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对照品来源中检所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%
110.265694595699285695965695855690385695210.06
210.315781515780115780810.02
单位质量响应值RSD%判断
55508.8756069.930.72数据可信
长期12月-供试品溶液-2024052811批-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%
5min1420727-42072767.87468.294.2167.8768.294.22
2422409-42240968.14568.15
3446662-44666272.05872.06
4429562-42956269.29969.30
5392137-39213763.26263.26
6428234-42823469.08569.08
10min1530406-53040685.56887.192.1285.6887.302.12
2548513-54851388.48988.60
3551492-55149288.96989.09
4550468-55046888.80488.92
5524522-52452284.61984.72
6537408-53740886.69786.81
15min1561377-56137790.56491.821.9190.8292.081.91
2579882-57988293.54993.81
3575910-57591092.90993.18
4579417-57941793.47493.74
5553670-55367089.32189.57
6564722-56472291.10491.36
20min1577081-57708193.09893.691.9393.5094.101.93
2593501-59350195.74796.16
3584233-58423394.25194.67
4590224-59022495.21895.64
5562527-56252790.75091.15
6576948-57694893.07693.49
30min1589439-58943995.09195.241.7195.6595.801.71
2601117-60111796.97597.55
3589182-58918295.05095.63
4598923-59892396.62197.20
5572568-57256892.37092.92
6590825-59082595.31595.88
45min1594402-59440295.89295.871.4396.6196.591.43
2599267-59926796.67797.41
3592968-59296895.66196.40
4601792-60179297.08497.82
5578258-57825893.28793.99
6598755-59875596.59497.32
60min1597428-59742896.38096.141.3197.2697.031.31
2600979-60097996.95397.85
3594835-59483595.96296.86
4602870-60287097.25898.16
5581133-58113393.75194.61
6598554-59855496.56297.45
极限1602670-60267097.22698.371.1198.2799.411.10
2607464-60746497.99999.06
3621211-621211100.217101.27
4613950-61395099.046100.11
5605806-60580697.73298.74
6607321-60732197.97699.02
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对照品来源中检所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%
110.265670355670255670055670375668245669850.02
210.315785105782245783670.04
单位质量响应值RSD%判断
55261.7056097.671.07数据可信
长期12月-供试品溶液-2024052811批-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%
5min1397855-39785564.31267.675.1864.3167.675.18
2431929-43192969.82069.82
3431508-43150869.75269.75
4406247-40624765.66965.67
5395670-39567063.95963.96
6448472-44847272.49572.49
10min1544771-54477188.06189.132.1388.1789.252.14
2562218-56221890.88191.00
3547745-54774588.54288.66
4543638-54363887.87887.99
5540382-54038287.35287.46
6569601-56960192.07592.20
15min1568145-56814591.83993.181.4592.0993.451.46
2584292-58429294.45094.72
3574251-57425192.82793.09
4573595-57359592.72092.98
5569535-56953592.06492.32
6588943-58894395.20195.48
20min1578633-57863393.53594.751.2893.9495.171.29
2592630-59263095.79796.22
3584437-58443794.47394.89
4583408-58340894.30794.72
5580043-58004393.76394.17
6597761-59776196.62797.06
30min1583786-58378694.36895.891.2394.9396.471.24
2598838-59883896.80197.39
3598152-59815296.69097.27
4592448-59244895.76896.34
5585268-58526894.60795.17
6600730-60073097.10797.70
45min1586662-58666294.83396.431.2195.5597.161.21
2602827-60282797.44698.19
3598266-59826696.70897.45
4603087-60308797.48898.22
5588522-58852295.13395.85
6599906-59990696.97497.73
60min1587528-58752894.97396.791.4795.8597.691.47
2605033-60503397.80298.71
3600005-60000596.99097.89
4609938-60993898.59599.48
5589339-58933995.26596.14
6600932-60093297.13998.06
极限1590331-59033195.42697.911.6696.4698.971.65
2612266-61226698.972100.04
3613856-61385699.229100.29
4615857-61585799.552100.61
5599151-59915196.85297.89
6602822-60282297.44598.52
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对照品来源中检所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%
110.265730795731685727565736055729465731110.06
210.315769615771495770550.03
单位质量响应值RSD%判断
55858.7755970.420.15数据可信
长期12月-供试品溶液-2024052911批-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%
5min1412687-41268766.42666.283.5366.4366.283.53
2407115-40711565.52965.53
3399489-39948964.30264.30
4400465-40046564.45964.46
5411572-41157266.24766.25
6439213-43921370.69670.70
10min1527629-52762984.92786.752.6885.0486.862.68
2542572-54257287.33287.44
3536221-53622186.31086.42
4533436-53343685.86285.97
5527895-52789584.97085.08
6566073-56607391.11591.23
15min1560318-56031890.18991.842.5190.4492.102.51
2577893-57789393.01893.27
3576135-57613592.73592.99
4565153-56515390.96791.22
5552008-55200888.85189.10
6591976-59197695.28495.55
20min1577791-57779193.00193.912.6493.4094.312.64
2595727-59572795.88896.30
3588701-58870194.75795.16
4576803-57680392.84293.24
5559338-55933890.03190.43
6602135-60213596.92097.35
30min1596240-59624095.97195.992.3696.5396.552.36
2607816-60781697.83498.40
3600994-60099496.73697.30
4593936-59393695.60096.16
5570320-57032091.79992.35
6608669-60866997.97198.56
45min1605333-60533397.43497.072.1398.1597.802.12
2611639-61163998.44999.18
3608348-60834897.92098.64
4602847-60284797.03497.75
5578050-57805093.04393.75
6612315-61231598.55899.31
60min1607224-60722497.73997.462.0398.6298.352.03
2616424-61642499.220100.12
3611672-61167298.45599.34
4604800-60480097.34998.23
5581807-58180793.64894.51
6611153-61115398.37199.29
极限1621325-621325100.00899.351.48101.05100.401.48
2624505-624505100.520101.58
3624737-624737100.558101.61
4609312-60931298.07599.12
5602578-60257896.99198.01
6620827-62082799.928101.01
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对照品来源中检所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%
110.265807285809215802075801355801615804300.07
210.315817465820275818860.04
单位质量响应值RSD%判断
56572.1256438.990.17数据可信
长期12月-供试品溶液-2024052911批-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%
5min1426469-42646967.92767.253.8167.9367.253.81
2418606-41860666.67466.67
3438849-43884969.89869.90
4440588-44058870.17570.18
5402062-40206264.03964.04
6406832-40683264.79964.80
10min1560266-56026689.23788.062.5989.3588.182.59
2561522-56152289.43789.55
3567939-56793990.45990.58
4550314-55031487.65287.77
5527421-52742184.00684.11
6549923-54992387.59087.70
15min1589562-58956293.90393.002.2994.1793.262.29
2595329-59532994.82295.08
3590140-59014093.99594.26
4578924-57892492.20992.47
5558979-55897989.03289.28
6590332-59033294.02694.28
20min1598191-59819195.27894.562.4395.7094.982.43
2603653-60365396.14896.57
3599077-59907795.41995.84
4590483-59048394.05094.47
5566127-56612790.17190.57
6604673-60467396.31096.72
30min1603817-60381796.17495.901.9996.7596.471.99
2610611-61061197.25697.83
3605121-60512196.38296.96
4598129-59812995.26895.84
5580535-58053592.46693.01
6614450-61445097.86798.44
45min1607781-60778196.80596.761.3697.5497.501.37
2612871-61287197.61698.36
3608040-60804096.84797.59
4602246-60224695.92496.66
5595165-59516594.79695.50
6619002-61900298.59399.33
60min1607654-60765496.78596.840.9497.6897.730.94
2612941-61294197.62798.53
3608361-60836196.89897.80
4604097-60409796.21997.11
5599678-59967895.51596.37
6615171-61517197.98298.88
极限1607754-60775496.80197.580.6497.8698.630.63
2612042-61204297.48498.55
3611087-61108797.33298.40
4610708-61070897.27198.32
5615381-61538198.01699.03
6618856-61885698.56999.63
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