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%
19.671989019906200491999020024199720.36
29.702013920045200920.34
单位质量响应值RSD%判断
2065.362071.340.21数据可信
长期18月-供试品溶液-2022081601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%
5min122981-2298194.79894.394.1894.8094.394.18
220986-2098686.56886.57
323301-2330196.11896.12
423051-2305195.08695.09
523576-2357697.25297.25
623400-2340096.52696.53
10min123390-2339096.48597.401.7097.5498.451.70
223581-2358197.27398.23
323689-2368997.71898.79
422975-2297594.77395.83
524086-2408699.356100.44
623956-2395698.81999.89
15min122658-2265893.46596.162.1695.5998.292.14
223169-2316995.57397.62
323537-2353797.09199.24
422861-2286194.30396.41
523956-2395698.819101.00
623691-2369197.72699.90
20min122795-2279594.03095.200.9397.1998.400.94
223153-2315395.50798.61
323174-2317495.59498.83
422911-2291194.50997.67
523401-2340196.53099.81
623036-2303695.02498.28
30min122213-2221391.62992.901.2795.8497.151.24
222642-2264293.39997.56
322231-2223191.70496.00
422569-2256993.09897.31
522979-2297994.78999.14
622486-2248692.75697.07
45min122173-2217391.46492.341.1596.6997.631.13
222475-2247592.71097.91
322418-2241892.47597.79
422016-2201690.81796.06
522492-2249292.78098.19
622741-2274193.80899.15
极限122034-2203490.89192.622.0697.1398.941.98
222346-2234692.17898.41
323266-2326695.973102.31
422091-2209191.12697.38
522698-2269893.630100.07
622290-2229091.94798.33
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%
114.011635961636111633801634801637401635610.09
214.061638501636321637410.10
单位质量响应值RSD%判断
11674.5911645.870.18数据可信
长期18月-供试品溶液-2022081601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%
5min1165325-16532591.91393.071.2591.9193.071.25
2164695-16469591.56291.56
3166806-16680692.73692.74
4169326-16932694.13794.14
5168892-16889293.89693.90
6169365-16936594.15994.16
10min1173734-17373496.58897.801.2997.6198.841.28
2177910-17791098.90999.93
3175251-17525197.43198.46
4173065-17306596.21697.26
5178600-17860099.293100.34
6176926-17692698.36299.41
15min1169838-16983894.42297.141.7296.5299.261.69
2176173-17617397.944100.06
3174830-17483097.19799.31
4172932-17293296.14298.26
5178334-17833499.145101.29
6176290-17629098.009100.15
20min1172069-17206995.66296.200.9998.8199.400.97
2175844-17584497.761100.97
3171615-17161595.41098.60
4172299-17229995.79098.97
5174411-17441196.964100.21
6171966-17196695.60598.83
30min1166934-16693492.80793.871.3297.0198.131.28
2171448-17144895.31799.61
3166072-16607292.32896.58
4171034-17103495.08799.33
5169718-16971894.35598.68
6167821-16782193.30097.59
45min1166322-16632292.46793.011.0097.7098.320.98
2170220-17022094.63499.98
3165716-16571692.13097.41
4166098-16609892.34297.65
5167942-16794293.36898.74
6167539-16753993.14498.47
极限1165632-16563292.08392.750.9198.3599.100.91
2168803-16880393.846100.25
3165882-16588292.22298.52
4165354-16535491.92998.26
5168582-16858293.723100.13
6166771-16677192.71799.08
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%
19.671984120225200282007720114200570.71
29.702006720214201400.52
单位质量响应值RSD%判断
2074.152076.290.08数据可信
长期18月-供试品溶液-2022081701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%
5min122832-2283293.87194.960.8093.8794.960.80
223213-2321395.43795.44
323057-2305794.79694.80
422943-2294394.32794.33
523281-2328195.71795.72
623259-2325995.62795.63
10min123078-2307894.88294.720.8395.9395.780.82
222659-2265993.16094.22
323103-2310394.98596.04
423070-2307094.84995.90
523160-2316095.21996.28
623168-2316895.25296.31
15min122677-2267793.23494.060.9195.3396.170.89
222820-2282093.82295.92
322853-2285393.95796.07
423212-2321295.43397.54
522682-2268293.25495.38
623019-2301994.64096.76
20min122679-2267993.24293.701.1596.3896.861.12
222753-2275393.54696.68
323223-2322395.47998.63
422835-2283593.88397.05
522420-2242092.17795.33
622835-2283593.88397.06
30min122116-2211690.92792.581.1495.1096.781.10
222442-2244292.26896.44
322874-2287494.04498.26
422662-2266293.17297.38
522583-2258392.84797.03
622438-2243892.25196.47
45min121509-2150988.43289.661.2893.6194.881.22
222055-2205590.67695.88
322114-2211490.91996.18
421930-2193090.16295.40
521779-2177989.54294.76
621454-2145488.20593.45
极限121850-2185089.83489.630.9396.0095.860.86
221809-2180989.66595.88
321577-2157788.71194.98
422096-2209690.84597.09
521574-2157488.69994.91
621903-2190390.05196.27
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%
114.011637671636701640011636151641641638430.15
214.061639961637551638760.11
单位质量响应值RSD%判断
11694.7211655.480.24数据可信
长期18月-供试品溶液-2022081701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%
5min1165220-16522091.73793.571.7291.7493.571.72
2168362-16836293.48293.48
3167718-16771893.12493.12
4165988-16598892.16492.16
5172458-17245895.75695.76
6171429-17142995.18595.18
10min1172973-17297396.04296.321.7897.0697.361.77
2169527-16952794.12995.17
3174241-17424196.74697.78
4170557-17055794.70195.72
5176162-17616297.81398.88
6177350-17735098.47399.53
15min1171041-17104194.97095.781.0497.0697.891.05
2171035-17103594.96697.05
3173043-17304396.08198.19
4171122-17112295.01497.09
5173240-17324096.19098.34
6175492-17549297.44199.59
20min1169667-16966794.20794.951.4397.3598.121.41
2170801-17080194.83697.98
3172895-17289595.99999.18
4167844-16784493.19496.33
5170117-17011794.45697.68
6174670-17467096.984100.22
30min1165791-16579192.05494.201.6996.2498.431.67
2168337-16833793.46897.66
3172874-17287495.987100.23
4167544-16754493.02897.20
5172494-17249495.776100.05
6170895-17089594.88899.20
45min1161139-16113989.47191.631.5294.6896.911.49
2166258-16625892.31497.55
3167676-16767693.10198.41
4162813-16281390.40195.60
5166078-16607892.21497.55
6166236-16623692.30297.67
极限1163629-16362990.85490.861.3197.0697.151.27
2163572-16357290.82297.08
3161651-16165189.75696.10
4161697-16169789.78195.99
5163782-16378290.93997.30
6167499-16749993.00399.39
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%
19.672001120139199792001419996200280.32
29.702000520133200690.46
单位质量响应值RSD%判断
2071.152068.970.08数据可信
长期18月-供试品溶液-2022081701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%
5min123309-2330996.07194.001.5996.0794.001.59
222654-2265493.37193.37
322570-2257093.02593.03
422331-2233192.04092.04
522868-2286894.25394.25
623111-2311195.25595.25
10min123323-2332396.12994.711.0997.2095.751.10
222925-2292594.48895.53
322599-2259993.14594.18
422853-2285394.19195.21
523020-2302094.88095.93
623150-2315095.41696.47
15min122860-2286094.22093.821.1896.3695.921.16
222228-2222891.61593.70
322820-2282094.05596.12
422969-2296994.67096.74
522880-2288094.30396.40
622826-2282694.08096.20
20min122544-2254492.91893.060.7696.1096.200.75
222300-2230091.91295.02
322493-2249392.70895.82
422761-2276193.81296.93
522659-2265993.39296.54
622716-2271693.62796.79
30min122165-2216591.35690.640.9495.5794.810.93
221774-2177489.74493.87
321983-2198390.60694.75
421736-2173689.58893.75
522253-2225391.71895.91
622031-2203190.80395.01
45min122192-2219291.46790.991.5896.7096.171.52
221913-2191390.31795.44
321864-2186490.11595.27
421806-2180689.87695.04
522731-2273193.68998.89
621947-2194790.45795.67
极限122016-2201690.74289.520.8296.9995.700.81
221464-2146488.46794.59
321703-2170389.45295.60
421726-2172689.54695.70
521663-2166389.28795.53
621739-2173989.60095.82
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%
114.011641681637341638041636861639131638610.12
214.061639821636491638160.15
单位质量响应值RSD%判断
11696.0011651.210.28数据可信
长期18月-供试品溶液-2022081701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%
5min1169383-16938394.06192.051.6294.0692.051.62
2164013-16401391.07991.08
3163263-16326390.66290.66
4163197-16319790.62690.63
5166441-16644192.42792.43
6168294-16829493.45693.46
10min1174570-17457096.94195.681.5897.9996.701.57
2170280-17028094.55995.57
3168446-16844693.54194.55
4172314-17231495.68996.70
5172363-17236395.71696.74
6175838-17583897.64698.68
15min1172979-17297996.05895.071.4098.1897.161.39
2167200-16720092.84994.91
3169308-16930894.01996.07
4172950-17295096.04298.11
5172380-17238095.72597.82
6172387-17238795.72997.85
20min1169997-16999794.40294.051.4097.5997.191.39
2165328-16532891.80994.90
3167915-16791593.24696.34
4171106-17110695.01898.16
5170094-17009494.45697.61
6171750-17175095.37598.56
30min1167220-16722092.86091.821.2397.1096.001.22
2162331-16233190.14594.26
3165048-16504891.65495.78
4163757-16375790.93795.13
5166300-16630092.34996.55
6167408-16740892.96497.21
45min1167584-16758493.06292.011.9298.3397.221.86
2163542-16354290.81795.93
3162884-16288490.45295.60
4163120-16312090.58395.79
5170961-17096194.937100.17
6166021-16602192.19497.47
极限1165830-16583092.08890.621.4398.3996.851.40
2159362-15936288.49694.62
3162544-16254490.26396.41
4164500-16450091.34997.56
5162221-16222190.08496.37
6164657-16465791.43797.74
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%
19.672001819975200062006519985200100.18
29.702000220053200280.19
单位质量响应值RSD%判断
2069.292064.740.16数据可信
长期18月-供试品溶液-2022081801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%
5min122786-2278694.05496.392.1894.0596.392.18
222698-2269893.69093.69
323905-2390598.67398.67
423630-2363097.53797.54
523344-2334496.35796.36
623746-2374698.01698.02
10min123361-2336196.42796.590.7097.4797.660.70
223461-2346196.84097.88
323456-2345696.81997.92
423592-2359297.38198.46
523104-2310495.36696.44
623435-2343596.73397.82
15min123463-2346396.84896.561.2898.9698.701.27
222865-2286594.38096.50
323490-2349096.96099.13
423777-2377798.144100.31
523424-2342496.68798.82
623338-2333896.33298.50
20min122886-2288694.46696.321.4197.6699.541.39
223164-2316495.61498.78
323795-2379598.219101.47
423377-2337796.49399.75
523183-2318395.69298.90
623600-2360097.414100.65
30min122510-2251092.91492.511.5897.1696.801.55
221952-2195290.61194.84
322657-2265793.52197.86
422884-2288494.45898.79
522062-2206291.06595.33
622403-2240392.47396.79
45min122061-2206191.06191.980.9396.3497.300.90
222324-2232492.14797.38
322434-2243492.60197.98
422544-2254493.05598.43
522325-2232592.15197.43
622019-2201990.88896.23
极限121889-2188990.35191.210.9396.6497.540.90
222254-2225491.85898.12
322196-2219691.61898.03
422296-2229692.03198.44
521801-2180189.98896.29
622142-2214291.39597.75
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%
114.011641451638391635491636851637141637860.14
214.061638211638211638210.00
单位质量响应值RSD%判断
11690.6511651.560.24数据可信
长期18月-供试品溶液-2022081801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%
5min1164649-16464991.45294.352.2491.4594.352.24
2166066-16606692.23992.24
3173072-17307296.13096.13
4169385-16938594.08294.08
5173276-17327696.24396.24
6172742-17274295.94795.95
10min1176148-17614897.83998.140.8998.8599.180.87
2178976-17897699.409100.43
3176644-17664498.11499.18
4174897-17489797.14498.19
5178022-17802298.87999.95
6175404-17540497.42598.49
15min1176385-17638597.97097.780.69100.0799.920.68
2174476-17447696.91099.04
3176151-17615197.840100.00
4176720-17672098.156100.28
5177682-17768298.691100.86
6174824-17482497.10399.25
20min1173125-17312596.16097.601.1599.35100.821.14
2175689-17568997.584100.79
3177463-17746398.569101.81
4173787-17378796.52799.74
5178322-17832299.046102.31
6175887-17588797.694100.92
30min1168807-16880793.76193.480.6798.0297.780.64
2166973-16697392.74297.03
3169790-16979094.30798.65
4169190-16919093.97498.26
5167492-16749293.03197.40
6167510-16751093.04197.35
45min1167061-16706192.79193.221.2398.0998.571.18
2168428-16842893.55198.87
3167419-16741992.99098.38
4168499-16849993.59098.92
5170934-17093494.943100.34
6164695-16469591.47796.82
极限1165762-16576292.07092.271.1798.4098.661.11
2168988-16898893.862100.22
3166119-16611992.26898.69
4163546-16354690.83997.21
5167569-16756993.07499.53
6164784-16478491.52797.89
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%
19.671991820155199892002820162200500.54
29.702013220174201530.15
单位质量响应值RSD%判断
2073.422077.630.15数据可信
长期18月-供试品溶液-2022081801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%
5min123344-2334495.96295.480.9895.9695.480.98
223033-2303394.68394.68
323143-2314395.13695.14
423035-2303594.69294.69
523187-2318795.31695.32
623626-2362697.12197.12
10min123933-2393398.38396.922.3199.4597.982.30
223961-2396198.49899.55
322953-2295394.35495.41
422899-2289994.13395.18
523536-2353696.75197.81
624174-2417499.374100.45
15min123721-2372197.51295.651.8799.6797.791.85
222674-2267493.20895.35
323316-2331695.84797.95
422851-2285193.93596.03
523331-2333195.90898.04
623721-2372197.51299.69
20min123265-2326595.63795.011.2598.8898.211.23
222837-2283793.87897.06
322725-2272593.41796.59
423372-2337296.07799.22
523056-2305694.77897.98
623414-2341496.25099.52
30min123254-2325495.59293.592.0899.9097.852.05
222571-2257192.78497.01
322310-2231091.71195.92
422380-2238091.99996.21
522641-2264193.07297.32
623452-2345296.406100.74
45min122774-2277493.61992.191.3898.9997.491.37
222281-2228191.59296.85
322103-2210390.86096.09
422086-2208690.79096.02
522723-2272393.40998.70
622590-2259092.86298.27
极限122398-2239892.07390.891.3798.4897.211.36
221748-2174889.40195.67
322083-2208390.77897.02
421767-2176789.47995.72
522221-2222191.34597.67
622445-2244592.26698.71
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%
114.011642021641211640311640441643321641460.08
214.061641471640141640800.06
单位质量响应值RSD%判断
11716.3511669.990.29数据可信
长期18月-供试品溶液-2022081801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%
5min1167174-16717492.67993.261.2292.6893.261.22
2168955-16895593.66693.67
3172013-17201395.36295.36
4166574-16657492.34692.35
5166769-16676992.45592.45
6167896-16789693.07993.08
10min1178186-17818698.78497.461.9799.8198.491.95
2179011-17901199.241100.28
3172569-17256995.67096.73
4170678-17067894.62295.65
5175795-17579597.45898.49
6178496-17849698.95699.99
15min1177984-17798498.67296.961.46100.8099.081.44
2173202-17320296.02198.16
3176600-17660097.905100.03
4170994-17099494.79796.87
5174444-17444496.70998.82
6176132-17613297.64599.78
20min1172926-17292695.86895.790.4399.0998.990.40
2171851-17185195.27298.48
3172535-17253595.65198.86
4173861-17386196.38699.52
5172223-17222395.47898.66
6173324-17332496.08999.31
30min1172668-17266895.72594.441.42100.0198.701.39
2169872-16987294.17598.44
3169741-16974194.10298.38
4166665-16666592.39796.60
5169741-16974194.10298.35
6173397-17339796.129100.42
45min1168750-16875093.55393.250.7598.9198.560.74
2168057-16805793.16998.48
3168533-16853393.43298.75
4165856-16585691.94897.18
5169578-16957894.01299.30
6168459-16845993.39198.75
极限1167545-16754592.88592.100.8999.2898.450.89
2165527-16552791.76698.12
3167352-16735292.77899.13
4163585-16358590.68996.94
5165917-16591791.98298.32
6166857-16685792.50398.90
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