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%
111.231853321852611852851852041855071853180.07
211.321847471846851847160.03
单位质量响应值RSD%判断
16502.0516317.670.80数据可信
中间条件6月-供试品溶液-2025060821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%
5min1108779-10877959.61455.366.9859.6155.366.98
299385-9938554.46654.47
3108248-10824859.32359.32
4103073-10307356.48756.49
591040-9104049.89349.89
695580-9558052.38152.38
10min1152983-15298383.83982.241.9183.9482.331.91
2151242-15124282.88582.98
3153068-15306883.88683.98
4149483-14948381.92182.02
5146757-14675780.42780.51
6146827-14682780.46680.55
15min1163951-16395189.85088.581.2390.0988.801.23
2162136-16213688.85589.08
3162551-16255189.08389.32
4162027-16202788.79689.03
5160977-16097788.22088.44
6158105-15810586.64686.87
20min1167741-16774191.92791.181.0392.3291.561.03
2168171-16817192.16392.54
3165059-16505990.45790.84
4166918-16691891.47691.85
5166685-16668591.34891.71
6163679-16367989.70190.07
30min1173705-17370595.19594.231.2895.7494.761.28
2172685-17268594.63695.17
3172051-17205194.28994.83
4172808-17280894.70495.23
5172852-17285294.72895.24
6167612-16761291.85692.37
45min1176978-17697896.98996.470.9097.6997.160.90
2177662-17766297.36498.05
3175854-17585496.37397.07
4176385-17638596.66497.35
5176270-17627096.60197.28
6173086-17308694.85695.52
60min1178678-17867897.92197.511.0098.7898.361.00
2179042-17904298.12098.97
3177761-17776197.41898.27
4178769-17876997.97198.82
5178900-17890098.04298.88
6174423-17442395.58996.42
极限1177730-17773097.40197.811.0598.4398.821.05
2180828-18082899.099100.11
3178111-17811197.61098.63
4179066-17906698.13399.15
5179703-17970398.48399.48
6175424-17542496.13897.12
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%
111.231846851845881844841843411842631844720.10
211.321843911842401843160.06
单位质量响应值RSD%判断
16426.7116282.330.63数据可信
中间条件6月-供试品溶液-2025060821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%
5min197625-9762553.68252.7112.9453.6852.7112.94
275870-7587041.71941.72
394621-9462152.03052.03
4113218-11321862.25662.26
5102407-10240756.31156.31
691383-9138350.24950.25
10min1149375-14937582.13881.182.9882.2381.262.99
2144077-14407779.22579.29
3147286-14728680.98981.08
4152834-15283484.04084.14
5151033-15103383.05083.14
6141145-14114577.61277.70
15min1160177-16017788.07888.051.1688.3088.271.17
2159505-15950587.70887.91
3158636-15863687.23087.45
4162465-16246589.33689.58
5162089-16208989.12989.36
6157873-15787386.81187.02
20min1164866-16486690.65691.130.7391.0391.500.74
2166365-16636591.48091.83
3164222-16422290.30290.67
4166904-16690491.77792.17
5167095-16709591.88292.26
6164958-16495890.70791.06
30min1170521-17052193.76694.010.7094.2994.530.70
2172252-17225294.71795.22
3169327-16932793.10993.63
4171855-17185594.49995.04
5171812-17181294.47595.01
6169984-16998493.47093.98
45min1173467-17346795.38696.190.7096.0796.870.69
2176537-17653797.07497.73
3173768-17376895.55196.22
4174596-17459696.00696.71
5176029-17602996.79497.49
6175163-17516396.31896.98
60min1176336-17633696.96397.350.6997.8098.190.68
2179061-17906198.46299.28
3175622-17562296.57097.40
4176349-17634996.97097.83
5177494-17749497.60098.45
6177427-17742797.56398.39
极限1177850-17785097.79697.870.7698.8098.870.74
2179536-17953698.72399.71
3176238-17623896.90997.90
4176559-17655997.08698.11
5178820-17882098.32999.34
6178862-17886298.35299.34
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%
111.231836811837061837191838201837941837440.04
211.321839541838471839000.05
单位质量响应值RSD%判断
16361.8916245.580.51数据可信
中间条件6月-供试品溶液-2025060921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%
5min155654-5565430.69840.6412.3630.7040.6412.35
274591-7459141.14341.14
375767-7576741.79241.79
478872-7887243.50543.50
576483-7648342.18742.19
680687-8068744.50644.51
10min1136955-13695575.54277.482.6775.5977.552.67
2141668-14166878.14278.21
3142811-14281178.77378.84
4138596-13859676.44876.52
5136645-13664575.37175.44
6146164-14616480.62280.70
15min1157316-15731686.77386.860.9086.9587.060.90
2156812-15681286.49586.69
3158018-15801887.16187.36
4157264-15726486.74586.94
5155619-15561985.83786.03
6159857-15985788.17588.38
20min1164462-16446290.71590.490.7991.0490.830.79
2163179-16317990.00790.35
3164287-16428790.61890.96
4164734-16473490.86591.21
5162015-16201589.36589.70
6165679-16567991.38691.74
30min1169941-16994193.73793.940.7594.2194.440.75
2169500-16950093.49493.99
3170266-17026693.91694.41
4171132-17113294.39494.89
5168727-16872793.06793.56
6172306-17230695.04295.55
45min1177240-17724097.76396.750.9498.3997.400.94
2173775-17377595.85296.50
3174598-17459896.30696.96
4176691-17669197.46098.11
5173462-17346295.67996.32
6176621-17662197.42298.09
60min1179758-17975899.15297.821.1299.9498.631.11
2175793-17579396.96597.77
3175355-17535596.72397.54
4178593-17859398.50999.33
5175558-17555896.83597.64
6178980-17898098.72399.55
极限1181544-181544100.13798.341.46101.0999.311.45
2174504-17450496.25497.22
3177229-17722997.75798.73
4179348-17934898.92699.91
5176726-17672697.48098.44
6180320-18032099.462100.46
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%
111.231848501850501849471850361849561849680.05
211.321843421842651843040.03
单位质量响应值RSD%判断
16470.8816281.270.82数据可信
中间条件6月-供试品溶液-2025060921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%
5min163126-6312634.66637.7918.4934.6737.7918.49
282307-8230745.20045.20
351724-5172428.40528.40
458433-5843332.08932.09
579542-7954243.68143.68
677740-7774042.69242.69
10min1139843-13984376.79676.414.5276.8576.474.53
2145275-14527579.77979.85
3128560-12856070.60070.65
4135172-13517274.23174.28
5143826-14382678.98479.06
6142173-14217378.07678.15
15min1157031-15703186.23586.310.9086.4286.500.91
2158444-15844487.01187.22
3155630-15563085.46685.63
4155795-15579585.55785.73
5157001-15700186.21986.42
6159142-15914287.39587.60
20min1164454-16445490.31290.250.7290.6490.580.71
2164853-16485390.53190.88
3165317-16531790.78691.09
4163254-16325489.65389.97
5162638-16263889.31489.66
6165576-16557690.92891.27
30min1171239-17123994.03893.800.9694.5294.280.95
2170419-17041993.58794.09
3172800-17280094.89595.35
4170121-17012193.42493.89
5168156-16815692.34592.84
6172049-17204994.48394.98
45min1175625-17562596.44696.530.9897.0897.170.96
2175534-17553496.39697.06
3178484-17848498.01698.63
4174978-17497896.09196.72
5173367-17336795.20695.86
6176637-17663797.00297.66
60min1177521-17752197.48897.580.9998.2998.380.97
2176856-17685697.12297.94
3180734-18073499.252100.03
4177463-17746397.45698.24
5175406-17540696.32697.14
6178114-17811497.81398.63
极限1178482-17848298.01598.330.9498.9899.290.93
2178257-17825797.89298.87
3181573-18157399.713100.66
4179056-17905698.33199.28
5176725-17672597.05098.02
6180196-18019698.95799.94
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