非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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 11.041906481904071904681903451901751904090.10
2 11.101895891897621896760.07
单位质量响应值RSD%判断
17247.1917087.930.66数据可信
供试品溶液-2025060821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%
5min147859-4785925.07022.5824.9125.0722.5824.91
237469-3746919.62819.63
345987-4598724.09024.09
447332-4733224.79424.79
524565-2456512.86812.87
655443-5544329.04329.04
10min1121501-12150163.64757.758.1263.6957.798.13
299221-9922151.97652.01
3115093-11509360.29060.33
4114059-11405959.74859.79
599683-9968352.21852.24
6111900-11190058.61758.67
15min1150944-15094479.07072.785.6679.2272.915.66
2129685-12968567.93468.05
3140222-14022273.45373.59
4144165-14416575.51975.66
5136115-13611571.30271.41
6132501-13250169.40969.55
20min1161506-16150684.60379.354.5084.8879.614.51
2144629-14462975.76275.99
3151393-15139379.30579.57
4157162-15716282.32782.59
5149766-14976678.45378.68
6144457-14445775.67275.93
30min1169419-16941988.74884.953.8089.1785.343.80
2156956-15695682.21982.58
3161127-16112784.40484.80
4169490-16949088.78589.19
5161234-16123484.46084.82
6154817-15481781.09981.49
45min1174714-17471491.52288.303.4692.0988.833.46
2163919-16391985.86786.36
3167425-16742587.70388.24
4176176-17617692.28792.84
5167660-16766087.82688.33
6161515-16151584.60785.13
60min1177169-17716992.80889.693.3893.5390.373.38
2166817-16681787.38588.02
3169953-16995389.02889.71
4178788-17878893.65694.36
5170649-17064989.39290.04
6163937-16393785.87686.54
极限1180396-18039694.49893.951.3295.3794.781.34
2176817-17681792.62393.41
3178389-17838993.44794.28
4183562-18356296.15697.02
5178555-17855593.53494.33
6178388-17838893.44694.25
非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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 11.041889421887311888691885981888011887880.07
2 11.101882331880841881580.06
单位质量响应值RSD%判断
17100.3616951.170.62数据可信
供试品溶液-2025061021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%
5min142239-4223922.31121.6026.7022.3121.6026.71
227964-2796414.77114.77
328387-2838714.99414.99
455148-5514829.12929.13
542724-4272422.56722.57
648882-4888225.81925.82
10min1105185-10518555.55857.3118.6555.6057.3518.66
284625-8462544.69944.72
385755-8575545.29645.32
4132846-13284670.16970.22
5117607-11760762.12062.16
6125036-12503666.04466.09
15min1135707-13570771.68072.2410.7171.8172.3710.73
2119540-11954063.14163.24
3118894-11889462.80062.90
4152179-15217980.38180.55
5146116-14611677.17877.32
6148181-14818178.26978.42
20min1148813-14881378.60379.087.2978.8579.337.31
2139371-13937173.61573.82
3134213-13421370.89171.10
4160866-16086684.96985.27
5156983-15698382.91883.19
6158014-15801483.46383.75
30min1162562-16256285.86585.684.2086.2586.074.23
2157523-15752383.20383.53
3150964-15096479.73980.06
4168261-16826188.87589.32
5166747-16674788.07588.48
6167246-16724688.33988.76
45min1172148-17214890.92890.112.8691.4590.642.90
2167059-16705988.24088.71
3162454-16245485.80886.26
4175351-17535192.62093.21
5173566-17356691.67792.23
6173036-17303691.39791.97
60min1177504-17750493.75792.102.6394.4392.782.67
2170663-17066390.14490.76
3166767-16676788.08688.69
4178001-17800194.02094.76
5176468-17646893.21093.92
6176844-17684493.40994.13
极限1182072-18207296.17094.791.1797.0095.621.21
2177032-17703293.50894.27
3176800-17680093.38594.13
4180460-18046095.31996.22
5180300-18030095.23496.10
6180090-18009095.12396.00
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