达格列净二甲双胍片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
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%
112.601643081644351642991641721643601643150.06
212.681623691624271623980.03
单位质量响应值RSD%判断
13040.8712807.411.28数据可信
供试品溶液-25010701批-达格列净-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%
5min1137473-13747368.42263.7914.8368.4263.7914.83
2117481-11748158.47258.47
3130232-13023264.81864.82
4158550-15855078.91378.91
5122571-12257161.00561.01
6102735-10273551.13351.13
10min1193360-19336096.23894.861.0096.3494.960.99
2190085-19008594.60894.70
3190404-19040494.76794.86
4187518-18751893.33093.45
5191069-19106995.09895.19
6191122-19112295.12495.20
15min1199409-19940999.24998.490.9899.5098.730.97
2198506-19850698.79999.03
3198443-19844398.76899.01
4194242-19424296.67796.94
5197414-19741498.25698.49
6199303-19930399.19699.42
20min1201976-201976100.52699.871.10100.92100.261.09
2201913-201913100.495100.87
3201800-201800100.439100.83
4196326-19632697.71498.12
5200433-20043399.758100.14
6201500-201500100.289100.66
30min1204826-204826101.945101.641.56102.49102.171.55
2204959-204959102.011102.54
3208672-208672103.859104.40
4198841-19884198.96699.52
5203383-203383101.227101.76
6204561-204561101.813102.33
45min1206319-206319102.688102.360.40103.39103.050.40
2206058-206058102.558103.24
3205778-205778102.419103.11
4204273-204273101.669102.37
5205133-205133102.098102.78
6206402-206402102.729103.40
60min1207565-207565103.308102.681.19104.16103.521.17
2208791-208791103.918104.75
3206540-206540102.798103.65
4201676-201676100.377101.23
5206180-206180102.619103.45
6207044-207044103.049103.87
120min1208789-208789103.917102.961.08104.93103.961.07
2207407-207407103.229104.22
3207429-207429103.240104.24
4202521-202521100.798101.80
5207033-207033103.043104.03
6208077-208077103.563104.54
180min1217185-217185108.096107.251.41109.26108.401.39
2214593-214593106.806107.95
3219180-219180109.089110.25
4210231-210231104.635105.79
5215382-215382107.199108.34
6216324-216324107.667108.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1216341-216341107.676106.721.11109.00108.031.09
2214339-214339106.679107.99
3215007-215007107.012108.33
4209824-209824104.432105.74
5215132-215132107.074108.38
6215888-215888107.450108.75
360min1216253-216253107.632107.091.62109.12108.561.60
2220130-220130109.562111.03
3214228-214228106.624108.11
4209388-209388104.215105.68
5215228-215228107.122108.59
6215796-215796107.405108.86
480min1215115-215115107.066106.051.19108.72107.681.18
2213250-213250106.137107.77
3213234-213234106.130107.77
4208158-208158103.603105.23
5213912-213912106.467108.09
6214767-214767106.893108.51
600min1217352-217352108.179106.441.19109.99108.231.17
2212538-212538105.783107.57
3212408-212408105.718107.52
4210640-210640104.838106.62
5216206-216206107.609109.40
6213977-213977106.499108.28
720min1213096-213096106.061105.371.42108.03107.321.40
2211273-211273105.153107.10
3214620-214620106.819108.78
4206027-206027102.542104.48
5212259-212259105.644107.59
6212928-212928105.977107.92
极限1212603-212603105.815104.831.29107.95106.941.27
2211028-211028105.032107.14
3210412-210412104.725106.84
4205401-205401102.231104.32
5211782-211782105.407107.51
6212550-212550105.789107.89
达格列净二甲双胍片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.299649349662219679019690219692409674630.20
210.359813099819639816360.05
单位质量响应值RSD%判断
94019.7394844.060.62数据可信
供试品溶液-25010701批-二甲双胍-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%
5min157823-578236.1234.6826.056.124.6826.07
259070-590706.2556.26
340355-403554.2744.27
441092-410924.3524.35
532042-320423.3933.39
634994-349943.7063.71
10min187247-872479.2399.214.999.259.215.02
289019-890199.4279.44
388927-889279.4179.42
492758-927589.8239.83
581857-818578.6698.67
681832-818328.6668.67
15min1129723-12972313.73713.815.2713.7613.835.26
2132588-13258814.04114.06
3131631-13163113.94013.96
4141808-14180815.01715.04
5122646-12264612.98813.01
6124161-12416113.14813.17
20min1163214-16321417.28417.212.8417.3317.252.84
2167517-16751717.74017.78
3166089-16608917.58917.63
4164477-16447717.41817.46
5156634-15663416.58716.62
6157115-15711516.63816.68
30min1217239-21723923.00522.972.6423.0723.042.65
2223780-22378023.69823.77
3222944-22294423.60923.68
4216421-21642122.91922.99
5210361-21036122.27722.34
6210817-21081722.32522.39
45min1281360-28136029.79630.133.1529.9030.233.15
2289290-28929030.63530.74
3286873-28687330.37930.48
4298522-29852231.61331.72
5274739-27473929.09429.19
6276192-27619229.24829.35
60min1335119-33511935.48935.451.9935.6435.591.99
2344206-34420636.45136.60
3340636-34063636.07336.22
4332176-33217635.17735.33
5327346-32734634.66534.80
6328846-32884634.82434.96
120min1489624-48962451.85051.911.5252.0552.101.52
2500359-50035952.98753.19
3497367-49736752.67052.87
4488480-48848051.72951.93
5481444-48144450.98451.18
6483673-48367351.22051.41
180min1621614-62161465.82866.011.8766.1166.291.87
2631040-63104066.82667.11
3642312-64231268.02068.30
4620445-62044565.70465.99
5611842-61184264.79365.06
6612807-61280764.89565.16
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1706909-70690974.86174.981.1675.2475.351.16
2718307-71830776.06876.45
3716448-71644875.87176.25
4707880-70788074.96375.34
5699320-69932074.05774.42
6699206-69920674.04574.41
360min1831027-83102788.00488.141.4188.5088.631.41
2852534-85253490.28290.78
3837314-83731488.67089.17
4830369-83036987.93588.43
5821930-82193087.04187.52
6820735-82073586.91587.39
480min1904479-90447995.78395.601.0896.4196.231.08
2915802-91580296.98297.62
3909783-90978396.34596.98
4903290-90329095.65796.28
5891139-89113994.37094.98
6892267-89226794.49095.10
600min1956906-956906101.335100.381.00102.10101.151.00
2955663-955663101.203101.99
3947144-947144100.301101.08
4953717-953717100.997101.77
5941298-94129899.682100.43
6932851-93285198.78799.54
720min1961392-961392101.810101.781.21102.73102.701.21
2973245-973245103.065104.00
3975377-975377103.291104.22
4958870-958870101.543102.46
5946149-946149100.196101.09
6951570-951570100.770101.67
极限1962106-962106101.886101.580.99102.96102.641.00
2973822-973822103.126104.21
3962669-962669101.945103.03
4958007-958007101.451102.52
5946441-946441100.227101.27
6952168-952168100.833101.88
达格列净二甲双胍片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
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%
112.601617321618111617131614041616241616570.10
212.681629991627581628780.11
单位质量响应值RSD%判断
12829.9212845.270.09数据可信
供试品溶液-25010702批-达格列净-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%
5min1122175-12217561.21357.6613.9361.2157.6613.93
2112159-11215956.19556.19
3124160-12416062.20862.21
4128059-12805964.16164.16
584215-8421542.19442.19
6119732-11973259.98959.99
10min1179496-17949689.93390.006.7590.0290.086.76
2182650-18265091.51391.60
3188789-18878994.58994.68
4189447-18944794.91895.01
5156322-15632278.32278.39
6181019-18101990.69690.79
15min1186699-18669993.54293.624.9593.7793.844.96
2190537-19053795.46495.69
3193750-19375097.07497.31
4194593-19459397.49797.74
5169376-16937684.86285.04
6186173-18617393.27893.50
20min1192889-19288996.64395.344.1097.0195.704.11
2193040-19304096.71997.08
3195999-19599998.20198.58
4196239-19623998.32198.71
5175623-17562387.99288.30
6187935-18793594.16194.53
30min1190426-19042695.40996.213.2395.9296.713.25
2195640-19564098.02198.53
3196739-19673998.57299.10
4197705-19770599.05699.59
5181107-18110790.74091.18
6190475-19047595.43395.94
45min1191064-19106495.72996.932.9296.3897.582.93
2197277-19727798.84199.50
3198309-19830999.358100.03
4198518-19851899.463100.14
5184235-18423592.30792.88
6191420-19142095.90796.56
60min1191569-19156995.98297.262.7296.7898.062.74
2198048-19804899.228100.03
3198611-19861199.510100.33
4198648-19864899.528100.36
5185565-18556592.97393.69
6192308-19230896.35297.15
120min1191724-19172496.05997.522.2697.0098.462.28
2198616-19861699.512100.47
3197814-19781499.110100.08
4198877-19887799.643100.62
5188336-18833694.36295.22
6192523-19252396.46097.40
180min1198485-19848599.447100.982.03100.53102.072.05
2205733-205733103.078104.18
3203970-203970102.195103.32
4205657-205657103.040104.17
5196216-19621698.31099.31
6199214-19921499.812100.90
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1198102-19810299.255100.791.98100.49102.032.00
2204971-204971102.696103.95
3203905-203905102.162103.44
4205205-205205102.814104.10
5196161-19616198.28299.43
6198622-19862299.515100.75
360min1199858-199858100.135100.591.73101.52101.981.76
2204278-204278102.349103.76
3203085-203085101.751103.18
4203739-203739102.079103.52
5195964-19596498.18499.47
6197639-19763999.023100.41
480min1195182-19518297.79299.761.9199.33101.301.93
2202824-202824101.621103.19
3201859-201859101.137102.72
4202734-202734101.576103.17
5194871-19487197.63699.07
6197136-19713698.771100.30
600min1193574-19357496.98699.152.0298.67100.842.03
2201292-201292100.853102.57
3200359-200359100.386102.12
4202643-202643101.530103.27
5194142-19414297.27198.85
6195386-19538697.89499.57
720min1193336-19333696.86798.681.6198.69100.521.64
2200161-200161100.286102.16
3198958-19895899.684101.57
4199658-199658100.034101.93
5193045-19304596.72198.45
6196632-19663298.518100.34
极限1196556-19655698.48098.941.14100.45100.931.15
2199808-199808100.110102.13
3198504-19850499.456101.49
4199036-19903699.723101.77
5197457-19745798.932100.81
6193536-19353696.96798.94
达格列净二甲双胍片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.299791259790839789269780259778439786000.07
210.359896289893689894980.02
单位质量响应值RSD%判断
95102.0495603.670.38数据可信
供试品溶液-25010702批-二甲双胍-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%
5min140834-408344.2824.163.514.284.163.46
241906-419064.3954.39
339531-395314.1464.15
438730-387304.0624.06
538950-389504.0854.08
638288-382884.0154.02
10min186602-866029.0829.261.849.099.271.84
289926-899269.4319.44
389527-895279.3899.40
488048-880489.2349.24
589596-895969.3969.40
686202-862029.0409.05
15min1127920-12792013.41613.353.7213.4413.373.71
2130786-13078613.71613.74
3131595-13159513.80113.82
4128690-12869013.49613.52
5118481-11848112.42612.45
6126178-12617813.23313.25
20min1161950-16195016.98416.854.0517.0216.894.04
2165665-16566517.37417.42
3166480-16648017.45917.50
4161869-16186916.97617.02
5148533-14853315.57715.62
6159327-15932716.70916.75
30min1212967-21296722.33522.313.4722.4022.383.47
2219401-21940123.01023.08
3218716-21871622.93823.00
4214289-21428922.47322.54
5198993-19899320.86920.93
6212152-21215222.24922.31
45min1275727-27572728.91729.003.0329.0229.103.04
2283905-28390529.77429.88
3285447-28544729.93630.04
4277160-27716029.06729.17
5261908-26190827.46727.56
6275246-27524628.86628.96
60min1327762-32776234.37434.462.6134.5234.602.61
2336673-33667335.30835.45
3336534-33653435.29435.44
4329362-32936234.54234.68
5313195-31319532.84632.98
6327866-32786634.38534.53
120min1478724-47872450.20650.461.9950.4050.652.00
2489843-48984351.37251.57
3491314-49131451.52651.73
4482050-48205050.55550.75
5464688-46468848.73448.92
6480131-48013150.35350.55
180min1605368-60536863.48863.871.6363.7664.141.64
2618446-61844664.85965.14
3619957-61995765.01865.29
4609690-60969063.94164.21
5592621-59262162.15162.41
6608139-60813963.77864.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1689689-68968972.33172.791.5272.7073.151.53
2703521-70352173.78174.16
3706671-70667174.11274.49
4694127-69412772.79673.16
5677123-67712371.01371.36
6693083-69308372.68773.05
360min1814236-81423685.39285.301.3885.8785.781.38
2824751-82475186.49586.98
3824205-82420586.43886.92
4809795-80979584.92785.40
5794305-79430583.30283.76
6812865-81286585.24985.72
480min1867591-86759190.98892.421.5391.5993.021.53
2894289-89428993.78894.40
3895161-89516193.87994.49
4878197-87819792.10092.70
5863958-86395890.60791.19
6888070-88807093.13693.74
600min1902990-90299094.70096.511.4895.4497.251.47
2931950-93195097.73898.49
3933853-93385397.93798.69
4919903-91990396.47497.22
5904775-90477594.88895.61
6927743-92774397.29698.04
720min1925715-92571597.08498.511.5397.9699.401.54
2950608-95060899.694100.60
3949869-94986999.617100.52
4931769-93176997.71998.60
5922461-92246196.74397.60
6955675-955675100.226101.11
极限1921638-92163896.65698.641.2897.6899.671.27
2951343-95134399.771100.82
3950645-95064599.698100.75
4930666-93066697.60398.64
5941679-94167998.75899.76
6947151-94715199.332100.37
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