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%
113.424460074461514453604456854458474458100.07
213.594434024446314440160.20
单位质量响应值RSD%判断
33219.8232672.261.18数据可信
供试品溶液-2024102421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%
5min164239-6423914.55215.535.6614.5515.535.66
265547-6554714.84814.85
365401-6540114.81514.81
471343-7134316.16116.16
572572-7257216.43916.44
672244-7224416.36516.36
10min1183459-18345941.55841.0111.5741.7241.1811.54
2170486-17048638.61938.78
3146801-14680133.25433.42
4200080-20008045.32345.50
5181077-18107741.01841.20
6204292-20429246.27746.46
15min1257267-25726758.27760.027.1358.9060.647.15
2257141-25714158.24858.84
3239358-23935854.22054.75
4292747-29274766.31467.00
5263105-26310559.59960.24
6280076-28007663.44364.14
20min1303908-30390868.84272.597.2370.1173.887.23
2293338-29333866.44867.69
3302123-30212368.43869.57
4347104-34710478.62780.05
5336449-33644976.21377.51
6339683-33968376.94678.35
30min1365044-36504482.69186.424.3284.7388.534.36
2374926-37492684.92986.91
3372592-37259284.40086.30
4405189-40518991.78494.08
5372196-37219684.31186.46
6399214-39921490.43192.69
45min1396475-39647589.81093.622.7692.7796.682.78
2413244-41324493.60996.53
3411815-41181593.28596.12
4412889-41288993.52996.84
5413002-41300293.55496.64
6432359-43235997.939101.20
60min1400718-40071890.77294.652.1994.7298.752.23
2422153-42215395.62799.59
3417593-41759394.59498.47
4422515-42251595.709100.06
5417127-41712794.48998.61
6426982-42698296.721101.07
极限1413735-41373593.72095.290.9398.68100.451.03
2422138-42213895.624100.65
3421604-42160495.503100.43
4421861-42186195.561100.98
5419376-41937694.998100.17
6425355-42535596.352101.78
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%
113.424445084440764445314447434434724442660.12
213.594447534455324451420.13
单位质量响应值RSD%判断
33104.7732755.110.76数据可信
供试品溶液-2024102421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%
5min161817-6181714.00914.7931.4114.0114.7831.42
229099-290996.5956.59
361090-6109013.84413.84
484828-8482819.22419.22
583978-8397819.03119.03
670653-7065316.01216.01
10min1177121-17712140.14041.8612.9540.3042.0313.03
2144294-14429432.70032.77
3180780-18078040.96941.12
4206840-20684046.87547.09
5210085-21008547.61047.82
6189242-18924242.88743.06
15min1261840-26184059.33961.118.1859.9461.748.27
2235768-23576853.43153.87
3257747-25774758.41259.02
4285303-28530364.65665.39
5296064-29606467.09567.84
6281325-28132563.75564.41
20min1323068-32306873.21573.315.6574.4874.625.75
2300010-30001067.98969.02
3303187-30318768.70969.97
4335881-33588176.11977.57
5343894-34389477.93579.42
6334990-33499075.91777.28
30min1383918-38391887.00587.012.7789.0889.132.93
2366494-36649483.05684.84
3377784-37778485.61587.64
4387461-38746187.80890.11
5395903-39590389.72192.07
6391987-39198788.83491.04
45min1437396-43739699.12494.412.79102.1797.502.80
2404030-40403091.56394.27
3408662-40866292.61395.59
4412746-41274693.53896.81
5418340-41834094.80698.15
6418446-41844694.83098.02
60min1433013-43301398.13194.772.22102.2798.912.11
2415172-41517294.08897.81
3419196-41919695.00099.00
4404823-40482391.74396.06
5415211-41521194.09798.50
6421776-42177695.58599.83
极限1451078-451078102.22595.843.80107.46101.033.55
2421932-42193295.620100.39
3429455-42945597.325102.38
4405763-40576391.95697.29
5417179-41717994.54399.99
6411925-41192593.35298.66
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%
113.424450474462754453424454184454184455000.11
213.594433774450274442020.27
单位质量响应值RSD%判断
33196.7232685.951.10数据可信
供试品溶液-2024102521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%
5min130155-301556.8329.7056.666.839.7056.65
266269-6626915.01315.01
35723-57231.2971.30
441764-417649.4629.46
571962-7196216.30316.30
640929-409299.2739.27
10min1130561-13056129.57933.1927.8329.6533.3027.92
2181087-18108741.02641.19
376265-7626517.27817.29
4156692-15669235.49935.60
5189148-18914842.85243.03
6145311-14531132.92133.02
15min1222050-22205050.30652.3814.9250.7152.8615.09
2253885-25388557.51858.14
3170586-17058638.64738.85
4243093-24309355.07355.57
5270163-27016361.20661.86
6227508-22750851.54352.01
20min1277129-27712962.78465.579.2863.7566.639.50
2310435-31043570.33071.59
3243245-24324555.10855.74
4302636-30263668.56369.67
5315818-31581871.54972.89
6287255-28725565.07866.12
30min1350874-35087479.49181.954.3681.1583.744.62
2368501-36850183.48585.53
3337676-33767676.50177.75
4377607-37760785.54887.42
5377172-37717285.44987.58
6358624-35862481.24783.01
45min1399806-39980690.57791.462.3893.1294.162.59
2396855-39685589.90992.88
3392810-39281088.99291.09
4410865-41086593.08395.91
5418784-41878494.87797.96
6403127-40312791.33094.00
60min1420744-42074495.32195.961.1598.8799.671.30
2422902-42290295.81099.78
3423979-42397996.05499.14
4420314-42031495.22399.08
5433002-43300298.098102.23
6420415-42041595.24698.93
极限1423675-42367595.98596.411.38100.59101.191.39
2423675-42367595.985101.02
3426703-42670396.671100.82
4435590-43559098.684103.60
5425924-42592496.494101.72
6417731-41773194.63899.38
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%
113.424473414481614476114470004466034473430.14
213.594499094507404503240.14
单位质量响应值RSD%判断
33334.0533136.420.43数据可信
供试品溶液-2024102521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%
5min150306-5030611.29610.3434.3811.3010.3434.38
267969-6796915.26215.26
356332-5633212.64912.65
439828-398288.9438.94
522132-221324.9694.97
639829-398298.9438.94
10min1161346-16134636.22835.0711.4836.3535.1811.54
2179723-17972340.35540.52
3167694-16769437.65437.79
4151297-15129733.97234.07
5127461-12746128.62028.68
6149624-14962433.59633.70
15min1250424-25042456.23054.395.1256.7654.905.22
2253830-25383056.99457.61
3251386-25138656.44657.00
4235722-23572252.92853.41
5221304-22130449.69150.06
6240825-24082554.07454.55
20min1323634-32363472.66868.184.3773.8269.294.43
2308142-30814269.19070.44
3308151-30815169.19270.38
4297780-29778066.86367.93
5283859-28385963.73764.66
6300290-30029067.42668.50
30min1396162-39616288.95384.083.1790.9185.953.17
2369899-36989983.05685.08
3367049-36704982.41684.37
4372213-37221383.57685.38
5362899-36289981.48583.12
6378608-37860885.01286.83
45min1427964-42796496.09493.511.8899.0496.301.90
2409237-40923791.88994.83
3413072-41307292.75095.62
4417892-41789293.83396.57
5408002-40800291.61294.15
6422452-42245294.85697.62
60min1462881-462881103.93496.574.07107.95100.414.01
2421002-42100294.53198.49
3419539-41953994.20298.10
4427653-42765396.02499.80
5414876-41487693.15596.71
6434575-43457597.578101.40
极限1465111-465111104.43597.703.56109.61102.613.52
2430417-43041796.645101.66
3422258-42225894.81399.76
4432407-43240797.092101.94
5425033-42503395.436100.03
6435449-43544997.775102.68
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