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250201对照品来源原料对照品使用方法直接使用
对照品含量(%)99.40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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.027296327300997304627305327303227302090.05
222.067379567385307382430.06
单位质量响应值RSD%判断
33161.1733465.230.65数据可信
供试品溶液-25091801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%
5min1248194-24819433.32631.0210.2033.3331.0210.19
2240716-24071632.32232.32
3204198-20419827.41827.42
10min1174032-17403223.36827.6617.4823.4227.7117.45
2245009-24500932.89832.95
3199031-19903126.72526.77
15min1630002-63000284.59365.4128.9684.6965.5128.92
2483331-48333164.89965.01
3348017-34801746.73046.82
20min1312666-31266641.98351.2015.7742.2251.4115.67
2424558-42455857.00757.22
3406769-40676954.61854.79
30min1661690-66169088.84873.8019.3489.1574.0919.29
2536962-53696272.10072.41
3450281-45028160.46160.72
45min1429312-42931257.64561.064.9558.1061.484.87
2471855-47185563.35863.79
3463156-46315662.19062.55
60min1669950-66995089.95778.2413.3490.5178.7513.30
2556827-55682774.76775.30
3521182-52118269.98170.44
极限1474746-47474663.74665.402.2864.4566.052.21
2496304-49630466.64167.30
3490093-49009365.80766.39
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c031-5250311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100
标示量(mg)100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%
110.761634687163571016366461637330163861016365970.10
210.811651308165411716527120.13
单位质量响应值RSD%判断
152100.09152887.330.37数据可信
供试品溶液-25091801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%
5min194330-943305.5625.128.825.565.128.80
287228-872285.1435.14
379034-790344.6604.66
10min170443-704434.1534.3610.744.164.3610.76
282978-829784.8924.90
368287-682874.0264.03
15min1319131-31913118.81615.4222.1818.8315.4322.17
2262341-26234115.46815.48
3203155-20315511.97811.99
20min1185794-18579410.95412.5111.6211.0012.5511.55
2234556-23455613.82913.87
3216394-21639412.75912.79
30min1425898-42589825.11121.3918.1025.1821.4518.08
2367504-36750421.66821.73
3294855-29485517.38517.44
45min1293245-29324517.29018.294.7917.4018.394.72
2320582-32058218.90219.00
3317001-31700118.69018.78
60min1488530-48853028.80425.3613.3128.9425.4913.29
2427614-42761425.21225.35
3374132-37413222.05922.17
极限1365303-36530321.53822.062.0721.7222.232.01
2378824-37882422.33622.51
3378550-37855022.31922.47
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250201对照品来源原料对照品使用方法直接使用
对照品含量(%)99.40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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.027400517405887397597408737403797403300.06
222.067419937413027416480.07
单位质量响应值RSD%判断
33620.8033619.580.01数据可信
供试品溶液-25091802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%
5min1110750-11075014.73513.4125.6214.7313.4125.60
2120076-12007615.97615.98
371450-714509.5069.51
10min1117670-11767015.65512.3028.4115.6812.3328.38
294513-9451312.57412.60
365259-652598.6828.70
15min1180693-18069324.04024.2116.8324.0924.2616.84
2213244-21324428.37128.42
3152030-15203020.22720.26
20min1214976-21497628.60122.5325.1828.6922.6125.12
2162431-16243121.61121.71
3130570-13057017.37217.44
30min1231415-23141530.78932.6311.7930.9332.7511.77
2278506-27850637.05437.18
3225896-22589630.05430.15
45min1270214-27021435.95128.9422.8236.1429.1222.74
2210686-21068628.03128.22
3171688-17168822.84222.99
60min1282491-28249137.58439.648.0937.8339.868.08
2325654-32565443.32743.57
3285613-28561337.99938.18
极限1312281-31228141.54734.2620.1541.8634.5520.07
2251034-25103433.39933.71
3209126-20912627.82328.07
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c031-5250311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100
标示量(mg)100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%
110.761657154165904016593511658535166156716591290.10
210.811656814166248716596500.25
单位质量响应值RSD%判断
154194.14153529.140.31数据可信
供试品溶液-25091802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%
5min1109549-1095496.4024.4143.076.404.4142.99
271755-717554.1934.19
344927-449272.6252.63
10min158584-585843.4234.3318.303.434.3318.22
280010-800104.6754.68
383661-836614.8894.89
15min1292841-29284117.11217.552.2917.1317.562.28
2306396-30639617.90517.92
3301540-30154017.62117.63
20min1192910-19291011.27314.0323.2411.3214.0723.15
2225670-22567013.18713.23
3301645-30164517.62717.67
30min1418452-41845224.45324.761.6024.5224.831.61
2421333-42133324.62124.69
3431328-43132825.20525.28
45min1280860-28086016.41220.0321.1016.5220.1421.02
2325058-32505818.99519.10
3422202-42220224.67224.79
60min1405381-40538123.68923.234.7523.8223.374.66
2411092-41109224.02324.16
3375988-37598821.97122.13
极限1339570-33957019.84322.189.1320.0122.369.11
2397938-39793823.25423.43
3401047-40104723.43623.63
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250201对照品来源原料对照品使用方法直接使用
对照品含量(%)99.40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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.027403257415017411657413877406457410050.07
222.067497297517197507240.19
单位质量响应值RSD%判断
33651.4534031.010.80数据可信
供试品溶液-25091803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%
5min1171680-17168022.69325.7617.6422.6925.7617.66
2178537-17853723.59923.60
3234344-23434430.97630.98
10min1320805-32080542.40427.6746.2442.4427.7146.15
2147053-14705319.43719.48
3160086-16008621.16021.21
15min1566417-56641774.86968.388.5874.9868.478.59
2480256-48025663.48063.55
3505216-50521666.78066.87
20min1525657-52565769.48153.4526.2269.7153.6526.17
2358094-35809447.33347.51
3329340-32934043.53243.73
30min1631392-63139283.45880.935.1683.8181.225.18
2575831-57583176.11376.37
3629568-62956883.21683.49
45min1599646-59964679.26168.6413.5379.7569.0613.51
2488093-48809364.51664.90
3470027-47002762.12862.54
60min1642510-64251084.92784.103.9885.5584.643.98
2608394-60839480.41880.91
3657819-65781986.95187.46
极限1619431-61943181.87774.429.5282.6475.119.51
2556869-55686973.60774.23
3512846-51284667.78868.45
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c031-5250311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100
标示量(mg)100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%
110.761656867165849416564391658993165857916578740.07
210.811681213168291916820660.08
单位质量响应值RSD%判断
154077.51155602.780.70数据可信
供试品溶液-25091803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%
5min1109539-1095396.3616.8210.086.366.8210.12
2111661-1116616.4846.48
3131011-1310117.6087.61
10min1136799-1367997.9446.2423.697.956.2523.63
293344-933445.4205.43
392151-921515.3515.36
15min1248215-24821514.41314.093.6214.4414.113.65
2232538-23253813.50313.52
3247184-24718414.35314.38
20min1268152-26815215.57112.0525.5615.6212.1025.47
2184557-18455710.71710.76
3169828-1698289.8629.91
30min1372148-37214821.61021.143.2121.6821.203.22
2350629-35062920.36020.42
3369191-36919121.43821.50
45min1371882-37188221.59417.9517.9521.7018.0517.88
2288928-28892816.77716.87
3266592-26659215.48015.58
60min1416873-41687324.20723.941.9024.3524.071.92
2403296-40329623.41823.54
3416801-41680124.20324.33
极限1398175-39817523.12121.447.9423.3121.617.94
2369829-36982921.47521.64
3339587-33958719.71919.88
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250201对照品来源原料对照品使用方法直接使用
对照品含量(%)99.40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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.027371157369467378617373357367227371960.06
222.067548917535777542340.13
单位质量响应值RSD%判断
33478.4734190.121.49数据可信
供试品溶液批-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%
5min195128-9512812.57812.2716.4712.5812.2716.46
2106747-10674714.11414.11
376467-7646710.11010.11
10min1177100-17710023.41625.6922.7623.4425.7122.74
2244513-24451332.32932.35
3161271-16127121.32321.34
15min1229722-22972230.37333.9023.7130.4333.9623.70
2325951-32595143.09743.17
3213512-21351228.23028.28
20min1266172-26617235.19339.3822.9835.3039.5022.98
2376380-37638049.76449.91
3250962-25096233.18233.28
30min1326667-32666743.19147.2219.3443.3647.4119.35
2436202-43620257.67457.91
3308625-30862540.80640.96
45min1394465-39446552.15555.8815.8152.4056.1415.83
2498841-49884165.95666.28
3374503-37450349.51649.74
60min1449921-44992159.48863.5215.2759.8263.8715.29
2564044-56404474.57775.01
3427203-42720356.48456.79
极限1635594-63559484.03786.263.4184.4686.723.49
2677582-67758289.58890.15
3644123-64412385.16485.56
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c031-5250311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100
标示量(mg)100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%
110.761651024165021616519281649134165022816505060.07
210.811687423169129316893580.17
单位质量响应值RSD%判断
153392.75156277.341.32数据可信
供试品溶液批-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%
5min1174892-17489210.1579.4442.4810.169.4542.43
288255-882555.1255.13
3224762-22476213.05313.05
10min1332243-33224319.29418.4517.2219.3118.4617.24
2257141-25714114.93314.94
3363533-36353321.11221.13
15min1413432-41343224.00923.584.1324.0623.634.17
2386837-38683722.46522.50
3417795-41779524.26324.32
20min1398203-39820323.12524.116.4223.2124.206.35
2445927-44592725.89625.97
3401608-40160823.32323.42
30min1404128-40412823.46923.112.6923.6023.232.74
2385561-38556122.39122.50
3403954-40395423.45923.60
45min1391165-39116522.71622.222.6522.8822.382.68
2371456-37145621.57221.72
3385197-38519722.37022.55
60min1375699-37569921.81821.870.2222.0222.070.19
2377282-37728221.91022.10
3376558-37655821.86822.08
极限1371923-37192321.59922.614.8321.8422.854.81
2386882-38688222.46822.69
3409241-40924123.76624.02
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