氨氯地平厄贝沙坦片项目信息
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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.566458064808647856464064754647130.16
212.556516664840650030.36
单位质量响应值RSD%判断
5152.315179.520.38数据可信
供试品溶液-2025020511批-氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137460-3746047.01445.156.4947.0145.156.48
237634-3763447.23247.23
332149-3214940.34840.35
435428-3542844.46444.46
534788-3478843.66043.66
638401-3840148.19548.19
10min159013-5901374.06473.964.6974.5974.464.70
261514-6151477.20377.73
355251-5525169.34269.79
456604-5660471.04171.53
558723-5872373.70074.19
662459-6245978.38978.92
15min161325-6132576.96676.223.3978.3177.553.39
264461-6446180.90182.28
359344-5934474.47975.70
459707-5970774.93576.22
558745-5874573.72875.03
660818-6081876.32977.74
20min162461-6246178.39177.333.0880.5979.503.10
264297-6429780.69682.98
358532-5853273.46075.51
461153-6115376.75078.87
561243-6124376.86378.99
662001-6200177.81480.07
30min167116-6711684.23482.005.1787.3185.035.12
268800-6880086.34789.53
359655-5965574.87077.73
463487-6348779.67982.65
565159-6515981.77784.75
667808-6780885.10288.22
45min168484-6848485.95086.633.8289.9690.583.81
272790-7279091.35595.49
366250-6625083.14786.84
466338-6633883.25787.11
568996-6899686.59390.48
671317-7131789.50693.57
60min171971-7197190.32790.092.5095.2994.992.52
271472-7147289.70194.85
368892-6889286.46391.08
471644-7164489.91694.70
572198-7219890.61295.46
674503-7450393.50598.56
极限172036-7203690.40889.353.8796.3795.263.83
273152-7315291.80997.96
366304-6630483.21488.79
469595-6959587.34593.12
573072-7307291.70997.56
673016-7301691.63897.74
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
19.011342399134242313443281342884134264813429360.06
29.051346192134459513453940.09
单位质量响应值RSD%判断
149049.50148662.320.19数据可信
供试品溶液-2025020511批-厄贝沙坦-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187938-879385.3174.999.625.324.999.64
289431-894315.4075.41
382049-820494.9614.96
484209-842095.0915.09
567312-673124.0704.07
684552-845525.1125.11
10min1177746-17774610.74711.213.5310.8111.273.52
2193040-19304011.67111.73
3187288-18728811.32411.38
4187939-18793911.36311.42
5176988-17698810.70110.75
6189458-18945811.45511.51
15min1205086-20508612.40013.013.9712.5813.193.96
2222007-22200713.42313.61
3220832-22083213.35213.53
4220742-22074213.34613.53
5203501-20350112.30412.47
6219206-21920613.25313.44
20min1223529-22352913.51514.163.0313.8314.493.04
2237898-23789814.38414.72
3235867-23586714.26114.59
4241841-24184114.62214.95
5227711-22771113.76814.07
6238770-23877014.43614.77
30min1245241-24524114.82815.482.3315.2915.962.28
2259636-25963615.69816.20
3255965-25596515.47615.96
4255599-25559915.45415.95
5262981-26298115.90016.35
6256263-25626315.49415.99
45min1253641-25364115.33517.1311.2415.9717.7910.83
2269620-26962016.30216.97
3263540-26354015.93416.59
4270815-27081516.37417.04
5304612-30461218.41719.05
6338052-33805220.43921.10
60min1263925-26392515.95717.3211.9516.7618.1611.40
2275323-27532316.64617.50
3271364-27136416.40717.24
4275585-27558516.66217.51
5355657-35565721.50322.34
6277086-27708616.75317.64
极限1262654-26265415.88017.8014.8716.8618.8314.18
2276089-27608916.69317.73
3274896-27489616.62117.64
4288426-28842617.43918.47
5381925-38192523.09224.17
6282108-28210817.05718.13
氨氯地平厄贝沙坦片项目信息
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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.566460264430644076454564470644910.13
212.556491264666647890.27
单位质量响应值RSD%判断
5134.635162.470.39数据可信
供试品溶液-2025020511批-氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131893-3189340.16244.796.6140.1644.796.61
234397-3439743.31543.32
337032-3703246.63446.63
436712-3671246.23146.23
538523-3852348.51148.51
634845-3484543.88043.88
10min154603-5460368.76071.583.4069.2172.083.41
254317-5431768.40068.88
358537-5853773.71474.23
457611-5761172.54873.06
558735-5873573.96474.50
657241-5724172.08272.57
15min157691-5769172.64973.022.5573.8674.312.54
256449-5644971.08572.33
358505-5850573.67475.01
456206-5620670.77972.10
559893-5989375.42276.78
659161-5916174.50075.79
20min156754-5675471.46973.784.7673.4975.884.70
256190-5619070.75972.79
361319-6131977.21879.37
455441-5544169.81671.92
561802-6180277.82680.02
660021-6002175.58377.70
30min160449-6044976.12279.554.5878.9382.474.54
261070-6107076.90479.72
366470-6647083.70486.72
460185-6018575.79078.67
565621-6562182.63585.70
665213-6521382.12185.08
45min164056-6405680.66484.692.8184.3288.502.84
266457-6645783.68887.36
369218-6921887.16591.11
467168-6716884.58388.31
568965-6896586.84690.83
667651-6765185.19189.06
60min166792-6679284.11087.192.6088.6691.942.62
268766-6876686.59691.20
370731-7073189.07093.98
467606-6760685.13589.80
570408-7040888.66393.61
671141-7114189.58694.40
极限167210-6721084.63687.283.0590.1292.993.04
267375-6737584.84490.41
370856-7085689.22795.13
467730-6773085.29190.90
570620-7062088.93094.86
672046-7204690.72696.54
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
19.011340632133822513399501339420133998013396410.07
29.051345707134539913455530.02
单位质量响应值RSD%判断
148683.80148679.890.01数据可信
供试品溶液-2025020511批-厄贝沙坦-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181602-816024.9405.019.494.945.019.50
284159-841595.0945.09
387269-872695.2835.28
486871-868715.2585.26
588912-889125.3825.38
667601-676014.0924.09
10min1185082-18508211.20311.012.7711.2611.062.79
2181977-18197711.01511.07
3186056-18605611.26211.32
4186503-18650311.28911.35
5177257-17725710.73010.79
6174357-17435710.55410.60
15min1214549-21454912.98712.792.6113.1712.972.62
2215436-21543613.04113.22
3214274-21427412.97013.15
4215295-21529513.03213.22
5204325-20432512.36812.55
6204203-20420312.36112.52
20min1230053-23005313.92613.892.8214.2514.212.83
2232404-23240414.06814.39
3237417-23741714.37114.70
4233323-23332314.12314.45
5222434-22243413.46413.78
6220938-22093813.37413.67
30min1257603-25760315.59315.223.3816.0715.703.26
2250837-25083715.18415.66
3254471-25447115.40415.89
4245174-24517414.84115.33
5238814-23881414.45614.92
6262126-26212615.86716.32
45min1259581-25958115.71316.145.5316.3616.785.29
2264796-26479616.02916.68
3264212-26421215.99316.65
4260920-26092015.79416.44
5254688-25468815.41716.04
6295796-29579617.90518.53
60min1263782-26378215.96716.9111.5216.7917.7411.00
2271671-27167116.44517.27
3266836-26683616.15216.99
4269864-26986416.33517.16
5259898-25989815.73216.53
6344569-34456920.85721.68
极限1275156-27515616.65617.5214.5317.6618.5313.87
2278391-27839116.85217.86
3273293-27329316.54317.56
4276277-27627716.72417.73
5259133-25913315.68616.66
6374034-37403422.64123.70
氨氯地平厄贝沙坦片项目信息
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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.566401064171646676436664357643140.39
212.556500964841649250.19
单位质量响应值RSD%判断
5120.545173.310.73数据可信
供试品溶液-2025020511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%
5min139614-3961449.90262.4813.2549.9062.4813.25
252908-5290866.64866.65
346218-4621858.22158.22
447169-4716959.41959.42
553656-5365667.59067.59
658043-5804373.11773.12
10min173974-7397493.18596.412.4193.7497.102.45
278555-7855598.95699.70
375353-7535394.92295.57
477324-7732497.40598.07
578374-7837498.72899.48
675611-7561195.24796.06
15min177208-7720897.25997.151.2698.8598.911.21
277411-7741197.51599.35
377524-7752497.65799.36
477150-7715097.18698.93
578140-7814098.433100.28
675287-7528794.83996.71
20min176567-7656796.45197.041.5999.1299.891.59
278679-7867999.112102.04
377044-7704497.05299.84
476359-7635996.18999.01
578193-7819398.500101.44
675374-7537494.94997.87
30min175475-7547595.07696.342.0198.82100.261.97
277002-7700296.999101.02
378172-7817298.473102.34
475642-7564295.28699.18
578146-7814698.441102.48
674440-7444093.77297.75
45min176221-7622196.01695.872.20100.81100.862.14
277672-7767297.843102.95
375528-7552895.143100.10
475610-7561095.246100.20
578110-7811098.395103.53
673489-7348992.57497.60
60min175196-7519694.72494.322.09100.59100.382.03
276308-7630896.125102.31
374421-7442193.74899.76
474539-7453993.89799.90
576560-7656096.443102.67
672246-7224691.00897.06
极限175149-7514994.66594.181.72101.58101.291.66
276502-7650296.370103.63
374993-7499394.469101.53
474428-7442893.757100.81
574954-7495494.420101.71
672553-7255391.39598.46
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
19.011338942133806613385651337919134062013388220.09
29.051350862135042413506430.03
单位质量响应值RSD%判断
148592.90149242.320.31数据可信
供试品溶液-2025020511批-厄贝沙坦-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%
5min124471-244711.4792.1118.921.482.1118.98
238994-389942.3572.36
331833-318331.9241.92
435940-359402.1722.17
534461-344612.0832.08
643970-439702.6572.66
10min172933-729334.4084.855.684.424.875.77
283599-835995.0525.08
377574-775744.6884.71
483818-838185.0665.09
578955-789554.7724.79
684442-844425.1035.13
15min198933-989335.9796.122.066.046.192.14
2101770-1017706.1516.23
3100943-1009436.1016.17
4103793-1037936.2736.35
598699-986995.9656.04
6102965-1029656.2236.31
20min1112120-1121206.7766.871.456.917.021.51
2115944-1159447.0077.16
3113532-1135326.8617.00
4114900-1149006.9447.09
5111660-1116606.7486.89
6114212-1142126.9037.06
30min1128064-1280647.7407.781.137.958.011.10
2128899-1288997.7908.02
3131361-1313617.9398.16
4129334-1293347.8168.04
5127595-1275957.7117.93
6127504-1275047.7067.94
45min1142757-1427578.6288.511.148.928.821.05
2142036-1420368.5848.90
3139432-1394328.4278.73
4141703-1417038.5648.88
5140670-1406708.5028.80
6138639-1386398.3798.70
60min1148736-1487368.9898.841.259.389.241.16
2147148-1471488.8939.30
3145815-1458158.8139.21
4147238-1472388.8999.31
5144900-1449008.7579.15
6143707-1437078.6859.10
极限1154293-1542939.3259.181.629.819.671.54
2153595-1535959.2839.79
3152643-1526439.2259.72
4152322-1523229.2069.71
5147567-1475678.9189.41
6150523-1505239.0979.60
氨氯地平厄贝沙坦片项目信息
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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.566512664852646946464664692648020.31
212.556458764393644900.22
单位质量响应值RSD%判断
5159.395138.650.29数据可信
供试品溶液-2025020511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%
5min144289-4428955.76761.5410.1655.7761.5410.16
241810-4181052.64552.65
354813-5481369.01869.02
450174-5017463.17763.18
552760-5276066.43366.43
649403-4940362.20662.21
10min173708-7370892.81093.612.0193.4394.302.04
272325-7232591.06991.65
373494-7349492.54193.31
474882-7488294.28894.99
576592-7659296.44297.18
675073-7507394.52995.22
15min174401-7440193.68395.061.1695.3396.781.19
274866-7486694.26895.87
375021-7502194.46396.26
475747-7574795.37897.13
576600-7660096.45298.26
676313-7631396.09097.83
20min174874-7487494.27894.431.8196.9797.201.80
274149-7414993.36596.01
372873-7287391.75994.60
475700-7570095.31898.13
576758-7675896.65199.53
675592-7559295.18297.99
30min174661-7466194.01094.671.6797.7598.501.63
275409-7540994.95298.63
372962-7296291.87195.74
475589-7558995.17999.05
576545-7654596.382100.34
675951-7595195.63499.50
45min173757-7375792.87292.451.4497.6697.341.36
273882-7388293.02997.77
371583-7158390.13495.02
473192-7319292.16097.09
573373-7337392.38897.41
674755-7475594.12899.06
60min172147-7214790.84592.231.6196.6698.141.56
274010-7401093.19098.96
371876-7187690.50396.39
473477-7347792.51998.47
575005-7500594.443100.50
672962-7296291.87197.85
极限172165-7216590.86790.771.5097.6997.711.46
271676-7167690.25197.06
370431-7043188.68495.58
473233-7323392.21299.19
573302-7330292.29999.40
671743-7174390.33697.33
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
19.011348074134692613459971343377134062913450010.23
29.051336032133287413344530.17
单位质量响应值RSD%判断
149278.69147453.370.87数据可信
供试品溶液-2025020511批-厄贝沙坦-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%
5min131983-319831.9402.1214.231.942.1214.23
227930-279301.6941.69
341910-419102.5422.54
433922-339222.0582.06
538964-389642.3642.36
635199-351992.1352.14
10min177694-776944.7134.754.444.734.774.49
273242-732424.4434.46
382178-821784.9855.01
475859-758594.6024.62
581877-818774.9674.99
678993-789934.7924.82
15min199189-991896.0176.012.396.096.092.48
296471-964715.8525.92
3101904-1019046.1826.27
496085-960855.8295.90
5100960-1009606.1256.21
699786-997866.0536.13
20min1112338-1123386.8156.721.476.966.871.50
2108700-1087006.5946.73
3111209-1112096.7466.90
4109153-1091536.6226.76
5112648-1126486.8346.98
6111081-1110816.7396.88
30min1126908-1269087.6997.660.897.927.880.90
2126181-1261817.6557.86
3125707-1257077.6267.85
4124534-1245347.5557.77
5127870-1278707.7577.98
6126251-1262517.6597.88
45min1137984-1379848.3718.231.548.678.531.47
2137575-1375758.3468.64
3134183-1341838.1408.45
4133003-1330038.0688.36
5134291-1342918.1478.46
6136854-1368548.3028.61
60min1143377-1433778.6988.701.079.099.091.01
2145379-1453798.8199.20
3143364-1433648.6979.10
4142319-1423198.6349.02
5144749-1447498.7819.18
6141187-1411878.5658.96
极限1148757-1487579.0248.901.119.529.391.06
2147592-1475928.9539.44
3145301-1453018.8149.31
4146637-1466378.8959.38
5147547-1475478.9519.45
6144348-1443488.7579.25
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