氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.006451316467076473366481556460216466700.19
214.116461016436576448790.27
单位质量响应值RSD%判断
46190.7145703.690.75数据可信
供试品溶液-1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%
5min1287477-28747736.30736.605.0436.3136.605.04
2294730-29473037.22337.22
3302310-30231038.18038.18
4298396-29839637.68637.69
5261757-26175733.05933.06
6293957-29395737.12537.13
10min1562008-56200870.97972.114.3171.0472.174.31
2571850-57185072.22272.28
3585935-58593574.00174.06
4599174-59917475.67375.74
5527848-52784866.66566.72
6579132-57913273.14273.20
15min1716215-71621590.45592.593.2190.6392.773.21
2726829-72682991.79591.98
3742138-74213893.72993.92
4767084-76708496.87997.07
5700840-70084088.51388.68
6745395-74539594.14094.32
20min1763849-76384996.47199.571.8996.8099.911.89
2789396-78939699.697100.03
3780800-78080098.61298.95
4807623-807623101.999102.35
5793866-793866100.262100.58
6794975-794975100.402100.74
30min1761590-76159096.18599.362.3096.6899.862.29
2772982-77298297.62498.13
3779497-77949798.44798.95
4806588-806588101.868102.39
5802611-802611101.366101.85
6796904-796904100.645101.15
45min1759860-75986095.96799.002.4296.6299.672.41
2766297-76629796.78097.44
3776595-77659598.08098.75
4804507-804507101.606102.30
5801186-801186101.186101.84
6795025-795025100.408101.08
极限1760905-76090596.09998.882.5196.9199.712.50
2761401-76140196.16296.99
3775467-77546797.93898.77
4804172-804172101.563102.42
5800881-800881101.148101.97
6794680-794680100.365101.21
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.006442346470766465476463506436046455620.24
214.116456986454216455600.04
单位质量响应值RSD%判断
46111.5745751.950.56数据可信
供试品溶液-2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%
5min1275734-27573434.83536.385.9034.8436.385.90
2292344-29234436.93436.93
3277725-27772535.08735.09
4317517-31751740.11440.11
5271536-27153634.30534.30
6293004-29300437.01737.02
10min1560801-56080170.85072.624.4270.9172.684.42
2580469-58046973.33473.40
3546199-54619969.00569.06
4617243-61724377.98078.05
5558714-55871470.58670.64
6585478-58547873.96774.03
15min1718568-71856890.78193.133.5590.9693.313.55
2752913-75291395.12095.30
3702187-70218788.71288.89
4771073-77107397.41597.61
5724080-72408091.47891.65
6754026-75402695.26195.45
20min1763748-76374896.48999.362.7496.8299.702.75
2814674-814674102.923103.27
3767359-76735996.94597.27
4808632-808632102.160102.52
5774584-77458497.85898.19
6789683-78968399.766100.11
30min1766379-76637996.82299.402.6597.3199.902.65
2814498-814498102.901103.41
3768320-76832097.06797.55
4808331-808331102.122102.65
5773661-77366197.74298.23
6789639-78963999.760100.27
45min1766372-76637296.82199.392.6797.47100.052.67
2816063-816063103.098103.78
3768492-76849297.08897.73
4806935-806935101.945102.64
5773605-77360597.73498.39
6788615-78861599.631100.31
极限1764016-76401696.52399.102.6797.3399.942.67
2811482-811482102.520103.38
3765478-76547896.70897.51
4806531-806531101.894102.76
5771309-77130997.44498.26
6787836-78783699.532100.37
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