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500
标示量(mg)20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%
111.383925433926633927763926003926283926420.03
211.473959413959683959540.01
单位质量响应值RSD%判断
34502.8134520.840.04数据可信
加速2月-供试品溶液-24101601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%
5min1134346-13434635.00733.4748.4435.0133.4748.45
263494-6349416.54516.54
3187493-18749348.85548.86
10min1117007-11700730.48936.6928.6730.5536.7528.70
2117991-11799130.74530.77
3187411-18741148.83448.92
15min1219714-21971457.25154.6130.4057.3654.7230.41
2141402-14140236.84536.92
3267565-26756569.72069.88
20min1203074-20307452.91557.9913.2553.1258.2013.31
2208117-20811754.22954.37
3256468-25646866.82867.11
30min1261715-26171568.19564.8520.7968.4965.1520.81
2191929-19192950.01150.24
3292952-29295276.33576.73
45min1243479-24347963.44467.548.0463.8567.968.10
2251337-25133765.49165.81
3282826-28282673.69674.21
60min1284954-28495474.25171.2915.0374.7671.8215.07
2228004-22800459.41159.83
3307844-30784480.21580.86
极限1265226-26522669.11073.566.8269.7574.216.88
2278579-27857972.59073.11
3303151-30315178.99379.77
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500
标示量(mg)20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%
111.383935533935533937893936683933553935840.05
211.473918103916103917100.04
单位质量响应值RSD%判断
34585.5934150.830.90数据可信
加速2月-供试品溶液-24101601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%
5min1160876-16087642.09732.5327.1842.1032.5327.18
294276-9427624.66924.67
3117784-11778430.82130.82
10min1176545-17654546.19732.0042.5546.2732.0542.52
2117503-11750330.74730.79
372814-7281419.05319.10
15min1250249-25024965.48355.8415.1665.6355.9415.19
2189860-18986049.68149.77
3200029-20002952.34252.42
20min1252870-25287066.16954.2319.0966.4354.4319.11
2185979-18597948.66548.84
3182853-18285347.84748.02
30min1284471-28447174.43866.809.9874.8067.0910.03
2237503-23750362.14862.40
3243915-24391563.82564.08
45min1280345-28034573.35864.3712.2373.8564.7712.27
2224535-22453558.75459.11
3233063-23306360.98661.34
60min1302926-30292679.26773.117.3479.8873.627.40
2265634-26563469.50969.97
3269611-26961170.54971.01
极限1292766-29276676.60870.428.2677.3571.058.31
2248707-24870765.07965.65
3265857-26585769.56770.14
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