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%
18.819771698039976769750697275976420.29
28.789637696308963420.05
单位质量响应值RSD%判断
11083.0910972.890.71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%
5min185339-8533986.88587.522.8486.8987.522.85
287319-8731988.90188.90
389547-8954791.16991.17
486617-8661788.18688.19
582510-8251084.00584.00
684422-8442285.95185.95
10min195339-9533997.06696.431.7197.5596.921.71
296903-9690398.65999.15
395947-9594797.68598.19
493556-9355695.25195.74
592642-9264294.32094.79
693923-9392395.62596.10
15min194516-9451696.22896.411.2697.2597.431.25
296659-9665998.41099.45
394352-9435296.06197.11
493364-9336495.05596.07
595451-9545197.18098.17
693840-9384095.54096.55
20min195506-9550697.23695.792.5198.7997.342.49
297490-9749099.256100.84
395260-9526096.98698.57
492035-9203593.70295.25
591485-9148593.14294.67
692713-9271394.39395.93
30min194060-9406095.76496.172.0297.8698.262.00
297448-9744899.213101.35
394636-9463696.35098.47
495367-9536797.09599.16
593422-9342295.11497.16
691811-9181193.47495.54
45min192694-9269494.37394.541.4297.0097.171.42
294327-9432796.03698.73
393381-9338195.07397.73
493956-9395695.65898.27
592017-9201793.68496.26
690779-9077992.42495.01
60min191445-9144593.10292.371.3696.2595.511.36
291785-9178593.44896.67
390755-9075592.39995.58
491317-9131792.97196.11
590673-9067392.31695.41
688356-8835689.95793.05
极限191501-9150193.15991.930.8896.8395.600.84
289640-8964091.26495.01
390438-9043892.07695.77
489891-8989191.52095.17
589458-8945891.07994.69
690864-9086492.51096.11
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%
18.819667296688966369657896402965950.13
28.789699397128970600.10
单位质量响应值RSD%判断
10964.2511054.670.59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%
5min171832-7183273.25667.714.9573.2667.724.95
263959-6395965.22765.23
365426-6542666.72366.72
468313-6831369.66769.67
566158-6615867.46967.47
662694-6269463.93763.94
10min182848-8284884.49081.122.6584.9081.502.65
279510-7951081.08681.45
380344-8034481.93782.31
479160-7916080.72981.12
576354-7635477.86878.24
679050-7905080.61780.97
15min184706-8470686.38584.992.2787.2685.822.24
285676-8567687.37488.19
381587-8158783.20484.03
480687-8068782.28683.12
583863-8386385.52586.33
683516-8351685.17185.97
20min183485-8348585.14085.480.5886.5086.780.56
283835-8383585.49786.80
383397-8339785.05086.34
484631-8463186.30987.60
583469-8346985.12486.41
684096-8409685.76387.04
30min187904-8790489.64687.222.1691.4888.992.13
284041-8404185.70787.48
384212-8421285.88187.64
483752-8375285.41287.18
585652-8565287.35089.11
687565-8756589.30191.05
45min186191-8619187.89986.961.8590.2389.211.82
284711-8471186.39088.64
384516-8451686.19188.43
482885-8288584.52886.77
585876-8587687.57889.82
687412-8741289.14591.39
60min184786-8478686.46785.931.6389.2888.671.60
284041-8404185.70788.44
384501-8450186.17688.89
481734-8173483.35486.07
585847-8584787.54990.28
684641-8464186.31989.06
极限183116-8311684.76484.950.8088.0688.170.77
283227-8322784.87788.08
383989-8398985.65488.85
482139-8213983.76786.95
583525-8352585.18188.39
683816-8381685.47788.70
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%
18.819745397594975359756297310974910.12
28.789838298452984170.06
单位质量响应值RSD%判断
11065.9511209.230.91数据可信
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%
5min117698-1769817.84217.555.5417.8417.565.54
218786-1878618.93818.94
316335-1633516.46816.47
416388-1638816.52116.52
518064-1806418.21118.21
617209-1720917.34917.35
10min125306-2530625.51125.054.0525.6125.154.06
225804-2580426.01326.12
323859-2385924.05324.14
423888-2388824.08224.17
526097-2609726.30926.41
624155-2415524.35124.45
15min129176-2917629.41328.173.9029.6528.403.90
228448-2844828.67928.93
326546-2654626.76126.99
427196-2719627.41727.64
529027-2902729.26329.51
627254-2725427.47527.71
20min130218-3021830.46329.843.4030.8730.243.39
229514-2951429.75330.16
328770-2877029.00329.38
429015-2901529.25029.63
531320-3132031.57431.98
628781-2878129.01529.40
30min133209-3320933.47831.654.5534.0532.214.53
230943-3094331.19431.77
329515-2951529.75530.29
430614-3061430.86231.40
532971-3297133.23933.82
631112-3111231.36431.91
45min134324-3432434.60333.343.1735.3634.073.18
233094-3309433.36334.11
332495-3249532.75933.46
431864-3186432.12332.83
534323-3432334.60235.37
632332-3233232.59433.31
60min135165-3516535.45033.584.8436.4034.504.80
233142-3314233.41134.34
331470-3147031.72532.61
432927-3292733.19434.08
535282-3528235.56836.53
631874-3187432.13333.03
极限135492-3549235.78035.164.3836.9336.274.35
234091-3409134.36835.49
333611-3361133.88434.94
434935-3493535.21836.29
537582-3758237.88739.05
633556-3355633.82834.91
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%
18.819625396176962259605895907961240.15
28.789679096864968270.06
单位质量响应值RSD%判断
10910.7811028.130.76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%
5min16341-63416.4906.978.526.496.978.55
26198-61986.3446.34
36620-66206.7766.78
47158-71587.3277.33
56784-67846.9446.94
67774-77747.9577.96
10min110424-1042410.67010.673.1210.7110.713.13
29992-999210.22710.26
310402-1040210.64710.68
410728-1072810.98111.02
510174-1017410.41410.45
610853-1085311.10911.15
15min111919-1191912.20012.673.1612.3012.773.16
212057-1205712.34112.43
312322-1232212.61212.71
412452-1245212.74512.85
512504-1250412.79912.89
613030-1303013.33713.44
20min113122-1312213.43113.701.9013.5913.861.93
213054-1305413.36113.52
313363-1336313.67813.84
413551-1355113.87014.04
513519-1351913.83714.00
613698-1369814.02114.20
30min114510-1451014.85215.172.8115.0915.422.80
214167-1416714.50114.74
314804-1480415.15315.40
415191-1519115.54915.80
515215-1521515.57315.82
615041-1504115.39515.65
45min115474-1547415.83816.322.2216.1616.662.22
215517-1551715.88216.20
316134-1613416.51416.84
416210-1621016.59216.93
516166-1616616.54716.88
616192-1619216.57316.92
60min116549-1654916.93917.342.1517.3517.762.16
216467-1646716.85517.26
316960-1696017.35917.78
417273-1727317.68018.11
517095-1709517.49817.92
617325-1732517.73318.17
极限117822-1782218.24218.421.6918.7418.941.71
217527-1752717.94018.44
317989-1798918.41318.93
418022-1802218.44618.97
518389-1838918.82219.34
618235-1823518.66419.20
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