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%
1 10.312509822509072507112508602506622508240.06
2 10.292504852504012504430.03
单位质量响应值RSD%判断
24328.2324338.480.03数据可信
供试品溶液-24122701批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1115687-11568747.30553.0817.5047.3053.0817.50
2116157-11615747.49747.50
3106918-10691843.71943.72
4126008-12600851.52551.53
5166352-16635268.02268.02
6147677-14767760.38660.39
10min1185694-18569475.93174.697.4276.0774.857.43
2188668-18866877.14777.29
3158781-15878164.92665.06
4177149-17714972.43772.59
5198533-19853381.18181.38
6187171-18717176.53576.72
15min1205176-20517683.89782.414.9384.2782.804.95
2205726-20572684.12284.50
3183776-18377675.14775.47
4199676-19967681.64882.02
5213465-21346587.28787.73
6201486-20148682.38882.80
20min1214491-21449187.70686.153.9988.3386.784.02
2213269-21326987.20687.83
3195961-19596180.12980.68
4208361-20836185.20085.82
5221157-22115790.43291.14
6210897-21089786.23786.89
30min1224960-22496091.98790.722.8892.8791.612.91
2223317-22331791.31592.20
3210916-21091686.24487.04
4218893-21889389.50690.38
5229605-22960593.88694.87
6223455-22345591.37292.29
45min1232554-23255495.09294.552.2396.2595.722.27
2231922-23192294.83496.00
3222635-22263591.03692.09
4228231-22823193.32594.47
5236426-23642696.67597.94
6235669-23566996.36697.56
60min1234990-23499096.08896.102.0597.5397.542.09
2233643-23364395.53896.98
3227967-22796793.21794.54
4232827-23282795.20496.62
5239233-23923397.82399.38
6241472-24147298.739100.22
极限1238978-23897897.71998.202.0799.4599.942.09
2236188-23618896.57898.31
3236001-23600196.50298.10
4238294-23829497.43999.15
5242387-24238799.113100.96
6249139-249139101.874103.65
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%
1 10.312516542516102514562506812510612512920.17
2 10.292503752503242503500.02
单位质量响应值RSD%判断
24373.6224329.450.13数据可信
供试品溶液-24122701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%
5min193010-9301038.00439.9813.8338.0039.9813.84
291513-9151337.39237.39
389434-8943436.54336.54
4123611-12361150.50750.51
587749-8774935.85435.85
6101803-10180341.59741.60
10min1163868-16386866.95663.077.2867.0763.197.27
2146890-14689060.01960.13
3154902-15490263.29363.40
4155458-15545863.52063.67
5137092-13709256.01656.12
6167936-16793668.61868.74
15min1179977-17997773.53869.786.2173.8570.096.21
2165120-16512067.46867.76
3174762-17476271.40871.71
4167969-16796968.63268.97
5154110-15411062.96963.24
6182778-18277874.68375.01
20min1186367-18636776.14973.395.2876.6873.915.28
2176287-17628772.03172.53
3185181-18518175.66576.18
4174490-17449071.29671.84
5164887-16488767.37367.84
6190487-19048777.83378.39
30min1195270-19527079.78777.723.7080.5578.463.71
2187946-18794676.79577.51
3194583-19458379.50680.25
4185295-18529575.71176.47
5179810-17981073.47074.14
6198300-19830081.02581.81
45min1203532-20353283.16381.882.7284.1782.862.74
2200005-20000581.72282.66
3204034-20403483.36884.35
4196163-19616380.15281.14
5192112-19211278.49779.38
6206576-20657684.40785.44
60min1208257-20825785.09484.422.1786.3585.642.19
2207011-20701184.58485.77
3209866-20986685.75186.98
4202054-20205482.55983.79
5200485-20048581.91883.04
6211953-21195386.60487.89
极限1230433-23043394.15595.600.8495.6697.060.82
2235303-23530396.14597.58
3235743-23574396.32497.81
4233046-23304695.22296.70
5234456-23445695.79897.17
6234769-23476995.92697.47
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