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%
114.556690806681056684516680496685206684410.07
214.536680266671786676020.09
单位质量响应值RSD%判断
45940.9645946.460.01数据可信
供试品溶液-24042601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%
5min1329882-32988241.66541.047.4641.6641.047.46
2367112-36711246.36746.37
3305105-30510538.53538.54
4331047-33104741.81241.81
5299990-29999037.88937.89
6316282-31628239.94739.95
10min1624891-62489178.92580.375.7578.9980.435.75
2697252-69725288.06488.14
3611468-61146877.22977.29
4663183-66318383.76183.83
5619541-61954178.24978.31
6601453-60145375.96476.03
15min1773658-77365897.714100.994.8997.92101.204.89
2836214-836214105.615105.84
3781400-78140098.69298.88
4851701-851701107.571107.78
5805567-805567101.744101.94
6749115-74911594.61494.81
20min1791585-79158599.978105.205.25100.34105.575.25
2847875-847875107.088107.49
3830448-830448104.887105.24
4891117-891117112.549112.94
5861863-861863108.855109.22
6774677-77467797.84398.19
30min1790815-79081599.881105.155.24100.41105.705.23
2845271-845271106.759107.34
3831401-831401105.007105.54
4889702-889702112.371112.95
5863553-863553109.068109.61
6774518-77451897.82398.34
45min1790816-79081699.881105.045.23100.58105.765.22
2844559-844559106.669107.43
3829896-829896104.817105.52
4888928-888928112.273113.04
5862228-862228108.901109.63
6773484-77348497.69298.37
60min1786484-78648499.334104.505.17100.20105.405.16
2842284-842284106.382107.32
3823437-823437104.001104.88
4883877-883877111.635112.59
5857023-857023108.243109.15
6771279-77127997.41498.25
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%
114.553276363273503275303275613272823274720.05
214.533276583275423276000.03
单位质量响应值RSD%判断
22506.6722546.460.13数据可信
供试品溶液-24050201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%
5min1232156-23215659.80357.828.8659.8057.828.86
2235814-23581460.74560.74
3239281-23928161.63861.64
4216314-21631455.72255.72
5235721-23572160.72160.72
6187400-18740048.27448.27
10min1382514-38251498.53496.504.2198.6396.594.22
2384825-38482599.13099.23
3384856-38485699.13899.24
4363556-36355693.65193.74
5384622-38462299.07799.18
6347293-34729389.46289.54
15min1413801-413801106.594104.801.71106.86105.061.71
2398989-398989102.778103.04
3411741-411741106.063106.33
4397542-397542102.405102.65
5407804-407804105.049105.32
6411144-411144105.909106.14
20min1414507-414507106.776104.901.82107.22105.341.81
2398485-398485102.648103.09
3410725-410725105.801106.25
4397824-397824102.478102.90
5408138-408138105.135105.58
6413782-413782106.589106.99
30min1413770-413770106.586104.761.93107.21105.371.93
2397603-397603102.421103.03
3411630-411630106.035106.66
4396379-396379102.106102.70
5407405-407405104.946105.56
6413295-413295106.463107.05
45min1412861-412861106.352104.651.93107.15105.431.93
2397598-397598102.420103.20
3410833-410833105.829106.63
4395331-395331101.836102.60
5407855-407855105.062105.85
6413028-413028106.395107.16
60min1411940-411940106.114104.431.89107.09105.381.88
2396582-396582102.158103.11
3409910-409910105.591106.57
4395316-395316101.832102.76
5406248-406248104.648105.61
6412361-412361106.223107.16
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%
114.556675406680496675916681176681656678920.05
214.536680316685166682740.06
单位质量响应值RSD%判断
45903.2345992.700.14数据可信
供试品溶液-24042601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%
5min1249024-24902431.44932.7812.2231.4532.7812.22
2299595-29959537.83637.84
3216414-21641427.33127.33
4277374-27737435.03035.03
5233841-23384129.53229.53
6281264-28126435.52135.52
10min1510622-51062264.48667.668.5864.5467.728.59
2582648-58264873.58373.65
3478928-47892860.48460.53
4571924-57192472.22872.29
5495258-49525862.54662.60
6575199-57519972.64272.70
15min1693330-69333087.56189.184.7787.7289.354.79
2750415-75041594.77094.96
3668180-66818084.38484.53
4717820-71782090.65390.83
5672348-67234884.91185.06
6734918-73491892.81392.99
20min1785734-78573499.23096.932.2899.5497.242.27
2785818-78581899.24199.58
3769987-76998797.24297.53
4739845-73984593.43593.76
5764506-76450696.54996.84
6759077-75907795.86496.20
30min1792538-792538100.09097.722.85100.5698.202.83
2784866-78486699.12199.63
3790792-79079299.869100.32
4735320-73532092.86493.35
5778016-77801698.25698.71
6761224-76122496.13596.63
45min1786751-78675199.35997.132.57100.0097.772.55
2779268-77926898.41499.09
3782950-78295098.87999.49
4736807-73680793.05193.69
5775755-77575597.97098.59
6753218-75321895.12495.78
60min1788681-78868199.60397.222.60100.4198.022.57
2776661-77666198.08498.92
3786979-78697999.388100.17
4737355-73735593.12193.92
5774254-77425497.78198.56
6755011-75501195.35096.16
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%
114.553258383258733257113257803256423257690.03
214.533257523264613261060.16
单位质量响应值RSD%判断
22389.6222443.630.18数据可信
供试品溶液-24050201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%
5min1239147-23914761.90651.9221.7261.9151.9221.72
2237113-23711361.37961.38
3190899-19089949.41649.42
4166337-16633743.05843.06
5135417-13541735.05435.05
6234464-23446460.69360.69
10min1370563-37056395.92488.6010.8096.0388.6810.81
2374755-37475597.00997.11
3342504-34250488.66188.74
4311361-31136180.59980.67
5285019-28501973.78073.84
6369382-36938295.61895.72
15min1392604-392604101.630101.152.83101.89101.382.85
2401610-401610103.961104.22
3400476-400476103.667103.90
4388297-388297100.515100.72
5371099-37109996.06396.24
6390309-390309101.035101.30
20min1393644-393644101.899102.701.95102.33103.101.95
2400958-400958103.792104.23
3407065-407065105.373105.78
4401906-401906104.037104.41
5388450-388450100.554100.90
6388432-388432100.550100.98
30min1395325-395325102.334102.622.10102.94103.202.10
2398539-398539103.166103.78
3406912-406912105.333105.91
4403173-403173104.365104.91
5384341-38434199.491100.00
6390301-390301101.033101.63
45min1393648-393648101.900102.351.35102.67103.091.35
2397674-397674102.942103.72
3403732-403732104.510105.26
4396647-396647102.676103.40
5388166-388166100.481101.16
6392358-392358101.566102.33
60min1393941-393941101.976101.902.17102.92102.822.18
2399059-399059103.300104.25
3399678-399678103.461104.39
4401930-401930104.044104.94
5379775-37977598.30999.15
6387518-387518100.313101.25
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%
114.556714676716756719086717126719816717490.04
214.536723196738336730760.16
单位质量响应值RSD%判断
46168.3246323.190.24数据可信
供试品溶液-24042601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%
5min1310942-31094239.01636.039.8539.0236.039.85
2231642-23164229.06629.07
3296934-29693437.25837.26
4293512-29351236.82936.83
5301821-30182137.87237.87
6287999-28799936.13736.14
10min1603614-60361475.74072.245.1775.8072.305.18
2518156-51815665.01765.07
3587828-58782873.75973.82
4578259-57825972.55872.62
5589233-58923373.93574.00
6577171-57717172.42272.48
15min1759743-75974395.33093.432.7795.5293.612.78
2709080-70908088.97389.13
3766871-76687196.22596.41
4743956-74395693.34993.53
5735723-73572392.31692.50
6752328-75232894.40094.58
20min1783691-78369198.33599.133.0798.6999.463.06
2791910-79191099.36699.67
3829616-829616104.098104.44
4776068-77606897.37997.72
5758129-75812995.12895.47
6800659-800659100.464100.80
30min1781069-78106998.00699.103.0798.5299.603.06
2794494-79449499.691100.16
3831651-831651104.353104.87
4775661-77566197.32897.83
5760662-76066295.44695.94
6795270-79527099.788100.29
45min1776265-77626597.40398.563.0998.0899.233.08
2790505-79050599.19099.83
3827258-827258103.802104.49
4771033-77103396.74797.41
5756467-75646794.91995.58
6791607-79160799.328100.00
60min1777078-77707897.50598.483.0598.3599.323.04
2787683-78768398.83699.64
3825897-825897103.631104.50
4770084-77008496.62897.45
5756033-75603394.86595.68
6792419-79241999.430100.27
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%
114.553266453266133266613269703266123267000.05
214.533272403271493271940.02
单位质量响应值RSD%判断
22453.6122518.510.21数据可信
供试品溶液-24050201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%
5min1111262-11126228.71256.8824.3328.7156.8824.33
2240938-24093862.17762.18
3240193-24019361.98461.98
4246622-24662263.64463.64
5236820-23682061.11461.11
6246658-24665863.65363.65
10min1249616-24961664.41694.0715.5764.4694.1615.58
2380753-38075398.25798.36
3377696-37769697.46997.57
4395255-395255102.000102.11
5390470-390470100.765100.87
6393272-393272101.488101.59
15min1343254-34325488.580103.267.5688.74103.527.58
2393512-393512101.550101.82
3405161-405161104.556104.82
4424175-424175109.463109.74
5424012-424012109.421109.69
6410806-410806106.013106.29
20min1391086-391086100.924105.183.37101.23105.613.40
2394023-394023101.682102.12
3404585-404585104.408104.85
4421723-421723108.830109.29
5423994-423994109.416109.87
6410122-410122105.836106.29
30min1410242-410242105.867105.962.81106.34106.562.81
2393158-393158101.459102.06
3404129-404129104.290104.90
4423473-423473109.282109.92
5422825-422825109.115109.75
6409757-409757105.742106.37
45min1409753-409753105.741105.722.82106.39106.502.81
2391943-391943101.145101.92
3403383-403383104.097104.89
4421671-421671108.817109.64
5422486-422486109.027109.84
6408824-408824105.502106.31
60min1410551-410551105.947105.442.74106.77106.392.74
2392078-392078101.180102.12
3400985-400985103.479104.44
4419055-419055108.142109.15
5421993-421993108.900109.90
6406837-406837104.989105.97
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