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%
110.987470174434745627524574755747390.42
211.237601476291761520.26
单位质量响应值RSD%判断
6806.836781.120.27数据可信
供试品溶液-6042201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%
5min19269-926912.24110.5614.8212.2410.5614.83
28962-896211.83511.84
37911-791110.44710.45
46379-63798.4248.42
56806-68068.9888.99
68644-864411.41511.42
10min117318-1731822.87021.288.5022.8921.308.50
217627-1762723.27823.30
316168-1616821.35121.37
414284-1428418.86318.88
514690-1469019.40019.41
616609-1660921.93421.95
15min121886-2188628.90327.217.0328.9627.267.03
221868-2186828.87928.94
320514-2051427.09127.14
418765-1876524.78124.83
518949-1894925.02425.07
621649-2164928.59028.65
20min124985-2498532.99531.585.2933.1031.685.30
225351-2535133.47933.59
323810-2381031.44431.54
422234-2223429.36229.45
522640-2264029.89829.99
624479-2447932.32732.43
30min129182-2918238.53837.163.5238.7037.313.53
229189-2918938.54738.71
327721-2772136.60836.76
427080-2708035.76235.90
527049-2704935.72135.86
628595-2859537.76337.92
45min133370-3337044.06842.742.3144.2942.952.32
233222-3322243.87344.10
331822-3182242.02442.24
431988-3198842.24342.44
531612-3161241.74741.95
632153-3215342.46142.68
60min135629-3562947.05246.181.3147.3546.471.33
235368-3536846.70747.01
334619-3461945.71846.00
434598-3459845.69045.96
534551-3455145.62845.90
635056-3505646.29546.59
90min139391-3939152.02051.051.6552.4051.411.66
239392-3939252.02152.40
338242-3824250.50250.86
438714-3871451.12651.47
537825-3782549.95250.30
638374-3837450.67751.04
120min140856-4085653.95454.791.0554.4255.231.02
241438-4143854.72355.19
341235-4123554.45554.90
441552-4155254.87455.30
542141-4214155.65156.08
641689-4168955.05555.51
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141516-4151654.82655.320.7855.3855.860.78
241982-4198255.44156.00
341648-4164855.00055.53
441680-4168055.04355.56
542229-4222955.76856.29
642298-4229855.85956.40
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%
110.925410955370395369785368815376895379360.34
211.335469545467285468410.03
单位质量响应值RSD%判断
49261.5448264.871.45数据可信
供试品溶液-6042201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%
5min13188-31880.5880.5513.540.590.5513.42
23223-32230.5940.59
33341-33410.6160.62
42381-23810.4390.44
52582-25820.4760.48
63246-32460.5990.60
10min14722-47220.8710.897.050.870.907.24
24870-48700.8980.90
35447-54471.0041.01
44424-44240.8160.82
54685-46850.8640.86
64923-49230.9080.91
15min15216-52160.9620.953.450.960.953.37
25316-53160.9800.98
35168-51680.9530.96
44983-49830.9190.92
54900-49000.9040.91
65341-53410.9850.99
20min14887-48870.9010.985.330.910.995.24
25440-54401.0031.01
35109-51090.9420.95
45336-53360.9840.99
55383-53830.9931.00
65706-57061.0521.06
30min14882-48820.9000.923.500.910.933.23
25234-52340.9650.97
34827-48270.8900.90
44994-49940.9210.93
54933-49330.9100.92
65230-52300.9640.97
45min14630-46300.8540.935.160.860.935.24
25258-52580.9700.98
34820-48200.8890.90
45307-53070.9790.99
55025-50250.9270.93
65064-50640.9340.94
60min14666-46660.8600.923.720.870.933.62
25101-51010.9410.95
34997-49970.9210.93
44982-49820.9190.93
55030-50300.9280.94
65219-52190.9620.97
90min14906-49060.9050.903.390.910.913.26
24711-47110.8690.88
34881-48810.9000.91
44721-47210.8710.88
54945-49450.9120.92
65161-51610.9520.96
120min14977-49770.9180.902.740.930.922.83
24670-46700.8610.87
34983-49830.9190.93
44801-48010.8850.90
54928-49280.9090.92
65011-50110.9240.94
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15153-51530.9500.885.410.960.895.19
24431-44310.8170.83
34654-46540.8580.87
44715-47150.8690.88
54693-46930.8650.88
64987-49870.9200.93
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%
110.987449774665742627424274171743670.28
211.237675676747767520.01
单位质量响应值RSD%判断
6772.956834.550.65数据可信
供试品溶液-6042201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%
5min18833-883311.64812.628.1111.6512.628.10
210679-1067914.08314.08
39021-902111.89611.90
48837-883711.65411.65
510036-1003613.23513.23
69994-999413.17913.18
10min116782-1678222.13122.933.6922.1522.953.69
218175-1817523.96823.99
317201-1720122.68322.70
416563-1656321.84221.86
517881-1788123.58023.60
617714-1771423.36023.38
15min121301-2130128.09028.911.9428.1528.971.94
222131-2213129.18529.25
322047-2204729.07429.13
421494-2149428.34528.40
522298-2229829.40529.47
622282-2228229.38429.44
20min124445-2444532.23632.901.4832.3433.001.49
225316-2531633.38533.50
324922-2492232.86532.97
424571-2457132.40232.51
525141-2514133.15433.26
625282-2528233.34033.45
30min128211-2821137.20338.111.6937.3638.271.69
229130-2913038.41438.58
329105-2910538.38238.54
428392-2839237.44137.60
529103-2910338.37938.54
629464-2946438.85539.02
45min132330-3233042.63443.361.2442.8543.591.25
232987-3298743.50143.73
333174-3317443.74743.97
432478-3247842.83043.05
532926-3292643.42043.65
633394-3339444.03844.27
60min135056-3505646.22946.800.9446.5247.100.95
235600-3560046.94747.25
335636-3563646.99447.29
435103-3510346.29146.58
535864-3586447.29547.60
635690-3569047.06547.37
90min138727-3872751.07051.370.6951.4451.750.69
238706-3870651.04351.43
338970-3897051.39151.77
438857-3885751.24251.61
539023-3902351.46151.84
639437-3943752.00752.39
120min141242-4124254.38754.470.7954.8454.930.79
241303-4130354.46754.93
341160-4116054.27954.74
440904-4090453.94154.39
541341-4134154.51754.98
641885-4188555.23555.70
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141674-4167454.95755.350.6855.5055.900.69
241739-4173955.04255.60
342112-4211255.53456.09
441796-4179655.11755.66
542106-4210655.52656.08
642409-4240955.92656.49
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%
110.925347325337045339095360065335325343770.20
211.335548665560865554760.16
单位质量响应值RSD%判断
48935.6249027.010.14数据可信
供试品溶液-6042201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%
5min13106-31060.5700.588.840.570.589.19
23313-33130.6080.61
33364-33640.6170.62
42634-26340.4830.48
53359-33590.6170.62
63230-32300.5930.59
10min14397-43970.8070.864.460.810.864.45
24719-47190.8660.87
34590-45900.8430.84
44938-49380.9060.91
54854-48540.8910.89
64500-45000.8260.83
15min14887-48870.8970.914.130.900.914.25
24619-46190.8480.85
34991-49910.9160.92
45254-52540.9640.97
54976-49760.9130.92
65009-50090.9190.92
20min15461-54611.0020.963.051.010.973.25
25276-52760.9680.97
35152-51520.9460.95
45385-53850.9880.99
55234-52340.9610.96
65013-50130.9200.92
30min15132-51320.9420.913.290.950.923.30
24872-48720.8940.90
35098-50980.9360.94
44705-47050.8640.87
54955-49550.9100.92
65076-50760.9320.94
45min14919-49190.9030.943.690.910.953.76
24882-48820.8960.90
35302-53020.9730.98
45231-52310.9600.97
55310-53100.9750.98
65110-51100.9380.94
60min15111-51110.9380.895.580.950.905.81
24389-43890.8060.81
34671-46710.8570.87
44963-49630.9110.92
54816-48160.8840.89
65050-50500.9270.94
90min14969-49690.9120.866.740.920.876.71
24428-44280.8130.82
34242-42420.7790.79
45059-50590.9290.94
54829-48290.8860.90
64664-46640.8560.87
120min14479-44790.8220.832.980.830.843.05
24588-45880.8420.85
34473-44730.8210.83
44779-47790.8770.89
54465-44650.8200.83
64401-44010.8080.82
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14719-47190.8660.864.430.880.884.49
24349-43490.7980.81
34747-47470.8710.88
44865-48650.8930.91
54641-46410.8520.86
64949-49490.9080.92
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%
110.987680276824765057727177382769570.48
211.237453775320749280.74
单位质量响应值RSD%判断
7008.836672.133.49数据不可信!(响应值差异过大,请重新称样测定!)
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%
5min18735-873511.46412.895.6011.4612.895.61
210182-1018213.36313.36
39884-988412.97212.97
49980-998013.09813.10
510219-1021913.41213.41
69925-992513.02613.03
10min116255-1625521.33322.713.3821.3522.733.38
217872-1787223.45523.48
317447-1744722.89822.92
417308-1730822.71522.74
517786-1778623.34323.36
617141-1714122.49622.52
15min120916-2091627.45028.272.2327.5128.332.23
221836-2183628.65828.72
321881-2188128.71728.78
421659-2165928.42628.49
521986-2198628.85528.92
620952-2095227.49827.56
20min123809-2380931.24732.101.7831.3532.211.77
224587-2458732.26832.38
324569-2456932.24532.35
424614-2461432.30432.41
525056-2505632.88432.99
624132-2413231.67131.78
30min128216-2821637.03137.511.6537.1837.671.65
228845-2884537.85738.02
328454-2845437.34337.50
428406-2840637.28037.44
529403-2940338.58938.75
628159-2815936.95637.11
45min132078-3207842.10042.401.7142.3142.621.71
232543-3254342.71042.94
332621-3262142.81243.04
432027-3202742.03342.26
533065-3306543.39543.62
631501-3150141.34241.56
60min134362-3436245.09745.611.1945.3845.911.19
235043-3504345.99146.29
335037-3503745.98346.28
434497-3449745.27445.57
535276-3527646.29746.60
634316-3431645.03745.33
90min138076-3807649.97150.540.8950.3350.910.90
238978-3897851.15551.53
338443-3844350.45350.82
438333-3833350.30950.68
538864-3886451.00651.38
638383-3838350.37450.74
120min140633-4063353.32753.770.8553.7754.230.85
241006-4100653.81754.28
340498-4049853.15053.61
441061-4106153.88954.34
541220-4122054.09854.56
641414-4141454.35254.80
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140947-4094753.73954.771.2554.2755.321.24
241528-4152854.50255.05
341754-4175454.79955.34
441590-4159054.58355.13
542173-4217355.34855.90
642421-4242155.67456.21
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%
110.925552275560165593725561045558575565150.30
211.335360615376785368700.22
单位质量响应值RSD%判断
50962.9147384.825.15数据不可信!(响应值差异过大,请重新称样测定!)
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%
5min13703-37030.6780.725.300.680.725.15
23932-39320.7200.72
34117-41170.7540.75
43838-38380.7030.70
53807-38070.6970.70
64260-42600.7800.78
10min14669-46690.8550.871.630.860.871.79
24840-48400.8860.89
34709-47090.8620.86
44818-48180.8820.88
54778-47780.8750.88
64660-46600.8530.85
15min14806-48060.8800.915.440.880.915.48
25094-50940.9330.94
35180-51800.9480.95
45220-52200.9560.96
54510-45100.8260.83
64902-49020.8970.90
20min14659-46590.8530.904.480.860.914.43
25076-50760.9290.93
35193-51930.9510.96
44790-47900.8770.88
55128-51280.9390.94
64782-47820.8760.88
30min14882-48820.8940.932.580.900.932.67
24969-49690.9100.92
35248-52480.9610.97
45074-50740.9290.93
55021-50210.9190.92
65148-51480.9430.95
45min14542-45420.8320.884.480.840.894.70
25025-50250.9200.93
35078-50780.9300.94
44850-48500.8880.90
54730-47300.8660.87
64628-46280.8470.85
60min14798-47980.8780.914.830.890.924.68
25363-53630.9820.99
35145-51450.9420.95
44956-49560.9070.92
54903-49030.8980.91
64706-47060.8620.87
90min14962-49620.9080.896.460.920.906.30
25430-54300.9941.00
34745-47450.8690.88
44924-49240.9020.91
54631-46310.8480.86
64556-45560.8340.84
120min14861-48610.8900.834.400.900.844.46
24541-45410.8310.84
34584-45840.8390.85
44277-42770.7830.79
54439-44390.8130.82
64411-44110.8080.82
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14551-45510.8330.842.580.850.852.74
24647-46470.8510.86
34634-46340.8480.86
44543-45430.8320.84
54426-44260.8100.82
64772-47720.8740.89
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