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)0
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%
1 11.341892951897811893441895781890721894140.15
2 11.361880291891921886100.44
单位质量响应值RSD%判断
16703.1716602.990.43数据可信
供试品溶液-2025060821批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161504-6150433.21344.4415.5533.2144.4415.56
289059-8905948.09348.09
381329-8132943.91943.92
497034-9703452.40052.40
574596-7459640.28340.28
690236-9023648.72948.73
10min1155720-15572084.09188.223.0184.1588.303.02
2163053-16305388.05188.13
3168070-16807090.76090.83
4166287-16628789.79789.88
5159614-15961486.19486.26
6167505-16750590.45590.54
15min1174311-17431194.13095.741.1694.3395.961.17
2176765-17676595.45595.68
3178785-17878596.54696.77
4179379-17937996.86797.10
5175650-17565094.85395.06
6178912-17891296.61596.85
20min1180960-18096097.72197.990.5198.0798.370.52
2180705-18070597.58397.97
3181677-18167798.10898.49
4182221-18222198.40298.80
5180441-18044197.44097.81
6182746-18274698.68599.08
30min1183335-18333599.00399.260.5699.5299.800.57
2184047-18404799.38899.94
3182766-18276698.69699.24
4185555-185555100.202100.76
5183001-18300198.82399.35
6184169-18416999.454100.01
45min1185234-185234100.029100.230.61100.71100.940.62
2185383-185383100.109100.82
3185743-185743100.304101.02
4187366-187366101.180101.91
5183947-18394799.334100.03
6186019-186019100.453101.18
60min1185444-185444100.142100.490.61100.99101.360.61
2186199-186199100.550101.43
3186096-186096100.494101.37
4188097-188097101.575102.47
5184745-18474599.765100.63
6185945-185945100.413101.30
极限1186738-186738100.841100.710.76101.85101.750.76
2186352-186352100.632101.68
3186425-186425100.672101.72
4188807-188807101.958103.03
5184406-18440699.582100.61
6186195-186195100.548101.61
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)0
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%
1 11.341885561887941880481883231885891884620.16
2 11.361889311884811887060.17
单位质量响应值RSD%判断
16619.2216611.440.04数据可信
供试品溶液-2025060921批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194931-9493151.38051.9818.4551.3851.9818.45
298271-9827153.18853.19
380131-8013143.37043.37
4118772-11877264.28464.28
572557-7255739.27039.27
6111562-11156260.38160.38
10min1170818-17081892.45388.824.7792.5488.914.78
2164289-16428988.91989.01
3156567-15656784.74084.81
4173503-17350393.90694.01
5153544-15354483.10383.17
6165953-16595389.82089.92
15min1178878-17887896.81595.061.4497.0595.291.46
2174642-17464294.52294.76
3173781-17378194.05694.27
4178494-17849496.60796.87
5172684-17268493.46393.67
6175296-17529694.87695.13
20min1181110-18111098.02396.950.9398.4297.340.94
2178860-17886096.80597.20
3177459-17745996.04796.42
4181191-18119198.06798.49
5178463-17846396.59096.95
6177658-17765896.15596.56
30min1183760-18376099.45798.490.79100.0299.050.80
2180475-18047597.67998.24
3181571-18157198.27398.80
4183752-18375299.453100.04
5181278-18127898.11498.63
6181040-18104097.98598.55
45min1181521-18152198.24698.990.6998.9899.710.68
2182463-18246398.75599.47
3183357-18335799.23999.93
4184787-184787100.013100.77
5183561-18356199.350100.03
6181693-18169398.33999.07
60min1184978-184978100.11799.620.53101.01100.500.53
2183212-18321299.161100.04
3184072-18407299.626100.49
4185250-185250100.264101.18
5184061-18406199.620100.47
6182770-18277098.92299.82
极限1185139-185139100.20499.780.80101.26100.830.79
2182628-18262898.84599.89
3183785-18378599.471100.50
4185445-185445100.369101.46
5186236-186236100.797101.81
6182907-18290798.996100.06
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)0
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%
1 11.341882121887421887891884021889341886160.16
2 11.361879371886301882840.27
单位质量响应值RSD%判断
16632.8016574.300.25数据可信
供试品溶液-2025061021批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191064-9106449.32243.1620.5549.3243.1620.55
259457-5945732.20332.20
363556-6355634.42334.42
493083-9308350.41650.42
573327-7332739.71539.72
697606-9760652.86552.87
10min1168779-16877991.41485.947.9191.5086.027.92
2137913-13791374.69774.75
3154151-15415183.49183.55
4169344-16934491.72091.80
5153520-15352083.15083.22
6168346-16834691.18091.27
15min1177451-17745196.11194.681.8096.3594.891.81
2173426-17342693.93194.11
3173936-17393694.20794.40
4179305-17930597.11597.35
5170481-17048192.33692.54
6174208-17420894.35594.59
20min1180519-18051997.77397.411.1498.1797.781.14
2180370-18037097.69298.03
3179378-17937897.15597.51
4182830-18283099.02599.42
5176588-17658895.64496.00
6179404-17940497.16997.57
30min1182691-18269198.94999.171.0899.5199.701.09
2184419-18441999.885100.38
3182431-18243198.80899.32
4186243-186243100.873101.44
5180530-18053097.77998.30
6182266-18226698.71999.28
45min1183983-18398399.64999.960.93100.37100.660.92
2186091-186091100.791101.45
3184586-18458699.976100.66
4186958-186958101.260101.99
5182500-18250098.84699.53
6183222-18322299.23799.96
60min1184702-184702100.038100.451.15100.93101.321.14
2187824-187824101.729102.56
3184716-184716100.046100.89
4188337-188337102.007102.91
5183134-18313499.189100.03
6184038-18403899.679100.57
极限1185283-185283100.353100.621.06101.41101.661.05
2188190-188190101.928102.93
3185132-185132100.271101.28
4188192-188192101.929103.00
5183632-18363299.459100.47
6184261-18426199.800100.85
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