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%
111.103099423102563105993098243104603102160.11
211.073101323095013098160.15
单位质量响应值RSD%判断
27947.3927986.990.11数据可信
供试品溶液-6031001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%
5min199070-9907031.88134.2311.9431.8834.2311.94
2131332-13133242.26342.26
3105462-10546233.93833.94
4105177-10517733.84733.85
5100490-10049032.33832.34
696715-9671531.12331.12
10min1273751-27375188.09588.582.0788.1588.642.08
2279966-27996690.09590.17
3273074-27307487.87787.93
4281322-28132290.53190.59
5277693-27769389.36389.42
6265753-26575385.52185.57
15min1327501-327501105.392105.751.69105.59105.951.69
2328513-328513105.717105.94
3327885-327885105.515105.72
4338798-338798109.027109.23
5326987-326987105.226105.43
6321916-321916103.594103.79
20min1353619-353619113.797114.471.47114.17114.851.47
2351181-351181113.012113.41
3355522-355522114.409114.79
4365950-365950117.765118.15
5354582-354582114.107114.48
6353458-353458113.745114.11
30min1377662-377662121.534121.911.46122.10122.481.46
2372579-372579119.898120.48
3378420-378420121.778122.35
4389161-389161125.234125.82
5378380-378380121.765122.33
6376801-376801121.257121.81
45min1390518-390518125.671125.591.29126.44126.371.28
2383090-383090123.281124.07
3388672-388672125.077125.85
4398409-398409128.210129.00
5391951-391951126.132126.90
6389010-389010125.186125.94
60min1393444-393444126.613126.501.18127.59127.491.18
2386398-386398124.345125.34
3391676-391676126.044127.02
4400547-400547128.898129.91
5394855-394855127.067128.05
6391695-391695126.050127.02
极限1393770-393770126.717126.281.27127.91127.481.27
2384580-384580123.760124.96
3391671-391671126.042127.23
4399857-399857128.676129.90
5393827-393827126.736127.93
6390838-390838125.774126.95
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%
1 11.124091254093094093014081474092124090190.13
2 11.184091414086764089080.09
单位质量响应值RSD%判断
36782.2836574.960.40数据可信
供试品溶液-6031001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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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%
111.103101533102903106083103113103153103350.06
211.073098323098083098200.01
单位质量响应值RSD%判断
27958.1127987.350.08数据可信
供试品溶液-6031002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%
5min195829-9582930.83232.0519.3730.8332.0519.36
2115522-11552237.16837.17
390891-9089129.24329.24
469979-6997922.51522.52
5124860-12486040.17340.17
6100649-10064932.38332.38
10min1261060-26106083.99486.473.5584.0586.523.56
2275087-27508788.50788.57
3265171-26517185.31785.37
4260304-26030483.75183.79
5284954-28495491.68291.75
6265923-26592385.55985.61
15min1326884-326884105.172105.901.53105.36106.101.54
2330794-330794106.430106.64
3326397-326397105.016105.21
4327193-327193105.272105.45
5338605-338605108.943109.16
6325032-325032104.576104.77
20min1357844-357844115.133115.171.03115.50115.551.04
2358890-358890115.470115.86
3353334-353334113.682114.05
4358607-358607115.379115.73
5364035-364035117.125117.53
6355103-355103114.252114.62
30min1385426-385426124.008123.660.50124.57124.230.50
2385423-385423124.007124.59
3380942-380942122.565123.12
4384711-384711123.778124.32
5386091-386091124.222124.82
6383524-383524123.396123.96
45min1397577-397577127.917128.110.76128.68128.880.76
2397944-397944128.035128.82
3395059-395059127.107127.87
4395882-395882127.372128.12
5398907-398907128.345129.15
6403608-403608129.858130.62
60min1400887-400887128.982128.590.51129.96129.580.51
2402091-402091129.370130.37
3396525-396525127.579128.55
4398109-398109128.088129.05
5400240-400240128.774129.79
6400150-400150128.745129.73
极限1400515-400515128.862128.430.48130.06129.630.48
2400204-400204128.762129.98
3396075-396075127.434128.62
4397571-397571127.915129.09
5400289-400289128.790130.02
6400407-400407128.828130.03
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%
1 11.124097094101094104394098924098454099990.07
2 11.184090814090814090810.00
单位质量响应值RSD%判断
36870.4136590.430.54数据可信
供试品溶液-6031002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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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%
111.103106903108663107013109393107583107910.04
211.073098233103113100670.12
单位质量响应值RSD%判断
27999.1928009.670.03数据可信
供试品溶液-6031101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%
5min1260564-26056483.73959.9324.8483.7459.9424.84
2156624-15662450.33550.34
3147009-14700947.24547.25
4207840-20784066.79566.80
5204977-20497765.87565.88
6141882-14188245.59845.60
10min1308753-30875399.22697.314.1699.3797.424.17
2300555-30055596.59296.68
3302632-30263297.25997.34
4303335-30333597.48597.60
5320029-320029102.850102.96
6281511-28151190.47190.55
15min1311377-311377100.070100.881.90100.37101.141.90
2309184-30918499.36599.61
3314804-314804101.171101.41
4309379-30937999.42899.70
5325168-325168104.502104.78
6313510-313510100.755100.98
20min1310911-31091199.920101.141.81100.39101.571.81
2309411-30941199.43899.85
3316404-316404101.685102.09
4310969-31096999.939100.38
5324786-324786104.379104.83
6315712-315712101.463101.86
30min1310345-31034599.738101.061.94100.38101.661.94
2309979-30997999.620100.20
3316441-316441101.697102.28
4309363-30936399.422100.03
5325314-325314104.549105.18
6315305-315305101.332101.90
45min1311904-311904100.239101.341.66101.04102.111.66
2310289-31028999.720100.46
3316884-316884101.839102.59
4312706-312706100.497101.27
5324833-324833104.394105.20
6315363-315363101.351102.08
60min1310468-31046899.778100.901.92100.75101.841.91
2309571-30957199.489100.40
3317009-317009101.880102.80
4307914-30791498.95799.90
5324062-324062104.146105.12
6314826-314826101.178102.08
极限1310662-31066299.840100.881.87100.98101.991.87
2309729-30972999.540100.61
3315274-315274101.322102.41
4308663-30866399.197100.30
5324594-324594104.317105.47
6314558-314558101.092102.16
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%
1 11.124101654104384101194099334102774101860.05
2 11.184087514089294088400.04
单位质量响应值RSD%判断
36887.2336568.870.62数据可信
供试品溶液-6031101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%
5min174400-7440018.21316.6115.9718.2116.6015.97
262105-6210515.20415.20
373593-7359318.01618.02
482731-8273120.25320.25
553586-5358613.11813.12
660596-6059614.83414.83
10min1277739-27773967.99264.836.6968.0264.866.69
2257807-25780763.11263.14
3265832-26583265.07765.11
4282617-28261769.18669.22
5271537-27153766.47366.50
6233404-23340457.13857.16
15min1339819-33981983.18982.022.3083.3382.152.31
2333858-33385881.73081.86
3337101-33710182.52482.66
4341970-34197083.71683.86
5337115-33711582.52782.66
6320364-32036478.42678.55
20min1363224-36322488.91988.161.4889.2088.431.49
2359304-35930487.95988.23
3361716-36171688.54988.83
4365113-36511389.38189.67
5361302-36130288.44888.72
6350045-35004585.69285.94
30min1383388-38338893.85592.811.0594.2993.231.06
2378069-37806992.55392.97
3378743-37874392.71893.14
4380571-38057193.16593.60
5381875-38187593.48493.90
6372118-37211891.09691.49
45min1393769-39376996.39694.711.1396.9895.281.13
2385052-38505294.26294.83
3385233-38523394.30794.88
4386370-38637094.58595.18
5389597-38959795.37595.95
6381151-38115193.30793.85
60min1394093-39409396.47594.941.0397.2295.671.04
2385149-38514994.28695.01
3387317-38731794.81795.55
4387318-38731894.81795.57
5390365-39036595.56396.30
6382690-38269093.68494.38
极限1394280-39428096.52194.921.1297.4395.821.13
2385470-38547094.36595.25
3384895-38489594.22495.12
4388424-38842495.08896.00
5390930-39093095.70196.59
6382508-38250893.63994.50
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%
111.103116973116393114873115223115833115860.03
211.073114043113233113640.02
单位质量响应值RSD%判断
28070.8128126.830.15数据可信
供试品溶液-6031101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%
5min1288844-28884492.51688.5611.3992.5288.5611.39
2223278-22327871.51671.52
3307816-30781698.59398.59
4254397-25439781.48381.48
5291418-29141893.34193.34
6293161-29316193.89993.90
10min1318282-318282101.945101.401.90102.10101.551.90
2314237-314237100.650100.77
3322697-322697103.359103.52
4307180-30718098.38998.53
5322861-322861103.412103.57
6314198-314198100.637100.79
15min1320542-320542102.669102.121.83102.99102.441.83
2318853-318853102.128102.42
3324073-324073103.800104.14
4308687-30868798.87299.17
5324324-324324103.880104.21
6316513-316513101.379101.70
20min1318717-318717102.085101.981.71102.58102.471.72
2318583-318583102.042102.50
3323462-323462103.604104.11
4309055-30905598.99099.45
5323966-323966103.766104.27
6316583-316583101.401101.89
30min1318987-318987102.171101.961.78102.84102.621.78
2318516-318516102.020102.65
3323508-323508103.619104.30
4308924-30892498.94899.58
5324407-324407103.907104.58
6315676-315676101.111101.77
45min1318698-318698102.078101.881.44102.91102.701.45
2317688-317688101.755102.55
3323191-323191103.518104.37
4310961-31096199.600100.39
5322477-322477103.289104.14
6315378-315378101.015101.85
60min1318118-318118101.893101.871.70102.90102.861.71
2315949-315949101.198102.16
3323499-323499103.616104.64
4309728-30972899.205100.17
5324378-324378103.898104.92
6316544-316544101.389102.39
极限1319134-319134102.218101.711.56103.39102.871.57
2317183-317183101.593102.73
3321460-321460102.963104.16
4308779-30877998.901100.03
5322548-322548103.312104.50
6316095-316095101.245102.41
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%
1 11.124107714110244109194111064112924110220.05
2 11.184108684107914108300.02
单位质量响应值RSD%判断
36962.4136746.870.42数据可信
供试品溶液-6031101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%
5min1145792-14579235.56737.4611.4335.5737.4611.43
2143480-14348035.00335.00
3162237-16223739.57939.58
4183470-18347044.75944.76
5133420-13342032.54932.55
6152917-15291737.30637.31
10min1300957-30095773.42273.402.6073.4873.472.60
2306150-30615074.68974.75
3306636-30663674.80774.87
4308482-30848275.25775.33
5289121-28912170.53470.59
6293959-29395971.71471.78
15min1343996-34399683.92184.011.8984.1084.191.89
2355463-35546386.71986.90
3346267-34626784.47584.67
4344558-34455884.05984.26
5338416-33841682.56082.73
6337445-33744582.32382.50
20min1360454-36045487.93788.461.7088.2688.781.70
2374211-37421191.29391.62
3363436-36343688.66489.00
4362011-36201188.31688.66
5358282-35828287.40787.72
6357087-35708787.11587.43
30min1376652-37665291.88892.241.4692.3692.721.46
2388844-38884494.86395.34
3377950-37795092.20592.68
4374788-37478891.43391.92
5376980-37698091.96892.42
6373427-37342791.10191.57
45min1383710-38371093.61093.691.2394.2394.311.23
2393270-39327095.94296.58
3383417-38341793.53994.17
4382208-38220893.24493.88
5381182-38118292.99393.60
6380407-38040792.80493.42
60min1384002-38400293.68193.990.9094.4694.780.90
2392053-39205395.64596.44
3385019-38501993.92994.72
4382101-38210193.21894.01
5384462-38446293.79494.56
6384051-38405193.69394.46
极限1385172-38517293.96793.891.1794.9094.821.16
2393532-39353296.00696.96
3383022-38302293.44294.39
4381078-38107892.96893.92
5382456-38245693.30494.22
6383795-38379593.63194.56
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