二甲双胍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2000
标示量(mg)5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%
110.059385294605942919403794059941690.31
210.029383093742937860.07
单位质量响应值RSD%判断
9370.059359.880.08数据可信
中间条件12月-供试品溶液-恩格列净-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20241204211106144-106144102.0198.952.4996.37%～101.53%
2102003-10200398.03
3103278-10327899.25
4103170-10317099.15
5104568-104568100.49
698599-9859994.76
20241205211103166-10316699.1599.871.5198.29%～101.45%
2103576-10357699.54
3103107-10310799.09
4105743-105743101.62
5105916-105916101.79
6102011-10201198.04
20241206211101182-10118297.2497.941.0896.84%～99.05%
2101568-10156897.61
3100465-10046596.55
4101933-10193397.96
5103412-10341299.38
6102924-10292498.91
F247061101703-10170397.7497.511.0096.50%～98.52%
2101695-10169597.73
3102627-10262798.63
499664-9966495.78
5101955-10195597.98
6101139-10113997.20
二甲双胍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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.939881199946699907809900399885339904280.27
29.949852139847049849580.04
单位质量响应值RSD%判断
99740.9999090.340.47数据可信
中间条件12月-供试品溶液-二甲双胍-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
202412042111124090-1124090101.7698.282.2395.99%～100.57%
21079754-107975497.75
31080388-108038897.81
41084664-108466498.19
51095001-109500199.13
61049821-104982195.04
202412052111083494-108349498.0998.701.1997.47%～99.92%
21086287-108628798.34
31087031-108703198.41
41103151-110315199.87
51107957-1107957100.30
61073465-107346597.18
202412062111073835-107383597.2197.500.6196.89%～98.12%
21072803-107280397.12
31069793-106979396.85
41075808-107580897.39
51085144-108514498.24
61084996-108499698.22
F2470611082315-108231597.9897.320.7796.54%～98.10%
21084635-108463598.19
31073970-107397097.23
41078007-107800797.59
51066362-106636296.54
61064708-106470896.39
二甲双胍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2000
标示量(mg)5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%
110.059195991967918089142991892918110.25
210.029186491786918250.07
单位质量响应值RSD%判断
9135.429164.170.23数据可信
中间条件12月-供试品溶液-恩格列净-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20241204211101573-10157399.9199.682.1797.41%～101.95%
299454-9945497.83
3105369-105369103.64
499714-9971498.08
5100114-10011498.48
6101809-101809100.14
20241205211101494-10149499.8399.120.8698.23%～100.00%
2100070-10007098.43
3100101-10010198.46
4101343-10134399.68
5101779-101779100.11
699817-9981798.18
2024120621199427-9942797.8099.031.0697.94%～100.13%
2101326-10132699.67
3101984-101984100.31
4100236-10023698.60
599631-9963198.00
6101478-10147899.82
F247061102002-102002100.33100.680.47100.18%～101.18%
2103038-103038101.35
3102226-102226100.55
4101735-101735100.07
5102754-102754101.07
6102390-102390100.71
二甲双胍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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.935404045414285417425416775405765411650.12
29.945399175402195400680.04
单位质量响应值RSD%判断
54497.9954332.800.22数据可信
中间条件12月-供试品溶液-二甲双胍-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20241204211594338-59433898.3097.621.7295.87%～99.37%
2583078-58307896.44
3607794-607794100.53
4580296-58029695.98
5584437-58443796.66
6591386-59138697.81
20241205211595156-59515698.4497.500.5596.94%～98.06%
2585826-58582696.89
3587235-58723597.13
4589178-58917897.45
5590464-59046497.66
6589061-58906197.43
20241206211577262-57726295.4897.061.1095.95%～98.18%
2590209-59020997.62
3590552-59055297.67
4581180-58118096.12
5587535-58753597.18
6594383-59438398.31
F247061585811-58581196.8997.510.4297.09%～97.94%
2592135-59213597.94
3589120-58912097.44
4587789-58778997.22
5591608-59160897.85
6590952-59095297.74
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