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%
110.442164721864216992172821818217510.41
210.432183121909218700.26
单位质量响应值RSD%判断
2083.432096.840.46数据可信
供试品溶液-2022081601批-培哚普利-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122876-2287693.38293.372.7393.3893.372.73
222069-2206990.08790.09
323037-2303794.03994.04
422982-2298293.81493.81
523884-2388497.49697.50
622385-2238591.37791.38
10min123790-2379097.11397.981.9198.1599.011.92
223488-2348895.88096.88
324499-24499100.007101.05
423912-2391297.61198.65
524624-24624100.517101.60
623696-2369696.72997.74
15min123010-2301093.92996.583.2196.0598.713.18
223126-2312694.40296.47
324514-24514100.068102.22
423870-2387097.43999.57
524554-24554100.231102.43
622890-2289093.43995.53
20min123517-2351795.99897.302.2699.16100.502.26
223172-2317294.59097.71
324492-2449299.978103.25
423897-2389797.549100.76
524431-2443199.729103.04
623500-2350095.92999.06
30min123278-2327895.02396.522.5199.25100.802.50
222933-2293393.61497.78
324401-2440199.607103.99
423849-2384997.354101.65
524198-2419898.778103.20
623210-2321094.74598.94
45min123695-2369596.72596.181.95102.01101.531.95
222873-2287393.36998.58
323971-2397197.852103.34
423872-2387297.447102.82
523848-2384897.349102.87
623103-2310394.30899.56
极限123214-2321494.76194.891.27101.12101.311.33
222849-2284993.27199.52
323457-2345795.753102.33
423203-2320394.716101.17
523687-2368796.692103.29
623065-2306594.153100.45
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%
113.981646631641671642001647451641531643860.18
213.991638301652611645460.62
单位质量响应值RSD%判断
11758.6611761.690.02数据可信
供试品溶液-2022081601批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1152947-15294784.30882.691.2784.3182.691.27
2147789-14778981.46581.47
3148930-14893082.09482.09
4151039-15103983.25783.26
5150669-15066983.05383.05
6148673-14867381.95281.95
10min1163098-16309889.90489.861.2690.8490.781.25
2160738-16073888.60389.51
3162808-16280889.74490.66
4165671-16567191.32292.25
5164978-16497890.94091.86
6160853-16085388.66689.58
15min1157781-15778186.97388.691.9888.9190.611.95
2159304-15930487.81289.70
3163016-16301689.85991.77
4163901-16390190.34692.29
5164237-16423790.53292.46
6157185-15718586.64488.54
20min1159716-15971688.04088.591.4290.9491.491.41
2158548-15854887.39690.26
3160635-16063588.54691.45
4164291-16429190.56193.51
5162464-16246489.55492.49
6158642-15864287.44890.31
30min1159436-15943687.88587.861.5791.7791.751.55
2157221-15722186.66490.50
3158834-15883487.55391.45
4163099-16309989.90493.85
5161302-16130288.91492.85
6156445-15644586.23790.07
45min1158791-15879187.53087.352.1592.3992.222.11
2154956-15495685.41690.22
3157829-15782986.99991.86
4163647-16364790.20695.16
5160743-16074388.60693.53
6154837-15483785.35090.14
极限1165703-16570391.34091.140.8397.1796.980.87
2163774-16377490.27696.02
3164693-16469390.78396.61
4166892-16689291.99597.95
5166898-16689891.99997.91
6164102-16410290.45796.19
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%
110.442142821563215682180721653216040.65
210.432190421854218790.17
单位质量响应值RSD%判断
2069.352097.700.97数据可信
供试品溶液-2022081601批-培哚普利-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122209-2220990.95093.942.2190.9593.942.20
223415-2341595.88995.89
322765-2276593.22793.23
423597-2359796.63496.63
522943-2294393.95693.96
622711-2271193.00693.01
10min123799-2379997.46199.251.2398.47100.291.23
224201-2420199.107100.17
324229-2422999.222100.26
424083-2408398.62499.70
524673-24673101.040102.08
624430-24430100.045101.08
15min123228-2322895.12398.011.7997.22100.161.77
224274-2427499.406101.57
324099-2409998.690100.83
423604-2360496.66398.83
524085-2408598.632100.80
624313-2431399.566101.71
20min123373-2337395.71797.420.9098.87100.660.91
223967-2396798.149101.42
323799-2379997.461100.70
423906-2390697.899101.14
523863-2386397.723100.99
623830-2383097.588100.84
30min123193-2319394.97997.021.1299.19101.331.13
223799-2379997.461101.82
323606-2360696.671100.99
423833-2383397.600101.93
523926-2392697.981102.33
623786-2378697.408101.74
45min123392-2339295.79496.450.95101.06101.840.93
223641-2364196.814102.26
323207-2320795.037100.43
423633-2363396.781102.20
523590-2359096.605102.04
623844-2384497.645103.06
极限123115-2311594.66096.121.22100.99102.591.19
223154-2315494.820101.34
323496-2349696.220102.67
423813-2381397.518104.01
523540-2354096.400102.91
623717-2371797.125103.63
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%
113.981624801631841632641631691637361631670.28
213.991656611654021655320.12
单位质量响应值RSD%判断
11671.4611832.170.97数据可信
供试品溶液-2022081601批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1149980-14998082.73682.380.7182.7482.380.71
2148504-14850481.92181.92
3148553-14855381.94881.95
4151149-15114983.38083.38
5149155-14915582.28082.28
6148644-14864481.99982.00
10min1160124-16012488.33189.510.7489.2590.420.73
2162836-16283689.82790.74
3161608-16160889.15090.06
4163224-16322490.04290.97
5163105-16310589.97690.89
6162624-16262489.71190.62
15min1157788-15778887.04388.701.0888.9490.611.07
2161893-16189389.30791.22
3160812-16081288.71190.61
4161300-16130088.98090.91
5162789-16278989.80291.72
6160145-16014588.34390.25
20min1157160-15716086.69688.020.9489.5690.920.93
2160356-16035688.45991.36
3159295-15929587.87490.76
4161574-16157489.13192.05
5160015-16001588.27191.18
6159012-15901287.71890.61
30min1158098-15809887.21487.590.6491.0491.470.64
2158481-15848187.42591.31
3158229-15822987.28691.15
4160293-16029388.42592.33
5159790-15979088.14792.04
6157832-15783287.06790.93
45min1156303-15630386.22487.111.4291.0291.961.37
2156991-15699186.60391.46
3156892-15689286.54891.38
4161744-16174489.22594.11
5159464-15946487.96792.84
6156069-15606986.09490.93
极限1165447-16544791.26891.591.2197.0397.411.17
2162973-16297389.90395.72
3165702-16570291.40897.20
4168901-16890193.17399.05
5167427-16742792.36098.21
6165783-16578391.45397.24
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%
110.442212421988219082217522109220610.50
210.432216321942220520.71
单位质量响应值RSD%判断
2113.122114.290.04数据可信
供试品溶液-2022081701批-培哚普利-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122248-2224889.80492.862.0689.8092.862.06
222714-2271491.68591.69
323542-2354295.02895.03
423241-2324193.81393.81
523340-2334094.21294.21
622946-2294692.62292.62
10min123436-2343694.60096.951.5495.6097.981.54
223729-2372995.78296.80
324148-2414897.47498.53
424252-2425297.89498.94
524443-2444398.66599.71
624097-2409797.26898.30
15min123823-2382396.16296.081.7998.2198.191.77
223420-2342094.53596.62
323634-2363495.39997.54
424119-2411997.35799.49
524458-2445898.725100.87
623360-2336094.29396.40
20min123962-2396296.72396.850.8999.84100.030.87
223682-2368295.59398.73
323909-2390996.50999.71
424105-2410597.300100.51
523984-2398496.812100.05
624320-2432098.168101.33
30min123903-2390396.48596.800.75100.68101.060.73
223954-2395496.691100.89
323800-2380096.069100.34
424319-2431998.164102.46
523912-2391296.521100.84
624005-2400596.897101.14
45min122946-2294692.62294.202.4197.8999.532.31
223317-2331794.11999.39
322425-2242590.51995.86
423703-2370395.678101.06
523811-2381196.113101.50
623823-2382396.162101.49
极限123491-2349194.82296.021.83101.12102.391.77
223394-2339494.430100.75
323331-2333194.176100.52
424153-2415397.494103.94
524002-2400296.884103.34
624350-2435098.289104.68
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%
113.981649891650031649791645211644541647890.17
213.991637811652761645280.65
单位质量响应值RSD%判断
11787.4811760.400.17数据可信
供试品溶液-2022081701批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1148457-14845781.73882.971.2781.7482.971.26
2148201-14820181.59781.60
3152605-15260584.02284.02
4151358-15135883.33583.33
5152219-15221983.80983.81
6151363-15136383.33883.34
10min1162412-16241289.42190.171.4290.3391.091.41
2162611-16261189.53190.44
3162044-16204489.21990.15
4165889-16588991.33592.26
5167474-16747492.20893.14
6162197-16219789.30390.23
15min1162308-16230889.36489.821.5391.2791.751.51
2160696-16069688.47690.38
3160206-16020688.20790.13
4165332-16533291.02992.97
5166304-16630491.56493.52
6164012-16401290.30292.22
20min1164361-16436190.49489.681.0393.3992.601.02
2161310-16131088.81491.70
3160609-16060988.42891.33
4164349-16434990.48893.44
5164187-16418790.39893.37
6162495-16249589.46792.39
30min1162432-16243289.43289.401.1993.3393.311.16
2163659-16365990.10893.98
3161181-16118188.74392.63
4164270-16427090.44494.40
5163530-16353090.03794.01
6159132-15913287.61591.53
45min1155144-15514485.41987.911.8790.3192.821.81
2160110-16011088.15493.03
3158002-15800286.99391.87
4163629-16362990.09195.05
5161943-16194389.16394.14
6159207-15920787.65792.55
极限1167988-16798892.49193.040.9498.3398.920.94
2169406-16940693.27299.12
3166827-16682791.85297.69
4171033-17103394.168100.13
5170346-17034693.78999.76
6168270-16827092.64698.51
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%
110.442247722103222372210122191222220.70
210.432227322505223890.74
单位质量响应值RSD%判断
2128.542146.600.60数据可信
供试品溶液-2022081701批-培哚普利-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122483-2248389.74193.302.2389.7493.302.23
223604-2360494.21694.22
323553-2355394.01294.01
423028-2302891.91791.92
523816-2381695.06295.06
623769-2376994.87494.87
10min124016-2401695.86097.581.0596.8698.621.06
224789-2478998.94699.99
324575-2457598.09299.14
424366-2436697.25798.28
524445-2444597.57398.63
624494-2449497.76898.82
15min123832-2383295.12696.111.1997.1998.231.17
224348-2434897.18699.33
323771-2377194.88297.02
424433-2443397.52599.63
524203-2420396.60798.75
623879-2387995.31397.45
20min124029-2402995.91297.300.9299.03100.490.91
224430-2443097.513100.74
324337-2433797.142100.33
424625-2462598.291101.48
524250-2425096.794100.01
624584-2458498.128101.33
30min124460-2446097.63397.930.97101.82102.200.94
224652-2465298.399102.71
324503-2450397.804102.07
424445-2444597.573101.85
524216-2421696.659100.95
624926-2492699.493103.78
45min124009-2400995.83295.441.14101.10100.801.06
223478-2347893.71399.12
324316-2431697.058102.41
423902-2390295.405100.77
523938-2393895.549100.91
623817-2381795.066100.46
极限124076-2407696.10096.410.58102.43102.820.55
224408-2440897.425103.87
324068-2406896.068102.50
424182-2418296.523102.94
524156-2415696.419102.84
624027-2402795.904102.36
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%
113.981663241667271668461670611665371666990.17
213.991662151675821668980.58
单位质量响应值RSD%判断
11924.1111929.810.04数据可信
供试品溶液-2022081701批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1148557-14855780.74382.291.1280.7482.291.12
2152664-15266482.97682.98
3152640-15264082.96382.96
4150502-15050281.80081.80
5151172-15117282.16582.16
6152869-15286983.08783.09
10min1164228-16422889.26189.910.8190.1690.820.80
2165242-16524289.81290.73
3166572-16657290.53591.46
4165879-16587990.15891.07
5167012-16701290.77491.69
6163598-16359888.91889.84
15min1163425-16342588.82489.381.1290.7191.291.11
2164687-16468789.51091.43
3167774-16777491.18893.12
4162987-16298788.58690.50
5164885-16488589.61891.54
6162917-16291788.54890.46
20min1164474-16447489.39589.550.9492.2792.460.91
2164554-16455489.43892.35
3164908-16490889.63092.57
4167619-16761991.10494.00
5163044-16304488.61791.53
6163997-16399789.13592.03
30min1165915-16591590.17889.990.3694.0593.890.35
2165720-16572090.07293.98
3165953-16595390.19894.14
4164452-16445289.38393.29
5165958-16595890.20194.10
6165412-16541289.90493.79
45min1161350-16135087.69788.070.4892.5792.970.47
2162828-16282888.50093.41
3162044-16204488.07493.01
4162297-16229788.21193.11
5162776-16277688.47293.38
6160904-16090487.45492.34
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