120min197224-9722418.24918.983.8118.4819.213.75
2106192-10619219.93320.16
3100989-10098918.95619.18
4100710-10071018.90419.13
596792-9679218.16818.40
6104909-10490919.69219.91
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1104847-10484719.68019.325.3519.9419.585.29
2104047-10404719.53019.79
392005-9200517.27017.52
4107550-10755020.18720.44
5104743-10474319.66119.92
6104451-10445119.60619.86
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