替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号H220301-1对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.851260881259931263121259541260941260880.12
213.991249821250861250340.06
单位质量响应值RSD%判断
9103.838937.381.31数据可信
供试品溶液-24111401-1批-氢氯噻嗪-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%
5min196506-9650677.03579.722.2977.0479.722.29
299748-9974879.62379.62
3103103-10310382.30182.30
4100370-10037080.11980.12
5101164-10116480.75380.75
698319-9831978.48278.48
10min1107775-10777586.03089.182.6286.4689.622.61
2109428-10942887.35087.79
3115887-11588792.50692.96
4112998-11299890.20090.64
5113229-11322990.38490.83
6111028-11102888.62789.06
15min1114239-11423991.19092.972.3292.1093.912.31
2113670-11367090.73691.66
3120402-12040296.11097.08
4118765-11876594.80395.75
5116862-11686293.28494.23
6114887-11488791.70792.64
20min1115649-11564992.31694.622.3693.7396.072.35
2115378-11537892.09993.53
3122693-12269397.93999.44
4118098-11809894.27195.74
5119165-11916595.12296.59
6120216-12021695.96197.40
30min1111943-11194389.35793.462.2891.2895.442.27
2116948-11694893.35395.30
3119359-11935995.27797.33
4118308-11830894.43896.43
5118573-11857394.65096.65
6117331-11733193.65895.63
45min1116312-11631292.84594.412.3095.2796.912.29
2115304-11530492.04094.50
3122535-12253597.812100.39
4117864-11786494.08496.61
5120408-12040896.11598.64
6117179-11717993.53796.03
60min1108828-10882886.87192.923.6989.8195.943.64
2115100-11510091.87794.85
3121570-12157097.042100.16
4118426-11842694.53297.58
5117866-11786694.08597.14
6116652-11665293.11696.13
极限1114893-11489391.71294.102.7495.1397.642.72
2115132-11513291.90395.39
3123402-12340298.504102.17
4118148-11814894.31197.88
5116271-11627192.81296.39
6119454-11945495.35398.88
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100320240115对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.144314204320574307794312694306944312440.13
211.044273724272244272980.03
单位质量响应值RSD%判断
38711.3138704.530.02数据可信
供试品溶液-24111401-1批-替米沙坦-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%
5min1116649-11664927.12225.817.3727.1225.817.38
2104314-10431424.25424.25
3107451-10745124.98324.98
4103448-10344824.05324.05
5109538-10953825.46925.47
6124648-12464828.98228.98
10min1232080-23208053.96150.324.7554.1150.464.75
2203959-20395947.42347.56
3219295-21929550.98851.13
4205994-20599447.89648.03
5217975-21797550.68150.82
6219105-21910550.94451.11
15min1325736-32573675.73768.935.5476.1969.355.53
2278878-27887864.84265.24
3301709-30170970.15170.57
4287236-28723666.78567.19
5297039-29703969.06569.49
6288159-28815967.00067.44
20min1388240-38824090.27082.046.2491.1482.846.22
2330308-33030876.80077.56
3360980-36098083.93284.74
4332582-33258277.32978.10
5361864-36186484.13784.94
6342965-34296579.74380.56
30min1416073-41607396.74193.112.7698.1194.372.78
2394012-39401291.61292.80
3403085-40308593.72295.00
4387490-38749090.09691.30
5409562-40956295.22796.50
6392441-39244191.24792.51
45min1434582-434582101.04598.771.94102.96100.551.97
2426915-42691599.262100.96
3430026-43002699.986101.78
4410784-41078495.51297.21
5425454-42545498.923100.73
6421013-42101397.89099.66
60min1401789-40178993.42097.212.0295.8999.531.91
2425389-42538998.907101.15
3421337-42133797.965100.32
4417830-41783097.15099.38
5419041-41904197.43199.78
6423028-42302898.358100.67
极限1421871-42187198.08998.381.79101.08101.251.73
2426867-42686799.251102.05
3427887-42788799.488102.39
4418884-41888497.395100.17
5411020-41102095.56698.46
6432192-432192100.489103.35
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号H220301-1对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.851254031255551253311255651257011255110.12
213.991252281255341253810.18
单位质量响应值RSD%判断
9062.178962.190.79数据可信
供试品溶液-24111401-2批-氢氯噻嗪-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%
5min196186-9618676.84778.001.7276.8578.001.72
297836-9783678.16578.17
3100309-10030980.14180.14
498677-9867778.83778.84
596955-9695577.46277.46
695840-9584076.57176.57
10min1109403-10940387.40788.691.6187.8389.131.61
2109808-10980887.73088.16
3114228-11422891.26291.71
4111854-11185489.36589.80
5110583-11058388.35088.78
6110208-11020888.05088.48
15min1113425-11342590.62092.382.2591.5393.302.25
2115569-11556992.33393.25
3120011-12001195.88296.83
4116396-11639692.99493.93
5115718-11571892.45293.37
6112611-11261189.97090.88
20min1115618-11561892.37294.121.5893.7995.561.58
2117608-11760893.96295.40
3120034-12003495.90097.39
4119537-11953795.50396.95
5118261-11826194.48495.92
6115774-11577492.49793.91
30min1115078-11507891.94194.212.3993.8796.172.37
2119403-11940395.39697.35
3121413-12141397.00299.02
4118993-11899395.06997.05
5118583-11858394.74196.70
6114003-11400391.08293.01
45min1115883-11588392.58494.801.7295.0297.281.72
2117104-11710493.55996.05
3120915-12091596.60499.16
4120573-12057396.33198.84
5119684-11968495.62198.11
6117771-11777194.09296.53
60min1117106-11710693.56193.721.9396.5296.741.91
2116415-11641593.00996.02
3119649-11964995.59398.69
4118245-11824594.47197.52
5119046-11904695.11198.13
6113399-11339990.59993.56
极限1114734-11473491.66693.932.0295.1497.462.00
2116820-11682093.33396.86
3121195-12119596.828100.45
4118750-11875094.87598.44
5118364-11836494.56698.11
6115517-11551792.29295.75
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100320240115对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.144284224287954287954284334285154285920.05
211.044291434288484289960.05
单位质量响应值RSD%判断
38473.2538858.330.71数据可信
供试品溶液-24111401-2批-替米沙坦-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%
5min1122192-12219228.44331.309.9928.4431.3010.00
2123044-12304428.64128.64
3121848-12184828.36328.36
4144073-14407333.53633.54
5150232-15023234.96934.97
6145427-14542733.85133.85
10min1243945-24394556.78361.946.6556.9462.126.65
2255601-25560159.49659.66
3257916-25791660.03560.19
4267173-26717362.19062.38
5278897-27889764.91965.11
6293094-29309468.22368.41
15min1325080-32508075.66981.364.7976.1481.884.80
2351034-35103481.71082.20
3346727-34672780.70881.20
4342298-34229879.67780.21
5356142-35614282.89983.45
6375893-37589387.49688.06
20min1372536-37253686.71592.444.8887.6193.414.88
2402320-40232093.64894.59
3398378-39837892.73093.67
4389946-38994690.76891.74
5388863-38886390.51691.53
6430649-430649100.242101.30
30min1398212-39821292.69296.502.8494.0797.982.85
2425496-42549699.043100.51
3421257-42125798.05699.51
4407545-40754594.86496.34
5407636-40763694.88596.40
6427322-42732299.468101.08
45min1412104-41210495.92597.851.5297.8299.871.56
2416431-41643196.93398.95
3422197-42219798.275100.27
4420245-42024597.82099.83
5420284-42028497.82999.87
6431074-431074100.341102.50
60min1415374-41537496.68696.440.9099.1199.000.93
2411272-41127295.73298.28
3411618-41161895.81298.36
4410491-41049195.55098.10
5418017-41801797.30299.89
6419156-41915697.567100.29
极限1410748-41074895.61096.391.4098.5799.481.44
2408307-40830795.04198.13
3416869-41686997.034100.11
4409436-40943695.30498.38
5415471-41547196.70999.84
6423658-42365898.615101.88
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号H220301-1对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.851260451259201258071255241258321258260.16
213.991253781253371253580.03
单位质量响应值RSD%判断
9084.918960.540.98数据可信
供试品溶液-24111401-3批-氢氯噻嗪-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%
5min195554-9555476.25477.401.6776.2577.401.67
295562-9556276.26176.26
396054-9605476.65376.65
497032-9703277.43477.43
598128-9812878.30878.31
699599-9959979.48279.48
10min1107595-10759585.86387.031.0586.2987.461.05
2108163-10816386.31786.74
3109720-10972087.55987.98
4110497-11049788.17988.61
5108487-10848786.57587.01
6109901-10990187.70488.15
15min1111232-11123288.76690.951.2789.6791.861.27
2114322-11432291.23292.13
3115393-11539392.08693.00
4113907-11390790.90091.82
5114858-11485891.65992.58
6114099-11409991.05491.98
20min1113245-11324590.37292.581.6491.7794.001.62
2114817-11481791.62793.04
3118538-11853894.59696.02
4115498-11549892.17093.60
5117409-11740993.69595.12
6116537-11653792.99994.43
30min1115675-11567592.31193.471.8394.2195.401.80
2117221-11722193.54595.46
3120641-12064196.27498.22
4116061-11606192.61994.56
5118429-11842994.50996.45
6114748-11474891.57293.52
45min1115742-11574292.36593.781.3594.7796.241.34
2117398-11739893.68696.13
3119590-11959095.43697.92
4118052-11805294.20896.66
5118663-11866394.69697.17
6115677-11567792.31394.77
60min1111897-11189789.29691.772.8492.2294.752.77
2116308-11630892.81695.78
3120609-12060996.24999.26
4115641-11564192.28495.26
5112596-11259689.85492.85
6112949-11294990.13693.11
极限1116725-11672593.14992.203.4696.5795.693.35
2117529-11752993.79197.27
3118390-11839094.47898.03
4115617-11561792.26595.75
5117376-11737693.66997.16
6107603-10760385.87089.34
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100320240115对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.144297054292924294764293154290784293730.06
211.044293524292454292980.02
单位质量响应值RSD%判断
38543.3638885.690.63数据可信
供试品溶液-24111401-3批-替米沙坦-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%
5min198593-9859322.92025.4413.1722.9225.4413.17
2100067-10006723.26323.26
3112258-11225826.09726.10
4102212-10221223.76223.76
5106377-10637724.73024.73
6137045-13704531.86031.86
10min1189180-18918043.98045.939.8944.1146.079.89
2187634-18763443.62043.75
3191624-19162444.54844.69
4200567-20056746.62746.76
5181089-18108942.09942.24
6235269-23526954.69454.87
15min1263124-26312461.17062.679.0661.5463.079.07
2260769-26076960.62260.99
3255025-25502559.28759.68
4274402-27440263.79264.18
5248120-24812057.68258.05
6316120-31612073.49073.97
20min1319512-31951274.27975.269.2974.9976.019.29
2310901-31090172.27772.99
3301567-30156770.10770.83
4332155-33215577.21877.96
5298579-29857969.41270.10
6379806-37980688.29689.18
30min1374732-37473287.11688.416.4888.2489.576.51
2373784-37378486.89688.01
3356581-35658182.89684.01
4395188-39518891.87293.05
5359408-35940883.55484.63
6421969-42196998.09799.48
45min1403517-40351793.80895.143.6495.4296.793.69
2414614-41461496.38897.98
3390110-39011090.69192.26
4426502-42650299.151100.84
5396558-39655892.19093.73
6424162-42416298.607100.53
60min1395712-39571291.99394.492.9494.1296.672.96
2414507-41450796.36398.49
3407349-40734994.69996.77
4418817-41881797.36599.60
5388494-38849490.31592.37
6413718-41371896.17998.65
极限1411133-41113395.57894.022.5298.2296.722.36
2413852-41385296.21098.87
3396414-39641492.15794.76
4410787-41078795.49898.27
5406522-40652294.50697.06
6387807-38780790.15693.16
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