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L-2103220301V对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4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%
110.385930765930345923055925455922495926420.07
210.385928525931105929810.04
单位质量响应值RSD%判断
57094.6157127.260.05数据可信
供试品溶液-24022201批-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%
5min1531407-53140783.24177.5111.8383.2477.5211.83
2439813-43981368.89368.89
3553738-55373886.73986.74
4407010-40701063.75563.76
5533513-53351383.57183.57
6503624-50362478.88978.89
10min1577918-57791890.52791.272.9490.6791.402.95
2566342-56634288.71388.83
3593459-59345992.96193.11
4560094-56009487.73587.84
5600575-60057594.07694.21
6597658-59765893.61993.75
15min1584120-58412091.49895.565.3791.7995.855.36
2600453-60045394.05694.32
3598835-59883593.80394.10
4594442-59444293.11593.37
5607583-60758395.17395.47
6675029-675029105.738106.03
20min1586156-58615691.81794.621.7092.2695.061.69
2609421-60942195.46195.88
3599772-59977293.95094.41
4604314-60431494.66195.07
5609591-60959195.48895.94
6615157-61515796.36096.82
30min1587210-58721091.98295.011.8392.5895.611.82
2613441-61344196.09196.67
3600123-60012394.00594.62
4610795-61079595.67696.24
5610139-61013995.57496.19
6617464-61746496.72197.35
45min1588187-58818792.13595.091.8092.8895.851.80
2614672-61467296.28497.02
3600226-60022694.02194.79
4612033-61203395.87096.60
5610203-61020395.58496.36
6617137-61713796.67097.46
60min1589394-58939492.32495.241.8293.2396.151.81
2614733-61473396.29397.19
3600671-60067194.09195.02
4612421-61242195.93196.82
5611063-61106395.71896.65
6619654-61965497.06498.01
极限1611803-61180395.83497.430.9896.8998.500.97
2621946-62194697.42398.48
3618727-61872796.91998.00
4628747-62874798.48999.53
5625021-62502197.90599.00
6625691-62569198.01099.12
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L-2103220301V对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4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%
110.385915365920965917375913365913175916040.06
210.385922645932255927440.12
单位质量响应值RSD%判断
56994.6157104.430.14数据可信
供试品溶液-24022201批-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%
5min1509037-50903779.82379.338.8479.8279.338.84
2542831-54283185.12285.12
3427140-42714066.98066.98
4518793-51879381.35381.35
5549763-54976386.20986.21
6487802-48780276.49376.49
10min1583999-58399991.57890.273.2291.7190.403.22
2603112-60311294.57594.72
3555009-55500987.03287.14
4565736-56573688.71488.85
5586254-58625491.93192.07
6559926-55992687.80387.93
15min1595306-59530693.35192.492.7993.6492.772.78
2612215-61221596.00296.30
3593474-59347493.06393.32
4563407-56340788.34988.63
5593841-59384193.12193.42
6580483-58048391.02691.30
20min1599076-59907693.94293.152.7694.3893.582.75
2612911-61291196.11196.57
3605033-60503394.87695.29
4566429-56642988.82289.25
5594847-59484793.27993.73
6585720-58572091.84892.27
30min1597544-59754493.70293.382.6994.3093.972.68
2613641-61364196.22696.85
3608589-60858995.43496.00
4569161-56916189.25189.83
5597007-59700793.61794.23
6586912-58691292.03492.61
45min1598244-59824493.81193.542.6294.5794.292.61
2614259-61425996.32397.10
3609638-60963895.59896.33
4570821-57082189.51190.24
5597645-59764593.71794.48
6588577-58857792.29693.03
60min1600437-60043794.15593.672.5295.0794.572.52
2614242-61424296.32097.26
3610159-61015995.68096.57
4572746-57274689.81390.69
5597216-59721693.65094.57
6589081-58908192.37593.26
极限1621420-62142097.44697.850.7098.5198.910.70
2626056-62605698.17399.27
3622554-62255497.62398.67
4617478-61747896.82897.85
5627558-62755898.40899.48
6628986-62898698.63299.67
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L-2103220301V对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4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%
110.385937645953125947915940665934465942760.13
210.385920685922755921720.03
单位质量响应值RSD%判断
57252.0257049.330.26数据可信
供试品溶液-24022201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%
5min1390754-39075461.16677.7310.7561.1777.7310.74
2515981-51598180.76980.77
3499656-49965678.21378.21
4513919-51391980.44680.45
5538746-53874684.33284.33
6520267-52026781.44081.44
10min1508044-50804479.52688.645.3979.6388.775.40
2574562-57456289.93990.07
3562840-56284088.10488.23
4583904-58390491.40191.53
5594867-59486793.11793.26
6573325-57332589.74589.88
15min1541457-54145784.75690.943.6684.9991.223.67
2586783-58678391.85292.14
3579832-57983290.76391.04
4594886-59488693.12093.41
5602477-60247794.30894.60
6580217-58021790.82491.11
20min1553758-55375886.68291.592.9687.0692.022.98
2589000-58900092.19992.64
3581900-58190091.08791.52
4596350-59635093.34993.79
5604129-60412994.56795.02
6585549-58554991.65892.10
30min1562489-56248988.04992.052.5888.5792.632.59
2589015-58901592.20192.79
3584706-58470691.52692.11
4599684-59968493.87194.47
5606397-60639794.92295.53
6585870-58587091.70992.30
45min1564489-56448988.36292.242.6089.0392.972.61
2591374-59137492.57093.32
3584964-58496491.56792.30
4600936-60093694.06794.82
5608701-60870195.28296.05
6584996-58499691.57292.31
60min1566571-56657188.68892.472.5289.5093.362.53
2591916-59191692.65593.55
3586389-58638991.79092.68
4602409-60240994.29895.21
5609429-60942995.39696.32
6587598-58759891.97992.87
极限1628465-62846598.37698.090.8899.3499.140.88
2624413-62441397.74298.80
3622445-62244597.43498.47
4630964-63096498.76799.83
5634150-63415099.266100.35
6619529-61952996.97798.03
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