厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.573113931119312313130031227312030.24
213.593141131311313610.23
单位质量响应值RSD%判断
2299.412307.650.26数据可信
加速6月-供试品溶液-24032001批-左氨氯地平-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%
5min119207-1920752.64551.785.0852.6551.785.08
218698-1869851.25051.25
319718-1971854.04654.05
417463-1746347.86547.86
518234-1823449.97849.98
620029-2002954.89854.90
10min129200-2920080.03581.822.0680.3382.112.06
230070-3007082.42082.70
330786-3078684.38284.68
429286-2928680.27180.54
529556-2955681.01181.29
630208-3020882.79883.10
15min132561-3256189.24790.202.0089.9890.942.00
232713-3271389.66490.41
333797-3379792.63593.40
432783-3278389.85690.57
532036-3203687.80888.54
633556-3355691.97592.74
20min133579-3357992.03892.051.5193.2793.291.51
233490-3349091.79493.03
334538-3453894.66695.95
433197-3319790.99192.20
533567-3356792.00593.22
633130-3313090.80792.08
30min133480-3348091.76692.611.9293.5194.361.91
233341-3334191.38593.14
334745-3474595.23497.04
433694-3369492.35394.07
533073-3307390.65192.38
634391-3439194.26396.04
45min135170-3517096.39895.861.0798.6598.131.07
234409-3440994.31396.57
335377-3537796.96699.30
434634-3463494.92997.16
535062-3506296.10298.33
635191-3519196.45698.76
60min134707-3470795.12995.871.7797.9298.671.74
233994-3399493.17595.96
335722-3572297.911100.79
435529-3552997.382100.14
534985-3498595.89198.66
634924-3492495.72498.56
90min134671-3467195.03196.351.8998.3599.681.86
234021-3402193.24996.55
335601-3560197.580101.00
435542-3554297.418100.72
535393-3539397.010100.31
635679-3567997.794101.17
120min135237-3523796.58296.982.08100.43100.842.04
234979-3497995.87599.69
336377-3637799.707103.67
435916-3591698.443102.28
534275-3427593.94597.78
635499-3549997.300101.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限134722-3472295.17198.192.3699.55102.592.28
234838-3483895.48899.84
336012-3601298.706103.22
436440-3644099.879104.27
536738-36738100.696105.05
636183-3618399.175103.63
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.152042628204393020435622044762204268920435140.05
215.202039729203682820382780.11
单位质量响应值RSD%判断
134885.41134097.240.42数据可信
加速6月-供试品溶液-24032001批-厄贝沙坦-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%
5min1458171-45817120.44019.685.8320.4419.685.83
2447390-44739019.95919.96
3456670-45667020.37320.37
4416489-41648918.58118.58
5402314-40231417.94817.95
6466064-46606420.79220.79
10min1919790-91979041.03540.812.0741.1540.922.08
2922985-92298541.17741.29
3933499-93349941.64641.76
4897149-89714940.02440.13
5885899-88589939.52339.62
6928860-92886041.43941.55
15min11207132-120713253.85452.972.2754.2053.302.27
21183348-118334852.79353.13
31213876-121387654.15554.50
41172147-117214752.29352.62
51142833-114283350.98551.30
61204108-120410853.71954.06
20min11385251-138525161.80060.861.6862.4461.481.68
21363439-136343960.82761.46
31394456-139445662.21162.86
41359664-135966460.65961.27
51332791-133279159.46060.06
61348776-134877660.17360.82
30min11619216-161921672.23871.481.9673.2272.441.96
21617150-161715072.14673.12
31641724-164172473.24274.23
41587839-158783970.83871.79
51551366-155136669.21170.14
61595704-159570471.18972.17
45min11867708-186770883.32481.911.4984.7183.271.50
21844626-184462682.29483.67
31851297-185129782.59283.99
41833971-183397181.81983.17
51787352-178735279.73981.06
61830619-183061981.66983.04
60min11982335-198233588.43887.061.1390.2988.881.13
21932354-193235486.20888.04
31974178-197417888.07489.93
41949932-194993286.99288.79
51933240-193324086.24788.01
61936184-193618486.37988.21
90min12122045-212204594.67193.980.6797.0196.280.67
22086534-208653493.08695.39
32119845-211984594.57296.92
42109215-210921594.09896.38
52108024-210802494.04596.28
62094132-209413293.42595.73
120min12187847-218784797.60695.931.29100.4798.761.29
22154873-215487396.13598.96
32176674-217667497.10899.98
42134244-213424495.21598.02
52130772-213077295.06097.82
62117577-211757794.47197.30
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12148411-214841195.84796.790.7199.25100.150.65
22169382-216938296.782100.14
32158486-215848696.29699.71
42191112-219111297.752101.09
52180504-218050497.279100.57
62169662-216966296.795100.15
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.573153231623312443129531385314160.51
213.593162731677316520.12
单位质量响应值RSD%判断
2315.112329.070.43数据可信
加速6月-供试品溶液-24032501批-左氨氯地平-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%
5min122451-2245161.04559.834.6561.0559.834.65
223581-2358164.11864.12
321274-2127457.84557.84
421617-2161758.77858.78
520704-2070456.29556.30
622396-2239660.89660.90
10min132077-3207787.21984.992.0887.5685.322.08
231578-3157885.86286.22
331799-3179986.46386.78
430903-3090384.02784.35
530507-3050782.95083.26
630672-3067283.39983.74
15min133531-3353191.17289.612.2992.0090.412.26
231849-3184986.59987.43
333490-3349091.06191.86
433756-3375691.78492.58
532648-3264888.77189.54
632457-3245788.25289.05
20min134786-3478694.58593.271.6995.9194.571.68
233752-3375291.77393.09
335022-3502295.22696.53
434495-3449593.79395.10
533555-3355591.23892.50
634198-3419892.98694.28
30min136501-3650199.24895.572.61101.1097.392.58
234014-3401492.48694.31
335352-3535296.12497.96
435249-3524995.84497.67
534217-3421793.03894.81
635564-3556496.70098.51
45min134722-3472294.41192.162.6696.8294.512.61
232467-3246788.27990.62
333587-3358791.32593.70
434996-3499695.15697.51
533754-3375491.77994.07
633842-3384292.01894.36
60min135219-3521995.76295.261.3098.6998.131.30
234627-3462794.15296.98
334977-3497795.10497.98
435844-3584497.461100.35
534633-3463394.16996.97
634914-3491494.93397.79
90min136215-3621598.47096.392.52101.9399.782.48
234345-3434593.38696.74
336147-3614798.285101.69
436379-3637998.916102.34
534728-3472894.42797.75
634889-3488994.86598.25
120min135805-3580597.35595.483.81101.3799.413.71
234074-3407492.64996.52
334980-3498095.11299.06
437460-37460101.855105.83
533936-3393692.27396.12
634438-3443893.63897.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限139203-39203106.59595.835.80111.15100.295.60
234391-3439193.51197.90
334851-3485194.76199.24
435431-3543196.338100.88
533986-3398692.40996.77
633610-3361091.38795.82
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.152044485204507520438702045117204376520444620.04
215.202043055204296420430100.01
单位质量响应值RSD%判断
134947.99134408.550.29数据可信
加速6月-供试品溶液-24032501批-厄贝沙坦-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%
5min1470410-47041020.95721.115.6720.9621.115.66
2521068-52106823.21423.21
3447320-44732019.92819.93
4456329-45632920.33020.33
5460571-46057120.51920.52
6487014-48701421.69721.70
10min1945329-94532942.11542.130.9742.2342.250.97
2949760-94976042.31342.44
3950259-95025942.33542.45
4934530-93453041.63441.75
5935833-93583341.69241.81
6958271-95827142.69242.81
15min11206210-120621053.73853.810.7954.0954.160.78
21190791-119079153.05153.41
31212961-121296154.03854.38
41208469-120846953.83854.18
51209326-120932653.87654.22
61219013-121901354.30854.67
20min11410874-141087462.85662.481.0463.5063.131.03
21379509-137950961.45862.12
31401639-140163962.44463.09
41398130-139813062.28862.93
51401489-140148962.43763.08
61423433-142343363.41564.07
30min11671935-167193574.48673.361.6275.4874.351.61
21613323-161332371.87572.88
31643729-164372973.22974.22
41628777-162877772.56373.55
51637686-163768672.96073.95
61684043-168404375.02576.04
45min11819843-181984381.07581.042.0582.4982.442.02
21747556-174755677.85579.25
31828766-182876681.47382.87
41832507-183250781.64083.03
51829034-182903481.48582.88
61856528-185652882.71084.14
60min11991758-199175888.73487.651.5390.6089.511.51
21912985-191298585.22587.06
31981306-198130688.26990.12
41965503-196550387.56589.41
51959749-195974987.30889.16
61993471-199347188.81190.70
90min12120195-212019594.45692.902.0496.8195.242.01
22003476-200347689.25691.56
32101653-210165393.63095.97
42090222-209022293.12195.45
52082787-208278792.79095.12
62113666-211366694.16696.55
120min12115010-211501094.22593.261.9197.1196.121.89
22025038-202503890.21793.02
32120602-212060294.47597.34
42088834-208883493.05995.91
52075501-207550192.46595.32
62134941-213494195.11398.02
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12134026-213402695.07393.821.2698.4897.201.25
22059288-205928891.74395.05
32106712-210671293.85697.24
42128094-212809494.80898.18
52101489-210148993.62396.99
62106233-210623393.83497.27
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.573158631548314753156231239314820.46
213.593116631419312920.58
单位质量响应值RSD%判断
2319.972302.580.54数据可信
加速6月-供试品溶液-24032502批-左氨氯地平-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%
5min118760-1876051.24854.9411.1651.2554.9411.16
220028-2002854.71254.71
322778-2277862.22462.22
420829-2082956.90056.90
521761-2176159.44659.45
616509-1650945.09945.10
10min130086-3008682.18882.364.3582.4782.664.37
230049-3004982.08782.39
330490-3049083.29283.64
431486-3148686.01386.33
531042-3104284.80085.13
627730-2773075.75276.00
15min133280-3328090.91489.373.2191.6590.143.23
232623-3262389.11989.88
333523-3352391.57792.39
432414-3241488.54889.34
533632-3363291.87592.68
630823-3082384.20284.87
20min135900-3590098.07191.974.2099.3293.234.18
232853-3285389.74791.00
334203-3420393.43594.75
433262-3326290.86492.15
534039-3403992.98794.30
631737-3173786.69887.84
30min133775-3377592.26692.013.0594.0693.783.07
233992-3399292.85994.61
334444-3444494.09395.93
432906-3290689.89291.68
534887-3488795.30497.13
632092-3209287.66889.29
45min135411-3541196.73594.622.3299.0496.902.35
234555-3455594.39796.67
335038-3503895.71698.08
434808-3480895.08897.38
534900-3490095.33997.70
633105-3310590.43692.54
60min136310-3631099.19194.463.10102.0397.273.07
234578-3457894.45997.25
335108-3510895.90798.80
433602-3360291.79394.61
534520-3452094.30197.19
633361-3336191.13593.75
90min133479-3347991.45790.871.3694.8594.201.40
232956-3295690.02993.35
333338-3333891.07294.50
433014-3301490.18793.52
534017-3401792.92796.34
632782-3278289.55392.67
120min134272-3427293.62491.921.4497.5295.751.47
233522-3352291.57595.39
333346-3334691.09495.02
433503-3350391.52395.35
534194-3419493.41097.34
633050-3305090.28593.90
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限134628-3462894.59693.772.2299.0298.112.23
233729-3372992.14096.47
334351-3435193.83998.27
434192-3419293.40597.74
535609-3560997.276101.72
633438-3343891.34595.46
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.152039427203911720381212039272203900520389880.03
215.202029643203036120300020.03
单位质量响应值RSD%判断
134586.67133552.760.55数据可信
加速6月-供试品溶液-24032502批-厄贝沙坦-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%
5min1432698-43269819.36520.829.1919.3620.829.19
2487433-48743321.81421.81
3514613-51461323.03123.03
4483253-48325321.62721.63
5476505-47650521.32521.33
6396793-39679317.75817.76
10min1911461-91146140.79140.972.8140.9041.082.82
2935197-93519741.85341.97
3946192-94619242.34542.47
4913923-91392340.90141.02
5913951-91395140.90341.02
6871497-87149739.00339.10
15min11194958-119495853.47953.222.3353.8153.562.35
21200279-120027953.71754.07
31222668-122266854.71955.08
41199001-119900153.65954.01
51177099-117709952.67953.03
61141106-114110651.06851.38
20min11394816-139481662.42361.392.6263.0562.022.62
21398128-139812862.57163.22
31414377-141437763.29863.97
41357174-135717460.73861.38
51339709-133970959.95760.60
61325599-132559959.32559.92
30min11634459-163445973.14872.882.2274.1373.862.22
21678121-167812175.10276.10
31662069-166206974.38375.40
41607081-160708171.92372.91
51603418-160341871.75972.73
61586137-158613770.98571.91
45min11869343-186934383.66082.382.2785.0483.762.27
21873810-187381083.86085.28
31881458-188145884.20285.63
41838902-183890282.29783.68
51783112-178311279.80181.17
61798001-179800180.46781.79
60min11980032-198003288.61387.451.8690.4689.301.86
21992717-199271789.18191.06
31972423-197242388.27390.17
41956679-195667987.56889.41
51896716-189671684.88586.70
61926273-192627386.20787.98
90min12018067-201806790.31690.071.3492.6692.401.36
22044272-204427291.48893.87
32036413-203641391.13793.53
42007933-200793389.86292.19
51970017-197001788.16590.45
61999061-199906189.46591.71
120min12086469-208646993.37792.191.3096.2295.021.31
22079004-207900493.04395.93
32066332-206633292.47695.37
42062495-206249592.30495.13
52010511-201051189.97792.75
62055233-205523391.97994.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12096510-209651093.82693.280.9897.1996.620.98
22100187-210018793.99197.39
32099184-209918493.94697.36
42066293-206629392.47495.81
52051982-205198291.83395.11
62091577-209157793.60596.86
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.573139531498315103132631274314010.34
213.593163531534315840.23
单位质量响应值RSD%判断
2314.002324.060.31数据可信
加速6月-供试品溶液-2024042411批-左氨氯地平-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%
5min121877-2187759.56350.0612.6959.5650.0612.69
214832-1483240.38240.38
318882-1888251.40851.41
418651-1865150.77950.78
518993-1899351.71151.71
617089-1708946.52746.53
10min132680-3268088.97587.102.7589.3187.372.78
230772-3077283.78084.00
332178-3217887.60887.89
433191-3319190.36690.65
531387-3138785.45585.74
631731-3173186.39186.65
15min134097-3409792.83392.472.8793.6693.232.87
233576-3357691.41492.10
333891-3389192.27293.04
435807-3580797.48998.27
533245-3324590.51391.28
633161-3316190.28591.02
20min135216-3521695.88093.763.0097.2295.043.00
234279-3427993.32894.53
334481-3448193.87895.16
435906-3590697.75899.08
532997-3299789.83891.10
633756-3375691.90593.14
30min135259-3525995.99795.562.7097.8797.362.70
234903-3490395.02796.74
335050-3505095.42897.23
436835-36835100.287102.16
534404-3440493.66995.43
634144-3414492.96194.71
45min133991-3399192.54492.661.4894.9594.981.50
233254-3325490.53892.78
334357-3435793.54195.88
434655-3465594.35296.78
533699-3369991.74994.03
634239-3423993.22095.49
60min135377-3537796.31894.352.8999.2497.192.89
233489-3348991.17893.92
334167-3416793.02495.88
436280-3628098.776101.73
534356-3435693.53896.33
634249-3424993.24796.03
90min135469-3546996.56896.134.56100.0299.504.48
234746-3474694.60097.85
335412-3541296.41399.79
438265-38265104.181107.68
534365-3436593.56396.88
633598-3359891.47494.78
120min134959-3495995.18094.914.8799.1798.814.78
233887-3388792.26196.04
334295-3429593.37297.28
438212-38212104.037108.11
533917-3391792.34396.18
633884-3388492.25396.06
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限134517-3451793.97694.321.7698.5098.751.81
234339-3433993.49297.78
334741-3474194.58699.01
435769-3576997.385102.04
534531-3453194.01598.36
633967-3396792.47996.80
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.152036861203657620370112033970203354420355920.09
215.202032765203404820334060.05
单位质量响应值RSD%判断
134362.51133776.710.31数据可信
加速6月-供试品溶液-2024042411批-厄贝沙坦-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%
5min1466352-46635220.87117.2712.8320.8717.2712.83
2315716-31571614.12914.13
3403170-40317018.04318.04
4379505-37950516.98416.98
5387830-38783017.35717.36
6363173-36317316.25316.25
10min1980361-98036143.87442.722.4943.9942.812.51
2923214-92321441.31741.40
3979881-97988143.85343.95
4961998-96199843.05243.15
5947599-94759942.40842.50
6933908-93390841.79541.89
15min11245034-124503455.71955.901.1956.0856.231.19
21246129-124612955.76856.08
31271176-127117656.88957.23
41261751-126175156.46756.80
51239679-123967955.47955.81
61230671-123067155.07655.40
20min11457612-145761265.23364.510.9765.9065.150.97
21450685-145068564.92365.54
31443037-144303764.58065.24
41446641-144664164.74265.39
51419525-141952563.52864.17
61430667-143066764.02764.66
30min11668404-166840474.66675.231.1175.7076.231.10
21688125-168812575.54976.53
31715905-171590576.79277.81
41671897-167189774.82375.83
51673089-167308974.87675.87
61668185-166818574.65675.64
45min11819755-181975581.44082.871.2982.8984.291.26
21871516-187151683.75685.15
31880541-188054184.16085.61
41831500-183150081.96583.39
51843775-184377582.51583.92
61862868-186286883.36984.77
60min11963057-196305787.85387.710.8089.7589.590.80
21944925-194492587.04188.90
31988687-198868789.00090.91
41950667-195066787.29889.18
51960461-196046187.73789.60
61951505-195150587.33689.20
90min12048642-204864291.68391.941.1894.0794.311.17
22066606-206660692.48794.83
32095299-209529993.77196.18
42044089-204408991.47993.84
52024278-202427890.59392.95
62047927-204792791.65194.00
120min12072013-207201392.72994.331.0395.6397.211.01
22113935-211393594.60597.47
32128890-212889095.27498.20
42121772-212177294.95697.83
52091263-209126393.59096.45
62118950-211895094.83097.69
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12103712-210371294.14894.950.9097.5698.350.89
22141653-214165395.84699.23
32146950-214695096.08399.54
42100996-210099694.02697.42
52118801-211880194.82398.20
62117077-211707794.74698.13
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