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%
114.636764396747096759416768396756616759180.13
214.696741546740876741200.01
单位质量响应值RSD%判断
46200.8245889.720.48数据可信
供试品溶液-2025011221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%
5min1237754-23775429.96330.433.3529.9630.433.35
2250167-25016731.52731.53
3251227-25122731.66131.66
4230166-23016629.00729.01
5241525-24152530.43830.44
6237749-23774929.96229.96
10min1488722-48872261.59163.883.1861.6463.933.18
2514361-51436164.82264.87
3531119-53111966.93466.99
4509057-50905764.15464.20
5508867-50886764.13064.18
6489284-48928461.66261.71
15min1673334-67333484.85787.512.9085.0187.672.90
2714368-71436890.02890.19
3719738-71973890.70590.87
4684488-68448886.26286.42
5699936-69993688.20988.37
6674335-67433584.98385.14
20min1770347-77034797.08398.682.2797.3898.982.28
2795091-795091100.201100.51
3807891-807891101.814102.13
4783664-78366498.76199.06
5783711-78371198.76799.07
6757472-75747295.46095.75
30min1789107-78910799.447100.051.5799.90100.521.57
2802345-802345101.115101.59
3809364-809364102.000102.48
4799483-799483100.754101.22
5788496-78849699.37099.84
6774469-77446997.60298.06
45min1787941-78794199.30099.851.7099.92100.481.70
2802888-802888101.183101.83
3807585-807585101.775102.43
4799010-799010100.695101.33
5785103-78510398.94299.58
6771325-77132597.20697.82
极限1784381-78438198.85199.601.5699.64100.401.57
2800108-800108100.833101.65
3805275-805275101.484102.31
4796675-796675100.401101.20
5782404-78240498.60299.40
6773062-77306297.42598.20
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%
114.636750536760416758066766046764906759990.10
214.696766076769036767550.04
单位质量响应值RSD%判断
46206.3646069.090.22数据可信
供试品溶液-2025011221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%
5min1228160-22816028.69629.954.8628.7029.954.86
2221457-22145727.85327.85
3249992-24999231.44231.44
4239497-23949730.12230.12
5239540-23954030.12730.13
6250238-25023831.47331.47
10min1468811-46881158.96362.554.3859.0162.604.38
2482935-48293560.73960.79
3519840-51984065.38165.43
4487228-48722861.27961.33
5524279-52427965.93965.99
6500771-50077162.98263.03
15min1640007-64000780.49485.564.1580.6485.714.15
2674483-67448384.83084.98
3705623-70562388.74788.91
4659866-65986682.99283.14
5715341-71534189.96990.13
6686325-68632586.32086.48
20min1765635-76563596.29498.321.8996.5798.611.90
2776596-77659697.67397.96
3797163-797163100.260100.57
4764673-76467396.17396.46
5795706-795706100.077100.39
6790460-79046099.41799.72
30min1813110-813110102.265101.031.17102.71101.501.16
2795878-795878100.098100.55
3813463-813463102.310102.79
4796409-796409100.165100.62
5792805-79280599.712100.19
6808237-808237101.653102.12
45min1815029-815029102.507101.111.41103.12101.741.40
2794197-79419799.887100.51
3815038-815038102.508103.15
4795541-795541100.056100.67
5791374-79137499.532100.17
6812229-812229102.155102.79
极限1810137-810137101.892101.191.04102.67101.981.04
2798870-798870100.474101.26
3812092-812092102.137102.96
4794975-79497599.985100.77
5797446-797446100.295101.10
6813652-813652102.334103.14
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