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%
19.742021320139200472029420060201510.52
29.782014120067201040.27
单位质量响应值RSD%判断
2068.892055.620.46数据可信
长期18月-供试品溶液-2022081601批-培哚普利-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%
5min123489-2348997.18097.891.2197.1897.891.21
223832-2383298.59998.60
323985-2398599.23299.23
423873-2387398.76998.77
523228-2322896.10096.10
623561-2356197.47897.48
10min123693-2369398.024100.092.1999.10101.182.16
224254-24254100.345101.44
324270-24270100.411101.51
423985-2398599.232100.33
525160-25160104.093105.16
623795-2379598.44699.53
15min123254-2325496.20897.630.8198.3899.830.81
223753-2375398.272100.48
323749-2374998.256100.47
423540-2354097.39199.59
523579-2357997.55299.78
623712-2371298.103100.28
20min123356-2335696.63097.460.6799.87100.740.66
223653-2365397.859101.16
323787-2378798.413101.72
423427-2342796.924100.21
523528-2352897.341100.65
623588-2358897.590100.86
30min122761-2276194.16894.820.8898.4899.180.84
222657-2265793.73898.13
322964-2296495.00899.41
423010-2301095.19899.56
522884-2288494.67799.07
623231-2323196.113100.46
45min121767-2176790.05693.412.0095.4198.831.93
222701-2270193.92099.35
323018-2301895.231100.69
422371-2237192.55597.97
522846-2284694.52099.96
622766-2276694.18999.61
极限121945-2194590.79292.911.4397.1599.371.38
222431-2243192.80399.28
322592-2259293.46999.99
422446-2244692.86599.31
522391-2239192.63799.13
622935-2293594.888101.35
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%
114.171662951660581659091661951664581661830.13
214.181659291661461660380.10
单位质量响应值RSD%判断
11727.8111709.310.12数据可信
长期18月-供试品溶液-2022081601批-氨氯地平-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%
5min1177731-17773198.31896.831.7098.3296.831.70
2175395-17539597.02697.03
3177214-17721498.03298.03
4176716-17671697.75697.76
5170003-17000394.04394.04
6173171-17317195.79595.80
10min1180627-18062799.92099.431.47101.01100.511.47
2180378-18037899.782100.86
3183124-183124101.301102.39
4179917-17991799.527100.61
5175053-17505396.83697.88
6179383-17938399.232100.30
15min1177361-17736198.11398.290.70100.32100.470.70
2177096-17709697.967100.15
3179354-17935499.216101.43
4176918-17691897.868100.06
5176306-17630697.53099.65
6179075-17907599.061101.23
20min1177694-17769498.29797.741.01101.59101.021.01
2175339-17533996.995100.27
3179592-17959299.347102.66
4175468-17546897.066100.35
5174959-17495996.78499.99
6177092-17709297.964101.23
30min1173604-17360496.03594.851.44100.4299.211.41
2169440-16944093.73198.08
3172345-17234595.33899.76
4172140-17214095.22599.58
5167562-16756292.69396.97
6173733-17373396.106100.46
45min1165696-16569691.66093.431.2997.1198.851.24
2169550-16955093.79299.19
3172008-17200895.152100.63
4167598-16759892.71298.13
5168458-16845893.18898.50
6170095-17009594.09499.52
极限1166798-16679892.27092.480.6898.7498.930.69
2166393-16639392.04698.48
3169438-16943893.730100.27
4166931-16693192.34498.79
5166551-16655192.13398.48
6166925-16692592.34098.81
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%
19.742019920151201722019020122201670.16
29.782003820087200620.18
单位质量响应值RSD%判断
2070.532051.330.66数据可信
长期18月-供试品溶液-2022081701批-培哚普利-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%
5min123483-2348397.21996.591.0697.2296.591.06
223350-2335096.66896.67
323226-2322696.15596.15
423230-2323096.17196.17
523708-2370898.15098.15
622990-2299095.17895.18
10min123336-2333696.61097.101.0897.6998.181.08
223387-2338796.82197.90
323328-2332896.57797.65
423549-2354997.49298.56
523918-2391899.020100.11
623212-2321296.09797.15
15min123226-2322696.15595.960.9898.3198.120.97
223171-2317195.92798.08
322837-2283794.54496.69
423085-2308595.57197.72
523529-2352997.40999.60
623228-2322896.16398.29
20min122459-2245992.97994.251.5496.2097.471.51
222747-2274794.17297.39
322708-2270894.01097.20
423027-2302795.33198.54
523293-2329396.43299.71
622358-2235892.56195.76
30min122738-2273894.13593.342.0598.3997.611.99
222151-2215191.70495.97
322109-2210991.53095.77
422954-2295495.02999.30
523155-2315595.861100.21
622172-2217291.79196.01
45min122299-2229992.31792.200.9197.6297.500.89
222448-2244892.93498.21
321891-2189190.62895.88
422251-2225192.11897.45
522422-2242292.82698.24
622315-2231592.38397.63
极限121827-2182790.36392.051.7296.6998.381.66
222409-2240992.77299.09
321848-2184890.45096.71
422350-2235092.52898.88
522832-2283294.524100.96
622137-2213791.64697.92
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%
114.171668781667321664351667771664781666600.12
214.181659191658131658660.05
单位质量响应值RSD%判断
11761.4711697.180.39数据可信
长期18月-供试品溶液-2022081701批-氨氯地平-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%
5min1175204-17520496.83295.621.4196.8395.621.41
2172350-17235095.25495.25
3171025-17102594.52294.52
4171056-17105694.53994.54
5176835-17683597.73397.73
6171587-17158794.83394.83
10min1177198-17719897.93497.571.1099.0198.641.10
2174718-17471896.56397.62
3175396-17539696.93897.99
4176817-17681797.72398.77
5179954-17995499.457100.54
6175207-17520796.83397.89
15min1177152-17715297.90896.471.05100.0798.611.04
2173014-17301495.62197.75
3172403-17240395.28497.41
4173654-17365495.97598.11
5175169-17516996.81299.00
6175860-17586097.19499.32
20min1169780-16978093.83494.411.4497.0997.631.41
2169870-16987093.88497.08
3170199-17019994.06697.25
4172555-17255595.36898.57
5174733-17473396.57199.84
6167789-16778992.73495.94
30min1172581-17258195.38293.592.0099.6897.861.95
2165500-16550091.46995.71
3165807-16580791.63895.87
4171722-17172294.90799.17
5172695-17269595.44599.78
6167709-16770992.68996.93
45min1168710-16871093.24392.061.0698.6097.371.05
2167181-16718192.39897.65
3163771-16377190.51395.76
4165443-16544391.43796.75
5167771-16777192.72498.12
6166596-16659692.07497.34
极限1164536-16453690.93691.801.3997.3398.141.34
2166096-16609691.79898.08
3163427-16342790.32396.58
4166059-16605991.77798.11
5170196-17019694.064100.49
6166327-16632791.92698.22
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%
19.742014520115201512011419998201050.31
29.782021220114201630.35
单位质量响应值RSD%判断
2064.172061.660.09数据可信
长期18月-供试品溶液-2022081701批-培哚普利-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%
5min123636-2363697.75696.271.3397.7696.261.33
223082-2308295.46595.46
322888-2288894.66394.66
423652-2365297.82297.82
523155-2315595.76795.77
623241-2324196.12296.12
10min123620-2362097.69097.792.3598.7898.862.34
223734-2373498.16199.22
322972-2297295.01096.06
424238-24238100.246101.33
523044-2304495.30896.37
624251-24251100.300101.37
15min124794-24794102.54696.933.33104.7299.083.29
222976-2297695.02697.18
322774-2277494.19196.30
423779-2377998.348100.55
522782-2278294.22496.35
623507-2350797.22399.41
20min122649-2264993.67494.360.7496.9997.600.74
222908-2290894.74597.95
322671-2267193.76596.92
423077-2307795.44498.74
522710-2271093.92697.10
622881-2288194.63497.90
30min122618-2261893.54693.101.6997.9097.381.68
222653-2265393.69197.95
322040-2204091.15595.35
423027-2302795.23799.59
522085-2208591.34195.56
622639-2263993.63397.95
45min122424-2242492.74391.971.4398.1397.281.44
222168-2216891.68596.99
321983-2198390.92096.13
422690-2269093.84499.26
521809-2180990.20095.43
622345-2234592.41797.77
极限122073-2207391.29292.262.0997.7198.602.03
222274-2227492.12398.44
322197-2219791.80598.02
423005-2300595.146101.60
521659-2165989.57995.81
622632-2263293.60499.99
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%
114.171663151666131666821665141665111665270.09
214.181668001668811668400.04
单位质量响应值RSD%判断
11752.0811765.870.09数据可信
长期18月-供试品溶液-2022081701批-氨氯地平-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%
5min1176377-17637797.23394.581.8797.2394.581.87
2170285-17028593.87593.88
3171372-17137294.47494.47
4174278-17427896.07696.08
5167972-16797292.60092.60
6169115-16911593.23093.23
10min1178536-17853698.42497.472.1299.5098.522.11
2177721-17772197.97499.02
3174480-17448096.18897.24
4180692-18069299.612100.68
5170434-17043493.95794.99
6179004-17900498.68299.72
15min1176452-17645297.27596.131.4599.4598.261.45
2173505-17350595.65097.78
3173024-17302495.38597.50
4176659-17665997.38999.56
5170360-17036093.91695.99
6176253-17625397.16599.30
20min1171860-17186094.74394.580.9298.0097.780.93
2171419-17141994.50097.69
3173029-17302995.38898.57
4172369-17236995.02498.28
5168567-16856792.92896.04
6172143-17214394.89998.11
30min1170509-17050993.99993.021.7098.3197.271.69
2168809-16880993.06197.31
3167121-16712192.13196.37
4171613-17161394.60798.92
5163831-16383190.31794.47
6170479-17047993.98298.25
45min1168502-16850292.89291.681.6098.2496.971.58
2165758-16575891.37996.66
3166354-16635491.70896.97
4167911-16791192.56697.93
5161352-16135288.95094.10
6167956-16795692.59197.90
极限1165905-16590591.46091.702.0497.8498.001.99
2164853-16485390.88197.17
3167602-16760292.39698.68
4170406-17040693.942100.33
5160690-16069088.58694.73
6168543-16854392.91599.25
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%
19.742018020105200472013120215201360.33
29.782041420294203540.42
单位质量响应值RSD%判断
2067.352081.190.48数据可信
长期18月-供试品溶液-2022081801批-培哚普利-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%
5min123413-2341396.30595.551.6496.3095.551.64
222630-2263093.08493.08
323269-2326995.71295.71
423431-2343196.37996.38
523689-2368997.44097.44
622952-2295294.40994.41
10min123511-2351196.70896.680.7997.7897.740.79
223408-2340896.28497.32
323295-2329595.81996.88
423379-2337996.16597.24
523793-2379397.86898.95
623635-2363597.21898.27
15min123218-2321895.50395.940.6497.6598.080.62
223452-2345296.46598.57
323382-2338296.17798.31
423081-2308194.93997.08
523355-2335596.06698.24
623460-2346096.49898.63
20min122992-2299294.57394.601.0297.7897.800.99
222872-2287294.07997.26
322960-2296094.44197.64
423445-2344596.43699.63
522960-2296094.44197.68
622764-2276493.63596.84
30min122513-2251392.60393.373.8296.8697.623.64
224302-2430299.961104.18
322562-2256292.80497.05
422716-2271693.43897.70
522435-2243592.28296.57
621673-2167389.14893.39
45min122255-2225591.54291.771.0396.8397.061.01
222377-2237792.04397.38
322325-2232591.82997.11
422540-2254092.71498.02
522475-2247592.44697.76
621892-2189290.04895.28
极限122010-2201090.53490.750.4896.8497.070.49
222112-2211290.95397.31
322094-2209490.87997.18
422202-2220291.32497.66
522073-2207390.79397.13
621891-2189190.04496.28
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%
114.171660901660131663331663781662321662090.10
214.181673721671221672470.11
单位质量响应值RSD%判断
11729.6411794.570.40数据可信
长期18月-供试品溶液-2022081801批-氨氯地平-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%
5min1170810-17081094.14093.661.3894.1493.661.39
2168327-16832792.77292.77
3170934-17093494.20894.21
4171073-17107394.28594.29
5172452-17245295.04595.05
6166007-16600791.49391.49
10min1174384-17438496.11096.081.0797.1697.121.07
2176278-17627897.15498.18
3173960-17396095.87696.92
4174258-17425896.04097.09
5176014-17601497.00898.06
6171073-17107394.28595.30
15min1172832-17283295.25595.491.0997.3797.601.06
2176496-17649697.27499.38
3174455-17445596.14998.26
4172180-17218094.89597.01
5171749-17174994.65896.79
6171843-17184394.70996.77
20min1170391-17039193.90994.071.7097.0897.241.67
2172683-17268395.17298.36
3172391-17239195.01198.19
4173554-17355495.65298.82
5169366-16936693.34496.53
6165682-16568291.31494.43
30min1165939-16593991.45691.502.3795.6795.712.31
2170890-17089094.18498.43
3167277-16727792.19396.43
4167156-16715692.12696.36
5165924-16592491.44795.67
6158912-15891287.58391.71
45min1164964-16496490.91891.181.6096.1596.411.59
2168356-16835692.78898.08
3166818-16681891.94097.20
4166894-16689491.98297.24
5164876-16487690.87096.11
6160757-16075788.60093.70
极限1162488-16248889.55489.861.2595.8096.101.25
2165579-16557991.25797.58
3164403-16440390.60996.89
4163376-16337690.04396.32
5162774-16277489.71195.96
6159610-15961087.96794.06
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%
19.742027720150202442030220129202200.39
29.782034820200202740.52
单位质量响应值RSD%判断
2075.982073.010.11数据可信
长期18月-供试品溶液-2022081801批-培哚普利-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%
5min122434-2243492.26792.800.4992.2792.800.49
222711-2271193.40693.41
322445-2244592.31292.31
422639-2263993.11093.11
522591-2259192.91392.91
622564-2256492.80292.80
10min122959-2295994.42695.422.1295.4596.462.10
222826-2282693.87994.92
323196-2319695.40196.43
422747-2274793.55494.59
524073-2407399.008100.04
623410-2341096.28197.31
15min122540-2254092.70394.031.7094.7896.121.69
222354-2235491.93894.02
323000-2300094.59596.68
422743-2274393.53895.61
523383-2338396.17098.30
623158-2315895.24597.35
20min122298-2229891.70893.813.1294.8196.953.05
222045-2204590.66793.77
322507-2250792.56795.70
422671-2267193.24296.36
523875-2387598.194101.39
623465-2346596.50799.67
30min121998-2199890.47492.582.1494.6096.752.11
222033-2203390.61894.73
322298-2229891.70895.87
422666-2266693.22197.37
523198-2319895.40999.70
622861-2286194.02398.25
45min122040-2204090.64791.141.8695.7896.351.84
221668-2166889.11794.23
321920-2192090.15395.34
422337-2233791.86897.05
522866-2286694.04499.40
622134-2213491.03396.31
极限121378-2137887.92490.262.5594.0696.482.49
221390-2139087.97394.08
321649-2164989.03895.22
422174-2217491.19897.40
522735-2273593.50599.90
622352-2235291.93098.22
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%
114.171666201669101672491669231670271669460.14
214.181665781665811665800.01
单位质量响应值RSD%判断
11781.6511747.530.21数据可信
长期18月-供试品溶液-2022081801批-氨氯地平-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%
5min1164545-16454590.66891.841.0290.6791.841.03
2166982-16698292.01092.01
3164846-16484690.83390.83
4168346-16834692.76292.76
5168589-16858992.89692.90
6166708-16670891.85991.86
10min1171628-17162894.57095.432.5695.5896.452.54
2169092-16909293.17394.20
3171919-17191994.73195.74
4169877-16987793.60694.64
5180933-18093399.698100.73
6175683-17568396.80597.83
15min1168748-16874892.98494.442.1095.0496.522.08
2167144-16714492.10094.16
3170118-17011893.73895.80
4171134-17113494.29896.37
5176638-17663897.33199.47
6174557-17455796.18498.28
20min1166129-16612991.54093.713.0294.6396.842.97
2163618-16361890.15793.24
3168369-16836992.77595.88
4170231-17023193.80196.92
5176289-17628997.139100.36
6175771-17577196.853100.02
30min1163346-16334690.00792.502.5694.1296.682.53
2164101-16410190.42394.51
3165843-16584391.38395.52
4169077-16907793.16597.33
5174674-17467496.249100.55
6170185-17018593.77598.02
45min1163521-16352190.10390.942.6695.2196.142.62
2160442-16044288.40793.49
3160685-16068588.54193.69
4167096-16709692.07397.27
5171877-17187794.708100.08
6166589-16658991.79497.08
极限1159767-15976788.03589.862.9294.1496.072.87
2159101-15910187.66893.74
3159257-15925787.75493.89
4162779-16277989.69495.91
5170566-17056693.985100.41
6166991-16699192.01598.32
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