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80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33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%
115.038706798677248662948694228683928685020.20
215.048706888707888707380.01
单位质量响应值RSD%判断
57784.5657894.810.14数据可信
供试品溶液-25112602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%
5min1228610-22861023.66017.5445.8723.6617.5445.87
2220576-22057622.82922.83
365505-655056.7806.78
4212808-21280822.02522.02
5216254-21625422.38122.38
673339-733397.5907.59
10min1666108-66610868.94061.7610.9269.2061.9511.02
2644621-64462166.71666.97
3516182-51618253.42353.50
4598562-59856261.94962.19
5635870-63587065.81066.06
6518816-51881653.69553.78
15min1861563-86156389.16888.251.9790.2089.132.01
2874789-87478990.53791.53
3832018-83201886.11186.78
4839454-83945486.88087.81
5843630-84363087.31288.29
6864831-86483189.50790.19
20min1900530-90053093.20191.532.4995.2293.392.50
2915030-91503094.70296.70
3867931-86793189.82891.45
4862703-86270389.28691.18
5865446-86544689.57091.52
6894702-89470292.59894.27
30min1899541-89954193.09991.962.3396.1594.842.38
2924149-92414995.64698.70
3872121-87212190.26192.88
4880128-88012891.09093.98
5868492-86849289.88692.83
6886791-88679191.77994.48
45min1879722-87972291.04891.671.5895.1495.571.61
2899487-89948793.09397.21
3863048-86304889.32292.95
4889448-88944892.05495.96
5882299-88229991.31595.26
6900338-90033893.18296.91
60min1876112-87611290.67490.701.7795.7895.621.78
2891370-89137092.25397.40
3856155-85615588.60993.23
4885393-88539391.63596.56
5859146-85914688.91893.88
6890117-89011792.12496.88
极限1886782-88678291.77994.131.2797.89100.061.12
2915078-91507894.707100.88
3918489-91848995.060100.66
4914540-91454094.651100.59
5913113-91311394.504100.45
6909109-90910994.08999.87
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240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06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%
1 10.181302291300211297941303871302331301330.18
2 10.191299391302531300960.18
单位质量响应值RSD%判断
12783.2012767.030.09数据可信
供试品溶液-25112602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%
5min15260-52603.7113.6712.753.713.6712.78
25405-54053.8133.81
35764-57644.0664.07
44195-41952.9592.96
55933-59334.1864.19
64664-46643.2903.29
10min127065-2706519.09416.9815.1019.1417.0215.08
220704-2070414.60614.65
329048-2904820.49320.54
421477-2147715.15215.18
520592-2059214.52714.57
625511-2551117.99818.03
15min145803-4580332.31329.1513.0732.5729.3813.06
237514-3751426.46526.67
348230-4823034.02534.30
437344-3734426.34526.55
534988-3498824.68324.89
644046-4404631.07431.31
20min158956-5895641.59237.0512.2542.2037.6012.25
249400-4940034.85135.35
360723-6072342.83943.49
446826-4682633.03533.53
545198-4519831.88632.37
653988-5398838.08738.67
30min175009-7500952.91748.389.5553.9949.349.61
266002-6600246.56347.45
377553-7755354.71255.84
463355-6335544.69645.56
560931-6093142.98643.82
668584-6858448.38549.39
45min188960-8896062.76060.025.8964.4261.526.02
281840-8184057.73759.14
392437-9243765.21266.95
480684-8068456.92158.28
580121-8012156.52457.84
686378-8637860.93862.48
60min198761-9876169.67467.564.4472.0369.734.60
293068-9306865.65867.70
3101939-10193971.91674.38
493516-9351665.97467.96
590362-9036263.74965.69
696956-9695668.40170.62
极限1126139-12613988.98986.646.7992.1289.566.79
2123811-12381187.34690.12
3131744-13174492.94396.20
4122123-12212386.15588.88
5107138-10713875.58478.23
6125887-12588788.81191.79
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80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33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%
115.038637518682668668198634018676678659810.27
215.048625988614358620160.10
单位质量响应值RSD%判断
57616.8357314.890.38数据可信
供试品溶液-25112602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%
5min111612-116121.2100.9348.461.210.9348.45
216332-163321.7011.70
36132-61320.6390.64
45282-52820.5500.55
55600-56000.5830.58
68789-87890.9160.92
10min132118-321183.3462.7319.293.362.7419.41
232867-328673.4243.44
323641-236412.4632.47
421583-215832.2482.25
521823-218232.2732.28
625164-251642.6212.63
15min139774-397744.1433.934.774.193.974.96
240261-402614.1944.25
336649-366493.8183.85
436180-361803.7693.80
536516-365163.8043.84
636985-369853.8533.89
20min143413-434134.5224.452.674.624.542.92
244486-444864.6344.74
342344-423444.4114.49
441087-410874.2804.35
542591-425914.4374.51
642444-424444.4214.50
30min145996-459964.7914.921.594.945.051.52
247550-475504.9535.11
347038-470384.9005.03
446879-468794.8835.00
548139-481395.0155.14
647660-476604.9655.10
45min149821-498215.1905.261.065.395.450.84
250104-501045.2195.43
350262-502625.2365.42
451179-511795.3315.51
550981-509815.3115.49
650736-507365.2855.47
60min151628-516285.3785.471.385.645.721.32
253000-530005.5215.79
351556-515565.3715.61
452922-529225.5135.75
552836-528365.5045.74
653133-531335.5355.78
极限154334-543345.6605.691.505.986.001.45
255101-551015.7406.07
354747-547475.7036.00
455697-556975.8026.10
553265-532655.5495.85
654630-546305.6916.00
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240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06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%
1 10.181297531309291302941300051303841302730.35
2 10.191298071298101298080.01
单位质量响应值RSD%判断
12796.9512738.760.33数据可信
供试品溶液-25112602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%
5min111837-118378.3566.8958.778.366.8958.73
210686-106867.5437.54
316284-1628411.49511.49
43153-31532.2262.23
52434-24341.7181.72
614161-141619.99610.00
10min171886-7188650.74340.9119.8350.8440.9919.89
261124-6112443.14643.23
366267-6626746.77746.90
446826-4682633.05433.08
541842-4184229.53629.55
659798-5979842.21042.32
15min185958-8595860.67658.982.3161.3359.512.47
282223-8222358.04058.60
385301-8530160.21360.86
483299-8329958.79959.19
580748-8074856.99957.35
683775-8377559.13559.72
20min193073-9307365.69964.891.1667.0366.081.34
291374-9137464.50065.71
393223-9322365.80567.12
490658-9065863.99465.04
591090-9109064.29965.28
692126-9212665.03066.27
30min196602-9660268.19069.691.5870.2571.601.47
296960-9696068.44370.37
399957-9995770.55872.61
499037-9903769.90971.67
5100031-10003170.61072.31
699798-9979870.44672.41
45min1102569-10256972.40272.721.7975.2275.401.67
299704-9970470.38073.06
3103369-10336972.96775.80
4105165-10516574.23476.77
5103943-10394373.37275.85
6103384-10338472.97775.72
60min1104756-10475673.94674.561.0877.5778.050.96
2104021-10402173.42776.89
3106032-10603274.84678.49
4107090-10709075.59378.95
5106494-10649475.17278.47
6105348-10534874.36477.92
极限1107474-10747475.86475.701.5380.3180.021.54
2106283-10628375.02479.31
3108576-10857676.64281.12
4109119-10911977.02581.22
5104597-10459773.83377.96
6107392-10739275.80680.19
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80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33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%
115.038661798638048679438670568636578657280.23
215.048618978660488639720.34
单位质量响应值RSD%判断
57600.0057444.950.20数据可信
供试品溶液-25112602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%
5min135381-353813.6826.1939.263.686.1939.28
254603-546035.6825.68
384663-846638.8118.81
436777-367773.8273.83
590302-903029.3979.40
655012-550125.7255.72
10min1264858-26485827.56331.8811.8827.6031.9511.92
2293083-29308330.50030.56
3349127-34912736.33336.43
4322519-32251933.56433.61
5340443-34044335.42935.53
6268097-26809727.90027.96
15min1487394-48739450.72253.333.0051.0753.753.08
2514475-51447553.54053.94
3531799-53179955.34355.84
4515110-51511053.60654.02
5521908-52190854.31354.81
6503856-50385652.43552.81
20min1602684-60268462.72063.791.5063.6364.801.60
2613107-61310763.80464.80
3627614-62761465.31466.43
4610261-61026163.50864.52
5618766-61876664.39365.49
6605165-60516562.97863.93
30min1717091-71709174.62674.840.8476.2376.560.91
2715915-71591574.50376.21
3727062-72706275.66377.51
4723728-72372875.31677.03
5720857-72085775.01776.83
6710374-71037473.92675.58
45min1795056-79505682.73983.370.7885.1885.920.80
2809425-80942584.23486.77
3802142-80214283.47786.16
4806889-80688983.97186.52
5798890-79889083.13885.79
6794247-79424782.65585.13
60min1832095-83209586.59486.401.0089.9589.880.97
2840690-84069087.48890.96
3826236-82623685.98489.59
4837789-83778987.18690.67
5826168-82616885.97789.55
6818334-81833485.16288.56
极限1850659-85065988.52688.170.7592.8492.620.71
2852057-85205788.67193.11
3841212-84121287.54292.11
4855223-85522389.00093.46
5844983-84498387.93592.46
6839499-83949987.36491.71
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240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06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%
1 10.181302741299461301491300161298041300380.14
2 10.191295321299671297500.24
单位质量响应值RSD%判断
12773.8712733.070.23数据可信
供试品溶液-25112602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%
5min15531-55313.9095.6131.093.915.6131.07
212226-122268.6408.64
36111-61114.3194.32
49269-92696.5506.55
57461-74615.2735.27
66998-69984.9454.95
10min135494-3549425.08327.839.8325.1327.899.86
243194-4319430.52430.62
339372-3937227.82327.87
443654-4365430.84930.92
540291-4029128.47328.53
634264-3426424.21424.27
15min154350-5435038.40840.863.3838.7341.233.44
259509-5950942.05442.49
359139-5913941.79242.15
458787-5878741.54441.96
558370-5837041.24941.62
656721-5672140.08440.41
20min164219-6421945.38247.072.6646.1347.902.68
266884-6688447.26648.17
369358-6935849.01449.84
466138-6613846.73847.62
567544-6754447.73248.57
665523-6552346.30447.07
30min173754-7375452.12053.221.6653.3754.571.71
275150-7515053.10754.53
376912-7691254.35255.72
475616-7561653.43654.83
576395-7639553.98755.35
674076-7407652.34853.63
45min181140-8114057.34058.901.4959.1760.841.55
284144-8414459.46361.48
384563-8456359.75961.73
483419-8341958.95060.94
583982-8398259.34861.31
682862-8286258.55760.42
60min185988-8598860.76661.711.1963.2464.311.26
288094-8809462.25464.93
388190-8819062.32264.96
487512-8751261.84364.49
588115-8811562.26964.89
686079-8607960.83063.35
极限188320-8832062.41463.370.9665.5666.661.03
289932-8993263.55366.92
390503-9050363.95767.28
489793-8979363.45566.79
590498-9049863.95367.27
689031-8903162.91666.11
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