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)10补液体积(ml)10
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(%)100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%
113.585384153778539135366254019538430.26
213.605455154681546160.17
单位质量响应值RSD%判断
3964.874015.880.91数据可信
供试品溶液-25052101批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136042-3604265.03563.213.0565.0363.213.05
232962-3296259.47759.48
335414-3541463.90263.90
435037-3503763.22163.22
535472-3547264.00664.01
635262-3526263.62763.63
10min137404-3740467.49265.193.5168.2165.893.51
233713-3371360.83261.49
336690-3669066.20466.91
436200-3620065.32066.02
536120-3612065.17565.89
636633-3663366.10166.81
15min137126-3712666.99166.133.5268.4667.563.51
234061-3406161.46062.80
337510-3751067.68469.13
436807-3680766.41567.84
537203-3720367.13068.56
637199-3719967.12268.56
20min137985-3798568.54166.503.8870.7668.663.87
234008-3400861.36563.38
337348-3734867.39169.59
437042-3704266.83969.01
537494-3749467.65569.84
637232-3723267.18269.37
30min138068-3806868.69066.503.6471.6769.403.63
234274-3427461.84464.55
337662-3766267.95870.90
437286-3728667.27970.19
536817-3681766.43369.37
637015-3701566.79069.72
45min138168-3816868.87166.834.1572.6170.474.11
233976-3397661.30764.70
337364-3736467.42071.12
437415-3741567.51271.17
537406-3740667.49671.17
637894-3789468.37672.05
极限137912-3791268.40966.903.5772.9271.283.57
234417-3441762.10366.17
337623-3762367.88772.34
437261-3726167.23471.64
537504-3750467.67372.09
637732-3773268.08472.52
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)10补液体积(ml)10
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(%)100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%
113.585436954053541715430454375542540.26
213.605484255118549800.36
单位质量响应值RSD%判断
3995.144042.650.84数据可信
供试品溶液-25052301批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135429-3542963.47563.091.0063.4763.081.00
235525-3552563.64763.65
335138-3513862.95362.95
435313-3531363.26763.27
535320-3532063.27963.28
634545-3454561.89161.89
10min137155-3715566.56766.470.9867.2767.180.98
237146-3714666.55167.26
336969-3696966.23466.93
437652-3765267.45768.16
537169-3716966.59267.30
636530-3653065.44766.13
15min138016-3801668.10967.981.2069.5569.421.20
238257-3825768.54169.99
337644-3764467.44368.88
438237-3823768.50569.96
538327-3832768.66770.11
637167-3716766.58868.00
20min138228-3822868.48968.350.9470.6970.540.94
238362-3836268.72970.94
338401-3840168.79970.98
438238-3823868.50770.72
538235-3823568.50270.71
637433-3743367.06569.22
30min138332-3833268.67669.090.9771.6472.040.96
238613-3861369.17972.15
338860-3886069.62272.57
438831-3883169.57072.54
538812-3881269.53672.50
637915-3791567.92970.83
45min138463-3846368.91069.330.8872.6473.060.87
239057-3905769.97573.72
338821-3882169.55273.27
438887-3888769.67073.42
538833-3883369.57373.31
638136-3813668.32471.98
极限139048-3904869.95869.931.1074.4574.421.08
239203-3920370.23674.75
339438-3943870.65775.15
439259-3925970.33674.86
539025-3902569.91774.43
638217-3821768.47072.88
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)10补液体积(ml)10
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(%)100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%
113.585452254052540595391854398541900.48
213.605413554214541740.11
单位质量响应值RSD%判断
3990.433983.380.13数据可信
供试品溶液-25052302批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134646-3464662.56861.922.4262.5761.922.42
234623-3462362.52662.53
335334-3533463.81063.81
434069-3406961.52661.53
534185-3418561.73561.74
632866-3286659.35359.35
10min136427-3642765.78465.572.4166.4866.262.41
236730-3673066.33167.03
337520-3752067.75868.47
436131-3613165.24965.93
536184-3618465.34566.03
634862-3486262.95863.62
15min137148-3714867.08667.082.3168.5168.502.31
237660-3766068.01169.44
338251-3825169.07870.54
436940-3694066.71068.12
537198-3719867.17668.59
635683-3568364.44065.80
20min137783-3778368.23367.872.3370.4070.032.33
238095-3809568.79670.98
338764-3876470.00472.23
437376-3737667.49869.65
537319-3731967.39569.55
636160-3616065.30267.38
30min138387-3838769.32469.092.5472.2572.002.53
238969-3896970.37573.33
339444-3944471.23274.24
437975-3797568.58071.48
538149-3814968.89471.80
636616-3661666.12568.93
45min138571-3857169.65669.852.3473.3673.532.34
239161-3916170.72174.46
339966-3996672.17575.97
438540-3854069.60073.26
538609-3860969.72573.40
637216-3721667.20970.74
极限138615-3861569.73570.332.3274.2174.792.32
239545-3954571.41575.93
340091-4009172.40177.00
438901-3890170.25274.69
539072-3907270.56175.01
637441-3744167.61571.90
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)10补液体积(ml)10
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(%)100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%
113.585402754132541675399554197541040.17
213.605415454474543140.42
单位质量响应值RSD%判断
3984.093993.680.18数据可信
供试品溶液-25052101批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157389-57389103.58893.3510.52103.5993.3510.52
253445-5344596.46996.47
353827-5382797.15997.16
452674-5267495.07895.08
551601-5160193.14193.14
641364-4136474.66374.66
10min159170-59170106.80394.7910.79107.9595.8310.79
254275-5427597.96799.04
353897-5389797.28598.36
453681-5368196.89597.95
552030-5203093.91594.95
642051-4205175.90376.73
15min158434-58434105.47494.8410.48107.8196.9310.49
254706-5470698.745100.91
353530-5353096.62398.78
454090-5409097.63399.77
552384-5238494.55496.63
642117-4211776.02277.69
20min158942-58942106.39195.4810.40109.9098.6310.41
254875-5487599.050102.31
353889-5388997.271100.50
454017-5401797.502100.72
553189-5318996.00799.14
642481-4248176.67979.20
30min159092-59092106.66295.6010.68111.3599.8010.67
254659-5465998.660103.02
354365-5436598.130102.44
454441-5444198.267102.57
552976-5297695.62399.82
642234-4223476.23379.60
45min159441-59441107.29295.7111.28113.17100.9811.24
254773-5477398.866104.32
354772-5477298.864104.27
454596-5459698.547103.94
552908-5290895.500100.76
641672-4167275.21979.44
极限159211-59211106.87795.2411.16113.95101.5711.13
254456-5445698.294104.85
354152-5415297.745104.25
454413-5441398.216104.70
552732-5273295.182101.50
641624-4162475.13280.18
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)10补液体积(ml)10
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(%)100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%
113.585429254086543405423354220542340.18
213.605440654135542700.36
单位质量响应值RSD%判断
3993.673990.440.06数据可信
供试品溶液-25052301批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155404-5540499.92699.371.3299.9399.371.32
254155-5415597.67397.67
354661-5466198.58698.59
455458-55458100.023100.02
556185-56185101.334101.33
654700-5470098.65698.66
10min157586-57586103.861102.561.24104.97103.671.24
256699-56699102.261103.35
356495-56495101.893102.99
456363-56363101.655102.77
557891-57891104.411105.54
656167-56167101.302102.40
15min158779-58779106.013103.621.57108.28105.871.56
256952-56952102.718104.94
356679-56679102.225104.45
457108-57108102.999105.24
558393-58393105.317107.60
656811-56811102.463104.69
20min158442-58442105.405103.041.58108.85106.441.56
257175-57175103.120106.48
356420-56420101.758105.12
456363-56363101.655105.04
557978-57978104.568108.02
656414-56414101.747105.11
30min159229-59229106.824104.761.77111.44109.301.75
257521-57521103.744108.25
356996-56996102.797107.29
458262-58262105.080109.60
559337-59337107.019111.64
657157-57157103.087107.58
45min159076-59076106.548104.571.65112.35110.271.63
257447-57447103.610109.27
356711-56711102.283107.92
457617-57617103.917109.60
559136-59136106.657112.46
657879-57879104.390110.03
极限158532-58532105.567104.311.12112.55111.181.14
257512-57512103.728110.54
357375-57375103.481110.25
457475-57475103.661110.50
558786-58786106.025113.02
657333-57333103.405110.20
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