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%
110.811850601845751851591843721849241848180.19
210.761826801828011827400.05
单位质量响应值RSD%判断
17096.9516983.270.48数据可信
供试品溶液-BXK34K1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%
5min139813-3981321.01120.1112.4421.0120.1212.45
240930-4093021.60121.60
330849-3084916.28116.28
433781-3378117.82817.83
543231-4323122.81522.82
640071-4007121.14721.15
10min199676-9967652.60451.368.2952.6451.398.29
289783-8978347.38347.42
395208-9520850.24650.27
487078-8707845.95545.99
5106558-10655856.23656.27
6105582-10558255.72155.76
15min1128290-12829067.70566.915.1767.8367.035.19
2120777-12077763.74063.85
3125339-12533966.14866.26
4118462-11846262.51862.62
5135279-13527971.39371.53
6132522-13252269.93870.07
20min1144552-14455276.28775.963.4376.5276.193.44
2139453-13945373.59673.82
3141573-14157374.71574.94
4138600-13860073.14673.36
5149428-14942878.86079.11
6149998-14999879.16179.41
30min1158900-15890083.85984.481.2084.2284.831.21
2158648-15864883.72684.07
3158290-15829083.53783.88
4161103-16110385.02285.35
5163347-16334786.20686.59
6160138-16013884.51384.89
45min1167733-16773388.52189.301.9189.0289.801.89
2167740-16774088.52589.01
3167312-16731288.29988.78
4175489-17548992.61493.09
5169867-16986789.64790.17
6167170-16717088.22488.74
60min1171921-17192190.73191.512.0291.3892.151.99
2172680-17268091.13291.76
3171600-17160090.56291.19
4180361-18036195.18595.81
5172832-17283291.21291.89
6170945-17094590.21690.88
极限1181953-18195396.02695.910.9396.8396.710.91
2182266-18226696.19196.97
3182354-18235496.23797.02
4183910-18391097.05897.85
5178846-17884694.38695.21
6181091-18109195.57196.39
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%
110.811833121832161828811832611827001830740.15
210.761818531824221821380.23
单位质量响应值RSD%判断
16935.6216927.320.04数据可信
供试品溶液-BXK34K1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%
5min139422-3942220.93820.369.7620.9420.369.76
237418-3741819.87419.87
332833-3283317.43917.44
438686-3868620.54720.55
537255-3725519.78719.79
644366-4436623.56423.56
10min1100207-10020753.22348.395.7953.2648.435.79
289808-8980847.70047.73
388851-8885147.19147.22
491258-9125848.47048.50
584183-8418344.71244.75
692364-9236449.05749.10
15min1132610-13261070.43364.944.4870.5665.064.48
2118527-11852762.95363.07
3122247-12224764.92965.04
4120850-12085064.18764.30
5117087-11708762.18862.30
6122291-12229164.95265.07
20min1149191-14919179.24074.753.1079.4874.973.11
2137520-13752073.04173.26
3139865-13986574.28674.50
4139608-13960874.15074.37
5137407-13740772.98173.19
6140855-14085574.81275.04
30min1166910-16691088.65185.412.3789.0285.752.37
2161526-16152685.79186.13
3155869-15586982.78783.13
4157749-15774983.78584.13
5160997-16099785.51085.84
6161752-16175285.91186.27
45min1177184-17718494.10892.152.8194.6392.642.80
2174508-17450892.68693.17
3163969-16396987.08987.57
4173726-17372692.27192.76
5174803-17480392.84393.32
6176825-17682593.91794.41
60min1180313-18031395.77094.422.6796.4595.062.67
2177340-17734094.19094.83
3168640-16864089.57090.19
4178173-17817394.63395.27
5180464-18046495.85096.48
6181653-18165396.48197.13
极限1181821-18182196.57096.550.7297.4197.340.73
2181690-18169096.50197.29
3180353-18035395.79196.56
4180366-18036695.79896.59
5182808-18280897.09597.88
6183617-18361797.52498.34
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%
110.811823411826391822371826041822161824070.12
210.761822561817211819880.21
单位质量响应值RSD%判断
16873.9116913.380.17数据可信
供试品溶液-BXK3152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%
5min139007-3900720.76422.5112.9020.7622.5112.90
238881-3888120.69720.70
336439-3643919.39719.40
451066-5106627.18327.18
542178-4217822.45222.45
646177-4617724.58124.58
10min1107393-10739357.16755.1110.4457.2055.1510.44
2101502-10150254.03154.07
387367-8736746.50746.54
4120506-12050664.14864.19
599764-9976453.10653.14
6104685-10468555.72655.77
15min1134811-13481171.76271.145.5271.8971.275.53
2131586-13158670.04670.17
3122087-12208764.98965.10
4144672-14467277.01277.16
5132103-13210370.32170.45
6136580-13658072.70472.84
20min1149842-14984279.76479.153.2980.0179.403.30
2146396-14639677.92978.17
3141113-14111375.11775.34
4155775-15577582.92283.20
5148136-14813678.85679.10
6150833-15083380.29180.55
30min1162229-16222986.35887.011.6186.7487.381.62
2159251-15925184.77285.14
3162932-16293286.73287.08
4166051-16605188.39288.81
5163943-16394387.27087.64
6166282-16628288.51588.90
45min1168250-16825089.56391.122.1790.0991.642.15
2165873-16587388.29788.81
3175114-17511493.21793.70
4170023-17002390.50691.07
5174341-17434192.80593.33
6173416-17341692.31392.85
60min1168867-16886789.89192.452.8090.5793.132.78
2168067-16806789.46590.12
3178229-17822994.87595.52
4171249-17124991.15991.88
5178914-17891495.23995.91
6176719-17671994.07194.76
极限1183612-18361297.74097.440.5598.5798.270.54
2182000-18200096.88297.69
3184214-18421498.06198.86
4182314-18231497.04997.92
5183995-18399597.94498.78
6182148-18214896.96197.81
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%
110.811820431816091810171811841811231813950.24
210.761807261814661810960.29
单位质量响应值RSD%判断
16780.3016830.480.22数据可信
供试品溶液-BXK3152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%
5min141297-4129722.09920.5714.7122.1020.5714.71
235714-3571419.11119.11
332402-3240217.33917.34
433402-3340217.87417.87
547265-4726525.29225.29
640526-4052621.68621.69
10min1103446-10344655.35654.286.6255.3954.326.63
297148-9714851.98552.02
396000-9600051.37151.40
493920-9392050.25850.29
5109450-10945058.56858.61
6108697-10869758.16558.20
15min1137182-13718273.40873.204.4573.5473.334.45
2128711-12871168.87568.99
3134936-13493672.20672.32
4132877-13287771.10571.22
5145675-14567577.95378.09
6141424-14142475.67875.81
20min1152908-15290881.82382.082.6982.0782.322.69
2146008-14600878.13178.36
3154187-15418782.50882.74
4152929-15292981.83582.07
5157869-15786984.47884.75
6156369-15636983.67583.93
30min1167202-16720289.47290.541.9989.8690.931.98
2163804-16380487.65488.02
3171592-17159291.82192.19
4172726-17272692.42892.80
5171347-17134791.69092.10
6168551-16855190.19490.59
45min1173243-17324392.70594.471.8893.2495.001.87
2173108-17310892.63393.14
3177697-17769795.08895.61
4181595-18159597.17497.70
5178374-17837495.45196.01
6175261-17526193.78594.33
60min1175347-17534793.83195.322.0794.5296.012.06
2177405-17740594.93295.60
3179238-17923895.91396.60
4183461-18346198.17398.86
5180222-18022296.44097.16
6173083-17308392.61993.32
极限1183068-18306897.96298.250.2798.8199.100.28
2183328-18332898.10298.92
3183569-18356998.23199.07
4183915-18391598.41699.26
5184390-18439098.67099.55
6183339-18333998.10798.97
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