非奈利酮卡格列净片项目信息
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D250501对照品来源原料对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
120.146861706867326868396873416869336868030.07
220.236912446887446899940.26
单位质量响应值RSD%判断
34101.4434107.460.02数据可信
供试品溶液-5122201批-非奈利酮-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%
5min121917-2191714.44515.9219.8914.4515.9219.88
220678-2067813.62813.63
330790-3079020.29320.29
421089-2108913.89913.90
520632-2063213.59813.60
629856-2985619.67719.68
10min135898-3589823.66025.5710.6523.6825.6010.66
236210-3621023.86523.89
344494-4449429.32529.36
435797-3579723.59323.62
536662-3666224.16324.19
643719-4371928.81428.85
15min149624-4962432.70633.768.0432.7733.838.06
249441-4944132.58532.65
356492-5649237.23337.32
446022-4602230.33230.39
549836-4983632.84632.91
655938-5593836.86836.95
20min158513-5851338.56540.186.7538.6840.306.77
259624-5962439.29739.41
367771-6777144.66644.81
456961-5696137.54237.65
558826-5882638.77138.89
664103-6410342.24942.39
30min175951-7595150.05850.913.4050.2451.103.42
278177-7817751.52551.71
381081-8108153.43953.66
474063-7406348.81348.99
575241-7524149.59049.77
678947-7894752.03252.24
45min194909-9490962.55263.852.7562.8264.132.77
298353-9835364.82265.09
3100501-10050166.23866.55
493625-9362561.70661.96
595278-9527862.79663.06
698636-9863665.00965.31
60min1106787-10678770.38172.062.8870.7572.452.89
2110735-11073572.98373.36
3111975-11197573.80074.22
4105377-10537769.45269.81
5107849-10784971.08171.45
6113329-11332974.69375.10
90min1124806-12480682.25784.121.9182.7484.621.92
2130410-13041085.95086.45
3130634-13063486.09886.64
4126474-12647483.35683.83
5127714-12771484.17484.66
6125722-12572282.86183.39
120min1133614-13361488.06290.621.6088.6991.261.61
2138165-13816591.06291.70
3140068-14006892.31693.00
4136937-13693790.25290.87
5138811-13881191.48792.12
6137366-13736690.53591.21
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1142214-14221493.73094.380.6594.5095.180.67
2143799-14379994.77595.57
3144428-14442895.18996.03
4142117-14211793.66694.43
5142994-14299494.24495.03
6143635-14363594.66795.49
非奈利酮卡格列净片项目信息
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101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.121740705174188017432161743712174414117427310.09
211.131781563177567817786200.24
单位质量响应值RSD%判断
156720.41159804.131.38数据可信
供试品溶液-5122201批-卡格列净-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%
5min119081-190815.3125.1417.365.315.1417.38
216589-165894.6184.62
322034-220346.1346.13
416638-166384.6324.63
514273-142733.9743.97
622182-221826.1756.18
10min165188-6518818.14817.972.1018.1617.982.09
266147-6614718.41518.42
365645-6564518.27518.29
463005-6300517.54017.55
562963-6296317.52817.54
664327-6432717.90817.92
15min190734-9073425.26025.446.2425.3025.486.22
288994-8899424.77524.81
390958-9095825.32225.36
484406-8440623.49823.54
5101739-10173928.32328.36
691525-9152525.48025.52
20min199307-9930727.64629.5115.1627.7329.5915.11
2100615-10061528.01128.09
3138587-13858738.58238.66
497174-9717427.05327.13
598284-9828427.36227.44
6101960-10196028.38528.47
30min1113705-11370531.65531.601.2031.7831.731.20
2115648-11564832.19632.32
3114094-11409431.76331.91
4113116-11311631.49131.61
5111579-11157931.06331.19
6112905-11290531.43231.56
45min1122789-12278934.18434.641.1134.3634.821.12
2125391-12539134.90835.09
3125308-12530834.88535.09
4125776-12577635.01535.19
5122624-12262434.13834.32
6124699-12469934.71534.90
60min1124401-12440134.63236.064.4334.8736.304.39
2128244-12824435.70235.94
3127761-12776135.56835.83
4130506-13050636.33236.56
5125874-12587435.04235.28
6140430-14043039.09539.33
90min1130493-13049336.32836.892.1336.6237.192.12
2134745-13474537.51237.81
3135425-13542537.70138.02
4134923-13492337.56237.85
5130647-13064736.37136.67
6128914-12891435.88936.19
120min1131599-13159936.63637.301.5036.9937.661.49
2132812-13281236.97437.33
3136548-13654838.01438.39
4136267-13626737.93638.29
5133519-13351937.17137.53
6133052-13305237.04137.41
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1139655-13965538.87938.700.2939.3039.130.30
2138896-13889638.66839.09
3139364-13936438.79839.24
4138763-13876338.63139.05
5138648-13864838.59939.02
6138814-13881438.64539.07
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