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%
111.021889551887481888841888221885061887830.10
211.081875011876721875860.07
单位质量响应值RSD%判断
17130.9416930.140.84数据可信
供试品溶液-25031101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%
5min149737-4973726.26421.2129.2426.2621.2129.25
223108-2310812.20212.20
328697-2869715.15415.15
443207-4320722.81622.82
552568-5256827.75927.76
643721-4372123.08723.09
10min1122628-12262864.75555.4217.3764.8055.4617.38
278456-7845641.42941.45
387424-8742446.16546.19
4109080-10908057.60157.64
5122163-12216364.50964.56
6109961-10996158.06658.10
15min1146572-14657277.39870.489.4877.5570.619.50
2115750-11575061.12361.21
3120255-12025563.50263.60
4140077-14007773.96974.10
5143090-14309075.56075.71
6135102-13510271.34271.48
20min1155167-15516781.93777.245.7382.2277.485.76
2134886-13488671.22871.42
3137685-13768572.70672.91
4152076-15207680.30580.56
5152117-15211780.32780.61
6145698-14569876.93777.19
30min1164966-16496687.11283.753.4487.5384.123.48
2151722-15172280.11880.43
3153159-15315980.87781.21
4163230-16323086.19586.59
5161347-16134785.20185.61
6157138-15713882.97883.36
45min1171794-17179490.71787.812.4691.2888.322.49
2162047-16204785.57086.01
3162748-16274885.94086.40
4170141-17014189.84490.38
5167270-16727088.32888.88
6163728-16372886.45886.98
60min1174367-17436792.07689.641.9192.7990.301.95
2165848-16584887.57788.16
3167434-16743488.41589.02
4172385-17238591.02991.71
5170511-17051190.04090.74
6168000-16800088.71489.38
极限1177356-17735693.65492.081.1394.5292.881.14
2174216-17421691.99692.73
3174243-17424392.01092.76
4175645-17564592.75193.59
5172905-17290591.30492.16
6171837-17183790.74091.55
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%
111.021874881872441876091873391872031873770.10
211.081870061868631869340.06
单位质量响应值RSD%判断
17003.3616871.300.56数据可信
供试品溶液-25031101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%
5min138401-3840120.38918.929.3120.3918.929.31
229437-2943715.63015.63
338546-3854620.46620.47
435444-3544418.81918.82
535755-3575518.98418.98
636237-3623719.24019.24
10min187352-8735246.38043.384.7246.4143.414.72
277343-7734341.06641.09
381183-8118343.10443.14
480905-8090542.95742.99
585058-8505845.16245.19
678354-7835441.60241.63
15min1109002-10900257.87554.893.4557.9955.003.45
2101186-10118653.72553.82
3102155-10215554.24054.35
4102098-10209854.20954.31
5106338-10633856.46156.57
699498-9949852.82952.93
20min1121786-12178664.66362.092.5964.8762.292.60
2115341-11534161.24161.42
3115592-11559261.37461.57
4116025-11602561.60461.80
5119360-11936063.37563.58
6113578-11357860.30560.49
30min1136501-13650172.47670.651.7672.7970.951.77
2131701-13170169.92770.21
3132062-13206270.11970.42
4131936-13193670.05270.35
5135475-13547571.93172.24
6130733-13073369.41369.70
45min1149148-14914879.19177.651.0379.6378.061.04
2145610-14561077.31277.71
3145517-14551777.26377.68
4145123-14512377.05477.47
5146546-14654677.80978.24
6145495-14549577.25177.66
60min1155744-15574482.69381.540.7883.2682.090.79
2153802-15380281.66282.19
3152386-15238680.91081.45
4153001-15300181.23681.78
5153753-15375381.63682.19
6152802-15280281.13181.67
极限1161803-16180385.91084.570.9186.6285.250.91
2159563-15956384.72185.39
3157581-15758183.66884.35
4158956-15895684.39885.07
5158355-15835584.07984.77
6159422-15942284.64685.32
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