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%
114.018797887951880118799487963879790.03
214.058812888054880910.06
单位质量响应值RSD%判断
6279.736269.820.12数据可信
中间条件24月-供试品溶液-2022032901批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min184293-8429394.25486.647.2394.2586.647.23
276681-7668185.74385.74
373421-7342182.09882.10
479795-7979589.22589.22
569079-6907977.24377.24
681641-8164191.28991.29
10min182839-8283992.62993.203.9393.5794.073.88
287079-8707997.37098.23
386297-8629796.49597.32
477978-7797887.19388.09
582099-8209991.80192.57
683802-8380293.70594.62
15min184337-8433794.30493.473.4896.1795.263.44
286265-8626596.46098.29
384639-8463994.64196.43
477995-7799587.21288.98
583296-8329693.14094.83
684991-8499195.03596.88
20min180443-8044389.94993.073.0292.7695.802.94
285439-8543995.53698.33
385707-8570795.83698.57
480127-8012789.59692.23
584926-8492694.96297.58
682739-8273992.51795.32
30min180349-8034989.84490.663.4593.5694.333.35
282479-8247992.22695.98
384824-8482494.84898.54
477016-7701686.11789.65
582620-8262092.38495.96
679184-7918488.54292.27
45min179918-7991889.36290.493.1793.9795.063.08
282711-8271192.48697.16
384237-8423794.19298.83
477367-7736786.51090.90
582194-8219491.90796.40
679118-7911888.46893.08
60min177889-7788987.09488.823.2192.6094.293.11
281116-8111690.70296.30
383317-8331793.16398.74
476799-7679985.87591.13
580158-8015889.63195.05
677299-7729986.43491.93
极限179787-7978789.21688.963.3095.5995.323.23
281060-8106090.63997.14
382953-8295392.75699.27
475073-7507383.94590.06
579603-7960389.01095.32
678860-7886088.17994.54
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%
114.018807688076881358825188176881430.09
214.058799087924879570.06
单位质量响应值RSD%判断
6291.436260.280.36数据可信
中间条件24月-供试品溶液-2022033001批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169033-6903377.17885.396.4677.1885.396.46
278379-7837987.62787.63
373642-7364282.33182.33
483451-8345193.29793.30
578564-7856487.83487.83
675176-7517684.04684.05
10min184297-8429794.24394.162.3995.0195.022.40
286167-8616796.33497.21
381201-8120190.78291.61
486696-8669696.92597.86
583352-8335293.18794.07
683642-8364293.51194.35
15min181120-8112090.69191.571.3292.4193.371.36
282217-8221791.91893.76
380844-8084490.38392.11
482938-8293892.72494.63
583342-8334293.17594.99
680990-8099090.54692.32
20min180770-8077090.30090.652.7692.9293.362.74
282236-8223691.93994.70
376749-7674985.80588.44
482089-8208991.77594.60
582906-8290692.68895.43
681755-8175591.40194.08
30min181474-8147491.08792.201.5994.6195.821.62
283418-8341893.26096.94
380275-8027589.74793.24
483098-8309892.90396.65
583541-8354193.39897.07
683005-8300592.79996.39
45min182193-8219391.89190.792.4496.3395.332.38
282257-8225791.96296.57
379222-7922288.56992.96
481830-8183091.48596.16
583424-8342493.26797.87
678340-7834087.58392.11
60min181140-8114090.71489.991.4996.0795.441.48
280990-8099090.54696.08
379645-7964589.04294.32
481946-8194691.61597.21
580620-8062090.13295.67
678595-7859587.86893.27
极限179354-7935488.71789.282.4194.9895.632.37
279937-7993789.36995.80
376453-7645385.47491.64
481842-8184291.49998.01
581483-8148391.09797.53
680095-8009589.54595.82
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%
114.018787087904879438796387969879300.05
214.058897289003889880.03
单位质量响应值RSD%判断
6276.236333.670.65数据可信
中间条件24月-供试品溶液-2022033101批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181235-8123590.40287.164.5290.4087.164.51
271398-7139879.45579.46
380087-8008789.12589.12
479476-7947688.44588.44
579562-7956288.54088.54
678168-7816886.98986.99
10min185256-8525694.87792.542.6295.7893.412.61
281755-8175590.98191.78
385290-8529094.91595.81
484228-8422893.73394.62
579811-7981188.81889.70
682588-8258891.90892.78
15min185634-8563495.29893.342.0797.1595.142.07
281810-8181091.04292.75
384476-8447694.00995.85
483786-8378693.24195.06
581869-8186991.10892.88
685661-8566195.32897.12
20min184046-8404693.53091.761.8696.3494.501.88
280386-8038689.45792.07
383718-8371893.16595.95
483007-8300792.37495.13
580762-8076289.87692.56
682840-8284092.18894.93
30min185626-8562695.28991.533.0199.0395.182.96
278712-7871287.59491.10
381482-8148290.67794.39
481786-8178691.01594.69
581401-8140190.58794.17
684486-8448694.02097.68
45min183101-8310192.47989.832.1897.1794.392.18
278324-7832487.16391.55
380442-8044289.52094.14
480729-8072989.83994.43
579453-7945388.41992.91
682257-8225791.54096.14
60min181505-8150590.70388.961.7096.3294.431.71
277988-7798886.78992.05
380417-8041789.49295.01
478587-7858787.45592.94
580374-8037489.44494.82
680788-8078889.90595.42
极限182978-8297892.34289.102.9998.8795.452.93
276225-7622584.82790.95
379664-7966488.65495.06
479804-7980488.81095.17
579465-7946588.43294.70
682237-8223791.51797.94
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%
114.018869788683887238865288680886870.03
214.058994589860899020.07
单位质量响应值RSD%判断
6330.266398.720.77数据可信
中间条件24月-供试品溶液-FA2515批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176922-7692284.80279.603.8884.8079.603.88
270931-7093178.19878.20
374290-7429081.90181.90
469752-6975276.89876.90
570866-7086678.12678.13
670442-7044277.65877.66
10min179341-7934187.46984.095.9488.3284.895.90
278984-7898487.07687.86
376883-7688384.75985.58
480278-8027888.50289.27
568287-6828775.28376.06
673892-7389281.46282.24
15min179526-7952687.67385.133.7189.4086.773.66
278723-7872386.78888.44
373533-7353381.06682.73
480161-8016188.37390.03
577459-7745985.39486.93
673905-7390581.47683.07
20min181345-8134589.67886.264.9392.2888.754.83
278261-7826186.27888.80
371171-7117178.46280.94
481924-8192490.31792.85
579101-7910187.20589.59
677671-7767185.62888.03
30min176972-7697284.85784.224.9688.3587.574.82
272463-7246379.88783.27
374319-7431981.93385.19
483441-8344191.98995.43
575105-7510582.79986.06
676053-7605383.84487.11
45min179270-7927087.39185.683.8391.7489.873.74
278405-7840586.43790.62
377089-7708984.98689.07
480211-8021188.42892.79
579283-7928387.40591.49
672032-7203279.41183.51
60min178374-7837486.40386.431.8291.6291.481.85
278832-7883286.90891.95
377758-7775885.72490.66
480822-8082289.10294.35
578079-7807986.07891.04
676522-7652284.36189.26
极限178412-7841286.44583.906.2392.5389.815.83
278358-7835886.38592.30
379887-7988788.07193.86
474943-7494382.62188.76
567009-6700973.87479.70
677997-7799785.98791.73
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