苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.018851088668887908886288822887300.17
214.058903689087890620.05
单位质量响应值RSD%判断
6333.336338.930.07数据可信
长期24月-供试品溶液-2022032901批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min171603-7160379.28984.725.8379.2984.725.83
277414-7741485.72485.72
374529-7452982.53082.53
473338-7333881.21181.21
578033-7803386.41086.41
684141-8414193.17393.17
10min183886-8388692.89193.092.0893.6893.932.09
281892-8189290.68391.54
383873-8387392.87793.70
482592-8259291.45892.27
585737-8573794.94195.80
686395-8639595.66996.60
15min181483-8148390.23092.721.5491.9594.501.55
284240-8424093.28395.05
383874-8387492.87894.63
483298-8329892.24093.97
585347-8534794.50996.32
684131-8413193.16295.05
20min181992-8199290.79490.822.2493.4293.532.13
284496-8449693.56696.26
382704-8270491.58294.26
482683-8268391.55994.21
579006-7900687.48790.25
681217-8121789.93592.76
30min179759-7975988.32188.643.1991.8592.253.12
279044-7904487.52991.16
379159-7915987.65791.26
476607-7660784.83188.40
581600-8160090.36093.99
684105-8410593.13496.85
45min181144-8114489.85588.952.3094.2793.452.24
281705-8170590.47694.98
378570-7857087.00491.48
479363-7936387.88292.30
578314-7831486.72191.26
682862-8286291.75796.41
60min178197-7819786.59188.952.3691.9194.342.30
282323-8232391.16096.57
381300-8130090.02795.37
477740-7774086.08591.38
580899-8089989.58394.99
681511-8151190.26195.83
极限180204-8020488.81488.742.5094.9995.022.35
281646-8164690.41196.73
382680-8268091.55697.80
477110-7711085.38891.54
580450-8045089.08695.39
678736-7873687.18893.66
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.018892688869888988885288834888760.05
214.058869988739887190.04
单位质量响应值RSD%判断
6343.756314.520.33数据可信
长期24月-供试品溶液-2022033001批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161731-6173168.43480.2212.4168.4380.2212.41
260658-6065867.24467.24
373652-7365281.64981.65
480527-8052789.27089.27
578116-7811686.59886.60
679516-7951688.15088.15
10min175485-7548583.68189.284.2884.3790.094.29
281392-8139290.22990.90
380907-8090789.69290.51
485467-8546794.74795.64
581977-8197790.87891.74
678010-7801086.48087.36
15min177452-7745285.86290.864.5387.3892.554.48
285975-8597595.31096.88
382892-8289291.89293.61
483597-8359792.67494.51
584554-8455493.73595.51
677276-7727685.66687.41
20min177266-7726685.65588.743.0288.0491.343.04
280257-8025788.97191.50
381514-8151490.36593.00
480905-8090589.68992.46
583203-8320392.23794.95
677142-7714285.51888.12
30min177254-7725485.64288.492.4188.8891.982.42
282011-8201190.91694.33
380703-8070389.46693.00
481053-8105389.85493.52
580235-8023588.94792.58
677678-7767886.11289.57
45min178388-7838886.89989.313.3890.9993.693.30
283776-8377692.87297.20
383185-8318592.21796.65
481263-8126390.08694.65
579981-7998188.66593.19
676783-7678385.12089.44
60min175723-7572383.94588.224.3288.9193.484.19
284004-8400493.12598.38
381382-8138290.21895.57
482213-8221391.14096.60
577956-7795686.42091.83
676179-7617984.45089.62
极限175588-7558883.79586.714.3489.6092.864.23
281060-8106089.86196.05
377093-7709385.46491.72
482131-8213191.04997.42
579977-7997788.66194.94
673431-7343181.40487.42
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.018859288610886338868088705886440.06
214.058876588613886890.13
单位质量响应值RSD%判断
6327.196312.380.17数据可信
长期24月-供试品溶液-2022033101批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169821-6982177.51680.926.4877.5280.926.48
279130-7913087.85187.85
369659-6965977.33677.34
477654-7765486.21286.21
567469-6746974.90574.90
673588-7358881.69881.70
10min182505-8250591.59890.393.1892.3791.203.11
276480-7648084.90985.79
381847-8184790.86891.64
481081-8108190.01790.88
582848-8284891.97992.73
683747-8374792.97793.79
15min182511-8251191.60590.061.8193.3091.781.78
279900-7990088.70690.43
380917-8091789.83591.52
479708-7970888.49390.26
580394-8039489.25490.92
683300-8330092.48194.23
20min183256-8325692.43289.482.8095.0492.092.71
280708-8070889.60392.22
383147-8314792.31194.89
478013-7801386.61189.26
578433-7843387.07789.64
680006-8000688.82491.50
30min181768-8176890.78088.053.6894.3191.563.54
276688-7668885.14088.65
384042-8404293.30596.81
477769-7776986.34089.85
577991-7799186.58790.02
677579-7757986.12989.69
45min180109-8010988.93887.991.8493.3892.381.79
276693-7669385.14689.51
379666-7966688.44692.88
478936-7893687.63692.01
579119-7911987.83992.14
680996-8099689.92394.34
60min177496-7749686.03784.041.8691.3789.311.80
273548-7354881.65486.87
376977-7697785.46190.78
475565-7556583.89389.15
575182-7518283.46888.64
675410-7541083.72189.04
极限176077-7607784.46285.862.0790.6591.971.93
277712-7771286.27792.31
379852-7985288.65394.83
475289-7528983.58789.68
577980-7798086.57492.59
677093-7709385.59091.75
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.018943289406893898935789313893790.06
214.058886188907888840.04
单位质量响应值RSD%判断
6379.666326.260.60数据可信
长期24月-供试品溶液-FA2515批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161638-6163868.07566.876.8668.0866.876.86
253699-5369959.30759.31
358366-5836664.46164.46
466024-6602472.91972.92
562216-6221668.71368.71
661324-6132467.72867.73
10min173279-7327980.93276.297.9781.6176.967.96
260112-6011266.39066.98
365419-6541972.25172.90
474823-7482382.63783.37
569101-6910176.31877.00
671746-7174679.23979.92
15min176794-7679484.81480.347.2586.3081.777.24
264737-6473771.49872.75
368602-6860275.76677.13
478129-7812986.28887.84
572072-7207279.59981.05
676150-7615084.10385.57
20min180649-8064989.07283.175.6891.4185.405.69
271711-7171179.20081.17
370287-7028777.62779.75
479797-7979788.13190.55
573346-7334681.00683.25
676034-7603483.97586.29
30min182036-8203690.60385.384.5493.8388.454.58
273239-7323980.88883.65
376162-7616284.11687.02
481123-8112389.59592.89
574883-7488382.70385.76
676420-7642084.40187.55
45min178768-7876886.99486.282.5291.1390.202.62
275305-7530583.16986.74
378253-7825386.42590.17
481174-8117489.65193.85
578328-7832886.50890.39
676898-7689884.92988.92
60min181072-8107289.53988.131.5594.5492.911.39
280806-8080689.24593.65
380787-8078789.22493.83
479027-7902787.28092.37
578827-7882787.05991.81
678239-7823986.41091.25
极限180474-8047488.87890.371.6394.7896.031.52
282738-8273891.37996.68
381392-8139289.89295.39
482321-8232190.91896.88
580307-8030788.69494.31
683694-8369492.43598.14
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