奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号070220417对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.107719077289772207705076827771150.24
2 16.057713377105771190.03
单位质量响应值RSD%判断
4789.754804.920.23数据可信
供试品溶液-24122501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%
5min110564-1056414.26164.9438.4114.2664.9438.41
253685-5368572.47172.47
358258-5825878.64478.64
455776-5577675.29375.29
553702-5370272.49472.49
656655-5665576.48076.48
10min167729-6772991.42991.250.9491.4591.350.94
266680-6668090.01390.13
367931-6793191.70291.83
468451-6845192.40492.53
567078-6707890.55090.67
667691-6769191.37891.51
15min169774-6977494.19093.620.7294.3793.880.71
268994-6899493.13793.41
370044-7004494.55494.84
469085-6908593.25993.54
568752-6875292.81093.08
669462-6946293.76894.05
20min170574-7057495.27094.721.1495.6095.131.14
268810-6881092.88893.31
371105-7110595.98696.43
470196-7019694.75995.19
569765-6976594.17794.60
670549-7054995.23695.67
30min170685-7068595.41994.402.0595.9194.972.03
268719-6871992.76593.35
371268-7126896.20696.81
470595-7059595.29895.89
567614-6761491.27491.86
670681-7068195.41496.01
45min171344-7134496.30995.401.2796.9696.121.25
269025-6902593.17893.91
371505-7150596.52697.29
470872-7087295.67296.42
570438-7043895.08695.82
670818-7081895.59996.35
60min171430-7143096.42595.011.4897.2495.901.45
268553-6855392.54193.43
371247-7124796.17897.10
470503-7050395.17496.08
570532-7053295.21396.11
670018-7001894.51995.43
极限172705-7270598.14696.701.0199.1297.750.98
270591-7059195.29296.34
371997-7199797.19098.27
471246-7124696.17797.25
571456-7145696.46097.51
671805-7180596.93198.00
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号OM230503W对照品来源原料药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250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.964567294568844565044601854569264574460.34
2 10.974561144557774559460.06
单位质量响应值RSD%判断
41737.7741562.990.30数据可信
供试品溶液-24122501批-奥美沙坦酯-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%
5min146470-4647010.03136.7335.6410.0336.7335.64
2196197-19619742.35342.35
3196169-19616942.34742.35
4195060-19506042.10742.11
5190988-19098841.22841.23
6196064-19606442.32442.32
10min1288475-28847562.27361.641.0762.2961.701.05
2281261-28126160.71660.79
3282839-28283961.05661.13
4286279-28627961.79961.87
5288881-28888162.36162.43
6285467-28546761.62461.69
15min1326952-32695270.57970.590.6070.7070.750.60
2324754-32475470.10470.28
3330425-33042571.32971.50
4325562-32556270.27970.45
5327516-32751670.70170.87
6326818-32681870.55070.72
20min1353470-35347076.30376.050.7276.5476.340.71
2347696-34769675.05775.35
3355339-35533976.70777.00
4352388-35238876.07076.36
5352649-35264976.12676.42
6352330-35233076.05776.35
30min1375413-37541381.04080.760.9681.4181.170.96
2369011-36901179.65880.07
3379753-37975381.97782.40
4374711-37471180.88981.31
5372139-37213980.33380.75
6373681-37368180.66681.08
45min1387372-38737283.62283.560.9884.1284.100.97
2380478-38047882.13482.68
3392110-39211084.64585.20
4386804-38680483.49984.05
5387636-38763683.67984.23
6388173-38817383.79584.35
60min1389496-38949684.08083.771.1184.7284.451.10
2382480-38248082.56683.25
3394135-39413585.08285.78
4389711-38971184.12784.82
5388713-38871383.91184.60
6383794-38379482.84983.54
极限1409636-40963688.42887.570.9489.2188.390.93
2399189-39918986.17386.99
3408567-40856788.19789.04
4404793-40479387.38288.21
5404310-40431087.27888.11
6407411-40741187.94888.78
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号070220417对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.107733277291771967728977142772500.11
2 16.057788977936779120.05
单位质量响应值RSD%判断
4798.144854.330.83数据可信
供试品溶液-24122503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%
5min158412-5841278.38271.1113.0078.3871.1113.01
255889-5588974.99775.00
342839-4283957.48557.48
445690-4569061.31161.31
558356-5835678.30778.31
656779-5677976.19176.19
10min168729-6872992.22687.777.7392.3687.897.74
266553-6655389.30689.43
355551-5555174.54374.64
464865-6486587.04187.14
568761-6876192.26992.40
667984-6798491.22791.35
15min169630-6963093.43590.576.8293.7290.846.83
269659-6965993.47493.75
358325-5832578.26578.49
467582-6758290.68790.93
570607-7060794.74695.03
669173-6917392.82293.10
20min172210-7221096.89792.215.6797.3492.635.69
270346-7034694.39694.83
361392-6139282.38182.73
467511-6751190.59290.99
570568-7056894.69495.14
670292-7029294.32494.76
30min171294-7129495.66893.174.2396.2793.744.25
271242-7124295.59896.19
363649-6364985.41085.90
469460-6946093.20793.76
571039-7103995.32695.93
669926-6992693.83394.42
45min171922-7192296.51194.203.3197.2794.923.34
271444-7144495.87096.62
365721-6572188.19088.82
469789-6978993.64994.35
571548-7154896.00996.77
670775-7077594.97295.72
60min172370-7237097.11295.082.0698.0395.962.10
271576-7157696.04796.95
368871-6887192.41793.19
469285-6928592.97293.83
572044-7204496.67597.59
670990-7099095.26096.17
极限173271-7327198.32196.901.2099.4097.931.20
271880-7188096.45597.52
371996-7199696.61097.54
472867-7286797.77998.79
572433-7243397.19798.28
670802-7080295.00896.07
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号OM230503W对照品来源原料药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250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.964569044560804561314559794561064562400.09
2 10.974603764601074602420.05
单位质量响应值RSD%判断
41627.7441954.600.56数据可信
供试品溶液-24122503批-奥美沙坦酯-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%
5min1206781-20678144.48840.4810.4544.4940.4810.45
2189734-18973440.82040.82
3156530-15653033.67733.68
4173038-17303837.22837.23
5201897-20189743.43743.44
6200958-20095843.23543.23
10min1302607-30260765.10461.987.1365.1862.047.13
2293251-29325163.09163.16
3250935-25093553.98754.04
4277784-27778459.76459.83
5301724-30172464.91464.99
6302086-30208664.99265.06
15min1340243-34024373.20170.895.6773.3871.065.67
2335438-33543872.16872.34
3293648-29364863.17763.32
4325020-32502069.92670.09
5342948-34294873.78373.96
6339637-33963773.07173.25
20min1363858-36385878.28275.774.9778.5976.064.98
2360608-36060877.58377.88
3319633-31963368.76769.02
4344758-34475874.17374.45
5360125-36012577.47977.78
6364177-36417778.35178.65
30min1378842-37884281.50680.663.3681.9481.083.38
2379143-37914381.57181.99
3350734-35073475.45875.82
4372736-37273680.19280.59
5385232-38523282.88183.31
6382825-38282582.36382.80
45min1390907-39090784.10183.192.4584.6783.742.47
2390667-39066784.05084.61
3368730-36873079.33079.82
4383754-38375482.56383.10
5393667-39366784.69585.27
6392338-39233884.40984.98
60min1391183-39118384.16183.791.0584.8784.481.07
2391133-39113384.15084.85
3386542-38654283.16283.79
4382684-38268482.33283.01
5393783-39378384.72085.43
6391548-39154884.23984.95
极限1409677-40967788.14087.570.5688.9988.400.58
2408129-40812987.80788.65
3403811-40381186.87887.64
4408363-40836387.85788.67
5407552-40755287.68388.54
6404725-40472587.07487.93
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号070220417对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.107755977630776527768577733776520.09
2 16.057811878414782660.27
单位质量响应值RSD%判断
4823.114876.390.78数据可信
供试品溶液-24122702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%
5min158036-5803677.50077.472.9677.5077.472.96
254636-5463672.95972.96
358630-5863078.29378.29
458809-5880978.53278.53
559452-5945279.39179.39
658510-5851078.13378.13
10min166355-6635588.60987.881.8788.7488.011.87
263597-6359784.92685.05
365974-6597488.10088.23
465321-6532187.22887.36
566633-6663388.98089.11
666974-6697489.43589.57
15min168271-6827191.16790.511.7891.4490.791.78
265440-6544087.38787.65
367775-6777590.50590.78
468317-6831791.22991.50
568868-6886891.96492.25
668009-6800990.81791.10
20min165443-6544387.39191.532.5587.8291.962.54
267801-6780190.54090.95
369435-6943592.72293.15
468580-6858091.58092.01
569780-6978093.18293.62
670205-7020593.75094.18
30min168016-6801690.82792.881.5091.4093.461.50
268459-6845991.41891.98
370032-7003293.51994.10
470434-7043494.05694.64
570159-7015993.68894.28
670217-7021793.76694.35
45min170178-7017893.71493.960.9694.4494.700.97
269081-6908192.24992.96
370812-7081294.56095.30
470617-7061794.30095.04
570591-7059194.26595.01
670896-7089694.67395.42
60min168748-6874891.80492.971.5592.6993.861.54
269695-6969593.06993.93
370909-7090994.69095.59
470350-7035093.94394.84
570042-7004293.53294.43
667989-6798990.79191.69
极限172602-7260296.95196.240.5997.9997.290.59
271544-7154495.53896.56
372312-7231296.56397.62
471615-7161595.63396.68
572049-7204996.21297.27
672312-7231296.56397.62
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号OM230503W对照品来源原料药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250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.964577704580264580204581534577474579430.04
2 10.974615834624424620120.14
单位质量响应值RSD%判断
41783.1242115.950.57数据可信
供试品溶液-24122702批-奥美沙坦酯-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%
5min1198931-19893142.63741.774.1442.6441.774.14
2178516-17851638.26238.26
3198094-19809442.45842.46
4197975-19797542.43242.43
5198819-19881942.61342.61
6197049-19704942.23442.23
10min1282789-28278960.61160.501.7560.6860.571.75
2272999-27299958.51358.58
3282970-28297060.65060.72
4285242-28524261.13761.21
5282236-28223660.49260.56
6287409-28740961.60161.67
15min1324050-32405069.45469.510.9269.6369.680.93
2318806-31880668.33068.49
3325819-32581969.83470.01
4325965-32596569.86570.04
5323835-32383569.40869.58
6327249-32724970.14070.31
20min1338184-33818472.48474.141.3072.7774.431.30
2343265-34326573.57373.85
3348477-34847774.69074.98
4348699-34869974.73775.03
5346740-34674074.31874.61
6350148-35014875.04875.34
30min1367042-36704278.66979.031.0479.0879.441.04
2361722-36172277.52977.93
3371105-37110579.54079.95
4371572-37157279.64080.05
5369614-36961479.22079.63
6371294-37129479.58080.00
45min1381665-38166581.80381.870.5782.3482.400.58
2377810-37781080.97781.50
3382939-38293982.07682.62
4383819-38381982.26582.81
5382303-38230381.94082.48
6383205-38320582.13382.68
60min1380300-38030081.51182.410.7982.1983.090.79
2381416-38141681.75082.41
3386718-38671882.88683.57
4385583-38558382.64383.33
5384886-38488682.49483.17
6388041-38804183.17083.85
极限1401676-40167686.09285.540.6186.9086.350.61
2397202-39720285.13385.93
3395472-39547284.76285.58
4398725-39872585.46086.28
5400342-40034285.80686.62
6401133-40113385.97686.80
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号070220417对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.107782677966780347804078225780180.19
2 16.057843578362783980.07
单位质量响应值RSD%判断
4845.844884.610.57数据可信
供试品溶液-1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%
5min160011-6001179.88178.071.4279.8878.071.42
258705-5870578.14378.14
357389-5738976.39176.39
458572-5857277.96577.97
558620-5862078.02978.03
658596-5859677.99778.00
10min165795-6579587.58088.041.3387.7188.171.33
267356-6735689.65889.79
364977-6497786.49186.62
465652-6565287.39087.52
566948-6694889.11589.24
666103-6610387.99088.12
15min167115-6711589.33790.451.0089.6290.731.00
267746-6774690.17790.46
367372-6737289.67989.95
468768-6876891.53791.81
568692-6869291.43691.71
668020-6802090.54290.82
20min169126-6912692.01491.720.7992.4492.150.78
268778-6877891.55191.98
368325-6832590.94891.37
468319-6831990.94091.37
569693-6969392.76993.20
669187-6918792.09592.52
30min169817-6981792.93492.720.8993.5293.310.88
269772-6977292.87493.46
368918-6891891.73792.31
469371-6937192.34092.92
570721-7072194.13794.72
669361-6936192.32792.91
45min170199-7019993.44292.701.5794.1893.441.56
268805-6880591.58792.32
369493-6949392.50293.23
469072-6907291.94292.68
571563-7156395.25896.00
668714-6871491.46692.20
60min169810-6981092.92492.881.3093.8293.771.29
270419-7041993.73594.63
369514-6951492.53093.41
468832-6883291.62392.51
571174-7117494.74095.64
668913-6891391.73092.62
极限172415-7241596.39294.891.5597.4495.931.54
271864-7186495.65996.70
371560-7156095.25496.29
469947-6994793.10794.15
572052-7205295.90996.97
669872-6987293.00794.05
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号OM230503W对照品来源原料药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250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.964556104554344556144555974557234555960.03
2 10.974622344621144621740.02
单位质量响应值RSD%判断
41568.9842130.720.95数据可信
供试品溶液-1批-奥美沙坦酯-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%
5min1200417-20041743.05942.462.9843.0642.462.98
2195052-19505241.90741.91
3186712-18671240.11540.11
4200343-20034343.04443.04
5200995-20099543.18443.18
6202145-20214543.43143.43
10min1282321-28232160.65661.531.3360.7361.611.33
2286845-28684561.62861.70
3281687-28168760.52060.59
4289982-28998262.30262.37
5290839-29083962.48762.56
6286774-28677461.61361.69
15min1329122-32912270.71270.271.4670.8870.441.46
2327368-32736870.33570.51
3320384-32038468.83469.00
4328868-32886870.65770.83
5333715-33371571.69871.87
6323003-32300369.39769.57
20min1351986-35198675.62475.251.2775.9175.541.27
2349922-34992275.18075.47
3345709-34570974.27574.56
4349318-34931875.05175.34
5358014-35801476.91977.21
6346568-34656874.46074.75
30min1372008-37200879.92679.721.3680.3480.141.36
2370407-37040779.58280.00
3365276-36527678.47978.89
4369574-36957479.40379.82
5380254-38025481.69782.12
6368765-36876579.22979.64
45min1383717-38371782.44182.201.6182.9982.741.60
2383320-38332082.35682.90
3377807-37780781.17281.71
4381163-38116381.89382.44
5393437-39343784.53085.09
6376000-37600080.78381.33
60min1383247-38324782.34082.521.7883.0383.201.78
2385657-38565782.85883.54
3379501-37950181.53582.21
4383414-38341482.37683.06
5396298-39629885.14485.85
6376359-37635980.86081.54
极限1402222-40222286.41785.951.4987.2486.781.48
2404528-40452886.91387.74
3399577-39957785.84986.66
4395189-39518984.90685.73
5407388-40738887.52788.37
6391446-39144684.10284.92
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号070220417对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.107917379196791927899078914790930.17
2 16.057825378435783440.17
单位质量响应值RSD%判断
4912.614881.250.46数据可信
供试品溶液-3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%
5min158443-5844377.29076.322.9977.2976.322.99
258905-5890577.90177.90
356368-5636874.54674.55
458592-5859277.48777.49
554830-5483072.51272.51
659125-5912578.19278.19
10min165288-6528886.34285.534.1886.4785.664.18
267335-6733589.04989.18
364755-6475585.63785.76
466113-6611387.43387.56
559495-5949578.68178.80
665058-6505886.03886.17
15min168153-6815390.13189.221.9690.4089.491.96
268478-6847890.56190.84
366123-6612387.44687.71
467497-6749789.26389.54
565631-6563186.79687.05
668889-6888991.10491.38
20min167639-6763989.45189.492.2289.8789.912.22
269526-6952691.94792.38
366372-6637287.77688.19
469161-6916191.46491.89
565707-6570786.89687.29
667597-6759789.39689.82
30min168754-6875490.92690.991.3291.5091.561.33
269609-6960992.05792.64
368476-6847690.55891.12
469240-6924091.56992.14
567186-6718688.85289.39
669548-6954891.97692.55
45min169061-6906191.33291.421.2092.0692.141.21
269576-6957692.01392.75
369208-6920891.52692.24
469060-6906091.33092.06
567682-6768289.50890.20
670187-7018792.82193.55
60min168666-6866690.80991.471.3691.6992.351.37
270403-7040393.10794.00
368960-6896091.19892.06
469117-6911791.40692.29
567821-6782189.69290.53
670041-7004192.62893.51
极限170923-7092393.79494.901.0694.8295.931.07
272939-7293996.46097.50
371552-7155294.62695.64
472140-7214095.40496.44
571020-7102093.92394.91
671997-7199795.21596.25
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号OM230503W对照品来源原料药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250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.964676444673544671644666664656864669030.17
2 10.974615374624834620100.15
单位质量响应值RSD%判断
42600.6442115.770.81数据可信
供试品溶液-3批-奥美沙坦酯-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%
5min1197654-19765441.95639.054.8541.9639.054.85
2187252-18725239.74839.75
3176660-17666037.49937.50
4187907-18790739.88739.89
5172872-17287236.69536.70
6181314-18131438.48738.49
10min1275971-27597158.58058.191.7758.6558.261.77
2279594-27959459.34959.42
3269370-26937057.17957.24
4277009-27700958.80058.87
5267041-26704156.68456.75
6275819-27581958.54858.61
15min1319998-31999867.92567.411.1168.0967.571.12
2319730-31973067.86868.03
3314903-31490366.84467.00
4316714-31671467.22867.39
5312424-31242466.31866.47
6321715-32171568.29068.45
20min1337491-33749171.63972.100.8971.9272.370.89
2341882-34188272.57172.85
3339485-33948572.06272.33
4341562-34156272.50372.78
5334879-33487971.08471.35
6342585-34258572.72073.00
30min1363925-36392577.25077.470.2977.6577.860.29
2364947-36494777.46777.87
3365643-36564377.61478.00
4364588-36458877.39077.79
5363978-36397877.26177.65
6366651-36665177.82878.23
45min1376988-37698880.02380.330.6780.5580.850.66
2379222-37922280.49781.03
3380537-38053780.77681.29
4376282-37628279.87380.40
5375674-37567479.74480.26
6381880-38188081.06181.59
60min1377335-37733580.09680.660.6780.7681.320.66
2382808-38280881.25881.92
3381661-38166181.01481.67
4378604-37860480.36681.03
5377297-37729780.08880.73
6382154-38215481.11981.78
极限1396686-39668684.20485.010.6485.0085.800.63
2402863-40286385.51586.31
3403801-40380185.71486.50
4399832-39983284.87285.66
5400144-40014484.93885.72
6399622-39962284.82785.62
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