奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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)60供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.474542164538644541154535684539404539410.06
213.494524224525974525100.03
单位质量响应值RSD%判断
33700.1533544.110.33数据可信
供试品溶液-2024102321批-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%
5min135726-357267.9307.475.457.937.465.48
233625-336257.4637.46
331015-310156.8846.88
435717-357177.9287.93
532979-329797.3207.32
632752-327527.2697.27
10min1102750-10275022.80622.633.8422.8222.643.84
2104654-10465423.22823.24
395185-9518521.12721.14
4106523-10652323.64323.66
5101934-10193422.62522.64
6100662-10066222.34222.35
15min1158258-15825835.12635.693.3735.1835.743.38
2166603-16660336.97837.03
3152135-15213533.76733.81
4165111-16511136.64736.70
5163840-16384036.36536.41
6158873-15887335.26235.31
20min1206674-20667445.87246.843.3645.9846.953.36
2218043-21804348.39548.51
3200400-20040044.47944.58
4214778-21477847.67147.78
5217975-21797548.38048.49
6208402-20840246.25546.36
30min1281837-28183762.55563.602.8262.7463.782.82
2291529-29152964.70664.90
3276202-27620261.30461.48
4290553-29055364.48964.68
5297858-29785866.11166.30
6281262-28126262.42762.61
45min1353184-35318478.39079.412.5678.6879.702.56
2359850-35985079.87080.17
3347044-34704477.02877.31
4358834-35883479.64479.94
5373932-37393282.99583.30
6353737-35373778.51378.80
60min1394115-39411587.47588.462.3787.9088.882.37
2397773-39777388.28788.72
3389765-38976586.51086.92
4397375-39737588.19988.63
5416890-41689092.53092.97
6395298-39529887.73888.16
极限1419192-41919293.04193.642.2993.6194.212.29
2419739-41973993.16293.74
3412817-41281791.62692.18
4418181-41818192.81793.40
5440776-44077697.83298.43
6420599-42059993.35393.92
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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)60供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.474534774528454535184525454541894533150.15
213.494611524611054611280.01
单位质量响应值RSD%判断
33653.6734182.951.11数据可信
供试品溶液-2024102321批-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%
5min132116-321167.0667.326.637.077.326.61
235208-352087.7477.75
336378-363788.0048.00
430312-303126.6696.67
532395-323957.1287.13
633124-331247.2887.29
10min198294-9829421.62722.072.5021.6422.082.50
2100661-10066122.14822.16
3104610-10461023.01723.03
4100477-10047722.10822.12
5100402-10040222.09122.10
697391-9739121.42921.44
15min1157891-15789134.74035.052.2634.7935.102.26
2156764-15676434.49234.54
3163638-16363836.00536.06
4162170-16217035.68235.73
5161130-16113035.45335.50
6154256-15425633.94133.99
20min1207921-20792145.74845.912.2545.8546.022.25
2205447-20544745.20445.31
3212676-21267646.79546.91
4213401-21340146.95447.06
5211119-21111946.45246.56
6201300-20130044.29144.40
30min1282447-28244762.14662.192.1862.3362.382.18
2276988-27698860.94561.13
3285353-28535362.78562.98
4290133-29013363.83764.02
5287045-28704563.15863.34
6274020-27402060.29260.47
45min1353949-35394977.87878.041.8778.1678.331.87
2346923-34692376.33376.62
3355733-35573378.27178.57
4363716-36371680.02780.32
5359953-35995379.19979.49
6347763-34776376.51776.80
60min1396766-39676687.29987.171.6787.7187.581.67
2386412-38641285.02185.43
3396550-39655087.25287.68
4403634-40363488.81089.24
5402494-40249488.56088.98
6391102-39110286.05386.46
极限1427777-42777794.12393.641.1794.6894.201.17
2418400-41840092.05992.61
3423643-42364393.21393.78
4432431-43243195.14795.72
5428412-42841294.26294.83
6422858-42285893.04093.59
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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)60供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.474716194777874791914775304798784772010.69
213.494833224847584840400.21
单位质量响应值RSD%判断
35426.9535881.390.91数据可信
供试品溶液-6000597批-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%
5min130892-308926.4666.3340.526.476.3240.54
242240-422408.8418.84
342718-427188.9418.94
424463-244635.1205.12
59861-98612.0642.06
631145-311456.5196.52
10min1124509-12450926.06124.2620.0826.0724.2720.08
2135765-13576528.41728.43
3139074-13907429.11029.12
4108629-10862922.73722.75
575510-7551015.80515.81
6111895-11189523.42123.43
15min1210151-21015143.98741.8610.0144.0441.9110.02
2212139-21213944.40344.47
3222977-22297746.67146.73
4192871-19287140.37040.42
5166001-16600134.74634.78
6195794-19579440.98241.03
20min1277677-27767758.12157.564.1458.2557.684.16
2280464-28046458.70458.84
3290900-29090060.88961.03
4264054-26405455.26955.38
5259810-25981054.38154.47
6277201-27720158.02158.14
30min1377752-37775279.06876.823.2979.2977.043.31
2369739-36973977.39077.62
3379463-37946379.42679.67
4360875-36087575.53575.74
5346712-34671272.57172.75
6367581-36758176.93977.15
45min1435909-43590991.24089.113.0191.6089.463.02
2424572-42457288.86889.23
3435180-43518091.08891.46
4410966-41096686.02086.35
5409780-40978085.77186.07
6438046-43804691.68892.03
60min1458581-45858195.98692.912.4696.4993.402.47
2449416-44941694.06894.58
3449625-44962594.11194.64
4435205-43520591.09391.57
5428616-42861689.71490.16
6441878-44187892.49092.99
极限1456299-45629995.50896.072.7096.1896.722.69
2441294-44129492.36893.04
3479251-479251100.312101.00
4455943-45594395.43496.06
5457478-45747895.75596.35
6463695-46369597.05697.71
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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)60供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.474867774844694824704822584849164841780.39
213.494774704783564779130.14
单位质量响应值RSD%判断
35944.9135427.211.03数据可信
供试品溶液-6000597批-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%
5min122306-223064.6653.8530.334.663.8530.32
27178-71781.5011.50
320719-207194.3334.33
419741-197414.1284.13
519742-197424.1294.13
620758-207584.3414.34
10min1108789-10878922.75121.166.8722.7621.176.87
290312-9031218.88718.89
3103497-10349721.64421.65
497478-9747820.38520.39
599338-9933820.77420.78
6107712-10771222.52522.53
15min1193256-19325640.41539.992.0740.4640.042.08
2186657-18665739.03539.07
3189854-18985439.70339.75
4187749-18774939.26339.30
5192661-19266140.29040.33
6197299-19729941.26041.31
20min1288322-28832260.29658.813.6760.4158.923.66
2294106-29410661.50561.60
3288804-28880460.39760.51
4272060-27206056.89557.00
5273319-27331957.15857.27
6270752-27075256.62156.73
30min1364373-36437376.20074.052.2276.4174.252.21
2362153-36215375.73675.94
3347259-34725972.62172.83
4354178-35417874.06874.27
5351554-35155473.51973.72
6344992-34499272.14772.35
45min1415984-41598486.99387.600.9087.3387.930.90
2424991-42499188.87789.20
3416077-41607787.01387.34
4421352-42135288.11688.44
5419328-41932887.69388.02
6415612-41561286.91587.24
60min1455258-45525895.20694.781.4695.6995.261.46
2451704-45170494.46394.94
3443102-44310292.66493.14
4462035-46203596.62497.10
5457595-45759595.69596.17
6449624-44962494.02894.50
极限1484237-484237101.26797.422.16101.9198.062.15
2468522-46852297.98098.61
3458086-45808695.79896.43
4463285-46328596.88597.52
5464663-46466397.17397.81
6456332-45633295.43196.06
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