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%
110.212074420731207932068220768207440.21
210.162093420825208800.37
单位质量响应值RSD%判断
2031.732055.120.81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%
5min122954-2295495.84495.630.9995.8495.630.99
222790-2279095.15995.16
322598-2259894.35794.36
423265-2326597.14297.14
522992-2299296.00396.00
622822-2282295.29395.29
10min123150-2315096.66295.371.2797.7396.441.26
222760-2276095.03496.09
322551-2255194.16195.21
422641-2264194.53795.62
522687-2268794.72995.80
623254-2325497.09798.16
15min123059-2305996.28294.652.0698.4296.772.02
222488-2248893.89896.01
322657-2265794.60496.70
423047-2304796.23298.36
521839-2183991.18893.31
622921-2292195.70697.84
20min122437-2243793.68592.970.9896.8996.140.98
222063-2206392.12495.28
321941-2194191.61494.76
422399-2239993.52796.73
522276-2227693.01396.15
622473-2247393.83697.04
30min121745-2174590.79692.121.7295.0596.331.64
221810-2181091.06795.25
321680-2168090.52494.69
422468-2246893.81598.05
522547-2254794.14498.31
622128-2212892.39596.64
45min121898-2189891.43591.321.4596.6996.551.41
221899-2189991.43996.63
321332-2133289.07194.24
422326-2232693.22298.50
521909-2190991.48196.69
621862-2186291.28496.55
极限121710-2171090.65090.501.1296.9296.741.11
221644-2164490.37496.58
321316-2131689.00495.16
421997-2199791.84898.16
521518-2151889.84896.08
621862-2186291.28497.57
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%
114.121658281666821658921660131660571660940.21
214.121671641665341668490.27
单位质量响应值RSD%判断
11763.0311816.500.33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%
5min1102346-10234656.27454.115.3256.2754.115.32
298241-9824154.01754.02
3103387-10338756.84756.85
4100656-10065655.34555.35
596805-9680553.22853.23
688990-8899048.93148.93
10min1136671-13667175.14873.541.3975.7774.141.38
2130931-13093171.99272.59
3133738-13373873.53574.17
4133055-13305573.16073.77
5134006-13400673.68374.27
6134081-13408173.72474.27
15min1154802-15480285.11783.671.2986.5885.081.28
2149195-14919582.03483.43
3150676-15067682.84884.30
4152709-15270983.96685.39
5152785-15278584.00885.42
6152817-15281784.02685.39
20min1156311-15631185.94784.801.1688.3587.151.14
2152466-15246683.83386.14
3151787-15178783.45985.83
4154151-15415184.75987.12
5155283-15528385.38287.73
6155360-15536085.42487.72
30min1156422-15642286.00886.281.7289.3789.581.66
2153522-15352284.41387.66
3155066-15506685.26288.56
4157430-15743086.56289.86
5161398-16139888.74492.04
6157716-15771686.71989.96
45min1160953-16095388.49987.321.5992.8291.561.53
2157796-15779686.76390.94
3154705-15470585.06489.31
4161262-16126288.66992.93
5157823-15782386.77891.06
6160265-16026588.12192.33
极限1160664-16066488.34087.581.4393.6492.791.38
2158351-15835187.06992.21
3155160-15516085.31490.50
4160706-16070688.36393.61
5159503-15950387.70292.94
6161258-16125888.66793.86
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%
110.212070520827207262083720796207780.29
210.162081020900208550.31
单位质量响应值RSD%判断
2035.062052.660.61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%
5min123053-2305396.23595.312.5996.2495.312.59
223263-2326397.11297.11
323341-2334197.43897.44
422802-2280295.18895.19
521714-2171490.64690.65
622811-2281195.22595.23
10min123064-2306496.28196.690.6297.3597.750.62
223102-2310296.44097.52
323119-2311996.51197.59
423437-2343797.83898.90
523056-2305696.24897.26
623193-2319396.82097.88
15min123114-2311496.49095.951.0698.6398.081.06
222817-2281795.25097.40
323273-2327397.15499.31
423191-2319196.81298.96
522655-2265594.57496.65
622853-2285395.40197.53
20min122589-2258994.29894.680.7897.5197.880.77
222742-2274294.93798.15
322973-2297395.90199.14
422643-2264394.52497.74
522689-2268994.71697.84
622441-2244193.68196.87
30min122029-2202991.96192.831.3896.2297.091.36
222112-2211292.30796.57
322685-2268594.69999.00
422565-2256594.19898.47
521955-2195591.65295.83
622084-2208492.19096.43
45min122156-2215692.49192.051.4297.7797.331.38
221727-2172790.70095.99
322392-2239293.47698.83
422403-2240393.52298.84
521906-2190691.44796.65
621717-2171790.65895.92
极限122066-2206692.11591.090.8998.4297.400.84
221697-2169790.57596.87
321937-2193791.57797.97
421597-2159790.15796.51
521664-2166490.43796.65
621965-2196591.69497.96
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%
114.121656111659091656191656411659641657490.11
214.121670731670481670600.02
单位质量响应值RSD%判断
11738.6011831.440.56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%
5min1105881-10588158.24258.012.5858.2458.012.58
2107109-10710958.91858.92
3109106-10910660.01660.02
4102822-10282256.56056.56
5101816-10181656.00656.01
6106049-10604958.33558.33
10min1138507-13850776.18976.071.9576.8476.721.94
2135564-13556474.57075.22
3142044-14204478.13478.80
4138308-13830876.07976.71
5140325-14032577.18977.81
6135036-13503674.28074.93
15min1157317-15731786.53685.371.7988.0386.861.79
2152757-15275784.02785.51
3159854-15985487.93189.47
4154171-15417184.80586.28
5153611-15361184.49785.98
6153527-15352784.45185.92
20min1160764-16076488.43287.921.1690.8990.361.17
2159823-15982387.91490.33
3162875-16287589.59392.11
4157487-15748786.62989.05
5159239-15923987.59390.01
6158850-15885087.37989.79
30min1159575-15957587.77887.551.7291.2290.961.71
2157617-15761786.70190.09
3164298-16429890.37693.88
4159277-15927787.61490.99
5157230-15723086.48889.88
6156983-15698386.35289.73
45min1162355-16235589.30787.831.7593.7292.221.73
2156744-15674486.22190.58
3163528-16352889.95294.46
4159983-15998388.00292.35
5158190-15819087.01691.37
6157255-15725586.50290.84
极限1163979-16397990.20088.551.2895.6193.911.27
2160295-16029588.17493.49
3163000-16300089.66295.17
4158704-15870487.29992.63
5159746-15974687.87293.19
6160114-16011488.07493.38
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%
110.212082720912208672074820852208410.30
210.162085620915208860.20
单位质量响应值RSD%判断
2041.232055.710.50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%
5min123099-2309996.21095.171.8996.2195.171.89
222442-2244293.47393.47
322584-2258494.06594.06
422552-2255293.93293.93
522838-2283895.12395.12
623584-2358498.23098.23
10min123278-2327896.95596.201.8498.0297.261.84
222408-2240893.33294.37
323100-2310096.21497.26
422988-2298895.74896.79
523090-2309096.17297.23
623716-2371698.78099.87
15min123313-2331397.10194.891.8299.2597.011.81
222148-2214892.24994.32
323024-2302495.89798.01
422512-2251293.76595.87
522716-2271694.61596.74
622977-2297795.70297.89
20min123108-2310896.24793.822.0199.4797.001.99
222050-2205091.84194.94
322821-2282195.05298.23
422029-2202991.75394.90
522331-2233193.01196.19
622818-2281895.03998.29
30min123155-2315596.44393.192.07100.7497.412.04
221861-2186191.05395.17
322063-2206391.89596.13
422371-2237193.17897.35
522172-2217292.34996.56
622618-2261894.20698.51
45min122391-2239193.26192.121.2098.6397.381.22
221825-2182590.90496.04
322263-2226392.72897.98
421779-2177990.71295.92
522104-2210492.06697.30
622347-2234793.07898.43
极限122160-2216092.29990.701.4998.7096.991.48
221309-2130988.75494.90
321542-2154289.72596.01
421668-2166890.25096.46
521984-2198491.56697.83
621999-2199991.62898.02
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%
114.121668281670271668401668051668511668700.06
214.121661951657951659950.18
单位质量响应值RSD%判断
11817.9911756.020.38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%
5min1111161-11116161.13659.862.2961.1459.862.29
2110414-11041460.72560.72
3109131-10913160.01960.02
4110240-11024060.62960.63
5104411-10441157.42357.42
6107674-10767459.21859.22
10min1142309-14230978.26677.071.3778.9577.741.37
2138287-13828776.05476.73
3140544-14054477.29677.96
4141192-14119277.65278.33
5137341-13734175.53476.17
6141153-14115377.63178.29
15min1155581-15558185.56684.351.3087.1185.871.29
2151044-15104483.07084.59
3155519-15551985.53287.06
4152945-15294584.11685.65
5151300-15130083.21184.69
6153814-15381484.59486.11
20min1159091-15909187.49685.941.8090.0088.401.77
2155471-15547185.50587.95
3159104-15910487.50389.98
4152648-15264883.95386.42
5153531-15353184.43886.84
6157686-15768686.72389.18
30min1162578-16257889.41487.141.4892.8990.561.46
2156871-15687186.27589.67
3156643-15664386.15089.60
4158918-15891887.40190.80
5156500-15650086.07189.41
6159185-15918587.54890.97
45min1160437-16043788.23687.300.7592.7091.680.74
2158186-15818686.99891.35
3159482-15948287.71192.12
4157321-15732186.52390.90
5159269-15926987.59491.89
6157734-15773486.75091.15
极限1160492-16049288.26787.450.8693.7192.800.83
2157550-15755086.64991.97
3157632-15763286.69492.07
4158175-15817586.99292.33
5159998-15999887.99593.26
6160169-16016988.08993.45
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%
110.212084120770209302092020886208690.32
210.162092820904209160.09
单位质量响应值RSD%判断
2043.982058.660.51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%
5min123159-2315996.32697.392.5696.3397.382.56
222746-2274694.60894.61
324497-24497101.891101.89
423622-2362298.25298.25
523245-2324596.68496.68
623214-2321496.55596.55
10min122655-2265594.23096.883.1295.3097.963.11
222490-2249093.54394.59
324473-24473101.791102.92
423701-2370198.58099.67
523283-2328396.84297.92
623152-2315296.29797.37
15min122467-2246793.44895.902.9195.5698.062.91
222320-2232092.83694.93
324085-24085100.177102.44
423574-2357498.052100.24
522962-2296295.50797.66
622928-2292895.36597.51
20min122235-2223592.48395.223.4095.6498.443.38
221893-2189391.06094.18
324015-2401599.886103.26
423412-2341297.378100.65
523072-2307295.96499.18
622734-2273494.55897.76
30min121433-2143389.14793.763.7393.3398.043.68
221743-2174390.43694.57
323729-2372998.697103.18
422942-2294295.42399.78
522825-2282594.93799.21
622575-2257593.89798.15
45min122560-2256093.83493.832.8299.0199.162.81
221744-2174490.44095.58
323651-2365198.372103.95
422723-2272394.51299.93
522477-2247793.48998.82
622206-2220692.36297.66
极限121448-2144889.20992.063.3795.4398.423.34
221222-2122288.26994.41
323150-2315096.288102.96
422756-2275694.650101.12
522260-2226092.58798.96
621962-2196291.34797.67
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%
114.121673051661951667991668521668471668000.24
214.121668701669901669300.06
单位质量响应值RSD%判断
11813.0311822.240.06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%
5min1111622-11162261.23074.859.6061.2374.859.60
2142812-14281278.33978.34
3145998-14599880.08780.09
4145254-14525479.67879.68
5140432-14043277.03377.03
6132564-13256472.71772.72
10min1162022-16202288.87688.961.2589.5689.801.26
2160619-16061988.10788.98
3164179-16417990.06090.95
4165113-16511390.57291.46
5160617-16061788.10688.96
6160522-16052288.05488.86
15min1166420-16642091.28991.011.4192.9692.831.40
2165102-16510290.56692.42
3166434-16643491.29793.19
4169832-16983293.16195.05
5162839-16283989.32591.16
6164862-16486290.43492.22
20min1166183-16618391.15991.221.7393.8494.061.71
2163169-16316989.50692.36
3166244-16624491.19294.10
4171398-17139894.02096.95
5166720-16672091.45494.28
6164081-16408190.00692.80
30min1163664-16366489.77790.321.0993.4794.161.12
2163210-16321089.52893.38
3165012-16501290.51794.43
4167937-16793792.12196.09
5164787-16478790.39394.24
6163285-16328589.56993.36
45min1169913-16991393.20590.591.8197.9095.441.71
2164420-16442090.19295.04
3165260-16526090.65395.58
4166955-16695591.58296.58
5161885-16188588.80193.65
6162412-16241289.09093.88
极限1162986-16298689.40588.672.7495.1394.522.60
2160936-16093688.28194.13
3154577-15457784.79390.72
4168328-16832892.33698.35
5162186-16218688.96694.80
6160828-16082888.22194.00
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%
110.212096520857209782086720937209210.27
210.162101120980209960.11
单位质量响应值RSD%判断
2049.072066.540.61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%
5min122563-2256393.55296.191.6293.5596.181.62
223460-2346097.27197.27
323568-2356897.71997.72
423356-2335696.84096.84
523291-2329196.57096.57
622951-2295195.16095.16
10min123615-2361597.91499.491.6098.95100.561.60
224308-24308100.787101.87
324537-24537101.736102.82
424049-2404999.713100.79
523901-2390199.099100.17
623566-2356697.71098.77
15min123520-2352097.52097.871.2499.65100.041.24
223734-2373498.407100.61
323940-2394099.261101.48
423830-2383098.805100.99
523456-2345697.25499.43
623143-2314395.95798.10
20min123406-2340697.04797.211.24100.26100.481.24
223659-2365998.096101.39
323728-2372898.382101.70
423673-2367398.154101.44
523178-2317896.10299.36
623032-2303295.49698.71
30min122950-2295095.15695.562.0399.4599.901.99
223559-2355997.681102.07
323348-2334896.807101.22
423266-2326696.467100.84
522922-2292295.04099.36
622232-2223292.17996.45
45min122627-2262793.81794.661.3599.16100.061.34
223332-2333296.740102.21
323021-2302195.451100.94
422864-2286494.800100.24
522562-2256293.54898.93
622574-2257493.59798.89
极限122451-2245193.08793.541.2299.4899.991.22
222794-2279494.510101.05
322803-2280394.547101.10
422776-2277694.435100.93
522142-2214291.80698.22
622388-2238892.82699.16
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%
114.121671911671351669301664031661661667650.28
214.121672581673361672970.04
单位质量响应值RSD%判断
11810.5511848.230.23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%
5min1117484-11748464.38171.655.0864.3871.655.08
2133601-13360173.21473.21
3131660-13166072.15072.15
4133295-13329573.04673.05
5135802-13580274.42074.42
6132626-13262672.67972.68
10min1160964-16096488.20989.101.4288.9289.891.42
2165512-16551290.70191.51
3164866-16486690.34791.15
4163047-16304789.35090.16
5161489-16148988.49689.32
6159623-15962387.47488.28
15min1168101-16810192.12092.011.0193.8293.801.00
2169126-16912692.68194.50
3166863-16686391.44193.25
4169750-16975093.02394.83
5168463-16846392.31894.13
6165078-16507890.46392.24
20min1170472-17047293.41992.381.4396.1495.181.39
2170020-17002093.17196.02
3170406-17040693.38396.20
4169033-16903392.63095.47
5167050-16705091.54494.38
6164430-16443090.10892.89
30min1165455-16545590.67090.301.5994.4394.141.55
2164486-16448690.13994.02
3165853-16585390.88894.75
4167820-16782091.96695.83
5165157-16515790.50694.36
6159963-15996387.66091.45
45min1163629-16362989.66990.141.2194.4394.981.20
2167544-16754491.81496.70
3165022-16502290.43295.30
4165362-16536290.61995.51
5163711-16371189.71494.57
6161696-16169688.61093.37
极限1167434-16743491.75490.431.2897.5196.271.23
2165911-16591190.92096.83
3166240-16624091.10096.97
4165440-16544090.66196.56
5163455-16345589.57495.43
6161633-16163388.57594.32
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