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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.123797113794913793203791273790023793300.08
211.133764733766743765740.04
单位质量响应值RSD%判断
34112.4133834.140.58数据可信
供试品溶液-24072301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%
5min199890-9989026.46323.4316.9326.4623.4316.91
293966-9396624.89324.89
371516-7151618.94618.95
10min155377-5537714.67024.2835.1314.7124.3235.07
2116829-11682930.95030.99
3102741-10274127.21827.25
15min1190264-19026450.40446.5810.1750.4746.6610.15
2181441-18144148.06748.16
3155835-15583541.28441.36
20min1136978-13697836.28844.8417.4236.4445.0017.38
2194734-19473451.58951.76
3176106-17610646.65446.80
30min1234661-23466162.16658.297.1962.3858.527.16
2222142-22214258.85059.11
3203246-20324653.84454.07
45min1186858-18685849.50256.0510.7549.8256.3810.72
2231598-23159861.35561.71
3216297-21629757.30157.61
60min1263403-26340369.78065.556.5770.1865.976.53
2247985-24798565.69666.16
3230924-23092461.17661.58
极限1225248-22524859.67263.716.0260.1964.256.01
2254033-25403367.29867.87
3242215-24221564.16764.68
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.123779943779703779463781783783263780830.05
211.133754573755013754790.01
单位质量响应值RSD%判断
34000.2733735.760.56数据可信
供试品溶液-24073101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%
5min1143597-14359738.16040.285.6038.1640.285.59
2160468-16046842.64342.64
3150617-15061740.02540.03
10min159183-5918315.72731.5743.5415.7931.6443.46
2151532-15153240.26840.34
3145738-14573838.72938.80
15min1236836-23683662.93762.211.1363.0362.341.10
2233939-23393962.16762.31
3231578-23157861.54061.67
20min1183501-18350148.76457.2313.2948.9657.4613.28
2238861-23886163.47563.72
3223722-22372259.45259.69
30min1271795-27179572.22771.301.2472.5071.611.18
2265220-26522070.48070.83
3267862-26786271.18271.51
45min1232812-23281261.86867.838.1762.2668.268.18
2274033-27403372.82273.29
3258858-25885868.78969.24
60min1288953-28895376.78776.261.2577.2976.821.20
2282865-28286575.16975.76
3289124-28912476.83277.40
极限1256877-25687768.26372.445.0468.8973.125.05
2282175-28217574.98675.70
3278719-27871974.06774.76
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.123762883759783761303760103756323760080.07
211.133756233758413757320.05
单位质量响应值RSD%判断
33813.6733758.490.12数据可信
供试品溶液-24082601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%
5min1108692-10869228.95432.159.2828.9532.159.29
2130861-13086134.85934.86
3122495-12249532.63032.63
10min139821-3982110.60825.8664.3310.6625.9164.20
287734-8773423.37123.43
3163661-16366143.59643.65
15min1244933-24493365.24665.441.4465.3165.531.46
2242550-24255064.61164.71
3249470-24947066.45466.58
20min1191889-19188951.11660.5514.4751.2960.7614.47
2233221-23322162.12662.33
3256852-25685268.42168.66
30min1283436-28343675.50275.191.3175.7675.491.31
2278128-27812874.08874.40
3285187-28518775.96976.32
45min1258145-25814568.76573.015.4569.1573.445.48
2276374-27637473.62174.05
3287707-28770776.64077.12
60min1301788-30178880.39179.901.7080.8980.461.70
2294218-29421878.37478.93
3303879-30387980.94881.55
极限1285536-28553676.06278.703.2176.7079.393.24
2296465-29646578.97379.66
3304373-30437381.08081.82
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.123759023762363760463757803758623759650.05
211.133762333763383762860.02
单位质量响应值RSD%判断
33809.8033808.270.01数据可信
供试品溶液-24082602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%
5min1166075-16607544.20934.4539.9044.2134.4539.90
2151749-15174940.39640.40
370367-7036718.73218.73
10min1154634-15463441.16444.208.4341.2444.268.37
2161843-16184343.08343.15
3181660-18166048.35848.39
15min1243058-24305864.70255.3123.5164.8455.4423.49
2228260-22826060.76360.90
3152035-15203540.47240.58
20min1252815-25281567.30066.051.7967.5566.271.80
2244017-24401764.95865.20
3247517-24751765.88966.07
30min1270287-27028771.95164.8416.3272.3165.1716.30
2262531-26253169.88670.23
3197915-19791552.68552.97
45min1284781-28478175.80973.762.4276.2974.202.45
2273460-27346072.79573.26
3272982-27298272.66873.04
60min1285261-28526175.93770.4411.6876.5571.0011.67
2279445-27944574.38974.98
3229093-22909360.98561.48
极限1301426-30142680.24077.772.8180.9878.452.86
2288996-28899676.93177.64
3285972-28597276.12676.73
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