熊去氧胆酸口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号C092A240304对照品来源原料对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
113.945424054356545105440854295543620.20
214.035446454501544820.05
单位质量响应值RSD%判断
3899.713883.250.30数据可信
供试品溶液-00637A批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144906-4490682.75384.432.4982.7584.432.49
244725-4472582.41982.42
344826-4482682.60582.61
447411-4741187.36987.37
546472-4647285.63985.64
646543-4654385.77085.77
10min145831-4583184.45785.833.1584.9286.303.15
244971-4497182.87383.33
345176-4517683.25083.71
447905-4790588.27988.76
548474-4847489.32889.80
647114-4711486.82287.30
15min146802-4680286.24787.783.1087.1888.723.09
245872-4587284.53385.45
346297-4629785.31686.24
449201-4920190.66891.64
548978-4897890.25791.23
648639-4863989.63290.59
20min147332-4733287.22488.812.7588.6390.252.76
246661-4666185.98787.37
347068-4706886.73788.13
449719-4971991.62293.10
549389-4938991.01492.49
649003-4900390.30391.76
30min148414-4841489.21790.823.1091.1192.753.10
247587-4758787.69389.56
347750-4775087.99489.87
450601-5060193.24895.24
550851-5085193.70895.69
650502-5050293.06595.02
45min149381-4938190.99992.552.6593.3994.982.66
248646-4864689.64592.00
349095-4909590.47292.84
451606-5160695.10097.61
551572-5157295.03797.54
651024-5102494.02796.50
60min149876-4987691.91293.862.7194.8196.812.72
249393-4939391.02293.87
349819-4981991.80794.68
452405-5240596.57299.61
552255-5225596.29699.32
651862-5186295.57198.57
极限150511-5051193.08294.462.6596.4997.932.66
249570-4957091.34894.70
350140-5014092.39895.78
452695-5269597.106100.68
552666-5266697.053100.62
651976-5197695.78299.31
熊去氧胆酸口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号C092A240304对照品来源原料对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
113.945469054506546375453154648546020.15
214.035497755085550310.14
单位质量响应值RSD%判断
3916.933922.380.10数据可信
供试品溶液-00637A批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144320-4432081.08679.061.8981.0979.061.89
243581-4358179.73479.73
342868-4286878.42978.43
442768-4276878.24678.25
542030-4203076.89676.90
643706-4370679.96279.96
10min144976-4497682.28681.481.4682.7481.911.46
244875-4487582.10182.54
344376-4437681.18881.62
444496-4449681.40881.84
543346-4334679.30479.73
645129-4512982.56683.01
15min146009-4600984.17683.541.4285.0884.431.42
246011-4601184.17985.08
345537-4553783.31284.20
445760-4576083.72084.61
544428-4442881.28382.15
646208-4620884.54085.44
20min146899-4689985.80484.811.3787.1886.161.37
246844-4684485.70387.07
346271-4627184.65586.00
446263-4626384.64085.99
545192-4519282.68184.00
646667-4666785.38086.75
30min148077-4807787.95986.991.6089.8188.821.60
248247-4824788.27090.11
347682-4768287.23789.06
447387-4738786.69788.52
546127-4612784.39286.17
647755-4775587.37089.22
45min149070-4907089.77689.071.5492.1291.381.54
249354-4935490.29692.63
348628-4862888.96791.27
448312-4831288.38990.69
547408-4740886.73588.98
649321-4932190.23592.57
60min149753-4975391.02690.471.7793.8693.281.76
250349-5034992.11694.95
349536-4953690.62993.43
449148-4914889.91992.71
547883-4788387.60490.33
650042-5004291.55494.39
极限151119-5111993.52591.262.0796.8794.572.05
250427-5042792.25995.61
349827-4982791.16194.46
449512-4951290.58593.88
548104-4810488.00991.22
650303-5030392.03295.37
熊去氧胆酸口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号C092A240304对照品来源原料对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
113.945474954605547625484654701547330.17
214.035512355202551620.11
单位质量响应值RSD%判断
3926.333931.720.10数据可信
供试品溶液-00637A批-pH1.2(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112051-1205121.99524.489.9522.0024.489.94
214833-1483327.07327.07
314026-1402625.60025.60
412853-1285323.45923.46
511887-1188721.69621.70
614832-1483227.07127.07
10min112816-1281623.39225.9510.6023.5126.0810.59
216310-1631029.76929.92
314706-1470626.84126.98
412984-1298423.69823.83
512970-1297023.67323.79
615512-1551228.31228.46
15min114010-1401025.57128.318.8725.8228.598.89
217249-1724931.48331.80
315677-1567728.61328.90
414813-1481327.03727.30
514315-1431526.12826.38
617008-1700831.04331.35
20min114955-1495527.29630.077.9527.6930.517.97
217870-1787032.61633.11
316270-1627029.69630.15
415938-1593829.09029.50
515572-1557228.42228.82
618254-1825433.31733.80
30min115999-1599929.20133.107.9829.7533.707.98
219600-1960035.77436.45
317648-1764832.21132.83
417719-1771932.34132.91
517892-1789232.65633.21
619943-1994336.40037.06
45min117428-1742831.80935.957.5032.5236.737.49
220699-2069937.78038.65
318832-1883234.37235.17
419845-1984536.22136.97
519673-1967335.90736.64
621687-2168739.58340.45
60min118565-1856533.88538.367.6434.7739.357.60
221687-2168739.58340.66
319756-1975636.05837.04
421898-2189839.96840.92
521184-2118438.66539.60
623025-2302542.02543.11
极限137883-3788369.14472.737.5970.2273.937.55
245397-4539782.85884.16
338450-3845070.17871.36
440266-4026673.49374.67
536894-3689467.33868.49
640182-4018273.34074.66
熊去氧胆酸口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号C092A240304对照品来源原料对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
113.945487954734549945494154812548720.19
214.035488854798548430.12
单位质量响应值RSD%判断
3936.303908.980.50数据可信
供试品溶液-00637A批-pH1.2(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111528-1152821.07521.644.7921.0821.644.80
211698-1169821.38621.39
311161-1116120.40420.40
411793-1179321.56021.56
511993-1199321.92521.93
612841-1284123.47623.48
10min114265-1426526.07924.443.7926.2024.563.77
213379-1337924.45924.58
312861-1286123.51223.63
413147-1314724.03524.15
512999-1299923.76423.89
613546-1354624.76524.89
15min115739-1573928.77426.974.2629.0427.224.25
214894-1489427.22927.48
314389-1438926.30626.55
414730-1473026.92927.18
513845-1384525.31125.56
614907-1490727.25327.52
20min116918-1691830.92929.054.3031.3529.464.28
216140-1614029.50729.91
315569-1556928.46328.85
416039-1603929.32229.73
514848-1484827.14527.54
615834-1583428.94729.37
30min118271-1827133.40331.864.3734.0032.434.35
217977-1797732.86533.44
317029-1702931.13231.68
417883-1788332.69333.26
516215-1621529.64430.19
617203-1720331.45032.03
45min119537-1953735.71734.514.5236.5035.254.48
219239-1923935.17235.92
318446-1844633.72334.44
419918-1991836.41437.16
517583-1758332.14532.85
618536-1853633.88734.64
60min120435-2043537.35936.444.1838.3437.384.14
219944-1994436.46137.41
319638-1963835.90236.81
421156-2115638.67739.63
518673-1867334.13835.03
619749-1974936.10537.05
极限140972-4097274.90473.152.9476.0974.292.91
241058-4105875.06176.21
340396-4039673.85174.96
438312-3831270.04171.21
538770-3877070.87871.96
640572-4057274.17375.32
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