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MAD-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(%)94.94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%
114.884491414510764502654521484523284509920.30
214.884521544525214523380.06
单位质量响应值RSD%判断
30308.6030399.060.22数据可信
供试品溶液-24020202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%
5min1307123-30712358.65146.6037.3958.6546.6037.39
2277506-27750652.99553.00
365366-6536612.48312.48
4293818-29381856.11056.11
5288376-28837655.07155.07
6231938-23193844.29344.29
10min1483443-48344392.32392.621.2292.4292.691.21
2473944-47394490.50990.60
3488842-48884293.35493.37
4489975-48997593.57193.66
5485509-48550992.71892.81
6488148-48814893.22293.30
15min1520663-52066399.43199.790.8899.68100.020.88
2523349-52334999.944100.18
3525703-525703100.393100.57
4528949-528949101.013101.26
5520906-52090699.47799.72
6515636-51563698.47198.70
20min1521477-52147799.586100.221.05100.00100.621.05
2531405-531405101.482101.89
3526964-526964100.634100.98
4529872-529872101.190101.61
5521975-52197599.682100.09
6517138-51713898.75899.15
30min1521171-52117199.52899.880.94100.11100.440.93
2524277-524277100.121100.70
3528422-528422100.913101.42
4528122-528122100.855101.44
5520258-52025899.35499.93
6515775-51577598.49899.06
45min1521928-52192899.67399.760.99100.42100.490.98
2522415-52241599.766100.51
3528210-528210100.872101.55
4527730-527730100.781101.54
5519280-51928099.16799.91
6514613-51461398.27699.00
60min1519342-51934299.17999.680.77100.09100.570.76
2522345-52234599.752100.66
3527451-527451100.727101.58
4525522-525522100.359101.28
5520228-52022899.348100.26
6516757-51675798.68599.57
极限1539043-539043102.941100.131.61104.02101.191.60
2521373-52137399.567100.64
3526216-526216100.491101.51
4525412-525412100.338101.43
5519678-51967899.243100.32
6514139-51413998.18599.24
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MAD-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(%)94.94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%
114.884521264522484520454530684522344523440.10
214.884510784514424512600.06
单位质量响应值RSD%判断
30399.4630326.610.17数据可信
供试品溶液-24012201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%
5min152494-5249410.02228.7336.8910.0228.7336.89
2211723-21172340.42040.42
3125969-12596924.04924.05
4166517-16651731.79031.79
5182400-18240034.82234.82
6163870-16387031.28531.28
10min1218873-21887341.78571.1221.6241.8071.1721.63
2455877-45587787.03287.10
3371401-37140170.90570.94
4390542-39054274.55974.61
5406735-40673577.65177.71
6391808-39180874.80174.85
15min1351929-35192967.18792.1513.3367.2792.3213.35
2514711-51471198.26498.48
3508097-50809797.00297.16
4507161-50716196.82397.00
5514707-51470798.26498.45
6499477-49947795.35695.53
20min1441436-44143684.27596.336.1984.4796.656.24
2515957-51595798.50298.88
3523194-52319499.884100.20
4519041-51904199.09199.43
5517820-51782098.85899.21
6509985-50998597.36297.70
30min1498859-49885995.23898.011.6995.5898.491.74
2516316-51631698.57199.11
3524343-524343100.103100.59
4517111-51711198.72399.23
5514595-51459598.24298.76
6508967-50896797.16897.67
45min1506912-50691296.77698.151.1097.2798.801.14
2515208-51520898.35999.06
3522905-52290599.829100.48
4515848-51584898.48299.15
5514741-51474198.27098.95
6509170-50917097.20797.87
60min1510180-51018097.39998.041.0598.0698.851.06
2512631-51263197.86798.74
3522855-52285599.819100.64
4515217-51521798.36199.19
5513168-51316897.97098.81
6507114-50711496.81497.64
极限1512021-51202197.75198.090.8698.5799.060.87
2515214-51521498.36099.39
3520782-52078299.423100.41
4514621-51462198.24799.24
5512622-51262297.86698.87
6507435-50743596.87597.86
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