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%
114.476660326665856658356656936641536656600.14
214.546665836669596667710.04
单位质量响应值RSD%判断
46002.7645857.700.23数据可信
加速2月-供试品溶液-24030401-PVC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%
5min1356541-35654145.04537.0622.6445.0537.0622.64
2334453-33445342.25442.25
3320032-32003240.43340.43
4245245-24524530.98430.98
5181539-18153922.93522.94
6322371-32237140.72840.73
10min1650158-65015882.14069.9319.4482.2269.9919.44
2629444-62944479.52379.59
3604853-60485376.41676.48
4460913-46091358.23158.28
5380841-38084148.11548.15
6594949-59494975.16575.23
15min1801934-801934101.31590.8614.53101.5391.0414.55
2791146-79114699.953100.16
3773098-77309897.67297.87
4653638-65363882.58082.73
5535573-53557367.66467.78
6759682-75968295.97796.17
20min1827755-827755104.57898.289.14104.9698.629.17
2831353-831353105.032105.40
3812087-812087102.598102.96
4738433-73843393.29393.58
5650192-65019282.14582.38
6807849-807849102.063102.42
30min1829709-829709104.825102.572.24105.38103.072.30
2830403-830403104.912105.46
3819358-819358103.517104.05
4799733-799733101.037101.48
5784077-78407799.05999.43
6808133-808133102.099102.62
45min1828570-828570104.681103.181.28105.41103.841.31
2830143-830143104.879105.60
3815012-815012102.968103.67
4812555-812555102.657103.27
5808240-808240102.112102.65
6805482-805482101.764102.46
极限1824243-824243104.134103.081.13105.04103.921.17
2828915-828915104.724105.62
3816623-816623103.171104.04
4812190-812190102.611103.39
5808094-808094102.094102.80
6805457-805457101.761102.62
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%
114.476674706670246668876671696677626672620.06
214.546645026646606645810.02
单位质量响应值RSD%判断
46113.4845707.080.63数据可信
加速2月-供试品溶液-G031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%
5min1195956-19595624.76824.037.5424.7724.037.54
2216939-21693927.42027.42
3182962-18296223.12623.13
4180739-18073922.84522.84
5181396-18139622.92822.93
6182498-18249823.06723.07
10min1402965-40296550.93352.983.2050.9753.023.21
2426665-42666553.92953.97
3424453-42445353.64953.69
4403301-40330150.97651.01
5421006-42100653.21353.25
6436395-43639555.15955.20
15min1590464-59046474.63276.831.9974.7676.961.99
2616666-61666677.94478.08
3617104-61710477.99978.13
4596420-59642075.38575.51
5607364-60736476.76876.90
6619177-61917778.26178.39
20min1724350-72435091.55592.881.0091.8193.141.00
2741469-74146993.71993.98
3738046-73804693.28693.54
4727876-72787692.00192.25
5734947-73494792.89493.15
6742281-74228193.82194.08
30min1794349-794349100.403100.680.30100.81101.100.30
2798084-798084100.875101.30
3793631-793631100.312100.73
4799923-799923101.107101.51
5797149-797149100.756101.17
6796133-796133100.628101.05
45min1795261-795261100.518100.580.14101.09101.160.14
2795791-795791100.585101.17
3794233-794233100.388100.97
4796056-796056100.618101.19
5797621-797621100.816101.39
6795737-795737100.578101.16
极限1795369-795369100.531100.430.21101.27101.170.21
2794979-794979100.482101.24
3791998-791998100.105100.85
4796746-796746100.706101.44
5794677-794677100.444101.19
6793426-793426100.286101.04
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%
114.473332393337583334543338393333983335380.08
214.543328903326863327880.05
单位质量响应值RSD%判断
23050.3122887.760.51数据可信
加速2月-供试品溶液-G246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%
5min1124435-12443531.43727.2211.8331.4427.2211.84
2122010-12201030.82430.82
394579-9457923.89423.89
4104333-10433326.35826.36
596024-9602424.25924.26
6105008-10500826.52926.53
10min1256962-25696264.91860.737.6164.9760.777.62
2257827-25782765.13765.19
3220477-22047755.70155.74
4249788-24978863.10663.15
5215730-21573054.50154.54
6241454-24145461.00061.04
15min1345658-34565887.32685.703.4887.4985.853.48
2346946-34694687.65287.81
3332526-33252684.00884.14
4351926-35192688.91089.06
5319582-31958280.73880.87
6338789-33878985.59185.74
20min1392555-39255599.17498.471.9199.4898.761.92
2392029-39202999.04199.35
3385841-38584197.47897.75
4399072-399072100.820101.12
5377229-37722995.30295.57
6391951-39195199.02199.31
30min1402534-402534101.695100.951.37102.17101.411.38
2397272-397272100.366100.84
3398204-398204100.601101.04
4406536-406536102.706103.17
5390759-39075998.72099.14
6402283-402283101.632102.09
45min1399847-399847101.016100.631.32101.66101.261.32
2396252-396252100.108100.75
3397097-397097100.322100.92
4405189-405189102.366103.00
5389950-38995098.51699.11
6401616-401616101.463102.09
极限1401049-401049101.320100.571.27102.13101.361.28
2395468-39546899.910100.72
3396271-396271100.113100.88
4404220-404220102.121102.93
5390232-39023298.58799.34
6401152-401152101.346102.14
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