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%
113.574559214569434572174570904561514566640.13
213.494573154570204571680.05
单位质量响应值RSD%判断
33652.4733889.400.50数据可信
供试品溶液-24062101-1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%
5min197735-9773521.59718.0717.6221.6018.0717.62
292367-9236720.41120.41
390748-9074820.05320.05
480230-8023017.72917.73
562994-6299413.92013.92
666466-6646614.68714.69
10min1242911-24291153.67849.728.5753.9249.928.60
2238296-23829652.65852.88
3241698-24169853.41053.63
4217994-21799448.17248.37
5194698-19469843.02443.18
6214450-21445047.38847.55
15min1327120-32712072.28668.935.2073.1269.685.25
2316801-31680170.00670.82
3323460-32346071.47772.29
4313149-31314969.19969.93
5281651-28165162.23862.87
6309327-30932768.35469.04
20min1365366-36536680.73779.273.8882.3880.793.93
2361695-36169579.92681.52
3371435-37143582.07983.69
4363716-36371680.37381.87
5331804-33180473.32174.65
6358290-35829079.17480.62
30min1403910-40391089.25589.232.9591.7991.632.98
2399925-39992588.37490.85
3415259-41525991.76394.29
4419329-41932992.66295.06
5387286-38728685.58187.72
6396994-39699487.72690.06
45min1421135-42113593.06193.222.2196.5996.612.25
2417345-41734592.22495.68
3428526-42852694.69498.24
4432602-43260295.59599.02
5406391-40639189.80392.89
6425162-42516293.95197.25
60min1417788-41778892.32192.161.5196.8896.581.56
2412695-41269591.19695.68
3419524-41952492.70597.30
4421075-42107593.04897.53
5406865-40686589.90894.00
6424267-42426793.75398.10
极限1411737-41173790.98492.431.6996.5797.881.67
2410980-41098090.81796.31
3426730-42673094.29799.92
4426325-42632594.20899.73
5414366-41436691.56596.65
6419652-41965292.73398.12
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%
113.574577724594124583014569924579874580930.20
213.494554334567694561010.21
单位质量响应值RSD%判断
33757.7733810.300.11数据可信
供试品溶液-24062102-1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%
5min184231-8423118.60616.4113.9518.6116.4113.96
285894-8589418.97318.97
377809-7780917.18717.19
462389-6238913.78113.78
562132-6213213.72413.72
673183-7318316.16516.17
10min1234480-23448051.79448.807.7852.0048.987.80
2234712-23471251.84552.06
3238239-23823952.62452.82
4200393-20039344.26544.42
5202219-20221944.66844.82
6215532-21553247.60947.79
15min1323560-32356071.47168.584.3872.2569.304.43
2325932-32593271.99572.78
3313889-31388969.33470.11
4292410-29241064.59065.23
5297214-29721465.65166.30
6309901-30990168.45469.16
20min1370563-37056381.85379.982.7183.4381.472.78
2373503-37350382.50384.09
3363577-36357780.31081.86
4350389-35038977.39778.76
5350513-35051377.42478.80
6363956-36395680.39481.86
30min1403645-40364589.16188.662.2391.6591.042.27
2415444-41544491.76794.27
3404894-40489489.43691.87
4394044-39404487.04089.26
5400209-40020988.40290.64
6390072-39007286.16288.52
45min1424164-42416493.69393.780.6297.1797.140.70
2425355-42535593.95697.48
3428742-42874294.70498.14
4420551-42055192.89596.08
5424224-42422493.70696.93
6424284-42428493.71997.04
60min1415492-41549291.77794.311.5796.2998.721.42
2425978-42597894.09498.66
3429269-42926994.82199.30
4428015-42801594.54498.77
5436148-43614896.340100.60
6426947-42694794.30898.67
极限1426722-42672294.25894.350.8699.8099.800.68
2422192-42219293.25798.87
3424325-42432593.72899.27
4432410-43241095.514100.79
5429481-42948194.867100.20
6427767-42776794.48999.90
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%
113.574564564562164562774559134553764560480.10
213.494577224569764573490.12
单位质量响应值RSD%判断
33607.0733902.820.62数据可信
供试品溶液-24062103-1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%
5min177539-7753917.14317.864.8117.1417.864.80
285637-8563718.93318.93
382603-8260318.26218.26
480043-8004317.69617.70
575311-7531116.65016.65
683510-8351018.46318.46
10min1213630-21363047.23048.122.3947.4248.322.39
2222017-22201749.08449.29
3224777-22477749.69449.90
4211451-21145146.74846.94
5214859-21485947.50247.69
6219148-21914848.45048.66
15min1295586-29558665.34967.372.7466.0668.102.70
2306078-30607867.66968.42
3295112-29511265.24466.00
4317218-31721870.13170.85
5308120-30812068.12068.83
6306193-30619367.69468.44
20min1349936-34993677.36579.142.5678.8180.632.52
2358605-35860579.28180.79
3371981-37198182.23983.72
4346034-34603476.50278.00
5361405-36140579.90081.37
6359913-35991379.57181.07
30min1395076-39507687.34588.832.3089.6591.192.26
2395481-39548187.43489.82
3417574-41757492.31894.71
4393160-39316086.92189.27
5404043-40404389.32791.68
6405323-40532389.61091.99
45min1411131-41113190.89492.522.4894.1795.872.44
2412015-41201591.08994.45
3436401-43640196.48199.90
4412553-41255391.20894.52
5413004-41300491.30894.66
6425897-42589794.15997.53
60min1417962-41796292.40494.032.0496.6998.412.01
2417431-41743192.28796.66
3437542-43754296.733101.22
4417909-41790992.39396.72
5431112-43111295.31299.68
6430011-43001195.06899.49
极限1422420-42242093.39093.081.0098.7098.500.99
2416712-41671292.12897.53
3428022-42802294.628100.19
4420433-42043392.95198.30
5416864-41686492.16297.59
6421673-42167393.22598.70
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