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%
111.021888171880141881091879931880521881970.19
210.881863511865841864680.09
单位质量响应值RSD%判断
17077.7717138.600.26数据可信
供试品溶液-2025042521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%
5min161849-6184932.51132.9834.8132.5132.9834.81
255135-5513528.98128.98
341154-4115421.63221.63
4103814-10381454.56954.57
549730-4973026.14026.14
664826-6482634.07534.08
10min1128877-12887767.74470.979.3067.8071.039.31
2137685-13768572.37372.42
3119216-11921662.66562.70
4157115-15711582.58782.68
5133636-13363670.24570.29
6133599-13359970.22670.28
15min1159273-15927383.72183.213.6483.8983.383.66
2154336-15433681.12681.29
3151738-15173879.76079.90
4168539-16853988.59288.82
5157463-15746382.77082.93
6158476-15847683.30283.48
20min1169930-16993089.32388.012.6289.6388.322.64
2161414-16141484.84685.15
3165037-16503786.75187.02
4174195-17419591.56591.94
5166167-16616787.34587.64
6167892-16789288.25288.56
30min1177534-17753493.32092.002.3093.7892.462.31
2167992-16799288.30488.75
3175162-17516292.07392.49
4179817-17981794.52095.05
5173952-17395291.43791.88
6175731-17573192.37292.83
45min1182423-18242395.89094.432.4596.5095.042.46
2171770-17177090.29090.88
3181114-18111495.20295.77
4184004-18400496.72197.41
5177673-17767393.39393.99
6180907-18090795.09395.71
60min1184525-18452596.99595.642.3397.7796.412.34
2173978-17397891.45192.19
3183461-18346196.43597.17
4185909-18590997.72298.57
5181109-18110995.19995.95
6182737-18273796.05596.83
极限1186828-18682898.20596.302.3799.1497.222.37
2175316-17531692.15493.05
3184933-18493397.20998.10
4186693-18669398.13499.14
5181530-18153095.42096.33
6183874-18387496.65297.58
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%
111.021877151878381875001873751875591875970.10
210.881869611867801868700.07
单位质量响应值RSD%判断
17023.3217175.550.63数据可信
供试品溶液-2025042521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%
5min163690-6369033.49633.3815.8033.5033.3815.80
264991-6499134.18034.18
361771-6177132.48732.49
478875-7887541.48241.48
547370-4737024.91324.91
664087-6408733.70533.70
10min1141740-14174074.54472.174.9374.6072.224.93
2132191-13219169.52269.58
3131533-13153369.17669.23
4146860-14686077.23777.31
5130449-13044968.60668.65
6140545-14054573.91673.97
15min1158226-15822683.21582.501.4783.3982.671.48
2155130-15513081.58681.76
3156027-15602782.05882.23
4159868-15986884.07884.28
5153725-15372580.84781.00
6158207-15820783.20583.38
20min1164804-16480486.67486.340.7886.9986.650.79
2163831-16383186.16286.47
3164273-16427386.39586.70
4165818-16581887.20787.55
5161991-16199185.19585.49
6164271-16427186.39486.71
30min1171013-17101389.94090.090.7590.4090.540.76
2171432-17143290.16090.61
3171762-17176290.33390.78
4173208-17320891.09491.58
5169288-16928889.03289.46
6171092-17109289.98190.44
45min1174881-17488191.97492.240.5492.5992.840.54
2176099-17609992.61493.22
3176273-17627392.70693.31
4175610-17561092.35792.99
5173744-17374491.37691.96
6175669-17566992.38893.00
60min1177464-17746493.33293.480.5694.1094.240.57
2178382-17838293.81594.57
3179051-17905194.16794.92
4177775-17777593.49694.28
5176090-17609092.61093.34
6177715-17771593.46494.23
极限1179522-17952294.41593.970.5595.3494.880.56
2179031-17903194.15695.07
3179552-17955294.43095.34
4178259-17825993.75094.70
5176938-17693893.05693.94
6178705-17870593.98594.91
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%
111.021872981874831873901873011872351873410.06
210.881863881866161865020.09
单位质量响应值RSD%判断
17000.0917141.730.59数据可信
供试品溶液-2025042521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%
5min171388-7138837.60737.4522.6837.6137.4522.68
293207-9320749.10149.10
376399-7639940.24740.25
470100-7010036.92936.93
543174-4317422.74422.74
672247-7224738.06038.06
10min1141255-14125574.41374.514.3674.4874.574.37
2149762-14976278.89578.98
3144222-14422275.97676.04
4143010-14301075.33875.40
5131204-13120469.11869.16
6139126-13912673.29273.36
15min1155972-15597282.16683.441.9482.3583.621.96
2162674-16267485.69785.91
3160790-16079084.70484.90
4159113-15911383.82184.01
5154489-15448981.38581.54
6157277-15727782.85483.04
20min1162120-16212085.40586.831.4185.7387.161.42
2167285-16728588.12688.48
3167718-16771888.35488.69
4165012-16501286.92887.26
5162655-16265585.68785.98
6164171-16417186.48586.81
30min1168390-16839088.70890.231.1289.1790.701.13
2173204-17320491.24491.75
3173560-17356091.43191.91
4171096-17109690.13390.61
5170288-17028889.70890.14
6171092-17109290.13190.60
45min1173115-17311591.19792.621.1291.8193.241.12
2177312-17731293.40894.06
3178603-17860394.08894.72
4174557-17455791.95792.58
5175987-17598792.71093.29
6175316-17531692.35692.97
60min1174104-17410491.71893.661.1992.4894.441.20
2179136-17913694.36995.18
3180377-18037795.02395.81
4177815-17781593.67394.45
5178026-17802693.78494.52
6177316-17731693.41094.18
极限1175756-17575692.58894.101.0793.5195.041.08
2179488-17948894.55495.52
3181601-18160195.66796.62
4178123-17812393.83594.77
5178322-17832293.94094.83
6178499-17849994.03394.96
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%
111.021863651862161863391864451864481863630.06
210.881858661860151859400.06
单位质量响应值RSD%判断
16911.3417090.070.75数据可信
供试品溶液-2025042521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%
5min173678-7367838.97434.6021.1238.9734.6021.11
244968-4496823.78723.79
374470-7447039.39339.39
454581-5458128.87228.87
581619-8161943.17543.17
663153-6315333.40733.41
10min1137673-13767372.82672.133.5272.8972.193.53
2129507-12950768.50768.55
3142352-14235275.30175.37
4131811-13181169.72569.77
5139158-13915873.61273.68
6137693-13769372.83772.89
15min1151217-15121779.99180.961.6780.1881.141.68
2149439-14943979.05079.20
3156147-15614782.59982.79
4153402-15340281.14781.31
5152586-15258680.71580.91
6155528-15552882.27182.45
20min1156407-15640782.73683.951.2783.0684.261.27
2156620-15662082.84983.13
3161090-16109085.21485.54
4160077-16007784.67884.98
5157795-15779583.47183.80
6160163-16016384.72385.04
30min1161269-16126985.30886.641.5885.7787.101.57
2161089-16108985.21385.64
3166510-16651088.08188.55
4165781-16578187.69588.14
5162059-16205985.72686.19
6166038-16603887.83188.29
45min1164423-16442386.97788.061.2687.5888.651.25
2165332-16533287.45788.02
3168463-16846389.11489.73
4166689-16668988.17588.76
5164512-16451287.02487.63
6169368-16936889.59290.19
60min1164717-16471787.13288.471.5687.8889.221.55
2164750-16475087.15087.86
3168369-16836989.06489.83
4170251-17025190.06090.79
5165445-16544587.51788.27
6169985-16998589.91990.67
极限1164413-16441386.97188.471.6487.8689.361.63
2165755-16575587.68188.54
3168560-16856089.16590.08
4170138-17013890.00090.88
5164400-16440086.96487.87
6170250-17025090.05990.96
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