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100309-201404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%
112.829565595817954749560595429955960.17
212.919561495595956040.02
单位质量响应值RSD%判断
7456.797405.420.49数据可信
长期12月-供试品溶液-2023061421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%
5min141797-4179744.86247.557.1044.8647.567.10
247653-4765351.14851.15
346994-4699450.44150.44
443098-4309846.25946.26
546348-4634849.74749.75
639938-3993842.86742.87
10min184246-8424690.42587.952.7390.6588.192.71
278980-7898084.77285.03
379689-7968985.53385.79
482370-8237088.41188.64
584305-8430590.48890.74
682044-8204488.06188.28
15min189238-8923895.78394.511.0996.4695.191.09
288769-8876995.27995.96
386460-8646092.80193.48
487773-8777394.21094.88
588170-8817094.63695.34
687896-8789694.34295.00
20min192568-9256899.35796.321.88100.5197.471.86
290728-9072897.38298.54
388185-8818594.65295.80
488232-8823294.70395.85
589662-8966296.23897.41
689035-8903595.56596.69
30min190831-9083197.49297.211.5899.1498.841.57
292135-9213598.892100.54
390638-9063897.28598.90
490954-9095497.62499.24
590980-9098097.65299.31
687863-8786394.30795.91
45min189724-8972496.30496.740.9098.4498.860.87
290167-9016796.78098.92
389295-8929595.84497.95
491545-9154598.259100.36
589586-8958696.15698.30
690482-9048297.11899.19
60min190785-9078597.44397.251.51100.0699.851.46
291157-9115797.842100.46
389414-8941495.97298.55
489725-8972596.30598.90
589562-8956296.13098.75
692987-9298799.807102.37
极限191926-9192698.66899.072.18101.78102.162.12
291969-9196998.714101.82
392513-9251399.298102.36
495847-95847102.876105.96
591918-9191898.659101.76
689639-8963996.21399.27
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100607-201804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%
115.322716512714432711942712942712022713570.08
215.352716802715892716340.03
单位质量响应值RSD%判断
17712.6017696.030.07数据可信
长期12月-供试品溶液-2023061421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%
5min191811-9181134.57236.957.5334.5736.957.53
2107431-10743140.45440.45
3103766-10376639.07439.07
493756-9375635.30435.30
5102618-10261838.64138.64
689439-8943933.67933.68
10min1214917-21491780.92879.112.3581.1079.302.34
2203901-20390176.78076.98
3205897-20589777.53277.73
4210710-21071079.34479.52
5216432-21643281.49981.69
6208710-20871078.59178.76
15min1244559-24455992.09091.720.9792.6792.300.98
2246921-24692192.98093.57
3240938-24093890.72791.31
4242137-24213791.17891.75
5245272-24527292.35992.96
6241615-24161590.98291.54
20min1260272-26027298.00795.891.6499.0496.921.63
2258643-25864397.39498.44
3252096-25209694.92895.96
4249762-24976294.04995.08
5255270-25527096.12397.19
6251819-25181994.82495.84
30min1258743-25874397.43197.671.7698.9699.181.75
2264936-26493699.763101.30
3261193-26119398.35499.87
4258879-25887997.48298.98
5261144-26114498.33599.88
6251304-25130494.63096.12
45min1253314-25331495.38796.820.8197.4098.820.79
2258373-25837397.29299.33
3257207-25720796.85398.86
4259356-25935697.66299.65
5256689-25668996.65898.69
6257707-25770797.04199.00
60min1257873-25787397.10497.091.6299.6099.581.58
2260488-26048898.088100.61
3255302-25530296.13698.62
4253038-25303895.28397.76
5255707-25570796.28898.81
6264633-26463399.649102.10
极限1262809-26280998.96299.181.89101.94102.151.83
2262859-26285998.981101.99
3264313-26431399.529102.50
4271983-271983102.417105.37
5261590-26159098.503101.50
6256714-25671496.66799.61
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100309-201404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%
112.829568995492956729571895625956390.10
212.919532095606954630.22
单位质量响应值RSD%判断
7460.147394.500.63数据可信
长期12月-供试品溶液-2023061421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%
5min146767-4676750.22344.8817.6350.2244.8817.64
238657-3865741.51441.51
338569-3856941.41941.42
453354-5335457.29757.30
541200-4120044.24444.24
632183-3218334.56134.56
10min180241-8024186.17087.872.8886.4288.092.90
281218-8121887.22087.43
379799-7979985.69685.90
485247-8524791.54691.83
584294-8429490.52390.74
680116-8011686.03686.21
15min184940-8494091.21792.922.7091.9093.582.70
283360-8336089.52090.16
385194-8519491.48992.12
488789-8878995.35096.09
588933-8893395.50596.18
687958-8795894.45895.06
20min188542-8854295.08595.422.9296.2296.552.90
284140-8414090.35791.45
390032-9003296.68597.78
489238-8923895.83297.05
591924-9192498.71799.87
689247-8924795.84296.92
30min188971-8897195.54595.961.9597.1697.571.94
286425-8642592.81194.35
390554-9055497.24598.82
489163-8916395.75297.45
591547-9154798.31299.96
689503-8950396.11797.67
45min190754-9075497.46097.011.3999.5599.101.40
288454-8845494.99097.00
391549-9154998.314100.38
490429-9042997.11199.29
591572-9157298.339100.48
689274-8927495.87197.91
60min193660-93660100.58198.971.65103.16101.541.66
290463-9046397.14899.63
392354-9235499.178101.73
493700-93700100.624103.29
592551-9255199.390102.02
690217-9021796.88499.40
极限192130-9213098.93898.130.98102.02101.190.98
290221-9022196.88899.86
392620-9262099.464102.51
490995-9099597.719100.89
591517-9151798.280101.40
690770-9077097.477100.48
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100607-201804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%
115.322717172717052717782715072715152716440.05
215.352712462711832712140.02
单位质量响应值RSD%判断
17731.3317668.660.26数据可信
长期12月-供试品溶液-2023061421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%
5min1105459-10545939.72134.9319.4439.7234.9319.45
285985-8598532.38632.39
384992-8499232.01232.01
4120635-12063545.43745.44
590546-9054634.10434.10
668771-6877125.90325.90
10min1208590-20859078.56579.663.4078.7679.833.42
2211091-21109179.50779.67
3203406-20340676.61376.77
4222873-22287383.94584.17
5216695-21669581.61881.79
6206314-20631477.70877.84
15min1236857-23685789.21290.772.7889.8091.342.79
2233475-23347587.93888.50
3234992-23499288.51089.05
4249193-24919393.85894.51
5246954-24695493.01593.59
6244442-24444292.06992.59
20min1252982-25298295.28595.272.3696.3296.302.35
2241414-24141490.92891.93
3254680-25468095.92596.91
4254705-25470595.93497.05
5258831-25883197.48898.53
6255008-25500896.04997.03
30min1255030-25503096.05796.811.9797.5798.311.95
2249050-24905093.80495.26
3260269-26026998.03099.50
4255614-25561496.27797.87
5263714-26371499.328100.86
6258493-25849397.36198.82
45min1258439-25843997.34197.511.2799.3499.501.28
2253898-25389895.63097.55
3261403-26140398.457100.41
4259667-25966797.80399.88
5263094-26309499.094101.12
6256858-25685896.74598.69
60min1267340-267340100.69398.891.27103.17101.361.27
2259034-25903497.56599.97
3263817-26381799.366101.81
4262479-26247998.862101.43
5264090-26409099.469101.99
6258537-25853797.37899.81
极限1262831-26283198.99598.440.94101.98101.410.94
2258695-25869597.437100.33
3264944-26494499.791102.74
4260826-26082698.240101.30
5262164-26216498.744101.76
6258725-25872597.449100.36
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100309-201404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%
112.829568595483958269561595630956480.13
212.919561695860957380.19
单位质量响应值RSD%判断
7460.847415.800.43数据可信
长期12月-供试品溶液-2023061421批-氢氯噻嗪-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123943-2394325.67434.0717.8925.6734.0717.89
232265-3226534.59834.60
331889-3188934.19434.19
435589-3558938.16238.16
539791-3979142.66842.67
627182-2718229.14729.15
10min169705-6970574.74477.124.6874.8777.294.69
272349-7234977.57977.75
367253-6725372.11572.29
472580-7258077.82778.02
577311-7731182.90083.11
672342-7234277.57277.72
15min179140-7914084.86184.902.1885.3685.452.19
278075-7807583.71984.28
376497-7649782.02782.56
479457-7945785.20185.78
581224-8122487.09687.72
680651-8065186.48287.02
20min179840-7984085.61286.751.8786.5487.731.88
282086-8208688.02089.00
379259-7925984.98985.93
479603-7960385.35886.36
582777-8277788.76189.82
681849-8184987.76688.73
30min181699-8169987.60590.072.7588.9691.482.76
282434-8243488.39489.81
381700-8170087.60688.97
486156-8615692.38593.82
586683-8668392.95094.46
685307-8530791.47492.88
45min182651-8265188.62691.171.4190.4293.041.43
285527-8552791.71093.57
385080-8508091.23193.04
485323-8532391.49193.39
585586-8558691.77393.75
685962-8596292.17794.04
60min187335-8733593.64993.781.1795.8896.101.14
287262-8726293.57195.89
386430-8643092.67894.94
488838-8883895.26197.61
586413-8641392.66095.09
688492-8849294.88997.21
极限190685-9068597.24197.031.0099.9499.821.01
290250-9025096.77599.56
389846-8984696.34199.07
491713-9171398.343101.17
591208-9120897.802100.70
689249-8924995.70198.50
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100607-201804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%
115.322714902715652718822715132713372715570.08
215.352714262715012714640.02
单位质量响应值RSD%判断
17725.6517684.950.17数据可信
长期12月-供试品溶液-2023061421批-厄贝沙坦-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142646-4264616.05821.7019.7616.0621.7019.76
257714-5771421.73121.73
359012-5901222.22022.22
463324-6332423.84423.84
574937-7493728.21628.22
648153-4815318.13118.13
10min1164475-16447561.93161.905.1862.0162.015.19
2163045-16304561.39261.50
3151033-15103356.86956.98
4163794-16379461.67461.79
5177717-17771766.91767.06
6166349-16634962.63662.73
15min1207079-20707977.97375.933.3178.3676.353.31
2196733-19673374.07774.49
3191356-19135672.05272.45
4200699-20069975.57076.00
5208340-20834078.44778.92
6205790-20579077.48777.89
20min1220575-22057583.05482.282.3083.8383.072.31
2219369-21936982.60083.39
3211126-21112679.49680.25
4213942-21394280.55781.36
5224600-22460084.57085.44
6221426-22142683.37584.17
30min1234609-23460988.33989.602.5889.5390.802.59
2232787-23278787.65388.85
3230449-23044986.77287.93
4243307-24330791.61492.82
5245320-24532092.37293.66
6241235-24123590.83492.04
45min1241754-24175491.02992.450.8892.6794.110.89
2246948-24694892.98594.62
3244325-24432591.99793.58
4246039-24603992.64294.31
5246695-24669592.88994.64
6247456-24745693.17694.84
60min1253364-25336495.40195.041.1997.4997.161.17
2252013-25201394.89296.99
3248791-24879193.67995.73
4256109-25610996.43498.56
5249212-24921293.83796.05
6255010-25501096.02098.15
极限1256944-25694496.74996.810.9299.3299.400.92
2257711-25771197.03799.61
3254624-25462495.87598.39
4260879-26087998.230100.84
5257900-25790097.10999.79
6254589-25458995.86298.47
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100309-201404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%
112.829542495654957869553795598956000.15
212.919569895800957490.08
单位质量响应值RSD%判断
7457.107416.650.39数据可信
长期12月-供试品溶液-2023061421批-氢氯噻嗪-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125486-2548627.33432.1425.5527.3332.1425.56
222498-2249824.12924.13
335077-3507737.62037.62
424937-2493726.74526.74
542803-4280345.90645.91
628983-2898331.08431.08
10min168868-6886873.86176.733.8274.0076.893.86
269379-6937974.40974.53
372078-7207877.30477.49
471362-7136276.53676.67
576519-7651982.06782.30
671053-7105376.20476.36
15min174193-7419379.57283.132.4880.0883.682.52
277346-7734682.95483.45
379001-7900184.72985.30
476959-7695982.53983.06
579698-7969885.47686.12
677866-7786683.51184.05
20min178913-7891384.63486.021.7585.5486.981.79
280220-8022086.03686.94
381931-8193187.87188.87
478264-7826483.93884.87
581345-8134587.24388.31
680537-8053786.37687.33
30min176877-7687782.45187.933.2883.7889.323.27
282225-8222588.18689.52
384762-8476290.90792.34
482133-8213388.08889.44
582561-8256188.54790.05
683358-8335889.40290.79
45min185061-8506191.22891.392.0392.9793.221.97
285055-8505591.22293.00
387419-8741993.75795.65
486346-8634692.60694.40
582254-8225488.21890.16
685159-8515991.33393.17
60min186251-8625192.50492.611.6694.7094.891.57
286095-8609592.33794.57
385259-8525991.44093.80
488731-8873195.16497.42
584695-8469590.83593.22
687045-8704593.35695.65
极限188913-8891395.35994.700.9998.0297.450.99
287503-8750393.84796.54
387978-8797894.35797.17
488069-8806994.45497.18
589764-8976496.27299.11
687586-8758693.93696.69
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100607-201804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%
115.322718162718742719162716052720172718460.06
215.352719042718362718700.02
单位质量响应值RSD%判断
17744.5217711.400.14数据可信
长期12月-供试品溶液-2023061421批-厄贝沙坦-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145777-4577717.21520.7230.0017.2120.7230.00
239532-3953214.86614.87
365577-6557724.66124.66
444741-4474116.82516.83
583488-8348831.39631.40
651451-5145119.34819.35
10min1164882-16488262.00562.125.7462.0962.225.77
2158418-15841859.57459.65
3161047-16104760.56260.69
4161747-16174760.82660.91
5184041-18404169.20969.37
6160935-16093560.52060.62
15min1198246-19824674.55175.062.9374.9575.472.97
2197282-19728274.18974.56
3197921-19792174.42974.86
4195202-19520273.40773.79
5211320-21132079.46879.97
6197608-19760874.31174.71
20min1221046-22104683.12582.112.4783.8982.902.50
2217382-21738281.74782.49
3217864-21786481.92982.73
4210324-21032479.09379.85
5226707-22670785.25486.15
6216806-21680681.53182.30
30min1221366-22136683.24687.572.7884.4388.772.78
2232965-23296587.60788.76
3237807-23780789.42890.64
4230464-23046486.66787.82
5239078-23907889.90691.23
6235537-23553788.57589.75
45min1247720-24772093.15692.371.4594.7694.011.38
2245075-24507592.16193.75
3249889-24988993.97295.63
4247566-24756693.09894.68
5239867-23986790.20391.98
6243722-24372291.65393.27
60min1250657-25065794.26193.671.4296.3395.771.35
2248786-24878693.55795.61
3243433-24343391.54493.67
4254065-25406595.54297.59
5247635-24763593.12495.35
6249881-24988193.96996.05
极限1253874-25387495.47094.451.3998.0197.021.40
2247266-24726692.98595.50
3249958-24995893.99896.58
4250588-25058894.23596.76
5256619-25661996.50399.20
6248713-24871393.53096.08
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