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对照品来源中检所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%
113.855335253861536155397953795537200.46
213.905393954389541640.59
单位质量响应值RSD%判断
3878.703896.690.33数据可信
供试品溶液-00637A批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1478-4780.8821.0614.470.881.0614.32
2492-4920.9080.91
3565-5651.0421.04
4702-7021.2951.29
5615-6151.1341.13
6599-5991.1051.10
10min1673-6731.2411.178.611.251.178.63
2664-6641.2251.23
3615-6151.1341.14
4529-5290.9760.98
5659-6591.2161.22
6654-6541.2061.21
15min1657-6571.2121.1611.101.221.1711.07
2681-6811.2561.27
3635-6351.1711.18
4488-4880.9000.91
5647-6471.1931.21
6650-6501.1991.21
20min1549-5491.0131.1611.551.031.1711.46
2632-6321.1661.18
3544-5441.0031.02
4620-6201.1441.16
5710-7101.3101.33
6706-7061.3021.32
30min1597-5971.1011.1316.541.131.1616.01
2794-7941.4651.49
3521-5210.9610.99
4582-5821.0741.10
5664-6641.2251.25
6532-5320.9811.01
45min1685-6851.2641.198.381.291.228.12
2673-6731.2411.27
3700-7001.2911.32
4574-5741.0591.09
5642-6421.1841.22
6581-5811.0721.10
60min1689-6891.2711.2410.121.311.289.77
2664-6641.2251.27
3558-5581.0291.07
4670-6701.2361.27
5667-6671.2301.27
6770-7701.4201.46
极限1724-7241.3351.2313.411.381.2813.09
2780-7801.4391.49
3675-6751.2451.29
4655-6551.2081.25
5660-6601.2171.26
6513-5130.9460.99
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对照品来源中检所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%
113.855373054149544035392654693541800.71
213.905397854643543100.87
单位质量响应值RSD%判断
3911.913907.190.09数据可信
供试品溶液-00637A批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1621-6211.1391.2711.981.141.2712.10
2683-6831.2531.25
3626-6261.1481.15
4692-6921.2691.27
5848-8481.5551.56
6671-6711.2311.23
10min1613-6131.1241.147.251.131.147.29
2554-5541.0161.02
3688-6881.2621.27
4636-6361.1671.17
5597-5971.0951.10
6636-6361.1671.17
15min1616-6161.1301.205.251.141.215.25
2658-6581.2071.22
3620-6201.1371.15
4681-6811.2491.26
5637-6371.1681.18
6701-7011.2861.30
20min1698-6981.2801.257.621.301.277.37
2700-7001.2841.30
3684-6841.2551.27
4732-7321.3431.36
5582-5821.0681.09
6705-7051.2931.31
30min1700-7001.2841.1811.611.311.2111.30
2693-6931.2711.30
3525-5250.9630.99
4601-6011.1021.13
5722-7221.3241.35
6626-6261.1481.18
45min1644-6441.1811.228.381.211.268.15
2735-7351.3481.38
3666-6661.2221.25
4672-6721.2331.27
5712-7121.3061.34
6575-5751.0551.09
60min1774-7741.4201.299.261.461.348.95
2712-7121.3061.35
3786-7861.4421.48
4633-6331.1611.20
5638-6381.1701.21
6690-6901.2661.31
极限1658-6581.2071.1814.091.251.2213.55
2751-7511.3781.43
3672-6721.2331.28
4479-4790.8790.93
5670-6701.2291.28
6620-6201.1371.18
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)5补液体积(ml)5
对照品批号110755-202306对照品来源中检所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%
113.855309153660537595328353636534860.54
213.905349553547535210.07
单位质量响应值RSD%判断
3861.813850.430.21数据可信
供试品溶液-00287A批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1635-6351.1811.3218.591.181.3218.50
2607-6071.1291.13
3828-8281.5401.54
4850-8501.5811.58
5791-7911.4711.47
6536-5360.9971.00
10min1656-6561.2201.129.301.231.139.36
2582-5821.0821.09
3527-5270.9800.99
4676-6761.2571.27
5567-5671.0541.06
6604-6041.1231.13
15min1537-5370.9991.0910.331.011.1010.23
2603-6031.1211.13
3580-5801.0791.09
4698-6981.2981.31
5550-5501.0231.04
6544-5441.0121.02
20min1546-5461.0151.169.911.031.1810.00
2562-5621.0451.06
3708-7081.3171.34
4629-6291.1701.19
5620-6201.1531.17
6668-6681.2421.26
30min1657-6571.2221.2111.391.251.2311.34
2661-6611.2291.25
3595-5951.1071.13
4763-7631.4191.45
5673-6731.2521.28
6546-5461.0151.04
45min1704-7041.3091.148.931.341.178.59
2636-6361.1831.21
3562-5621.0451.08
4563-5631.0471.08
5586-5861.0901.12
6633-6331.1771.21
60min1480-4800.8931.049.330.931.089.06
2641-6411.1921.23
3556-5561.0341.07
4573-5731.0661.11
5565-5651.0511.09
6539-5391.0021.04
极限1547-5471.0171.1012.441.061.1511.98
2481-4810.8950.94
3645-6451.2001.24
4566-5661.0531.10
5667-6671.2401.29
6654-6541.2161.26
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对照品来源中检所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%
113.855314853306536205330353182533120.35
213.905450154349544250.20
单位质量响应值RSD%判断
3849.243915.471.21数据可信
供试品溶液-00287A批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1554-5541.0231.086.121.021.086.04
2593-5931.0951.10
3540-5400.9981.00
4593-5931.0951.10
5572-5721.0571.06
6641-6411.1841.18
10min1956-9561.7661.2622.971.771.2722.98
2626-6261.1561.16
3734-7341.3561.36
4638-6381.1791.18
5481-4810.8890.89
6668-6681.2341.24
15min1483-4830.8921.038.360.911.058.11
2609-6091.1251.14
3600-6001.1081.12
4555-5551.0251.04
5577-5771.0661.08
6534-5340.9861.00
20min1610-6101.1271.0510.781.151.0710.63
2546-5461.0091.03
3568-5681.0491.07
4493-4930.9110.93
5533-5330.9851.00
6667-6671.2321.25
30min1583-5831.0771.159.461.101.179.29
2675-6751.2471.27
3534-5340.9861.01
4603-6031.1141.14
5653-6531.2061.23
6684-6841.2641.29
45min1690-6901.2751.0910.141.311.1210.01
2548-5481.0121.04
3532-5320.9831.01
4628-6281.1601.19
5600-6001.1081.14
6554-5541.0231.06
60min1743-7431.3731.2011.681.411.2411.41
2698-6981.2891.33
3550-5501.0161.05
4648-6481.1971.23
5683-6831.2621.30
6569-5691.0511.09
极限1590-5901.0901.0811.421.141.1211.05
2546-5461.0091.05
3652-6521.2041.25
4475-4750.8770.92
5597-5971.1031.14
6648-6481.1971.24
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