卡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)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%
111.003762973775143766633775803759263767960.20
211.033779383749053764220.57
单位质量响应值RSD%判断
34254.1834127.110.27数据可信
供试品溶液-6012201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%
5min1185035-18503548.65852.199.5848.6652.209.58
2229154-22915460.26060.26
3202442-20244253.23653.24
4193215-19321550.80950.81
5206520-20652054.30854.31
6174494-17449445.88645.89
10min1300353-30035378.98380.032.6479.0680.122.64
2313568-31356882.45882.56
3309417-30941781.36781.46
4309808-30980881.46981.55
5300941-30094179.13879.23
6291975-29197576.78076.86
15min1340475-34047589.53489.291.6889.7589.501.69
2346155-34615591.02891.27
3343001-34300190.19890.42
4342336-34233690.02390.24
5333460-33346087.68987.91
6331749-33174987.23987.44
20min1357715-35771594.06794.121.4794.4394.491.47
2362413-36241395.30395.69
3360336-36033694.75795.13
4363194-36319495.50895.88
5349540-34954091.91892.29
6354309-35430993.17293.52
30min1375650-37565098.78498.441.2499.3098.961.24
2376863-37686399.10399.65
3377546-37754699.28299.81
4378824-37882499.618100.15
5367773-36777396.71297.23
6369392-36939297.13897.64
45min1386313-386313101.588100.901.21102.27101.591.21
2383827-383827100.934101.65
3386877-386877101.736102.43
4388657-388657102.204102.90
5376497-37649799.00799.69
6380093-38009399.952100.62
60min1388147-388147102.070101.571.03102.92102.431.03
2386868-386868101.734102.62
3387156-387156101.809102.68
4391633-391633102.987103.85
5380256-38025699.995100.84
6383371-383371100.814101.65
极限1388351-388351102.124101.611.15103.15102.641.15
2389476-389476102.420103.47
3389236-389236102.356103.39
4389756-389756102.493103.53
5380109-38010999.956100.97
6381393-381393100.294101.30
卡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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.541665768167169216660671673794166488116684400.25
210.561672985166084816669160.52
单位质量响应值RSD%判断
158296.02157851.890.20数据可信
供试品溶液-6012201批-卡格列净-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%
5min1135849-1358497.5728.4815.337.578.4815.33
2188901-18890110.52910.53
3149831-1498318.3528.35
4132296-1322967.3747.37
5171772-1717729.5759.57
6134317-1343177.4877.49
10min1443454-44345424.71824.712.3124.7324.732.31
2447053-44705324.91924.94
3442993-44299324.69224.71
4437401-43740124.38124.39
5459852-45985225.63225.65
6429206-42920623.92423.94
15min1520624-52062429.01930.112.6129.0730.162.61
2532697-53269729.69229.75
3552746-55274630.81030.87
4530789-53078929.58629.64
5548053-54805330.54830.61
6555835-55583530.98231.03
20min1520327-52032729.00329.983.0529.1130.093.05
2535531-53553129.85029.96
3548018-54801830.54630.65
4543830-54383030.31330.42
5560957-56095731.26831.38
6518914-51891428.92429.03
30min1502122-50212227.98829.155.2128.1429.315.20
2484667-48466727.01527.17
3543562-54356230.29830.46
4537528-53752829.96230.11
5556036-55603630.99331.16
6514301-51430128.66728.82
45min1480025-48002526.75727.384.4926.9527.584.47
2485578-48557827.06627.27
3527264-52726429.39029.60
4505243-50524328.16228.36
5485086-48508627.03927.25
6464044-46404425.86626.07
60min1473983-47398326.42028.727.6026.6628.977.55
2456765-45676525.46025.71
3538268-53826830.00330.26
4544687-54468730.36130.61
5542223-54222330.22330.48
6535675-53567529.85830.10
极限1476690-47669026.57126.755.0726.8627.045.01
2472006-47200626.31026.60
3518923-51892328.92529.23
4492105-49210527.43027.73
5445829-44582924.85025.16
6473379-47337926.38626.68
卡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)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%
111.003794743823823794103815613802383806130.35
211.033761543790173775860.54
单位质量响应值RSD%判断
34601.1834232.640.76数据可信
供试品溶液-6012601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%
5min1214104-21410455.93454.157.2355.9354.157.23
2216444-21644456.54556.54
3223899-22389958.49358.49
4211912-21191255.36155.36
5188326-18832649.19949.20
6188977-18897749.36949.37
10min1312163-31216381.55180.780.9381.6480.860.94
2310793-31079381.19381.29
3312247-31224781.57381.67
4307397-30739780.30680.40
5306729-30672980.13280.21
6305829-30582979.89679.98
15min1342086-34208689.36889.680.8289.6089.910.82
2346390-34639090.49390.72
3342558-34255889.49289.73
4342797-34279789.55489.78
5346647-34664790.56090.78
6339236-33923688.62488.84
20min1360421-36042194.15894.360.5494.5494.730.53
2361602-36160294.46794.85
3357764-35776493.46493.85
4362604-36260494.72995.10
5361484-36148494.43694.80
6363264-36326494.90195.26
30min1374623-37462397.86998.500.7798.4099.030.76
2375817-37581798.18098.72
3373542-37354297.58698.12
4378346-37834698.84199.37
5378627-37862798.91599.44
6381216-38121699.591100.11
45min1384540-384540100.459100.820.82101.16101.520.81
2384114-384114100.348101.05
3381734-38173499.726100.43
4386997-386997101.101101.80
5387545-387545101.244101.93
6390701-390701102.069102.76
60min1385625-385625100.743101.480.98101.61102.350.97
2388985-388985101.621102.49
3382466-38246699.917100.78
4389572-389572101.774102.64
5392215-392215102.464103.32
6391922-391922102.388103.25
极限1385546-385546100.722101.611.03101.76102.651.02
2388648-388648101.532102.57
3383165-383165100.100101.13
4390511-390511102.019103.06
5392677-392677102.585103.61
6393195-393195102.720103.75
卡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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.541683547169252216829401688552168370916862540.25
210.561666359167596916711640.41
单位质量响应值RSD%判断
159986.15158254.170.77数据可信
供试品溶液-6012601批-卡格列净-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%
5min1148186-1481868.2067.8214.328.217.8214.30
2136918-1369187.5827.58
3173530-1735309.6099.61
4147144-1471448.1488.15
5125059-1250596.9256.93
6116040-1160406.4266.43
10min1492451-49245127.26924.566.3527.2824.586.35
2447801-44780124.79724.81
3450080-45008024.92324.94
4410086-41008622.70822.72
5425128-42512823.54123.55
6436153-43615324.15224.16
15min1460654-46065425.50925.836.9525.5725.886.94
2445757-44575724.68424.74
3531311-53131129.42129.48
4455256-45525625.21025.26
5446495-44649524.72524.78
6458809-45880925.40625.46
20min1536032-53603229.68325.378.7629.7825.478.73
2427005-42700523.64523.74
3460370-46037025.49325.60
4431785-43178523.91024.00
5452430-45243025.05325.15
6441612-44161224.45424.55
30min1459038-45903825.41924.675.1625.5724.815.13
2422136-42213623.37623.51
3443773-44377324.57424.72
4438644-43864424.29024.42
5483762-48376226.78826.92
6425693-42569323.57323.71
45min1431064-43106423.87024.573.7524.0624.753.72
2432677-43267723.95924.13
3442927-44292724.52724.72
4444747-44474724.62824.80
5435322-43532224.10624.28
6475816-47581626.34826.52
60min1488185-48818527.03324.546.2827.2724.766.24
2465267-46526725.76425.98
3431721-43172123.90724.14
4433676-43367624.01524.23
5414690-41469022.96323.18
6425428-42542823.55823.78
极限1423936-42393623.47523.751.3223.7524.011.29
2423013-42301323.42423.68
3430157-43015723.82024.09
4428273-42827323.71623.97
5429050-42905023.75924.02
6438779-43877924.29724.55
卡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)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%
111.003789443802603777413792303804363793220.29
211.033861583889223875400.51
单位质量响应值RSD%判断
34483.8235135.091.33数据可信
供试品溶液-6012602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%
5min1210637-21063754.41149.748.2054.4149.748.20
2194538-19453850.25250.25
3174994-17499445.20345.20
4205148-20514852.99352.99
5197813-19781351.09851.10
6172117-17211744.46044.46
10min1315939-31593981.61279.632.0681.7079.712.06
2313158-31315880.89380.98
3303583-30358378.42078.50
4308778-30877879.76279.85
5309478-30947879.94380.03
6298569-29856977.12577.20
15min1350659-35065990.58089.511.2290.8189.731.22
2349058-34905890.16790.39
3344738-34473889.05189.26
4343325-34332588.68688.91
5350666-35066690.58290.80
6340677-34067788.00288.20
20min1367735-36773594.99194.170.9995.3794.540.99
2366803-36680394.75195.12
3362758-36275893.70694.06
4360960-36096093.24193.61
5368596-36859695.21495.58
6360532-36053293.13193.48
30min1380307-38030798.23997.980.7998.7798.500.78
2380742-38074298.35198.88
3378626-37862697.80598.32
4374977-37497796.86297.39
5383588-38358899.08699.61
6377511-37751197.51798.02
45min1387150-387150100.006100.290.84100.71100.970.84
2391024-391024101.007101.70
3387857-387857100.189100.86
4383725-38372599.12299.81
5392787-392787101.463102.16
6386832-38683299.924100.59
60min1392633-392633101.423100.870.99102.29101.720.99
2392748-392748101.453102.31
3388571-388571100.374101.21
4384220-38422099.250100.10
5395058-395058102.049102.91
6389635-389635100.648101.48
极限1391858-391858101.223101.220.76102.26102.240.76
2393066-393066101.535102.56
3390602-390602100.898101.91
4386980-38698099.963100.98
5395916-395916102.271103.30
6392578-392578101.409102.41
卡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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.541676227168251816748861677224168313116787970.23
210.561710270171930617147880.38
单位质量响应值RSD%判断
159278.65162385.231.37数据可信
供试品溶液-6012602批-卡格列净-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%
5min1115095-1150956.3066.1417.356.316.1417.33
2128657-1286577.0497.05
396648-966485.2955.30
4139214-1392147.6277.63
5104169-1041695.7075.71
688292-882924.8374.84
10min1382155-38215520.93821.607.1520.9521.617.15
2438769-43876924.04024.05
3387304-38730421.22021.23
4415495-41549522.76522.78
5359784-35978419.71219.72
6382080-38208020.93420.94
15min1410955-41095522.51624.0011.6522.5624.0411.63
2428045-42804523.45223.50
3428032-42803223.45123.50
4540505-54050529.61429.66
5406932-40693222.29522.34
6413444-41344422.65222.70
20min1410678-41067822.50124.548.5622.5824.638.54
2429179-42917923.51423.61
3497840-49784027.27627.36
4493930-49393027.06227.16
5438096-43809624.00324.08
6418050-41805022.90522.99
30min1409557-40955722.43922.865.8822.5622.985.85
2414062-41406222.68622.82
3466013-46601325.53225.66
4405701-40570122.22822.37
5398282-39828221.82121.94
6409357-40935722.42822.55
45min1410124-41012422.47022.452.0622.6322.612.09
2415964-41596422.79022.96
3409399-40939922.43122.60
4421739-42173923.10723.29
5399795-39979521.90422.06
6401155-40115521.97922.14
60min1401609-40160922.00422.151.3722.2022.361.37
2398918-39891821.85622.06
3412348-41234822.59222.80
4403340-40334022.09922.32
5409918-40991822.45922.65
6399874-39987421.90922.10
极限1403630-40363022.11422.342.8622.3522.582.86
2394933-39493321.63821.88
3409733-40973322.44922.70
4429415-42941523.52723.78
5404129-40412922.14222.37
6404678-40467822.17222.40
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