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%
111.171878181876521868301870571844321867580.73
211.081862631864361863500.07
单位质量响应值RSD%判断
16719.6116818.590.42数据可信
加速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%
5min156990-5699030.56229.6825.3430.5629.6825.33
243506-4350623.33123.33
376294-7629440.91540.91
436506-3650619.57719.58
556778-5677830.44930.45
662018-6201833.25933.26
10min1128050-12805068.67070.149.3068.7270.189.31
2121857-12185765.34965.39
3146521-14652178.57678.64
4113172-11317260.69260.72
5136537-13653773.22273.27
6138553-13855374.30374.36
15min1159158-15915885.35385.351.4785.5285.521.49
2155308-15530883.28883.44
3160865-16086586.26886.47
4157594-15759484.51484.65
5160708-16070886.18486.36
6161321-16132186.51386.69
20min1167327-16732789.73490.680.8090.0490.990.80
2167591-16759189.87590.16
3169677-16967790.99491.34
4170259-17025991.30691.58
5169288-16928890.78591.10
6170451-17045191.40991.73
30min1174959-17495993.82694.050.4894.2894.510.49
2173918-17391893.26893.70
3176136-17613694.45894.95
4175839-17583994.29894.73
5175935-17593594.35094.82
6175443-17544394.08694.56
45min1178683-17868395.82495.900.6296.4496.520.62
2177101-17710194.97595.57
3179041-17904196.01696.67
4179031-17903196.01096.59
5178612-17861295.78596.41
6180508-18050896.80297.43
60min1180544-18054496.82297.090.5797.5997.870.57
2179399-17939996.20896.96
3181276-18127697.21498.03
4182021-18202197.61498.36
5180872-18087296.99797.78
6182153-18215397.68498.48
极限1182159-18215997.68897.410.6898.6298.350.67
2181132-18113297.13798.05
3181501-18150197.33598.31
4182791-18279198.02798.93
5179521-17952196.27397.22
6182758-18275898.00998.97
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%
111.171866921866501862201853531858871861600.31
211.081865361862921864140.10
单位质量响应值RSD%判断
16666.0716824.370.67数据可信
加速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%
5min163339-6333934.01630.2122.8234.0230.2122.82
235654-3565419.14819.15
364625-6462534.70734.71
470864-7086438.05738.06
548305-4830525.94225.94
654720-5472029.38729.39
10min1140573-14057375.49570.7910.0975.5570.8410.10
2108051-10805158.02958.06
3142203-14220376.37076.43
4141351-14135175.91275.98
5125426-12542667.36067.40
6133234-13323471.55371.60
15min1159155-15915585.47484.762.2985.6684.932.31
2151356-15135681.28681.41
3160949-16094986.43786.62
4161078-16107886.50786.70
5156867-15686784.24584.40
6157523-15752384.59884.77
20min1165938-16593889.11789.180.8189.4489.490.83
2163862-16386288.00288.27
3167344-16734489.87290.20
4167401-16740189.90390.24
5166464-16646489.39989.70
6165328-16532888.78989.10
30min1172187-17218792.47392.860.6192.9593.320.63
2171210-17121091.94892.36
3173657-17365793.26293.74
4174005-17400593.44993.93
5173429-17342993.14093.58
6173002-17300292.91193.37
45min1176650-17665094.87095.440.4395.5096.060.43
2177369-17736995.25695.82
3177930-17793095.55796.19
4178855-17885596.05496.69
5177440-17744095.29495.89
6178062-17806295.62896.24
60min1178481-17848195.85396.600.4796.6497.380.47
2180089-18008996.71797.44
3180443-18044396.90797.70
4180766-18076697.08097.88
5180211-18021196.78297.54
6179296-17929696.29197.06
极限1181260-18126097.34597.190.3498.2998.120.35
2180696-18069697.04397.93
3180336-18033696.84997.80
4181922-18192297.70198.66
5180430-18043096.90097.82
6181163-18116397.29398.23
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%
111.171859901859421859841857001862711859770.11
211.081858281861821860050.14
单位质量响应值RSD%判断
16649.6916787.450.59数据可信
加速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%
5min145717-4571724.59129.0713.9424.5929.0713.94
252869-5286928.43828.44
365615-6561535.29435.29
452699-5269928.34728.35
559883-5988332.21132.21
647489-4748925.54425.54
10min1120633-12063364.88969.544.8664.9369.594.87
2128409-12840969.07169.12
3137764-13776474.10474.16
4127384-12738468.52068.57
5135312-13531272.78572.84
6126152-12615267.85767.90
15min1153408-15340882.51883.111.3782.6783.281.37
2155250-15525083.50983.67
3158099-15809985.04285.22
4152377-15237781.96482.13
5155037-15503783.39583.57
6152878-15287882.23382.39
20min1162964-16296487.65987.870.8787.9588.180.88
2164418-16441888.44188.74
3165733-16573389.14889.47
4162571-16257187.44787.75
5162139-16213987.21587.53
6162331-16233187.31887.61
30min1171881-17188192.45591.980.8892.8992.430.88
2172185-17218592.61993.07
3172425-17242592.74893.22
4171240-17124092.11092.55
5169087-16908790.95291.41
6169178-16917891.00191.44
45min1176486-17648694.93294.590.9795.5295.190.97
2176639-17663995.01495.62
3178310-17831095.91396.54
4175664-17566494.49095.09
5173469-17346993.30993.92
6174528-17452893.87994.47
60min1178564-17856496.05095.640.9796.8096.400.97
2178855-17885596.20696.97
3180013-18001396.82997.62
4176986-17698695.20195.96
5175158-17515894.21894.98
6177206-17720695.31996.07
极限1180059-18005996.85495.951.0697.7696.861.06
2179548-17954896.57997.50
3180503-18050397.09398.04
4176678-17667895.03595.95
5176176-17617694.76595.69
6177259-17725995.34896.25
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%
111.171861111862171862101858241862501861220.10
211.081855171854101854640.05
单位质量响应值RSD%判断
16662.6716738.630.33数据可信
加速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%
5min127788-2778814.96324.5630.2214.9624.5630.23
250090-5009026.97226.97
365999-6599935.53935.54
432692-3269217.60417.60
546083-4608324.81424.81
651032-5103227.47927.48
10min193374-9337450.27963.3515.6950.3063.3915.70
2126440-12644068.08568.13
3140687-14068775.75675.82
497134-9713452.30452.33
5124102-12410266.82666.87
6124128-12412866.84066.89
15min1146727-14672779.00981.843.6479.1281.993.66
2153836-15383682.83782.99
3159588-15958885.93486.12
4145255-14525578.21678.33
5156004-15600484.00484.16
6150527-15052781.05581.21
20min1160399-16039986.37187.591.5186.6187.881.54
2162348-16234887.42087.72
3165442-16544289.08689.41
4160102-16010286.21186.46
5165818-16581889.28989.58
6161896-16189687.17787.47
30min1170715-17071591.92592.281.1092.3192.711.11
2170287-17028791.69592.14
3173009-17300993.16193.64
4170619-17061991.87492.26
5174300-17430093.85694.30
6169324-16932491.17691.61
45min1176842-17684295.22594.901.3895.7695.481.38
2174785-17478594.11794.71
3178074-17807495.88896.52
4175727-17572794.62495.17
5179425-17942596.61697.21
6172616-17261692.94993.54
60min1178865-17886596.31495.911.9297.0196.641.91
2176724-17672495.16195.91
3179642-17964296.73297.52
4179046-17904696.41197.11
5182232-18223298.12798.89
6172132-17213292.68893.43
极限1180564-18056497.22997.060.9698.0997.960.95
2177832-17783295.75896.67
3181274-18127497.61198.56
4180484-18048497.18698.05
5182578-18257898.31399.24
6178762-17876296.25897.16
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