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%
110.997009370127701987028470393702190.18
210.997150971564715360.06
单位质量响应值RSD%判断
6389.356509.191.32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%
5min18968-896812.47712.594.0812.4812.594.09
28687-868712.08612.09
39678-967813.46513.47
48718-871812.12912.13
58996-899612.51612.52
69234-923412.84712.85
10min116596-1659623.09023.091.2023.1123.111.21
216211-1621122.55422.57
316706-1670623.24323.27
416631-1663123.13923.16
516777-1677723.34223.36
616649-1664923.16423.19
15min120810-2081028.95328.910.7629.0128.970.75
220706-2070628.80828.87
320781-2078128.91328.97
421015-2101529.23829.30
520539-2053928.57628.64
620836-2083628.98929.05
20min123928-2392833.29133.100.6933.4033.200.69
223536-2353632.74632.85
323844-2384433.17433.28
423953-2395333.32633.43
523813-2381333.13133.24
623650-2365032.90433.01
30min127903-2790338.82138.730.7838.9838.890.77
227583-2758338.37638.54
328022-2802238.98739.15
428083-2808339.07239.23
527867-2786738.77138.93
627577-2757738.36838.53
45min132072-3207244.62244.310.6744.8544.530.67
231641-3164144.02244.25
331814-3181444.26344.49
432063-3206344.60944.84
531913-3191344.40144.63
631566-3156643.91844.14
60min134693-3469348.26847.991.1348.5748.291.13
234128-3412847.48247.78
334302-3430247.72448.03
434992-3499248.68448.99
534795-3479548.41048.71
634038-3403847.35747.66
90min137990-3799052.85653.010.6253.2453.390.61
238243-3824353.20753.58
338273-3827353.24953.63
438229-3822953.18853.57
538198-3819853.14553.53
637672-3767252.41352.79
120min141475-4147557.70457.280.7458.1757.750.73
240633-4063356.53357.00
341275-4127557.42657.90
441397-4139757.59658.07
541067-4106757.13757.61
641164-4116457.27157.74
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142245-4224558.77558.580.8759.3459.140.87
241486-4148657.71958.28
341884-4188458.27358.84
442444-4244459.05259.62
542154-4215458.64959.21
642419-4241959.01859.58
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%
110.214973484978614990724984634980274981540.14
210.355112785124365118570.16
单位质量响应值RSD%判断
48790.7949454.780.96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%
5min14726-47260.8650.816.630.870.816.63
24144-41440.7590.76
34778-47780.8750.87
44116-41160.7530.75
54309-43090.7890.79
64604-46040.8430.84
10min14965-49650.9091.0013.740.911.0013.51
25383-53830.9850.99
35061-50610.9260.93
45110-51100.9350.94
56949-69491.2721.27
65232-52320.9580.96
15min15268-52680.9640.942.480.970.952.56
25074-50740.9290.93
35323-53230.9740.98
45185-51850.9490.95
55046-50460.9240.93
65003-50030.9160.92
20min15319-53190.9740.963.720.980.963.81
25503-55031.0071.01
35104-51040.9340.94
45082-50820.9300.93
55384-53840.9850.99
65015-50150.9180.92
30min15242-52420.9590.952.380.970.962.51
24949-49490.9060.91
35288-52880.9680.97
45242-52420.9590.97
55198-51980.9510.96
65250-52500.9610.97
45min15289-52890.9680.962.250.980.972.30
25343-53430.9780.99
35217-52170.9550.96
45201-52010.9520.96
55404-54040.9891.00
65072-50720.9280.94
60min14922-49220.9010.923.810.910.943.99
25006-50060.9160.93
35077-50770.9290.94
45076-50760.9290.94
55398-53980.9881.00
64839-48390.8860.89
90min15103-51030.9340.9814.180.940.9814.05
26840-68401.2521.26
35139-51390.9410.95
44759-47590.8710.88
55248-52480.9610.97
64930-49300.9020.91
120min14841-48410.8860.865.390.900.875.11
24668-46680.8540.87
35087-50870.9310.94
44733-47330.8660.88
54475-44750.8190.83
64388-43880.8030.82
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14787-47870.8760.9518.400.890.9618.24
24650-46500.8510.87
35247-52470.9600.97
44646-46460.8500.86
54658-46580.8530.87
67059-70591.2921.31
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%
110.997176171923719467199572123719500.19
210.997259672748726720.15
单位质量响应值RSD%判断
6546.866612.560.71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%
5min19904-990413.50512.5510.6913.5112.5510.69
29244-924412.60512.61
37312-73129.9719.97
410048-1004813.70213.70
59404-940412.82412.82
69289-928912.66712.67
10min116948-1694823.11122.365.0523.1322.385.04
216304-1630422.23322.25
314828-1482820.22020.24
417154-1715423.39223.41
516569-1656922.59422.62
616597-1659722.63222.65
15min121399-2139929.18028.284.1929.2428.344.19
220991-2099128.62428.68
319015-1901525.93025.98
421198-2119828.90628.97
521010-2101028.65028.71
620805-2080528.37028.43
20min124437-2443733.32332.443.5633.4332.553.56
223880-2388032.56432.67
322136-2213630.18530.28
424357-2435733.21433.32
523866-2386632.54532.65
624068-2406832.82032.93
30min128208-2820838.46537.752.6038.6337.912.61
227954-2795438.11938.28
326243-2624335.78635.93
427781-2778137.88338.05
527957-2795738.12338.28
627966-2796638.13538.30
45min131999-3199943.63543.141.3643.8643.361.37
231972-3197243.59843.82
330829-3082942.04042.24
431647-3164743.15543.38
531783-3178343.34043.56
631579-3157943.06243.29
60min134816-3481647.47646.920.8247.7847.220.83
234687-3468747.30047.60
334100-3410046.50046.77
434248-3424846.70247.00
534334-3433446.81947.12
634262-3426246.72147.02
90min138420-3842052.39151.850.6352.7752.220.63
238191-3819152.07952.45
337809-3780951.55851.91
437856-3785651.62252.00
537890-3789051.66852.04
637967-3796751.77352.15
120min140572-4057255.32555.890.8355.7956.340.82
240614-4061455.38355.84
341057-4105755.98756.42
441454-4145456.52856.99
541037-4103755.96056.42
641165-4116556.13456.59
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141144-4114456.10556.911.1956.6757.461.19
241338-4133856.37056.92
341581-4158156.70157.23
442245-4224557.60758.17
541693-4169356.85457.41
642398-4239857.81558.37
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%
110.215160795153935159935135105144315150810.22
210.355238365243465240910.07
单位质量响应值RSD%判断
50448.6850636.810.27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%
5min14235-42350.7530.756.710.750.756.86
24497-44970.8000.80
33820-38200.6800.68
44500-45000.8010.80
53962-39620.7050.70
64366-43660.7770.78
10min14822-48220.8580.9413.700.860.9413.89
25014-50140.8920.89
36723-67231.1961.20
45178-51780.9210.92
55051-50510.8990.90
64850-48500.8630.86
15min15190-51900.9230.914.440.930.924.52
25493-54930.9770.98
34986-49860.8870.89
44833-48330.8600.86
55189-51890.9230.93
65020-50200.8930.90
20min14897-48970.8710.883.110.880.883.02
24829-48290.8590.86
35225-52250.9290.93
44899-48990.8710.88
55051-50510.8990.90
64837-48370.8600.86
30min14898-48980.8710.894.420.880.894.35
24923-49230.8760.88
34936-49360.8780.88
44949-49490.8800.89
55423-54230.9650.97
64799-47990.8540.86
45min14917-49170.8750.893.870.880.903.78
25218-52180.9280.94
34894-48940.8710.88
45041-50410.8970.90
54726-47260.8410.85
65215-52150.9280.93
60min14573-45730.8130.843.150.820.853.14
24806-48060.8550.86
34562-45620.8120.82
44710-47100.8380.85
54950-49500.8810.89
64677-46770.8320.84
90min14459-44590.7930.9010.170.800.9010.13
25016-50160.8920.90
35325-53250.9470.96
44443-44430.7900.80
55247-52470.9330.94
65740-57401.0211.03
120min14761-47610.8470.847.680.860.857.51
25008-50080.8910.90
35137-51370.9140.93
44586-45860.8160.83
54132-41320.7350.75
64545-45450.8090.82
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14808-48080.8550.8911.100.870.9010.98
24562-45620.8120.82
35168-51680.9190.93
44910-49100.8730.89
54496-44960.8000.81
66007-60071.0691.08
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%
110.997252772619727877250172577726020.16
210.996973769597696670.15
单位质量响应值RSD%判断
6606.196339.132.92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%
5min18836-883612.25312.695.0212.2512.695.02
29565-956513.26413.26
38478-847811.75711.76
49171-917112.71812.72
59134-913412.66712.67
69726-972613.48713.49
10min117142-1714223.77223.961.8223.7923.981.82
217384-1738424.10724.13
316891-1689123.42323.44
417230-1723023.89423.91
517183-1718323.82823.85
617826-1782624.72024.74
15min121767-2176730.18530.310.5030.2530.370.50
221881-2188130.34330.41
321759-2175930.17430.23
421789-2178930.21630.28
521906-2190630.37830.44
622038-2203830.56130.62
20min124831-2483134.43434.520.6134.5434.620.61
224699-2469934.25134.36
324773-2477334.35434.46
424918-2491834.55534.67
525097-2509734.80334.91
625018-2501834.69434.81
30min128917-2891740.10039.990.4640.2740.160.45
228608-2860839.67239.84
328896-2889640.07140.24
428955-2895540.15340.32
528882-2888240.05240.22
628759-2875939.88140.05
45min132668-3266845.30245.490.8845.5445.720.88
232318-3231844.81745.05
332927-3292745.66145.89
433176-3317646.00746.24
532885-3288545.60345.84
632829-3282945.52545.76
60min135414-3541449.11048.820.7449.4249.140.73
234864-3486448.34748.66
335070-3507048.63348.94
435566-3556649.32149.63
535259-3525948.89549.21
635068-3506848.63048.95
90min139051-3905154.15453.820.7554.5554.220.75
238361-3836153.19753.59
338857-3885753.88554.27
439180-3918054.33354.73
538693-3869353.65754.05
638729-3872953.70754.10
120min140831-4083156.62256.840.5357.1057.320.53
240725-4072556.47556.96
341078-4107856.96557.44
441328-4132857.31157.80
540897-4089756.71457.20
641078-4107856.96557.45
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141609-4160957.70157.920.9858.2858.500.98
241164-4116457.08457.66
341747-4174757.89258.47
442313-4231358.67759.26
541633-4163357.73458.31
642125-4212558.41759.00
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%
110.215224065225525225535227995215305223680.10
210.354965904965844965870.01
单位质量响应值RSD%判断
51162.3947979.424.55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%
5min13489-34890.6330.622.160.630.622.14
23528-35280.6410.64
33318-33180.6020.60
43411-34110.6190.62
53442-34420.6250.62
63407-34070.6190.62
10min14865-48650.8830.854.870.880.864.83
25039-50390.9150.92
34787-47870.8690.87
44456-44560.8090.81
54603-46030.8360.84
64487-44870.8150.82
15min14622-46220.8390.886.240.840.886.27
25083-50830.9230.93
35116-51160.9290.93
45115-51150.9290.93
54581-45810.8320.83
64482-44820.8140.82
20min14766-47660.8650.896.830.870.906.83
25544-55441.0071.01
34798-47980.8710.88
44982-49820.9050.91
54823-48230.8760.88
64575-45750.8310.83
30min15021-50210.9120.907.300.920.907.16
25140-51400.9330.94
35214-52140.9470.95
45337-53370.9690.97
54451-44510.8080.81
64574-45740.8300.84
45min14700-47000.8530.889.590.860.899.27
24877-48770.8850.89
35655-56551.0271.03
45022-50220.9120.92
54300-43000.7810.79
64572-45720.8300.84
60min14669-46690.8480.845.850.860.856.03
25013-50130.9100.92
34805-48050.8720.88
44610-46100.8370.85
54334-43340.7870.79
64314-43140.7830.79
90min14476-44760.8130.837.110.820.847.22
25167-51670.9380.95
34635-46350.8420.85
44205-42050.7630.77
54471-44710.8120.82
64458-44580.8090.82
120min14499-44990.8170.818.440.830.828.50
25062-50620.9190.93
34665-46650.8470.86
44450-44500.8080.82
53934-39340.7140.72
64281-42810.7770.79
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14466-44660.8110.8811.720.820.9011.48
24662-46620.8460.86
34988-49880.9060.92
44917-49170.8930.91
54291-42910.7790.79
65906-59061.0721.08
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