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520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5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%
113.424541384549434539664542174541074542740.09
213.594503924510514507220.11
单位质量响应值RSD%判断
33850.5233165.711.45数据可信
供试品溶液-2024102621批-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%
5min175442-7544216.80318.4110.6316.8018.4110.63
283294-8329418.55218.55
393483-9348320.82220.82
493012-9301220.71720.72
574784-7478416.65716.66
675824-7582416.88816.89
10min1190986-19098642.53844.195.2142.7344.405.22
2195505-19550543.54543.75
3210026-21002646.77947.01
4212286-21228647.28347.51
5187137-18713741.68141.87
6194595-19459543.34243.53
15min1263130-26313058.60760.613.5959.2761.303.62
2272774-27277460.75561.45
3279995-27999562.36363.11
4286031-28603163.70864.46
5260421-26042158.00458.65
6270358-27035860.21760.89
20min1311178-31117869.30971.933.8870.6273.303.90
2319840-31984071.23872.60
3331417-33141773.81775.26
4342232-34223276.22677.69
5309107-30910768.84870.14
6323842-32384272.12973.47
30min1360767-36076780.35484.744.0582.4386.914.05
2377882-37788284.16686.32
3386927-38692786.18088.44
4405166-40516690.24392.55
5369087-36908782.20784.26
6383058-38305885.31987.46
45min1416505-41650592.76892.942.3195.7496.052.34
2406101-40610190.45193.54
3420756-42075693.71596.94
4432216-43221696.26899.58
5407761-40776190.82193.79
6420374-42037493.63096.72
60min1427462-42746295.20995.411.0799.2199.561.04
2431900-43190096.197100.29
3435339-43533996.963101.23
4422764-42276494.16298.55
5425147-42514794.69398.67
6427669-42766995.25599.38
极限1431338-43133896.07296.980.54101.13102.180.54
2437503-43750397.445102.61
3434300-43430096.732102.07
4435353-43535396.966102.40
5437210-43721097.380102.41
6436690-43669097.264102.45
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520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5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%
113.424518814514764507094516604522804516010.13
213.594508594498374503480.17
单位质量响应值RSD%判断
33651.3433138.191.09数据可信
供试品溶液-2024102621批-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%
5min183241-8324118.60217.5412.0018.6017.5411.99
291301-9130120.40420.40
372473-7247316.19616.20
481852-8185218.29218.29
578113-7811317.45617.46
664029-6402914.30914.31
10min1185467-18546741.44741.974.7941.6542.174.81
2195300-19530043.64543.87
3180210-18021040.27340.45
4196705-19670543.95944.16
5194224-19422443.40443.60
6175016-17501639.11239.27
15min1252964-25296456.53158.734.0057.2059.394.02
2273561-27356161.13461.85
3253113-25311356.56557.19
4274735-27473561.39762.09
5268206-26820659.93860.61
6254253-25425356.82057.41
20min1302570-30257067.61769.874.1668.9171.184.16
2326739-32673973.01874.41
3293467-29346765.58366.84
4319435-31943571.38672.76
5323756-32375672.35273.69
6309813-30981369.23670.46
30min1362166-36216680.93683.082.6082.9885.182.62
2385164-38516486.07588.28
3363084-36308481.14183.13
4370278-37027882.74884.92
5381855-38185585.33687.48
6368151-36815182.27384.27
45min1402181-40218189.87891.172.3792.8294.182.39
2425157-42515795.01398.17
3397914-39791488.92491.81
4403706-40370690.21993.31
5411971-41197192.06695.16
6406776-40677690.90593.81
60min1417310-41731093.25994.551.5997.2098.581.64
2435721-43572197.373101.59
3417452-41745293.29197.16
4423205-42320594.57698.67
5422258-42225894.36598.48
6422557-42255794.43198.35
极限1424846-42484694.94396.091.3599.92101.171.41
2438452-43845297.984103.28
3422734-42273494.47199.38
4434060-43406097.002102.14
5429583-42958396.002101.17
6430275-43027596.156101.12
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