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%
113.474443614407714440764440344441734434830.35
213.494423134422114422620.02
单位质量响应值RSD%判断
32923.7632784.430.30数据可信
供试品溶液-2024102421批-120mg规格-pH4.5(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%
5min19453-94532.1475.1957.332.155.1957.32
216511-165113.7503.75
338223-382238.6828.68
435445-354458.0518.05
58503-85031.9311.93
628884-288846.5616.56
10min174371-7437116.89320.6823.2816.9220.7423.36
285519-8551919.42519.47
3116380-11638026.43526.53
4108176-10817624.57124.66
560975-6097513.85013.87
6100860-10086022.91022.98
15min1144204-14420432.75536.0013.1732.9736.2813.30
2154906-15490635.18635.44
3183864-18386441.76342.15
4172635-17263539.21339.58
5126635-12663528.76428.94
6168592-16859238.29438.62
20min1207106-20710647.04248.688.5347.6249.378.68
2210348-21034847.77948.43
3237512-23751253.94954.80
4221865-22186550.39551.19
5184355-18435541.87542.37
6224710-22471051.04151.79
30min1287101-28710165.21365.873.9466.3167.104.11
2289096-28909665.66666.85
3306571-30657169.63571.09
4288892-28889265.61966.98
5271946-27194661.77062.73
6296254-29625467.29268.61
45min1370961-37096184.26182.291.9586.0884.251.96
2364948-36494882.89584.80
3368685-36868583.74485.97
4353722-35372280.34582.43
5355416-35541680.73082.38
6360091-36009181.79283.86
60min1398273-39827390.46490.031.7793.2292.901.70
2398426-39842690.49993.33
3394345-39434589.57292.73
4385027-38502787.45690.44
5395540-39554089.84492.39
6406496-40649692.33295.31
极限1425855-42585596.72994.843.31100.4998.723.26
2408140-40814092.70696.54
3436315-43631599.105103.26
4397685-39768590.33194.28
5413997-41399794.03697.58
6423361-42336196.163100.17
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%
113.474431044423624426274424174424724425960.07
213.494401234440554420890.63
单位质量响应值RSD%判断
32857.9132771.610.19数据可信
供试品溶液-2024102421批-120mg规格-pH4.5(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%
5min130347-303476.9015.0561.416.905.0461.42
232756-327567.4497.45
310787-107872.4532.45
432543-325437.4017.40
526703-267036.0736.07
6-0.0000.00
10min199165-9916522.55119.4625.6922.6319.5225.79
2104343-10434323.72923.81
363318-6331814.39914.43
4101873-10187323.16723.25
592013-9201320.92520.99
652768-5276812.00012.00
15min1159826-15982636.34734.1514.9636.6734.4215.10
2174660-17466039.72040.07
3129160-12916029.37329.56
4166322-16632237.82438.16
5154166-15416635.05935.36
6116871-11687126.57826.71
20min1210520-21052047.87546.609.9848.6147.2510.15
2229100-22910052.10052.89
3185152-18515242.10642.62
4221408-22140850.35151.11
5206810-20681047.03147.72
6176534-17653440.14640.57
30min1278880-27888063.42164.635.6264.6865.805.79
2309624-30962470.41371.78
3272935-27293562.06963.05
4294599-29459966.99668.32
5283873-28387364.55765.77
6265136-26513660.29561.17
45min1350076-35007679.61281.242.8181.5883.132.97
2373379-37337984.91187.06
3356776-35677681.13682.81
4362923-36292382.53484.60
5355509-35550980.84782.78
6344775-34477578.40679.95
60min1377025-37702585.74189.532.7288.5992.322.75
2409629-40962993.15596.25
3397478-39747890.39292.96
4396471-39647190.16393.14
5391271-39127188.98091.81
6390196-39019688.73691.15
极限1387647-38764788.15693.473.1691.9697.263.11
2421136-42113695.77299.90
3421906-42190695.94799.52
4418156-41815695.09499.08
5410801-41080193.42297.24
6406441-40644192.43095.83
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%
113.474405844439654437744431384432674429460.31
213.494417324440884429100.38
单位质量响应值RSD%判断
32883.8932832.470.12数据可信
供试品溶液-2024102521批-120mg规格-pH4.5(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%
5min120316-203164.6144.4032.934.614.4032.90
224655-246555.5995.60
328852-288526.5536.55
413455-134553.0563.06
515092-150923.4283.43
613787-137873.1313.13
10min181693-8169318.55418.7410.2218.6018.7810.27
290573-9057320.57020.63
392668-9266821.04621.12
472551-7255116.47716.51
573326-7332616.65316.69
684228-8422819.12919.16
15min1147233-14723333.43833.295.1433.7033.555.21
2154573-15457335.10535.40
3156218-15621835.47935.79
4138530-13853031.46231.68
5139329-13932931.64331.87
6143590-14359032.61132.86
20min1205979-20597946.78046.383.3247.4147.003.39
2211475-21147548.02948.71
3212138-21213848.17948.88
4200966-20096645.64246.21
5195618-19561844.42745.00
6199083-19908345.21445.82
30min1290601-29060165.99966.232.4267.1567.372.46
2296544-29654467.34968.56
3300735-30073568.30169.54
4294493-29449366.88367.96
5285390-28539064.81665.88
6281955-28195564.03665.15
45min1367202-36720283.39682.582.0285.2884.462.01
2367766-36776683.52485.49
3363329-36332982.51784.51
4373160-37316084.74986.57
5355275-35527580.68782.48
6354817-35481780.58382.41
60min1400387-40038790.93390.421.3793.7493.221.33
2399015-39901590.62193.51
3394028-39402889.48992.40
4407335-40733592.51195.27
5395794-39579489.89092.57
6392315-39231589.10091.82
极限1417895-41789594.90993.541.2198.7397.341.20
2411852-41185293.53797.43
3409593-40959393.02496.93
4416823-41682394.66698.45
5404404-40440491.84595.53
6410499-41049993.22996.94
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%
113.474439554449864448604456154449464448720.14
213.494424524430794427660.11
单位质量响应值RSD%判断
33026.8732821.790.45数据可信
供试品溶液-2024102521批-120mg规格-pH4.5(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%
5min115404-154043.4913.9732.313.493.9832.37
220904-209044.7384.74
326012-260125.8965.90
419537-195374.4284.43
511475-114752.6012.60
611881-118812.6932.69
10min176371-7637117.31017.199.3117.3517.239.36
279974-7997418.12718.18
384694-8469419.19719.26
478892-7889217.88217.93
569051-6905115.65115.68
665943-6594314.94714.98
15min1138728-13872831.44431.655.9831.6731.886.03
2144876-14487632.83733.09
3149530-14953033.89234.17
4144015-14401532.64232.89
5134101-13410130.39530.60
6126524-12652428.67828.87
20min1194673-19467344.12444.494.2544.7045.084.31
2199740-19974045.27345.89
3206597-20659746.82747.48
4200734-20073445.49846.11
5193873-19387343.94344.48
6182123-18212341.28041.79
30min1277866-27786662.98164.553.0864.0565.643.09
2288724-28872465.44266.56
3287216-28721665.10066.28
4290417-29041765.82566.94
5293935-29393566.62367.65
6270699-27069961.35662.33
45min1347369-34736978.73481.513.2680.5083.313.26
2364510-36451082.61984.47
3363422-36342282.37384.27
4366926-36692683.16785.01
5372519-37251984.43586.20
6342944-34294477.73179.39
60min1383159-38315986.84689.631.9789.4992.341.97
2397234-39723490.03692.80
3397292-39729290.05092.86
4398354-39835490.29093.06
5406037-40603792.03294.74
6390619-39061988.53791.06
极限1402728-40272891.28292.932.2194.8996.632.12
2409069-40906992.71996.49
3399946-39994690.65194.47
4411378-41137893.24297.02
5425814-42581496.514100.24
6411114-41111493.18296.68
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