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%
19.952070820585206652053620674206340.35
29.992064420709206760.23
单位质量响应值RSD%判断
2073.772069.670.14数据可信
供试品溶液-2022081601批-培哚普利-磷酸盐缓冲液(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%
5min122311-2231191.88491.802.1791.8891.802.17
223098-2309895.12595.13
322100-2210091.01591.01
421607-2160788.98588.98
522349-2234992.04092.04
622275-2227591.73691.74
10min123038-2303894.87895.581.6795.9096.601.67
223638-2363897.34998.41
323642-2364297.36598.38
422674-2267493.37994.37
523280-2328095.87596.90
622983-2298394.65195.67
15min122809-2280993.93595.151.1796.0197.241.18
223519-2351996.85999.00
323225-2322595.64897.74
422812-2281293.94795.97
523092-2309295.10097.19
623174-2317495.43897.51
20min122757-2275793.72194.151.7296.8497.281.70
223545-2354596.966100.18
322921-2292194.39697.55
422624-2262493.17396.24
522388-2238892.20195.35
622926-2292694.41797.55
30min122416-2241692.31693.531.5696.4897.721.55
223321-2332196.043100.34
322908-2290894.34398.55
422464-2246492.51496.62
522454-2245492.47396.64
622703-2270393.49897.68
45min122222-2222291.51792.971.7696.7098.191.74
223194-2319495.520100.88
322611-2261193.11998.37
422079-2207990.92896.06
522752-2275293.70098.90
622589-2258993.02998.25
极限121982-2198290.52991.671.1296.7397.921.11
222663-2266393.33499.75
322141-2214191.18497.47
422418-2241892.32598.47
522083-2208390.94597.18
622265-2226591.69497.95
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%
113.931639341636401633371637761634071636190.16
214.001632021632631632320.03
单位质量响应值RSD%判断
11745.8011659.430.53数据可信
供试品溶液-2022081601批-氨氯地平-磷酸盐缓冲液(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%
5min158727-5872732.53235.236.7732.5335.236.78
269011-6901138.22838.23
358529-5852932.42232.42
463149-6314934.98134.98
565326-6532636.18736.19
666857-6685737.03537.04
10min1106637-10663759.07159.401.3859.4359.791.37
2108832-10883260.28760.71
3109058-10905860.41260.77
4105811-10581158.61359.00
5105621-10562158.50858.91
6107391-10739159.48959.90
15min1127808-12780870.79970.651.6371.8271.701.62
2130554-13055472.32073.41
3127908-12790870.85471.89
4126639-12663970.15171.19
5124215-12421568.80869.86
6128123-12812370.97372.05
20min1136450-13645075.58675.722.3277.3977.552.30
2141085-14108578.15380.05
3138373-13837376.65178.47
4133084-13308473.72175.54
5133087-13308773.72375.54
6138026-13802676.45978.32
30min1144887-14488780.25981.072.0582.9083.742.04
2150407-15040783.31786.08
3148447-14844782.23184.90
4142035-14203578.68081.32
5144870-14487080.25082.89
6147408-14740881.65684.37
45min1150771-15077183.51984.202.1687.0587.782.15
2156720-15672086.81490.51
3152491-15249184.47288.06
4146765-14676581.30084.81
5151785-15178584.08087.61
6153482-15348285.02188.64
极限1156165-15616586.50787.841.5890.9792.361.56
2162592-16259290.06794.72
3156982-15698286.95991.48
4160125-16012588.70093.12
5156578-15657886.73691.20
6159004-15900488.07992.64
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%
19.952065520571206902073420658206620.29
29.992074120593206670.51
单位质量响应值RSD%判断
2076.582068.770.27数据可信
供试品溶液-2022081601批-培哚普利-磷酸盐缓冲液(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%
5min120377-2037783.88188.362.8283.8888.362.82
221392-2139288.05988.06
321730-2173089.45089.45
421355-2135587.90687.91
521802-2180289.74689.75
622132-2213291.10591.10
10min122365-2236592.06494.121.5893.0095.101.58
222460-2246092.45593.43
323219-2321995.57996.57
423006-2300694.70395.68
523041-2304194.84795.84
623101-2310195.09496.11
15min122380-2238092.12693.151.4494.0895.181.44
222186-2218691.32793.33
322956-2295694.49796.55
422491-2249192.58394.61
522802-2280293.86395.91
622963-2296394.52696.59
20min122398-2239892.20092.951.0795.1896.011.08
222294-2229491.77294.79
322822-2282293.94597.05
422480-2248092.53795.60
522909-2290994.30397.40
622574-2257492.92496.04
30min122478-2247892.52992.141.8796.5396.231.82
221934-2193490.29094.33
322914-2291494.32498.47
422047-2204790.75594.84
522107-2210791.00295.14
622817-2281793.92598.08
45min122049-2204990.76391.510.8295.7996.630.82
222024-2202490.66095.70
322409-2240992.24597.44
422461-2246192.45997.55
522187-2218791.33196.48
622259-2225991.62896.82
极限121746-2174689.51690.851.0395.5696.991.02
221956-2195690.38096.43
322285-2228591.73597.96
422111-2211191.01897.14
522356-2235692.02798.19
621968-2196890.43096.64
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%
113.931633771635171636881632451630961633850.15
214.001633231634701633960.07
单位质量响应值RSD%判断
11729.0011671.140.35数据可信
供试品溶液-2022081601批-氨氯地平-磷酸盐缓冲液(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%
5min155287-5528730.63236.648.7830.6336.648.79
266170-6617036.66236.66
368709-6870938.06938.07
467404-6740437.34637.35
566529-6652936.86136.86
672645-7264540.25040.25
10min1101603-10160356.29459.312.8856.6359.722.92
2105975-10597558.71759.12
3109269-10926960.54260.96
4109187-10918760.49660.91
5106606-10660659.06659.48
6109655-10965560.75661.20
15min1125648-12564869.61769.471.6370.5870.531.63
2123576-12357668.46969.53
3126269-12626969.96171.06
4123566-12356668.46369.55
5124308-12430868.87469.94
6128881-12888171.40872.53
20min1136267-13626775.50074.931.0377.2476.771.00
2132694-13269473.52175.34
3135675-13567575.17277.05
4134694-13469474.62976.48
5136360-13636075.55277.38
6135745-13574575.21177.13
30min1148601-14860182.33480.271.9384.9182.941.86
2142909-14290979.18081.82
3146779-14677981.32484.03
4141566-14156678.43681.11
5142872-14287279.16081.83
6146520-14652081.18183.93
45min1145105-14510580.39782.501.6183.8986.061.60
2147553-14755381.75385.27
3150243-15024383.24486.86
4150456-15045683.36286.91
5148403-14840382.22485.77
6151680-15168084.04087.69
极限1159861-15986188.57388.311.2192.9692.791.14
2158358-15835887.74092.17
3159838-15983888.56093.10
4157370-15737087.19391.67
5162764-16276490.18194.64
6158141-15814187.62092.21
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%
19.952100220762208792078420751208360.51
29.992100221025210140.08
单位质量响应值RSD%判断
2094.072103.500.32数据可信
供试品溶液-2022081901批-培哚普利-磷酸盐缓冲液(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%
5min120825-2082584.65872.1314.9084.6672.1314.90
219542-1954279.44379.44
319059-1905977.47977.48
417943-1794372.94272.94
514560-1456059.19059.19
614533-1453359.08059.08
10min122617-2261791.94389.733.4092.8890.543.47
222044-2204489.61490.50
322188-2218890.19991.06
423112-2311293.95694.77
521110-2111085.81786.47
621371-2137186.87887.53
15min122904-2290493.11091.042.2095.0792.842.29
222549-2254991.66793.55
322182-2218290.17592.04
422951-2295193.30195.16
521722-2172288.30589.92
622058-2205889.67191.29
20min122474-2247491.36290.692.1194.3693.502.19
222580-2258091.79394.69
322145-2214590.02492.89
422979-2297993.41596.31
522036-2203689.58192.17
621634-2163487.94790.57
30min122362-2236290.90790.142.2094.9293.962.27
222649-2264992.07395.99
321910-2191089.06992.93
422771-2277192.56996.50
521681-2168188.13891.73
621668-2166888.08591.68
45min121704-2170488.23289.281.8393.2594.101.87
222354-2235490.87495.81
321920-2192089.11093.96
422539-2253991.62696.58
521733-2173388.35092.92
621524-2152487.50092.07
极限121668-2166888.08589.622.0994.0995.432.06
222394-2239491.03796.99
321676-2167688.11893.96
422807-2280792.71698.69
521931-2193189.15494.70
621791-2179188.58594.13
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%
113.938148981959814828173081725816770.25
214.008130281695814980.35
单位质量响应值RSD%判断
5863.395821.290.51数据可信
供试品溶液-2022081901批-氨氯地平-磷酸盐缓冲液(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%
5min126297-2629729.17924.8413.7329.1824.8413.74
224312-2431226.97626.98
324085-2408526.72426.72
421851-2185124.24624.25
519298-1929821.41321.41
618451-1845120.47320.47
10min150480-5048056.01252.755.4256.3453.025.47
248318-4831853.61353.91
348552-4855253.87354.17
449124-4912454.50754.78
543905-4390548.71748.95
644859-4485949.77550.00
15min162497-6249769.34667.222.8070.2968.082.85
260492-6049267.12168.02
360783-6078367.44468.34
462175-6217568.98969.86
557918-5791864.26565.04
659608-5960866.14066.92
20min167022-6702274.36773.372.8276.0874.982.85
266174-6617473.42675.07
366295-6629573.56075.21
468966-6896676.52478.17
563625-6362570.59872.09
664645-6464571.72973.24
30min172389-7238980.32278.622.7282.8781.042.76
270246-7024677.94480.40
372297-7229780.22082.68
472818-7281880.79883.29
568208-6820875.68377.96
669175-6917576.75679.07
45min172953-7295380.94881.912.4784.3885.212.47
273624-7362481.69285.02
376042-7604284.37587.73
475895-7589584.21287.60
571397-7139779.22182.34
673016-7301681.01884.18
极限178255-7825586.83189.262.4991.1793.472.42
281333-8133390.24694.48
380057-8005788.83093.12
483958-8395893.15997.48
579856-7985688.60792.61
679226-7922687.90891.97
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%
19.952087520815208642089420947208790.23
29.992087320920208960.16
单位质量响应值RSD%判断
2098.392091.690.23数据可信
供试品溶液-2022081901批-培哚普利-磷酸盐缓冲液(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%
5min120361-2036182.92083.356.6782.9283.356.67
217815-1781572.55172.55
321525-2152587.66087.66
420803-2080384.72084.72
521379-2137987.06687.07
620910-2091085.15685.16
10min122392-2239291.19194.773.1592.1195.693.17
222464-2246491.48492.29
324015-2401597.80198.77
423630-2363096.23397.17
524011-2401197.78498.75
623113-2311394.12795.07
15min122577-2257791.94494.593.1593.8896.573.16
222438-2243891.37893.20
324014-2401497.79799.86
423829-2382997.04399.05
523812-2381296.97499.03
622686-2268692.38894.38
20min122037-2203789.74593.193.2492.7096.223.25
222270-2227090.69493.53
323797-2379796.913100.06
423234-2323494.62097.71
523560-2356095.94899.08
622400-2240091.22494.24
30min122010-2201089.63592.573.0793.5996.633.09
221910-2191089.22893.07
323545-2354595.887100.11
423184-2318494.41698.56
523270-2327094.76798.96
622462-2246291.47695.51
45min121919-2191989.26591.412.3294.2196.502.38
221798-2179888.77293.61
322919-2291993.33798.63
422988-2298893.61898.81
522772-2277292.73997.99
622275-2227590.71595.76
极限121653-2165388.18190.552.3694.1296.662.42
221673-2167388.26394.09
322743-2274392.62098.95
422546-2254691.81898.05
522793-2279392.82499.10
622002-2200289.60395.66
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%
113.938131681574814098155581568814840.15
214.008181281561816860.22
单位质量响应值RSD%判断
5849.535834.710.18数据可信
供试品溶液-2022081901批-氨氯地平-磷酸盐缓冲液(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%
5min125240-2524028.00729.1111.0628.0129.1111.06
221394-2139423.73923.74
329659-2965932.91032.91
426373-2637329.26429.26
528660-2866031.80231.80
626085-2608528.94428.94
10min150623-5062356.17256.323.8456.4856.653.87
247798-4779853.03753.30
353638-5363859.51859.88
451371-5137157.00257.33
551404-5140457.03957.39
649724-4972455.17555.50
15min162041-6204168.84269.573.4469.7870.523.47
260111-6011166.70067.55
364628-6462871.71272.74
464346-6434671.39972.36
564719-6471971.81372.80
660330-6033066.94367.88
20min167493-6749374.89175.413.1176.5977.143.13
265917-6591773.14374.74
368950-6895076.50878.33
469372-6937276.97678.73
570754-7075478.51080.29
665291-6529172.44874.13
30min171562-7156279.40681.513.5281.9484.083.52
270674-7067478.42180.83
374697-7469782.88585.56
476106-7610684.44987.06
576425-7642584.80287.46
671301-7130179.11781.60
45min175083-7508383.31384.452.8486.7387.922.87
273401-7340181.44784.73
376957-7695785.39388.99
478100-7810086.66190.21
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279598-7959888.32392.51
380842-8084289.70494.25
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678019-7801986.57190.85
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