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%
110.511986794198686219876601986510199289019881430.14
210.552012148201332520127360.05
单位质量响应值RSD%判断
189166.79190780.660.61数据可信
长期36月-供试品溶液-23112901-1批-20mg规格-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1406873-40687319.27628.1428.2719.2828.1428.27
2573397-57339727.16527.17
3699913-69991333.15933.16
4815183-81518338.62038.62
5672225-67222531.84731.85
6396038-39603818.76318.76
10min11269248-126924860.13263.534.9260.1763.594.94
21341324-134132463.54663.61
31374776-137477665.13165.20
41419360-141936067.24367.33
51385247-138524765.62765.70
61255516-125551659.48159.52
15min11621606-162160676.82577.370.5477.0077.570.54
21634351-163435177.42977.63
31625502-162550277.01077.23
41633107-163310777.37077.61
51645844-164584477.97378.19
61637685-163768577.58777.76
20min11759973-175997383.38083.730.8883.7384.110.86
21778413-177841384.25484.63
31750025-175002582.90983.30
41751278-175127882.96883.38
51784109-178410984.52484.91
61780585-178058584.35784.70
30min11907987-190798790.39290.650.9890.9291.220.96
21922423-192242391.07691.64
31894259-189425989.74290.32
41890910-189091089.58390.17
51933618-193361891.60792.18
61931868-193186891.52492.06
45min11990577-199057794.30595.091.1295.0495.851.10
22016585-201658595.53796.30
31986344-198634494.10594.88
41988829-198882994.22295.01
52017672-201767295.58996.37
62042446-204244696.76397.50
60min12058003-205800397.50097.871.1198.4498.841.09
22074518-207451898.28299.26
32044487-204448796.85997.84
42038179-203817996.56097.56
52084139-208413998.73899.73
62095823-209582399.291100.24
极限12077360-207736098.41799.001.2899.58100.191.26
22102252-210225299.596100.79
32055046-205504697.36098.56
42070023-207002398.06999.28
52106736-210673699.808101.02
62126802-2126802100.759101.93
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%
110.511986636198797219910731990261198881319889510.09
210.551983696198269719831960.04
单位质量响应值RSD%判断
189243.67187980.660.48数据可信
长期36月-供试品溶液-23112901-1批-20mg规格-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%
5min1997164-99716447.58245.0725.7047.5845.0725.70
21280336-128033661.09461.09
3681536-68153632.52132.52
4673916-67391632.15832.16
51131197-113119753.97853.98
6902766-90276643.07843.08
10min11757397-175739783.85984.894.1183.9684.994.13
21857135-185713588.61888.75
31744133-174413383.22683.30
41697433-169743380.99781.07
51881119-188111989.76289.88
61737065-173706582.88882.98
15min12000067-200006795.43896.180.7495.7396.470.75
22005804-200580495.71296.04
32007583-200758395.79796.05
42017217-201721796.25796.51
52041549-204154997.41897.74
62021421-202142196.45796.74
20min12066707-206670798.61898.940.7199.1299.440.70
22050983-205098397.86898.41
32069912-206991298.77199.24
42078136-207813699.16399.63
52093755-209375599.909100.44
62081732-208173299.33599.83
30min12112323-2112323100.795100.630.99101.52101.350.97
22068736-206873698.71599.48
32106396-2106396100.512101.20
42125768-2125768101.436102.12
52118492-2118492101.089101.85
62121578-2121578101.236101.95
45min12123110-2123110101.309101.520.83102.26102.460.81
22096391-2096391100.035101.02
32125151-2125151101.407102.32
42141462-2141462102.185103.10
52132242-2132242101.745102.73
62146178-2146178102.410103.35
60min12123780-2123780101.341101.880.87102.51103.060.85
22111022-2111022100.733101.94
32128993-2128993101.590102.73
42146976-2146976102.448103.59
52136398-2136398101.944103.15
62163701-2163701103.246104.41
极限12124655-2124655101.383101.750.74102.78103.150.72
22111655-2111655100.763102.19
32124224-2124224101.363102.73
42148913-2148913102.541103.91
52132932-2132932101.778103.21
62152196-2152196102.697104.09
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%
110.511990070199044819875621987238198585519882350.10
210.552035257203465220349540.03
单位质量响应值RSD%判断
189175.55192886.641.38数据可信
长期36月-供试品溶液-23112901-1批-20mg规格-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%
5min1475490-47549022.40427.7811.9422.4027.7811.95
2671062-67106231.61931.62
3604423-60442328.47928.48
4646891-64689130.48030.48
5549453-54945325.88925.89
6590686-59068627.83127.83
10min11056428-105642849.77653.544.3749.8353.604.38
21182479-118247955.71555.79
31167932-116793255.03055.09
41178061-117806155.50755.57
51104732-110473252.05252.11
61128689-112868953.18153.24
15min11368611-136861164.48566.622.1064.6566.802.11
21445797-144579768.12268.32
31429641-142964167.36167.55
41439046-143904667.80467.99
51395381-139538165.74665.92
61404740-140474066.18766.37
20min11528331-152833172.01173.381.4872.3173.711.50
21580123-158012374.45174.80
31561575-156157573.57773.91
41583831-158383174.62674.97
51533712-153371272.26472.58
61557245-155724573.37373.70
30min11716216-171621680.86381.340.4481.3381.840.45
21734277-173427781.71482.23
31722474-172247481.15881.66
41735895-173589581.79182.30
51725671-172567181.30981.79
61723790-172379081.22081.71
45min11853755-185375587.34487.620.4387.9988.300.44
21861871-186187187.72688.42
31856647-185664787.48088.16
41874070-187407088.30188.99
51860014-186001487.63988.30
61851978-185197887.26087.93
60min11933968-193396891.12391.290.4791.9692.160.48
21946453-194645391.71192.60
31939514-193951491.38492.26
41947294-194729491.75192.64
51923432-192343290.62791.48
61934358-193435891.14292.01
极限12003323-200332394.39194.160.2995.4395.240.29
22005747-200574794.50595.60
31993796-199379693.94295.02
42000175-200017594.24395.33
51997137-199713794.09995.16
61990895-199089593.80594.87
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%
110.511988906198653019869641986929198589519870450.06
210.552021916201768320198000.15
单位质量响应值RSD%判断
189062.32191450.240.89数据可信
长期36月-供试品溶液-23112901-1批-20mg规格-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%
5min1714422-71442233.79727.3518.8533.8027.3418.86
2385406-38540618.23218.23
3549891-54989126.01326.01
4603161-60316128.53328.53
5622492-62249229.44829.45
6592933-59293328.05028.05
10min11275433-127543360.33658.126.4560.4158.186.46
21097426-109742651.91551.96
31163111-116311155.02355.08
41281860-128186060.64060.70
51284776-128477660.77860.84
61269513-126951360.05660.12
15min11522382-152238272.01971.822.9172.2372.022.92
21455865-145586568.87269.03
31479632-147963269.99670.18
41576791-157679174.59274.79
51545546-154554673.11473.31
61529498-152949872.35572.55
20min11670575-167057579.02978.641.2279.4078.991.23
21650730-165073078.09078.40
31647257-164725777.92678.26
41698571-169857180.35380.72
51661451-166145178.59778.96
61645516-164551677.84478.20
30min11813371-181337185.78486.151.1786.3386.671.16
21827779-182777986.46686.95
31832180-183218086.67487.18
41853361-185336187.67688.22
51805574-180557485.41585.95
61794150-179415084.87585.40
45min11925072-192507291.06891.491.2091.8092.201.19
21944216-194421691.97492.65
31947928-194792892.15092.85
41966962-196696293.05093.79
51914021-191402190.54691.27
61905736-190573690.15490.87
60min11990504-199050494.16494.631.2095.1095.551.19
22016177-201617795.37896.26
32012109-201210995.18696.09
42032001-203200196.12797.07
51984165-198416593.86494.79
61966904-196690493.04793.97
极限12035872-203587296.31096.661.2897.4697.791.27
22056608-205660897.29198.38
32063639-206363997.62398.74
42073082-207308298.07099.23
52027067-202706795.89397.03
62003252-200325294.76795.89
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