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101278-202104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%
110.323951410395256339458293942324393899839462250.15
210.353981534398800639847700.12
单位质量响应值RSD%判断
382386.14385001.930.49数据可信
供试品溶液-2024011311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%
5min11274391-127439129.89346.0023.6929.8946.0023.69
22395732-239573256.19556.20
31482486-148248634.77434.77
42150493-215049350.44350.44
52288845-228884553.68853.69
62174870-217487051.01551.01
10min13011678-301167870.64384.3412.0770.6984.4212.08
23932889-393288992.25292.35
33063645-306364571.86271.92
43841158-384115890.10090.18
53876132-387613290.92091.01
63849125-384912590.28790.37
15min13705286-370528686.91395.496.2387.0895.706.25
24218710-421871098.95699.20
33790305-379030588.90789.08
44270418-4270418100.169100.40
54255361-425536199.816100.06
64185255-418525598.17198.41
20min14043379-404337994.84399.353.1795.1699.723.20
24298977-4298977100.839101.25
34098826-409882696.14496.47
44377329-4377329102.677103.08
54331279-4331279101.596102.00
64262488-426248899.983100.38
30min14238741-423874199.426101.451.6799.90101.991.70
24342398-4342398101.857102.44
34263718-4263718100.012100.50
44432088-4432088103.961104.53
54373163-4373163102.579103.16
64299865-4299865100.860101.43
45min14288597-4288597100.595101.881.40101.23102.591.43
24355251-4355251102.159102.91
34296783-4296783100.787101.44
44440268-4440268104.153104.90
54382055-4382055102.788103.54
64297115-4297115100.795101.53
60min14309012-4309012101.074102.031.38101.88102.911.40
24356439-4356439102.187103.11
34301324-4301324100.894101.71
44449778-4449778104.376105.30
54383097-4383097102.812103.73
64298264-4298264100.822101.72
极限14289457-4289457100.61598.184.85101.5999.234.83
24361757-4361757102.311103.40
33790508-379050888.91289.90
44263875-4263875100.015101.11
54229758-422975899.215100.31
64177817-417781797.99799.07
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101278-202104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%
110.324019033402334340225674025536402443840229830.07
210.353977912397766339777880.01
单位质量响应值RSD%判断
389823.93384327.341.01数据可信
供试品溶液-2024011311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%
5min12031082-203108247.22845.7322.0447.2345.7422.04
22134520-213452049.63349.63
32216760-221676051.54551.55
42342091-234209154.45954.46
51948170-194817045.30045.30
61128356-112835626.23726.24
10min13574250-357425083.11083.3110.2983.1983.3810.30
23478143-347814380.87580.96
33832749-383274989.12189.21
43937004-393700491.54591.64
53761136-376113687.45687.53
62913123-291312367.73767.78
15min14098495-409849595.30095.004.4395.5295.224.46
24103598-410359895.41995.64
34182845-418284597.26197.50
44225886-422588698.26298.51
54172935-417293597.03197.25
63729959-372995986.73186.89
20min14246127-424612798.73398.571.8099.1198.951.83
24261404-426140499.08899.46
34263211-426321199.13099.53
44293882-429388299.843100.25
54282898-428289899.58899.97
64087913-408791395.05495.36
30min14307881-4307881100.169100.941.51100.71101.481.53
24312407-4312407100.274100.82
34466088-4466088103.847104.41
44349028-4349028101.126101.70
54329683-4329683100.676101.22
64280456-428045699.53199.99
45min14310982-4310982100.241100.480.39100.95101.180.41
24320584-4320584100.464101.17
34311397-4311397100.251100.99
44341540-4341540100.951101.69
54341381-4341381100.948101.66
64301735-4301735100.026100.65
60min14311522-4311522100.253100.530.36101.13101.410.38
24324708-4324708100.560101.44
34311176-4311176100.245101.15
44345306-4345306101.039101.95
54338077-4338077100.871101.76
64310674-4310674100.234101.03
极限14305720-4305720100.119100.260.42101.16101.300.44
24318616-4318616100.418101.46
34294783-429478399.864100.93
44342399-4342399100.971102.05
54313693-4313693100.304101.36
64295161-429516199.873100.83
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101278-202104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%
110.323993639399416939903763991510398906639917520.06
210.354081583408254140820620.02
单位质量响应值RSD%判断
386797.67394402.131.38数据可信
供试品溶液-2024011411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%
5min11118240-111824025.76847.9322.9025.7747.9322.89
22157585-215758549.71949.72
32266725-226672552.23452.23
42342694-234269453.98453.98
52252329-225232951.90251.90
62343145-234314553.99553.99
10min13030587-303058769.83683.478.1769.8883.558.18
23721114-372111485.74885.83
33801463-380146387.60087.69
43782476-378247687.16287.25
53637080-363708083.81283.90
63761689-376168986.68386.77
15min13767443-376744386.81693.633.6886.9893.853.70
24088535-408853594.21594.44
34150882-415088295.65295.88
44177806-417780696.27296.51
54082962-408296294.08694.31
64111175-411117594.73794.97
20min14040331-404033193.10496.762.0093.4197.142.03
24189701-418970196.54696.93
34237582-423758297.64998.04
44281430-428143098.66099.06
54237559-423755997.64998.03
64206980-420698096.94497.34
30min14218793-421879397.21699.001.9497.6899.541.95
24247166-424716697.87098.41
34282568-428256898.68699.24
44445019-4445019102.430102.99
54336169-433616999.921100.47
64248189-424818997.89498.45
45min14282488-428248898.68499.010.6899.3199.710.69
24260060-426006098.16798.87
34298245-429824599.04799.77
44342271-4342271100.062100.79
54315037-431503799.434100.15
64281579-428157998.66399.38
60min14286408-428640898.77599.000.7299.5699.860.73
24257462-425746298.10898.98
34293709-429370998.94399.83
44346149-4346149100.151101.05
54313687-431368799.403100.28
64279285-427928598.61099.49
极限14257400-425740098.10698.620.8399.0699.650.85
24229371-422937197.46098.49
34289826-428982698.85399.90
44333953-433395399.870100.93
54293731-429373198.94399.99
64274227-427422798.49499.54
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101278-202104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%
110.324100057410079840999774100768409829340999790.03
210.354105466410599441057300.01
单位质量响应值RSD%判断
397284.79396688.890.11数据可信
供试品溶液-2024011411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%
5min12162764-216276449.03251.554.8649.0351.554.87
22216419-221641950.24850.25
32176324-217632449.33949.34
42431597-243159755.12655.13
52378719-237871953.92753.93
62277825-227782551.64051.64
10min13729924-372992484.56085.852.0084.6485.942.00
23784554-378455485.79985.88
33721893-372189384.37884.46
43925681-392568188.99889.09
53751106-375110685.04185.13
63807775-380777586.32586.41
15min14118944-411894493.38094.391.3893.6094.621.38
24110242-411024293.18293.41
34144774-414477493.96594.19
44262793-426279396.64196.88
54148128-414812894.04194.27
64196079-419607995.12895.36
20min14203274-420327495.29296.631.4395.6797.021.43
24200729-420072995.23495.62
34251360-425136096.38296.76
44352929-435292998.68499.09
54251392-425139296.38296.77
64314456-431445697.81298.20
30min14264196-426419696.67397.741.3197.2198.291.31
24250323-425032396.35896.90
34301916-430191697.52898.07
44404473-440447399.853100.42
54303543-430354397.56598.11
64344342-434434298.49099.04
45min14275429-427542996.92797.971.2097.6398.681.20
24272270-427227096.85697.56
34311265-431126597.74098.44
44409700-440970099.971100.70
54309215-430921597.69398.40
64350135-435013598.62199.34
60min14259693-425969396.57197.811.2297.4398.681.22
24271968-427196896.84997.71
34300308-430030897.49198.36
44398519-439851999.718100.62
54302012-430201297.53098.40
64353103-435310398.68899.57
极限14263648-426364896.66097.561.0497.6898.601.05
24273023-427302396.87397.90
34287484-428748497.20198.23
44384840-438484099.408100.47
54289036-428903697.23698.27
64322636-432263697.99899.04
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