利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.104736354730984731684737494728644733030.08
215.024733724733144733430.01
单位质量响应值RSD%判断
31344.5731514.180.39数据可信
供试品溶液-1批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1307523-30752358.23858.095.1058.2458.105.10
2284826-28482653.94053.94
3321146-32114660.81860.82
4291567-29156755.21655.22
5312199-31219959.12459.12
6323308-32330861.22861.23
10min1434454-43445482.27681.231.1582.3781.331.15
2422483-42248380.00980.10
3433887-43388782.16982.27
4424125-42412580.32080.41
5429012-42901281.24681.34
6429752-42975281.38681.49
15min1470173-47017389.04188.010.7489.2788.240.74
2464695-46469588.00388.23
3463519-46351987.78088.02
4460396-46039687.18987.41
5462665-46266587.61987.85
6466800-46680088.40288.64
20min1485701-48570191.98190.940.7692.3691.320.76
2481016-48101691.09491.46
3478193-47819390.55990.94
4476026-47602690.14990.52
5477601-47760190.44790.83
6482634-48263491.40091.79
30min1500408-50040894.76693.960.8195.3094.490.81
2499204-49920494.53895.06
3492470-49247093.26393.80
4491974-49197493.16993.69
5493113-49311393.38593.92
6499763-49976394.64495.18
45min1511930-51193096.94896.190.9997.6496.880.99
2509734-50973496.53397.21
3502959-50295995.25095.94
4502437-50243795.15195.83
5505791-50579195.78696.47
6514763-51476397.48598.18
60min1519439-51943998.37197.381.0899.2398.231.07
2517758-51775898.05298.89
3509079-50907996.40997.26
4507449-50744996.10096.94
5511537-51153796.87497.72
6519924-51992498.46299.32
极限1521897-52189798.83698.210.9299.8699.220.92
2520936-52093698.65499.66
3513320-51332097.21298.22
4514096-51409697.35998.35
5516290-51629097.77498.78
6525144-52514499.451100.47
利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.104742314739734742164743834745514742710.05
215.024759854755354757600.07
单位质量响应值RSD%判断
31408.6831675.100.60数据可信
供试品溶液-2批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1323689-32368961.08256.624.8261.0856.624.82
2294909-29490955.65155.65
3311550-31155058.79158.79
4287251-28725154.20654.21
5288657-28865754.47154.47
6294288-29428855.53455.53
10min1427414-42741480.65579.172.1780.7679.262.17
2412694-41269477.87777.97
3426143-42614380.41580.51
4411409-41140977.63577.73
5409869-40986977.34477.44
6429645-42964581.07681.17
15min1460510-46051086.90086.701.4387.1486.931.43
2449403-44940384.80585.03
3464890-46489087.72787.96
4460260-46026086.85387.07
5454522-45452285.77085.99
6467109-46710988.14688.37
20min1477722-47772290.14890.121.2090.5390.491.20
2468470-46847088.40388.77
3481439-48143990.85091.23
4479762-47976290.53390.90
5473682-47368289.38689.75
6484227-48422791.37691.75
30min1493426-49342693.11293.321.1993.6493.841.19
2484386-48438691.40691.92
3497287-49728793.84094.37
4497726-49772693.92394.44
5493039-49303993.03993.55
6501362-50136294.60995.14
45min1505662-50566295.42195.601.2096.1196.281.20
2496480-49648093.68894.35
3510422-51042296.31997.01
4508072-50807295.87696.55
5504827-50482795.26395.93
6514254-51425497.04297.73
60min1510388-51038896.31396.681.0597.1697.511.06
2503565-50356595.02595.84
3515211-51521197.22398.07
4514536-51453697.09597.93
5510877-51087796.40597.23
6519303-51930397.99598.84
极限1512465-51246596.70597.450.9597.7198.450.95
2509332-50933296.11397.09
3519469-51946998.02699.03
4518216-51821697.79098.78
5516327-51632797.43398.42
6522700-52270098.63699.65
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