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 11.041901751893191901431895361892331896810.24
2 11.101874461877821876140.13
单位质量响应值RSD%判断
17181.2516902.161.16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%
5min154983-5498329.01627.8333.6629.0227.8333.66
270150-7015037.02037.02
334558-3455818.23718.24
460041-6004131.68531.69
568844-6884436.33136.33
627785-2778514.66314.66
10min1119031-11903162.81661.119.0662.8661.159.08
2126357-12635766.68266.74
399582-9958252.55252.58
4114527-11452760.43960.49
5126473-12647366.74366.80
6108766-10876657.39957.42
15min1143895-14389575.93875.024.4776.0975.164.48
2147112-14711277.63577.81
3130752-13075269.00269.12
4139119-13911973.41773.57
5147506-14750677.84378.01
6144509-14450976.26276.38
20min1154129-15412981.33880.852.6981.6281.122.71
2156061-15606182.35882.66
3146049-14604977.07477.31
4150870-15087079.61879.89
5157220-15722082.97083.27
6154891-15489181.74081.99
30min1163675-16367586.37686.141.0686.7986.551.08
2164694-16469486.91487.35
3160735-16073584.82585.19
4161932-16193285.45685.86
5165347-16534787.25887.70
6163018-16301886.02986.41
45min1170162-17016289.79989.720.8090.3690.270.82
2170371-17037189.91090.49
3167586-16758688.44088.94
4171527-17152790.52091.07
5170770-17077090.12090.71
6169624-16962489.51690.04
60min1171692-17169290.60790.860.8591.3291.560.88
2172558-17255891.06491.80
3170015-17001589.72290.37
4173489-17348991.55592.26
5173931-17393191.78892.52
6171296-17129690.39891.07
极限1178459-17845994.17894.321.1395.0495.181.11
2177202-17720293.51594.40
3178878-17887894.39995.20
4182613-18261396.37097.22
5177386-17738693.61294.50
6177874-17787493.86994.70
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 11.041878901873701869951870161870321872610.21
2 11.101873931870471872200.14
单位质量响应值RSD%判断
16962.0516866.670.40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%
5min151111-5111127.17420.3825.1027.1720.3725.10
241764-4176422.20522.20
329047-2904715.44315.44
426667-2666714.17814.18
535479-3547918.86318.86
645875-4587524.39024.39
10min1129286-12928668.73858.2718.0068.7858.3118.00
2124241-12424166.05566.09
385309-8530945.35645.38
486665-8666546.07746.10
5107608-10760857.21257.24
6124532-12453266.21066.25
15min1149386-14938679.42474.769.4679.5874.899.48
2152047-15204780.83980.99
3122433-12243365.09465.20
4125296-12529666.61666.72
5143823-14382376.46776.59
6150669-15066980.10680.26
20min1158125-15812584.07081.725.0384.3681.975.06
2160884-16088485.53785.82
3142681-14268175.85976.07
4145491-14549177.35377.56
5155353-15535382.59782.85
6159654-15965484.88385.17
30min1166832-16683288.70087.692.4489.1388.082.48
2170195-17019590.48890.91
3160726-16072685.45385.79
4159661-15966184.88785.23
5165291-16529187.88088.27
6166936-16693688.75589.18
45min1172582-17258291.75791.351.5392.3491.891.57
2174883-17488392.98093.56
3168999-16899989.85290.33
4168198-16819889.42689.91
5172842-17284291.89592.43
6173382-17338292.18292.76
60min1174648-17464892.85592.831.3193.5993.521.34
2178133-17813394.70895.44
3173181-17318192.07592.70
4171383-17138391.11991.75
5174668-17466892.86693.56
6175580-17558093.35194.08
极限1178569-17856994.94095.200.6095.8396.050.61
2180669-18066996.05696.94
3179727-17972795.55696.34
4177533-17753394.38995.17
5179005-17900595.17296.02
6178861-17886195.09595.98
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