磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.811646611646401650111650501655911649910.24
212.851655641655781655710.01
单位质量响应值RSD%判断
12879.8612884.900.03数据可信
长期36月-供试品溶液-2022030401批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1130442-13044270.88978.418.2070.8978.428.20
2134067-13406772.85972.86
3155406-15540684.45684.46
4156712-15671285.16685.17
5136654-13665474.26574.27
6152436-15243682.84282.84
10min1155662-15566284.59587.652.6184.7187.782.62
2157004-15700485.32485.45
3164125-16412589.19489.34
4166618-16661890.54990.69
5161643-16164387.84687.97
6162654-16265488.39588.53
15min1165020-16502089.68190.581.4689.9490.861.47
2163058-16305888.61488.88
3168149-16814991.38191.67
4169976-16997692.37492.67
5167334-16733490.93891.21
6166563-16656390.51990.80
20min1169119-16911991.90892.531.4692.3292.961.46
2166554-16655490.51490.93
3170816-17081692.83193.27
4172518-17251893.75694.20
5173296-17329694.17894.60
6169317-16931792.01692.45
30min1171018-17101892.94094.201.6593.5094.781.65
2169975-16997592.37492.94
3177520-17752096.47497.07
4175521-17552195.38895.99
5173809-17380994.45795.04
6172186-17218693.57594.16
45min1173358-17335894.21295.161.2094.9395.901.21
2172509-17250993.75194.47
3176177-17617795.74496.50
4178192-17819296.83997.60
5176065-17606595.68396.42
6174321-17432194.73595.48
极限1177318-17731896.36496.680.9097.2497.580.91
2175920-17592095.60496.48
3178183-17818396.83497.75
4179599-17959997.60498.53
5179831-17983197.73098.63
6176565-17656595.95596.86
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.811650811656031653571650211653091652740.15
212.851661331668031664680.29
单位质量响应值RSD%判断
12901.9512954.710.29数据可信
长期36月-供试品溶液-2022030501批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1126985-12698568.76574.538.3468.7774.538.34
2137816-13781674.63174.63
3129627-12962770.19670.20
4158914-15891486.05686.06
5139598-13959875.59675.60
6132828-13282871.93071.93
10min1154651-15465183.74786.293.2383.8686.423.24
2160466-16046686.89687.02
3155563-15556384.24184.36
4167689-16768990.80890.95
5162389-16238987.93888.06
6155352-15535284.12784.25
15min1164127-16412788.87990.081.5589.1390.351.56
2166613-16661390.22590.49
3165031-16503189.36889.63
4171050-17105092.62892.92
5166848-16684890.35290.62
6164397-16439789.02589.29
20min1168344-16834491.16291.651.3791.5692.071.38
2169034-16903491.53691.96
3167308-16730890.60191.01
4173601-17360194.00994.46
5169591-16959191.83892.26
6167569-16756990.74391.15
30min1172697-17269793.52093.631.0094.0794.201.02
2173319-17331993.85694.43
3172339-17233993.32693.88
4175804-17580495.20295.81
5172827-17282793.59094.17
6170462-17046292.30992.87
45min1176425-17642595.53895.220.7396.2595.950.74
2175886-17588695.24795.98
3174888-17488894.70695.42
4177728-17772896.24497.01
5176069-17606995.34696.08
6174024-17402494.23894.95
极限1180030-18003097.49196.700.6398.3697.580.63
2179006-17900696.93697.82
3178061-17806196.42497.30
4179114-17911496.99597.92
5178444-17844496.63297.52
6176750-17675095.71496.59
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.811660231660611655671652531654571656720.22
212.851666151663441664800.12
单位质量响应值RSD%判断
12933.0212955.640.13数据可信
长期36月-供试品溶液-2022030601批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1140350-14035075.90977.879.9475.9177.879.94
2139577-13957775.49175.49
3158138-15813885.52985.53
4131220-13122070.97170.97
5129889-12988970.25170.25
6164689-16468989.07389.07
10min1159659-15965986.35287.054.8086.4887.184.81
2160326-16032686.71386.84
3167084-16708490.36890.51
4151417-15141781.89482.01
5154844-15484483.74883.86
6172361-17236193.22293.37
15min1167307-16730790.48990.633.1090.7690.903.11
2168294-16829491.02291.29
3170790-17079092.37292.67
4160046-16004686.56186.82
5164002-16400288.70188.96
6174932-17493294.61394.92
20min1169362-16936291.60092.122.8392.0292.542.84
2171442-17144292.72593.15
3172359-17235993.22193.67
4162978-16297888.14788.55
5168277-16827791.01391.42
6177471-17747195.98696.45
30min1172628-17262893.36694.111.9893.9494.692.00
2174734-17473494.50595.08
3176235-17623595.31795.92
4169410-16941091.62692.17
5171877-17187792.96093.52
6179124-17912496.88097.50
45min1175733-17573395.04695.402.1595.7896.142.16
2177408-17740895.95296.69
3177483-17748395.99296.75
4170191-17019192.04892.75
5175688-17568895.02195.73
6181858-18185898.35899.14
极限1178640-17864096.61897.422.3497.5198.312.35
2180416-18041697.57998.47
3186314-186314100.769101.69
4173795-17379593.99894.85
5178915-17891596.76797.64
6182630-18263098.77699.72
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.811666231666481660851664791668911665450.18
212.851663681667561665620.17
单位质量响应值RSD%判断
13001.1712962.020.22数据可信
长期36月-供试品溶液-U028516批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1138223-13822374.54466.318.2774.5466.318.27
2126235-12623568.07968.08
3123579-12357966.64666.65
4106694-10669457.54057.54
5120239-12023964.84564.85
6122769-12276966.21066.21
10min1160778-16077886.70880.595.5386.8380.705.53
2153582-15358282.82782.94
3150109-15010980.95481.07
4135610-13561073.13573.23
5147699-14769979.65479.76
6148818-14881880.25880.37
15min1171660-17166092.57687.413.8692.8587.663.87
2165045-16504589.00989.26
3161750-16175087.23287.48
4152702-15270282.35282.57
5161818-16181887.26987.51
6159511-15951186.02586.27
20min1172334-17233492.94091.223.5093.3691.613.49
2169321-16932191.31591.71
3166486-16648689.78690.18
4161685-16168587.19787.55
5166235-16623589.65190.04
6178795-17879596.42496.81
30min1176575-17657595.22793.341.2895.8193.881.30
2173116-17311693.36293.91
3172150-17215092.84193.38
4169978-16997891.66992.17
5174224-17422493.95994.49
6172423-17242392.98893.54
45min1179610-17961096.86495.101.0297.6095.801.04
2177256-17725695.59496.30
3175170-17517094.46995.17
4174947-17494794.34995.00
5175566-17556694.68395.38
6175514-17551494.65595.36
极限1184159-18415999.31797.391.07100.2298.251.09
2181007-18100797.61798.48
3179191-17919196.63897.49
4180311-18031197.24298.05
5178713-17871396.38097.23
6180167-18016797.16498.03
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