恩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101566-202301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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.893093833097663091543094143091813093800.08
210.923078363077373077860.03
单位质量响应值RSD%判断
28409.5528185.530.56数据可信
加速3月-供试品溶液-6020503-1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%
5min1304376-30437696.80889.2422.0696.8189.2422.06
2306281-30628197.41497.41
3303166-30316696.42396.42
4154335-15433549.08749.09
5308831-30883198.22598.22
6306441-30644197.46597.46
10min1314784-314784100.11898.984.02100.2899.134.05
2314078-31407899.894100.06
3313928-31392899.846100.01
4286169-28616991.01791.10
5319336-319336101.566101.73
6318937-318937101.439101.60
15min1316794-316794100.758100.271.78101.09100.581.81
2314653-314653100.077100.41
3314543-314543100.042100.37
4305083-30508397.03397.27
5319883-319883101.740102.07
6320606-320606101.970102.30
20min1316245-316245100.583100.511.21101.08100.991.24
2315224-315224100.258100.75
3315201-315201100.251100.74
4309642-30964298.48398.88
5319622-319622101.657102.16
6320153-320153101.826102.33
30min1317093-317093100.853100.780.83101.52101.430.86
2314993-314993100.185100.85
3315242-315242100.264100.92
4313901-31390199.837100.40
5320264-320264101.861102.53
6319684-319684101.677102.35
45min1317165-317165100.876100.920.74101.71101.730.74
2314804-314804100.125100.95
3314930-314930100.165100.99
4316819-316819100.765101.49
5320263-320263101.861102.70
6319754-319754101.699102.54
60min1317084-317084100.850100.930.68101.85101.920.69
2315244-315244100.265101.26
3314971-314971100.178101.17
4317095-317095100.853101.75
5320313-320313101.877102.89
6319367-319367101.576102.59
极限1317602-317602101.015101.250.78102.18102.400.75
2316133-316133100.547101.71
3315211-315211100.254101.42
4321844-321844102.364103.43
5319528-319528101.627102.81
6319648-319648101.665102.84
恩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对照品来源中检院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%
111.144000854007514010604007884005474006460.10
211.153980333978913979620.03
单位质量响应值RSD%判断
35964.6335691.660.54数据可信
加速3月-供试品溶液-6020503-1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%
5min1204917-20491751.42458.5513.8551.4258.5513.85
2268785-26878567.45267.45
3233772-23377258.66558.67
4187760-18776047.11947.12
5238966-23896659.96959.97
6265676-26567666.67266.67
10min1298290-29829074.85681.384.6174.9481.484.62
2339213-33921385.12685.24
3325582-32558281.70581.80
4316645-31664579.46379.54
5331367-33136783.15783.26
6334701-33470183.99484.10
15min1337804-33780484.77288.942.6684.9889.172.67
2360020-36002090.34890.60
3354015-35401588.84189.07
4351335-35133588.16888.38
5364866-36486691.56491.80
6358462-35846289.95790.21
20min1357628-35762889.74792.441.8690.1092.821.87
2370636-37063693.01293.42
3367277-36727792.16992.55
4366120-36612091.87892.24
5378608-37860895.01295.40
6369872-36987292.82093.22
30min1375968-37596894.35095.431.5494.8595.961.54
2378315-37831594.93995.50
3376704-37670494.53495.07
4379359-37935995.20195.71
5391792-39179298.32198.87
6379438-37943895.22195.78
45min1385342-38534296.70296.981.5197.3697.681.51
2382023-38202395.86996.59
3383443-38344396.22696.92
4385685-38568596.78897.46
5398020-39802099.884100.60
6384202-38420296.41697.13
60min1387253-38725397.18297.441.5498.0098.301.54
2383706-38370696.29297.17
3385127-38512796.64897.50
4387263-38726397.18498.02
5400165-400165100.422101.30
6386143-38614396.90397.78
极限1392295-39229598.44797.721.4899.4398.741.47
2383802-38380296.31697.35
3387061-38706197.13498.15
4386256-38625696.93297.92
5399646-399646100.292101.34
6387314-38731497.19798.23
恩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101566-202301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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.893080563087453096763103343107903095200.37
210.923077803078553078180.02
单位质量响应值RSD%判断
28422.4128188.460.59数据可信
加速3月-供试品溶液-6020503-1加速3月批-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%
5min1302165-30216596.07895.332.0996.0895.332.09
2299283-29928395.16295.16
3288649-28864991.78091.78
4300113-30011395.42695.43
5307835-30783597.88197.88
6300847-30084795.65995.66
10min1313845-31384599.79299.261.5299.9599.421.53
2309822-30982298.51398.67
3308908-30890898.22298.38
4309019-30901998.25798.42
5321116-321116102.104102.27
6310269-31026998.65598.81
15min1314433-31443399.97999.731.41100.31100.061.41
2311782-31178299.13699.46
3310518-31051898.73499.05
4310772-31077298.81599.14
5322166-322166102.438102.77
6312265-31226599.29099.61
20min1314729-314729100.07399.971.45100.57100.461.45
2313138-31313899.567100.06
3311379-31137999.00899.49
4311292-31129298.98099.47
5323317-323317102.804103.31
6312567-31256799.38699.87
30min1315660-315660100.36999.971.46101.03100.631.47
2312622-31262299.403100.06
3311237-31123798.96399.61
4311115-31111598.92499.58
5323147-323147102.750103.43
6312616-31261699.401100.06
45min1315051-315051100.17599.971.48101.00100.801.48
2313259-31325999.606100.43
3311055-31105598.90599.72
4311401-31140199.01599.83
5323390-323390102.827103.67
6312282-31228299.295100.12
60min1314770-314770100.08699.921.33101.08100.911.33
2313670-31367099.736100.72
3311167-31116798.94099.92
4311654-31165499.095100.08
5322261-322261102.468103.49
6311894-31189499.172100.16
极限1314262-31426299.92499.851.55101.09101.011.55
2312535-31253599.375100.53
3310750-31075098.80899.95
4311571-31157199.069100.22
5323620-323620102.900104.09
6311522-31152299.053100.20
恩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对照品来源中检院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%
111.143986383994654001264007434016644001270.30
211.153976123974483975300.03
单位质量响应值RSD%判断
35918.0435652.910.53数据可信
加速3月-供试品溶液-6020503-1加速3月批-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%
5min1244149-24414961.34362.226.3761.3462.226.38
2255108-25510864.09664.10
3254603-25460363.96963.97
4254921-25492164.04964.05
5259795-25979565.27465.27
6217196-21719654.57154.57
10min1326850-32685082.12182.243.9282.2282.343.92
2330722-33072283.09483.20
3333642-33364283.82883.93
4330009-33000982.91583.02
5339885-33988585.39685.51
6302755-30275576.06776.16
15min1353449-35344988.80488.932.7689.0489.162.77
2353243-35324388.75389.00
3361146-36114690.73890.98
4355007-35500789.19689.44
5364436-36443691.56591.82
6336296-33629684.49584.71
20min1366476-36647692.07792.152.3992.4692.542.40
2364156-36415691.49491.89
3374353-37435394.05694.45
4367153-36715392.24792.64
5376641-37664194.63195.04
6351899-35189988.41588.77
30min1378289-37828995.04594.952.0995.5995.502.10
2371171-37117193.25793.80
3386194-38619497.03197.59
4379317-37931795.30495.85
5385988-38598896.98097.54
6366546-36654692.09592.60
45min1383511-38351196.35796.561.9197.0697.261.92
2376620-37662094.62695.33
3392280-39228098.56199.28
4386049-38604996.99597.70
5392106-39210698.51799.24
6375264-37526494.28594.94
60min1385484-38548496.85396.951.7997.7197.811.80
2378525-37852595.10595.96
3394089-39408999.01599.90
4386998-38699897.23398.10
5392567-39256798.63399.52
6377512-37751294.85095.67
极限1386718-38671897.16397.301.9198.1898.321.91
2377601-37760194.87295.89
3395663-39566399.411100.46
4386717-38671797.16398.19
5395650-39565099.407100.46
6381176-38117695.77196.75
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