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%
114.095697457166575285785357852574750.70
214.155801757889579530.16
单位质量响应值RSD%判断
4079.134095.620.29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%
5min128909-2890950.92450.461.2750.9250.461.27
228588-2858850.35950.36
328162-2816249.60849.61
429201-2920151.43851.44
528578-2857850.34150.34
628449-2844950.11450.11
10min130038-3003852.91353.771.8553.0053.851.84
231575-3157555.62055.70
330216-3021653.22653.31
430515-3051553.75353.84
530151-3015153.11253.20
630640-3064053.97354.06
15min130972-3097254.55854.002.2754.7354.172.26
231771-3177155.96656.14
330604-3060453.91054.08
430713-3071354.10254.28
529976-2997652.80452.98
629886-2988652.64552.82
20min130677-3067754.03854.451.6054.3054.711.59
231270-3127055.08355.35
330217-3021753.22853.49
431544-3154455.56655.83
530606-3060653.91354.17
631137-3113754.84955.11
30min131211-3121154.97954.930.8855.3355.280.88
231590-3159055.64756.01
331066-3106654.72455.07
431260-3126055.06555.42
530754-3075454.17454.52
631205-3120554.96855.32
45min131271-3127155.08555.121.6255.5355.571.61
231744-3174455.91856.37
330459-3045953.65454.10
431834-3183456.07656.53
531035-3103554.66955.11
631401-3140155.31455.76
60min131602-3160255.66855.321.8556.2155.861.84
231316-3131655.16455.71
330559-3055953.83154.36
432321-3232156.93457.48
531487-3148755.46556.00
631154-3115454.87955.42
极限131133-3113354.84255.301.5655.4755.931.55
232301-3230156.89957.54
331033-3103354.66655.29
430989-3098954.58855.23
531439-3143955.38156.00
631464-3146455.42556.05
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%
114.095613956078559415591156758561650.62
214.155666356197564300.59
单位质量响应值RSD%判断
3986.163987.990.04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%
5min128974-2897452.32251.791.5552.3251.791.54
228968-2896852.31152.31
329262-2926252.84252.84
428391-2839151.26951.27
528314-2831451.13051.13
628180-2818050.88850.89
10min130677-3067755.39854.911.6255.4855.001.62
231011-3101156.00156.09
330445-3044554.97955.07
429852-2985253.90853.99
529791-2979153.79853.88
630681-3068155.40555.49
15min131001-3100155.98355.140.9556.1655.320.95
230706-3070655.45055.63
330580-3058055.22255.40
430232-3023254.59454.77
530377-3037754.85655.03
630305-3030554.72654.90
20min130637-3063755.32555.170.9155.6055.440.91
230799-3079955.61855.89
330541-3054155.15255.42
430096-3009654.34854.61
530406-3040654.90855.17
630841-3084155.69455.96
30min129987-2998754.15255.801.8554.5256.161.84
231740-3174057.31757.68
331040-3104056.05356.42
430689-3068955.41955.78
530870-3087055.74656.10
631073-3107356.11356.47
45min130637-3063755.32555.721.4255.7856.181.41
231053-3105356.07756.54
331034-3103456.04256.50
430070-3007054.30154.75
531064-3106456.09656.55
631271-3127156.47056.93
60min131545-3154556.96556.130.9057.5156.680.89
231144-3114456.24156.80
331039-3103956.05156.60
431159-3115956.26856.81
530741-3074155.51356.06
630871-3087155.74856.30
极限131146-3114656.24555.751.2056.8956.391.19
230388-3038854.87655.52
331276-3127656.47957.12
430445-3044554.97955.61
531039-3103956.05156.69
630931-3093155.85656.50
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