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%
111.304060344059614055644051994050534055620.11
211.333991673986863989260.09
单位质量响应值RSD%判断
35890.4435209.711.36数据可信
供试品溶液-24072301-3批-20mg规格-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%
5min1110932-11093228.08730.7722.8028.0930.7722.80
2155971-15597139.49039.49
398122-9812224.84324.84
4154473-15447339.11139.11
5117952-11795229.86429.86
691653-9165323.20523.21
10min1206594-20659452.30754.3912.0952.3554.4412.10
2239885-23988560.73660.80
3193555-19355549.00649.05
4250543-25054363.43463.50
5214205-21420554.23454.28
6184054-18405446.60046.64
15min1252143-25214363.83965.317.9063.9765.457.91
2278741-27874170.57470.74
3237373-23737360.10060.22
4283797-28379771.85472.02
5260300-26030065.90566.04
6235368-23536859.59259.71
20min1277657-27765770.29971.805.5570.5472.055.57
2300114-30011475.98576.27
3265703-26570367.27367.50
4302700-30270076.64076.93
5286888-28688872.63672.89
6268404-26840467.95668.17
30min1307252-30725277.79278.743.2378.1579.113.26
2322408-32240881.63082.04
3296614-29661475.09975.43
4321413-32141381.37881.80
5313404-31340479.35079.72
6304942-30494277.20777.54
45min1329925-32992583.53384.042.0984.0284.542.12
2340020-34002086.08986.64
3321188-32118881.32181.78
4338383-33838385.67486.23
5333307-33330784.38984.89
6328716-32871683.22783.68
60min1340744-34074486.27286.731.6986.9087.371.72
2349056-34905688.37789.07
3332529-33252984.19284.79
4346985-34698587.85288.55
5343751-34375187.03387.68
6342221-34222186.64687.24
极限1360860-36086091.36590.830.8092.1491.620.81
2358925-35892590.87591.71
3355486-35548690.00590.74
4361012-36101291.40492.25
5354967-35496789.87390.66
6361205-36120591.45292.19
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%
111.303986243983893981763982213983553983530.05
211.333967473963873965670.07
单位质量响应值RSD%判断
35252.4835001.500.51数据可信
供试品溶液-24081401批-20mg规格-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%
5min1139660-13966035.78332.4821.4535.7832.4821.45
2117137-11713730.01230.01
3146890-14689037.63637.64
4105462-10546227.02127.02
589897-8989723.03323.03
6161659-16165941.42041.42
10min1226581-22658158.05457.1610.0758.1157.2210.08
2219928-21992856.34956.40
3235776-23577660.41060.47
4202170-20217051.79951.84
5196512-19651250.35050.39
6257677-25767766.02166.09
15min1260653-26065366.78466.196.0966.9466.346.11
2256828-25682865.80465.95
3266994-26699468.40868.57
4239750-23975061.42861.56
5243368-24336862.35562.48
6282500-28250072.38172.56
20min1277379-27737971.06970.923.7371.3471.183.76
2276840-27684070.93171.18
3281371-28137172.09272.37
4264093-26409367.66567.90
5267856-26785668.62968.86
6293233-29323375.13175.43
30min1295161-29516175.62575.732.1176.0176.112.14
2294569-29456975.47375.85
3296026-29602675.84776.24
4286996-28699673.53373.88
5294355-29435575.41975.76
6306409-30640978.50778.93
45min1309129-30912979.20479.251.6579.7279.751.66
2309903-30990379.40279.90
3308203-30820378.96779.49
4300434-30043476.97677.45
5312721-31272180.12480.59
6315375-31537580.80481.36
60min1315687-31568780.88481.121.5581.5381.751.55
2316416-31641681.07181.70
3315081-31508180.72981.38
4308803-30880379.12079.72
5322464-32246482.62183.22
6321132-32113282.27982.97
极限1326081-32608183.54783.851.3984.3384.621.36
2329132-32913284.32985.09
3324314-32431483.09583.88
4323202-32320282.81083.54
5335567-33556785.97886.72
6325350-32535083.36084.19
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