非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)5补液体积(ml)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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.043073833081913080863080523077933079010.11
211.203087053091673089360.11
单位质量响应值RSD%判断
27889.5827583.570.79数据可信
供试品溶液-G79580BJ84960批-10mg/10mg规格-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%
5min1245016-245016390.770387.152.17390.77387.152.17
2243400-243400388.192388.19
3248067-248067395.636395.64
4247055-247055394.022394.02
5234619-234619374.188374.19
6238319-238319380.089380.09
10min1281175-281175448.439460.361.78450.61462.511.77
2283507-283507452.158454.31
3293396-293396467.930470.13
4293148-293148467.534469.72
5289909-289909462.368464.45
6290772-290772463.745465.86
15min1286507-286507456.943467.701.50461.60472.411.50
2289113-289113461.099465.77
3297273-297273474.113478.91
4296355-296355472.649477.44
5295919-295919471.954476.60
6294336-294336469.429474.12
20min1288100-288100459.483469.141.59466.68476.441.58
2289157-289157461.169468.40
3299094-299094477.017484.45
4297452-297452474.398481.81
5297510-297510474.491481.76
6293598-293598468.252475.55
30min1288997-288997460.914469.461.74470.67479.371.73
2286802-286802457.413467.21
3298748-298748476.465486.55
4297689-297689474.776484.82
5296457-296457472.812482.72
6297438-297438474.376484.27
45min1288938-288938460.820469.321.69473.13481.841.68
2287161-287161457.986470.32
3298736-298736476.446489.17
4295773-295773471.721484.41
5298369-298369475.861488.39
6296628-296628473.084485.62
60min1291030-291030464.156469.211.20479.03484.341.21
2289580-289580461.844476.72
3299181-299181477.156492.53
4296193-296193472.391487.70
5295416-295416471.151486.33
6293796-293796468.568483.73
极限1294678-294678469.974480.651.73487.43498.381.71
2297287-297287474.135491.58
3305172-305172486.711504.74
4299511-299511477.682495.61
5308722-308722492.373510.17
6302844-302844482.998500.76
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)5补液体积(ml)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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.404152304162034161954163684158454159680.11
211.434166814173994170400.13
单位质量响应值RSD%判断
36488.4236486.440.01数据可信
供试品溶液-G79580BJ84960批-10mg/10mg规格-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%
5min1105684-105684130.340136.769.50130.34136.769.50
2101581-101581125.280125.28
3126954-126954156.573156.57
4118723-118723146.421146.42
599970-99970123.293123.29
6112419-112419138.647138.65
10min1322056-322056397.192398.603.10397.92399.363.10
2306367-306367377.843378.54
3337479-337479416.213417.08
4325945-325945401.988402.80
5322611-322611397.877398.56
6324722-324722400.480401.25
15min1360527-360527444.638450.580.96447.57453.560.97
2363475-363475448.274451.07
3370419-370419456.838460.02
4366451-366451451.945454.99
5367395-367395453.109456.00
6363804-363804448.680451.68
20min1366387-366387451.866459.041.13457.27464.521.14
2371132-371132457.718463.00
3377919-377919466.088471.81
4374292-374292461.615467.17
5374589-374589461.981467.39
6368929-368929455.001460.49
30min1369342-369342455.510460.480.88463.42468.510.90
2370029-370029456.357464.19
3378043-378043466.241474.55
4375481-375481463.081471.20
5373469-373469460.600468.58
6373864-373864461.087469.10
45min1373219-373219460.292460.830.73470.73471.420.75
2369998-369998456.319466.68
3378013-378013466.204477.10
4373101-373101460.146470.84
5375222-375222462.762473.30
6372403-372403459.285469.86
60min1375976-375976463.692459.200.95476.69472.340.94
2372117-372117458.932471.83
3376548-376548464.397477.89
4372389-372389459.268472.52
5369408-369408455.591468.70
6367562-367562453.315466.44
极限1381774-381774470.842477.201.36486.42492.901.33
2384560-384560474.278489.73
3390177-390177481.206497.28
4383532-383532473.011488.81
5395950-395950488.326503.97
6385601-385601475.562491.21
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)5补液体积(ml)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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.043095063090413087103086943085203088940.13
211.203075883094093084980.42
单位质量响应值RSD%判断
27979.5327544.461.11数据可信
供试品溶液-G79580BJ84960批-10mg/10mg规格-恩格列净-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%
5min139675-3967563.22166.032.8563.2266.032.85
240776-4077664.97564.98
341998-4199866.92266.92
441683-4168366.42066.42
541308-4130865.82365.82
643176-4317668.79968.80
10min152490-5249083.64185.131.0383.9985.501.04
253455-5345585.17985.54
354175-5417586.32686.70
453673-5367385.52685.89
553419-5341985.12185.49
653352-5335285.01485.40
15min154201-5420186.36788.052.2187.1888.892.20
254795-5479587.31488.15
356764-5676490.45191.30
456778-5677890.47491.32
554062-5406286.14686.98
654938-5493887.54288.40
20min155342-5534288.18587.861.9089.4889.181.88
254938-5493887.54288.86
357132-5713291.03892.39
454365-5436586.62987.98
554401-5440186.68688.00
654638-5463887.06488.40
30min154316-5431686.55188.161.8888.3489.981.86
255102-5510287.80389.61
357319-5731991.33693.20
454856-5485687.41189.24
555352-5535288.20190.00
655008-5500887.65389.48
45min153642-5364285.47787.892.3387.7490.202.30
253490-5349085.23487.53
356377-5637789.83592.20
455509-5550988.45290.77
555617-5561788.62490.91
656315-5631589.73692.05
60min153580-5358085.37887.271.7688.1290.061.75
253839-5383985.79088.56
356115-5611589.41792.28
454576-5457686.96589.77
555059-5505987.73490.52
655424-5542488.31691.13
极限154279-5427986.49288.011.3089.7191.291.29
255745-5574588.82892.07
356211-5621189.57092.93
454609-5460987.01790.31
555420-5542088.31091.58
655111-5511187.81791.12
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)5补液体积(ml)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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.404178634172454169334169054165364170960.12
211.434152814179034165920.45
单位质量响应值RSD%判断
36587.3736447.240.28数据可信
供试品溶液-G79580BJ84960批-10mg/10mg规格-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%
5min110730-1073013.2239.0927.5913.229.0927.60
27887-78879.7199.72
35983-59837.3737.37
45132-51326.3246.32
56217-62177.6617.66
68304-830410.23310.23
10min128175-2817534.72026.8420.1934.7926.8820.18
220714-2071425.52625.58
325604-2560431.55231.59
416240-1624020.01320.05
518811-1881123.18123.22
621118-2111826.02426.08
15min135867-3586744.19936.9016.9844.4737.1016.98
228254-2825434.81735.01
336694-3669445.21845.43
424823-2482330.58930.74
525982-2598232.01832.19
628030-2803034.54134.74
20min142225-4222552.03443.9216.7952.5544.3316.80
233359-3335941.10841.50
343985-4398554.20354.67
429379-2937936.20436.52
531648-3164839.00039.35
633259-3325940.98541.38
30min150450-5045062.16955.7613.1362.9756.4113.16
243186-4318653.21853.84
354382-5438267.01567.78
439082-3908248.16148.68
540624-4062450.06150.63
643785-4378553.95654.58
45min158587-5858772.19767.329.2973.3468.289.37
250763-5076362.55563.47
362279-6227976.74677.89
449995-4999561.60962.39
550499-5049962.23063.07
655679-5567968.61369.53
60min164442-6444279.41275.077.7380.9676.417.82
257680-5768071.07972.34
367434-6743483.09984.67
455825-5582568.79369.92
557080-5708070.34071.53
663066-6306677.71679.02
极限168322-6832284.19383.156.5486.1884.906.60
270585-7058586.98288.64
373040-7304090.00792.04
461535-6153575.82977.34
563019-6301977.65879.24
668362-6836284.24285.98
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