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%
110.973131023128463129873130443131133130180.04
211.073142233140813141520.04
单位质量响应值RSD%判断
28534.0028378.680.39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%
5min139622-3962212.31811.3831.7112.3211.3831.72
245631-4563114.18714.19
340666-4066612.64312.64
440051-4005112.45212.45
513356-133564.1524.15
640325-4032512.53712.54
10min155920-5592017.38614.9326.2517.4114.9526.25
258810-5881018.28418.31
352647-5264716.36816.39
448242-4824214.99815.02
523671-236717.3597.37
648749-4874915.15615.18
15min157307-5730717.81715.8818.0017.8715.9318.02
258165-5816518.08318.14
355564-5556417.27517.32
449467-4946715.37915.43
533505-3350510.41710.44
652499-5249916.32216.37
20min156874-5687417.68216.4211.9117.7616.4911.97
258759-5875918.26818.35
357236-5723617.79517.87
449414-4941415.36315.43
542097-4209713.08813.12
652591-5259116.35116.42
30min157201-5720117.78417.066.6417.8917.156.65
258852-5885218.29718.41
357762-5776217.95818.06
449474-4947415.38115.48
552813-5281316.42016.48
653059-5305916.49616.60
45min156951-5695117.70617.426.6817.8417.556.62
258401-5840118.15718.30
359052-5905218.35918.50
450378-5037815.66315.79
559042-5904218.35618.44
652380-5238016.28516.41
60min155639-5563917.29817.296.3117.4717.456.26
258033-5803318.04218.22
358570-5857018.20918.38
450733-5073315.77315.92
558733-5873318.26018.38
651949-5194916.15116.31
极限156249-5624917.48818.563.2717.6818.743.20
261209-6120919.03019.24
359811-5981118.59518.79
459604-5960418.53118.71
561878-6187819.23819.38
659416-5941618.47218.65
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%
111.133955583956933954713955143956963955860.03
211.163975333973093974210.04
单位质量响应值RSD%判断
35542.3235611.200.14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%
5min125472-254723.2222.2842.483.222.2842.44
222490-224902.8452.84
316661-166612.1072.11
424359-243593.0813.08
55688-56880.7190.72
613295-132951.6821.68
10min139509-395094.9973.8742.235.003.8742.23
244572-445725.6385.64
325716-257163.2533.26
440401-404015.1105.12
511800-118001.4931.49
621387-213872.7052.71
15min146432-464325.8734.6638.975.894.6838.95
251467-514676.5106.52
332260-322604.0804.09
448720-487206.1626.18
515055-150551.9041.91
627363-273633.4613.47
20min149626-496266.2775.2935.766.305.3035.78
257882-578827.3217.35
337905-379054.7944.81
454556-545566.9016.92
519078-190782.4132.42
631699-316994.0104.02
30min154584-545846.9046.1830.386.946.2130.45
264142-641428.1138.15
346766-467665.9155.94
463185-631857.9928.03
526118-261183.3043.31
638425-384254.8604.88
45min159802-598027.5647.0523.207.617.0923.28
268399-683998.6528.70
356155-561557.1037.14
468617-686178.6798.73
535878-358784.5384.55
645762-457625.7885.82
60min162152-621527.8617.5619.397.927.6119.46
270560-705608.9258.99
362256-622567.8757.92
471138-711388.9989.06
541161-411615.2065.23
651532-515326.5186.56
极限178324-783249.90710.031.959.9810.091.88
279334-7933410.03510.11
382190-8219010.39610.45
477718-777189.8309.91
579130-7913010.00910.04
679006-790069.99310.04
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%
110.973129773130273127993126663132143129370.07
211.073132463134293133380.05
单位质量响应值RSD%判断
28526.6228305.150.56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%
5min1176388-17638854.91764.4928.9954.9264.5028.99
2264813-26481382.44882.45
3264960-26496082.49482.49
4251446-25144678.28678.29
5150579-15057946.88246.88
6134693-13469341.93641.94
10min1312143-31214397.18488.3414.0397.2888.4514.04
2302367-30236794.14094.28
3299995-29999593.40293.54
4293743-29374391.45591.59
5290247-29024790.36790.44
6203979-20397963.50863.58
15min1322168-322168100.30592.3411.04100.5692.6011.05
2306390-30639095.39395.69
3309121-30912196.24396.54
4304285-30428594.73895.02
5306527-30652795.43695.66
6231066-23106671.94172.12
20min1326505-326505101.65694.359.53102.0894.769.54
2308748-30874896.12796.58
3313129-31312997.49197.94
4310975-31097596.82097.26
5313442-31344297.58997.98
6245527-24552776.44476.74
30min1330576-330576102.92396.098.04103.5196.658.07
2310798-31079896.76597.38
3317263-31726398.77899.39
4314975-31497598.06698.67
5318288-31828899.09799.65
6259814-25981480.89281.31
45min1331957-331957103.35397.585.73104.1198.305.77
2312610-31261097.32998.10
3317920-31792098.98399.76
4318412-31841299.13699.90
5320389-32038999.751100.47
6279159-27915986.91587.47
60min1332585-332585103.54998.185.14104.4899.075.17
2313435-31343597.58698.52
3319225-31922599.389100.33
4319292-31929299.410100.34
5322633-322633100.450101.33
6284944-28494488.71689.42
极限1336317-336317104.711100.763.38105.82101.813.44
2324568-324568101.053102.15
3323071-323071100.586101.70
4327375-327375101.926103.02
5327006-327006101.812102.86
6303370-30337094.45395.30
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%
111.133953903950213952873951963950943951980.04
211.163959403959533959460.01
单位质量响应值RSD%判断
35507.4635479.030.06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%
5min1150590-15059019.09315.8523.6919.0915.8523.68
286470-8647010.96310.96
3126136-12613615.99215.99
4144486-14448618.31918.32
5151430-15143019.19919.20
690909-9090911.52611.53
10min1245671-24567131.14731.284.5431.1831.314.55
2243147-24314730.82730.85
3257604-25760432.66032.69
4244661-24466131.01931.05
5260155-26015532.98433.02
6229117-22911729.04929.07
15min1286269-28626936.29537.603.7036.3837.683.70
2302676-30267638.37538.44
3313129-31312939.70039.78
4289219-28921936.66936.75
5301654-30165438.24538.33
6286368-28636836.30736.37
20min1310051-31005139.31040.702.9039.4540.842.89
2326616-32661641.41041.54
3334913-33491342.46242.61
4316957-31695740.18540.33
5324260-32426041.11141.26
6313353-31335339.72839.86
30min1332082-33208242.10343.582.4242.3143.792.42
2348306-34830644.16044.36
3355517-35551745.07445.29
4340568-34056843.17943.39
5347294-34729444.03244.25
6338635-33863542.93443.13
45min1345169-34516943.76245.401.9244.0445.681.91
2361790-36179045.86946.15
3364247-36424746.18146.47
4356261-35626145.16845.45
5359988-35998845.64145.93
6361054-36105445.77646.04
60min1351110-35111044.51546.211.9444.8746.561.92
2366480-36648046.46446.82
3369249-36924946.81547.19
4362500-36250045.95946.32
5367514-36751446.59546.96
6369843-36984346.89047.23
极限1371230-37123047.06648.271.6147.4948.701.61
2381464-38146448.36448.79
3380518-38051848.24448.69
4382798-38279848.53348.97
5389916-38991649.43549.88
6378205-37820547.95148.37
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%
110.973167403165183164323159503154383162160.17
211.073159463162763161110.08
单位质量响应值RSD%判断
28825.5228555.650.67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%
5min1235524-23552472.62864.8423.4672.6364.8423.46
2230969-23096971.22371.22
3211400-21140065.18965.19
4231816-23181671.48471.48
5111620-11162034.42034.42
6240283-24028374.09574.10
10min1275340-27534084.90582.168.7985.0382.278.80
2291188-29118889.79289.91
3243552-24355275.10375.21
4274508-27450884.64984.77
5231726-23172671.45671.51
6282349-28234987.06787.19
15min1279491-27949186.18585.976.8586.4586.226.86
2303625-30362593.62893.90
3257796-25779679.49579.73
4282997-28299787.26787.53
5255616-25561678.82379.00
6293211-29321190.41690.68
20min1280685-28068586.55487.906.0286.9688.296.03
2308403-30840395.10195.53
3263451-26345181.23981.61
4288032-28803288.81989.22
5270247-27024783.33583.64
6299540-29954092.36892.79
30min1284146-28414687.62189.475.6888.1790.015.69
2313210-31321096.58397.17
3270454-27045483.39983.90
4290889-29088989.70090.25
5277025-27702585.42585.87
6305184-30518494.10894.68
45min1283919-28391987.55190.885.4388.2591.565.45
2317569-31756997.92798.67
3278827-27882785.98186.62
4296887-29688791.55092.25
5281701-28170186.86787.46
6309373-30937395.40096.13
60min1283241-28324187.34291.115.6288.1891.945.63
2319246-31924698.44599.35
3278944-27894486.01786.80
4296568-29656891.45192.31
5283576-28357687.44588.18
6311099-31109995.93296.82
极限1290349-29034989.53496.944.4090.5297.924.38
2325797-325797100.465101.54
3326298-326298100.619101.55
4311184-31118495.95996.97
5309580-30958095.46496.34
6322943-32294399.585100.63
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%
111.133996073993793994643981803976823988620.22
211.163992543993523993030.02
单位质量响应值RSD%判断
35836.6635779.840.12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%
5min156519-565197.1037.3724.847.107.3724.88
242037-420375.2835.28
374607-746079.3769.38
462125-621257.8077.81
542284-422845.3145.31
674346-743469.3439.34
10min1143095-14309517.98316.4913.1817.9916.5013.18
2102856-10285612.92612.93
3153212-15321219.25419.27
4124514-12451415.64815.66
5134915-13491516.95516.96
6128746-12874616.17916.20
15min1193490-19349024.31621.9913.2324.3622.0313.24
2140005-14000517.59417.62
3203457-20345725.56825.62
4165632-16563220.81520.85
5183877-18387723.10823.14
6163342-16334220.52720.57
20min1226019-22601928.40425.8612.4428.4925.9312.45
2167931-16793121.10421.16
3235119-23511929.54729.64
4195308-19530824.54424.62
5220176-22017627.66927.75
6189894-18989423.86423.94
30min1271380-27138034.10431.1611.0134.2331.2811.00
2210500-21050026.45326.55
3276891-27689134.79734.94
4233875-23387529.39129.51
5266579-26657933.50133.62
6228306-22830628.69128.81
45min1301023-30102337.82935.878.7938.0236.048.80
2254757-25475732.01532.15
3312929-31292939.32639.52
4270414-27041433.98334.15
5308692-30869238.79338.97
6264547-26454733.24533.41
60min1317370-31737039.88438.327.2240.1338.557.24
2280280-28028035.22335.41
3326547-32654741.03741.30
4290938-29093836.56236.78
5329482-32948241.40641.65
6285102-28510235.82936.05
极限1340976-34097642.85042.532.9043.1742.822.94
2328408-32840841.27141.52
3346864-34686443.59043.92
4330356-33035641.51641.80
5352213-35221344.26244.57
6331518-33151841.66241.94
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%
110.973172403170303170173169423172243170910.05
211.073162513160723161620.05
单位质量响应值RSD%判断
28905.2928560.250.85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%
5min1270843-27084383.39779.726.7283.4079.726.72
2254274-25427478.29578.30
3254666-25466678.41678.42
4275836-27583684.93584.93
5269459-26945982.97182.97
6228408-22840870.33170.33
10min1314604-31460496.87295.712.5097.0195.842.50
2299196-29919692.12892.26
3312929-31292996.35696.49
4304174-30417493.66093.80
5320603-32060398.71998.86
6313446-31344696.51596.63
15min1318948-31894898.21097.213.0098.5197.502.99
2301810-30181092.93393.22
3319499-31949998.37998.67
4307083-30708394.55694.85
5327575-327575100.866101.17
6319355-31935598.33598.61
20min1319603-31960398.41197.502.7898.8897.962.78
2302587-30258793.17293.61
3318443-31844398.05498.51
4310722-31072295.67796.13
5327887-327887100.962101.43
6320652-32065298.73499.18
30min1319369-31936998.33997.352.8698.9797.972.85
2302928-30292893.27793.87
3319506-31950698.38199.00
4307674-30767494.73895.35
5327178-327178100.744101.38
6320300-32030098.62699.23
45min1321331-32133198.94397.582.8899.7498.362.88
2302822-30282293.24493.99
3319729-31972998.45099.23
4309496-30949695.29996.07
5328051-328051101.013101.82
6320080-32008098.55899.33
60min1318659-31865998.12197.252.8499.0898.202.83
2303686-30368693.51094.42
3319329-31932998.32799.27
4306459-30645994.36495.30
5327190-327190100.747101.72
6319731-31973198.45199.39
极限1319212-31921298.29197.372.9799.4198.472.97
2302646-30264693.19094.25
3318185-31818597.97599.09
4307726-30772694.75495.84
5328331-328331101.099102.24
6321210-32121098.906100.01
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)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%
111.134000993998383999614002084000444000300.04
211.163991583992443992010.02
单位质量响应值RSD%判断
35941.6035770.700.34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%
5min1180509-18050922.65416.6322.4722.6516.6322.46
2121067-12106715.19415.19
3115433-11543314.48714.49
4156613-15661319.65519.66
5101359-10135912.72112.72
6120151-12015115.07915.08
10min1289748-28974836.36434.253.3136.4034.283.32
2269975-26997533.88233.91
3264239-26423933.16333.19
4275601-27560134.58934.62
5268175-26817533.65733.68
6269778-26977833.85833.88
15min1327840-32784041.14539.951.5641.2440.041.57
2316560-31656039.72939.81
3317314-31731439.82439.90
4313673-31367339.36739.46
5318901-31890140.02340.10
6315824-31582439.63739.72
20min1345672-34567243.38342.611.1843.5542.761.19
2338512-33851242.48442.63
3338283-33828342.45542.60
4334522-33452241.98342.14
5342652-34265243.00443.15
6337393-33739342.34442.49
30min1363595-36359545.63245.001.4145.8745.221.41
2359095-35909545.06745.29
3358295-35829544.96745.18
4349842-34984243.90644.13
5363361-36336145.60345.82
6357221-35722144.83245.05
45min1376975-37697547.31146.721.6247.6347.021.62
2371787-37178746.66046.95
3376526-37652647.25547.55
4362662-36266245.51545.81
5377679-37767947.40047.69
6367847-36784746.16646.46
60min1379296-37929647.60247.281.7948.0047.661.78
2377548-37754847.38347.75
3382357-38235747.98748.36
4365399-36539945.85846.23
5383184-38318448.09048.46
6372597-37259746.76247.13
极限1381666-38166647.90047.491.8748.3747.941.86
2375045-37504547.06947.52
3384210-38421048.21948.67
4368298-36829846.22246.67
5386958-38695848.56449.01
6374149-37414946.95747.40
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