氢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%
114.856838166858046858766857786859926854530.14
214.776857296872456864870.16
单位质量响应值RSD%判断
46158.4546478.470.49数据可信
供试品溶液-H043批-枸橼酸盐溶液（pH3.0）
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1248743-24874331.16325.1521.9631.1625.1521.96
2191450-19145023.98523.99
3162073-16207320.30520.30
10min1267854-26785433.55732.492.8933.6132.532.91
2253958-25395831.81631.86
3256103-25610332.08532.12
15min1466480-46648058.44155.865.0558.5555.955.06
2421849-42184952.85052.94
3449284-44928456.28756.37
20min1542253-54225367.93466.382.0568.1466.572.06
2522308-52230865.43565.62
3525049-52504965.77965.96
30min1630599-63059979.00278.121.4279.3278.421.43
2613652-61365276.87977.17
3626363-62636378.47178.76
45min1697365-69736587.36786.501.2787.8286.931.28
2680605-68060585.26785.69
3693355-69335586.86487.29
极限1745294-74529493.37192.881.1193.9793.461.12
2731921-73192191.69692.26
3746915-74691593.57494.14
氢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%
114.856857986868216859366864146862816862500.06
214.776882446886446884440.05
单位质量响应值RSD%判断
46212.1246610.970.61数据可信
供试品溶液-H043批-枸橼酸盐溶液（pH3.5）
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1185661-18566123.21322.353.7723.2122.353.77
2178420-17842022.30822.31
3172221-17222121.53321.53
10min1255120-25512031.89831.800.2831.9431.840.28
2253768-25376831.72931.77
3254091-25409131.76931.81
15min1403564-40356450.45851.033.4150.5551.123.40
2423700-42370052.97653.07
3397091-39709149.64949.74
20min1513102-51310264.15463.930.4464.3364.110.44
2508842-50884263.62163.80
3512084-51208464.02664.20
30min1587331-58733173.43474.210.9573.7274.490.95
2598282-59828274.80475.09
3594991-59499174.39274.67
45min1675057-67505784.40384.500.2584.8184.910.24
2674758-67475884.36584.77
3677730-67773084.73785.14
极限1710579-71057988.84489.981.1089.3990.531.09
2724154-72415490.54291.09
3724276-72427690.55791.10
氢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%
114.856850516866246867896861786868186862920.11
214.776870506869156869820.02
单位质量响应值RSD%判断
46214.9546511.980.46数据可信
供试品溶液-H043批-枸橼酸盐溶液（pH3.8）
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1220568-22056827.60625.956.5327.6125.956.54
2193548-19354824.22424.22
3207969-20796926.02926.03
10min1152012-15201219.02628.1428.6519.0728.1828.61
2248152-24815231.05931.10
3274313-27431334.33334.38
15min1453792-45379256.79655.362.8856.8755.452.85
2444593-44459355.64555.74
3428620-42862053.64653.75
20min1391263-39126348.97060.2616.8849.1460.4416.85
2504207-50420763.10663.29
3548945-54894568.70668.90
30min1612739-61273976.69076.480.2876.9476.760.24
2611015-61101576.47476.76
3609389-60938976.27176.58
45min1565373-56537370.76281.1511.6171.1481.5611.59
2667500-66750083.54483.96
3712206-71220689.13989.57
极限1735758-73575892.08791.360.7992.5991.900.75
2729716-72971691.33191.89
3724260-72426090.64891.23
氢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%
114.856864816876876881296880266884036877450.11
214.776855436871346863380.17
单位质量响应值RSD%判断
46312.7946468.380.24数据可信
供试品溶液-H043批-枸橼酸盐溶液（pH4.0）
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1193740-19374024.23425.069.3224.2325.069.31
2185852-18585223.24723.25
3221366-22136627.69027.69
10min1253564-25356431.71730.723.1031.7630.763.11
2238412-23841229.82229.86
3244703-24470330.60930.65
15min1441659-44165955.24555.142.4155.3455.232.42
2429832-42983253.76653.85
3451010-45101056.41556.51
20min1536249-53624967.07763.215.5167.2663.395.50
2482303-48230360.32960.51
3497413-49741362.21962.41
30min1624230-62423078.08276.691.6378.3876.981.64
2605004-60500475.67775.96
3609963-60996376.29776.59
45min1707692-70769288.52283.864.9088.9584.284.89
2645928-64592880.79681.20
3657618-65761882.25882.68
极限1744118-74411893.07891.971.0693.6592.531.07
2729759-72975991.28291.82
3731967-73196791.55892.12
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