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DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99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%
110.189368793860938759391493848938370.10
210.219424594521943830.21
单位质量响应值RSD%判断
9217.789244.170.21数据可信
供试品溶液-311952B批-恩格列净-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%
5min121379-2137920.63421.3610.2320.6321.3610.23
225492-2549224.60324.60
319947-1994719.25219.25
422383-2238321.60321.60
523893-2389323.06023.06
619722-1972219.03419.03
10min147812-4781246.14547.2110.7046.1847.2510.70
254137-5413752.24952.29
343258-4325841.75041.78
448148-4814846.46946.51
556125-5612554.16854.21
644029-4402942.49442.53
15min171192-7119268.71069.7510.0368.8269.8610.03
277824-7782475.11075.24
363157-6315760.95561.06
471962-7196269.45369.57
582954-8295480.06280.19
666525-6652564.20564.31
20min187206-8720684.16584.806.9084.3985.036.91
289232-8923286.12186.37
379757-7975776.97677.18
488341-8834185.26185.49
598084-9808494.66494.93
684571-8457181.62281.83
30min1100014-10001496.52796.331.2196.8996.701.21
299149-9914995.69296.09
399546-9954696.07596.41
498006-9800694.58994.96
5101394-10139497.85998.28
6100739-10073997.22797.57
45min1102164-10216498.60298.570.8399.1399.100.83
2102401-10240198.83199.39
3102137-10213798.57699.07
4100553-10055397.04797.58
5102434-10243498.86299.45
6103097-10309799.502100.01
60min1102445-10244598.87398.740.4799.5699.440.47
2102638-10263899.05999.78
3102051-10205198.49399.15
4101563-10156398.02298.71
5102250-10225098.68599.43
6102914-10291499.326100.00
极限1103202-10320299.60499.150.37100.46100.010.37
2103117-10311799.522100.41
3102231-10223198.66699.49
4102723-10272399.141100.00
5102492-10249298.91899.83
6102626-10262699.04899.89
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20
标示量(mg)500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%
110.098837748840378840318836718840948839210.03
210.158861728881418871560.16
单位质量响应值RSD%判断
87603.6787404.530.17数据可信
供试品溶液-311952B批-二甲双胍-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%
5min1293845-29384530.22330.887.6830.2230.887.67
2330581-33058134.00134.00
3277196-27719628.51028.51
4300582-30058230.91630.92
5323662-32366233.28933.29
6275507-27550728.33728.34
10min1536959-53695955.22856.328.7055.2856.388.70
2586070-58607060.27960.34
3498711-49871151.29451.34
4539023-53902355.44055.49
5620889-62088963.86063.92
6504013-50401351.83951.89
15min1734783-73478375.57476.528.4275.7276.668.42
2782069-78206980.43880.59
3671255-67125569.04069.17
4735389-73538975.63775.78
5845337-84533786.94587.11
6694836-69483671.46671.60
20min1861041-86104188.56089.115.7788.8389.385.78
2871411-87141189.62789.92
3805098-80509882.80683.05
4867858-86785889.26189.53
5955070-95507098.23198.54
6837844-83784486.17486.43
30min1952038-95203897.91998.061.4398.3498.491.43
2943861-94386197.07897.52
3957481-95748198.47998.87
4935192-93519296.18796.61
5975089-975089100.290100.76
6957022-95702298.43298.83
45min1967410-96741099.50099.620.89100.08100.200.90
2965493-96549399.30399.91
3973396-973396100.116100.67
4954267-95426798.14998.73
5979873-979873100.782101.42
6970847-97084799.854100.41
60min1969569-96956999.72399.700.64100.47100.450.65
2966600-96660099.417100.19
3972783-972783100.053100.77
4960078-96007898.74699.49
5978451-978451100.636101.44
6968702-96870299.633100.36
极限1971168-97116899.88799.690.51100.80100.610.52
2966109-96610999.367100.30
3970937-97093799.863100.75
4963735-96373599.123100.03
5977336-977336100.521101.49
6966474-96647499.404100.30
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DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99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%
110.189466594265944089416794471943950.21
210.219491094880948950.03
单位质量响应值RSD%判断
9272.599294.320.17数据可信
供试品溶液-311952B批-恩格列净-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%
5min121397-2139720.53421.165.8120.5321.165.80
220973-2097320.12720.13
322426-2242621.52221.52
423724-2372422.76722.77
520546-2054619.71819.72
623228-2322822.29122.29
10min145226-4522643.40245.938.1543.4445.968.14
243148-4314841.40841.44
349203-4920347.21947.25
450218-5021848.19348.23
545627-4562743.78743.82
653726-5372651.56051.60
15min166059-6605963.39568.048.5363.5068.158.53
263075-6307560.53260.63
372924-7292469.98370.10
474943-7494371.92172.04
568898-6889866.12066.23
679480-7948076.27576.40
20min181678-8167878.38483.607.8078.6083.827.80
279170-7917075.97876.18
385891-8589182.42882.66
490659-9065987.00387.24
587034-8703483.52483.74
698242-9824294.28194.53
30min197656-9765693.71895.313.4294.0695.683.43
296259-9625992.37792.71
395458-9545891.60991.98
4102401-10240198.27298.65
5100307-10030796.26296.62
6103809-10380999.623100.03
45min1101615-10161597.51797.821.1198.0298.351.12
2101417-10141797.32797.81
3100331-10033196.28596.81
4102837-10283798.69099.24
5101878-10187897.77098.29
6103530-10353099.35599.93
60min1101519-10151997.42597.880.8598.0998.560.88
2101938-10193897.82798.47
3101354-10135497.26797.95
4102732-10273298.58999.30
5101081-10108197.00597.68
6103313-10331399.14799.89
极限1101918-10191897.80898.360.7298.6399.200.73
2102649-10264998.51099.32
3102955-10295598.80399.65
4102597-10259798.46099.34
5101387-10138797.29998.14
6103421-10342199.251100.15
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20
标示量(mg)500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%
110.098881718878988869998871018866908873720.08
210.158893758894878894310.01
单位质量响应值RSD%判断
87945.6987628.670.26数据可信
供试品溶液-311952B批-二甲双胍-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%
5min1295260-29526030.27030.764.2230.2730.764.22
2286991-28699129.42329.42
3304340-30434031.20131.20
4314103-31410332.20232.20
5285884-28588429.30929.31
6313769-31376932.16832.17
10min1516121-51612152.91355.556.4052.9655.606.40
2499598-49959851.21951.27
3554034-55403456.80056.85
4562563-56256357.67557.73
5525075-52507553.83153.88
6593797-59379760.87760.93
15min1693189-69318971.06675.456.7771.2175.596.76
2670045-67004568.69468.83
3753322-75332277.23177.38
4769538-76953878.89479.04
5725200-72520074.34874.49
6804250-80425082.45382.61
20min1823239-82323984.39988.615.8584.6688.885.85
2802798-80279882.30482.55
3853193-85319387.47087.75
4890126-89012691.25791.54
5871718-87171889.36989.63
6944629-94462996.84497.14
30min1939979-93997996.36897.742.3696.7798.162.36
2933365-93336595.69096.08
3926786-92678695.01595.44
4974655-97465599.923100.36
5968259-96825999.26799.68
6976895-976895100.152100.61
45min1968692-96869299.31199.590.6099.87100.160.60
2969126-96912699.35699.90
3962372-96237298.66399.24
4976592-976592100.121100.72
5977425-977425100.207100.78
6974058-97405899.861100.48
60min1969020-96902099.34599.610.22100.07100.350.23
2972147-97214799.665100.38
3969406-96940699.384100.13
4974640-97464099.921100.69
5972689-97268999.721100.46
6971548-97154899.604100.39
极限1966900-96690099.12899.640.31100.02100.550.31
2971949-97194999.645100.52
3976190-976190100.080100.99
4972035-97203599.654100.59
5972412-97241299.693100.60
6971810-97181099.631100.58
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