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%
113.364558564546794547384546764554734550840.13
213.404528614532914530760.07
单位质量响应值RSD%判断
34063.1733811.640.53数据可信
中间条件6月-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%
5min185585-8558518.82018.6910.1618.8218.6910.16
284396-8439618.55818.56
385296-8529618.75618.76
469276-6927615.23315.23
591313-9131320.07920.08
694199-9419920.71420.71
10min1194561-19456142.78342.579.0242.9942.789.02
2197631-19763143.45843.66
3196534-19653443.21643.42
4159660-15966035.10835.28
5204799-20479945.03445.26
6208379-20837945.82146.05
15min1253735-25373555.79556.789.0456.4857.469.04
2258069-25806956.74857.44
3261583-26158357.52058.21
4216358-21635847.57648.13
5281591-28159161.92062.64
6277939-27793961.11761.86
20min1295096-29509664.89065.539.0866.1966.849.08
2302004-30200466.40967.73
3297783-29778365.48066.81
4248534-24853454.65155.74
5323529-32352971.14272.55
6321034-32103470.59372.01
30min1347409-34740976.39377.296.4278.4279.346.49
2355954-35595478.27280.33
3358053-35805378.73380.79
4308832-30883267.91069.61
5371081-37108181.59883.80
6367692-36769280.85383.06
45min1375549-37554982.58184.325.7385.4587.225.81
2380000-38000083.55986.49
3391928-39192886.18289.11
4345928-34592876.06778.52
5408085-40808589.73592.84
6399237-39923787.78990.89
60min1399677-39967787.88689.053.9091.6892.884.05
2407378-40737889.58093.44
3406209-40620989.32393.21
4377439-37743982.99686.29
5423100-42310093.03797.14
6415948-41594891.46495.54
极限1408169-40816989.75492.641.8694.5297.461.84
2429608-42960894.46899.32
3419888-41988892.33097.21
4422634-42263492.93497.15
5428616-42861694.25099.39
6418761-41876192.08397.18
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%
113.364536444512884523234529674522514524950.20
213.404544604538764541680.10
单位质量响应值RSD%判断
33869.3933893.130.05数据可信
中间条件6月-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%
5min194874-9487420.89619.797.9920.9019.798.00
284362-8436218.58118.58
394666-9466620.85120.85
496238-9623821.19721.20
578137-7813717.21017.21
690805-9080520.00020.00
10min1194918-19491842.93243.175.1743.1643.395.18
2181318-18131839.93640.14
3207640-20764045.73445.97
4205121-20512145.17945.41
5187841-18784141.37341.56
6199286-19928643.89444.12
15min1267350-26735058.88558.783.7659.5959.483.78
2253112-25311255.74956.40
3279473-27947361.55562.30
4274612-27461260.48561.22
5257460-25746056.70757.36
6269127-26912759.27659.99
20min1305350-30535067.25566.832.8268.6268.192.86
2290267-29026763.93365.20
3312066-31206668.73470.16
4311911-31191168.70070.11
5296952-29695265.40566.69
6304072-30407266.97368.34
30min1343620-34362075.68475.863.0277.7977.953.01
2325517-32551771.69773.68
3356103-35610378.43380.62
4342985-34298575.54477.72
5348816-34881676.82878.84
6349347-34934776.94579.06
45min1384319-38431984.64885.502.2987.6088.442.32
2373385-37338582.24085.02
3394957-39495786.99190.05
4397774-39777487.61290.62
5386277-38627785.07987.94
6392314-39231486.40989.38
60min1388232-38823285.51087.772.9889.4091.652.96
2380912-38091283.89887.59
3408099-40809989.88693.91
4411426-41142690.61894.60
5403836-40383688.94792.75
6398378-39837887.74591.67
极限1406694-40669489.57692.191.8194.4297.051.81
2417696-41769691.99996.62
3425002-42500293.60998.63
4427103-42710394.07199.06
5413683-41368391.11695.91
6421114-42111492.75297.65
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%
113.364514764517644522584512164514854516400.09
213.404520774515114517940.09
单位质量响应值RSD%判断
33805.3933715.970.19数据可信
中间条件6月-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%
5min161224-6122413.53315.177.8313.5315.177.84
271872-7187215.88715.89
364893-6489314.34414.34
471697-7169715.84815.85
575734-7573416.74016.74
666397-6639714.67614.68
10min1169870-16987037.54838.333.0737.7038.503.08
2173053-17305338.25238.43
3168427-16842737.22937.39
4182343-18234340.30540.48
5176802-17680239.08139.27
6169904-16990437.55637.72
15min1232499-23249951.39252.522.5551.9653.122.56
2235445-23544552.04352.64
3233414-23341451.59452.17
4249196-24919655.08355.71
5237898-23789852.58553.21
6237248-23724852.44253.02
20min1278642-27864261.59162.131.8162.7363.311.83
2276446-27644661.10662.29
3277445-27744561.32762.47
4289814-28981464.06165.30
5284255-28425562.83264.04
6279843-27984361.85763.02
30min1327060-32706072.29473.762.1074.1275.632.09
2333339-33333973.68275.54
3335726-33572674.20976.04
4345501-34550176.37078.32
5334270-33427073.88875.79
6326253-32625372.11573.97
45min1361027-36102779.80281.491.8482.4384.181.85
2370948-37094881.99584.67
3363836-36383680.42383.08
4378426-37842683.64886.44
5373686-37368682.60085.32
6364087-36408780.47883.13
60min1391262-39126286.48586.791.7390.0090.391.72
2387438-38743885.64089.23
3384087-38408784.89988.45
4403307-40330789.14892.87
5393835-39383587.05490.70
6396007-39600787.53491.08
极限1402713-40271389.01690.091.3693.4994.651.33
2411617-41161790.98495.52
3409831-40983190.59095.08
4413784-41378491.46396.18
5399295-39929588.26192.87
6408261-40826190.24394.76
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%
113.364534584532814531264536454529334532890.07
213.404547034551154549090.07
单位质量响应值RSD%判断
33928.8233948.430.05数据可信
中间条件6月-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%
5min168450-6845015.05115.2111.5415.0515.2111.55
267587-6758714.86114.86
384023-8402318.47518.48
467144-6714414.76414.76
559709-5970913.12913.13
668115-6811514.97714.98
10min1175490-17549038.58738.062.9038.7538.232.94
2169437-16943737.25637.42
3181267-18126739.85740.06
4171031-17103137.60737.77
5167198-16719836.76436.91
6174126-17412638.28738.45
15min1234694-23469451.60552.071.0552.2052.671.06
2234094-23409451.47352.05
3239483-23948352.65853.31
4235016-23501651.67652.26
5239318-23931852.62253.18
6238351-23835152.40953.00
20min1282306-28230662.07460.802.4263.2461.972.41
2267391-26739158.79559.95
3283258-28325862.28363.52
4269616-26961659.28460.44
5276423-27642360.78161.92
6280100-28010061.58962.76
30min1332085-33208573.02072.812.1574.8874.652.14
2326454-32645471.78173.59
3340101-34010174.78276.71
4334035-33403573.44875.26
5319735-31973570.30472.12
6334270-33427073.50075.36
45min1375324-37532482.52781.921.5485.2084.581.51
2369463-36946381.23883.84
3378347-37834783.19285.95
4369015-36901581.14083.77
5378690-37869083.26785.86
6364621-36462180.17482.85
60min1395781-39578187.02586.630.7890.6190.200.80
2389333-38933385.60789.11
3396948-39694887.28290.96
4396605-39660587.20690.74
5391642-39164286.11589.64
6393674-39367486.56290.13
极限1410971-41097190.36590.481.5794.9295.011.53
2403176-40317688.65193.11
3418325-41832591.98296.63
4415866-41586691.44295.94
5416300-41630091.53796.01
6404441-40444188.92993.46
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%
113.364537634537054535604539214536314537160.04
213.404555924564074560000.13
单位质量响应值RSD%判断
33960.7834029.850.15数据可信
中间条件6月-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%
5min166270-6627014.54715.8510.8814.5515.8510.89
264795-6479514.22414.22
370113-7011315.39115.39
481311-8131117.84917.85
567944-6794414.91514.91
682838-8283818.18418.18
10min1162726-16272635.72137.183.8635.8837.363.89
2161442-16144235.43935.60
3171379-17137937.62037.79
4177814-17781439.03339.23
5168073-16807336.89537.06
6174764-17476438.36338.57
15min1225647-22564749.53350.902.3250.0951.492.33
2227481-22748149.93650.49
3239161-23916152.50053.09
4230157-23015750.52351.16
5231557-23155750.83051.41
6237315-23731552.09452.72
20min1270216-27021659.31760.812.5160.4361.962.51
2279878-27987861.43862.54
3280744-28074461.62862.80
4281393-28139361.77062.96
5266408-26640858.48159.62
6283439-28343962.21963.43
30min1327146-32714671.81471.251.5173.5873.081.44
2332288-33228872.94274.73
3318789-31878969.97971.84
4325610-32561071.47773.36
5320700-32070070.39972.19
6322809-32280970.86272.76
45min1363282-36328279.74681.202.1582.3183.822.05
2381390-38139083.72186.32
3371893-37189381.63684.27
4365890-36589080.31982.99
5376049-37604982.54985.12
6360891-36089179.22181.91
60min1388982-38898285.38885.502.2588.8489.022.15
2403326-40332688.53692.07
3390842-39084285.79689.34
4375987-37598782.53586.10
5387338-38733885.02788.52
6390383-39038385.69589.26
极限1405187-40518788.94588.471.4093.3592.951.35
2412462-41246290.54295.06
3398574-39857487.49391.99
4396618-39661887.06491.55
5401269-40126988.08592.52
6404122-40412288.71193.23
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%
113.364566014560954561394559304559714561470.06
213.404607624602114604860.09
单位质量响应值RSD%判断
34142.7434364.630.46数据可信
中间条件6月-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%
5min175783-7578316.51015.356.0916.5115.346.10
264759-6475914.10914.11
373248-7324815.95815.96
473160-7316015.93915.94
568904-6890415.01215.01
666759-6675914.54414.54
10min1173401-17340137.77837.141.3737.9637.311.38
2169507-16950736.92937.09
3172194-17219437.51537.69
4171471-17147137.35737.53
5169297-16929736.88337.05
6166966-16696636.37636.54
15min1236435-23643551.51050.892.7452.1151.472.73
2225749-22574949.18249.75
3243824-24382453.12053.71
4233938-23393850.96651.56
5233399-23339950.84951.43
6228123-22812349.69950.27
20min1280259-28025961.05859.482.5062.2360.632.49
2267690-26769058.31959.43
3280561-28056161.12462.31
4265472-26547257.83658.99
5276307-27630760.19761.34
6267825-26782558.34959.47
30min1326273-32627371.08369.812.7172.9471.622.69
2317120-31712069.08870.85
3326569-32656971.14773.01
4314877-31487768.60070.40
5330156-33015671.92873.74
6307519-30751966.99768.76
45min1372418-37241881.13680.021.9983.7882.611.96
2370049-37004980.62083.15
3371608-37160880.95983.61
4353511-35351177.01779.58
5371419-37141980.91883.53
6364835-36483579.48481.99
60min1398876-39887686.90085.232.0090.4588.701.95
2400266-40026687.20390.63
3386834-38683484.27687.83
4384150-38415083.69287.11
5394799-39479986.01289.52
6382203-38220383.26886.66
极限1433127-43312794.36290.132.6498.8794.552.55
2416719-41671990.78795.18
3412369-41236989.84094.33
4408497-40849788.99693.34
5400738-40073887.30691.77
6410725-41072589.48193.80
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