地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DRm0341024-D对照品来源自制对照品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100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.561714682171359117107021711837171757017136760.16
210.981780836177498717779120.24
单位质量响应值RSD%判断
162279.92161922.770.16数据可信
中间条件3月-供试品溶液-2025031021批-含0.5%吐温20的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%
5min11553179-155317995.81591.7510.8495.8291.7510.84
21678970-1678970103.575103.58
31590559-159055998.12198.12
41264151-126415177.98577.99
51321268-132126881.50981.51
61515337-151533793.48193.48
10min11607725-160772599.18095.525.85100.2496.545.90
21613887-161388799.560100.71
31620320-162032099.957101.05
41430107-143010788.22389.09
51435224-143522488.53989.44
61582756-158275697.64098.68
15min11584450-158445097.74596.234.7199.9198.314.78
21626428-1626428100.334102.59
31609682-160968299.301101.50
41467079-146707990.50492.35
51466574-146657490.47392.36
61605116-160511699.019101.14
20min11572068-157206896.98195.382.85100.2398.532.98
21593875-159387598.326101.70
31575158-157515897.171100.48
41491374-149137492.00394.86
51492853-149285392.09494.99
61551556-155155695.71598.94
30min11577861-157786197.33895.832.19101.67100.042.35
21578532-157853297.379101.84
31577114-157711497.292101.68
41503649-150364992.76096.63
51516813-151681393.57297.49
61566233-156623396.621100.91
极限11559266-155926696.19195.550.91101.60100.830.94
21552085-155208595.748101.29
31557651-155765196.091101.56
41561875-156187596.352101.26
51533171-153317194.58199.54
61529399-152939994.34899.71
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DRm0341024-D对照品来源自制对照品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100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.561752120173933717419821740504173794517423780.33
210.981791106180897718000420.71
单位质量响应值RSD%判断
164997.92163938.250.46数据可信
中间条件3月-供试品溶液-2025031121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11249679-124967975.98474.441.2075.9874.441.20
21225338-122533874.50474.50
31230336-123033674.80874.81
41214223-121422373.82873.83
51217873-121787374.05074.05
61208703-120870373.49273.49
10min11372394-137239483.44583.341.0184.2984.171.00
21389280-138928084.47285.30
31357786-135778682.55783.39
41364258-136425882.95183.77
51384184-138418484.16284.98
61356320-135632082.46883.28
15min11425558-142555886.67887.161.5588.4588.921.53
21466362-146636289.15990.93
31448081-144808188.04789.80
41431595-143159587.04588.79
51429285-142928586.90488.66
61400502-140050285.15486.89
20min11465643-146564389.11588.501.0391.8591.221.03
21474085-147408589.62892.39
31457536-145753688.62291.35
41443065-144306587.74290.45
51459730-145973088.75691.48
61433300-143330087.14989.83
30min11476403-147640389.76989.951.0393.4993.661.03
21507099-150709991.63695.39
31473424-147342489.58893.30
41470816-147081689.43093.11
51484975-148497590.29094.00
61464007-146400789.01692.66
极限11491370-149137090.67992.822.0195.4097.531.94
21554706-155470694.53099.30
31518102-151810292.30597.01
41558776-155877694.77899.46
51545037-154503793.94298.66
61491841-149184190.70895.34
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DRm0341024-D对照品来源自制对照品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100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.561775269176707317651451756315175859517644790.43
210.981830016181859918243080.45
单位质量响应值RSD%判断
167090.81166148.270.40数据可信
中间条件3月-供试品溶液-2025031221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11242379-124237974.56474.651.3674.5674.651.36
21226772-122677273.62873.63
31220866-122086673.27373.27
41260730-126073075.66675.67
51253832-125383275.25275.25
61258292-125829275.51975.52
10min11391759-139175983.53084.010.9584.3684.840.94
21399452-139945283.99284.81
31392085-139208583.54984.36
41387240-138724083.25984.10
51404800-140480084.31385.15
61423465-142346585.43386.27
15min11441552-144155286.51885.981.0688.2787.741.03
21436462-143646286.21387.96
31443125-144312586.61388.36
41403260-140326084.22085.99
51440545-144054586.45888.23
61430532-143053285.85787.65
20min11445631-144563186.76387.011.5389.4889.731.48
21492481-149248189.57592.28
31443229-144322986.61989.32
41440903-144090386.47989.18
51427513-142751385.67688.41
61449113-144911386.97289.71
30min11491585-149158589.52189.151.2793.2092.831.22
21482373-148237388.96892.67
31489122-148912289.37393.04
41454301-145430187.28390.95
51512298-151229890.76494.45
61482333-148233388.96692.67
极限11522196-152219691.35891.060.9096.0395.740.88
21512713-151271390.78995.48
31518136-151813691.11595.77
41492719-149271989.58994.22
51527573-152757391.68196.38
61530348-153034891.84896.54
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DRm0341024-D对照品来源自制对照品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100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.561785584179442418056241778346179619717920350.59
210.981848526185147318500000.12
单位质量响应值RSD%判断
169700.28168488.160.51数据可信
长期3月-供试品溶液-2025031221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11343661-134366179.46375.792.7479.4675.792.74
21279999-127999975.69875.70
31249985-124998573.92373.92
41297836-129783676.75376.75
51254907-125490774.21474.21
61263344-126334474.71374.71
10min11406534-140653483.18283.881.6784.0684.721.66
21422373-142237384.11884.96
31377736-137773681.47882.30
41437705-143770585.02585.88
51442656-144265685.31886.14
61422722-142272284.13984.97
15min11463734-146373486.56485.491.1188.3787.261.09
21450221-145022185.76587.54
31458852-145885286.27688.00
41447318-144731885.59387.39
51427590-142759084.42786.20
61425229-142522984.28786.05
20min11460451-146045186.37085.960.5889.1488.680.56
21458692-145869286.26688.99
31456109-145610986.11388.80
41438232-143823285.05687.80
51449719-144971985.73588.45
61457873-145787386.21888.92
30min11492771-149277188.28288.631.4592.0192.311.38
21479455-147945587.49491.18
31536334-153633490.85894.50
41511556-151155689.39293.09
51482183-148218387.65591.32
61490004-149000488.11891.78
极限11508287-150828789.19988.671.0493.9193.331.00
21485951-148595187.87892.54
31505344-150534489.02593.68
41508395-150839589.20693.89
51474442-147444287.19891.83
61513580-151358089.51294.15
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