阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.121027861028191024851029261028831027800.17
210.081023511021261022380.16
单位质量响应值RSD%判断
10156.1310142.660.10数据可信
中间条件24月-供试品溶液-2023111721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%
5min12994-29942.6472.4819.622.652.4919.60
23246-32462.8702.87
32000-20001.7681.77
43290-32902.9092.91
53096-30962.7372.74
62238-22381.9791.98
10min19161-91618.0997.4813.008.117.4912.99
29112-91128.0568.07
36771-67715.9866.00
49089-90898.0368.05
59273-92738.1988.21
67356-73566.5036.51
15min113048-1304811.53610.819.5111.6010.869.56
212878-1287811.38511.45
310302-103029.1089.15
412653-1265311.18611.25
513177-1317711.65011.71
611295-112959.98610.03
20min115662-1566213.84713.296.7113.9713.416.73
215167-1516713.40913.53
313507-1350711.94112.04
415948-1594814.10014.22
515824-1582413.99014.12
614097-1409712.46312.57
30min119173-1917316.95116.825.4717.1517.015.52
219167-1916716.94517.14
317622-1762215.57915.74
420331-2033117.97418.18
519855-1985517.55417.76
618020-1802015.93116.10
45min121856-2185619.32319.392.4619.6219.682.50
221485-2148518.99519.29
321561-2156119.06219.31
422764-2276420.12520.43
522431-2243119.83120.13
621524-2152419.02919.29
60min122847-2284720.19920.721.8820.6021.121.88
223174-2317420.48820.89
323640-2364020.90021.25
423903-2390321.13221.55
523905-2390521.13421.55
623165-2316520.48020.85
极限124169-2416921.36821.610.9721.8822.121.01
224655-2465521.79722.31
324420-2442021.59022.06
424785-2478521.91222.44
524391-2439121.56422.09
624242-2424221.43221.91
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.121021231023291022671021511024351022610.13
210.081022191020251021220.14
单位质量响应值RSD%判断
10104.8410131.150.19数据可信
中间条件24月-供试品溶液-2023111821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%
5min13878-38783.4393.0717.493.443.0717.49
23366-33662.9852.99
33021-30212.6792.68
44257-42573.7753.78
52580-25802.2882.29
63680-36803.2643.26
10min19684-96848.5888.257.828.618.277.86
29467-94678.3968.41
38725-87257.7387.75
410163-101639.0139.03
58166-81667.2427.25
69634-96348.5448.56
15min113655-1365512.11011.319.3312.1811.389.33
213698-1369812.14812.21
312194-1219410.81410.87
413552-1355212.01812.09
510653-106539.4479.50
612800-1280011.35211.42
20min116405-1640514.54913.836.9814.6813.957.01
216338-1633814.48914.62
315250-1525013.52413.64
416246-1624614.40814.55
513561-1356112.02612.13
615741-1574113.96014.09
30min119364-1936417.17316.633.7617.3916.833.80
219364-1936417.17317.38
318669-1866916.55616.75
419179-1917917.00917.23
517590-1759015.59915.77
618326-1832616.25216.46
45min122344-2234419.81519.986.0620.1320.285.92
222549-2254919.99720.30
321263-2126318.85719.14
422410-2241019.87420.19
525111-2511122.26922.53
621526-2152619.09019.39
60min124112-2411221.38320.841.8621.8021.251.90
223640-2364020.96521.38
323213-2321320.58620.98
423787-2378721.09521.52
522885-2288520.29520.68
623366-2336620.72221.12
极限124873-2487322.05821.771.5322.6022.291.57
224406-2440621.64422.18
324372-2437221.61422.12
425055-2505522.22022.76
524014-2401421.29721.79
624566-2456621.78622.30
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.121024081026001023821025321021371024120.18
210.081010801013391012100.19
单位质量响应值RSD%判断
10119.7610040.670.56数据可信
中间条件24月-供试品溶液-2023111921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%
5min15250-52504.6734.387.884.674.387.82
24907-49074.3684.37
34196-41963.7353.74
44903-49034.3654.36
55248-52484.6724.67
65021-50214.4704.47
10min110561-105619.4018.546.289.438.566.30
29612-96128.5568.58
38844-88447.8737.89
49106-91068.1068.13
59864-98648.7818.81
69551-95518.5028.53
15min113325-1332511.86211.355.1211.9411.425.13
212351-1235110.99511.07
311827-1182710.52810.59
412500-1250011.12711.20
513586-1358612.09412.17
612892-1289211.47611.55
20min115881-1588114.13713.694.0914.2813.824.11
215292-1529213.61313.75
314514-1451412.92013.04
414788-1478813.16413.29
516110-1611014.34114.48
615667-1566713.94614.08
30min118604-1860416.56116.382.3116.7816.592.34
218132-1813216.14116.35
317971-1797115.99716.19
418022-1802216.04316.25
519027-1902716.93717.16
618662-1866216.61216.83
45min121692-2169219.31019.031.7119.6219.331.74
221033-2103318.72319.02
320994-2099418.68818.97
421104-2110418.78619.08
521712-2171219.32719.64
621717-2171719.33219.64
60min123110-2311020.57220.341.6220.9920.751.65
222523-2252320.04920.45
322409-2240919.94820.34
422649-2264920.16220.56
523282-2328220.72521.15
623146-2314620.60421.02
极限123389-2338920.82021.132.5921.3621.652.57
223474-2347420.89621.41
323326-2332620.76421.26
423772-2377221.16121.67
524950-2495022.21022.75
623503-2350320.92221.45
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