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)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%
120.146486906509686492796508716515696502750.19
220.236627496622036624760.06
单位质量响应值RSD%判断
32287.7432747.211.00数据可信
供试品溶液-5122201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%
5min1194149-19414926.84226.766.7426.8426.766.74
2192169-19216926.56826.57
3208241-20824128.79028.79
4208313-20831328.80028.80
5177548-17754824.54724.55
6180956-18095625.01825.02
10min1423564-42356458.56059.821.5558.6059.861.56
2426135-42613558.91658.96
3438854-43885460.67460.72
4440270-44027060.87060.92
5432891-43289159.85059.89
6434408-43440860.05960.10
15min1518186-51818671.64272.250.8771.7872.400.87
2521540-52154072.10672.25
3522873-52287372.29072.44
4520099-52009971.90772.06
5531250-53125073.44873.59
6521570-52157072.11072.25
20min1560126-56012677.44178.041.0277.7078.311.02
2566404-56640478.30978.57
3563587-56358777.91978.19
4557733-55773377.11077.38
5574253-57425379.39479.66
6564716-56471678.07578.34
30min1606807-60680783.89584.111.2084.2984.501.19
2610992-61099284.47384.87
3601949-60194983.22383.62
4601169-60116983.11583.51
5621027-62102785.86086.26
6608064-60806484.06884.46
45min1640025-64002588.48788.671.1689.0289.201.16
2643986-64398689.03589.57
3634432-63443287.71488.25
4633775-63377587.62388.16
5654074-65407490.42990.97
6641626-64162688.70889.24
60min1657447-65744790.89690.901.1291.5791.581.11
2659260-65926091.14691.83
3650221-65022189.89790.58
4650357-65035789.91690.60
5670249-67024992.66693.35
6657511-65751190.90591.58
极限1663960-66396091.79691.801.1392.6392.631.13
2667215-66721592.24693.08
3656134-65613490.71491.55
4656083-65608390.70791.54
5676067-67606793.47094.31
6664381-66438191.85492.69
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%
111.121627802163601416277141631185163193516309300.22
211.131659667165851216590900.05
单位质量响应值RSD%判断
146666.37149064.691.15数据可信
供试品溶液-5122201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%
5min1106039-1060396.3195.3914.116.325.3914.10
291770-917705.4695.47
374009-740094.4104.41
482482-824824.9154.92
5104409-1044096.2226.22
684127-841275.0135.01
10min1314678-31467818.75218.647.1118.7618.657.10
2329118-32911819.61319.62
3308689-30868918.39518.40
4337513-33751320.11320.12
5313538-31353818.68418.69
6273158-27315816.27816.29
15min1481635-48163528.70228.483.3528.7428.523.35
2480637-48063728.64228.68
3479023-47902328.54628.58
4499888-49988829.78929.83
5476654-47665428.40528.45
6450153-45015326.82526.86
20min1492854-49285429.37032.024.3629.4632.104.35
2550456-55045632.80332.89
3560136-56013633.38033.47
4545549-54554932.51032.60
5536798-53679831.98932.08
6537728-53772832.04432.12
30min1536626-53662631.97933.497.3332.1233.647.30
2513269-51326930.58730.73
3606586-60658636.14836.29
4606200-60620036.12536.27
5581291-58129134.64034.78
6528302-52830231.48231.62
45min1629349-62934937.50433.0612.0137.7033.2611.95
2482187-48218728.73428.93
3610827-61082736.40036.60
4540244-54024432.19432.40
5592640-59264035.31735.52
6473816-47381628.23628.42
60min1485231-48523128.91629.434.2529.1729.684.20
2531760-53176031.68931.93
3503534-50353430.00730.27
4480871-48087128.65628.92
5474135-47413528.25528.51
6487812-48781229.07029.30
极限1449300-44930026.77528.4513.0627.0828.7512.95
2442375-44237526.36226.66
3532532-53253231.73532.05
4576633-57663334.36334.67
5444524-44452426.49026.80
6418697-41869724.95125.23
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)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%
120.146616896622426617296617676615506617950.04
220.236568756641466605100.78
单位质量响应值RSD%判断
32859.7332650.020.46数据可信
供试品溶液-5122202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%
5min1146184-14618420.06321.0715.1920.0621.0715.18
2192793-19279326.46026.46
3158986-15898621.82121.82
4157595-15759521.63021.63
5122452-12245216.80616.81
6143115-14311519.64219.64
10min1376897-37689751.72851.474.7951.7651.514.79
2391661-39166153.75553.80
3392157-39215753.82353.86
4378694-37869451.97552.01
5344216-34421647.24347.27
6366632-36663250.32050.35
15min1504695-50469569.26868.341.4269.3968.461.43
2503469-50346969.10069.23
3501688-50168868.85668.98
4498121-49812168.36668.49
5486077-48607766.71366.82
6493742-49374267.76567.88
20min1552121-55212175.77874.960.8176.0175.190.82
2550133-55013375.50575.75
3545808-54580874.91175.15
4545942-54594274.93075.17
5540924-54092474.24174.46
6541846-54184674.36774.60
30min1597947-59794782.06781.140.6382.4381.500.63
2592684-59268481.34581.72
3590478-59047881.04281.41
4588519-58851980.77381.13
5589076-58907680.85081.19
6588400-58840080.75781.11
45min1629688-62968886.42485.570.5786.9286.070.56
2625395-62539585.83486.34
3621377-62137785.28385.78
4620188-62018885.12085.62
5622452-62245285.43085.91
6621863-62186385.35085.84
60min1643622-64362288.33687.630.5288.9888.270.52
2641045-64104587.98288.64
3636900-63690087.41388.06
4635366-63536687.20387.84
5638176-63817687.58888.21
6635645-63564587.24187.87
极限1650465-65046589.27588.390.5390.0689.170.52
2642966-64296688.24689.05
3641509-64150988.04688.83
4641700-64170088.07288.86
5642770-64277088.21988.98
6644653-64465388.47789.25
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%
111.121656763165798516566511657152165685716570820.04
211.131644826166586416553450.90
单位质量响应值RSD%判断
149018.17148728.210.14数据可信
供试品溶液-5122202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%
5min192830-928305.4944.9216.695.494.9216.69
255600-556003.2913.29
391258-912585.4015.40
488396-883965.2325.23
583236-832364.9264.93
687034-870345.1515.15
10min1285459-28545916.89515.888.3016.9015.908.30
2228110-22811013.50113.51
3289221-28922117.11717.13
4272539-27253916.13016.14
5260009-26000915.38915.40
6275016-27501616.27716.29
15min1431351-43135125.52925.421.3125.5725.451.30
2430448-43044825.47625.50
3422622-42262225.01325.05
4438913-43891325.97726.01
5425972-42597225.21125.24
6427603-42760325.30825.34
20min1431475-43147525.53727.618.2725.6227.688.25
2433938-43393825.68225.75
3486722-48672228.80628.89
4529486-52948631.33731.42
5476320-47632028.19128.27
6440650-44065026.08026.16
30min1410166-41016624.27625.128.7324.4025.248.70
2401481-40148123.76223.87
3496238-49623829.37029.50
4410802-41080224.31324.44
5430862-43086225.50025.62
6397273-39727323.51223.63
45min1468341-46834127.71926.8617.7927.8827.0317.68
2498493-49849329.50329.66
3380730-38073022.53322.71
4585328-58532834.64234.81
5374029-37402922.13722.30
6416579-41657924.65524.82
60min1401945-40194523.78923.484.5824.0023.694.53
2430809-43080925.49725.70
3386891-38689122.89823.11
4384957-38495722.78423.01
5393307-39330723.27823.48
6382160-38216022.61822.82
极限1397034-39703423.49823.772.7523.7524.022.74
2384048-38404822.73022.97
3396382-39638223.46023.71
4412417-41241724.40924.68
5409024-40902424.20824.45
6410614-41061424.30224.54
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)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%
120.146668786669706674906673236674106672140.05
220.236627306637756632520.12
单位质量响应值RSD%判断
33128.8032785.570.74数据可信
供试品溶液-5122203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%
5min1200253-20025327.31624.3413.7827.3224.3413.79
2169667-16966723.14423.14
3148203-14820320.21620.22
4181597-18159724.77124.77
5212373-21237328.96928.97
6158594-15859421.63321.63
10min1423670-42367057.79256.373.6157.8456.413.62
2412892-41289256.32256.36
3392466-39246653.53553.57
4416392-41639256.79956.84
5433275-43327559.10259.15
6400567-40056754.64154.68
15min1509377-50937769.48369.442.0769.6269.572.07
2517053-51705370.53070.66
3501875-50187568.46068.58
4500473-50047368.26868.40
5525673-52567371.70671.85
6499770-49977068.17368.30
20min1548970-54897074.88475.472.0275.1475.722.02
2563467-56346776.86177.11
3554923-55492375.69675.93
4539803-53980373.63373.88
5568504-56850477.54877.81
6544041-54404174.21274.45
30min1592304-59230480.79581.482.0481.1881.862.04
2609990-60999083.20783.59
3604268-60426882.42782.79
4579861-57986179.09879.47
5608703-60870383.03283.43
6588989-58898980.34380.71
45min1619646-61964684.52585.802.2485.0486.322.24
2643730-64373087.81088.33
3640282-64028287.34087.84
4609160-60916083.09483.60
5639563-63956387.24187.78
6621732-62173284.80985.31
60min1634533-63453386.55588.032.2987.2188.692.29
2661961-66196190.29790.96
3657762-65776289.72490.37
4626522-62652285.46386.11
5655370-65537089.39890.08
6635989-63598986.75487.39
极限1644456-64445687.90988.842.3288.7189.642.32
2667516-66751691.05491.87
3664029-66402990.57991.37
4628772-62877285.77086.55
5660353-66035390.07790.91
6642509-64250987.64388.43
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%
111.121668876166927416708871669520167103716699190.06
211.131658586166108016598330.11
单位质量响应值RSD%判断
150172.57149131.450.50数据可信
供试品溶液-5122203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%
5min1162950-1629509.5949.304.119.599.304.10
2162258-1622589.5539.55
3153601-1536019.0449.04
4147949-1479498.7118.71
5164662-1646629.6959.69
6156212-1562129.1979.20
10min1332271-33227119.56319.369.2519.5819.389.24
2319419-31941918.80718.82
3279452-27945216.45316.47
4340621-34062120.05520.07
5372930-37293021.95721.97
6328710-32871019.35419.37
15min1419804-41980424.71724.244.0024.7724.293.98
2426382-42638225.10425.15
3425680-42568025.06325.11
4400398-40039823.57423.62
5384451-38445122.63522.69
6413666-41366624.35624.40
20min1430106-43010625.32325.418.4225.4125.508.39
2447772-44777226.36426.45
3495577-49557729.17829.26
4406739-40673923.94824.03
5413489-41348924.34524.44
6395638-39563823.29423.38
30min1449098-44909826.44223.736.1326.5723.866.09
2392853-39285323.13023.26
3390582-39058222.99623.13
4411597-41159724.23424.36
5380977-38097722.43122.56
6392854-39285423.13023.26
45min1370271-37027121.80124.4712.8021.9824.6412.71
2463461-46346127.28727.46
3409944-40994424.13624.31
4373865-37386522.01222.18
5378933-37893322.31122.48
6497337-49733729.28229.45
60min1439855-43985525.89722.527.4226.1122.737.36
2367810-36781021.65621.87
3367369-36736921.63021.84
4370598-37059821.82022.02
5371405-37140521.86722.07
6377719-37771922.23922.45
极限1389487-38948722.93222.997.2923.1923.247.20
2370794-37079421.83122.08
3441038-44103825.96726.21
4403801-40380123.77524.02
5367359-36735921.62921.87
6370759-37075921.82922.08
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)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%
120.146702456706346707836706596706696705980.04
220.236750936756146753540.06
单位质量响应值RSD%判断
33296.8233383.790.19数据可信
供试品溶液-cbjz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%
5min198740-9874013.31412.028.5913.3112.028.57
280671-8067110.87710.88
379847-7984710.76610.77
490266-9026612.17112.17
590031-9003112.14012.14
695515-9551512.87912.88
10min1310480-31048041.86440.048.1741.8940.068.18
2249379-24937933.62633.64
3312293-31229342.10942.13
4300909-30090940.57440.59
5296126-29612639.92939.95
6312602-31260242.15042.17
15min1502409-50240967.74365.916.3467.8466.006.34
2428137-42813757.72957.80
3515050-51505069.44869.54
4495441-49544166.80466.89
5489057-48905765.94366.03
6502797-50279767.79667.89
20min1583095-58309578.62377.402.9278.8377.602.93
2545414-54541473.54273.71
3594172-59417280.11680.32
4576901-57690177.78877.99
5566166-56616676.34076.54
6578583-57858378.01478.22
30min1635180-63518085.64685.212.1985.9885.532.19
2612049-61204982.52782.82
3649833-64983387.62287.96
4630211-63021184.97685.30
5621614-62161483.81784.14
6642624-64262486.65086.98
45min1656740-65674088.55388.332.4289.0388.802.42
2637952-63795286.02086.45
3673163-67316390.76791.25
4650140-65014087.66388.13
5638861-63886186.14286.61
6673571-67357190.82291.30
60min1662861-66286189.37889.152.6590.0089.762.65
2643664-64366486.79087.36
3678984-67898491.55292.19
4654753-65475388.28588.90
5642733-64273386.66487.27
6683965-68396592.22492.85
极限1681126-68112691.84191.531.4292.6292.291.43
2669327-66932790.25090.97
3689802-68980293.01193.80
4675333-67533391.06091.82
5667862-66786290.05390.80
6689447-68944792.96393.75
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%
111.121677223167661316788231678404167838916778900.06
211.131691517169323316923750.08
单位质量响应值RSD%判断
150889.39152055.260.55数据可信
供试品溶液-cbjz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%
5min1271078-27107815.76915.526.0415.7715.526.05
2272184-27218415.83315.83
3253260-25326014.73214.73
4253509-25350914.74714.75
5294610-29461017.13717.14
6255984-25598414.89114.89
10min1402939-40293923.43923.773.6923.4723.803.68
2402476-40247623.41223.44
3435792-43579225.35025.37
4396980-39698023.09223.12
5416383-41638324.22124.25
6397283-39728323.11023.13
15min1399438-39943823.23523.672.2923.3023.742.28
2405793-40579323.60523.67
3397497-39749723.12223.19
4423628-42362824.64224.71
5405906-40590623.61223.68
6409244-40924423.80623.87
20min1388290-38829022.58723.334.8522.6923.434.82
2390899-39089922.73922.84
3409226-40922623.80523.91
4437334-43733425.44025.54
5388549-38854922.60222.71
6391928-39192822.79822.90
30min1445409-44540925.90923.668.1926.0523.818.13
2385611-38561122.43122.57
3382861-38286122.27122.42
4453375-45337526.37326.52
5391980-39198022.80122.95
6381581-38158122.19722.34
45min1388805-38880522.61722.633.6022.8022.813.58
2392879-39287922.85423.03
3381439-38143922.18822.37
4381876-38187622.21422.40
5414534-41453424.11324.30
6374762-37476221.80021.98
60min1372578-37257821.67322.965.0221.9023.184.97
2417394-41739424.28024.50
3418390-41839024.33824.56
4382080-38208022.22622.45
5397717-39771723.13523.36
6379672-37967222.08522.30
极限1376579-37657921.90622.130.9822.1622.390.96
2384291-38429122.35422.61
3381847-38184722.21222.47
4379218-37921822.05922.32
5376290-37629021.88922.15
6384760-38476022.38122.63
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