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%
111.043106433114123111593099973129493112320.36
211.203103093131053117070.64
单位质量响应值RSD%判断
28191.3027830.980.91数据可信
供试品溶液-1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%
5min1288855-288855456.177458.981.21456.18458.981.21
2285541-285541450.943450.94
3292802-292802462.410462.41
4293077-293077462.844462.84
5294802-294802465.569465.57
6288710-288710455.948455.95
10min1296723-296723468.602477.221.99471.14479.771.98
2296649-296649468.485470.99
3305167-305167481.938484.51
4306498-306498484.040486.61
5310510-310510490.375492.96
6297519-297519469.859472.39
15min1298481-298481471.379480.991.57476.52486.191.57
2300227-300227474.136479.24
3309883-309883489.385494.63
4306102-306102483.414488.67
5309543-309543488.848494.16
6303181-303181478.801483.94
20min1300353-300353474.335481.431.77482.09489.301.76
2299445-299445472.901480.64
3309624-309624488.976496.94
4309197-309197488.302496.25
5310381-310381490.172498.20
6300073-300073473.893481.70
30min1298644-298644471.636478.841.77482.03489.391.77
2298471-298471471.363481.73
3304649-304649481.119491.80
4309944-309944489.482500.14
5308889-308889487.816498.57
6298648-298648471.642482.08
45min1296540-296540468.313478.351.42481.33491.561.42
2299863-299863473.561486.55
3306149-306149483.488496.84
4307339-307339485.368498.75
5306031-306031483.302496.76
6301451-301451476.069489.13
60min1296826-296826468.765477.041.77484.38492.911.76
2297825-297825470.343485.96
3304833-304833481.410497.45
4307606-307606485.789501.86
5308033-308033486.464502.61
6297278-297278469.479485.18
极限1295050-295050465.960475.921.64484.18494.441.64
2297845-297845470.374488.61
3302683-302683478.015496.73
4306425-306425483.924502.70
5307321-307321485.339504.19
6298824-298824471.920490.23
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%
111.404183814201954127794163924153574166210.69
211.434199604176224187910.40
单位质量响应值RSD%判断
36545.7036639.630.19数据可信
供试品溶液-1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%
5min1233640-233640287.320286.776.83287.32286.776.83
2248113-248113305.119305.12
3236964-236964291.408291.41
4220652-220652271.348271.35
5209291-209291257.377257.38
6250508-250508308.064308.06
10min1317232-317232390.118395.362.42391.71396.952.43
2330449-330449406.372408.07
3324040-324040398.490400.11
4321016-321016394.772396.28
5308818-308818379.771381.20
6327409-327409402.633404.34
15min1343175-343175422.022431.291.98425.79435.082.00
2359404-359404441.979445.93
3353564-353564434.798438.63
4351465-351465432.216435.92
5341680-341680420.183423.72
6354964-354964436.519440.47
20min1361607-361607444.689446.050.74450.80452.240.76
2367713-367713452.197458.61
3363665-363665447.219453.47
4360800-360800443.696449.80
5360879-360879443.793449.67
6361614-361614444.697451.07
30min1367663-367663452.136460.981.15460.71469.641.14
2379863-379863467.139476.06
3376822-376822463.399472.13
4374447-374447460.479469.05
5377579-377579464.330472.67
6372758-372758458.402467.25
45min1377360-377360464.061467.641.29475.15478.871.31
2387094-387094476.031487.55
3381259-381259468.856480.16
4378199-378199465.093476.22
5373600-373600459.437470.36
6384132-384132472.389483.78
60min1375410-375410461.663468.431.17475.33482.251.18
2386503-386503475.305489.46
3383927-383927472.137486.05
4382608-382608470.515484.22
5375843-375843462.195475.67
6381186-381186468.766482.78
极限1376914-376914463.512469.890.76479.75486.320.77
2385525-385525474.102490.90
3382576-382576470.475487.01
4382703-382703470.632486.95
5381440-381440469.078485.12
6383456-383456471.558488.18
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%
111.043111023119093124543113833091973112090.40
211.203111133130233120680.44
单位质量响应值RSD%判断
28189.2227863.210.83数据可信
供试品溶液-2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%
5min1276267-276267436.059430.953.20436.06430.953.20
2283399-283399447.316447.32
3261282-261282412.407412.41
4265999-265999419.852419.85
5270091-270091426.311426.31
6281142-281142443.754443.75
10min1300397-300397474.146465.081.59476.57467.481.60
2297869-297869470.156472.64
3287194-287194453.306455.60
4292113-292113461.070463.40
5293907-293907463.902466.27
6296450-296450467.916470.38
15min1299513-299513472.750466.401.66477.81471.381.66
2298159-298159470.613475.71
3287532-287532453.840458.65
4292478-292478461.646466.54
5294982-294982465.599470.54
6300290-300290473.977479.04
20min1304510-304510480.638470.181.98488.32477.751.98
2302380-302380477.276484.99
3289160-289160456.409463.74
4294894-294894465.460472.92
5294779-294779465.278472.81
6301583-301583476.018483.72
30min1299115-299115472.122467.291.67482.48477.471.68
2302066-302066476.780487.14
3288170-288170454.847464.71
4292604-292604461.845471.89
5297323-297323469.294479.41
6297027-297027468.827479.17
45min1298830-298830471.672467.551.35484.65480.331.36
2298897-298897471.778484.79
3289117-289117456.341468.73
4297457-297457469.505482.12
5293976-293976464.011476.74
6299049-299049472.018484.97
60min1300589-300589474.449465.262.27490.05480.642.25
2302320-302320477.181492.81
3284251-284251448.661463.59
4290462-290462458.464473.68
5294839-294839465.373480.68
6296158-296158467.455483.02
极限1297396-297396469.409464.401.64487.64482.361.64
2297809-297809470.061488.34
3287450-287450453.710471.13
4290478-290478458.490476.26
5292535-292535461.736479.62
6299681-299681473.016491.18
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%
111.404173444179354163654158864121004159260.55
211.434159634160224159920.02
单位质量响应值RSD%判断
36484.7436394.750.18数据可信
供试品溶液-2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%
5min1205231-205231253.443241.075.72253.44241.075.72
2183298-183298226.358226.36
3207863-207863256.694256.69
4188842-188842233.204233.20
5183827-183827227.011227.01
6202210-202210249.713249.71
10min1326771-326771403.535391.442.43404.94392.782.43
2310482-310482383.420384.68
3314283-314283388.114389.54
4307208-307208379.376380.67
5319014-319014393.956395.22
6324108-324108400.247401.63
15min1357957-357957442.047430.852.08445.70434.362.08
2349246-349246431.290434.68
3346366-346366427.733431.32
4336341-336341415.353418.76
5351348-351348433.886437.34
6352063-352063434.769438.38
20min1376742-376742465.245452.841.60471.35458.741.60
2361122-361122445.956451.74
3360991-360991445.794451.75
4366921-366921453.117458.83
5365337-365337451.161457.02
6369056-369056455.754461.78
30min1382815-382815472.745468.671.14481.44477.091.15
2379419-379419468.551476.81
3376588-376588465.055473.49
4372474-372474459.975468.20
5382035-382035471.782480.15
6383742-383742473.890482.45
45min1385566-385566476.142477.541.37487.46488.571.33
2378695-378695467.657478.52
3383138-383138473.144484.16
4392965-392965485.279496.06
5390465-390465482.192493.18
6389364-389364480.832492.02
60min1386100-386100476.802473.561.29490.76487.241.29
2381677-381677471.340484.80
3377828-377828466.586480.23
4378700-378700467.663481.14
5385956-385956476.624490.29
6390613-390613482.375496.24
极限1390681-390681482.459475.791.66499.07492.101.64
2383757-383757473.908489.99
3379722-379722468.925485.16
4376206-376206464.583480.66
5390745-390745482.538498.85
6390578-390578482.332498.87
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%
111.043145183142283152093152153129223144180.30
211.203127053140283133660.30
单位质量响应值RSD%判断
28479.8927979.111.26数据可信
供试品溶液-3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%
5min1262923-262923412.027400.855.82412.03400.855.82
2265384-265384415.884415.88
3253530-253530397.307397.31
4229399-229399359.491359.49
5251957-251957394.842394.84
6271540-271540425.531425.53
10min1299339-299339469.094465.792.17471.38468.022.16
2294324-294324461.235463.55
3286738-286738449.347451.55
4295967-295967463.810465.81
5304744-304744477.565479.76
6302265-302265473.680476.04
15min1299427-299427469.232466.451.24474.13471.271.24
2294697-294697461.820466.69
3293224-293224459.512464.22
4296211-296211464.193468.77
5303271-303271475.256480.10
6299083-299083468.693473.69
20min1300592-300592471.058468.821.24478.56476.231.24
2295124-295124462.489469.93
3294756-294756461.912469.17
4298588-298588467.918475.07
5303853-303853476.168483.66
6302069-302069473.373480.97
30min1301272-301272472.124467.531.61482.24477.541.60
2291578-291578456.932466.94
3294049-294049460.805470.63
4297586-297586466.347476.10
5303657-303657475.861485.99
6301894-301894473.098483.33
45min1296172-296172464.131465.921.41476.87478.531.39
2291613-291613456.987469.53
3293688-293688460.239472.62
4301214-301214472.033484.38
5301937-301937473.166485.94
6299263-299263468.975481.83
60min1298361-298361467.562466.541.35482.88481.741.34
2293250-293250459.552474.64
3292554-292554458.462473.40
4298808-298808468.262483.23
5302377-302377473.855489.26
6300896-300896471.534487.00
极限1301309-301309472.182468.501.68490.10486.291.66
2293409-293409459.802477.44
3294305-294305461.206478.69
4296513-296513464.666482.23
5306083-306083479.663497.70
6302156-302156473.509491.59
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%
111.404198424180194171304215424200324193130.42
211.434149804144224147010.10
单位质量响应值RSD%判断
36781.8436281.800.97数据可信
供试品溶液-3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%
5min1165239-165239203.551193.7813.78203.55193.7813.78
2185248-185248228.200228.20
3127349-127349156.876156.88
4174474-174474214.928214.93
5150568-150568185.479185.48
6140951-140951173.632173.63
10min1314332-314332387.213382.272.32388.34383.352.34
2318445-318445392.280393.55
3307392-307392378.664379.54
4315388-315388388.514389.71
5307643-307643378.973380.00
6298739-298739368.005368.97
15min1352777-352777434.572430.602.32437.85433.802.34
2361133-361133444.865448.31
3349872-349872430.993433.97
4351999-351999433.614436.97
5344192-344192423.997427.13
6337359-337359415.579418.59
20min1364231-364231448.682447.531.16454.38453.121.18
2365260-365260449.949455.87
3358757-358757441.939447.31
4368161-368161453.523459.28
5365743-365743450.544456.04
6357612-357612440.528445.85
30min1378325-378325466.044460.691.31474.23468.761.33
2375980-375980463.155471.57
3374252-374252461.026468.85
4376300-376300463.549471.83
5374523-374523461.360469.35
6364480-364480448.989456.75
45min1383813-383813472.804469.201.86483.58479.831.86
2382366-382366471.022482.01
3382269-382269470.902481.29
4386914-386914476.624487.48
5383081-383081471.902482.46
6366861-366861451.922462.18
60min1385438-385438474.806470.031.38488.21483.271.40
2384808-384808474.030487.64
3381791-381791470.313483.32
4384498-384498473.648487.15
5381428-381428469.866483.05
6371380-371380457.488470.26
极限1381409-381409469.843472.381.36485.89488.231.37
2386904-386904476.612492.85
3384513-384513473.666489.28
4385750-385750475.190491.33
5388234-388234478.250494.04
6373982-373982460.694476.01
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%
111.043149223120773113883131413110943125240.50
211.203138563128593133580.23
单位质量响应值RSD%判断
28308.3327978.390.83数据可信
供试品溶液-3批-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%
5min137870-3787059.52564.7117.4659.5364.7117.46
250434-5043479.27479.27
343754-4375468.77468.77
444806-4480670.42770.43
529277-2927746.01846.02
640861-4086164.22664.23
10min156929-5692989.48388.034.4989.8188.394.53
258525-5852591.99192.43
356399-5639988.65089.03
454963-5496386.39286.78
551510-5151080.96581.22
657715-5771590.71891.07
15min158649-5864992.18691.793.8893.0192.643.90
259986-5998694.28895.24
361626-6162696.86597.74
456651-5665189.04689.92
555324-5532486.96087.67
658147-5814791.39792.26
20min152489-5248982.50490.444.4683.8491.794.41
259288-5928893.19194.67
358160-5816091.41892.83
457396-5739690.21791.58
558931-5893192.62993.82
658948-5894892.65694.02
30min155150-5515086.68691.034.6388.4892.894.48
254467-5446785.61387.61
358450-5845091.87393.79
457960-5796091.10392.97
561033-6103395.93397.64
660427-6042794.98196.86
45min155580-5558087.36288.502.0589.6490.861.99
256954-5695489.52291.99
354501-5450185.66688.10
456046-5604688.09590.47
557092-5709289.73991.97
657634-5763490.59193.00
60min155390-5539087.06487.362.3989.8390.222.25
254787-5478786.11689.08
354685-5468585.95588.86
456971-5697189.54992.41
557441-5744190.28793.02
654186-5418685.17188.09
极限155366-5536687.02685.903.3390.2789.243.23
255303-5530386.92790.37
354939-5493986.35589.74
457202-5720289.91293.27
552326-5232682.24785.48
652766-5276682.93986.33
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%
111.404187794163474170694172814172144173380.22
211.434205504177184191340.48
单位质量响应值RSD%判断
36608.6036669.640.12数据可信
供试品溶液-3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%
5min113372-1337216.42317.1610.9616.4217.1610.95
215202-1520218.67118.67
313775-1377516.91816.92
411403-1140314.00514.01
514337-1433717.60917.61
615722-1572219.31019.31
10min133593-3359341.25940.7720.3941.3540.8620.35
233692-3369241.38041.48
328320-2832034.78334.88
424417-2441729.98930.07
544385-4438554.51354.61
634757-3475742.68842.80
15min150194-5019461.64852.0017.8361.9752.3217.79
241097-4109750.47550.81
343721-4372153.69853.99
428372-2837234.84635.09
547148-4714857.90758.31
643496-4349653.42253.77
20min152158-5215864.06061.1413.3364.7261.7513.34
251261-5126162.95963.57
347808-4780858.71859.30
439203-3920348.14948.59
559531-5953173.11673.84
648703-4870359.81760.46
30min156794-5679469.75469.1211.1070.7770.0711.13
256434-5643469.31270.28
357002-5700270.01070.92
444570-4457054.74155.45
562795-6279577.12578.25
660075-6007573.78474.76
45min161187-6118775.15077.557.8076.5678.887.85
262018-6201876.17077.52
367296-6729682.65383.95
455595-5559568.28269.29
569604-6960485.48787.04
663132-6313277.53878.92
60min167784-6778483.25283.954.5485.0885.724.61
264415-6441579.11480.89
370321-7032186.36888.13
465010-6501079.84581.23
571311-7131187.58489.62
671266-7126687.52989.34
极限173629-7362990.43191.442.8592.7293.672.75
278133-7813395.96398.17
374492-7449291.49193.73
473350-7335090.08891.92
571913-7191388.32390.84
675183-7518392.33994.64
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