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%
113.624597554609964600684598904606914602800.12
213.574606394601224603800.08
单位质量响应值RSD%判断
33794.4233926.310.28数据可信
长期6月-供试品溶液-2024102121批-pH6.8(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%
5min183107-8310718.31617.386.8418.3217.386.84
283258-8325818.34918.35
380813-8081317.81017.81
468913-6891315.18815.19
576939-7693916.95716.96
680005-8000517.63217.63
10min1190247-19024741.92941.853.6141.9641.883.61
2189478-18947841.75941.79
3187510-18751041.32641.36
4179813-17981339.62939.65
5191362-19136242.17542.20
6201055-20105544.31144.34
15min1258235-25823556.91355.763.5257.0155.863.51
2252561-25256155.66255.76
3245597-24559754.12754.23
4243108-24310853.57953.67
5251071-25107155.33455.43
6267514-26751458.95859.06
20min1301611-30161166.47265.203.3966.6765.393.39
2292939-29293964.56164.75
3286666-28666663.17963.37
4287223-28722363.30163.48
5293591-29359164.70564.90
6313037-31303768.99169.19
30min1358785-35878579.07377.733.0879.3878.033.08
2347629-34762976.61476.91
3342694-34269475.52775.82
4346327-34632776.32776.61
5348800-34880076.87277.17
6371967-37196781.97882.29
45min1404964-40496489.25187.862.8489.6988.292.84
2391637-39163786.31386.74
3389184-38918485.77386.19
4393810-39381086.79287.21
5393362-39336286.69487.12
6418882-41888292.31892.77
60min1430050-43005094.77993.532.5795.3794.102.57
2416968-41696891.89692.47
3416403-41640391.77292.33
4420715-42071592.72293.28
5418046-41804692.13492.70
6444095-44409597.87598.48
极限1452030-45203099.62398.282.44100.3799.012.44
2437229-43722996.36197.09
3439230-43923096.80297.52
4445399-44539998.16298.87
5437016-43701696.31597.04
6464655-464655102.406103.18
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%
113.624602134601524597434600664593964599140.08
213.574602004596254599120.09
单位质量响应值RSD%判断
33767.5533891.820.26数据可信
长期6月-供试品溶液-2024102121批-pH6.8(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%
5min176964-7696416.97816.0010.0316.9816.0010.03
266625-6662514.69714.70
369459-6945915.32215.32
485309-8530918.81818.82
567216-6721614.82714.83
669586-6958615.35015.35
10min1181289-18128939.99137.395.2140.0237.425.22
2176188-17618838.86538.89
3159946-15994635.28335.31
4174159-17415938.41838.45
5163597-16359736.08836.11
6161858-16185835.70435.73
15min1250143-25014355.17952.033.7755.2752.123.77
2241661-24166153.30853.40
3228482-22848250.40150.49
4235939-23593952.04652.14
5232844-23284451.36351.45
6226185-22618549.89449.98
20min1297690-29769065.66862.143.3765.8562.313.37
2286542-28654263.20963.39
3276876-27687661.07661.24
4281083-28108362.00462.19
5277547-27754761.22461.39
6270325-27032559.63159.80
30min1356946-35694678.73975.292.8579.0475.572.85
2342360-34236075.52275.81
3344544-34454476.00376.27
4339603-33960374.91375.20
5337051-33705174.35074.62
6327382-32738272.21872.49
45min1406773-40677389.73086.152.6890.1686.552.69
2388073-38807385.60586.01
3396827-39682787.53687.93
4389267-38926785.86986.28
5386642-38664285.29085.69
6375647-37564782.86483.25
60min1433239-43323995.56992.122.5496.1592.662.54
2415621-41562191.68292.23
3424958-42495893.74294.28
4415768-41576891.71592.27
5413781-41378191.27691.81
6402157-40215788.71289.24
极限1457792-457792100.98597.512.17101.7298.212.17
2439948-43994897.04997.75
3447269-44726998.66499.36
4438495-43849596.72897.43
5439053-43905396.85197.54
6429588-42958894.76395.44
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%
113.624609874612264619384614674607244612680.11
213.574558354592604575480.53
单位质量响应值RSD%判断
33866.9633717.610.32数据可信
长期6月-供试品溶液-2024102221批-pH6.8(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%
5min187209-8720919.25919.119.0119.2619.119.00
296511-9651121.31321.31
391055-9105520.10820.11
474701-7470116.49716.50
580505-8050517.77817.78
689160-8916019.69019.69
10min1184256-18425640.69040.736.6240.7240.766.62
2198204-19820443.77043.81
3191107-19110742.20342.24
4181032-18103239.97840.01
5162673-16267335.92435.95
6189394-18939441.82541.86
15min1248800-24880054.94455.853.2555.0455.953.25
2259676-25967657.34657.45
3254790-25479056.26756.37
4248145-24814554.79954.89
5241892-24189253.41853.51
6264171-26417158.33858.44
20min1293664-29366464.85165.702.0865.0465.892.08
2300250-30025066.30666.51
3296763-29676365.53665.73
4293170-29317064.74264.93
5292575-29257564.61164.79
6308631-30863168.15768.36
30min1348968-34896877.06577.491.8577.3677.791.85
2351123-35112377.54077.85
3346142-34614276.44076.75
4347860-34786076.82077.11
5347539-34753976.74977.04
6363644-36364480.30680.62
45min1393653-39365386.93387.281.5787.3687.711.57
2396265-39626587.50987.95
3389760-38976086.07386.51
4390442-39044286.22386.64
5394428-39442887.10487.52
6406845-40684589.84690.29
60min1416922-41692292.07192.421.4492.6493.001.44
2421111-42111192.99693.59
3411623-41162390.90191.48
4414003-41400391.42791.99
5418727-41872792.47093.03
6428703-42870394.67395.27
极限1440189-44018997.20997.341.2997.9498.071.29
2444640-44464098.19298.94
3433692-43369295.77596.50
4435126-43512696.09196.81
5442536-44253697.72898.44
6448529-44852999.05199.81
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%
113.624588654597014589724598344592864593320.10
213.574570064589174579620.30
单位质量响应值RSD%判断
33724.8233748.120.05数据可信
长期6月-供试品溶液-2024102221批-pH6.8(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%
5min185362-8536218.88218.408.2918.8818.408.29
276434-7643416.90716.91
383596-8359618.49118.49
474141-7414116.40016.40
586856-8685619.21319.21
692776-9277620.52220.52
10min1189044-18904441.81640.664.0141.8540.694.01
2173981-17398138.48538.51
3183770-18377040.65040.68
4175915-17591538.91238.94
5188626-18862641.72441.76
6191612-19161242.38542.42
15min1253516-25351656.07854.942.5956.1855.042.59
2237427-23742752.51952.61
3251049-25104955.53255.63
4243935-24393553.95854.05
5250786-25078655.47455.58
6253526-25352656.08056.18
20min1297783-29778365.87064.581.9766.0664.771.98
2282220-28222062.42762.61
3291319-29131964.44064.63
4289022-28902263.93264.11
5295846-29584665.44165.64
6295489-29548965.36265.56
30min1351505-35150577.75376.701.5178.0677.001.52
2337278-33727874.60674.89
3345747-34574776.47976.78
4345850-34585076.50276.79
5350505-35050577.53277.83
6349601-34960177.33277.64
45min1394823-39482387.33586.651.3987.7787.071.40
2381192-38119284.32084.73
3391648-39164886.63287.06
4392777-39277786.88287.30
5396655-39665587.74088.17
6393173-39317386.97087.41
60min1417773-41777392.41191.811.4092.9992.381.41
2404051-40405189.37689.92
3415487-41548791.90692.48
4417722-41772292.40092.96
5420767-42076793.07493.65
6414537-41453791.69692.28
极限1439412-43941297.19896.671.5297.9397.391.52
2425325-42532594.08294.78
3441414-44141497.64198.36
4439171-43917197.14597.86
5443372-44337298.07498.81
6433488-43348895.88796.62
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%
113.624599084597514601454585804600754596920.14
213.574584504607414595960.36
单位质量响应值RSD%判断
33751.2533868.530.25数据可信
长期6月-供试品溶液-2024102321批-pH6.8(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%
5min179827-7982717.61917.323.1817.6217.323.18
277532-7753217.11317.11
382282-8228218.16118.16
474861-7486116.52316.52
577655-7765517.14017.14
678702-7870217.37117.37
10min1181656-18165640.09539.882.7540.1239.902.75
2179566-17956639.63439.66
3188901-18890141.69441.72
4173552-17355238.30638.33
5179163-17916339.54539.57
6181214-18121439.99840.03
15min1246705-24670554.45355.403.4354.5555.503.44
2252410-25241055.71255.81
3265804-26580458.66858.77
4239686-23968652.90452.99
5251795-25179555.57655.67
6249577-24957755.08755.18
20min1290666-29066664.15665.363.2064.3465.553.20
2297796-29779665.73065.92
3312004-31200468.86669.06
4283405-28340562.55362.73
5296906-29690665.53365.72
6295952-29595265.32365.51
30min1346713-34671376.52777.632.6076.8277.932.60
2349535-34953577.14977.45
3367345-36734581.08081.39
4340051-34005175.05675.34
5352907-35290777.89478.19
6353741-35374178.07878.37
45min1392171-39217186.56087.262.3586.9887.682.36
2392411-39241186.61387.04
3410465-41046590.59891.05
4382215-38221584.36384.77
5396129-39612987.43487.86
6398566-39856687.97288.40
60min1425608-42560893.94092.622.0594.5193.192.06
2415291-41529191.66392.23
3430904-43090495.10995.71
4406122-40612289.63990.19
5418261-41826192.31992.89
6421458-42145893.02493.60
极限1436306-43630696.30296.261.7397.0296.981.74
2433993-43399395.79196.51
3447544-44754498.78299.54
4424179-42417993.62594.32
5436208-43620896.28097.01
6438404-43840496.76597.49
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%
113.624604334613234597854603684609214605660.13
213.574592254594454593350.04
单位质量响应值RSD%判断
33815.4233849.300.08数据可信
长期6月-供试品溶液-2024102321批-pH6.8(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%
5min181178-8117817.90616.648.7917.9116.648.80
284496-8449618.63818.64
377051-7705116.99517.00
469563-6956315.34415.34
567771-6777114.94814.95
672505-7250515.99315.99
10min1186430-18643041.12138.895.8041.1538.925.81
2188759-18875941.63541.67
3179209-17920939.52939.56
4173023-17302338.16438.19
5164777-16477736.34536.37
6165677-16567736.54436.57
15min1250438-25043855.24053.514.2155.3453.604.21
2256235-25623556.51856.62
3244311-24431153.88853.98
4242385-24238553.46453.55
5229369-22936950.59350.68
6232870-23287051.36551.45
20min1291071-29107164.20263.313.2064.3963.493.20
2301016-30101666.39666.59
3287439-28743963.40163.59
4288609-28860963.65963.84
5275849-27584960.84561.01
6278088-27808861.33961.51
30min1346308-34630876.38675.692.3176.6875.982.32
2353855-35385578.05178.36
3343202-34320275.70175.99
4347705-34770576.69476.98
5334369-33436973.75374.02
6333603-33360373.58473.86
45min1389971-38997186.01785.721.6086.4486.141.61
2396171-39617187.38587.82
3391453-39145386.34486.76
4391941-39194186.45286.86
5382085-38208584.27884.67
6380203-38020383.86284.26
60min1413795-41379591.27290.931.4891.8491.491.49
2418259-41825992.25792.84
3416638-41663891.89992.46
4415482-41548291.64492.20
5405287-40528789.39589.93
6403999-40399989.11189.65
极限1434710-43471095.88595.611.1796.6196.321.18
2437619-43761996.52797.26
3439169-43916996.86997.58
4432962-43296295.50096.21
5431417-43141795.15995.84
6424957-42495793.73494.42
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