恩格列净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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
110.482959812959202962652963742966562962390.11
210.522964302961912963100.06
单位质量响应值RSD%判断
28267.0828166.350.26数据可信
供试品溶液-25102202批-恩格列净-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%
5min1291012-29101291.24390.181.6091.2490.181.60
2281367-28136788.21988.22
3285743-28574389.59189.59
4288626-28862690.49590.50
5284835-28483589.30789.31
6294121-29412192.21892.22
10min1320906-320906100.61699.042.10100.7799.192.10
2308547-30854796.74196.89
3308375-30837596.68796.84
4314204-31420498.51598.67
5324389-324389101.708101.86
6318792-31879299.954100.11
15min1322508-322508101.11999.522.01101.4499.842.01
2309820-30982097.14197.45
3310537-31053797.36597.68
4315897-31589799.04699.36
5325087-325087101.927102.25
6320698-320698100.551100.87
20min1322517-322517101.12299.542.00101.61100.021.99
2310587-31058797.38197.85
3309955-30995597.18397.66
4316221-31622199.14799.63
5325273-325273101.986102.47
6320291-320291100.424100.91
30min1322918-322918101.24799.562.14101.90100.212.13
2309545-30954597.05497.69
3310286-31028697.28797.92
4316122-31612299.11699.76
5326125-326125102.253102.91
6320292-320292100.424101.08
45min1321843-321843100.91099.302.13101.74100.122.13
2309001-30900196.88497.68
3309314-30931496.98297.78
4314981-31498198.75999.57
5325154-325154101.948102.78
6320047-320047100.347101.17
60min1321678-321678100.85899.342.17101.85100.322.17
2308824-30882496.82897.78
3309537-30953797.05298.01
4314660-31466098.65899.63
5325471-325471102.048103.05
6320833-320833100.594101.58
极限1320226-320226100.40399.302.32101.57100.442.32
2308544-30854496.74097.86
3308639-30863996.77097.89
4314763-31476398.69099.83
5326726-326726102.441103.61
6321350-321350100.756101.91
恩格列净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250201对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
111.443984743988793986043985683988533986760.05
211.593986703985073985880.03
单位质量响应值RSD%判断
34849.3034390.680.94数据可信
供试品溶液-25102202批-非奈利酮-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%
5min1162772-16277242.31733.1920.6342.3233.1920.64
2156741-15674140.74940.75
3121833-12183331.67431.67
4119477-11947731.06131.06
5106328-10632827.64327.64
698804-9880425.68725.69
10min1279497-27949772.66365.6511.5372.7365.7011.53
2287550-28755074.75674.82
3247726-24772664.40364.46
4257604-25760466.97167.02
5233215-23321560.63060.68
6209441-20944154.45054.49
15min1317948-31794882.65977.957.3382.8578.127.34
2329597-32959785.68885.88
3300052-30005278.00778.17
4300132-30013278.02778.19
5279279-27927972.60672.75
6272045-27204570.72570.86
20min1338128-33812887.90583.966.2388.2384.256.25
2350222-35022291.05091.38
3325885-32588584.72385.01
4322597-32259783.86884.16
5303506-30350678.90579.17
6297268-29726877.28377.53
30min1356003-35600392.55389.385.5393.0389.815.55
2368289-36828995.74796.23
3351407-35140791.35891.79
4343994-34399489.43089.86
5322932-32293283.95584.35
6320110-32011083.22183.60
45min1365668-36566895.06592.555.0695.7093.145.08
2378158-37815898.31298.96
3366223-36622395.20995.79
4356919-35691992.79193.37
5336593-33659387.50688.05
6332425-33242586.42386.94
60min1369234-36923495.99294.034.7296.7894.774.75
2382170-38217099.355100.17
3372746-37274696.90597.65
4363140-36314094.40895.14
5345445-34544589.80890.49
6337359-33735987.70688.37
极限1370432-37043296.30494.943.3897.2595.833.42
2379742-37974298.72499.70
3373669-37366997.14598.05
4365671-36567195.06695.96
5355024-35502492.29893.13
6346568-34656890.10090.91
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