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%
110.987516575461751467533074971752150.25
211.237525475523753880.26
单位质量响应值RSD%判断
6850.186713.091.43数据可信
供试品溶液-6041601批-多替诺雷-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110407-1040713.77013.417.7413.7713.417.75
210037-1003713.28013.28
310963-1096314.50614.51
48694-869411.50311.50
510096-1009613.35813.36
610607-1060714.03414.03
10min117819-1781923.57723.302.3123.6023.322.31
217619-1761923.31223.33
318146-1814624.01024.03
416975-1697522.46022.48
517342-1734222.94622.97
617749-1774923.48423.51
15min121985-2198529.08929.231.8329.1529.281.83
222336-2233629.55429.61
322635-2263529.94930.01
421423-2142328.34628.40
522068-2206829.19929.26
622080-2208029.21529.28
20min125003-2500333.08233.011.4933.1933.121.49
225442-2544233.66333.77
325245-2524533.40333.52
424427-2442732.32032.42
524670-2467032.64232.75
624913-2491332.96333.07
30min128875-2887538.20638.321.3838.3738.491.38
229437-2943738.94939.12
329470-2947038.99339.16
428745-2874538.03438.19
528496-2849637.70437.87
628762-2876238.05638.22
45min132945-3294543.59143.760.9743.8243.990.97
233677-3367744.55944.79
333170-3317043.88844.12
432920-3292043.55843.78
532930-3293043.57143.80
632800-3280043.39943.63
60min135803-3580347.37247.420.8947.6747.720.89
236432-3643248.20448.51
335880-3588047.47447.78
435563-3556347.05547.35
535795-3579547.36247.66
635563-3556347.05547.36
90min139052-3905251.67151.802.5752.0552.182.55
240342-4034253.37853.76
339634-3963452.44152.83
437415-3741549.50549.88
539645-3964552.45652.83
638829-3882951.37651.76
120min141393-4139354.76955.401.2955.2455.871.28
242833-4283356.67457.15
342065-4206555.65856.13
441592-4159255.03255.49
541870-4187055.40055.87
641462-4146254.86055.33
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142206-4220655.84456.361.0056.4056.921.00
243368-4336857.38257.95
342568-4256856.32356.89
442305-4230555.97556.52
542731-4273156.53957.10
642395-4239556.09456.65
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%
110.925274845281805279355282915287265281230.09
211.335364805373825369310.12
单位质量响应值RSD%判断
48362.9147390.201.44数据可信
供试品溶液-6041601批-非布司他-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12989-29890.5610.627.220.560.627.33
23443-34430.6470.65
33566-35660.6700.67
43188-31880.5990.60
53045-30450.5720.57
63425-34250.6430.64
10min14564-45640.8570.902.960.860.902.82
24914-49140.9230.92
34753-47530.8930.89
44837-48370.9080.91
54948-49480.9290.93
64716-47160.8860.89
15min15152-51520.9680.973.780.970.983.83
25117-51170.9610.96
35002-50020.9390.94
45374-53741.0091.01
55453-54531.0241.03
64974-49740.9340.94
20min14773-47730.8960.966.840.900.966.72
25118-51180.9610.97
35487-54871.0311.03
45533-55331.0391.04
54730-47300.8880.89
64953-49530.9300.93
30min14901-49010.9200.944.960.930.945.00
25018-50180.9420.95
35397-53971.0141.02
45104-51040.9590.96
54720-47200.8860.89
64787-47870.8990.90
45min14933-49330.9260.942.730.930.942.58
24941-49410.9280.94
34934-49340.9270.93
45192-51920.9750.98
55125-51250.9630.97
64835-48350.9080.92
60min14848-48480.9110.935.470.920.945.45
25384-53841.0111.02
35018-50180.9420.95
44632-46320.8700.88
55009-50090.9410.95
64706-47060.8840.89
90min14816-48160.9050.895.510.910.905.29
24836-48360.9080.92
34701-47010.8830.89
44367-43670.8200.83
55133-51330.9640.97
64569-45690.8580.87
120min14703-47030.8830.883.770.890.893.93
24845-48450.9100.92
34594-45940.8630.87
44975-49750.9340.95
54575-45750.8590.87
64517-45170.8480.86
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15103-51030.9580.926.890.970.936.70
25282-52820.9921.01
34940-49400.9280.94
45061-50610.9510.96
54591-45910.8620.88
64391-43910.8250.84
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%
110.987699177101769667706177226770690.14
211.237761377697776550.08
单位质量响应值RSD%判断
7019.036914.961.06数据可信
供试品溶液-6041601批-多替诺雷-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19704-970412.49812.008.3112.5012.008.31
29479-947912.20812.21
39120-912011.74511.75
410000-1000012.87912.88
59748-974812.55412.55
67859-785910.12110.12
10min116470-1647021.21121.294.3321.2321.314.34
216869-1686921.72521.75
316459-1645921.19721.22
416959-1695921.84121.86
517240-1724022.20322.22
615208-1520819.58619.60
15min120633-2063326.57326.613.1126.6326.663.11
221126-2112627.20827.26
320646-2064626.58926.64
421043-2104327.10127.16
521076-2107627.14327.20
619428-1942825.02125.07
20min123445-2344530.19430.202.8630.2930.302.86
223941-2394130.83330.93
323458-2345830.21130.31
423785-2378530.63230.74
523922-2392230.80830.91
622161-2216128.54128.63
30min127309-2730935.17035.231.5735.3235.381.57
227843-2784335.85836.01
327346-2734635.21835.37
427552-2755235.48335.64
527495-2749535.41035.56
626570-2657034.21934.36
45min131445-3144540.49740.541.1340.7140.751.15
231969-3196941.17241.39
331446-3144640.49840.71
431479-3147940.54140.75
531649-3164940.76040.97
630878-3087839.76739.96
60min134012-3401243.80344.000.9144.0844.280.92
234721-3472144.71645.00
334079-3407943.88944.17
434179-3417944.01844.30
534189-3418944.03144.31
633798-3379843.52743.79
90min137771-3777148.64448.570.9948.9948.920.99
238314-3831449.34449.70
337286-3728648.02048.37
437921-3792148.83749.19
537544-3754448.35248.71
637437-3743748.21448.55
120min140034-4003451.55953.432.0351.9953.862.02
242546-4254654.79455.23
341966-4196654.04754.48
441304-4130453.19453.63
541659-4165953.65154.09
641428-4142853.35453.77
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140715-4071552.43654.422.0552.9554.942.04
243301-4330155.76656.30
342667-4266754.95055.47
442177-4217754.31954.84
542523-4252354.76455.29
642138-4213854.26854.77
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%
110.925483635493995490995491625497105491470.10
211.335585155588205586680.04
单位质量响应值RSD%判断
50288.1949308.741.40数据可信
供试品溶液-6041601批-非布司他-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13178-31780.5740.548.970.570.548.80
22823-28230.5100.51
33000-30000.5420.54
43403-34030.6140.61
52671-26710.4820.48
62838-28380.5120.51
10min14597-45970.8300.833.120.830.833.31
24610-46100.8320.83
34724-47240.8530.85
44390-43900.7930.79
54738-47380.8560.86
64440-44400.8020.80
15min14794-47940.8660.896.710.870.896.75
24535-45350.8190.82
35025-50250.9070.91
45374-53740.9700.97
55226-52260.9440.95
64644-46440.8390.84
20min15036-50360.9090.901.350.910.901.52
25026-50260.9080.91
34963-49630.8960.90
45052-50520.9120.92
54878-48780.8810.88
64938-49380.8920.90
30min14762-47620.8600.872.280.870.882.26
25000-50000.9030.91
34672-46720.8440.85
44775-47750.8620.87
54797-47970.8660.87
64844-48440.8750.88
45min14912-49120.8870.862.850.890.872.78
24616-46160.8330.84
34754-47540.8580.87
44932-49320.8910.90
54872-48720.8800.89
64656-46560.8410.85
60min14768-47680.8610.874.610.870.884.49
24830-48300.8720.88
35159-51590.9320.94
44766-47660.8610.87
54485-44850.8100.82
64936-49360.8910.90
90min14374-43740.7900.835.700.800.845.55
24893-48930.8840.89
34303-43030.7770.79
44905-49050.8860.90
54473-44730.8080.82
64697-46970.8480.86
120min14683-46830.8460.856.210.860.866.11
24788-47880.8650.88
34864-48640.8780.89
44685-46850.8460.86
54956-49560.8950.91
64129-41290.7460.76
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14776-47760.8620.885.770.870.895.91
24964-49640.8960.91
35336-53360.9630.98
44469-44690.8070.82
54830-48300.8720.88
64870-48700.8790.89
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%
110.987459174491745707458774482745440.08
211.237749277614775530.12
单位质量响应值RSD%判断
6789.076905.881.21数据可信
供试品溶液-6042401批-多替诺雷-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110140-1014013.28712.923.2913.2912.923.29
29233-923312.09912.10
39925-992513.00513.01
49889-988912.95812.96
510076-1007613.20313.20
69874-987412.93912.94
10min117604-1760423.06822.941.5323.0922.971.53
217015-1701522.29622.32
317527-1752722.96722.99
417804-1780423.33023.35
517471-1747122.89422.92
617637-1763723.11123.13
15min122013-2201328.84528.720.9628.9128.780.97
221800-2180028.56628.62
322215-2221529.11029.17
421713-2171328.45228.51
522065-2206528.91328.97
621705-2170528.44228.50
20min124756-2475632.44032.440.4632.5532.550.46
224663-2466332.31832.42
324823-2482332.52732.64
424826-2482632.53132.64
524891-2489132.61732.72
624594-2459432.22732.33
30min128864-2886437.82337.560.6337.9937.720.63
228717-2871737.63037.79
328824-2882437.77037.93
428660-2866037.55537.72
528431-2843137.25537.42
628467-2846737.30237.46
45min132563-3256342.67042.580.3142.9042.800.32
232553-3255342.65742.88
332625-3262542.75142.98
432400-3240042.45642.68
532380-3238042.43042.65
632438-3243842.50642.73
60min135212-3521246.14145.850.4746.4446.150.47
235077-3507745.96446.26
335118-3511846.01846.31
434824-3482445.63245.93
534890-3489045.71946.01
634838-3483845.65145.95
90min138584-3858450.55950.450.5250.9350.830.52
238780-3878050.81651.19
338595-3859550.57450.95
438368-3836850.27650.65
538209-3820950.06850.44
638487-3848750.43250.80
120min141108-4110853.86754.351.2654.3254.811.25
242436-4243655.60756.06
341656-4165654.58555.04
441133-4113353.90054.35
541443-4144354.30654.76
641099-4109953.85554.31
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141658-4165854.58855.511.3655.1456.061.34
243313-4331356.75657.30
342420-4242055.58656.13
442102-4210255.16955.71
542631-4263155.86356.41
642054-4205455.10655.65
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%
110.925291665291565289795300665303995295530.13
211.335602745606355604540.05
单位质量响应值RSD%判断
48493.8649466.371.41数据可信
供试品溶液-6042401批-非布司他-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13947-39470.7250.717.710.720.718.02
23563-35630.6540.65
33501-35010.6430.64
43958-39580.7270.73
54286-42860.7870.79
64046-40460.7430.74
10min14853-48530.8910.873.130.890.883.13
24617-46170.8480.85
34989-49890.9160.92
44608-46080.8460.85
54697-46970.8620.86
64807-48070.8820.88
15min15105-51050.9370.922.910.940.923.06
25029-50290.9230.93
35168-51680.9490.95
44802-48020.8820.88
54836-48360.8880.89
64961-49610.9110.91
20min15073-50730.9310.912.530.940.922.62
24854-48540.8910.90
35074-50740.9310.94
45112-51120.9380.94
54850-48500.8900.89
64870-48700.8940.90
30min14642-46420.8520.875.410.860.885.24
24930-49300.9050.91
34429-44290.8130.82
45050-50500.9270.93
54552-45520.8360.84
64988-49880.9160.92
45min15332-53320.9790.895.970.990.906.10
24855-48550.8910.90
34861-48610.8920.90
45010-50100.9200.93
54616-46160.8470.85
64523-45230.8300.84
60min15265-52650.9670.904.660.980.904.88
24916-49160.9020.91
34819-48190.8850.89
44726-47260.8680.88
54939-49390.9070.92
64601-46010.8450.85
90min14762-47620.8740.864.040.880.883.95
24939-49390.9070.92
34827-48270.8860.90
44442-44420.8150.83
54516-45160.8290.84
64713-47130.8650.88
120min14675-46750.8580.853.390.870.863.25
24467-44670.8200.83
34639-46390.8520.86
44713-47130.8650.88
54799-47990.8810.89
64384-43840.8050.82
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14930-49300.9050.836.820.920.846.61
24856-48560.8910.90
34357-43570.8000.81
44217-42170.7740.79
54268-42680.7840.80
64407-44070.8090.82
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