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(%) 100.0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%
111.273101653103323100453103423100683101900.05
211.213121383120023120700.04
单位质量响应值RSD%判断
27523.5127838.540.81数据可信
供试品溶液-25112402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%
5min1151330-15133049.20456.7322.1149.2056.7322.11
2162141-16214152.71952.72
3141165-14116545.89945.90
4150312-15031248.87348.87
5240131-24013178.07778.08
6201779-20177965.60765.61
10min1291637-29163794.82494.541.0494.9194.641.05
2288825-28882593.90994.00
3292633-29263395.14895.22
4285894-28589492.95693.04
5294371-29437195.71395.84
6291318-29131894.72094.83
15min1299563-29956397.40196.730.6597.6496.980.64
2298098-29809896.92497.17
3299207-29920797.28597.52
4296033-29603396.25396.49
5297444-29744496.71297.00
6294585-29458595.78296.05
20min1300322-30032297.64896.790.7598.0597.200.74
2297779-29777996.82197.23
3300078-30007897.56897.97
4296348-29634896.35596.75
5296910-29691096.53896.99
6294606-29460695.78996.22
30min1300971-30097197.85996.890.7698.4297.460.75
2298167-29816796.94797.51
3300127-30012797.58498.14
4296628-29662896.44797.00
5297192-29719296.63097.24
6294907-29490795.88796.47
45min1300461-30046197.69396.820.7998.4297.560.78
2298095-29809596.92497.65
3299909-29990997.51398.24
4296451-29645196.38997.11
5297687-29768796.79197.56
6294106-29410695.62796.37
60min1300435-30043597.68496.931.0998.5897.821.07
2302516-30251698.36199.25
3299225-29922597.29198.18
4296210-29621096.31197.19
5296560-29656096.42497.36
6293666-29366695.48396.39
极限1299911-29991197.51496.540.9098.5797.600.88
2298836-29883697.16498.22
3298516-29851697.06098.11
4295376-29537696.03997.08
5296062-29606296.26297.36
6292809-29280995.20596.27
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%
111.143919553922883918493915703919533919230.07
211.083935363939913937640.09
单位质量响应值RSD%判断
35181.6035538.270.72数据可信
供试品溶液-25112402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%
5min171501-7150118.18120.6511.1218.1820.6511.12
295481-9548124.27924.28
377355-7735519.67019.67
478007-7800719.83519.84
588782-8878222.57522.58
676056-7605619.33919.34
10min1233793-23379359.44863.093.4059.4863.133.40
2258888-25888865.82965.87
3247077-24707762.82662.86
4245652-24565262.46462.50
5252430-25243064.18764.22
6250927-25092763.80563.84
15min1294602-29460274.91177.471.8675.0477.611.86
2308229-30822978.37678.53
3303305-30330577.12477.26
4311188-31118879.12879.27
5305143-30514377.59177.74
6305591-30559177.70577.84
20min1319588-31958881.26483.541.7881.5283.821.78
2328918-32891883.63683.92
3327552-32755283.28983.56
4337930-33793085.92886.20
5327814-32781483.35683.63
6329533-32953383.79384.06
30min1343416-34341687.32389.341.6587.7189.741.65
2350314-35031489.07789.50
3349466-34946688.86189.27
4361124-36112491.82692.24
5350599-35059989.14989.56
6353074-35307489.77990.19
45min1357766-35776690.97292.851.5591.5193.401.55
2364870-36487092.77893.35
3362589-36258992.19892.75
4375086-37508695.37695.94
5365327-36532792.89493.46
6365177-36517792.85693.41
60min1363356-36335692.39394.361.5093.0895.071.50
2373414-37341494.95195.67
3368124-36812493.60694.31
4379861-37986196.59097.31
5369558-36955893.97094.69
6372215-37221594.64695.36
极限1365621-36562192.96994.761.4093.8195.631.40
2372499-37249994.71895.60
3369932-36993294.06594.93
4381268-38126896.94897.83
5371965-37196594.58295.46
6374636-37463695.26196.13
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(%) 100.0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%
111.273107133108043105623108373104063106640.06
211.213098253099473098860.03
单位质量响应值RSD%判断
27565.5727643.710.21数据可信
供试品溶液-25112401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%
5min1198637-19863764.76256.8727.0264.7656.8727.02
2224291-22429173.12673.13
3118688-11868838.69638.70
4183797-18379759.92459.92
5207734-20773467.72867.73
6113367-11336736.96136.96
10min1301349-30134998.25094.632.7398.3694.732.74
2284766-28476692.84392.96
3293688-29368895.75295.82
4287545-28754593.74993.85
5294892-29489296.14496.26
6279316-27931691.06691.13
15min1307577-307577100.28096.792.44100.5597.042.44
2288996-28899694.22294.50
3301805-30180598.39898.62
4293554-29355495.70895.96
5299114-29911497.52197.79
6290230-29023094.62494.84
20min1307525-307525100.26397.332.23100.7097.742.23
2289808-28980894.48794.92
3302803-30280398.72499.11
4299676-29967697.70498.12
5299423-29942397.62298.06
6291933-29193395.18095.55
30min1308333-308333100.52797.272.40101.1397.842.39
2289385-28938594.34994.94
3304027-30402799.12399.68
4294821-29482196.12196.70
5300253-30025397.89298.49
6293201-29320195.59396.12
45min1307553-307553100.27298.412.39101.0599.152.39
2311406-311406101.529102.28
3304024-30402499.12299.84
4295097-29509796.21196.95
5300132-30013297.85398.61
6292782-29278295.45796.15
60min1307237-307237100.16997.082.16101.1197.982.16
2289847-28984794.50095.42
3301612-30161298.33599.22
4294951-29495196.16497.06
5300140-30014097.85598.78
6292743-29274395.44496.29
极限1306392-30639299.89496.902.25101.0097.962.24
2289238-28923894.30195.38
3302977-30297798.78099.83
4293770-29377095.77996.84
5298806-29880697.42198.51
6292032-29203295.21296.22
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%
111.143928823923263928713922493926023925860.08
211.083915073911973913520.06
单位质量响应值RSD%判断
35241.1135320.580.16数据可信
供试品溶液-25112401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%
5min150284-5028412.81416.4322.8512.8116.4322.85
278504-7850420.00620.01
371197-7119718.14418.14
470280-7028017.91017.91
574517-7451718.99018.99
641979-4197910.69810.70
10min1159962-15996240.76542.844.8340.7942.874.84
2174489-17448944.46744.50
3171818-17181843.78643.82
4171457-17145743.69443.72
5175069-17506944.61544.65
6155931-15593139.73839.76
15min1215010-21501054.79356.212.4754.8856.312.48
2225050-22505057.35257.46
3223436-22343656.94157.04
4221454-22145456.43656.54
5225734-22573457.52657.63
6212766-21276654.22254.31
20min1247048-24704862.95864.872.0363.1465.072.04
2257636-25763665.65665.86
3257045-25704565.50665.70
4259729-25972966.19066.39
5256781-25678165.43865.64
6249148-24914863.49363.67
30min1288940-28894073.63474.771.0373.9275.071.04
2295461-29546175.29675.61
3296372-29637275.52875.84
4292718-29271874.59774.90
5295863-29586375.39875.71
6291000-29100074.15974.44
45min1320902-32090281.77983.191.5882.1983.611.58
2335883-33588385.59786.03
3327597-32759783.48583.92
4323983-32398382.56483.00
5326074-32607483.09783.53
6324111-32411182.59783.00
60min1339590-33959086.54287.040.6687.0987.600.65
2343393-34339387.51188.09
3338404-33840486.23986.81
4340963-34096386.89187.46
5343492-34349287.53688.11
6343403-34340387.51388.05
极限1346505-34650588.30489.050.6888.9989.760.68
2349562-34956289.08389.81
3352837-35283789.91790.63
4347061-34706188.44589.16
5350179-35017989.24089.96
6350476-35047689.31690.00
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(%) 100.0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%
111.273125403129193125253131553126133127500.09
211.213123003124603123800.04
单位质量响应值RSD%判断
27750.6727866.190.30数据可信
供试品溶液-25112402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%
5min1118851-11885138.46546.4320.1338.4746.4320.13
2110089-11008935.63035.63
3181299-18129958.67658.68
4141641-14164145.84145.84
5134767-13476743.61743.62
6174046-17404656.32956.33
10min1292093-29209394.53493.561.2894.6093.641.28
2286770-28677092.81192.87
3290882-29088294.14294.24
4282590-28259091.45991.54
5291070-29107094.20394.28
6291144-29114494.22794.32
15min1299327-29932796.87595.611.1697.1095.851.17
2292443-29244394.64894.86
3296485-29648595.95696.21
4290150-29015093.90594.13
5297081-29708196.14996.38
6297087-29708796.15196.40
20min1299652-29965296.98195.821.1297.3696.211.13
2292724-29272494.73895.11
3297197-29719796.18696.60
4291293-29129394.27594.66
5296979-29697996.11696.51
6298495-29849596.60697.02
30min1300272-30027297.18196.311.0197.7396.861.01
2299108-29910896.80597.33
3297426-29742696.26096.84
4291778-29177894.43294.97
5298456-29845696.59497.14
6298478-29847896.60197.17
45min1300632-30063297.29895.871.1198.0096.581.11
2292787-29278794.75995.45
3297247-29724796.20296.94
4291941-29194194.48595.18
5297018-29701896.12896.84
6297727-29772796.35897.09
60min1299777-29977797.02196.051.0397.8996.921.03
2291938-29193894.48495.33
3296737-29673796.03796.93
4295236-29523695.55196.41
5300192-30019297.15598.03
6296789-29678996.05496.95
极限1298875-29887596.72995.431.1397.7696.461.14
2291541-29154194.35695.36
3296503-29650395.96297.02
4290104-29010493.89194.91
5295992-29599295.79696.83
6296181-29618195.85796.91
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%
111.143950513945973944633951113944153947270.09
211.083949903947813948860.04
单位质量响应值RSD%判断
35433.3035639.530.42数据可信
供试品溶液-25112402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%
5min167084-6708416.97313.1240.4816.9713.1240.47
217031-170314.3094.31
352649-5264913.32113.32
471944-7194418.20318.20
564510-6451016.32216.32
637929-379299.5969.60
10min1180893-18089345.76843.046.4245.8043.066.44
2150410-15041038.05538.06
3168890-16889042.73142.75
4176682-17668244.70244.73
5176344-17634444.61744.64
6167351-16735142.34242.36
15min1228754-22875457.87756.792.9257.9856.892.94
2212795-21279553.83953.91
3221282-22128255.98756.08
4230439-23043958.30358.41
5228029-22802957.69457.80
6225531-22553157.06257.15
20min1261199-26119966.08665.241.8566.2965.421.87
2249793-24979363.20063.36
3254761-25476164.45764.64
4262156-26215666.32866.53
5260907-26090766.01266.21
6258261-25826165.34365.52
30min1300064-30006475.91975.380.9276.2375.680.92
2299114-29911475.67975.94
3293013-29301374.13574.43
4299660-29966075.81776.13
5299360-29936075.74176.05
6296497-29649775.01775.31
45min1331598-33159883.89883.011.0084.3483.431.01
2326098-32609882.50682.90
3322581-32258181.61682.03
4330342-33034283.58084.02
5329427-32942783.34883.78
6328393-32839383.08783.50
60min1347185-34718587.84187.291.2588.4287.861.26
2343532-34353286.91787.45
3337478-33747885.38585.94
4349268-34926888.36888.95
5348245-34824588.11088.68
6344382-34438287.13287.69
极限1355141-35514189.85488.970.8790.5889.680.87
2352103-35210389.08689.76
3345952-34595287.52988.23
4352052-35205289.07389.80
5352072-35207289.07889.80
6352612-35261289.21489.91
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(%) 100.0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%
111.273115433113623115943116103115483115310.04
211.213136173136483136320.01
单位质量响应值RSD%判断
27642.5027977.880.86数据可信
供试品溶液-25112403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%
5min1113724-11372436.80544.9829.9336.8044.9829.92
2163951-16395153.06053.06
377701-7770125.14725.15
4180814-18081458.51858.52
5177896-17789657.57357.57
6119849-11984938.78738.79
10min1285011-28501192.23992.021.7792.3092.101.78
2285351-28535192.34992.44
3275084-27508489.02789.07
4290407-29040793.98694.08
5285351-28535192.34992.45
6284871-28487192.19492.26
15min1296243-29624395.87495.001.7296.0995.231.72
2293168-29316894.87995.12
3286914-28691492.85593.05
4295811-29581195.73595.99
5288767-28876793.45593.70
6300379-30037997.21397.43
20min1297222-29722296.19195.241.3696.5795.621.37
2294570-29457095.33395.73
3287903-28790393.17593.52
4296476-29647695.95096.36
5291192-29119294.24094.65
6298266-29826696.52996.91
30min1299060-29906096.78695.461.4697.3296.001.46
2295291-29529195.56696.13
3288918-28891893.50494.00
4296489-29648995.95496.53
5290724-29072494.08894.65
6299284-29928496.85997.40
45min1298911-29891196.73895.441.5997.4396.151.59
2294466-29446695.29996.02
3288650-28865093.41794.07
4295798-29579895.73096.46
5290771-29077194.10394.82
6300880-30088097.37598.08
60min1298418-29841896.57895.381.5197.4496.241.51
2294546-29454695.32596.20
3288497-28849793.36794.18
4296166-29616695.84996.74
5290667-29066794.07094.95
6300018-30001897.09697.96
极限1299242-29924296.84595.341.7197.8696.361.71
2294671-29467195.36696.40
3288048-28804893.22294.19
4296415-29641595.93096.98
5289210-28921093.59894.63
6300021-30002197.09798.12
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%
111.143940433935383939683939033940463939000.06
211.083956203955873956040.01
单位质量响应值RSD%判断
35359.0735704.330.69数据可信
供试品溶液-25112403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%
5min132995-329958.34912.0037.758.3512.0037.75
242458-4245810.74410.74
322636-226365.7285.73
456346-5634614.25814.26
570287-7028717.78617.79
659706-5970615.10815.11
10min1162545-16254541.13242.315.1441.1542.335.15
2163506-16350641.37541.39
3154743-15474339.15739.17
4174380-17438044.12644.15
5178107-17810745.07045.10
6169887-16988742.99043.01
15min1224551-22455156.82257.072.5656.9057.162.58
2221782-22178256.12156.21
3216950-21695054.89954.97
4228781-22878157.89257.99
5227813-22781357.64857.75
6233411-23341159.06459.16
20min1260550-26055065.93265.431.4766.1165.611.48
2255782-25578264.72564.91
3252051-25205163.78163.95
4261352-26135266.13566.33
5261035-26103566.05466.26
6260524-26052465.92566.12
30min1302580-30258076.56775.371.0576.8575.661.05
2294815-29481574.60274.89
3294468-29446874.51474.79
4299809-29980975.86676.17
5296912-29691275.13375.44
6298465-29846575.52675.83
45min1335469-33546984.89083.201.1385.3083.621.13
2325719-32571982.42282.84
3325543-32554382.37882.77
4328532-32853283.13483.56
5327411-32741182.85183.29
6330125-33012583.53783.97
60min1352879-35287989.29587.421.1289.8587.981.11
2342532-34253286.67787.23
3343270-34327086.86487.40
4345453-34545387.41687.99
5343182-34318286.84187.42
6345590-34559087.45188.02
极限1362506-36250691.73189.381.3692.4490.081.36
2350003-35000388.56789.26
3350430-35043088.67589.35
4352892-35289289.29890.01
5349935-34993588.55089.27
6353456-35345689.44190.16
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