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101278-202003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%
110.043789402379912637787663797358381083737950980.32
210.173858224389467738764500.67
单位质量响应值RSD%判断
377997.81381165.190.60数据可信
供试品溶液-2024112521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%
5min12154828-215482851.09354.8911.3351.0954.8911.32
22513105-251310559.58859.59
32093378-209337849.63649.64
42724981-272498164.61164.61
52068212-206821249.03949.04
62334973-233497355.36455.36
10min13318996-331899678.69690.868.9978.8190.988.98
23991492-399149294.64194.77
34087269-408726996.91297.02
44218943-4218943100.034100.18
53534230-353423083.79983.91
63842075-384207591.09891.22
15min13948427-394842793.62099.162.9393.9199.482.94
24163918-416391898.73099.07
34247283-4247283100.706101.03
44287141-4287141101.651102.02
54196311-419631199.49899.79
64249103-4249103100.749101.07
20min14091724-409172497.01899.901.7697.51100.451.78
24162863-416286398.70599.27
34242797-4242797100.600101.15
44298240-4298240101.914102.51
54231124-4231124100.323100.84
64253746-4253746100.859101.41
30min14125763-412576397.825100.261.5598.54101.031.56
24176097-417609799.01899.80
34264921-4264921101.124101.90
44303631-4303631102.042102.86
54246106-4246106100.678101.42
64254305-4254305100.873101.65
45min14135476-413547698.055100.331.3798.98101.321.39
24202166-420216699.636100.64
34281987-4281987101.529102.53
44294768-4294768101.832102.88
54232591-4232591100.358101.32
64242727-4242727100.598101.60
60min14140569-414056998.176100.501.5299.32101.711.54
24188201-418820199.305100.53
34290201-4290201101.724102.95
44310815-4310815102.213103.48
54237417-4237417100.472101.66
64263074-4263074101.081102.30
极限14144879-414487998.278100.271.2899.64101.701.30
24195942-419594299.489100.93
34264449-4264449101.113102.56
44299621-4299621101.947103.45
54228273-4228273100.255101.66
64239061-4239061100.511101.96
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101278-202003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%
110.043903694390240338982213889298388147238950180.25
210.173910166393539739227820.46
单位质量响应值RSD%判断
387950.00385720.940.41数据可信
供试品溶液-2024112621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%
5min11652363-165236338.44446.0818.1638.4446.0818.16
21770771-177077141.19941.20
32610716-261071660.74160.74
42126613-212661349.47849.48
52015598-201559846.89546.89
61706256-170625639.69839.70
10min13859240-385924089.78990.443.8289.8790.543.82
23898224-389822490.69690.79
34048279-404827994.18794.32
44008063-400806393.25193.36
53625593-362559384.35384.46
63884640-388464090.38090.47
15min14191728-419172897.52497.961.8597.8198.261.86
24234674-423467498.52398.82
34237294-423729498.58498.93
44326821-4326821100.667100.98
54091878-409187895.20195.49
64180396-418039697.26197.55
20min14207544-420754497.89298.451.9898.3998.971.99
24270983-427098399.36899.88
34249300-424930098.86499.43
44349593-4349593101.197101.74
54096379-409637995.30695.81
64214360-421436098.05198.56
30min14207994-420799497.90398.731.4498.6299.471.46
24274834-427483499.458100.19
34269502-426950299.334100.12
44317572-4317572100.452101.22
54142398-414239896.37797.09
64250078-425007898.88299.60
45min14255400-425540099.00698.881.4899.9499.831.49
24270642-427064299.360100.31
34264678-426467899.222100.23
44340472-4340472100.985101.97
54150913-415091396.57597.50
64216790-421679098.10799.05
60min14247576-424757698.82498.881.7399.98100.061.74
24263569-426356999.196100.37
34258162-425816299.070100.29
44362723-4362723101.503102.72
54132762-413276296.15297.30
64234699-423469998.52499.68
极限14226305-422630598.32998.401.2899.7199.801.29
24243030-424303098.718100.11
34243934-424393498.739100.18
44311937-4311937100.321101.76
54147823-414782396.50397.86
64204446-420444697.82099.20
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101278-202003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%
110.043873102388122738799893878179387179938768590.11
210.173880310388750138839060.14
单位质量响应值RSD%判断
386141.33381898.330.79数据可信
供试品溶液-2024112721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%
5min12800924-280092465.64559.639.6565.6559.639.65
22794589-279458965.49765.50
32497842-249784258.54258.54
42198067-219806751.51651.52
52635030-263503061.75761.76
62338058-233805854.79754.80
10min14158848-415884897.47193.343.8797.6293.473.88
24164560-416456097.60597.75
33802264-380226489.11489.24
43915942-391594291.77891.89
54001470-400147093.78293.92
63852932-385293290.30190.42
15min14206054-420605498.57798.361.2398.9498.701.24
24285076-4285076100.429100.79
34178536-417853697.93298.26
44140810-414081097.04897.37
54214530-421453098.77699.12
64156940-415694097.42697.75
20min14228844-422884499.11199.490.8799.69100.040.87
24300912-4300912100.800101.39
34276905-4276905100.238100.78
44209229-420922998.65299.19
54238749-423874999.34499.91
64214284-421428498.77099.31
30min14221203-422120398.93299.711.2299.73100.491.22
24323117-4323117101.321102.13
34310499-4310499101.025101.79
44207249-420724998.60599.36
54255884-425588499.745100.53
64208907-420890798.64499.40
45min14228053-422805399.09399.560.90100.11100.560.90
24299297-4299297100.763101.80
34292799-4292799100.610101.60
44210219-421021998.67599.65
54232956-423295699.208100.22
64224495-422449599.01099.99
60min14199789-419978998.43099.141.3399.67100.371.33
24313161-4313161101.088102.35
34288682-4288682100.514101.73
44177206-417720697.90199.09
54203796-420379698.52499.75
64198903-419890398.41099.61
极限14181519-418151998.00299.191.2899.46100.641.28
24308323-4308323100.974102.46
34280290-4280290100.317101.76
44171492-417149297.76799.18
54235958-423595899.278100.73
64216889-421688998.831100.25
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