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%
114.686738916732056742086732966740706737340.07
214.576729176728896729030.01
单位质量响应值RSD%判断
45894.6946184.150.45数据可信
供试品溶液-2025011021批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1251153-25115331.65529.8710.9531.6629.8710.94
2279791-27979135.26535.26
3208990-20899026.34126.34
4235700-23570029.70829.71
5232216-23221629.26929.27
6214134-21413426.99026.99
10min1541036-54103668.19266.624.1268.2566.684.13
2563286-56328670.99771.06
3503939-50393963.51763.56
4527671-52767166.50866.56
5527087-52708766.43466.48
6508573-50857364.10164.15
15min1717520-71752090.43690.482.1390.6090.642.14
2735843-73584392.74692.92
3700440-70044088.28488.43
4720054-72005490.75690.92
5732919-73291992.37792.54
6700259-70025988.26188.41
20min1783203-78320398.71599.311.3099.0399.621.30
2790277-79027799.60799.94
3772891-77289197.41597.71
4790443-79044399.62899.94
5803900-803900101.324101.64
6786603-78660399.14499.44
30min1787457-78745799.25199.761.2899.73100.241.28
2789244-78924499.47799.97
3775336-77533697.72498.18
4793382-79338299.998100.48
5803986-803986101.335101.82
6799565-799565100.777101.24
45min1787076-78707699.20399.651.3399.85100.291.33
2788410-78841099.371100.03
3773403-77340397.48098.10
4792071-79207199.833100.48
5803120-803120101.225101.88
6799444-799444100.762101.39
极限1784233-78423398.84599.171.0099.6699.981.00
2786735-78673599.16099.99
3773599-77359997.50598.29
4790574-79057499.644100.45
5788585-78858599.393100.21
6797322-797322100.495101.29
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%
114.686871476859226857826857826864816862230.09
214.576727856732076729960.05
单位质量响应值RSD%判断
46745.4446190.530.85数据可信
供试品溶液-2025011021批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1255222-25522231.87230.994.3631.8730.994.36
2251454-25145431.40231.40
3229577-22957728.67028.67
4252004-25200431.47131.47
5259093-25909332.35632.36
6241617-24161730.17330.17
10min1539352-53935267.35567.621.9867.4167.671.99
2539580-53958067.38367.44
3526131-52613165.70465.75
4555933-55593369.42569.48
5551304-55130468.84768.90
6536514-53651467.00067.05
15min1726123-72612390.67991.321.4390.8491.481.44
2723303-72330390.32790.49
3726281-72628190.69990.86
4747545-74754593.35493.52
5741194-74119492.56192.73
6722997-72299790.28990.45
20min1788842-78884298.51198.771.5698.8399.091.55
2778686-77868697.24397.56
3791053-79105398.78899.10
4809811-809811101.130101.45
5799320-79932099.820100.14
6777809-77780997.13497.45
30min1791176-79117698.80399.411.3899.2899.891.38
2787830-78783098.38598.86
3806151-806151100.673101.15
4810204-810204101.179101.67
5798915-79891599.769100.26
6782037-78203797.66298.14
45min1790585-79058598.72998.941.2799.3799.591.27
2787649-78764998.36299.00
3789536-78953698.59899.24
4808357-808357100.948101.61
5798590-79859099.729100.38
6779165-77916597.30397.94
极限1790749-79074998.75098.931.5299.5699.741.52
2786164-78616498.17798.98
3787346-78734698.32599.13
4812996-812996101.528102.36
5797562-79756299.600100.42
6778156-77815697.17797.98
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%
114.686739546744616742596737466742886741420.05
214.576732306739116735700.08
单位质量响应值RSD%判断
45922.4846229.920.48数据可信
供试品溶液-2025011121批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1263713-26371333.21231.984.4033.2131.984.41
2242529-24252930.54430.54
3239073-23907330.10930.11
4251652-25165231.69331.69
5262886-26288633.10833.11
6263501-26350133.18533.19
10min1541640-54164068.21468.311.7768.2768.361.77
2536053-53605367.51067.56
3528733-52873366.58966.64
4541835-54183568.23968.29
5554218-55421869.79869.85
6552017-55201769.52169.58
15min1727289-72728991.59591.961.6391.7692.131.62
2738381-73838192.99293.15
3734254-73425492.47292.63
4720919-72091990.79290.96
5714033-71403389.92590.10
6746409-74640994.00394.17
20min1787723-78772399.20699.272.1499.5399.592.13
2800670-800670100.836101.15
3806926-806926101.624101.94
4774982-77498297.60197.92
5762430-76243096.02096.34
6796496-796496100.311100.64
30min1788997-78899799.36699.562.2599.85100.052.25
2800819-800819100.855101.34
3806379-806379101.555102.04
4776129-77612997.74698.23
5763558-76355896.16296.64
6807465-807465101.692102.19
45min1787409-78740999.16699.052.1999.8299.702.18
2799608-799608100.702101.36
3805147-805147101.400102.05
4769809-76980996.95097.59
5761902-76190295.95496.60
6795213-795213100.149100.81
极限1785099-78509998.87598.842.0699.6999.652.05
2796685-796685100.334101.16
3801510-801510100.942101.76
4771453-77145397.15797.96
5760026-76002695.71896.52
6793904-79390499.984100.82
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%
114.686719956716046717206719896719846718580.03
214.576732866736046734450.04
单位质量响应值RSD%判断
45766.8946221.350.70数据可信
供试品溶液-2025011121批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1262801-26280133.15732.946.9233.1632.946.92
2281973-28197335.57535.58
3237163-23716329.92229.92
4273607-27360734.52034.52
5241417-24141730.45930.46
6269703-26970334.02734.03
10min1559128-55912870.54368.874.7770.6068.934.77
2570904-57090472.02972.09
3535972-53597267.62267.67
4550290-55029069.42869.49
5498489-49848962.89262.94
6560476-56047670.71370.77
15min1747133-74713394.26392.432.9794.4492.602.97
2754168-75416895.15195.33
3739670-73967093.32193.48
4733070-73307092.48992.66
5692378-69237887.35587.51
6729034-72903491.97992.15
20min1798452-798452100.73899.872.07101.07100.192.07
2795745-795745100.396100.73
3815100-815100102.838103.16
4792396-79239699.974100.30
5767460-76746096.82897.13
6780145-78014598.42898.76
30min1800158-800158100.953100.291.67101.45100.781.66
2796246-796246100.459100.96
3815376-815376102.873103.36
4796326-796326100.469100.96
5782807-78280798.76499.23
6778295-77829598.19598.69
45min1800198-800198100.958100.211.71101.62100.871.71
2793669-793669100.134100.81
3815844-815844102.932103.59
4796279-796279100.464101.12
5779298-77929898.32198.95
6780463-78046398.46899.12
极限1799263-799263100.84099.881.58101.67100.711.58
2790555-79055599.741100.58
3812142-812142102.465103.30
4788935-78893599.537100.37
5780589-78058998.48499.27
6778622-77862298.23699.06
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