培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5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%
110.002042720354201592028520222202890.53
29.972046520263203640.71
单位质量响应值RSD%判断
2028.902042.530.48数据可信
供试品溶液-2025110421批-培哚普利-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113134-1313455.04754.3724.4755.0554.3824.47
210737-1073745.00145.00
311285-1128547.29847.30
410660-1066044.67844.68
512956-1295654.30154.30
619069-1906979.92279.92
10min121499-2149990.10793.924.0290.7294.534.01
222895-2289595.95896.46
323720-2372099.41599.94
421746-2174691.14291.64
521665-2166590.80291.41
622930-2293096.10496.99
15min122353-2235393.68696.683.2895.3098.323.21
223587-2358798.858100.42
324309-24309101.884103.51
422955-2295596.20997.72
522395-2239593.86295.47
622800-2280095.55997.52
20min122947-2294796.17696.922.2898.8399.642.18
223818-2381899.826102.49
323685-2368599.269102.03
423099-2309996.81399.39
522582-2258294.64697.30
622611-2261194.76797.78
30min122337-2233793.61994.842.0197.3498.641.91
222617-2261794.79398.57
323465-2346598.347102.21
422618-2261894.79798.45
522600-2260094.72198.43
622137-2213792.78196.85
45min122186-2218692.98694.902.5497.7599.752.40
223291-2329197.617102.44
323345-2334597.844102.80
422529-2252994.42499.13
522571-2257194.60099.36
621929-2192991.90997.01
极限122887-2288795.92495.340.83101.72101.240.76
222749-2274995.346101.26
322981-2298196.318102.36
422633-2263394.860100.62
522779-2277995.471101.28
622450-2245094.093100.22
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.698043180917805618070080821806860.25
213.748105280607808300.39
单位质量响应值RSD%判断
5893.795882.820.14数据可信
供试品溶液-2025110421批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133663-3366337.06039.7428.4337.0639.7428.43
228932-2893231.85231.85
332560-3256035.84635.85
428286-2828631.14031.14
537195-3719540.94840.95
655954-5595461.60161.60
10min172017-7201779.28486.446.5479.7086.896.55
281466-8146689.68790.04
384512-8451293.04093.44
475339-7533982.94283.29
574761-7476182.30582.76
683033-8303391.41292.10
15min178175-7817586.06491.083.7787.3692.493.78
285218-8521893.81895.17
386705-8670595.45596.89
481857-8185790.11791.39
580733-8073388.88090.25
683727-8372792.17693.88
20min181545-8154589.77491.923.0592.0294.333.01
287505-8750596.33598.73
385840-8584094.50297.00
482018-8201890.29592.56
581599-8159989.83392.19
682451-8245190.77193.50
30min180844-8084489.00291.152.1492.2594.582.10
284573-8457393.10896.57
385197-8519793.79597.34
482397-8239790.71293.98
582588-8258890.92294.28
681163-8116389.35393.09
45min180833-8083388.99091.522.6793.2395.972.60
286778-8677895.535100.03
384666-8466693.21097.79
482279-8227990.58294.86
582761-8276191.11395.48
681495-8149589.71994.44
极限183360-8336091.77292.220.9997.0097.691.05
283487-8348791.91297.47
385443-8544394.06599.69
483250-8325091.65196.94
583597-8359792.03397.41
683469-8346991.89297.61
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5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%
110.002042520299201752037920278203110.48
29.972038020494204370.40
单位质量响应值RSD%判断
2031.102049.850.65数据可信
供试品溶液-2025110521批-培哚普利-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110173-1017342.53857.9232.0442.5457.9232.04
29635-963540.28840.29
319752-1975282.59282.59
417705-1770574.03374.03
515727-1572765.76265.76
610117-1011742.30442.30
10min122461-2246193.92091.166.1994.3991.816.26
219413-1941381.17581.62
323048-2304896.37497.29
422603-2260394.51495.34
521050-2105088.02088.75
622237-2223792.98393.45
15min123400-2340097.84695.652.5999.3697.312.67
221725-2172590.84292.19
323166-2316696.86898.86
422871-2287195.63497.51
523008-2300896.20797.92
623077-2307796.49698.00
20min123301-2330197.43296.031.95100.0498.751.98
222308-2230893.28095.64
323231-2323197.140100.20
422732-2273295.05397.99
522737-2273795.07497.85
623488-2348898.214100.79
30min123083-2308396.52195.210.90100.2199.000.78
222782-2278295.26298.66
322498-2249894.07598.22
422731-2273195.04999.04
522892-2289295.72299.56
622638-2263894.66098.33
45min122929-2292995.87795.241.14100.64100.080.85
223069-2306996.462100.92
322329-2232993.36898.56
422679-2267994.83299.88
522747-2274795.116100.01
622907-2290795.785100.50
极限122434-2243493.80795.251.2199.63101.151.05
223174-2317496.901102.43
322824-2282495.438101.66
422511-2251194.129100.23
522937-2293795.910101.86
622796-2279695.321101.10
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.698110480664806798058480778807620.26
213.748099781069810330.07
单位质量响应值RSD%判断
5899.345897.600.03数据可信
供试品溶液-2025110521批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129792-2979232.74245.0733.2232.7445.0733.21
228243-2824331.03931.04
358701-5870164.51364.51
453013-5301358.26258.26
547264-4726451.94451.94
629068-2906831.94631.95
10min178777-7877786.57784.666.3386.9485.166.42
268950-6895075.77776.12
382420-8242090.58191.30
480986-8098689.00589.65
574773-7477382.17782.75
676301-7630183.85684.21
15min184066-8406692.39089.423.3893.7290.863.47
276424-7642483.99185.18
383729-8372992.01993.74
481838-8183889.94191.58
581207-8120789.24890.74
680932-8093288.94690.23
20min183704-8370491.99290.492.5794.3492.922.69
278655-7865586.44388.56
384928-8492893.33796.08
482032-8203290.15492.79
582084-8208490.21292.69
682608-8260890.78793.06
30min182551-8255190.72589.930.9494.1093.371.13
280674-8067488.66291.74
382241-8224190.38494.17
482422-8242290.58394.22
581992-8199290.11093.59
681108-8110889.13992.42
45min183114-8311491.34490.290.9295.7394.740.97
280964-8096488.98193.05
381638-8163889.72194.51
482436-8243690.59895.24
582344-8234490.49794.98
682460-8246090.62594.90
极限182379-8237990.53691.770.8695.9397.210.86
283767-8376792.06197.12
383036-8303691.25897.04
484231-8423192.57198.22
584193-8419392.52998.02
683387-8338791.64496.92
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5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%
110.002021320722205112052420376204690.93
29.972091620736208260.62
单位质量响应值RSD%判断
2046.902088.871.44数据可信
供试品溶液-2025110621批-培哚普利-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113075-1307553.95247.6127.5353.9547.6127.53
27614-761431.41831.42
310869-1086944.85044.85
412778-1277852.72752.73
58634-863435.62735.63
616254-1625467.07067.07
10min122484-2248492.77887.594.9793.3888.125.06
220269-2026983.63883.99
321304-2130487.90888.41
420019-2001982.60683.19
520848-2084886.02786.42
622434-2243492.57193.32
15min122870-2287094.37092.002.5296.0093.502.57
221779-2177989.86891.15
322467-2246792.70794.18
421433-2143388.44189.94
522604-2260493.27394.62
622620-2262093.33995.11
20min122554-2255493.06692.152.1895.7594.672.20
221879-2187990.28192.56
322728-2272893.78496.29
421576-2157689.03191.52
522733-2273393.80596.19
622518-2251892.91895.73
30min122075-2207591.09092.312.0094.8095.851.98
222127-2212791.30494.58
322942-2294294.66798.21
421771-2177189.83593.31
522653-2265393.47596.91
622652-2265293.47197.31
45min122348-2234892.21692.661.8796.9497.241.85
222144-2214491.37595.67
322802-2280294.09098.69
421875-2187590.26594.74
523004-2300494.92399.39
622561-2256193.09597.98
极限122275-2227591.91592.591.6397.6698.191.62
222328-2232892.13497.44
323026-2302695.014100.66
421927-2192790.47995.96
522556-2255693.07598.60
622520-2252092.92698.84
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.698152781531816588108481266814130.29
213.748078081048809140.24
单位质量响应值RSD%判断
5946.905888.940.70数据可信
供试品溶液-2025110621批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146476-4647650.91144.8022.9650.9144.8022.96
228575-2857531.30231.30
339365-3936543.12243.12
444445-4444548.68648.69
532509-3250935.61135.61
654035-5403559.19259.19
10min181393-8139389.16081.906.0189.7382.406.05
271079-7107977.86278.21
373849-7384980.89681.38
469358-6935875.97776.52
574525-7452581.63782.03
678381-7838185.86186.52
15min183107-8310791.03887.813.2092.5989.223.19
278851-7885186.37687.59
380006-8000687.64189.02
476241-7624183.51784.90
582795-8279590.69692.00
679952-7995287.58289.19
20min182661-8266190.54988.142.7093.1290.532.70
279954-7995487.58489.76
380291-8029187.95390.30
476831-7683184.16386.48
582755-8275590.65292.96
680305-8030587.96990.55
30min182620-8262090.50488.842.3994.0892.212.40
280009-8000987.64490.79
382322-8232290.17893.51
477823-7782385.25088.50
582808-8280890.71094.03
681047-8104788.78192.34
45min182219-8221990.06589.522.2794.6493.872.25
280854-8085488.57092.69
382491-8249190.36394.69
478751-7875186.26690.46
584300-8430092.34596.67
681732-8173289.53294.08
极限183139-8313991.07390.851.4596.6596.201.52
281861-8186189.67394.78
383981-8398191.99597.33
481079-8107988.81693.97
583656-8365691.63996.99
683897-8389791.90397.45
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