西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.171884071886831884641886821887121885900.08
213.241889221887181888200.08
单位质量响应值RSD%判断
14319.6714261.330.29数据可信
供试品溶液-2022030401批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1199590-19959097.78096.970.8197.7896.980.81
2199161-19916197.57097.57
3196358-19635896.19796.20
4199116-19911697.54897.55
5195801-19580195.92495.92
6197644-19764496.82796.83
10min1201110-20111098.52597.870.7098.6998.040.69
2200674-20067498.31198.47
3198153-19815397.07697.24
4201100-20110098.52098.68
5198212-19821297.10597.27
6199422-19942297.69897.86
15min1200498-20049898.22597.640.6098.5597.960.60
2200089-20008998.02598.35
3197573-19757396.79297.11
4200245-20024598.10198.43
5198245-19824597.12297.44
6199134-19913497.55797.88
20min1200843-20084398.39497.560.7198.8998.040.72
2199906-19990697.93598.43
3197305-19730596.66197.14
4200269-20026998.11398.60
5197916-19791696.96097.44
6198553-19855397.27297.76
30min1199701-19970197.83597.350.6998.4998.000.69
2199459-19945997.71698.37
3196852-19685296.43997.08
4200141-20014198.05098.70
5197248-19724896.63397.28
6198814-19881497.40098.05
45min1199608-19960897.78997.370.7298.6198.180.72
2200377-20037798.16698.98
3197065-19706596.54397.35
4199946-19994697.95598.77
5197298-19729896.65897.46
6198247-19824797.12297.93
极限1199426-19942697.70097.180.7598.6898.150.75
2199712-19971297.84098.82
3196530-19653096.28197.25
4199770-19977097.86998.85
5196773-19677396.40097.37
6197922-19792296.96397.94
西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.171890081882751884391886471887141886170.15
213.241886011888211887110.09
单位质量响应值RSD%判断
14321.7214253.100.34数据可信
供试品溶液-2022030401批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1198154-19815497.09899.241.4997.1099.241.49
2205508-205508100.702100.70
3201562-20156298.76898.77
4204629-204629100.271100.27
5200202-20020298.10298.10
6205051-205051100.478100.48
10min1200199-20019998.100100.091.4398.26100.251.43
2206858-206858101.363101.53
3203286-20328699.61399.78
4206145-206145101.014101.18
5201850-20185098.90999.07
6207201-207201101.531101.70
15min1199631-19963197.82299.981.3898.15100.311.38
2206366-206366101.122101.46
3203048-20304899.49699.83
4205682-205682100.787101.12
5202486-20248699.22199.55
6206989-206989101.427101.76
20min1199126-19912697.57499.641.4498.06100.131.44
2206271-206271101.076101.58
3202003-20200398.98499.48
4205194-205194100.548101.05
5201415-20141598.69699.19
6205992-205992100.939101.44
30min1199309-19930997.66499.601.3898.32100.271.38
2205454-205454100.675101.35
3202220-20222099.09099.75
4204934-204934100.420101.09
5201194-20119498.58899.25
6206482-206482101.179101.85
45min1199062-19906297.54399.591.4198.36100.421.41
2206187-206187101.034101.88
3202064-20206499.01499.84
4204604-204604100.259101.10
5201412-20141298.69599.52
6206106-206106100.995101.84
极限1199011-19901197.51899.441.4198.49100.441.41
2205092-205092100.498101.51
3201744-20174498.85799.85
4205036-205036100.470101.48
5200672-20067298.33299.32
6206036-206036100.960101.97
西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.171892791887511890771889901889451890080.11
213.241891751887591889670.16
单位质量响应值RSD%判断
14351.4014272.430.40数据可信
供试品溶液-2022030501批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1200211-20021197.93897.861.2597.9497.861.25
2200694-20069498.17498.17
3199889-19988997.78197.78
4200173-20017397.92097.92
5195809-19580995.78595.78
6203592-20359299.59299.59
10min1202036-20203698.83198.911.2198.9999.071.21
2202209-20220998.91699.08
3201501-20150198.56998.73
4203139-20313999.37199.53
5198360-19836097.03397.19
6205885-205885100.714100.88
15min1201452-20145298.54598.701.1698.8799.031.16
2202272-20227298.94699.27
3201542-20154298.58998.92
4202465-20246599.04199.37
5197837-19783796.77797.10
6205049-205049100.305100.64
20min1201090-20109098.36898.521.1298.8699.011.12
2201924-20192498.77699.27
3200830-20083098.24198.73
4202569-20256999.09299.59
5197606-19760696.66497.15
6204357-20435799.966100.47
30min1200689-20068998.17298.281.1798.8398.941.17
2201193-20119398.41999.08
3200465-20046598.06298.72
4201918-20191898.77399.43
5196996-19699696.36697.01
6204175-20417599.877100.54
45min1199979-19997997.82598.031.1598.6498.851.15
2200804-20080498.22899.05
3200157-20015797.91298.73
4201226-20122698.43599.26
5196555-19655596.15096.95
6203636-20363699.614100.45
极限1199436-19943697.55997.861.1698.5498.841.17
2199774-19977497.72498.71
3199585-19958597.63298.61
4201044-20104498.34699.33
5196691-19669196.21697.18
6203787-20378799.687100.69
西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.171890931889401887851890341886991889100.09
213.241908651905611907130.12
单位质量响应值RSD%判断
14343.9614404.310.30数据可信
供试品溶液-2022030501批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1202616-20261698.68597.531.2698.6997.531.26
2202394-20239498.57798.58
3202375-20237598.56898.57
4199151-19915196.99897.00
5197219-19721996.05796.06
6197704-19770496.29396.29
10min1204318-20431899.51498.580.9699.6898.740.96
2204246-20424699.47999.64
3203701-20370199.21499.38
4200362-20036297.58897.75
5200129-20012997.47497.63
6201689-20168998.23498.39
15min1204457-20445799.58298.620.9799.9198.950.97
2204168-20416899.44199.77
3203838-20383899.28199.61
4200691-20069197.74898.07
5199810-19981097.31997.64
6201935-20193598.35498.68
20min1204260-20426099.48698.530.9899.9899.020.98
2204181-20418199.44899.94
3203745-20374599.23599.73
4200470-20047097.64098.13
5200018-20001897.42097.90
6201116-20111697.95598.44
30min1204260-20426099.48698.440.97100.1599.100.97
2203803-20380399.26399.93
3203501-20350199.11699.78
4200718-20071897.76198.41
5199811-19981197.31997.97
6200626-20062697.71698.37
45min1203400-20340099.06798.200.9299.9099.030.92
2203599-20359999.16499.99
3202809-20280998.77999.61
4199820-19982097.32498.14
5199633-19963397.23298.04
6200519-20051997.66498.48
极限1203749-20374999.23798.391.01100.2399.371.01
2203729-20372999.227100.22
3203825-20382599.274100.26
4200022-20002297.42298.40
5199406-19940697.12298.09
6201319-20131998.05499.03
西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.171898211896601897781896301900491897880.09
213.241902311900071901190.09
单位质量响应值RSD%判断
14410.6314359.440.26数据可信
供试品溶液-2022030601批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1203178-20317898.88497.530.8298.8897.530.82
2199176-19917696.93696.94
3198572-19857296.64296.64
4201086-20108697.86697.87
5200501-20050197.58197.58
6199830-19983097.25597.25
10min1204783-20478399.66598.480.8999.8398.640.89
2200613-20061397.63697.80
3200213-20021397.44197.60
4203186-20318698.88899.05
5203537-20353799.05999.22
6201754-20175498.19198.35
15min1204729-20472999.63998.370.8599.9798.700.85
2200811-20081197.73298.06
3200163-20016397.41797.74
4202298-20229898.45698.78
5203422-20342299.00399.33
6201325-20132597.98298.31
20min1203799-20379999.18698.230.7799.6898.720.77
2200310-20031097.48897.98
3200000-20000097.33797.82
4202281-20228198.44798.94
5203260-20326098.92499.42
6201385-20138598.01198.50
30min1204017-20401799.29298.090.9799.9598.740.97
2199987-19998797.33197.98
3199461-19946197.07597.72
4202113-20211398.36699.02
5203525-20352599.05399.71
6200199-20019997.43498.09
45min1203294-20329498.94097.890.8699.7798.710.86
2200029-20002997.35198.16
3198710-19871096.70997.52
4201711-20171198.17098.99
5202652-20265298.62899.45
6200428-20042897.54698.36
极限1203295-20329598.94197.940.8299.9398.920.82
2199611-19961197.14898.12
3199310-19931097.00197.97
4201931-20193198.27799.26
5202685-20268598.64499.63
6200609-20060997.63498.61
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