非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.153896502391952439182363917989391477539134050.25
210.253942711395551439491120.23
单位质量响应值RSD%判断
385557.14385279.220.06数据可信
稳定性36月-长期36月-供试品溶液-2011707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%
5min11664963-166496338.87935.9824.7238.8835.9824.72
21384372-138437232.32732.33
32055790-205579048.00548.01
41450180-145018033.86433.86
51754361-175436140.96740.97
6935686-93568621.84921.85
10min13196305-319630574.63875.806.0574.7075.866.06
23283714-328371476.67976.73
33499624-349962481.72181.80
43341857-334185778.03778.09
53248870-324887075.86575.93
62906858-290685867.87967.92
15min13951071-395107192.26292.332.5092.4592.512.51
24014130-401413093.73593.92
34072404-407240495.09695.31
44004566-400456693.51293.70
53876804-387680490.52890.72
63804073-380407388.83088.98
20min14284936-4284936100.05998.721.41100.4099.061.42
24274673-427467399.819100.16
34276405-427640599.859100.23
44196312-419631297.98998.33
54192045-419204597.89098.24
64141343-414134396.70697.00
30min14435950-4435950103.585101.931.04104.09102.441.04
24393984-4393984102.605103.11
34375681-4375681102.178102.72
44324873-4324873100.991101.50
54335456-4335456101.238101.75
64324471-4324471100.982101.44
45min14435912-4435912103.584101.990.85104.27102.670.86
24372021-4372021102.092102.77
34373550-4373550102.128102.84
44333422-4333422101.191101.86
54343275-4343275101.421102.10
64347944-4347944101.530102.16
60min14432180-4432180103.497101.900.99104.35102.751.00
24392717-4392717102.575103.42
34370455-4370455102.056102.94
44321056-4321056100.902101.74
54338234-4338234101.303102.15
64328923-4328923101.086101.88
极限14411223-4411223103.008101.720.86104.04102.730.87
24383106-4383106102.351103.37
34366073-4366073101.953103.01
44313289-4313289100.721101.73
54335492-4335492101.239102.25
64326782-4326782101.036102.00
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.153952264395653839518083952281395011839526020.07
210.253955771397254239641560.30
单位质量响应值RSD%判断
389418.92386746.930.49数据可信
稳定性36月-长期36月-供试品溶液-2011707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%
5min12236897-223689751.87645.5016.1851.8845.5016.18
22093126-209312648.54248.54
32239676-223967651.94151.94
41423186-142318633.00533.01
51761538-176153840.85240.85
62018567-201856746.81346.81
10min13518484-351848481.59881.352.9181.6881.422.91
23580314-358031483.03283.11
33633419-363341984.26384.35
43423024-342302479.38479.44
53534602-353460281.97282.04
63356673-335667377.84577.92
15min14075669-407566994.52094.200.6294.7494.410.63
24088887-408888794.82695.05
34082537-408253794.67994.91
44058559-405855994.12394.31
54026522-402652293.38093.58
64038798-403879893.66593.87
20min14273142-427314299.09998.141.0599.4898.511.06
24264978-426497898.91099.29
34219905-421990597.86598.25
44212666-421266697.69798.04
54157035-415703596.40796.77
64262282-426228298.84799.21
30min14359867-4359867101.11199.901.36101.66100.431.36
24354806-4354806100.993101.54
34276805-427680599.18499.73
44308836-430883699.927100.43
54206881-420688197.56398.08
64338105-4338105100.606101.13
45min14372938-4372938101.414100.031.34102.13100.721.34
24356151-4356151101.024101.73
34283649-428364999.343100.06
44310634-431063499.969100.64
54215362-421536297.75998.44
64339764-4339764100.644101.34
60min14343859-4343859100.73999.721.33101.62100.581.33
24349733-4349733100.876101.75
34271037-427103799.05099.93
44294307-429430799.590100.43
54202519-420251997.46198.31
64338116-4338116100.606101.47
极限14333860-4333860100.50799.541.29101.56100.571.29
24340335-4340335100.658101.70
34249918-424991898.56199.60
44297672-429767299.668100.67
54203137-420313797.47698.48
64329227-4329227100.400101.43
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.151986016198263619842521978590197443919811870.24
210.251998117199921919986680.04
单位质量响应值RSD%判断
195190.84194992.000.08数据可信
稳定性36月-长期36月-供试品溶液-2011707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%
5min11341243-134124361.87554.4413.8261.8754.4413.82
2869678-86967840.12040.12
31187024-118702454.76054.76
41277177-127717758.91958.92
51209151-120915155.78155.78
61196152-119615255.18155.18
10min11934290-193429089.23387.721.9389.3487.811.95
21831958-183195884.51284.58
31903603-190360387.81787.91
41927357-192735788.91389.01
51898888-189888887.60087.69
61913033-191303388.25288.34
15min12089185-208918596.37996.470.5896.6396.710.58
22105628-210562897.13797.35
32084877-208487796.18096.42
42099093-209909396.83697.08
52097011-209701196.74096.98
62071738-207173895.57495.81
20min12138412-213841298.65099.130.9599.0699.530.93
22181210-2181210100.624100.99
32134354-213435498.46398.86
42158033-215803399.55599.96
52155970-215597099.46099.86
62125378-212537898.04898.45
30min12142625-214262598.84499.881.0099.42100.450.98
22200822-2200822101.529102.07
32152658-215265899.30799.87
42168291-2168291100.028100.60
52176630-2176630100.413100.98
62150047-215004799.18699.75
45min12152150-215215099.28399.861.00100.03100.590.99
22200278-2200278101.504102.21
32146610-214661099.02899.76
42169427-2169427100.081100.82
52175590-2175590100.365101.10
62143836-214383698.90099.63
60min12148071-214807199.095100.121.83100.00101.021.80
22195845-2195845101.299102.17
32144544-214454498.93399.83
42157921-215792199.550100.46
52238871-2238871103.284104.18
62136564-213656498.56499.46
极限12138634-213863498.66099.361.0099.73100.420.99
22188091-2188091100.942101.99
32138696-213869698.66399.72
42157275-215727599.520100.59
52167393-216739399.987101.06
62132302-213230298.36899.42
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.151997351200092219990902000349199741419990250.09
210.252002169200270520024370.02
单位质量响应值RSD%判断
196948.28195359.710.58数据可信
稳定性36月-长期36月-供试品溶液-2011707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%
5min1721537-72153733.10648.3321.0933.1148.3421.09
2953803-95380343.76343.76
3928268-92826842.59242.59
41171601-117160153.75753.76
51252330-125233057.46157.46
61293050-129305059.32959.33
10min11673775-167377576.79883.425.0976.8583.505.10
21761400-176140080.81880.89
31792308-179230882.23782.31
41872802-187280285.93086.02
51915402-191540287.88587.98
61892486-189248686.83386.93
15min12018769-201876992.62794.061.2892.8194.281.29
22051119-205111994.11294.32
32023811-202381192.85993.07
42076737-207673795.28795.52
52081787-208178795.51995.76
62047866-204786693.96294.21
20min12111451-211145196.88097.151.1697.2297.521.16
22133466-213346697.89098.25
32089233-208923395.86096.22
42146145-214614598.47298.86
52134486-213448697.93798.34
62089261-208926195.86296.26
30min12136847-213684798.04598.491.6498.5499.031.64
22160735-216073599.14199.67
32106885-210688596.67097.19
42166520-216652099.40799.96
52197687-2197687100.837101.40
62110570-211057096.83997.40
45min12132966-213296697.86797.831.0198.5398.531.00
22157909-215790999.01199.70
32109638-210963896.79797.48
42148626-214862698.58699.31
52139297-213929798.15898.89
62103877-210387796.53297.25
60min12124136-212413697.46297.661.2098.2998.531.20
22148828-214882898.59599.45
32093364-209336496.05096.89
42153370-215337098.80399.69
52147224-214722498.52199.42
62104224-210422496.54897.43
极限12124060-212406097.45897.611.1098.4598.641.10
22145809-214580998.45699.48
32101016-210101696.40197.41
42151994-215199498.74099.79
52142984-214298498.32799.39
62098652-209865296.29397.34
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