厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7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%
112.909701397165970699708896845970360.13
212.869662396997968100.28
单位质量响应值RSD%判断
7522.177527.990.06数据可信
供试品溶液-GA47051批-氢氯噻嗪-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119999-1999921.19719.0012.6321.2019.0012.64
221096-2109622.36022.36
316170-1617017.13917.14
415287-1528716.20316.20
516844-1684417.85317.85
618141-1814119.22819.23
10min162435-6243566.17664.733.5966.2864.823.59
260154-6015463.75963.87
357969-5796961.44361.53
459625-5962563.19863.28
562352-6235266.08866.18
663879-6387967.70767.80
15min183391-8339188.38891.572.2188.8291.982.19
287478-8747892.72093.15
388527-8852793.83294.22
485369-8536990.48490.88
587783-8778393.04393.46
685805-8580590.94791.38
20min191249-9124996.71796.022.2197.6096.902.18
289550-8955094.91695.81
388650-8865093.96294.82
494122-9412299.762100.61
590873-9087396.31897.20
689109-8910994.44995.34
30min189877-8987795.26395.341.2696.6396.691.23
288695-8869594.01095.38
391868-9186897.37398.70
490525-9052595.94997.30
589121-8912194.46195.83
689594-8959494.96396.32
45min188924-8892494.25395.622.6596.0997.462.60
287396-8739692.63394.47
392003-9200397.51699.33
489811-8981195.19397.02
589151-8915194.49396.33
694016-9401699.650101.49
60min187944-8794493.21494.871.6895.5297.181.64
290607-9060796.03698.34
387794-8779493.05595.36
489381-8938194.73797.04
591653-9165397.14599.46
689676-8967695.05097.38
极限188176-8817693.46095.821.7296.2498.601.67
290002-9000295.39598.18
391447-9144796.92799.70
490589-9058996.01798.79
592633-9263398.184100.98
689542-8954294.90897.72
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150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%
115.432732922735342729632733572720632730420.22
215.522719312719272719290.01
单位质量响应值RSD%判断
17695.5317521.200.71数据可信
供试品溶液-GA47051批-厄贝沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144809-4480916.96515.1313.7316.9715.1313.72
247890-4789018.13218.13
335969-3596913.61813.62
434096-3409612.90912.91
536341-3634113.75913.76
640645-4064515.38915.39
10min1155589-15558958.90956.843.9758.9956.913.97
2149042-14904256.43056.52
3141470-14147053.56353.63
4146487-14648755.46355.53
5150369-15036956.93257.00
6157716-15771659.71459.79
15min1219385-21938583.06385.271.7083.4485.631.68
2228163-22816386.38686.76
3230153-23015387.14087.48
4222998-22299884.43184.77
5225865-22586585.51685.87
6224734-22473485.08885.46
20min1249688-24968894.53693.502.2295.3394.292.19
2243971-24397192.37293.18
3242298-24229891.73892.51
4256908-25690897.27098.03
5244520-24452092.57993.36
6244358-24435892.51893.32
30min1253776-25377696.08495.801.7697.3597.051.73
2250492-25049294.84196.11
3259337-25933798.18999.42
4256173-25617396.99298.24
5246706-24670693.40794.65
6251646-25164695.27896.54
45min1252383-25238395.55797.132.8197.3098.862.76
2248796-24879694.19895.94
3262181-26218199.266100.99
4258324-25832497.80699.54
5250452-25045294.82596.54
6267032-267032101.103102.84
60min1249930-24993094.62897.141.7196.8599.351.67
2261155-26115598.878101.09
3252868-25286895.74097.96
4259727-25972798.337100.56
5259217-25921798.144100.33
6256414-25641497.08399.33
极限1251402-25140295.18598.361.8797.88101.061.81
2259863-25986398.389101.09
3262656-26265699.446102.14
4263913-26391399.922102.64
5263649-26364999.822102.50
6257268-25726897.406100.14
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7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%
112.909647596379966409662496186964610.20
212.869681596970968920.12
单位质量响应值RSD%判断
7477.607534.370.54数据可信
供试品溶液-GA47051批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117820-1782018.93620.1511.4518.9420.1511.45
218241-1824119.38419.38
316661-1666117.70517.70
419708-1970820.94220.94
522918-2291824.35324.35
618451-1845119.60719.61
10min165548-6554869.65466.735.1569.7566.835.15
259881-5988163.63263.73
361892-6189265.76965.86
463754-6375467.74767.85
566985-6698571.18171.30
658705-5870562.38262.48
15min186560-8656091.98292.430.5292.4292.860.52
287426-8742692.90293.32
387380-8738092.85393.27
486970-8697092.41792.86
587196-8719692.65793.14
686338-8633891.74692.16
20min188713-8871394.26995.441.5095.1796.341.47
291964-9196497.72498.60
389225-8922594.81495.70
488501-8850194.04494.95
589648-8964895.26396.20
690856-9085696.54797.42
30min189885-8988595.51595.201.3496.8996.581.34
290979-9097996.67798.05
388015-8801593.52894.88
490097-9009795.74097.12
590349-9034996.00897.43
688229-8822993.75595.11
45min189251-8925194.84196.021.4496.6997.861.40
290018-9001895.65697.51
392106-9210697.87599.70
488634-8863494.18696.04
591034-9103496.73698.63
691096-9109696.80298.62
60min188672-8867294.22696.091.6396.5598.421.58
292405-9240598.193100.52
390640-9064096.31798.63
489188-8918894.77497.10
589858-8985895.48697.87
691798-9179897.54899.85
极限187524-8752493.00696.012.4895.8098.822.41
291389-9138997.11399.93
391173-9117396.88499.68
488748-8874894.30797.11
589438-8943895.04097.90
693806-9380699.681102.47
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150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%
115.432708152709582707302715392714482710980.14
215.522719952728072724010.22
单位质量响应值RSD%判断
17569.5417551.610.08数据可信
供试品溶液-GA47051批-厄贝沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139997-3999715.18416.3212.1315.1816.3112.14
241401-4140115.71715.72
337522-3752214.24514.24
445363-4536317.22217.22
552261-5226119.84019.84
641315-4131515.68515.68
10min1163443-16344362.04959.245.0162.1359.325.02
2148842-14884256.50656.58
3153690-15369058.34758.42
4158275-15827560.08760.17
5165716-16571662.91263.01
6146337-14633755.55555.63
15min1228332-22833286.68486.890.3387.0787.270.34
2228721-22872186.83187.19
3229739-22973987.21887.58
4229663-22966387.18987.58
5229010-22901086.94187.35
6227835-22783586.49586.85
20min1244080-24408092.66293.651.3693.4894.471.33
2251954-25195495.65196.45
3245797-24579793.31494.11
4243139-24313992.30593.13
5245839-24583993.33094.18
6249345-24934594.66195.45
30min1254397-25439796.57996.051.2897.8697.321.27
2257232-25723297.65598.93
3248974-24897494.52095.79
4254210-25421096.50897.79
5253813-25381396.35797.67
6249323-24932394.65395.91
45min1256987-25698797.56297.811.5499.3399.571.50
2257104-25710497.60799.37
3263389-26338999.993101.73
4251279-25127995.39597.16
5257515-25751597.76399.56
6259540-25954098.531100.27
60min1254734-25473496.70798.401.7998.96100.651.74
2266032-266032100.996103.25
3260124-26012498.753100.99
4255246-25524696.90199.14
5256113-25611397.23099.52
6262979-26297999.837102.06
极限1254138-25413896.48198.742.4599.22101.482.38
2263923-263923100.195102.95
3263387-26338799.992102.72
4254797-25479796.73199.46
5254890-25489096.76699.54
6269384-269384102.269105.00
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7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%
112.909662296883965609673596551966700.15
212.869727796949971130.24
单位质量响应值RSD%判断
7493.807551.560.55数据可信
供试品溶液-FA4456批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127726-2772629.39729.8412.6829.4029.8412.67
226297-2629727.88227.88
325475-2547527.01127.01
432957-3295734.94434.94
532062-3206233.99533.99
624348-2434825.81625.82
10min182217-8221787.17383.805.2387.3283.945.23
281524-8152486.43886.58
376608-7660881.22681.36
474334-7433478.81578.99
584223-8422389.30089.47
675285-7528579.82379.95
15min183869-8386988.92493.333.5989.5193.903.57
289365-8936594.75295.32
386508-8650891.72292.26
485633-8563390.79591.36
591538-9153897.05697.67
691245-9124596.74597.27
20min190174-9017495.60992.602.5696.6493.632.53
287228-8722892.48693.53
385686-8568690.85191.85
484753-8475389.86290.88
586307-8630791.50992.61
689864-8986495.28196.29
30min186679-8667991.90493.712.1893.4195.202.15
290026-9002695.45296.96
387947-8794793.24894.70
486032-8603291.21892.69
588538-8853893.87595.43
691054-9105496.54298.03
45min189907-8990795.32695.172.1997.2997.132.15
289406-8940694.79596.78
393073-9307398.683100.60
486996-8699692.24094.17
590075-9007595.50497.53
689084-8908494.45496.42
60min187724-8772493.01294.601.2395.4597.041.19
289578-8957894.97797.44
390378-9037895.82698.24
488765-8876594.11596.50
588464-8846493.79696.30
690448-9044895.90098.34
极限189161-8916194.53595.691.0197.4498.601.02
290912-9091296.39299.33
389786-8978695.19898.09
489381-8938194.76997.63
591221-9122196.71999.69
691029-9102996.51699.44
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150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%
115.432719272712782721122720182716932718060.13
215.522727642728712728180.03
单位质量响应值RSD%判断
17615.4217578.480.15数据可信
供试品溶液-FA4456批-厄贝沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158620-5862022.20822.6614.2322.2122.6614.23
255729-5572921.11321.11
353572-5357220.29620.30
472162-7216227.33927.34
568123-6812325.80925.81
650671-5067119.19719.20
10min1194353-19435373.63170.975.2373.7471.085.23
2192243-19224372.83272.94
3181273-18127368.67668.78
4178308-17830867.55367.69
5200784-20078476.06876.20
6177031-17703167.06967.16
15min1217307-21730782.32886.423.6082.8186.893.58
2231676-23167687.77188.24
3224048-22404884.88185.33
4222221-22222184.18984.66
5238650-23865090.41390.92
6234753-23475388.93789.37
20min1242811-24281191.99089.212.5392.8890.112.50
2234835-23483588.96889.88
3231055-23105587.53688.41
4228445-22844586.54787.44
5233264-23326488.37389.33
6242485-24248591.86692.74
30min1239969-23996990.91393.082.1892.2694.422.15
2247714-24771493.84795.20
3245401-24540192.97194.28
4240027-24002790.93592.26
5246723-24672393.47294.88
6254238-25423896.31997.65
45min1251584-25158495.31496.132.0597.1297.942.00
2249938-24993894.69096.51
3263143-26314399.693101.46
4248857-24885794.28096.06
5255464-25546496.78498.65
6253392-25339295.99997.82
60min1247211-24721193.65796.381.8595.9498.681.80
2251958-25195895.45597.75
3257792-25779297.66699.94
4256619-25661997.22199.48
5252696-25269695.73598.09
6260149-26014998.558100.86
极限1252687-25268795.73197.761.4198.48100.531.39
2256484-25648497.17099.94
3255929-25592996.96099.72
4259761-25976198.411101.15
5261132-26113298.931101.76
6262201-26220199.336102.13
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7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%
112.909752697461974449757597731975470.12
212.869716996892970300.21
单位质量响应值RSD%判断
7561.787545.100.16数据可信
供试品溶液-FA4456批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135501-3550137.48735.367.5837.4935.367.58
231062-3106232.80032.80
333999-3399935.90135.90
434000-3400035.90235.90
529893-2989331.56531.57
636453-3645338.49238.49
10min183455-8345588.12484.674.8088.3184.854.80
276470-7647080.74880.91
380037-8003784.51584.69
480848-8084885.37185.55
575209-7520979.41679.57
685094-8509489.85490.05
15min185070-8507089.82994.843.4490.4695.443.42
290724-9072495.79996.37
393226-9322698.44199.04
489549-8954994.55995.17
587697-8769792.60393.16
692644-9264497.82798.47
20min187373-8737392.26193.593.2593.3494.673.20
291063-9106396.15797.20
383595-8359588.27289.37
488711-8871193.67494.75
589788-8978894.81195.83
691286-9128696.39397.52
30min187419-8741992.31095.302.6293.8596.842.59
293821-9382199.070100.60
388478-8847893.42894.96
489297-8929794.29395.84
590480-9048095.54297.03
691981-9198197.12798.74
45min188436-8843693.38395.781.7595.3897.801.74
292491-9249197.66599.69
389611-8961194.62496.63
491809-9180996.94598.96
590014-9001495.05097.02
691870-9187097.01099.11
60min185899-8589990.70594.862.6993.1797.352.65
291123-9112396.22198.73
388018-8801892.94295.42
490495-9049595.55898.06
591009-9100996.10098.55
692439-9243997.610100.19
极限184999-8499989.75494.073.0292.6797.042.97
292233-9223397.393100.39
386959-8695991.82494.76
489993-8999395.02898.01
589244-8924494.23797.16
691106-9110696.20399.27
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150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%
115.432747582749882747412743162748922747390.10
215.522728202732722730460.12
单位质量响应值RSD%判断
17805.5117593.170.85数据可信
供试品溶液-FA4456批-厄贝沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min175750-7575028.53327.277.6728.5327.277.67
267031-6703125.24925.25
374308-7430827.99027.99
474297-7429727.98627.99
564274-6427424.21024.21
678764-7876429.66829.67
10min1200894-20089475.67272.385.0975.8172.515.09
2181429-18142968.34068.47
3192262-19226272.42072.56
4194549-19454973.28273.42
5180027-18002767.81267.93
6203693-20369376.72676.87
15min1223256-22325684.09588.003.3984.6288.503.38
2232239-23223987.47987.95
3243927-24392791.88192.38
4234291-23429188.25288.76
5227011-22701185.50985.97
6240939-24093990.75691.29
20min1237390-23739089.41990.312.6890.3691.242.64
2244159-24415991.96992.87
3228155-22815585.94086.90
4240235-24023590.49191.44
5242793-24279391.45492.34
6245755-24575592.57093.56
30min1245310-24531092.40294.541.7993.7995.931.76
2258713-25871397.45198.82
3248805-24880593.71995.11
4249828-24982894.10495.50
5250733-25073394.44595.79
6252488-25248895.10696.55
45min1252059-25205994.94496.631.3396.8098.491.32
2259184-25918497.62899.48
3254943-25494396.03197.89
4261594-26159498.536100.41
5254828-25482895.98797.80
6256561-25656196.64098.56
60min1247141-24714193.09296.342.0795.4298.692.03
2257363-25736396.94299.28
3251512-25151294.73897.08
4259437-25943797.724100.09
5260282-26028298.042100.34
6258919-25891997.52899.94
极限1246179-24617992.73095.952.2195.5298.772.17
2261488-26148898.496101.32
3249899-24989994.13196.94
4257594-25759497.02999.88
5257315-25731596.92499.71
6255821-25582196.36199.26
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