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%
111.203838233836943834163834153822673833230.17
211.253851623850533851080.03
单位质量响应值RSD%判断
34225.2734231.820.02数据可信
供试品溶液-24111801-1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%
5min174579-7457919.59416.3213.3019.5916.3213.29
265507-6550717.21117.21
365172-6517217.12317.12
458218-5821815.29615.30
558987-5898715.49815.50
650297-5029713.21413.21
10min1149120-14912039.17835.645.1739.2135.665.16
2132180-13218034.72734.76
3134292-13429235.28235.31
4128726-12872633.82033.85
5134665-13466535.38035.41
6134829-13482935.42335.45
15min1195290-19529051.30849.402.9251.4149.492.93
2184099-18409948.36848.45
3183733-18373348.27248.36
4186066-18606648.88548.97
5184249-18424948.40748.49
6194811-19481151.18251.26
20min1222944-22294458.57457.252.2158.7657.422.21
2215484-21548456.61456.78
3213225-21322556.02056.19
4217560-21756057.15957.32
5213658-21365856.13456.30
6224570-22457059.00159.17
30min1255421-25542167.10666.041.6467.3966.311.64
2250110-25011065.71165.97
3247537-24753765.03565.30
4250950-25095065.93266.19
5247073-24707364.91365.17
6257128-25712867.55567.82
45min1279926-27992673.54472.990.9773.9473.360.98
2277683-27768372.95573.33
3275119-27511972.28172.65
4277893-27789373.01073.38
5274644-27464472.15772.52
6281619-28161973.98974.37
60min1292957-29295776.96876.720.6677.4877.220.67
2291892-29189276.68877.18
3290643-29064376.36076.85
4292346-29234676.80877.30
5289339-28933976.01776.50
6294903-29490377.47977.98
极限1302824-30282479.56079.180.5880.2079.800.58
2301697-30169779.26479.88
3301141-30114179.11879.74
4301505-30150579.21479.83
5298181-29818178.34178.95
6302896-30289679.57980.21
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%
111.201951061948841951111950681951871950710.06
211.251940251939981940120.01
单位质量响应值RSD%判断
17417.0517245.510.70数据可信
供试品溶液-24111801-2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%
5min124067-2406712.4889.0342.9312.499.0342.90
211481-114815.9575.96
313906-139067.2167.22
47237-72373.7553.76
524439-2443912.68112.68
623253-2325312.06612.07
10min176466-7646639.67733.1129.5039.7033.1229.51
248016-4801624.91524.92
368644-6864435.61935.63
433482-3348217.37317.38
580247-8024741.63941.66
675992-7599239.43139.45
15min1114136-11413659.22453.7315.1559.3153.8115.17
293348-9334848.43748.49
3111384-11138457.79657.87
476301-7630139.59239.63
5116879-11687960.64760.74
6109294-10929456.71256.80
20min1131971-13197168.47863.8710.8268.6664.0310.84
2115060-11506059.70359.84
3132816-13281668.91769.08
499717-9971751.74251.84
5132601-13260168.80569.00
6126356-12635665.56565.75
30min1149228-14922877.43374.486.9677.7374.746.99
2138368-13836871.79872.03
3153939-15393979.87780.16
4126156-12615665.46165.65
5148822-14882277.22277.53
6144655-14465575.06075.35
45min1162451-16245184.29482.564.4784.7282.954.51
2157088-15708881.51181.86
3168571-16857187.47087.89
4147205-14720576.38376.68
5161360-16136083.72884.16
6157998-15799881.98482.40
60min1168911-16891187.64686.843.4488.2287.373.47
2166404-16640486.34586.83
3176643-17664391.65892.22
4158987-15898782.49782.92
5168164-16816487.25987.83
6165072-16507285.65486.21
极限1173163-17316389.85289.702.2790.5790.372.29
2170580-17058088.51289.14
3180400-18040093.60894.32
4170039-17003988.23188.79
5172773-17277389.65090.37
6170276-17027688.35489.05
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