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%
113.705408853432537365347653064535590.72
2 13.775321753224532200.01
单位质量响应值RSD%判断
3909.423864.920.81数据可信
供试品溶液-240003A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%
5min128751-2875153.25651.623.9153.2651.623.92
229142-2914253.98053.98
327909-2790951.69651.70
428240-2824052.30952.31
526421-2642148.94048.94
626730-2673049.51249.51
10min133037-3303761.19558.474.5261.2858.564.51
233300-3330061.68261.77
331360-3136058.08858.17
431698-3169858.71458.80
529854-2985455.29955.38
630161-3016155.86755.95
15min134695-3469564.26661.833.2664.4662.013.26
234496-3449663.89764.09
333415-3341561.89562.08
433306-3330661.69361.88
532322-3232259.87060.04
632039-3203959.34659.52
20min135400-3540065.57263.492.8065.8763.782.80
235123-3512365.05965.36
334444-3444463.80164.09
434389-3438963.69963.99
533307-3330761.69561.97
632997-3299761.12161.40
30min135941-3594166.57464.792.4666.9865.182.46
235878-3587866.45766.86
335018-3501864.86465.26
435013-3501364.85565.25
534221-3422163.38863.76
633808-3380862.62363.00
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%
113.705354553328531105319553390533140.32
2 13.775479254637547140.21
单位质量响应值RSD%判断
3891.533973.421.48数据可信
供试品溶液-00287A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%
5min129992-2999254.91954.610.9354.9254.610.93
229612-2961254.22354.22
329581-2958154.16654.17
430271-3027155.42955.43
529615-2961554.22854.23
629857-2985754.67154.67
10min133232-3323260.85160.550.6060.9460.640.60
233049-3304960.51660.61
332943-3294360.32260.41
433380-3338061.12261.21
532885-3288560.21660.31
632925-3292560.28960.38
15min133882-3388262.04261.740.5262.2361.940.52
233804-3380461.89962.09
333921-3392162.11362.30
433642-3364261.60261.80
533577-3357761.48361.67
633494-3349461.33161.52
20min133930-3393062.12962.050.5762.4362.340.57
233778-3377861.85162.15
334118-3411862.47462.77
434083-3408362.41062.71
533759-3375961.81662.11
633636-3363661.59161.88
30min133694-3369461.69762.160.6462.1062.560.63
233859-3385961.99962.40
334290-3429062.78963.19
434055-3405562.35862.76
533788-3378861.86962.27
634010-3401062.27662.67
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%
113.705378153514538495369753862537410.27
2 13.775328953281532850.02
单位质量响应值RSD%判断
3922.703869.640.97数据可信
供试品溶液-25030602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%
5min132904-3290460.80859.542.0060.8159.542.00
232296-3229659.68559.68
331472-3147258.16258.16
431939-3193959.02559.02
533020-3302061.02361.02
631664-3166458.51758.52
10min136904-3690468.20166.481.3868.3066.581.38
235901-3590166.34766.45
335578-3557865.75065.85
436111-3611166.73566.83
535669-3566965.91866.02
635689-3568965.95566.05
15min137169-3716968.69068.230.4968.9168.440.49
236775-3677567.96268.17
336946-3694668.27868.48
437048-3704868.46768.68
536895-3689568.18468.40
636676-3667667.77967.99
20min137719-3771969.70768.211.9270.0468.541.92
237254-3725468.84769.17
336341-3634167.16067.48
437542-3754269.38069.70
535932-3593266.40466.73
636674-3667467.77668.10
30min136594-3659467.62865.547.4068.0765.977.36
233366-3336661.66262.10
337476-3747669.25869.69
438918-3891871.92372.36
534348-3434863.47763.91
632072-3207259.27159.70
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