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%
113.624600024601044597174595024597754598200.06
213.574593344582824588080.17
单位质量响应值RSD%判断
33760.6533810.460.11数据可信
长期6月-供试品溶液-2024102121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%
5min1100402-10040222.17719.906.7722.1819.906.78
287609-8760919.35119.35
386940-8694019.20319.20
485216-8521618.82218.82
585698-8569818.92918.93
694579-9457920.89020.89
10min1198887-19888743.93041.812.7743.9741.852.78
2184391-18439140.72840.76
3188631-18863141.66541.70
4188236-18823641.57741.61
5185062-18506240.87640.91
6190617-19061742.10342.14
15min1261746-26174657.81455.612.3457.9255.722.34
2244089-24408953.91454.01
3249794-24979455.17455.28
4251982-25198255.65755.76
5249294-24929455.06455.16
6253761-25376156.05056.16
20min1304327-30432767.21964.912.2167.4365.112.21
2285218-28521862.99963.19
3290780-29078064.22764.42
4296427-29642765.47465.67
5291238-29123864.32864.52
6295273-29527365.21965.42
30min1359598-35959879.42776.782.1079.7577.092.10
2338468-33846874.76075.06
3344574-34457476.10976.41
4350858-35085877.49777.80
5343526-34352675.87876.18
6348721-34872177.02577.33
45min1405053-40505389.46886.671.9689.9287.101.96
2383587-38358784.72685.15
3387180-38718085.52085.95
4395799-39579987.42487.86
5388498-38849885.81186.24
6394098-39409887.04887.48
60min1430436-43043695.07492.131.9095.6792.701.90
2409507-40950790.45191.01
3410141-41014190.59191.16
4420088-42008892.78893.37
5413278-41327891.28491.85
6419207-41920792.59493.17
极限1456973-456973100.93697.861.82101.6998.581.82
2439011-43901196.96897.68
3433301-43330195.70796.43
4445519-44551998.40699.14
5439469-43946997.06997.79
6443886-44388698.04598.78
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%
113.624584504584114588854580694581754583980.07
213.574587744578934583340.14
单位质量响应值RSD%判断
33656.2433775.530.26数据可信
长期6月-供试品溶液-2024102121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%
5min176538-7653816.94117.737.8016.9417.727.80
277262-7726217.10117.10
376427-7642716.91616.92
476873-7687317.01517.01
592310-9231020.43120.43
681096-8109617.94917.95
10min1183919-18391940.70839.025.6340.7439.055.62
2179640-17964039.76139.79
3166349-16634936.81936.85
4167025-16702536.96937.00
5190504-19050442.16542.20
6170389-17038937.71337.74
15min1252567-25256755.90252.855.4356.0052.945.43
2246037-24603754.45754.55
3223339-22333949.43349.52
4225778-22577849.97350.06
5251446-25144655.65455.76
6233387-23338751.65751.75
20min1297313-29731365.80662.294.9666.0062.474.96
2289657-28965764.11164.30
3264510-26451058.54558.72
4267763-26776359.26559.44
5293487-29348764.95965.16
6275729-27572961.02961.21
30min1351789-35178977.86374.004.2978.1674.284.29
2343987-34398776.13776.43
3313759-31375969.44669.72
4322972-32297271.48571.76
5342370-34237075.77976.08
6331004-33100473.26373.54
45min1396401-39640187.73884.303.8388.1784.723.83
2393094-39309487.00687.42
3357967-35796779.23179.62
4371789-37178982.29082.68
5388162-38816285.91486.35
6377928-37792883.64984.05
60min1421007-42100793.18489.953.2593.7690.503.26
2414832-41483291.81792.38
3384046-38404685.00385.52
4400248-40024888.58989.12
5413327-41332791.48492.06
6404921-40492189.62390.17
极限1441395-44139597.69696.351.8798.4397.051.88
2439025-43902597.17297.89
3420084-42008492.98093.64
4432464-43246495.72096.40
5438092-43809296.96597.69
6440756-44075697.55598.25
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%
113.624601474610164605624604294604964605300.07
213.574598154592904595520.09
单位质量响应值RSD%判断
33812.7833865.290.11数据可信
长期6月-供试品溶液-2024102221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%
5min1102767-10276722.66319.0710.6122.6619.0710.60
289365-8936519.70819.71
379158-7915817.45717.46
477146-7714617.01317.01
586399-8639919.05419.05
684009-8400918.52618.53
10min1203395-20339544.85540.745.2744.8940.775.27
2180930-18093039.90039.93
3181470-18147040.01940.05
4174885-17488538.56738.60
5183098-18309840.37940.41
6184605-18460540.71140.74
15min1263860-26386058.18954.034.2058.3054.124.21
2239427-23942752.80152.90
3244606-24460653.94354.04
4236882-23688252.23952.33
5236883-23688352.24052.34
6248232-24823254.74254.84
20min1304127-30412767.06963.273.2867.2863.463.28
2280839-28083961.93362.12
3284888-28488862.82663.01
4280323-28032361.81962.00
5280294-28029461.81362.00
6290935-29093564.16064.35
30min1355765-35576578.45774.802.8278.7875.102.83
2333037-33303773.44473.74
3336865-33686574.28974.58
4334583-33458373.78574.07
5329957-32995772.76573.05
6344917-34491776.06476.36
45min1399037-39903787.99984.512.6188.4584.932.61
2375382-37538282.78383.20
3383320-38332084.53384.95
4378524-37852483.47683.88
5372661-37266182.18382.59
6390444-39044486.10486.53
60min1427027-42702794.17290.412.5094.7790.982.50
2402437-40243788.74989.30
3410540-41054090.53691.09
4403089-40308988.89389.44
5400581-40058188.34088.89
6416220-41622091.78992.36
极限1446125-44612598.38495.912.0299.1496.632.03
2426641-42664194.08794.79
3441773-44177397.42498.13
4426468-42646894.04994.74
5428277-42827794.44895.14
6440283-44028397.09597.82
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%
113.624588444590164591824591984589844590450.04
213.574577214592934585070.25
单位质量响应值RSD%判断
33703.7433788.280.18数据可信
长期6月-供试品溶液-2024102221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%
5min189756-8975619.84818.526.7319.8518.526.72
275185-7518516.62616.63
387144-8714419.27119.27
479581-7958117.59817.60
588144-8814419.49219.49
682751-8275118.29918.30
10min1184608-18460840.82439.533.9440.8639.563.94
2173456-17345638.35838.39
3182836-18283640.43240.46
4170146-17014637.62637.66
5187351-18735141.43041.46
6174233-17423338.52938.56
15min1247160-24716054.65653.102.8354.7653.202.84
2236727-23672752.34952.44
3243169-24316953.77453.87
4230085-23008550.88050.97
5246975-24697554.61554.72
6236659-23665952.33452.43
20min1288538-28853863.80762.432.2664.0062.622.26
2279325-27932561.76961.95
3282937-28293762.56862.76
4271795-27179560.10460.28
5288899-28889963.88664.08
6282336-28233662.43562.62
30min1341302-34130275.47573.951.8375.7774.241.83
2336133-33613374.33274.61
3333553-33355373.76174.05
4324861-32486171.83972.12
5339821-33982175.14775.45
6330694-33069473.12973.41
45min1384835-38483585.10184.081.3085.5384.491.31
2383753-38375384.86285.27
3375109-37510982.95183.37
4373559-37355982.60883.00
5384358-38435884.99685.42
6379566-37956683.93684.34
60min1411215-41121590.93589.761.3491.5090.311.34
2410569-41056990.79291.34
3398064-39806488.02788.58
4401215-40121588.72489.26
5409441-40944190.54391.11
6404836-40483689.52490.07
极限1433426-43342695.84795.161.3296.5695.861.31
2437470-43747096.74197.44
3422343-42234393.39694.10
4427639-42763994.56795.25
5434270-43427096.03396.75
6426772-42677294.37595.07
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%
113.624590884588904594504592454591974591740.05
213.574577314572914575110.07
单位质量响应值RSD%判断
33713.2233714.890.01数据可信
长期6月-供试品溶液-2024102321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%
5min189040-8904019.70919.845.0019.7119.845.00
296421-9642121.34221.34
387257-8725719.31419.31
492529-9252920.48120.48
583344-8334418.44818.45
689158-8915819.73519.73
10min1184499-18449940.83841.434.3740.8741.464.37
2201788-20178844.66544.70
3185918-18591841.15241.18
4190537-19053742.17542.21
5180811-18081140.02240.05
6179465-17946539.72439.76
15min1244355-24435554.08755.214.0554.1955.314.05
2267622-26762259.23759.35
3247915-24791554.87554.98
4252726-25272655.94056.04
5245691-24569154.38354.48
6238257-23825752.73752.84
20min1285593-28559363.21564.574.2963.4164.774.29
2314687-31468769.65569.86
3288917-28891763.95164.14
4294208-29420865.12265.32
5289367-28936764.05064.24
6277631-27763161.45361.64
30min1341015-34101575.48376.212.7175.7876.512.71
2360796-36079679.86180.19
3341224-34122475.52975.83
4346007-34600776.58876.89
5344219-34421976.19276.49
6332559-33255973.61173.90
45min1388593-38859386.01485.981.9186.4486.411.92
2401513-40151388.87489.33
3383831-38383184.96085.38
4387815-38781585.84286.28
5389390-38939086.19086.61
6379483-37948383.99784.41
60min1413557-41355791.54091.321.5692.1191.891.57
2423146-42314693.66294.27
3407139-40713990.11990.69
4411619-41161991.11191.69
5414877-41487791.83292.40
6404995-40499589.64490.20
极限1436939-43693996.71596.311.0397.4397.031.03
2440852-44085297.58198.34
3428842-42884294.92395.64
4434855-43485596.25496.98
5437893-43789396.92697.64
6431171-43117195.43896.14
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%
113.624582944581314583774586174582004583240.05
213.574593834590984592400.05
单位质量响应值RSD%判断
33650.8133842.300.41数据可信
长期6月-供试品溶液-2024102321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%
5min184798-8479818.75219.018.9018.7519.028.90
285314-8531418.86618.87
399041-9904121.90121.90
475914-7591416.78716.79
588438-8843819.55719.56
682407-8240718.22318.22
10min1184164-18416440.72541.055.3140.7641.085.31
2186754-18675441.29841.33
3200266-20026644.28644.32
4173881-17388138.45138.48
5192321-19232142.52942.56
6176437-17643739.01639.05
15min1246692-24669254.55254.793.6754.6554.893.68
2249964-24996455.27655.38
3259891-25989157.47157.58
4236873-23687352.38152.47
5254867-25486756.36056.46
6238265-23826552.68952.78
20min1289442-28944264.00664.162.5764.2064.352.58
2292466-29246664.67564.87
3298231-29823165.94966.16
4280440-28044062.01562.19
5297606-29760665.81166.01
6282665-28266562.50762.69
30min1341643-34164375.54975.921.7175.8576.221.72
2344054-34405476.08376.38
3348787-34878777.12977.45
4334437-33443773.95674.24
5350532-35053277.51577.82
6340491-34049175.29575.58
45min1386484-38648485.46585.621.4685.8986.041.47
2387654-38765485.72486.15
3389234-38923486.07386.52
4377177-37717783.40783.81
5394491-39449187.23687.67
6388088-38808885.82086.23
60min1409017-40901790.44890.731.4191.0191.301.42
2409808-40980890.62391.19
3410151-41015190.69991.29
4400730-40073088.61689.16
5418092-41809292.45593.04
6413911-41391191.53092.09
极限1434527-43452796.08995.681.2296.8196.401.22
2430906-43090695.28996.01
3430186-43018695.12995.87
4424456-42445693.86294.55
5438664-43866497.00497.74
6437245-43724596.69097.40
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