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110755-202306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%
113.865306552834529285293652683528890.27
213.935200452247521260.33
单位质量响应值RSD%判断
3815.953742.001.39数据可信
供试品溶液-2025121851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%
5min127042-2704251.32153.653.3651.3253.653.36
227382-2738251.96751.97
328350-2835053.80453.80
429401-2940155.79855.80
528216-2821653.54953.55
629223-2922355.46155.46
10min135658-3565867.67368.742.6467.9669.042.64
235229-3522966.85967.15
335735-3573567.81968.12
436651-3665169.55869.87
536155-3615568.61668.91
637906-3790671.94072.25
15min141130-4113078.05877.572.6778.7278.252.66
239664-3966475.27675.94
339835-3983575.60176.28
440760-4076077.35678.05
541166-4116678.12778.81
642666-4266680.97381.68
20min143616-4361682.77683.191.6883.8784.301.69
242955-4295581.52282.60
343344-4334482.26083.36
443920-4392083.35384.48
544098-4409883.69184.80
645085-4508585.56486.72
30min148187-4818791.45188.832.5093.0190.402.48
245483-4548386.32087.85
345694-4569486.72088.27
446927-4692789.06090.65
546411-4641188.08189.66
648134-4813491.35192.98
45min149932-4993294.76392.172.4996.8394.242.47
247335-4733589.83491.85
347796-4779690.70992.74
447856-4785690.82392.91
548256-4825691.58293.65
650213-5021395.29697.44
60min150213-5021395.29692.702.6597.8995.282.63
247328-4732889.82192.33
347659-4765990.44992.99
448575-4857592.18894.78
548830-4883092.67295.25
650479-5047995.80198.47
极限150892-5089296.58594.572.3199.7097.672.30
248719-4871992.46195.47
348949-4894992.89795.94
448972-4897292.94196.04
549990-4999094.87397.96
651473-5147397.688100.89
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110755-202306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%
113.865236952679525295255152358524970.26
213.935257052800526850.31
单位质量响应值RSD%判断
3787.663782.120.11数据可信
供试品溶液-b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%
5min131298-3129859.30062.374.1659.3062.374.16
231071-3107158.87058.87
333657-3365763.77063.77
433724-3372463.89763.90
534244-3424464.88264.88
633506-3350663.48463.48
10min133395-3339563.27369.244.9563.6069.594.94
235931-3593168.07868.41
337496-3749671.04371.40
436496-3649669.14969.50
537260-3726070.59670.96
638693-3869373.31173.66
15min135689-3568967.62072.093.6168.3072.823.61
237237-3723770.55371.26
338307-3830772.58073.33
438615-3861573.16373.90
539305-3930574.47175.22
639151-3915174.17974.94
20min135941-3594168.09773.063.5969.1574.193.59
238195-3819572.36873.46
339109-3910974.09975.25
438999-3899973.89175.04
539757-3975775.32776.49
639351-3935174.55875.73
30min137845-3784571.70575.192.7473.1476.732.76
239345-3934574.54776.05
340243-4024376.24877.81
439391-3939174.63476.19
540899-4089977.49179.08
640397-4039776.54078.13
45min138780-3878073.47677.042.4275.3178.992.43
241287-4128778.22680.14
341015-4101577.71179.70
440512-4051276.75878.73
541506-4150678.64180.66
640852-4085277.40279.41
60min139219-3921974.30878.563.0876.5580.943.08
240874-4087477.44479.79
341924-4192479.43381.85
441661-4166178.93581.33
542806-4280681.10483.56
642286-4228680.11982.56
极限140076-4007675.93278.722.8378.5981.542.82
240233-4023376.22979.01
341714-4171479.03581.90
442651-4265180.81083.65
542847-4284781.18284.08
641752-4175279.10781.99
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110755-202306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%
113.865249552705528605303653008528210.43
213.935297653124530500.20
单位质量响应值RSD%判断
3811.043808.330.06数据可信
供试品溶液-2025121851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%
5min134013-3401364.02571.445.8364.0271.445.83
237266-3726670.14870.15
339461-3946174.28074.28
440226-4022675.72075.72
538945-3894573.30973.31
637809-3780971.17071.17
10min142487-4248779.97678.642.1080.3379.032.08
242379-4237979.77380.16
342743-4274380.45880.87
441302-4130277.74578.17
541150-4115077.45977.87
640591-4059176.40776.80
15min144127-4412783.06381.433.5183.8682.263.48
244360-4436083.50284.33
344817-4481784.36285.22
443470-4347081.82682.68
541535-4153578.18479.02
641243-4124377.63478.45
20min145097-4509784.88983.542.5786.1584.832.56
245013-4501384.73186.03
345261-4526185.19886.53
444890-4489084.49985.81
543647-4364782.15983.43
642379-4237979.77381.02
30min145848-4584886.30384.624.6188.0486.384.56
247057-4705788.57890.35
346424-4642487.38789.19
445127-4512784.94586.72
543930-4393082.69284.42
641350-4135077.83679.53
45min148328-4832890.97189.763.3093.1891.983.28
248727-4872791.72293.98
349605-4960593.37595.66
447395-4739589.21591.46
546904-4690488.29090.48
645143-4514384.97587.10
60min148196-4819690.72290.043.2493.4492.763.22
249128-4912892.47795.25
349194-4919492.60195.41
447412-4741289.24791.99
548076-4807690.49693.17
644993-4499384.69387.29
极限149263-4926392.73192.523.4095.9595.743.37
250708-5070895.45198.73
351379-5137996.714100.03
448518-4851891.32894.57
548175-4817590.68393.86
646870-4687088.22691.30
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110755-202306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%
113.865221452023521825276952288522950.54
213.935295052595527720.48
单位质量响应值RSD%判断
3773.093788.370.29数据可信
供试品溶液-b批-pH1.2(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12476-24764.6964.986.914.704.986.85
22659-26595.0445.04
32954-29545.6035.60
42662-26625.0495.05
52477-24774.6984.70
62528-25284.7954.80
10min13672-36726.9657.165.086.997.195.11
23887-38877.3737.40
34110-41107.7967.83
43717-37177.0507.08
53698-36987.0147.04
63578-35786.7876.81
15min14592-45928.7108.924.138.778.984.15
24819-48199.1419.21
35006-50069.4959.57
44715-47158.9439.01
54631-46318.7848.85
64448-44488.4378.50
20min15295-529510.04310.343.5310.1610.463.54
25561-556110.54810.67
35749-574910.90511.03
45487-548710.40810.52
55404-540410.25010.36
65215-52159.89210.00
30min16628-662812.57212.754.0512.7412.934.07
26716-671612.73912.92
37195-719513.64713.84
46719-671912.74412.92
56731-673112.76712.94
66351-635112.04612.21
45min17891-789114.96815.533.9615.2115.773.95
28438-843816.00516.25
38678-867816.46016.72
48223-822315.59715.84
58032-803215.23515.48
67859-785914.90715.14
60min19122-912217.30217.583.2717.6217.913.30
29474-947417.97018.31
39756-975618.50518.86
49260-926017.56417.90
59091-909117.24417.57
68914-891416.90817.22
极限110993-1099320.85121.555.4021.2721.985.34
212498-1249823.70624.14
311562-1156221.93122.39
411292-1129221.41821.85
510981-1098120.82921.25
610847-1084720.57420.98
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