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%
111.041926081916051918231925081912961919680.30
211.071893521899951896740.24
单位质量响应值RSD%判断
17388.4117134.061.05数据可信
供试品溶液-25032401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%
5min122153-2215311.54215.0130.0111.5415.0130.00
214832-148327.7287.73
337198-3719819.38119.38
429938-2993815.59815.60
533917-3391717.67117.67
634821-3482118.14218.14
10min172359-7235937.70048.4417.5837.7248.4617.59
272211-7221137.62337.64
3100472-10047252.34752.38
499258-9925851.71451.74
5105302-10530254.86354.89
6108194-10819456.37056.40
15min1117704-11770461.32569.218.3761.4169.318.38
2122231-12223163.68463.76
3131069-13106968.28868.41
4143154-14315474.58574.70
5144531-14453175.30275.42
6138298-13829872.05572.18
20min1134817-13481770.24176.935.9770.4377.155.99
2141293-14129373.61573.80
3146020-14602076.07876.31
4156600-15660081.59081.83
5157447-15744782.03282.28
6149725-14972578.00878.25
30min1150712-15071278.52383.804.2778.8284.154.29
2157407-15740782.01182.32
3158697-15869782.68383.04
4167598-16759887.32087.69
5169206-16920688.15888.54
6161439-16143984.11184.49
45min1160458-16045883.60088.043.4284.0388.533.45
2166940-16694086.97887.42
3166441-16644186.71887.22
4175108-17510891.23391.75
5175770-17577091.57892.11
6169157-16915788.13388.65
60min1165116-16511686.02789.933.0486.6090.563.06
2170080-17008088.61489.20
3170703-17070388.93889.58
4178032-17803292.75793.43
5179038-17903893.28193.96
6172642-17264289.94890.61
极限1179331-17933193.43394.090.7294.1594.880.74
2181206-18120694.41095.14
3179475-17947593.50894.30
4181282-18128294.45095.27
5182566-18256695.11995.96
6179735-17973593.64494.46
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%
111.041895041895591897031894991895301895590.05
211.071882491882811882650.02
单位质量响应值RSD%判断
17170.2017006.780.68数据可信
供试品溶液-25032401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%
5min119766-1976610.40214.0027.1910.4014.0027.19
218708-187089.8459.85
322051-2205111.60511.60
435286-3528618.57018.57
532375-3237517.03817.04
631377-3137716.51216.51
10min159558-5955831.34341.3213.2531.3641.3513.26
278120-7812041.11241.13
376096-7609640.04640.07
484380-8438044.40644.44
589145-8914546.91446.94
683849-8384944.12644.15
15min185876-8587645.19354.899.5245.2654.989.53
2104620-10462055.05755.14
3103261-10326154.34254.43
4107495-10749556.57056.68
5114995-11499560.51760.62
6109556-10955657.65557.76
20min1104331-10433154.90562.866.9755.0563.046.99
2119884-11988463.09063.27
3117793-11779361.99062.17
4121567-12156763.97664.18
5128755-12875567.75967.97
6124333-12433365.43265.63
30min1127339-12733967.01472.314.1667.2572.604.18
2137656-13765672.44372.72
3135631-13563171.37771.66
4138390-13839072.82973.14
5143593-14359375.56775.89
6141769-14176974.60874.91
45min1147210-14721077.47180.052.1677.8280.462.19
2152524-15252480.26780.67
3150738-15073879.32879.73
4150909-15090979.41879.84
5156373-15637382.29382.74
6154951-15495181.54581.98
60min1155975-15597582.08484.211.8282.5684.751.85
2160442-16044284.43484.97
3158911-15891183.62984.16
4158232-15823283.27183.83
5163691-16369186.14486.73
6162809-16280985.68086.25
极限1164542-16454286.59287.921.0187.2188.601.04
2167353-16735388.07188.75
3167984-16798488.40389.07
4165497-16549787.09587.79
5168885-16888588.87889.60
6168104-16810488.46789.18
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%
111.041881261882361884871883241885371883420.10
211.071878371882391880380.16
单位质量响应值RSD%判断
17059.9616986.270.31数据可信
供试品溶液-25032401批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1-0.0002.8282.030.002.8282.05
26980-69803.6873.69
39039-90394.7754.78
410035-100355.3015.30
55971-59713.1543.15
6-0.0000.00
10min113085-130856.9128.4826.236.918.4926.27
217834-178349.4219.43
316164-161648.5398.55
420322-2032210.73610.74
519633-1963310.37210.38
69299-92994.9124.91
15min120038-2003810.58611.4820.8310.6011.5020.84
224529-2452912.95812.98
319653-1965310.38210.40
425471-2547113.45613.48
526224-2622413.85313.88
614442-144427.6297.64
20min123505-2350512.41713.1219.0212.4513.1619.05
227340-2734014.44314.49
321732-2173211.48011.52
428455-2845515.03215.08
530268-3026815.99016.04
617684-176849.3429.36
30min128154-2815414.87315.0616.4314.9215.1116.46
230559-3055916.14316.21
324979-2497913.19613.25
431784-3178416.79116.86
534134-3413418.03218.10
621403-2140311.30711.34
45min132768-3276817.31017.0812.1617.3917.1712.19
233202-3320217.54017.63
328796-2879615.21215.29
435474-3547418.74018.84
537061-3706119.57819.68
626720-2672014.11514.17
60min136442-3644219.25118.756.6319.3518.866.68
235517-3551718.76318.89
332592-3259217.21717.32
437384-3738419.74919.88
538203-3820320.18220.32
632779-3277917.31617.40
极限137913-3791320.02820.181.6020.1620.321.55
237291-3729119.70019.85
338668-3866820.42720.56
437817-3781719.97820.14
538658-3865820.42220.59
638808-3880820.50120.61
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