非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103736328374118137319343739932374208037382910.12
2103777721379709237874060.37
单位质量响应值RSD%判断
373829.10378740.600.93数据可信
供试品溶液-4225B批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12709513-270951364.74448.8132.8164.7448.8132.80
22310532-231053255.21155.21
32086955-208695549.86849.87
42685180-268518064.16364.16
51234008-123400829.48729.49
61230169-123016929.39529.40
10min13733968-373396889.22480.449.8189.3780.549.84
23652169-365216987.26987.39
33279115-327911578.35578.47
43553513-355351384.91285.05
53016878-301687872.08972.15
62962068-296206870.77970.84
15min14020915-402091596.08090.434.8296.4290.724.86
23925612-392561293.80394.12
33718687-371868788.85989.14
43865059-386505992.35692.69
53552714-355271484.89385.12
63623297-362329786.57986.80
20min14144663-414466399.03794.843.0899.5995.323.12
24064420-406442097.12097.64
33894572-389457293.06193.54
43988913-398891395.31695.85
53809228-380922891.02291.44
63912058-391205893.47993.89
30min14183269-418326999.96096.841.79100.7497.541.83
24060354-406035497.02397.76
34014893-401489395.93696.63
44056771-405677196.93797.69
53967334-396733494.80095.42
64034096-403409696.39597.02
45min14233370-4233370101.15797.461.91102.1598.371.94
24066051-406605197.15998.12
34044798-404479896.65197.55
44066295-406629597.16598.13
54025899-402589996.19997.03
64035397-403539796.42697.26
60min14210902-4210902100.62097.481.64101.8498.611.67
24054048-405404896.87298.04
34065986-406598697.15798.27
44040504-404050496.54897.73
54077644-407764497.43698.48
64027321-402732196.23397.28
极限14336493-4336493103.62199.392.18105.07100.742.21
24126743-412674398.609100.00
34134285-413428598.789100.12
44159851-415985199.400100.79
54117480-411748098.38899.65
64082321-408232197.54898.81
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103705776375560237673653747578375490337462450.64
2103766109378998737780480.45
单位质量响应值RSD%判断
374624.50377804.800.60数据可信
供试品溶液-4225B批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12479103-247910359.24859.794.0359.2559.794.03
22474063-247406359.12859.13
32453912-245391258.64658.65
42396102-239610257.26457.26
52690515-269051564.30164.30
62517445-251744560.16460.16
10min13553816-355381684.93386.321.9185.0686.451.91
23653504-365350487.31587.45
33549055-354905584.81984.95
43570781-357078185.33885.47
53725412-372541289.03489.18
63617812-361781286.46286.60
15min14030632-403063296.32892.373.3496.6592.703.34
23803549-380354990.90191.23
33888614-388861492.93493.25
43662818-366281887.53887.85
53965144-396514494.76395.10
63840212-384021291.77792.10
20min14172027-417202799.70793.704.53100.2494.244.51
23827694-382769491.47892.01
33968914-396891494.85395.38
43774078-377407890.19790.71
54064085-406408597.12897.68
63717989-371798988.85689.39
30min14253460-4253460101.65495.953.89102.4196.693.88
23884494-388449492.83693.57
34068218-406821897.22697.96
43824940-382494091.41292.12
54094388-409438897.85298.62
63963742-396374294.73095.46
45min14255699-4255699101.70794.835.85102.6995.785.82
23903214-390321493.28394.22
34094878-409487897.86498.82
43827276-382727691.46892.38
54111886-411188698.27099.25
63613804-361380486.36687.30
60min14242281-4242281101.38694.505.57102.5995.675.53
23867659-386765992.43393.58
34030835-403083596.33397.50
43841907-384190791.81892.94
54115773-411577398.36399.57
63627206-362720686.68787.82
极限14257338-4257338101.74694.915.63103.1896.285.60
23886279-388627992.87894.23
34028435-402843596.27697.66
43851755-385175592.05393.38
54160044-416004499.421100.84
63644009-364400987.08888.41
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103785127380186338028413801697379464237972340.20
2103836174384531638407450.17
单位质量响应值RSD%判断
379723.40384074.500.81数据可信
供试品溶液-4225B批-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%
5min1284552-2845526.6997.368.456.707.368.44
2306502-3065027.2167.22
3304912-3049127.1797.18
4297874-2978747.0137.01
5360695-3606958.4928.49
6321073-3210737.5597.56
10min1568294-56829413.38014.004.4513.3914.014.47
2607633-60763314.30614.32
3561013-56101313.20813.22
4606033-60603314.26814.28
5631603-63160314.87014.89
6592786-59278613.95613.97
15min1607679-60767914.30715.925.2614.3515.975.26
2697316-69731616.41716.47
3667729-66772915.72115.77
4697863-69786316.43016.48
5696954-69695416.40916.46
6690457-69045716.25616.30
20min1637476-63747615.00916.267.1715.0816.357.16
2725688-72568817.08517.17
3702015-70201516.52816.61
4726451-72645117.10317.19
5733244-73324417.26317.35
6620019-62001914.59814.68
30min1735215-73521517.31016.387.7617.4216.507.70
2673096-67309615.84715.97
3728626-72862617.15517.27
4606101-60610114.27014.39
5751888-75188817.70217.83
6680527-68052716.02216.14
45min1765939-76593918.03316.4710.0218.1816.629.89
2761428-76142817.92718.08
3634286-63428614.93315.09
4760554-76055417.90618.06
5621402-62140214.63014.80
6652686-65268615.36715.52
60min1760575-76057517.90717.565.8818.1017.755.82
2658228-65822815.49715.69
3754963-75496317.77517.96
4765566-76556618.02418.22
5779309-77930918.34818.55
6756423-75642317.80918.00
极限1762124-76212417.94317.824.4818.1718.054.43
2784051-78405118.45918.69
3690987-69098716.26816.50
4766888-76688818.05518.29
5779667-77966718.35618.60
6756618-75661817.81418.04
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103792834380970338097693807821379848838037230.21
2103749648374922737494380.01
单位质量响应值RSD%判断
380372.30374943.801.02数据可信
供试品溶液-4225B批-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%
5min1385342-3853429.1748.4710.269.178.4710.26
2355745-3557458.4708.47
3286087-2860876.8116.81
4358520-3585208.5368.54
5385122-3851229.1699.17
6362863-3628638.6398.64
10min1630970-63097015.02214.543.5115.0414.563.50
2614948-61494814.64114.66
3581385-58138513.84213.86
4637227-63722715.17115.19
5594596-59459614.15614.18
6604200-60420014.38514.40
15min1703955-70395516.76016.216.5416.8116.266.53
2703098-70309816.74016.79
3651489-65148915.51115.56
4713891-71389116.99717.05
5710603-71060316.91816.97
6603197-60319714.36114.41
20min1730067-73006717.38216.738.1917.4716.828.16
2687797-68779716.37516.46
3715015-71501517.02317.10
4743221-74322117.69517.79
5746182-74618217.76517.85
6593668-59366814.13414.22
30min1629638-62963814.99116.2212.8615.1216.3412.76
2760848-76084818.11518.24
3753065-75306517.92918.05
4762833-76283318.16218.29
5567070-56707013.50113.63
6614126-61412614.62114.74
45min1779601-77960118.56117.579.8418.7217.739.74
2785213-78521318.69518.86
3770021-77002118.33318.49
4593219-59321914.12414.29
5756869-75686918.02018.18
6742388-74238817.67517.82
60min1790723-79072318.82618.441.4719.0318.641.44
2757696-75769618.04018.25
3772507-77250718.39218.59
4776556-77655618.48918.69
5768048-76804818.28618.49
6781612-78161218.60918.80
极限1789972-78997218.80819.158.8019.0519.398.70
2760377-76037718.10318.35
3767912-76791218.28318.52
4945431-94543122.50922.75
5798511-79851119.01119.25
6764314-76431418.19718.42
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103742041374727137474183747844374753437464220.07
2103737670373885537382620.03
单位质量响应值RSD%判断
374642.20373826.200.16数据可信
供试品溶液-4225B批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131867-318670.7660.7751.190.770.7751.23
225420-254200.6110.61
334886-348860.8380.84
435494-354940.8530.85
557961-579611.3931.39
67193-71930.1730.17
10min149354-493541.1861.0419.661.191.0519.70
245367-453671.0901.09
338246-382460.9190.92
446157-461571.1091.11
552723-527231.2671.27
629101-291010.6990.70
15min151521-515211.2381.0712.241.241.0812.20
242379-423791.0181.02
340461-404610.9720.98
446704-467041.1221.13
549228-492281.1831.19
637346-373460.8970.90
20min141099-410990.9871.064.450.991.064.52
243214-432141.0381.04
343656-436561.0491.05
446119-461191.1081.11
543870-438701.0541.06
646313-463131.1131.12
30min149904-499041.1991.1211.611.211.1311.40
242332-423321.0171.03
356356-563561.3541.36
444584-445841.0711.08
543243-432431.0391.05
643873-438731.0541.06
45min141949-419491.0081.059.361.021.079.28
251569-515691.2391.25
340604-406040.9760.99
445112-451121.0841.10
543307-433071.0401.05
640855-408550.9820.99
60min143169-431691.0371.0410.041.051.059.88
251541-515411.2381.25
339991-399910.9610.97
443701-437011.0501.06
540846-408460.9811.00
640247-402470.9670.98
极限142959-429591.0321.0610.671.051.0810.66
241973-419731.0081.02
353042-530421.2741.29
443994-439941.0571.07
543783-437831.0521.07
639091-390910.9390.95
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103736606374903437536313749281374942237475950.18
2103749300374663137479660.06
单位质量响应值RSD%判断
374759.50374796.600.01数据可信
供试品溶液-4225B批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118731-187310.4490.4516.670.450.4516.96
213847-138470.3320.33
322075-220750.5300.53
420063-200630.4810.48
521271-212710.5100.51
616443-164430.3940.39
10min135690-356900.8560.9117.180.860.9117.34
230959-309590.7430.74
335384-353840.8490.85
435499-354990.8520.85
539304-393040.9430.94
649908-499081.1971.20
15min138562-385620.9250.884.460.930.894.44
235852-358520.8600.86
336040-360400.8650.87
434459-344590.8270.83
537933-379330.9100.91
638313-383130.9190.92
20min138781-387810.9300.964.620.940.964.39
238077-380770.9130.92
339739-397390.9530.96
438961-389610.9350.94
543286-432861.0381.04
640111-401110.9620.97
30min140641-406410.9750.986.130.980.996.40
241943-419431.0061.01
339012-390120.9360.94
438213-382130.9170.92
541187-411870.9881.00
645347-453471.0881.10
45min140166-401660.9641.0322.020.971.0421.94
237560-375600.9010.91
361272-612721.4701.48
434749-347490.8340.84
541280-412800.9901.00
641706-417061.0011.01
60min140107-401070.9620.941.790.970.951.89
237983-379830.9110.92
339294-392940.9430.96
438864-388640.9320.94
539324-393240.9430.96
639035-390350.9360.95
极限139943-399430.9580.9715.220.970.9814.88
252096-520961.2501.26
335625-356250.8550.87
434944-349440.8380.85
540080-400800.9620.98
640264-402640.9660.98
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103774845377725037762063778055377633837765390.04
2103800574380498338027780.09
单位质量响应值RSD%判断
377653.90380277.800.49数据可信
供试品溶液-4225B批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12059476-205947648.86242.1519.4148.8642.1519.41
21639455-163945538.89738.90
32023973-202397348.02048.02
41149778-114977827.27927.28
51976686-197668646.89846.90
61809456-180945642.93042.93
10min13485208-348520882.68876.499.6282.8076.589.63
22965662-296566270.36170.45
33452419-345241981.91082.02
42722995-272299564.60464.66
53412769-341276980.96981.07
63303917-330391778.38778.48
15min13812739-381273990.45987.733.3090.7588.003.33
23668326-366832687.03287.28
33767540-376754089.38689.68
43471974-347197482.37482.58
53764123-376412389.30589.59
63702597-370259787.84688.12
20min13956531-395653193.87092.731.7094.3693.191.72
23973461-397346194.27294.71
33931355-393135593.27393.76
43787022-378702289.84990.24
53903813-390381392.61993.10
63899243-389924392.51192.98
30min14117223-411722397.68397.141.4698.3897.801.46
24203875-420387599.739100.38
34080956-408095696.82297.52
44038896-403889695.82496.41
54067639-406763996.50697.19
64057930-405793096.27696.95
45min14169752-416975298.92999.181.7999.85100.061.75
24313154-4313154102.331103.20
34132505-413250598.04598.96
44218142-4218142100.077100.88
54122226-412222697.80198.70
64125477-412547797.87898.76
60min14182925-418292599.24199.511.57100.38100.611.55
24320966-4320966102.517103.61
34186293-418629399.321100.45
44170019-417001998.93599.96
54127724-412772497.93299.05
64176441-417644199.088100.19
极限14207557-420755799.826100.081.23101.19101.411.22
24314535-4314535102.364103.69
34213958-421395899.978101.33
44171232-417123298.964100.21
54178278-417827899.131100.47
64224551-4224551100.229101.55
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103809392380278838046603794052379008938001960.21
2103810742381147738111100.02
单位质量响应值RSD%判断
380019.60381111.000.21数据可信
供试品溶液-4225B批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11814382-181438242.86641.499.9342.8741.499.93
21576151-157615137.23737.24
31931453-193145345.63145.63
41502079-150207935.48735.49
51837028-183702843.40143.40
61875450-187545044.30844.31
10min13212287-321228775.89275.734.3975.9975.834.40
22998803-299880370.84870.93
33311509-331150978.23678.34
43073943-307394372.62372.70
53288116-328811677.68377.78
63349140-334914079.12579.22
15min13745464-374546488.48887.051.6288.7587.311.63
23615084-361508485.40885.65
33711276-371127687.68087.96
43604510-360451085.15885.40
53707260-370726087.58687.85
63723524-372352487.97088.24
20min13956704-395670493.47992.161.3493.9492.621.35
23834291-383429190.58791.02
33883060-388306091.73992.21
43859529-385952991.18391.61
53964355-396435593.66094.12
63907473-390747392.31692.79
30min14143503-414350397.89296.721.1398.5697.381.13
24042702-404270295.51196.14
34052486-405248695.74296.42
44119661-411966197.32997.96
54141457-414145797.84498.52
64063385-406338595.99996.67
45min14226308-422630899.84899.161.44100.73100.041.43
24209112-420911299.442100.29
34157345-415734598.21999.11
44176510-417651098.67299.52
54293672-4293672101.440102.33
64120802-412080297.35698.24
60min14215180-421518099.58598.881.39100.6999.981.39
24165037-416503798.40199.47
34138994-413899497.78698.89
44166863-416686398.44499.51
54289239-4289239101.335102.45
64137189-413718997.74398.85
极限14222617-422261799.76199.230.63101.09100.540.65
24171694-417169498.55899.84
34192190-419219099.042100.36
44175483-417548398.64899.93
54238825-4238825100.144101.48
64200815-420081599.246100.57
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