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%
113.524615844620114617984615074618954617590.05
213.504619164616974618060.04
单位质量响应值RSD%判断
34153.7734207.850.12数据可信
中间条件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%
5min180167-8016717.50217.434.2617.5017.424.26
279939-7993917.45317.45
381155-8115517.71817.72
479067-7906717.26217.26
574071-7407116.17216.17
684525-8452518.45418.45
10min1172685-17268537.70138.051.3437.7338.081.34
2170296-17029637.18037.21
3175119-17511938.23338.26
4175767-17576738.37438.40
5175251-17525138.26238.29
6176487-17648738.53138.56
15min1235205-23520551.35151.391.6051.4451.481.60
2228311-22831149.84649.94
3235885-23588551.49951.59
4237913-23791351.94252.03
5239084-23908452.19852.29
6235905-23590551.50451.60
20min1276789-27678960.43060.301.4960.6160.471.49
2269181-26918158.76958.94
3277245-27724560.52960.71
4277954-27795460.68460.86
5281406-28140661.43861.62
6274472-27447259.92460.10
30min1331171-33117172.30372.041.1172.5872.321.12
2325290-32529071.01971.29
3332295-33229572.54872.83
4331275-33127572.32572.61
5334118-33411872.94673.23
6325570-32557071.08071.36
45min1377927-37792782.51181.971.0082.9182.371.00
2373647-37364781.57681.97
3377595-37759582.43882.84
4375526-37552681.98682.39
5379133-37913382.77483.18
6368961-36896180.55380.95
60min1404187-40418788.24487.551.0188.7888.081.00
2401483-40148387.65488.18
3402209-40220987.81288.35
4400901-40090187.52688.06
5403969-40396988.19688.74
6393270-39327085.86086.39
极限1432400-43240094.40394.021.2695.0994.701.25
2436822-43682295.36996.04
3433144-43314494.56695.25
4428982-42898293.65794.34
5431492-43149294.20594.89
6420931-42093191.90092.58
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%
113.524569624565784559074569074562304565170.10
213.504588704609664599180.33
单位质量响应值RSD%判断
33766.0534068.000.63数据可信
中间条件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%
5min178768-7876817.33117.907.2317.3317.907.22
286966-8696619.13519.13
376963-7696316.93416.93
486504-8650419.03319.03
585847-8584718.88918.89
673069-7306916.07716.08
10min1172765-17276538.01338.993.7738.0439.023.77
2186004-18600440.92640.96
3170661-17066137.55037.58
4179384-17938439.46939.50
5183508-18350840.37740.41
6171039-17103937.63337.66
15min1234990-23499051.70452.652.9851.8052.742.99
2248690-24869054.71854.82
3229801-22980150.56250.65
4242071-24207153.26253.36
5244935-24493553.89253.99
6235165-23516551.74351.83
20min1281497-28149761.93761.952.1962.1262.142.19
2289232-28923263.63963.83
3271702-27170259.78259.96
4282277-28227762.10862.29
5286296-28629662.99363.18
6278434-27843461.26361.44
30min1340213-34021374.85673.851.9375.1474.141.93
2342367-34236775.33075.63
3324173-32417371.32771.60
4335259-33525973.76674.06
5338213-33821374.41674.71
6333606-33360673.40273.68
45min1390160-39016085.84683.951.9586.2584.361.95
2386804-38680485.10785.53
3368579-36857981.09781.49
4379637-37963783.53083.94
5381564-38156483.95484.37
6382595-38259584.18184.58
60min1418129-41812992.00089.861.8392.5590.411.83
2412808-41280890.82991.39
3396189-39618987.17287.70
4405417-40541789.20389.75
5407258-40725889.60890.17
6410605-41060590.34490.88
极限1448729-44872998.73295.911.9499.4496.601.93
2439339-43933996.66697.38
3424312-42431293.36094.03
4433351-43335195.34996.05
5430576-43057694.73895.45
6438995-43899596.59197.28
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%
113.524608534612584609204605984618014610860.11
213.504629334627154628240.04
单位质量响应值RSD%判断
34103.9934283.260.38数据可信
中间条件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%
5min179145-7914517.27318.585.8217.2718.585.82
282777-8277718.06618.07
380434-8043417.55417.55
490438-9043819.73819.74
588313-8831319.27419.27
689689-8968919.57419.57
10min1176709-17670938.56639.794.1338.5939.824.14
2179929-17992939.26839.30
3171795-17179537.49337.52
4187200-18720040.85540.89
5185999-18599940.59340.63
6192199-19219941.94641.98
15min1238767-23876752.10953.293.7052.2053.393.71
2241226-24122652.64652.74
3230801-23080150.37150.46
4250262-25026254.61854.72
5248086-24808654.14354.24
6255948-25594855.85955.96
20min1281253-28125361.38262.473.3261.5662.663.32
2281621-28162161.46261.65
3272444-27244459.45959.63
4293003-29300363.94664.14
5290800-29080063.46563.66
6298367-29836765.11765.31
30min1335567-33556773.23574.212.8073.5274.502.81
2334186-33418672.93473.22
3326423-32642371.24071.51
4347175-34717575.76976.07
5345126-34512675.32275.62
6351648-35164876.74577.05
45min1381324-38132483.22283.982.5483.6384.402.55
2377323-37732382.34882.76
3371097-37109780.99081.38
4392590-39259085.68086.11
5390372-39037285.19685.62
6396200-39620086.46886.90
60min1408342-40834289.11889.592.2089.6690.142.20
2403057-40305787.96588.51
3397805-39780586.81987.35
4417884-41788491.20191.77
5414941-41494190.55891.12
6420990-42099091.87992.45
极限1439399-43939995.89695.262.0096.5995.972.00
2428301-42830193.47494.17
3424357-42435792.61393.29
4440452-44045296.12696.85
5438235-43823595.64296.36
6448234-44823497.82498.55
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%
113.524645544637994637364643824636394640220.09
213.504654564645364649960.14
单位质量响应值RSD%判断
34321.1534444.150.26数据可信
中间条件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%
5min190887-9088719.72618.685.2619.7318.685.27
290874-9087419.72419.72
388458-8845819.19919.20
482119-8211917.82317.82
581039-8103917.58917.59
682996-8299618.01418.01
10min1177669-17766938.56238.622.2938.5938.652.29
2171886-17188637.30737.34
3181687-18168739.43439.47
4178796-17879638.80638.84
5174954-17495437.97338.00
6182630-18263039.63939.67
15min1236492-23649251.32951.882.3851.4351.982.38
2232357-23235750.43250.53
3240362-24036252.16952.27
4242471-24247152.62752.72
5234639-23463950.92751.02
6247832-24783253.79053.89
20min1277894-27789460.31561.042.1160.5061.222.11
2276372-27637259.98560.16
3280656-28065660.91561.10
4285188-28518861.89862.08
5276140-27614059.93460.11
6291191-29119163.20163.39
30min1333602-33360272.40673.102.1272.6973.382.11
2334941-33494172.69772.98
3330581-33058171.75072.04
4341341-34134174.08674.37
5331215-33121571.88872.17
6349007-34900775.75076.04
45min1380375-38037582.55883.312.0282.9683.722.02
2384435-38443583.43983.84
3374023-37402381.17981.58
4387912-38791284.19484.60
5379912-37991282.45782.85
6396427-39642786.04286.46
60min1407877-40787788.52789.191.8489.0789.741.84
2412519-41251989.53490.07
3400321-40032186.88787.43
4413618-41361889.77390.32
5408294-40829488.61789.15
6423014-42301491.81292.37
极限1439196-43919695.32595.341.6696.0196.031.66
2442709-44270996.08796.78
3428970-42897093.10593.79
4439009-43900995.28495.98
5435126-43512694.44195.12
6450605-45060597.80198.51
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%
113.524581204567954567804573954551454568470.25
213.504581174574614577890.11
单位质量响应值RSD%判断
33790.4633910.300.26数据可信
中间条件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%
5min172989-7298916.09117.936.2416.0917.936.25
280128-8012817.66517.66
382668-8266818.22518.22
479755-7975517.58217.58
584515-8451518.63218.63
687897-8789719.37719.38
10min1161433-16143335.58938.154.0335.6238.184.03
2174107-17410738.38338.41
3173508-17350838.25138.28
4170789-17078937.65137.68
5175742-17574238.74338.77
6182770-18277040.29340.33
15min1218154-21815448.09351.253.5348.1851.353.53
2234298-23429851.65251.75
3231830-23183051.10851.20
4232194-23219451.18951.28
5235072-23507251.82351.92
6243403-24340353.66053.76
20min1258132-25813256.90760.373.1757.0760.553.18
2277759-27775961.23461.41
3273460-27346060.28660.47
4273269-27326960.24460.42
5276155-27615560.88061.06
6284230-28423062.66062.85
30min1314977-31497769.43972.322.2069.7072.602.21
2333819-33381973.59273.87
3329107-32910772.55472.83
4326426-32642671.96372.24
5328764-32876472.47872.76
6335201-33520173.89774.19
45min1359520-35952079.25882.281.9679.6482.681.96
2380528-38052883.89084.29
3373242-37324282.28382.68
4376826-37682683.07483.47
5372460-37246082.11182.52
6376711-37671183.04883.46
60min1388097-38809785.55888.181.6486.0788.721.64
2407680-40768089.87690.42
3401334-40133488.47789.01
4402109-40210988.64789.18
5398714-39871487.89988.44
6402134-40213488.65389.21
极限1415482-41548291.59693.691.2892.2594.381.28
2431360-43136095.09695.79
3427800-42780094.31195.00
4427234-42723494.18694.87
5423471-42347193.35794.04
6424616-42461693.60994.31
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%
113.524595514575554583694589224585464585890.17
213.504582364563834573100.29
单位质量响应值RSD%判断
33919.3033874.810.10数据可信
中间条件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%
5min191474-9147420.13818.709.6420.1418.709.63
282741-8274118.21618.22
387195-8719519.19619.20
483225-8322518.32218.32
594139-9413920.72520.72
670979-7097915.62615.63
10min1190235-19023541.88138.744.9441.9138.784.93
2174174-17417438.34538.38
3176189-17618938.78838.82
4174754-17475438.47238.50
5177494-17749439.07639.11
6163076-16307635.90135.93
15min1249792-24979254.99251.853.6555.1051.953.65
2234670-23467051.66351.76
3234110-23411051.54051.64
4236696-23669652.10952.20
5235082-23508251.75451.85
6222843-22284349.05949.15
20min1291331-29133164.13760.903.1164.3361.083.11
2274897-27489760.51960.70
3277405-27740561.07161.25
4277224-27722461.03161.21
5274351-27435160.39960.58
6264673-26467358.26858.44
30min1343041-34304175.52172.522.4875.8272.802.49
2326099-32609971.79172.07
3329586-32958672.55972.84
4332250-33225073.14573.43
5327072-32707272.00672.29
6318341-31834170.08370.35
45min1383180-38318084.35882.301.5884.7982.701.59
2370700-37070081.61082.01
3374597-37459782.46882.87
4376699-37669982.93183.34
5371945-37194581.88482.29
6365821-36582180.53680.92
60min1410220-41022090.31187.991.6090.8888.531.61
2395886-39588687.15587.69
3398962-39896287.83288.37
4402943-40294388.70989.25
5398503-39850387.73188.27
6391575-39157586.20686.72
极限1435673-43567395.91493.661.6596.6394.351.66
2418782-41878292.19692.88
3425076-42507693.58194.27
4431791-43179195.06095.75
5423121-42312193.15193.84
6418279-41827992.08592.74
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