盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.924398974398074398074397314396284397740.03
29.894432534436674434600.07
单位质量响应值RSD%判断
44332.0644839.230.81数据可信
供试品溶液-24081401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%
5min1130818-13081829.19531.7213.7129.2031.7213.71
2146551-14655132.70632.71
3124713-12471327.83327.83
4139693-13969331.17631.18
5132266-13226629.51829.52
6178782-17878239.89939.90
10min1218959-21895948.86657.7817.8548.9557.8717.84
2295062-29506265.85065.95
3252909-25290956.44356.53
4232281-23228151.83951.93
5220596-22059649.23149.32
6333473-33347374.42274.54
15min1264857-26485759.10966.9114.6259.3467.1814.62
2333763-33376374.48774.78
3307719-30771968.67568.93
4268900-26890060.01160.26
5257446-25744657.45557.69
6366260-36626081.73982.08
20min1290341-29034164.79671.6112.3565.2172.0812.37
2354065-35406579.01879.54
3334852-33485274.73075.19
4290688-29068864.87465.30
5279606-27960662.40162.81
6375722-37572283.85184.44
30min1324383-32438372.39477.598.5173.0078.278.56
2374686-37468683.62084.38
3362672-36267280.93981.62
4324700-32470072.46473.09
5315572-31557270.42771.02
6383965-38396585.69186.53
45min1347946-34794677.65282.486.0578.4883.396.11
2394067-39406787.94588.95
3384063-38406385.71386.64
4353731-35373178.94379.78
5346825-34682577.40278.21
6390738-39073887.20288.30
60min1359455-35945580.22184.944.9781.2886.105.04
2403811-40381190.12091.39
3394144-39414487.96289.15
4368266-36826682.18783.27
5363771-36377181.18482.22
6394046-39404687.94189.30
极限1407598-40759890.96592.281.9092.2693.701.80
2418596-41859693.41994.96
3410816-41081691.68393.13
4419326-41932693.58294.91
5422380-42238094.26495.55
6402307-40230789.78491.41
盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.924385294384374383294383214383924384020.02
29.894411574410074410820.03
单位质量响应值RSD%判断
44193.7544598.790.65数据可信
供试品溶液-24081402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%
5min1176709-17670939.60434.4811.7139.6034.4811.70
2140508-14050831.49131.49
3175485-17548539.33039.33
4136727-13672730.64430.64
5141331-14133131.67531.68
6152372-15237234.15034.15
10min1267999-26799960.06557.096.9060.1857.206.91
2247370-24737055.44155.54
3281000-28100062.97863.10
4233276-23327652.28252.37
5256653-25665357.52257.62
6242134-24213454.26854.37
15min1307988-30798869.02766.875.5669.3367.155.56
2298463-29846366.89267.15
3319105-31910571.51971.83
4269526-26952660.40760.66
5300472-30047267.34367.61
6294690-29469066.04766.31
20min1331819-33181974.36872.114.6074.8772.594.61
2319108-31910871.51971.98
3339192-33919276.02176.54
4295759-29575966.28666.72
5321379-32137972.02872.50
6323316-32331672.46272.93
30min1355239-35523979.61778.113.3280.3578.803.34
2346385-34638577.63378.31
3360290-36029080.74981.50
4326907-32690773.26773.90
5350933-35093378.65279.34
6351282-35128278.73079.41
45min1373981-37398183.81882.942.3884.7983.862.41
2366602-36660282.16483.07
3381496-38149685.50286.49
4355225-35522579.61480.46
5370187-37018782.96783.89
6372791-37279183.55184.47
60min1383911-38391186.04385.551.9587.2686.721.98
2376861-37686184.46385.62
3391410-39141087.72488.97
4369789-36978982.87883.97
5384230-38423086.11587.29
6383939-38393986.04987.22
极限1411689-41168992.26993.261.3293.7594.691.33
2410396-41039691.97993.39
3424272-42427295.08996.60
4415192-41519293.05494.39
5413911-41391192.76794.20
6421192-42119294.39995.82
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