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)1.5补液体积(ml)1.5
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(%)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%
114.095652856893563625684756957567170.46
214.155584355815558290.04
单位质量响应值RSD%判断
4025.343945.511.42数据可信
供试品溶液-00287A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%
5min126688-2668848.21947.264.7648.2247.264.76
226431-2643147.75547.75
326680-2668048.20448.20
424544-2454444.34544.35
527788-2778850.20650.21
624799-2479944.80644.81
10min135013-3501363.26062.834.5963.3462.914.59
234730-3473062.74962.83
335905-3590564.87264.95
432502-3250258.72358.80
536948-3694866.75666.84
633545-3354560.60860.68
15min140147-4014772.53671.294.4272.7271.474.42
239130-3913070.69970.88
340084-4008472.42272.61
437197-3719767.20667.38
542126-4212676.11276.31
638051-3805168.74968.92
20min143261-4326178.16278.135.4378.4778.435.42
243142-4314277.94778.25
344013-4401379.52179.83
440444-4044473.07373.36
547198-4719885.27685.60
641393-4139374.78775.08
30min146297-4629783.64884.724.5584.0885.154.55
247104-4710485.10685.54
348273-4827387.21887.66
443704-4370478.96379.37
549958-4995890.26290.73
645998-4599883.10883.52
45min149090-4909088.69490.794.1089.2791.364.10
249977-4997790.29790.87
351969-5196993.89694.48
447776-4777686.32086.86
553377-5337796.44097.05
649313-4931389.09789.65
60min150972-5097292.09492.203.9192.8292.933.91
251549-5154993.13793.86
353573-5357396.79497.54
448052-4805286.81987.50
552483-5248394.82495.60
649565-4956589.55290.25
极限152481-5248194.82196.544.1795.7097.424.17
253846-5384697.28798.17
355708-55708100.651101.56
450864-5086491.89992.72
556242-56242101.616102.55
651438-5143892.93693.79
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)1.5补液体积(ml)1.5
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(%)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%
114.095626956254565815596956536563220.44
214.155651456317564160.25
单位质量响应值RSD%判断
3997.303987.000.19数据可信
供试品溶液-00287A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%
5min125737-2573746.41843.237.4146.4243.227.41
225817-2581746.56246.56
321975-2197539.63339.63
425058-2505845.19345.19
523020-2302041.51841.52
622197-2219740.03340.03
10min132902-3290259.34056.295.7959.4256.365.79
232842-3284259.23259.31
328808-2880851.95652.02
432681-3268158.94259.02
530083-3008354.25654.33
629956-2995654.02754.09
15min137593-3759367.80164.306.2567.9864.466.25
237309-3730967.28867.46
331910-3191057.55157.70
437347-3734767.35767.53
534542-3454262.29862.46
635209-3520963.50163.66
20min141057-4105774.04869.216.5774.3469.496.57
240035-4003572.20572.49
334351-3435161.95362.20
440123-4012372.36472.65
537817-3781768.20568.47
636874-3687466.50466.77
30min145547-4554782.14676.046.1982.5676.436.19
243879-4387979.13879.55
337996-3799668.52768.88
442961-4296177.48277.89
541194-4119474.29574.67
641381-4138174.63275.01
45min148496-4849687.46581.996.5288.0182.506.51
248083-4808386.72087.26
340333-4033372.74273.21
446210-4621083.34283.88
544658-4465880.54381.04
644971-4497181.10781.60
60min150023-5002390.21984.937.4690.9185.587.44
247932-4793286.44787.13
340696-4069673.39773.98
447002-4700284.77085.44
550412-5041290.92091.56
646492-4649283.85084.48
极限152175-5217594.10089.106.0494.9589.906.04
250488-5048891.05791.89
343692-4369278.80079.51
448929-4892988.24689.06
550745-5074591.52192.31
650390-5039090.88191.65
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)1.5补液体积(ml)1.5
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(%)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%
114.095610256506565075592555598561280.70
214.155623556868565520.80
单位质量响应值RSD%判断
3983.533996.610.24数据可信
供试品溶液-00287A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%
5min144387-4438780.09682.143.8780.1082.143.87
244698-4469880.65780.66
348639-4863987.76887.77
445053-4505381.29781.30
543877-4387779.17579.18
646467-4646783.84983.85
10min148329-4832987.20987.852.9987.3487.992.99
247375-4737585.48785.62
351211-5121192.40992.56
447596-4759685.88686.02
548058-4805886.72086.85
649547-4954789.40789.55
15min149656-4965689.60389.392.5489.8889.672.55
248270-4827087.10287.38
351590-5159093.09393.39
448779-4877988.02188.30
548600-4860087.69887.97
650328-5032890.81691.10
20min151133-5113392.26991.152.3992.7091.582.39
249640-4964089.57590.00
352343-5234394.45294.91
449588-4958889.48189.91
549266-4926688.90089.32
651098-5109892.20692.65
30min149299-4929988.95992.712.7789.5493.292.77
250423-5042390.98791.56
353377-5337796.31896.93
451277-5127792.52993.10
551606-5160693.12293.69
652275-5227594.32994.92
45min150688-5068891.46694.372.5492.2095.102.54
251207-5120792.40293.13
353848-5384897.16897.94
452323-5232394.41695.14
551848-5184893.55994.28
653857-5385797.18497.94
60min152239-5223994.26496.473.0695.1597.363.05
251307-5130792.58393.46
355832-55832100.748101.68
453992-5399297.42898.31
552932-5293295.51596.40
654456-5445698.26599.18
极限151689-5168993.27295.853.3494.3196.903.33
251132-5113292.26793.30
355701-55701100.512101.61
452715-5271595.12396.17
552703-5270395.10296.14
654763-5476398.81999.90
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)1.5补液体积(ml)1.5
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(%)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%
114.095535655603550735524955688553940.46
214.155645256646565490.25
单位质量响应值RSD%判断
3931.443996.401.16数据可信
供试品溶液-00287A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%
5min146129-4612983.79485.994.2583.7986.004.25
245750-4575083.10583.11
347054-4705485.47485.47
451041-5104192.71692.72
548096-4809687.36787.37
645972-4597283.50883.51
10min148204-4820487.56390.193.8787.7090.333.87
248330-4833087.79287.93
349639-4963990.17090.31
452473-5247395.31895.47
551450-5145093.45993.60
647806-4780686.84086.98
15min149094-4909489.18092.173.6389.4792.463.63
249360-4936089.66389.95
350559-5055991.84192.13
453584-5358497.33697.65
552347-5234795.08995.39
649484-4948489.88890.17
20min148826-4882688.69392.744.5589.1393.184.55
248840-4884088.71889.15
351573-5157393.68394.13
454540-5454099.07299.55
552772-5277295.86196.32
649758-4975890.38690.82
30min150113-5011391.03194.474.2191.6195.074.20
249489-4948989.89790.48
352205-5220594.83195.43
455311-55311100.473101.11
553600-5360097.36597.98
651325-5132593.23293.82
45min151566-5156693.67096.504.0694.4097.264.06
251181-5118192.97193.70
353466-5346697.12197.88
456310-56310102.287103.10
554937-5493799.793100.58
651270-5127093.13293.87
60min151490-5149093.53298.053.5694.4298.963.56
255121-55121100.128101.01
353923-5392397.95198.87
456523-56523102.674103.65
554769-5476999.488100.44
652022-5202294.49895.39
极限151557-5155793.65496.693.8194.7097.773.81
251673-5167393.86494.92
352558-5255895.47296.56
456708-56708103.010104.16
554585-5458599.154100.27
652285-5228594.97696.03
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