奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号T12B-A020-230703对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数200
标示量(mg)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.524735064713594703654699724692954708990.35
213.494705564706914706240.03
单位质量响应值RSD%判断
34829.8134886.880.12数据可信
供试品溶液-1批-120mg规格-pH6.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157392-5739212.39813.5615.3412.4013.5615.34
279288-7928817.12817.13
365988-6598814.25514.25
457301-5730112.37812.38
551950-5195011.22211.22
664837-6483714.00614.01
10min1225108-22510848.62747.943.7248.7648.093.73
2231962-23196250.10850.30
3229167-22916749.50449.66
4211926-21192645.78045.92
5219991-21999147.52247.65
6213421-21342146.10346.26
15min1316542-31654268.37967.792.1569.0668.472.17
2322595-32259569.68670.43
3318963-31896368.90269.61
4306372-30637266.18266.83
5312113-31211367.42268.07
6306286-30628666.16366.83
20min1369256-36925679.76678.621.6981.2080.061.71
2368057-36805779.50781.03
3369501-36950179.81981.29
4355163-35516376.72178.10
5358083-35808377.35278.75
6363707-36370778.56779.97
30min1414534-41453489.54789.392.8891.8791.702.86
2427096-42709692.26094.66
3423042-42304291.38493.75
4411978-41197888.99491.23
5392837-39283784.86087.12
6413314-41331489.28391.56
45min1443715-44371595.85094.862.2699.1798.162.27
2448056-44805696.788100.22
3450876-45087697.397100.77
4435563-43556394.08997.31
5427049-42704992.25095.45
6429420-42942092.76296.03
60min1431213-43121393.14996.392.1797.53100.752.13
2459650-45965099.292103.80
3452815-45281597.816102.27
4442502-44250295.58899.86
5446740-44674096.504100.73
6444441-44444196.007100.31
极限1429455-42945592.77094.982.1098.19100.412.06
2448782-44878296.945102.55
3450423-45042397.299102.84
4436160-43616094.21899.55
5443337-44333795.768101.07
6429970-42997092.88198.25
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号T12B-A020-230703对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数200
标示量(mg)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.524702974707584710904713004711464709180.09
213.494703544704824704180.02
单位质量响应值RSD%判断
34831.2134871.610.09数据可信
供试品溶液-2批-60mg规格
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181971-8197117.71115.6810.3717.7115.6810.37
275952-7595216.41016.41
368439-6843914.78714.79
479141-7914117.09917.10
566830-6683014.43914.44
663097-6309713.63313.63
10min1236612-23661251.12247.085.8351.3247.255.85
2227567-22756749.16849.35
3213005-21300546.02246.19
4219639-21963947.45547.65
5208140-20814044.97145.13
6202411-20241143.73343.88
15min1329276-32927671.14367.004.3371.9167.704.35
2321798-32179869.52870.26
3306873-30687366.30366.98
4307913-30791366.52867.25
5302468-30246865.35166.01
6292219-29221963.13763.77
20min1380712-38071282.25778.593.4183.8180.033.44
2375141-37514181.05382.55
3362763-36276378.37979.79
4358283-35828377.41178.87
5359179-35917977.60478.99
6346459-34645974.85676.19
30min1431058-43105893.13490.152.6095.6092.472.63
2425680-42568091.97394.37
3417115-41711590.12292.41
4408374-40837488.23390.55
5419563-41956390.65192.90
6401722-40172286.79688.97
45min1453309-45330997.94295.662.04101.4598.982.07
2448939-44893996.998100.42
3442947-44294795.70398.99
4431613-43161393.25496.55
5447426-44742696.67199.93
6432301-43230193.40396.54
60min1456337-45633798.59696.551.89103.19100.931.92
2450824-45082497.405101.91
3447320-44732096.648101.00
4434786-43478693.94098.27
5453078-45307897.892102.22
6438746-43874694.79698.97
极限1452651-45265197.80096.291.82103.49101.741.83
2448782-44878296.964102.55
3448243-44824396.847102.27
4433042-43304293.56398.94
5452861-45286197.845103.26
6438475-43847594.73799.96
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