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500
标示量(mg)20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%
114.313297963299373300293302753301023300280.06
214.413297073300833298950.09
单位质量响应值RSD%判断
23062.7522893.480.53数据可信
供试品溶液-24061701-1批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1193171-19317148.78348.704.3448.7848.704.34
2208442-20844252.63952.64
3189030-18903047.73747.74
4187941-18794147.46247.46
5193810-19381048.94448.94
6184731-18473146.65246.65
10min1324217-32421781.87783.303.6981.9683.383.69
2352241-35224188.95489.04
3320535-32053580.94781.03
4323804-32380481.77381.85
5335450-33545084.71484.80
6322764-32276481.51081.59
15min1375970-37597094.94795.401.4595.1695.621.45
2379880-37988095.93496.17
3370089-37008993.46193.68
4376066-37606694.97195.19
5386702-38670297.65797.88
6377878-37787895.42895.64
20min1379804-37980495.91595.621.4196.2996.001.40
2378732-37873295.64496.04
3375519-37551994.83395.20
4371438-37143893.80294.18
5387460-38746097.84898.23
6378877-37887795.68196.05
30min1380035-38003595.97395.341.2596.5195.881.25
2377822-37782295.41495.97
3370912-37091293.66994.20
4374030-37403094.45794.99
5384421-38442197.08197.63
6377920-37792095.43995.97
45min1377298-37729895.28295.201.3895.9895.901.38
2374846-37484694.66395.38
3375057-37505794.71695.40
4369564-36956493.32994.02
5384673-38467397.14497.85
6380501-38050196.09196.78
极限1372119-37211993.97494.641.6594.8395.501.64
2376993-37699395.20596.08
3368767-36876793.12893.97
4368886-36888693.15894.00
5384853-38485397.19098.06
6376940-37694095.19296.04
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500
标示量(mg)20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%
114.313273423275783270153278773272543274130.11
214.413258303251023254660.16
单位质量响应值RSD%判断
22880.0122586.120.92数据可信
供试品溶液-24061701-1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%
5min1178310-17831045.51745.882.1345.5245.882.13
2184562-18456247.11347.11
3179248-17924845.75645.76
4173327-17332744.24544.24
5181176-18117646.24846.25
6181828-18182846.41546.41
10min1307616-30761678.52480.251.2478.6080.321.24
2316938-31693880.90480.98
3314393-31439380.25480.33
4312949-31294979.88679.96
5318844-31884481.39081.47
6315455-31545580.52580.60
15min1376628-37662896.14196.270.6996.3596.480.69
2381327-38132797.34097.55
3375818-37581895.93496.14
4379100-37910096.77296.98
5374640-37464095.63395.85
6375256-37525695.79196.00
20min1386319-38631998.61597.730.9298.9898.100.92
2386888-38688898.76099.14
3381276-38127697.32797.70
4384403-38440398.12598.49
5379880-37988096.97197.34
6378411-37841196.59696.97
30min1385300-38530098.35497.471.0198.8998.011.01
2386127-38612798.56699.11
3380448-38044897.11697.65
4383256-38325697.83398.36
5380087-38008797.02497.56
6375814-37581495.93396.47
45min1387277-38727798.85997.421.1499.5598.111.14
2385255-38525598.34399.05
3379614-37961496.90397.60
4383303-38330397.84598.54
5378289-37828996.56597.26
6376017-37601795.98596.68
极限1384174-38417498.06797.060.9698.9397.920.95
2384239-38423998.08498.95
3377881-37788196.46197.32
4381629-38162997.41798.28
5377834-37783496.44997.30
6375695-37569595.90396.75
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500
标示量(mg)20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%
114.313290593288993287563287083285943288030.06
214.413275313272443273880.07
单位质量响应值RSD%判断
22977.1522719.500.80数据可信
供试品溶液-24061701-1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%
5min1185210-18521047.03945.595.7047.0445.595.70
2178354-17835445.29845.30
3170632-17063243.33743.34
4192345-19234548.85148.85
5165030-16503041.91441.91
6185419-18541947.09247.09
10min1311460-31146079.10478.601.9179.1878.671.91
2310975-31097578.98079.06
3303546-30354677.09477.17
4313401-31340179.59779.68
5301097-30109776.47276.54
6316306-31630680.33480.41
15min1372721-37272194.66392.582.0394.8792.792.03
2365296-36529692.77792.98
3351904-35190489.37589.58
4370907-37090794.20294.42
5362379-36237992.03692.23
6363932-36393292.43092.64
20min1373875-37387594.95693.311.7995.3293.671.79
2365777-36577792.89993.26
3357207-35720790.72291.07
4374289-37428995.06195.43
5369542-36954293.85594.21
6363644-36364492.35792.72
30min1370575-37057594.11792.741.7194.6493.261.70
2363232-36323292.25392.77
3357140-35714090.70591.21
4373200-37320094.78495.31
5366893-36689393.18293.69
6359886-35988691.40391.92
45min1370352-37035294.06192.472.2894.7493.152.28
2362949-36294992.18192.85
3348983-34898388.63489.29
4371802-37180294.42995.12
5367800-36780093.41394.08
6362751-36275192.13092.80
极限1368365-36836593.55692.391.9494.4093.221.94
2355964-35596490.40791.23
3354717-35471790.09090.89
4371829-37182994.43695.28
5368194-36819493.51394.33
6363533-36353392.32993.16
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500
标示量(mg)20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%
114.313300023292513296333291093295773295140.11
214.413300903300573300740.01
单位质量响应值RSD%判断
23026.8322905.900.38数据可信
供试品溶液-24061701-1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%
5min1173407-17340743.81439.5424.0043.8139.5424.00
2122254-12225430.88930.89
397006-9700624.51024.51
4174567-17456744.10744.11
5185057-18505746.75746.76
6186692-18669247.17147.17
10min1309717-30971778.25573.1115.8178.3373.1715.82
2266862-26686267.42767.48
3206406-20640652.15252.19
4304793-30479377.01177.08
5324048-32404881.87681.95
6324195-32419581.91381.99
15min1375309-37530994.82889.5710.7395.0389.7610.75
2349606-34960688.33388.50
3280397-28039770.84770.97
4363983-36398391.96692.17
5377463-37746395.37295.59
6380248-38024896.07596.29
20min1380378-38037896.10893.675.7496.4794.015.77
2381841-38184196.47896.79
3328599-32859983.02683.27
4369258-36925893.29993.65
5380395-38039596.11396.49
6383982-38398297.01997.39
30min1378031-37803195.51595.151.9496.0495.641.97
2383428-38342896.87997.35
3366515-36651592.60692.99
4368616-36861693.13693.65
5379833-37983395.97196.50
6383101-38310196.79697.33
45min1377880-37788095.47795.081.6296.1695.731.65
2380748-38074896.20296.84
3370365-37036593.57894.12
4367335-36733592.81393.48
5378738-37873895.69496.39
6382758-38275896.71097.41
极限1377088-37708895.27794.751.6496.1295.561.66
2379303-37930395.83796.63
3369111-36911193.26293.96
4365740-36574092.41093.23
5377630-37763095.41496.27
6381184-38118496.31297.17
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