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%
111.023782953782033783993776613799373784990.23
210.953785133774143779640.21
单位质量响应值RSD%判断
34346.5534517.260.36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%
5min1111327-11132729.09923.6732.5329.1023.6732.53
275644-7564419.77219.77
358134-5813415.19515.20
4115625-11562530.22330.22
5123014-12301432.15432.15
659697-5969715.60415.60
10min1240323-24032362.81759.785.9162.8759.825.93
2226285-22628559.14859.18
3213461-21346155.79655.82
4237784-23778462.15462.20
5242243-24224363.31963.37
6212168-21216855.45855.48
15min1278646-27864672.83471.292.7572.9971.432.76
2278118-27811872.69672.83
3269009-26900970.31570.43
4274984-27498471.87772.03
5276456-27645672.26272.42
6259182-25918267.74767.87
20min1296485-29648577.49776.642.3377.7776.902.33
2301585-30158578.83079.08
3294800-29480077.05777.29
4290041-29004175.81376.09
5294758-29475877.04677.33
6281534-28153473.58973.82
30min1318504-31850483.25382.602.3483.6682.992.33
2326505-32650585.34485.73
3319197-31919783.43483.80
4311981-31198181.54881.95
5315204-31520482.39082.80
6304692-30469279.64380.00
45min1332476-33247686.90587.062.0187.4587.592.01
2343649-34364989.82590.35
3336964-33696488.07888.58
4327922-32792285.71586.25
5332793-33279386.98887.53
6324707-32470784.87485.36
60min1342984-34298489.65289.741.8990.3490.401.88
2352727-35272792.19892.87
3347940-34794090.94791.60
4338693-33869388.53089.21
5342968-34296889.64790.34
6334521-33452187.43988.07
极限1348532-34853291.10291.651.6991.9492.471.68
2361167-36116794.40495.23
3353747-35374792.46593.27
4344903-34490390.15390.98
5347785-34778590.90791.75
6347634-34763490.86791.64
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%
111.023758733760923762963756573756553759150.08
210.953785293771633778460.26
单位质量响应值RSD%判断
34112.0734506.480.82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%
5min1125729-12572932.98232.5529.8732.9832.5529.87
283591-8359121.92821.93
374806-7480619.62419.62
4164853-16485343.24643.25
5145624-14562438.20138.20
6149936-14993639.33239.33
10min1222395-22239558.34155.2318.6258.4055.2918.63
2161691-16169142.41642.45
3160051-16005141.98642.02
4245620-24562064.43364.51
5237054-23705462.18662.25
6236426-23642662.02162.09
15min1256808-25680867.36864.5612.5967.5264.7112.61
2207475-20747554.42754.53
3206017-20601754.04454.15
4273895-27389571.85072.03
5266091-26609169.80369.97
6266426-26642669.89170.06
20min1274554-27455472.02370.198.8772.2970.458.91
2238131-23813162.46962.67
3236959-23695962.16162.35
4289140-28914075.85076.15
5282686-28268674.15774.44
6283966-28396674.49274.78
30min1295040-29504077.39777.024.7577.7877.404.80
2274983-27498372.13672.44
3277903-27790372.90273.20
4307401-30740180.64081.07
5303859-30385979.71180.12
6302506-30250679.35679.77
45min1311620-31162081.74782.082.9882.2682.583.04
2299606-29960678.59579.02
3304424-30442479.85980.28
4321661-32166184.38184.94
5321659-32165984.38084.92
6318409-31840983.52884.07
60min1319187-31918783.73284.592.2884.3885.222.34
2311847-31184781.80682.36
3317425-31742583.27083.82
4329693-32969386.48887.19
5327798-32779885.99186.67
6328767-32876786.24586.93
极限1325864-32586485.48386.421.3686.2787.201.40
2322450-32245084.58885.28
3329593-32959386.46287.15
4332758-33275887.29288.14
5332181-33218187.14187.96
6333781-33378187.56088.39
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