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%
110.172474342476862475002475492474412475220.05
210.082469712473902471800.12
单位质量响应值RSD%判断
24338.4524521.830.54数据可信
供试品溶液-24101001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%
5min1130213-13021353.03451.6922.5853.0351.6922.58
2119002-11900248.46848.47
3168276-16827668.53768.54
4109588-10958844.63444.63
5147445-14744560.05360.05
686954-8695435.41535.42
10min1153178-15317862.38868.2914.1162.5568.4414.12
2185552-18555275.57375.72
3200705-20070581.74581.95
4145019-14501959.06559.20
5177640-17764072.35172.53
6143905-14390558.61158.72
15min1162931-16293166.36073.6511.2166.7174.0111.22
2200430-20043081.63382.01
3206257-20625784.00684.46
4158106-15810664.39564.71
5187928-18792876.54176.94
6169275-16927568.94469.23
20min1169461-16946169.02076.669.7969.5777.249.81
2208240-20824084.81485.43
3208567-20856784.94785.65
4167768-16776868.33068.83
5195054-19505479.44380.07
6180172-18017273.38273.87
30min1177725-17772572.38680.318.1073.1481.128.12
2217378-21737888.53689.41
3210361-21036185.67886.64
4180963-18096373.70474.41
5203230-20323082.77383.64
6193474-19347478.80079.51
45min1188488-18848876.76983.486.2577.7484.546.29
2222638-22263890.67891.82
3213703-21370387.03988.25
4193012-19301278.61279.54
5208764-20876485.02786.14
6203234-20323482.77583.72
60min1194828-19482879.35185.505.1880.5586.805.23
2225585-22558591.87893.29
3215242-21524287.66689.14
4200967-20096781.85283.02
5213017-21301786.76088.13
6209937-20993785.50586.70
极限1223267-22326790.93493.151.4392.3794.711.42
2232020-23202094.49996.18
3227064-22706492.48194.22
4230594-23059493.91995.33
5228223-22822392.95394.58
6231093-23109394.12295.57
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%
110.172474062477142479022474162472942475460.11
210.082475212476012475610.03
单位质量响应值RSD%判断
24340.8124559.620.64数据可信
供试品溶液-24101001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%
5min1232725-23272594.70990.233.4294.7190.233.42
2226139-22613992.02992.03
3211716-21171686.15986.16
4224281-22428191.27391.27
5215810-21581087.82687.83
6219666-21966689.39589.39
10min1245338-24533899.84296.212.37100.1396.482.37
2238006-23800696.85897.13
3237744-23774496.75297.01
4236620-23662096.29496.57
5230000-23000093.60093.86
6230800-23080093.92694.19
15min1246901-246901100.47896.812.32101.0697.372.32
2239800-23980097.58898.16
3238775-23877597.17197.72
4237236-23723696.54597.11
5231095-23109594.04694.59
6233481-23348195.01795.57
20min1246526-246526100.32696.612.50101.2197.462.50
2239230-23923097.35698.22
3239299-23929997.38598.22
4237384-23738496.60597.46
5230112-23011293.64694.47
6231776-23177694.32395.16
30min1245967-245967100.09896.462.38101.2897.602.38
2238841-23884197.19898.35
3238244-23824496.95598.09
4236995-23699596.44797.59
5230034-23003493.61494.72
6232077-23207794.44595.56
45min1244312-24431299.42596.972.74100.9198.402.71
2236591-23659196.28297.73
3236993-23699396.44697.87
4235517-23551795.84597.28
5229124-22912493.24494.63
6247197-247197100.599102.00
60min1244351-24435199.44095.562.57101.2397.282.56
2236951-23695196.42998.16
3236188-23618896.11897.83
4234564-23456495.45897.18
5227437-22743792.55794.23
6229376-22937693.34695.05
极限1242049-24204998.50495.092.34100.5997.102.34
2235465-23546595.82497.85
3235007-23500795.63897.64
4234068-23406895.25697.26
5226889-22688992.33494.28
6228459-22845992.97394.96
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