非奈利酮恩格列净片项目信息
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%
110.973169093166513160793170983167773167030.13
211.073161393160273160830.03
单位质量响应值RSD%判断
28869.9228553.120.79数据可信
供试品溶液-25092401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%
5min145761-4576114.10115.2314.4414.1015.2314.45
243047-4304713.26513.26
340819-4081912.57812.58
458082-5808217.89817.90
555384-5538417.06617.07
653387-5338716.45116.45
10min159730-5973018.40517.584.2518.4317.604.24
256631-5663117.45017.47
354513-5451316.79816.82
460214-6021418.55518.58
556338-5633817.36017.39
654812-5481216.89016.92
15min159431-5943118.31317.792.1118.3717.842.13
257370-5737017.67817.73
356057-5605717.27417.32
458691-5869118.08518.15
557871-5787117.83317.89
656926-5692617.54117.60
20min157743-5774317.79317.851.5017.8817.941.52
258087-5808717.89917.98
356321-5632117.35517.43
458683-5868318.08318.17
558638-5863818.06918.16
658164-5816417.92318.01
30min1-0.0000.00-0.110.114.56
2-0.0000.11
3-0.0000.11
4-0.0000.12
5-0.0000.12
6-0.0000.11
45min1-0.0000.00-0.110.114.56
2-0.0000.11
3-0.0000.11
4-0.0000.12
5-0.0000.12
6-0.0000.11
60min1-0.0000.00-0.110.114.56
2-0.0000.11
3-0.0000.11
4-0.0000.12
5-0.0000.12
6-0.0000.11
极限1-0.0000.00-0.110.114.56
2-0.0000.11
3-0.0000.11
4-0.0000.12
5-0.0000.12
6-0.0000.11
非奈利酮恩格列净片项目信息
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)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%
111.133988893988743985203986123985833986960.05
211.163984033980063982040.08
单位质量响应值RSD%判断
35821.7435681.360.28数据可信
供试品溶液-25092401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%
5min123810-238102.9972.9434.803.002.9434.70
215697-156971.9761.98
312372-123721.5571.56
434585-345854.3534.35
527360-273603.4443.44
626189-261893.2963.30
10min139524-395244.9754.7010.464.984.7110.43
233323-333234.1944.20
332527-325274.0944.10
442939-429395.4055.41
538120-381204.7984.80
637658-376584.7404.75
15min147651-476515.9986.287.496.016.297.51
246175-461755.8125.82
345837-458375.7695.78
452633-526336.6256.64
552750-527506.6406.65
654204-542046.8236.84
20min156790-567907.1488.3814.227.178.4014.22
257780-577807.2737.29
359462-594627.4847.50
475198-751989.4659.49
573985-739859.3129.34
676328-763289.6079.63
30min1-0.0000.00-0.040.0414.09
2-0.0000.03
3-0.0000.03
4-0.0000.04
5-0.0000.04
6-0.0000.04
45min1-0.0000.00-0.040.0414.09
2-0.0000.03
3-0.0000.03
4-0.0000.04
5-0.0000.04
6-0.0000.04
60min1-0.0000.00-0.040.0414.09
2-0.0000.03
3-0.0000.03
4-0.0000.04
5-0.0000.04
6-0.0000.04
极限1-0.0000.00-0.040.0414.09
2-0.0000.03
3-0.0000.03
4-0.0000.04
5-0.0000.04
6-0.0000.04
非奈利酮恩格列净片项目信息
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%
110.973157983156863155703152413155493155690.07
211.073168883171793170340.07
单位质量响应值RSD%判断
28766.5528639.020.32数据可信
供试品溶液-25092401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%
5min1219613-21961367.69170.0117.1267.6970.0117.12
2176718-17671854.47054.47
3189173-18917358.30958.31
4276280-27628085.15885.16
5248605-24860576.62776.63
6252384-25238477.79277.79
10min1288512-28851288.92884.614.6489.0484.734.64
2263981-26398181.36781.46
3262738-26273880.98481.08
4292055-29205590.02090.16
5272384-27238483.95784.08
6267391-26739182.41882.55
15min1295218-29521890.99588.023.5691.2688.283.57
2281801-28180186.85987.09
3271804-27180483.77884.01
4296733-29673391.46291.75
5290568-29056889.56289.83
6277192-27719285.43985.71
20min1299345-29934592.26791.533.3492.6891.943.35
2290579-29057989.56589.94
3279880-27988086.26786.64
4302348-30234893.19393.64
5305604-30560494.19694.61
6303973-30397393.69394.10
30min1-0.0000.00-0.570.565.72
2-0.0000.52
3-0.0000.52
4-0.0000.60
5-0.0000.57
6-0.0000.57
45min1-0.0000.00-0.570.565.72
2-0.0000.52
3-0.0000.52
4-0.0000.60
5-0.0000.57
6-0.0000.57
60min1-0.0000.00-0.570.565.72
2-0.0000.52
3-0.0000.52
4-0.0000.60
5-0.0000.57
6-0.0000.57
极限1-0.0000.00-0.570.565.72
2-0.0000.52
3-0.0000.52
4-0.0000.60
5-0.0000.57
6-0.0000.57
非奈利酮恩格列净片项目信息
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)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%
111.133971033970013972243966843970843970190.06
211.163978513987123982820.16
单位质量响应值RSD%判断
35671.0735688.350.04数据可信
供试品溶液-25092401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%
5min1113690-11369014.33923.8543.6614.3423.8543.66
2109340-10934013.79013.79
3124862-12486215.74815.75
4256316-25631632.32732.33
5295205-29520537.23237.23
6235155-23515529.65829.66
10min1312800-31280039.45140.769.2339.4740.809.23
2348324-34832443.93143.95
3281074-28107435.45035.48
4329179-32917941.51741.57
5362663-36266345.74045.80
6304928-30492838.45838.51
15min1340245-34024542.91243.826.4843.0043.926.48
2372616-37261646.99547.09
3321443-32144340.54140.63
4345404-34540443.56343.69
5375964-37596447.41747.56
6328781-32878141.46741.58
20min1349587-34958744.09146.245.7444.2546.425.76
2376619-37661947.50047.67
3331700-33170041.83541.99
4378242-37824247.70547.90
5382591-38259148.25348.47
6381192-38119248.07748.26
30min1-0.0000.00-0.230.2611.74
2-0.0000.25
3-0.0000.22
4-0.0000.28
5-0.0000.30
6-0.0000.26
45min1-0.0000.00-0.230.2611.74
2-0.0000.25
3-0.0000.22
4-0.0000.28
5-0.0000.30
6-0.0000.26
60min1-0.0000.00-0.230.2611.74
2-0.0000.25
3-0.0000.22
4-0.0000.28
5-0.0000.30
6-0.0000.26
极限1-0.0000.00-0.230.2611.74
2-0.0000.25
3-0.0000.22
4-0.0000.28
5-0.0000.30
6-0.0000.26
非奈利酮恩格列净片项目信息
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%
110.973171953171843171133165043172913170570.10
211.073191143191553191340.01
单位质量响应值RSD%判断
28902.1928828.730.18数据可信
供试品溶液-25092401批-非奈利酮-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1204738-20473862.75070.1814.2162.7570.1814.21
2207682-20768263.65363.65
3188419-18841957.74957.75
4264050-26405080.92980.93
5260348-26034879.79479.79
6248734-24873476.23576.23
10min1274371-27437184.09282.912.2384.2083.032.24
2271334-27133483.16283.27
3260687-26068779.89879.99
4276275-27627584.67684.81
5274492-27449284.12984.26
6265975-26597581.51981.65
15min1280205-28020585.88084.472.0386.1384.722.03
2276367-27636784.70484.95
3268001-26800182.14082.37
4281690-28169086.33686.61
5277554-27755485.06885.34
6269721-26972182.66782.93
20min1282460-28246086.57289.485.7386.9689.875.72
2278276-27827685.28985.68
3270820-27082083.00483.37
4310426-31042695.14395.56
5305026-30502693.48893.90
6304651-30465193.37393.77
30min1-0.0000.00-0.530.545.54
2-0.0000.53
3-0.0000.50
4-0.0000.58
5-0.0000.57
6-0.0000.56
45min1-0.0000.00-0.530.545.54
2-0.0000.53
3-0.0000.50
4-0.0000.58
5-0.0000.57
6-0.0000.56
60min1-0.0000.00-0.530.545.54
2-0.0000.53
3-0.0000.50
4-0.0000.58
5-0.0000.57
6-0.0000.56
极限1-0.0000.00-0.530.545.54
2-0.0000.53
3-0.0000.50
4-0.0000.58
5-0.0000.57
6-0.0000.56
非奈利酮恩格列净片项目信息
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)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%
111.133994933989523991393990953988673991090.07
211.164015894013884014880.04
单位质量响应值RSD%判断
35858.8535975.630.23数据可信
供试品溶液-25092401批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186981-8698110.89819.3438.5910.9019.3438.59
298671-9867112.36212.36
3121515-12151515.22415.22
4190684-19068423.89023.89
5197404-19740424.73224.73
6230762-23076228.91228.91
10min1245634-24563430.77534.828.8630.7934.858.88
2255082-25508231.95931.98
3282882-28288235.44235.47
4279697-27969735.04335.08
5290619-29061936.41136.45
6313627-31362739.29439.34
15min1316421-31642139.64442.564.7539.7142.654.78
2327811-32781141.07141.14
3342893-34289342.96143.04
4339246-33924642.50442.60
5349887-34988743.83743.94
6362111-36211145.36845.48
20min1348311-34831143.63946.293.7843.7746.453.81
2358485-35848544.91445.06
3369270-36927046.26546.42
4377208-37720847.26047.43
5377040-37704047.23947.41
6386412-38641248.41348.60
30min1-0.0000.00-0.210.249.36
2-0.0000.22
3-0.0000.23
4-0.0000.25
5-0.0000.25
6-0.0000.27
45min1-0.0000.00-0.210.249.36
2-0.0000.22
3-0.0000.23
4-0.0000.25
5-0.0000.25
6-0.0000.27
60min1-0.0000.00-0.210.249.36
2-0.0000.22
3-0.0000.23
4-0.0000.25
5-0.0000.25
6-0.0000.27
极限1-0.0000.00-0.210.249.36
2-0.0000.22
3-0.0000.23
4-0.0000.25
5-0.0000.25
6-0.0000.27
非奈利酮恩格列净片项目信息
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%
110.973189643189513185913187873190833188750.06
211.073182693183423183060.02
单位质量响应值RSD%判断
29067.9128753.930.77数据可信
供试品溶液-25092401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%
5min146839-4683914.33413.6522.7814.3313.6522.78
248670-4867014.89414.89
327743-277438.4908.49
456727-5672717.35917.36
538270-3827011.71111.71
649403-4940315.11815.12
10min163066-6306619.29917.9315.0619.3217.9515.06
260758-6075818.59318.62
343866-4386613.42413.44
468097-6809720.83920.87
552586-5258616.09216.11
663157-6315719.32719.35
15min163539-6353919.44418.6510.4219.5018.7010.43
261758-6175818.89918.95
350584-5058415.48015.52
469178-6917821.17021.23
557307-5730717.53717.58
663289-6328919.36819.42
20min163334-6333419.38118.569.4519.4718.659.48
261023-6102318.67418.76
352186-5218615.97016.03
468812-6881221.05821.16
556578-5657817.31417.39
662018-6201818.97919.07
30min162403-6240319.09618.925.6319.2219.045.63
259665-5966518.25918.38
362679-6267919.18119.27
467104-6710420.53520.67
556668-5666817.34117.45
662440-6244019.10819.23
45min163267-6326719.36118.965.1619.5119.115.14
258787-5878717.99018.14
364252-6425219.66219.78
466214-6621420.26320.43
558026-5802617.75717.89
661282-6128218.75318.91
60min162117-6211719.00918.805.0319.1918.985.03
258964-5896418.04418.22
363076-6307619.30219.46
465868-6586820.15720.36
557101-5710117.47417.64
661523-6152318.82719.01
极限161740-6174018.89418.745.6119.1118.955.58
257374-5737417.55717.77
363048-6304819.29419.48
466691-6669120.40920.64
558062-5806217.76817.96
660506-6050618.51618.73
非奈利酮恩格列净片项目信息
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)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%
111.134012044010144012834011734012534011850.03
211.164004404001484002940.06
单位质量响应值RSD%判断
36045.3735868.640.35数据可信
供试品溶液-25092401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%
5min112192-121921.5261.5227.801.531.5227.71
218236-182362.2822.28
38405-84051.0521.05
411715-117151.4661.47
59792-97921.2251.23
612486-124861.5631.56
10min124584-245843.0773.2532.053.083.2531.99
238178-381784.7784.78
316728-167282.0942.10
423698-236982.9662.97
519078-190782.3882.39
633545-335454.1984.20
15min132100-321004.0174.3128.534.024.3228.49
248633-486336.0866.10
322940-229402.8712.88
431810-318103.9813.99
527325-273253.4203.43
643660-436605.4645.47
20min137519-375194.6965.0225.224.715.0325.24
254960-549606.8786.90
328459-284593.5623.57
437188-371884.6544.67
532925-329254.1214.13
649496-494966.1946.21
30min145469-454695.6906.1219.475.716.1419.53
261865-618657.7427.78
339330-393304.9224.94
444847-448475.6135.63
542080-420805.2665.28
659799-597997.4847.51
45min155540-555406.9517.3414.216.987.3714.26
270802-708028.8618.91
351871-518716.4926.52
453328-533286.6746.71
552647-526476.5896.62
667557-675578.4558.50
60min161409-614097.6858.0712.257.738.1112.29
276170-761709.5339.59
358712-587127.3487.38
459552-595527.4537.50
558184-581847.2827.32
672742-727429.1049.16
极限178336-783369.8049.646.829.869.696.83
276517-765179.5769.65
366762-667628.3558.40
479854-798549.99410.05
579377-793779.9349.98
681091-8109110.14910.22
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