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%
110.212234022131223852243322260223100.54
210.162246022352224060.35
单位质量响应值RSD%判断
2185.112205.310.66数据可信
供试品溶液-2022081601批-培哚普利-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%
5min123821-2382192.58693.561.4992.5993.561.49
224653-2465395.81995.82
324235-2423594.19594.19
423877-2387792.80392.80
523667-2366791.98791.99
624183-2418393.99393.99
10min123974-2397493.18093.801.2294.2194.831.22
224249-2424994.24995.31
324367-2436794.70895.75
423833-2383392.63293.66
523840-2384092.65993.68
624532-2453295.34996.39
15min123990-2399093.24293.371.0695.3195.451.05
224186-2418694.00496.12
324216-2421694.12196.22
423541-2354191.49793.56
524173-2417393.95496.01
624027-2402793.38695.49
20min123456-2345691.16791.051.3794.2794.171.35
223647-2364791.90995.07
323433-2343391.07894.22
423181-2318190.09893.18
522967-2296789.26692.36
623866-2386692.76095.90
30min122903-2290389.01889.391.2193.1393.521.19
223423-2342391.03995.22
323206-2320690.19594.35
422922-2292289.09193.17
522625-2262587.93792.02
622919-2291989.08093.25
45min123028-2302889.50389.380.6994.6194.500.67
222956-2295689.22494.41
322927-2292789.11194.27
423024-2302489.48894.56
522782-2278288.54793.61
623259-2325990.40195.56
极限122608-2260887.87187.931.3093.9794.051.25
223135-2313589.91996.10
322329-2232986.78792.94
422389-2238987.02093.08
522527-2252787.55693.60
622749-2274988.41994.59
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%
114.121682471686691688531692921688611687840.23
214.121684601688841686720.18
单位质量响应值RSD%判断
11953.5411945.610.05数据可信
供试品溶液-2022081601批-氨氯地平-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%
5min1102651-10265155.68754.942.4955.6954.942.49
2104625-10462556.75856.76
398753-9875353.57253.57
4101891-10189155.27555.27
5101857-10185755.25655.26
697880-9788053.09953.10
10min1139671-13967175.77074.242.0876.3974.852.06
2136010-13601073.78474.41
3133780-13378072.57473.17
4134212-13421272.80973.42
5136702-13670274.15974.77
6140767-14076776.36576.95
15min1151239-15123982.04583.271.1283.5184.711.09
2153155-15315583.08584.54
3154949-15494984.05885.46
4151819-15181982.36083.78
5155361-15536184.28285.72
6154457-15445783.79185.23
20min1157763-15776385.58584.951.7187.9687.321.67
2157412-15741285.39487.77
3155478-15547884.34586.68
4153738-15373883.40185.74
5154281-15428183.69686.07
6160922-16092287.29889.67
30min1158421-15842185.94285.720.6589.2689.020.62
2159491-15949186.52289.84
3158582-15858286.02989.30
4157684-15768485.54288.81
5156998-15699885.17088.47
6156857-15685785.09388.43
45min1160605-16060587.12687.131.0991.4091.381.05
2158839-15883986.16890.45
3159118-15911886.32090.55
4160493-16049387.06691.28
5160881-16088187.27691.53
6163722-16372288.81793.10
极限1160545-16054587.09487.210.7592.3492.430.72
2161569-16156987.64992.89
3161727-16172787.73592.92
4158662-15866286.07291.26
5160325-16032586.97592.19
6161715-16171587.72993.00
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%
110.212145521537216002149621591215360.29
210.162171221636216740.25
单位质量响应值RSD%判断
2109.302133.270.80数据可信
供试品溶液-2022081701批-培哚普利-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%
5min124476-2447698.44897.752.2798.4597.752.27
225011-25011100.600100.60
324592-2459298.91498.91
423750-2375095.52895.53
523542-2354294.69194.69
624447-2444798.33198.33
10min124483-2448398.47697.232.3699.5798.322.35
224552-2455298.75399.87
324617-2461799.015100.11
423554-2355494.73995.80
523340-2334093.87994.93
624494-2449498.52099.61
15min124364-2436497.99796.832.05100.1999.002.05
224574-2457498.842101.06
324028-2402896.64698.85
423551-2355194.72796.84
523425-2342594.22096.32
624495-2449598.524100.71
20min123903-2390396.14395.631.8299.4298.881.83
224164-2416497.193100.51
324010-2401096.57399.85
423222-2322293.40496.57
523243-2324393.48896.63
624113-2411396.988100.27
30min123666-2366695.19094.322.3199.5398.622.30
223831-2383195.853100.25
323763-2376395.58099.93
422960-2296092.35096.55
522590-2259090.86295.04
623890-2389096.091100.45
45min123173-2317393.20792.571.6498.6197.921.67
223377-2337794.02799.49
323246-2324693.50098.91
422583-2258390.83496.06
522490-2249090.46095.65
623216-2321693.38098.81
极限122783-2278391.63892.332.3498.0898.712.31
223533-2353394.655101.16
323116-2311692.97899.42
422530-2253090.62196.86
522232-2223289.42295.62
623539-2353994.679101.14
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%
114.121677051678521681871678141679171678950.11
214.121681311683451682380.09
单位质量响应值RSD%判断
11890.5811914.870.15数据可信
供试品溶液-2022081701批-氨氯地平-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%
5min1109279-10927959.51657.753.3059.5257.753.30
2108693-10869359.19759.20
3106494-10649457.99958.00
499728-9972854.31454.31
5104697-10469757.02157.02
6107294-10729458.43558.43
10min1142384-14238477.54675.892.4878.2176.532.49
2142391-14239177.55078.21
3139546-13954676.00076.64
4137105-13710574.67175.27
5133578-13357872.75073.38
6141027-14102776.80777.46
15min1158906-15890686.54485.492.4888.0786.982.47
2162613-16261388.56390.08
3153638-15363883.67585.16
4156545-15654585.25886.69
5151807-15180782.67884.12
6158343-15834386.23787.74
20min1161970-16197088.21387.881.6590.7090.311.66
2164164-16416489.40891.91
3159336-15933686.77889.20
4161760-16176088.09890.48
5157189-15718985.60987.97
6163684-16368489.14691.61
30min1163751-16375189.18388.332.5592.6591.742.53
2166250-16625090.54494.04
3161590-16159088.00691.39
4160318-16031887.31390.67
5155260-15526084.55887.87
6165941-16594190.37693.83
45min1163225-16322588.89688.341.6193.3592.731.62
2166416-16641690.63495.14
3161608-16160888.01692.38
4161641-16164188.03492.36
5158445-15844586.29390.54
6161845-16184588.14592.60
极限1163275-16327588.92489.052.3194.3794.422.29
2169014-16901492.04997.56
3161045-16104587.70993.05
4162655-16265588.58693.89
5158511-15851186.32991.54
6166503-16650390.68296.12
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%
110.212143721699214542159921528215430.51
210.162161021533215720.26
单位质量响应值RSD%判断
2109.992123.230.45数据可信
供试品溶液-2022081801批-培哚普利-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%
5min123890-2389096.301100.674.2896.30100.664.28
224555-2455598.98298.98
326048-26048105.000105.00
424285-2428597.89397.89
526555-26555107.044107.04
624504-2450498.77698.78
10min124384-2438498.29299.461.1799.36100.581.16
224453-2445398.57099.67
324817-24817100.038101.20
425176-25176101.485102.57
524604-2460499.179100.37
624609-2460999.199100.30
15min122975-2297592.61397.302.5694.7799.522.54
224301-2430197.958100.15
324685-2468599.506101.78
424156-2415697.37399.59
524092-2409297.11599.41
624616-2461699.227101.43
20min123291-2329193.88696.311.8097.0899.621.78
224496-2449698.744102.03
324175-2417597.450100.83
423871-2387196.22499.52
523962-2396296.59199.96
623563-2356394.98398.29
30min123138-2313893.27094.610.9897.5098.991.01
223582-2358295.05999.44
323734-2373495.672100.14
423245-2324593.70198.07
523546-2354694.91499.36
623584-2358495.06799.43
45min123174-2317493.41593.900.4498.6999.330.49
223345-2334594.10499.54
323353-2335394.13699.67
423203-2320393.53298.94
523436-2343694.47199.97
623256-2325693.74599.16
极限122670-2267091.38392.941.1997.6999.411.20
223159-2315993.35499.84
323406-2340694.350100.93
422796-2279691.89198.34
523096-2309693.10099.65
623210-2321093.560100.02
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%
114.121674171685081686761676781678931680340.33
214.121673521678221675870.20
单位质量响应值RSD%判断
11900.4211868.770.19数据可信
供试品溶液-2022081801批-氨氯地平-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%
5min1110002-11000260.00160.131.0860.0060.131.08
2111097-11109760.59960.60
3109516-10951659.73659.74
4112154-11215461.17561.18
5109721-10972159.84859.85
6108912-10891259.40759.41
10min1143213-14321378.11677.621.0378.7878.291.03
2141747-14174777.31777.99
3142534-14253477.74678.41
4144094-14409478.59779.28
5139796-13979676.25376.92
6142445-14244577.69778.36
15min1154963-15496384.52586.151.4586.0687.681.43
2157641-15764185.98687.52
3159654-15965487.08488.61
4160261-16026187.41588.97
5155479-15547984.80786.32
6159604-15960487.05788.58
20min1157838-15783886.09488.061.6388.5790.541.61
2164273-16427389.60492.09
3162757-16275788.77791.27
4164033-16403389.47392.00
5160142-16014287.35089.80
6159577-15957787.04289.53
30min1162063-16206388.39888.051.0891.8391.521.06
2161612-16161288.15291.64
3163546-16354689.20792.69
4162563-16256388.67192.19
5158890-15889086.66790.09
6159907-15990787.22290.68
45min1163394-16339489.12488.621.0293.5493.061.01
2161368-16136888.01992.48
3163624-16362489.25093.72
4164658-16465889.81494.32
5160452-16045287.51991.91
6161274-16127487.96892.39
极限1161871-16187188.29388.971.5593.7094.401.50
2163768-16376889.32894.77
3167478-16747891.35296.82
4163758-16375889.32394.82
5161163-16116387.90793.27
6160584-16058487.59193.00
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%
110.212212321873221632196021877219990.63
210.162208621918220020.54
单位质量响应值RSD%判断
2154.652165.550.36数据可信
供试品溶液-726985批-培哚普利-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%
5min124903-2490398.36397.771.9298.3697.771.91
224584-2458497.10397.10
324167-2416795.45695.46
425418-25418100.397100.40
524350-2435096.17996.18
625098-2509899.13399.13
10min125040-2504098.90499.042.17100.00100.132.17
224548-2454896.96198.04
324603-2460397.17898.24
425987-25987102.644103.76
524874-2487498.24899.32
625396-25396100.310101.41
15min124409-2440996.41297.412.3698.6099.602.35
223967-2396794.66696.82
324424-2442496.47198.61
425304-2530499.947102.20
524422-2442296.46398.62
625448-25448100.516102.73
20min124398-2439896.36896.221.4199.6399.491.43
224033-2403394.92698.13
324153-2415395.40098.61
424874-2487498.248101.61
524058-2405895.02598.26
624647-2464797.352100.68
30min124189-2418995.54394.991.8399.8899.321.83
223649-2364993.41097.67
323870-2387094.28398.55
424636-2463697.308101.77
523529-2352992.93697.22
624414-2441496.431100.85
45min124121-2412195.27494.032.54100.6799.432.48
223843-2384394.17699.48
322776-2277689.96295.28
424536-2453696.913102.45
523529-2352992.93698.26
624038-2403894.946100.43
极限123498-2349892.81392.851.9399.2799.291.92
223091-2309191.20697.55
323353-2335392.24198.56
424288-2428895.934102.55
523092-2309291.21097.56
623726-2372693.714100.25
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%
114.121674711678061683901678391679391678890.20
214.121693471697551695510.18
单位质量响应值RSD%判断
11890.1612007.860.70数据可信
供试品溶液-726985批-氨氯地平-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%
5min1141203-14120376.60777.811.0976.6177.811.09
2145528-14552878.95378.95
3143855-14385578.04578.05
4144601-14460178.45078.45
5142884-14288477.51977.52
6142471-14247177.29477.29
10min1163613-16361388.76590.331.6589.6291.201.64
2164073-16407389.01489.89
3164542-16454289.26990.14
4170001-17000192.23093.10
5168644-16864491.49492.36
6168154-16815491.22892.09
15min1168673-16867391.51092.491.5893.3594.351.57
2167012-16701290.60992.47
3169233-16923391.81493.67
4172908-17290893.80795.70
5170865-17086592.69994.58
6174136-17413694.47496.35
20min1168321-16832191.31992.030.8594.1794.930.85
2168062-16806291.17894.05
3169464-16946491.93994.82
4172027-17202793.32996.27
5169954-16995492.20595.11
6169973-16997392.21595.14
30min1168181-16818191.24390.910.7095.1194.830.69
2166246-16624690.19394.08
3167321-16732190.77694.68
4169560-16956091.99195.97
5167305-16730590.76894.70
6166806-16680690.49794.44
45min1166405-16640590.27990.102.3095.1695.022.19
2167500-16750090.87395.76
3158583-15858386.03690.95
4169347-16934791.87596.87
5167781-16778191.02695.97
6166779-16677990.48295.43
极限1165676-16567689.88490.250.7695.7796.180.76
2164663-16466389.33495.23
3166002-16600290.06195.93
4168274-16827491.29397.31
5167193-16719390.70796.66
6166267-16626790.20496.16
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%
110.212157821620216552173321657216490.27
210.162158621433215100.51
单位质量响应值RSD%判断
2120.372117.130.11数据可信
供试品溶液-685501批-培哚普利-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%
5min124263-2426397.70598.101.5997.7098.101.59
224788-2478899.81999.82
324318-2431897.92697.93
424387-2438798.20498.20
524708-2470899.49799.50
623702-2370295.44695.45
10min124749-2474999.662100.891.16100.75101.981.16
225407-25407102.312103.42
325161-25161101.321102.41
425192-25192101.446102.54
525163-25163101.329102.43
624653-2465399.275100.34
15min124870-24870100.149100.301.40102.34102.511.38
224955-24955100.491102.74
325564-25564102.944105.16
424795-2479599.847102.07
524626-2462699.167101.40
624629-2462999.179101.34
20min124382-2438298.18499.011.29101.49102.341.27
225049-25049100.870104.23
324619-2461999.138102.50
424213-2421397.503100.83
524854-24854100.085103.42
624413-2441398.309101.57
30min124123-2412397.14196.701.41101.54101.121.39
224193-2419397.423101.91
324337-2433798.003102.46
423915-2391596.303100.71
524127-2412797.157101.60
623383-2338394.16198.52
45min123905-2390596.26396.250.53101.74101.750.53
223965-2396596.505102.07
323989-2398996.601102.15
424045-2404596.827102.31
523753-2375395.651101.18
623748-2374895.631101.04
极限123836-2383695.98595.740.64102.53102.310.59
223889-2388996.199102.84
323539-2353994.789101.41
423952-2395296.452103.01
523684-2368495.373101.96
623757-2375795.667102.13
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%
114.121678391681681682371680851680661680790.09
214.121673011677561675280.20
单位质量响应值RSD%判断
11903.6111864.590.24数据可信
供试品溶液-685501批-氨氯地平-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%
5min1137105-13710574.78873.541.5174.7973.541.51
2134178-13417873.19173.19
3133456-13345672.79772.80
4135168-13516873.73173.73
5137014-13701474.73874.74
6131983-13198371.99471.99
10min1164301-16430189.62389.360.6090.4590.170.60
2164353-16435389.65190.46
3162237-16223788.49789.31
4164258-16425889.59990.42
5164743-16474389.86490.69
6162986-16298688.90589.71
15min1170987-17098793.27093.440.7395.1095.250.71
2171644-17164493.62895.44
3173043-17304394.39196.18
4172098-17209893.87695.69
5170416-17041692.95894.79
6169574-16957492.49994.29
20min1170648-17064893.08593.041.4295.9595.891.38
2173698-17369894.74997.60
3168272-16827291.78994.63
4167902-16790291.58794.44
5173091-17309194.41897.28
6169830-16983092.63995.45
30min1168387-16838791.85291.181.1595.7595.061.13
2168217-16821791.75995.66
3167263-16726391.23895.10
4166648-16664890.90394.78
5168835-16883592.09696.01
6163613-16361389.24793.09
45min1166915-16691591.04991.651.3295.9796.551.23
2168561-16856191.94796.87
3166277-16627790.70195.58
4168623-16862391.98096.87
5165840-16584090.46295.40
6171880-17188093.75798.59
极限1168957-16895792.16391.641.3498.0997.561.27
2170098-17009892.78598.73
3163797-16379789.34895.23
4169284-16928492.34198.25
5167468-16746891.35097.29
6168400-16840091.85997.74
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