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2000
标示量(mg)10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%
110.762246622509223702229422469224220.40
210.832242022451224360.10
单位质量响应值RSD%判断
2083.832071.650.42数据可信
供试品溶液-2022082001批-培哚普利-醋酸盐缓冲液(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%
5min120076-2007682.44082.255.8382.4482.255.83
219693-1969380.86880.87
320747-2074785.19685.20
418572-1857276.26476.26
519215-1921578.90578.90
621871-2187189.81189.81
10min122057-2205790.57590.614.1191.4991.524.13
221994-2199490.31791.22
322399-2239991.98092.93
421120-2112086.72887.57
521216-2121687.12288.00
623607-2360796.94097.94
15min121890-2189089.88991.213.8291.8193.133.83
222052-2205290.55592.46
322658-2265893.04395.01
421663-2166388.95790.77
521318-2131887.54189.39
623682-2368297.24899.32
20min121949-2194990.13291.903.4093.0594.833.43
222332-2233291.70594.61
322730-2273093.33996.34
421838-2183889.67692.48
521699-2169989.10591.92
623731-2373197.449100.60
30min122129-2212990.87192.152.9794.7996.113.00
222699-2269993.21297.14
322279-2227991.48795.53
422068-2206890.62094.42
521814-2181489.57793.38
623659-2365997.154101.39
45min122282-2228291.49991.562.7996.4396.542.82
222252-2225291.37696.34
321894-2189489.90694.96
422147-2214790.94595.75
521717-2171789.17993.98
623484-2348496.435101.75
极限122009-2200990.37892.042.3196.3398.042.31
222639-2263992.96598.94
321989-2198990.29696.35
422724-2272493.31499.13
521931-2193190.05895.85
623196-2319695.252101.64
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2000
标示量(mg)10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%
113.988145480964811028092181349811580.29
213.988099780998809980.01
单位质量响应值RSD%判断
5805.295793.850.14数据可信
供试品溶液-2022082001批-氨氯地平-醋酸盐缓冲液(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%
5min161389-6138968.61870.545.5068.6270.545.50
263858-6385871.37871.38
365421-6542173.12573.12
459246-5924666.22366.22
560291-6029167.39167.39
668429-6842976.48776.49
10min177707-7770786.85886.765.0187.6287.545.01
278621-7862187.87988.67
378705-7870587.97388.79
473585-7358582.25082.99
573298-7329881.92982.68
683805-8380593.67494.52
15min177804-7780486.96687.824.4988.6989.574.50
279272-7927288.60790.38
379733-7973389.12290.91
476180-7618085.15186.80
574063-7406382.78584.44
684374-8437494.31096.20
20min177318-7731886.42388.014.6089.1290.734.61
279794-7979489.19091.94
380236-8023689.68492.46
475558-7555884.45687.05
574876-7487683.69386.27
684655-8465594.62497.56
30min177762-7776286.91988.653.8090.5792.353.83
280916-8091690.44594.19
379532-7953288.89892.67
477401-7740186.51690.05
575943-7594384.88688.39
684334-8433494.26598.25
45min178946-7894688.24388.753.6492.8693.443.67
279879-7987989.28594.04
378607-7860787.86492.63
478013-7801387.20091.70
576228-7622885.20489.66
684742-8474294.72199.76
极限179661-7966189.04291.542.3894.6497.222.38
283028-8302892.80598.55
379975-7997589.39395.13
482955-8295592.72498.19
581169-8116990.72796.13
684608-8460894.571100.66
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2000
标示量(mg)10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%
110.762238722406223702226622263223380.31
210.832237222318223450.18
单位质量响应值RSD%判断
2076.022063.250.44数据可信
供试品溶液-2022082001批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116193-1619366.75674.089.6666.7674.089.65
219503-1950380.40180.40
317735-1773573.11373.11
420267-2026783.55183.55
515932-1593265.68065.68
618186-1818674.97274.97
10min120883-2088386.09088.232.3986.8389.062.45
221700-2170089.45890.35
321128-2112887.10087.91
422293-2229391.90392.83
521219-2121987.47588.21
621196-2119687.38188.21
15min122203-2220391.53290.181.9593.2391.981.93
221765-2176589.72691.61
321409-2140988.25990.04
422447-2244792.53894.49
522023-2202390.79092.49
621406-2140688.24690.05
20min122354-2235492.15490.861.6994.8793.661.66
221814-2181489.92892.81
321605-2160589.06791.83
422423-2242392.43995.42
522339-2233992.09394.80
621699-2169989.45492.24
30min122382-2238292.27091.101.1596.0194.921.13
221927-2192790.39494.28
321765-2176589.72693.48
422332-2233292.06496.07
522243-2224391.69795.43
621939-2193990.44494.22
45min122592-2259293.13691.181.8397.9096.011.76
221881-2188190.20495.09
321896-2189690.26695.01
422376-2237692.24597.27
522421-2242192.43197.18
621544-2154488.81593.60
极限122519-2251992.83592.241.5698.6398.081.51
222180-2218091.43797.33
322521-2252192.84398.59
422658-2265893.40899.46
522615-2261593.23099.01
621750-2175089.66495.43
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2000
标示量(mg)10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%
113.988142780265803948085181048807970.59
213.988071481014808640.27
单位质量响应值RSD%判断
5779.475784.260.06数据可信
供试品溶液-2022082001批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151829-5182958.11062.028.2458.1162.028.24
258879-5887966.01466.01
351156-5115657.35557.36
462057-6205769.57769.58
551468-5146857.70557.70
656498-5649863.34463.34
10min174410-7441083.42783.632.1984.0784.312.21
274881-7488183.95584.69
371594-7159480.27080.91
476456-7645685.72186.49
575369-7536984.50285.14
674815-7481583.88184.58
15min178629-7862988.15786.222.4989.7387.842.47
276643-7664385.93187.60
373910-7391082.86684.40
478182-7818287.65689.38
578524-7852488.04089.62
675504-7550484.65486.29
20min178891-7889188.45186.422.9791.0089.002.92
275561-7556184.71787.34
373527-7352782.43784.89
477897-7789787.33790.04
579754-7975489.41991.98
676854-7685486.16788.74
30min179164-7916488.75787.352.1292.2990.882.12
276768-7676886.07189.63
375143-7514384.24987.61
479094-7909488.67992.35
579153-7915388.74592.30
678126-7812687.59391.13
45min181075-8107590.90088.112.1495.4292.622.11
277913-7791387.35491.87
376500-7650085.77090.07
478609-7860988.13592.79
579963-7996389.65394.19
677486-7748686.87691.38
极限182380-8238092.36391.491.3397.8996.981.30
281023-8102390.84196.33
381606-8160691.49596.75
482182-8218292.14197.78
582664-8266492.68198.22
679740-7974089.40394.88
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2000
标示量(mg)10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%
110.762246922420225702244922520224860.27
210.832257922569225740.04
单位质量响应值RSD%判断
2089.782084.400.19数据可信
供试品溶液-2022082101批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121386-2138687.42683.073.7187.4383.073.71
220276-2027682.88882.89
319289-1928978.85378.85
420273-2027382.87682.88
519787-1978780.88980.89
620909-2090985.47685.48
10min123047-2304794.21693.041.8195.1993.961.82
223193-2319394.81395.73
322344-2234491.34292.22
422360-2236091.40892.33
522458-2245891.80892.71
623147-2314794.62595.57
15min123165-2316594.69993.311.5896.7295.271.60
222865-2286593.47295.45
322543-2254392.15694.05
422597-2259792.37794.31
522451-2245191.78093.70
623335-2333595.39497.39
20min123052-2305294.23793.321.5497.3196.321.56
223149-2314994.63397.65
322431-2243191.69894.61
422625-2262592.49195.45
522497-2249791.96894.91
623218-2321894.91597.98
30min122728-2272892.91293.220.8797.0397.250.88
223042-2304294.19698.26
322622-2262292.47996.41
422878-2287893.52597.52
522562-2256292.23496.19
622986-2298693.96798.08
45min122597-2259792.37792.691.0397.5397.761.05
222898-2289893.60798.72
322507-2250792.00996.97
422476-2247691.88296.91
522531-2253192.10797.09
623032-2303294.15599.31
极限122548-2254892.17693.171.0798.3599.261.05
222856-2285693.43599.59
322517-2251792.05098.03
422722-2272292.88898.94
522946-2294693.80399.81
623152-2315294.645100.85
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2000
标示量(mg)10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%
113.988076281321812198088280948810260.29
213.988095481003809780.05
单位质量响应值RSD%判断
5795.855792.420.05数据可信
供试品溶液-2022082101批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170096-7009678.42474.044.9078.4274.044.90
262673-6267370.11970.12
362463-6246369.88469.88
466628-6662874.54474.54
565748-6574873.55973.56
669446-6944677.69777.70
10min182245-8224592.01689.512.2192.8990.342.22
280354-8035489.90190.68
378968-7896888.35089.13
477727-7772786.96187.79
578977-7897788.36089.18
681784-8178491.50092.36
15min182186-8218691.95090.661.4793.8492.481.49
280036-8003689.54591.32
380974-8097490.59492.35
479923-7992389.41891.21
580348-8034889.89491.69
682757-8275792.58994.47
20min183354-8335493.25790.662.0796.1793.482.06
281678-8167891.38294.15
379769-7976989.24692.01
479329-7932988.75491.54
579689-7968989.15791.95
682394-8239492.18395.09
30min181628-8162891.32690.301.0995.2894.131.12
281056-8105690.68694.47
380387-8038789.93793.69
479967-7996789.46893.24
579566-7956689.01992.81
681656-8165691.35795.29
45min181718-8171891.42789.861.7496.3994.691.73
281156-8115690.79895.59
379837-7983789.32294.08
479449-7944988.88893.66
578186-7818687.47592.25
681544-8154491.23296.18
极限182057-8205791.80692.630.8397.7998.460.78
283008-8300892.87098.67
381916-8191691.64897.40
482804-8280492.64298.40
583476-8347693.39399.14
683500-8350093.42099.38
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2000
标示量(mg)10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%
110.762243922375223522242722368223920.18
210.832237022450224100.26
单位质量响应值RSD%判断
2081.042069.250.41数据可信
供试品溶液-2022082101批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118431-1843175.78079.176.0475.7879.176.04
219368-1936879.63379.63
318461-1846175.90375.90
418031-1803174.13574.14
520949-2094986.13386.13
620288-2028883.41583.42
10min120926-2092686.03889.483.5986.8890.363.62
221698-2169889.21290.10
321238-2123887.32188.16
421290-2129087.53588.36
522836-2283693.89194.85
622595-2259592.90093.83
15min120961-2096186.18289.413.3987.9891.283.41
221611-2161188.85590.73
321283-2128387.50689.32
421391-2139187.95089.75
522950-2295094.36096.36
622278-2227891.59793.56
20min122041-2204190.62393.022.5693.3895.882.56
222483-2248392.44095.30
322824-2282493.84296.63
422473-2247392.39995.17
523674-2367497.337100.39
622246-2224691.46694.44
30min122127-2212790.97693.472.6094.7497.372.64
222721-2272193.41997.31
322256-2225691.50795.34
422407-2240792.12895.93
523562-2356296.876101.01
623329-2332995.91899.91
45min121989-2198990.40992.952.3795.1897.892.41
222787-2278793.69098.62
322457-2245792.33397.18
422094-2209490.84195.66
523407-2340796.239101.45
622905-2290594.17599.23
极限121866-2186689.90391.852.0095.6897.822.07
222517-2251792.58098.55
322230-2223091.40097.27
421882-2188289.96995.80
523044-2304494.747101.02
622495-2249592.48998.59
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2000
标示量(mg)10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%
113.988099680613809208083681058808850.22
213.988091780707808120.19
单位质量响应值RSD%判断
5785.775780.540.07数据可信
供试品溶液-2022082101批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157823-5782364.81669.457.9564.8269.457.95
260541-6054167.86267.86
358136-5813665.16665.17
458921-5892166.04666.05
569023-6902377.37077.37
667288-6728875.42575.43
10min171823-7182380.50985.905.0181.2386.685.03
275276-7527684.37985.13
374578-7457883.59784.32
475607-7560784.75085.48
581688-8168891.56792.43
680841-8084190.61791.46
15min172278-7227881.01986.224.5282.6387.944.55
274879-7487983.93485.63
375929-7592985.11186.76
476518-7651885.77187.45
581665-8166591.54193.42
680225-8022589.92791.77
20min175963-7596385.14989.433.8087.6692.113.84
277820-7782087.23189.85
379651-7965189.28391.88
479701-7970189.33991.97
584959-8495995.23398.13
680585-8058590.33093.17
30min176426-7642685.66890.294.0389.1393.974.06
278967-7896788.51692.11
379046-7904688.60592.20
479967-7996789.63793.26
584509-8450994.72998.68
684392-8439294.59898.45
45min177791-7779187.19890.783.3091.6195.463.37
279768-7976889.41493.99
380261-8026189.96794.54
479860-7986089.51794.13
585221-8522195.527100.53
683007-8300793.04597.94
极限179652-7965289.28490.981.9794.6796.672.10
281047-8104790.84896.42
380673-8067390.42996.00
479771-7977189.41895.03
583934-8393494.084100.15
681908-8190891.81397.75
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