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(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.031973421196622819661841969299196851419687290.16
210.121996664199392319952940.10
单位质量响应值RSD%判断
196284.05197163.440.32数据可信
供试品溶液-20250401-1批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100730-1007304.60814.2652.244.6114.2652.24
2324909-32490914.86414.86
3167235-1672357.6517.65
4524537-52453723.99724.00
5294982-29498213.49513.50
6458318-45831820.96820.97
10min1548791-54879125.10746.6632.7125.1146.6832.72
21094701-109470150.08250.11
3707685-70768532.37632.39
41377509-137750963.02163.06
51051209-105120948.09248.11
61339867-133986761.29861.33
15min1997869-99786945.65270.6823.1545.7070.7823.17
21710158-171015878.23978.35
31189437-118943754.41654.48
41806927-180692782.66682.81
51734491-173449179.35279.46
61830354-183035483.73883.88
20min11377581-137758163.02482.2213.7863.1582.4413.82
21934147-193414788.48788.73
31607067-160706773.52373.68
41929249-192924988.26288.55
51954772-195477289.43089.67
61979919-197991990.58190.86
30min11908461-190846187.31192.463.4687.5492.813.53
22054117-205411793.97594.36
31969269-196926990.09390.37
42027141-202714192.74193.17
52074836-207483694.92395.31
62091678-209167895.69496.12
45min12075697-207569794.96296.371.4995.3496.881.55
22115369-211536996.77797.32
32082067-208206795.25495.68
42081706-208170695.23795.82
52133661-213366197.61498.16
62150523-215052398.38698.97
60min12114814-211481496.75297.661.4197.2998.331.45
22138058-213805897.81598.52
32118295-211829596.91197.50
42100375-210037596.09196.83
52154407-215440798.56399.27
62182369-218236999.843100.59
极限12142366-214236698.01398.741.1298.7199.581.16
22162816-216281698.94899.82
32149052-214905298.31899.07
42128805-212880597.39298.30
52168692-216869299.217100.09
62198011-2198011100.558101.48
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(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.031974537197526119749781971054197079419733250.12
210.121997158199722919971940.01
单位质量响应值RSD%判断
196742.27197351.190.22数据可信
供试品溶液-20250401-1批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1484399-48439922.12523.389.6122.1223.389.61
2469413-46941321.44021.44
3452142-45214220.65120.65
4569830-56983026.02726.03
5551746-55174625.20125.20
6543472-54347224.82324.82
10min11286516-128651658.76157.218.8858.8057.258.88
21030917-103091747.08747.12
31271462-127146258.07358.11
41296627-129662759.22359.27
51341509-134150961.27361.31
61288948-128894858.87258.91
15min11579574-157957472.14670.571.8872.2870.701.88
21500771-150077168.54768.66
31536386-153638670.17470.30
41545980-154598070.61270.75
51573907-157390771.88872.03
61534121-153412170.07070.21
20min11704008-170400877.83076.521.4178.0876.771.40
21691684-169168477.26777.50
31652178-165217875.46275.71
41662494-166249475.93476.19
51692541-169254177.30677.57
61649233-164923375.32875.58
30min11865166-186516685.19183.751.7185.5884.121.70
21873227-187322785.55985.92
31804748-180474882.43182.80
41816147-181614782.95283.34
51841989-184198984.13284.52
61799887-179988782.20982.59
45min11973435-197343590.13689.111.6890.6689.631.67
21998149-199814991.26591.76
31917305-191730587.57288.08
41935192-193519288.38988.91
51963852-196385289.69890.23
61918097-191809787.60888.13
60min12046730-204673093.48392.051.8394.1692.721.82
22064518-206451894.29694.95
31978888-197888890.38591.04
41992286-199228690.99791.67
52030524-203052492.74393.43
61979740-197974090.42491.09
极限12078582-207858294.93894.061.6595.7794.881.63
22108945-210894596.32597.13
32025054-202505492.49393.30
42036405-203640593.01293.84
52077084-207708494.87095.71
62029857-202985792.71393.53
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(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.031966683196791419658811965972196596619664830.05
210.121980432198188619811590.06
单位质量响应值RSD%判断
196060.12195766.700.11数据可信
供试品溶液-20250401-1批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1530188-53018824.35628.208.7524.3628.208.74
2668954-66895430.73130.73
3644744-64474429.61929.62
4656048-65604830.13830.14
5573710-57371026.35526.36
6609157-60915727.98427.98
10min11232239-123223956.60757.361.5756.6557.411.57
21231149-123114956.55756.61
31280688-128068858.83358.88
41263693-126369358.05258.10
51242412-124241257.07557.12
61242161-124216157.06357.11
15min11459489-145948967.04767.030.9567.1867.180.95
21463344-146334467.22467.37
31481778-148177868.07168.22
41460882-146088267.11167.26
51445785-144578566.41766.56
61443960-144396066.33466.48
20min11586207-158620772.86872.560.9973.1172.810.99
21591233-159123373.09973.36
31599686-159968673.48773.75
41574874-157487472.34872.61
51564408-156440871.86772.12
61560003-156000371.66471.92
30min11741276-174127679.99279.431.1080.3679.801.10
21743216-174321680.08180.46
31751679-175167980.47080.85
41720907-172090779.05679.44
51711442-171144278.62178.99
61705284-170528478.33978.71
45min11870432-187043285.92585.611.4086.4386.121.40
21881551-188155186.43686.95
31902276-190227687.38887.91
41850846-185084685.02585.54
51842818-184281884.65785.16
61833508-183350884.22984.73
60min11952087-195208789.67688.901.2490.3289.551.24
21959254-195925490.00690.66
31956875-195687589.89690.56
41925062-192506288.43589.09
51912937-191293787.87888.52
61904427-190442787.48788.13
极限12004838-200483892.10091.681.1292.8992.481.12
22022253-202225392.90093.71
32016230-201623092.62393.44
41986209-198620991.24492.04
51978307-197830790.88191.67
61966242-196624290.32791.12
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