厄贝沙坦非奈利酮片项目信息
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对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.329233519225419231029224699229619228850.05
216.519243489249959246720.05
单位质量响应值RSD%判断
56549.3356006.780.69数据可信
供试品溶液-5122301批-厄贝沙坦-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%
5min174225-742257.91419.7654.647.9119.7654.65
2302329-30232932.23332.23
3292950-29295031.23331.23
4130819-13081913.94713.95
5223013-22301323.77723.78
688958-889589.4849.48
10min1417341-41734144.49565.1519.7444.5865.3719.85
2718324-71832476.58576.94
3750747-75074780.04280.39
4588521-58852162.74662.90
5635585-63558567.76468.03
6555749-55574959.25259.36
15min1859512-85951291.63893.542.0292.2294.482.24
2895852-89585295.51296.72
3902724-90272496.24597.48
4865153-86515392.23993.09
5867742-86774292.51593.53
6872896-87289693.06593.83
20min1910307-91030797.05397.251.3198.6599.231.39
2902583-90258396.23098.50
3934388-93438899.621101.93
4903413-90341396.31898.20
5906867-90686796.68798.73
6915261-91526197.58199.38
30min1909195-90919596.93598.261.8399.61101.321.86
2916776-91677697.743101.08
3938747-938747100.085103.50
4909270-90927096.94399.89
5909071-90907196.921100.04
6946718-946718100.935103.82
45min1922360-92236098.33898.991.55102.09103.151.53
2917278-91727897.796102.22
3940041-940041100.223104.75
4915783-91578397.637101.66
5923717-92371798.483102.68
6951826-951826101.480105.48
60min1896606-89660695.59396.661.34100.44101.921.42
2902058-90205896.174101.69
3921271-92127198.222103.86
4895622-89562295.488100.60
5901873-90187396.154101.44
6922394-92239498.342103.47
90min1906424-90642496.63995.441.14102.55101.771.09
2889116-88911694.794101.37
3903855-90385596.365103.10
4881208-88120893.951100.12
5888576-88857694.736101.10
6901759-90175996.142102.37
120min1899009-89900995.84994.771.13102.83102.161.08
2887076-88707694.576102.21
3899247-89924795.874103.67
4888403-88840394.718101.93
5872119-87211992.982100.39
6887495-88749594.621101.91
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1898684-89868495.81495.141.13103.86103.581.07
2887252-88725294.595103.28
3901853-90185396.152105.02
4890442-89044294.935103.20
5875557-87555793.348101.79
6900172-90017295.973104.32
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.571333451334921336541333881332541334270.12
210.551331221330371330800.05
单位质量响应值RSD%判断
12623.1812614.220.06数据可信
供试品溶液-5122301批-非奈利酮-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%
5min13912-39122.7882.909.552.792.909.43
24510-45103.2143.21
33631-36312.5882.59
43825-38252.7262.73
54581-45813.2653.26
63928-39282.7992.80
10min123024-2302416.40817.7514.6716.4417.7814.66
230835-3083521.97522.01
323175-2317516.51616.54
422803-2280316.25116.28
528000-2800019.95419.99
621588-2158815.38515.42
15min174101-7410152.80953.978.0253.0254.208.02
281476-8147658.06458.34
382559-8255958.83659.05
476278-7627854.36054.57
574221-7422152.89453.15
665755-6575546.86147.06
20min191184-9118464.98367.987.1165.7868.817.09
295743-9574368.23269.16
3106275-10627575.73876.60
495108-9510867.77968.59
597958-9795869.81070.66
686082-8608261.34762.07
30min1108835-10883577.56281.144.6179.0882.734.63
2114013-11401381.25282.94
3121883-12188386.86188.57
4112349-11234980.06681.63
5117735-11773583.90585.53
6108358-10835877.22278.63
45min1121638-12163886.68688.342.3289.0790.822.38
2123328-12332887.89190.48
3126553-12655390.18992.86
4122134-12213487.04089.50
5128434-12843491.52994.08
6121624-12162486.67688.94
60min1121274-12127486.42787.561.8389.7791.021.83
2121594-12159486.65590.22
3123880-12388088.28491.96
4120554-12055485.91489.34
5126657-12665790.26393.83
6123193-12319387.79491.02
90min1121815-12181586.81286.171.9391.1290.611.83
2118596-11859684.51889.04
3120571-12057185.92690.58
4117964-11796484.06888.45
5123998-12399888.36892.94
6122524-12252487.31891.52
120min1119916-11991685.45985.381.2290.7390.781.17
2117955-11795584.06189.53
3119759-11975985.34790.96
4118430-11843084.40089.71
5121804-12180486.80492.36
6120938-12093886.18791.36
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1118584-11858484.51084.571.4490.7390.921.31
2116474-11647483.00689.40
3118842-11884284.69491.25
4117266-11726683.57089.82
5119555-11955585.20291.72
6121305-12130586.44992.58
厄贝沙坦非奈利酮片项目信息
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对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.329231899223349225099232469228489228250.05
216.519237959240849239400.03
单位质量响应值RSD%判断
56545.6555962.450.74数据可信
供试品溶液-5122301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%
5min18398-83980.8961.0223.980.901.0223.87
212098-120981.2901.29
37254-72540.7740.77
49469-94691.0101.01
512496-124961.3331.33
67460-74600.7960.80
10min124959-249592.6622.899.732.672.909.83
229073-290733.1013.12
324927-249272.6592.67
425979-259792.7712.78
531530-315303.3633.38
626265-262652.8012.81
15min138146-381464.0694.173.284.114.223.35
239502-395024.2134.26
339617-396174.2264.26
437617-376174.0124.05
541234-412344.3984.45
638734-387344.1314.17
20min143767-437674.6684.752.604.754.842.67
246187-461874.9265.02
343532-435324.6434.73
443710-437104.6624.75
545833-458334.8894.99
644395-443954.7354.82
30min149744-497445.3065.322.225.445.462.27
251298-512985.4725.62
349552-495525.2855.42
448374-483745.1605.30
551088-510885.4495.60
649373-493735.2665.40
45min154714-547145.8365.911.396.036.111.50
256030-560305.9766.19
355495-554955.9196.11
454338-543385.7965.99
556376-563766.0136.23
655370-553705.9066.10
60min158661-586616.2576.141.986.526.412.00
258804-588046.2726.55
357393-573936.1226.38
456003-560035.9736.23
558116-581166.1996.48
656593-565936.0366.30
90min160168-601686.4186.371.536.756.711.59
259738-597386.3726.72
359953-599536.3956.72
458675-586756.2586.58
561104-611046.5176.87
658788-587886.2706.60
120min160955-609556.5026.571.406.906.971.47
263073-630736.7277.15
362036-620366.6177.02
460741-607416.4796.87
561465-614656.5566.98
661156-611566.5236.92
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限162994-629946.7196.653.087.197.133.02
264405-644056.8707.36
362484-624846.6657.14
459831-598316.3826.85
564235-642356.8517.35
660369-603696.4396.91
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.571337031335511333951336931336181335920.10
210.551338711337151337930.09
单位质量响应值RSD%判断
12638.7912681.800.25数据可信
供试品溶液-5122301批-非奈利酮-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%
5min12932-29322.0832.5931.462.082.5931.41
23435-34352.4402.44
33066-30662.1782.18
45495-54953.9033.90
54548-45483.2313.23
62432-24321.7271.73
10min134681-3468124.63525.2017.6524.6625.2317.68
238072-3807227.04327.07
330058-3005821.35121.37
445025-4502531.98232.03
537545-3754526.66926.70
627487-2748719.52419.54
15min177189-7718954.82955.723.3355.1356.033.40
278332-7833255.64155.97
378002-7800255.40655.67
481699-8169958.03258.43
580927-8092757.48457.82
674505-7450552.92253.16
20min190140-9014064.02865.412.4964.9366.332.55
293515-9351566.42567.37
389359-8935963.47364.35
494072-9407266.82167.86
594730-9473067.28868.26
690677-9067764.40965.23
30min199698-9969870.81771.921.9172.4373.571.93
2102672-10267272.93074.61
399151-9915170.42972.01
4100653-10065371.49673.28
5104309-10430974.09275.81
6100990-10099071.73573.27
45min1106568-10656875.69777.221.5578.1079.671.58
2108804-10880477.28579.78
3108615-10861577.15179.52
4108882-10888277.34179.92
5111621-11162179.28681.83
6107757-10775776.54278.88
60min1111758-11175879.38478.891.7582.6382.201.73
2111421-11142179.14482.50
3109397-10939777.70780.93
4109102-10910277.49780.94
5114383-11438381.24884.67
6110314-11031478.35881.55
90min1110957-11095778.81579.342.2782.9483.532.23
2110687-11068778.62382.86
3111057-11105778.88682.97
4110410-11041078.42682.73
5116826-11682682.98487.31
6110281-11028178.33482.39
120min1110118-11011878.21979.901.7083.2284.961.69
2114059-11405981.01886.12
3111474-11147479.18284.14
4111339-11133979.08684.26
5115264-11526481.87487.12
6112633-11263380.00584.93
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1112603-11260379.98481.033.9085.8686.993.72
2120255-12025585.41991.43
3112886-11288680.18586.03
4109725-10972577.94083.99
5118821-11882184.40190.56
6110152-11015278.24384.06
厄贝沙坦非奈利酮片项目信息
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对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.329169229161529153609166489177609165680.10
216.519196819191709194260.04
单位质量响应值RSD%判断
56162.2555689.040.60数据可信
供试品溶液-5122301批-厄贝沙坦-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%
5min179131-791318.4907.3618.628.497.3618.61
256276-562766.0386.04
357016-570166.1176.12
459127-591276.3446.34
585766-857669.2029.20
674465-744657.9897.99
10min1320222-32022234.35631.866.5334.4531.946.56
2293107-29310731.44731.51
3263094-26309428.22728.29
4293339-29333931.47231.54
5304170-30417032.63432.74
6307527-30752732.99433.08
15min1522475-52247556.05555.161.4856.5355.601.52
2510773-51077354.79955.22
3500673-50067353.71654.10
4516456-51645655.40955.83
5516705-51670555.43655.90
6517842-51784255.55856.01
20min1621797-62179766.71165.740.9167.8166.790.95
2609970-60997065.44266.47
3606809-60680965.10366.08
4608568-60856865.29266.33
5613568-61356865.82866.91
6615848-61584866.07367.15
30min1712098-71209876.39976.871.0078.2478.650.97
2715797-71579776.79678.55
3722630-72263077.52979.23
4707983-70798375.95877.72
5713350-71335076.53378.35
6727256-72725678.02579.83
45min1793001-79300185.07985.020.9287.7787.650.92
2784487-78448784.16586.77
3792292-79229285.00387.57
4786838-78683884.41887.02
5792668-79266885.04387.71
6805330-80533086.40289.08
60min1838667-83866789.97889.230.6193.6192.810.63
2823732-82373288.37691.92
3828831-82883188.92392.43
4831825-83182589.24492.79
5833938-83393889.47193.08
6833157-83315789.38793.02
90min1866877-86687793.00593.040.7197.6497.610.68
2863415-86341592.63397.16
3871789-87178993.53298.03
4866736-86673692.99097.52
5858570-85857092.11496.72
6875816-87581693.96498.59
120min1869306-86930693.26593.770.8998.9399.370.82
2865434-86543492.85098.40
3882306-88230694.660100.20
4879789-87978994.39099.96
5880677-88067794.485100.11
6866443-86644392.95898.63
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1884769-88476994.92493.851.48101.63100.491.39
2854167-85416791.64198.23
3880861-88086194.505101.09
4885912-88591295.047101.66
5879253-87925394.333101.01
6863385-86338592.63099.33
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.571330961329741330351332881333701331530.13
210.551332341334291333320.11
单位质量响应值RSD%判断
12597.2612638.100.23数据可信
供试品溶液-5122301批-非奈利酮-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%
5min13743-37432.6682.3843.452.672.3843.47
23021-30212.1532.15
32047-20471.4591.46
46063-60634.3214.32
52359-23591.6811.68
62840-28402.0242.02
10min137418-3741826.66825.3812.7426.7025.4012.76
233578-3357823.93223.96
328445-2844520.27320.29
442139-4213930.03330.08
535318-3531825.17225.19
636744-3674426.18826.21
15min161309-6130943.69642.914.1744.0243.224.23
258966-5896642.02642.32
357631-5763141.07541.32
464482-6448245.95746.34
560588-6058843.18243.48
658295-5829541.54841.86
20min171034-7103450.62749.852.4651.4450.642.53
269127-6912749.26850.02
368653-6865348.93049.63
472842-7284251.91652.81
569726-6972649.69550.47
668294-6829448.67449.45
30min178435-7843555.90256.541.5657.2857.881.62
278783-7878356.15057.45
379054-7905456.34357.58
481736-8173658.25559.72
579436-7943656.61557.95
678516-7851655.96057.28
45min186924-8692461.95261.861.2763.9563.821.35
285485-8548560.92762.85
386271-8627161.48763.35
488760-8876063.26165.38
586873-8687361.91663.88
686433-8643361.60263.54
60min192679-9267966.05465.162.0068.7467.812.02
289971-8997164.12466.73
390805-9080564.71867.27
493776-9377666.83669.66
592346-9234665.81668.46
688947-8894763.39466.02
90min196901-9690169.06369.131.4072.4872.511.45
296203-9620368.56571.88
397348-9734869.38172.65
499502-9950270.91774.48
596343-9634368.66572.04
695705-9570568.21071.54
120min199316-9931670.78470.892.2174.9775.032.20
297886-9788669.76573.84
3100401-10040171.55775.60
4102436-10243673.00877.36
5100530-10053071.64975.79
696180-9618068.54972.63
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1102036-10203672.72371.552.7677.6976.492.71
297412-9741269.42774.28
3101026-10102672.00376.84
4103886-10388674.04179.20
5101262-10126272.17177.11
696742-9674268.95073.80
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