奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
18.819659296736969479745197246969940.37
28.789744597397974210.04
单位质量响应值RSD%判断
11009.5311095.790.56数据可信
供试品溶液-TNA3004批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min186013-8601387.37587.371.9987.3787.371.99
288564-8856489.96689.97
386688-8668888.06188.06
485709-8570987.06687.07
583294-8329484.61384.61
685771-8577187.12987.13
10min195537-9553797.05097.052.5997.5497.542.58
298294-9829499.850100.35
397251-9725198.79199.28
495710-9571097.22597.71
591086-9108692.52893.00
695355-9535596.86597.35
15min194736-9473696.23695.721.5097.2696.741.51
293867-9386795.35396.41
394680-9468096.17997.22
495472-9547296.98498.01
591550-9155093.00093.98
695041-9504196.54697.57
20min193047-9304794.52094.492.0396.0896.052.01
291257-9125792.70294.29
395834-9583497.35198.92
494351-9435195.84597.41
590809-9080992.24793.75
692800-9280094.26995.83
30min193832-9383295.31895.542.0597.4097.622.03
293083-9308394.55796.66
395255-9525596.76398.88
496089-9608997.61099.71
590819-9081992.25794.27
695242-9524296.75098.83
45min193150-9315094.62594.712.2797.2497.322.25
293610-9361095.09297.72
394805-9480596.30698.96
494276-9427695.76998.41
589097-8909790.50893.03
694436-9443695.93198.55
60min192279-9227993.74091.324.5996.8894.464.45
292224-9222493.68496.84
392079-9207993.53796.72
492660-9266094.12797.30
587819-8781989.21092.24
682340-8234083.64486.80
极限190457-9045791.88992.101.5595.5595.751.52
288626-8862690.02993.70
392404-9240493.86797.57
491543-9154392.99396.68
589550-8955090.96894.49
691436-9143692.88496.50
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
18.819660396642966499647296845966420.14
28.789726596794970300.35
单位质量响应值RSD%判断
10969.5811051.250.53数据可信
供试品溶液-TNA3004批-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%
5min168501-6850169.85369.073.3369.8569.083.33
269311-6931170.67970.68
368918-6891870.27870.28
463780-6378065.03865.04
566354-6635467.66367.66
669564-6956470.93770.94
10min182122-8212283.74283.461.9184.1383.841.91
284168-8416885.82986.22
382658-8265884.28984.68
480711-8071182.30382.66
581714-8171483.32683.70
679674-7967481.24681.64
15min186333-8633388.03686.502.1288.8987.352.12
287542-8754289.26990.14
384411-8441186.07686.94
484048-8404885.70686.52
584084-8408485.74386.58
682560-8256084.18985.03
20min186691-8669188.40187.742.8689.7489.062.82
287839-8783989.57290.94
387064-8706488.78290.12
488140-8814089.87991.17
584907-8490786.58287.90
681599-8159983.20984.52
30min188696-8869690.44688.612.0592.2890.432.04
288696-8869690.44692.31
386299-8629988.00289.83
487622-8762289.35191.14
585907-8590787.60289.40
684168-8416885.82987.60
45min187267-8726788.98988.401.4891.3290.711.48
287630-8763089.35991.72
386603-8660388.31290.63
488010-8801089.74692.04
586166-8616687.86690.15
684460-8446086.12688.38
60min187061-8706188.77988.141.6891.6190.941.66
286988-8698888.70491.57
385957-8595787.65390.46
487262-8726288.98491.77
587624-8762489.35392.12
683694-8369485.34588.08
极限187317-8731789.04086.822.9492.3690.112.88
286671-8667188.38191.74
385871-8587187.56590.86
487029-8702988.74692.03
582270-8227083.89387.16
681704-8170483.31686.52
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
18.819531495440950009464994696950200.38
28.789826497747980060.38
单位质量响应值RSD%判断
10785.4711162.412.43数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-TNA3004批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min115105-1510515.45916.866.1015.4616.866.08
216236-1623616.61616.62
316908-1690817.30417.30
415766-1576616.13516.14
517983-1798318.40418.40
616849-1684917.24317.24
10min125946-2594626.55325.462.8326.6425.552.82
224437-2443725.00925.10
324209-2420924.77624.87
424344-2434424.91425.00
525504-2550426.10126.20
624823-2482325.40425.50
15min130910-3091031.63430.222.4931.8730.462.49
229053-2905329.73329.96
329121-2912129.80330.04
428975-2897529.65329.88
529783-2978330.48030.73
629360-2936030.04730.28
20min135095-3509535.91633.413.7836.3333.813.76
231662-3166232.40332.80
332132-3213232.88433.28
432112-3211232.86433.26
532427-3242733.18633.60
632429-3242933.18833.59
30min138539-3853939.44136.054.9240.0536.644.87
233450-3345034.23334.81
334747-3474735.56036.14
434570-3457035.37935.95
534786-3478635.60036.20
635258-3525836.08336.67
45min141414-4141442.38338.206.0143.2138.995.94
234676-3467635.48836.25
337693-3769338.57539.35
436461-3646137.31438.09
536952-3695237.81738.62
636754-3675437.61438.40
60min143104-4310444.11340.195.2145.1841.205.17
237040-3704037.90738.87
338723-3872339.62940.62
438718-3871839.62440.60
539527-3952740.45241.46
638538-3853839.44040.44
极限143109-4310944.11840.384.9145.4341.614.86
237696-3769638.57839.75
338999-3899939.91241.13
439906-3990640.84042.04
538287-3828739.18340.42
638747-3874739.65440.87
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
18.819615295887959209578296007959500.15
28.789719297066971290.10
单位质量响应值RSD%判断
10891.0311062.531.11数据可信
供试品溶液-TNA3004批-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%
5min16693-66936.8466.577.696.856.577.68
25967-59676.1046.10
36836-68366.9936.99
45747-57475.8795.88
56975-69757.1357.13
66334-63346.4796.48
10min110013-1001310.24210.552.0810.2810.582.10
210127-1012710.35910.39
310450-1045010.68910.73
410266-1026610.50110.53
510575-1057510.81710.86
610438-1043810.67710.71
15min112097-1209712.37412.722.7512.4712.812.72
212360-1236012.64312.73
312880-1288013.17513.27
412644-1264412.93413.02
511997-1199712.27212.37
612607-1260712.89612.99
20min113516-1351613.82613.801.6313.9913.971.63
213617-1361713.92914.09
313388-1338813.69513.87
413286-1328613.59013.75
513860-1386014.17714.35
613301-1330113.60613.77
30min115065-1506515.41014.923.4815.6515.163.43
214776-1477615.11415.35
314122-1412214.44514.69
413813-1381314.12914.37
515021-1502115.36515.61
614727-1472715.06415.31
45min116555-1655516.93416.202.7417.2616.532.70
215752-1575216.11316.44
315836-1583616.19916.53
415294-1529415.64415.96
516044-1604416.41116.74
615558-1555815.91416.24
60min117479-1747917.87916.953.2118.3017.363.16
216613-1661316.99317.41
316374-1637416.74917.17
415891-1589116.25516.66
516721-1672117.10417.53
616320-1632016.69417.11
极限118342-1834218.76218.062.4919.2818.572.47
217487-1748717.88818.39
317395-1739517.79318.30
417115-1711517.50718.00
517977-1797718.38918.91
617643-1764318.04718.55
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