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%
112.601617001620961620431616641615891618180.15
212.681627181625821626500.06
单位质量响应值RSD%判断
12842.7012827.290.09数据可信
供试品溶液-TL3539批-达格列净-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%
5min194951-9495147.58354.4120.9147.5854.4120.91
2141604-14160470.96270.96
3116675-11667558.46958.47
4124128-12412862.20462.20
592751-9275146.48046.48
681327-8132740.75540.76
10min1172928-17292886.65985.676.9986.7385.757.00
2184913-18491392.66592.77
3180668-18066890.53890.63
4171496-17149685.94286.04
5163955-16395582.16382.23
6151725-15172576.03476.10
15min1187492-18749293.95891.433.9994.1691.644.00
2188630-18863094.52894.77
3188377-18837794.40194.62
4182619-18261991.51691.74
5176613-17661388.50688.70
6170997-17099785.69285.87
20min1193612-19361297.02593.462.9697.3793.812.97
2188711-18871194.56994.96
3189629-18962995.02995.39
4186461-18646193.44193.80
5182450-18245091.43191.76
6178149-17814989.27689.58
30min1198928-19892899.68995.862.24100.1896.352.25
2192395-19239596.41596.94
3191964-19196496.19996.71
4188462-18846294.44494.94
5189029-18902994.72895.19
6186972-18697293.69794.13
45min1202179-202179101.31897.102.28101.9697.732.27
2190869-19086995.65096.32
3193303-19330396.87097.52
4189896-18989695.16395.80
5194238-19423897.33997.94
6192120-19212096.27796.86
60min1203549-203549102.00597.542.51102.7998.322.49
2190720-19072095.57696.39
3194020-19402097.22998.03
4190181-19018195.30596.09
5196167-19616798.30599.06
6193242-19324296.83997.56
120min1203343-203343101.90198.062.34102.8498.982.31
2191111-19111195.77196.73
3195369-19536997.90598.85
4191647-19164796.04096.97
5198192-19819299.320100.22
6194390-19439097.41598.28
180min1209865-209865105.170101.452.30106.26102.522.27
2198029-19802999.238100.34
3201369-201369100.912102.00
4197894-19789499.171100.24
5205769-205769103.117104.16
6201731-201731101.093102.11
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1209463-209463104.968101.252.44106.22102.472.41
2197390-19739098.918100.17
3201280-201280100.867102.11
4196880-19688098.66399.88
5206076-206076103.271104.47
6201157-201157100.806101.97
360min1208823-208823104.648101.102.64106.06102.472.61
2196145-19614598.29499.70
3201652-201652101.054102.45
4195847-19584798.14599.51
5206691-206691103.579104.94
6201246-201246100.850102.17
480min1207399-207399103.934100.212.44105.50101.742.41
2194835-19483597.63899.19
3199169-19916999.810101.35
4195064-19506497.75299.27
5203454-203454101.957103.47
6199892-199892100.172101.64
600min1206149-206149103.30799.842.39105.03101.522.36
2194884-19488497.66299.36
3198614-19861499.531101.23
4193613-19361397.02598.69
5203023-203023101.741103.41
6199060-19906099.755101.37
720min1205902-205902103.18499.442.56105.06101.262.53
2194215-19421597.32799.17
3197365-19736598.906100.75
4192559-19255996.49798.30
5202814-202814101.636103.45
6197715-19771599.081100.85
极限1205082-205082102.77398.992.56104.81100.972.53
2192232-19223296.33398.32
3196533-19653398.489100.48
4192317-19231796.37698.33
5201316-201316100.886102.86
6197757-19775799.102101.02
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%
110.291048358105068410518731052206105312610512490.18
210.351062306106281710625620.04
单位质量响应值RSD%判断
102162.20102663.000.35数据可信
供试品溶液-TL3539批-二甲双胍-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%
5min132116-321163.1363.8036.823.143.8036.75
235641-356413.4803.48
367922-679226.6326.63
435499-354993.4663.47
530614-306142.9892.99
631906-319063.1153.12
10min170055-700556.8417.177.476.857.187.47
280616-806167.8727.88
374024-740247.2287.24
479174-791747.7317.74
568245-682456.6646.67
668254-682546.6656.67
15min1106181-10618110.36810.736.3110.3810.756.31
2118778-11877811.59811.62
3110897-11089710.82910.85
4117342-11734211.45811.47
5102780-10278010.03610.05
6103567-10356710.11310.13
20min1138924-13892413.56513.844.8613.6013.884.86
2149796-14979614.62714.66
3143297-14329713.99214.03
4149452-14945214.59314.63
5134151-13415113.09913.13
6135081-13508113.19013.22
30min1193801-19380118.92419.424.3118.9719.484.30
2212842-21284220.78320.84
3197747-19774719.30919.37
4202641-20264119.78719.84
5187488-18748818.30718.36
6198863-19886319.41819.47
45min1266080-26608025.98125.652.2426.0625.732.25
2268050-26805026.17426.26
3263273-26327325.70725.79
4267816-26781626.15126.24
5254846-25484624.88424.96
6256067-25606725.00425.08
60min1318081-31808131.05930.951.6031.1831.071.61
2321718-32171831.41431.54
3319357-31935731.18431.31
4321300-32130031.37331.50
5310420-31042030.31130.42
6310934-31093430.36130.48
120min1481358-48135847.00247.050.5847.1747.220.59
2483103-48310347.17347.35
3483495-48349547.21147.38
4485061-48506147.36447.54
5477117-47711746.58846.75
6480717-48071746.94047.10
180min1622578-62257860.79260.830.6961.0361.070.69
2620736-62073660.61260.86
3630879-63087961.60261.85
4623223-62322360.85461.10
5618333-61833360.37760.61
6622159-62215960.75160.98
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1718434-71843470.15170.090.6070.4870.420.60
2716100-71610069.92370.26
3720338-72033870.33770.67
4709896-70989669.31869.65
5720192-72019270.32370.64
6721629-72162970.46370.79
360min1859105-85910583.88783.770.9084.3284.200.90
2853647-85364783.35483.79
3863948-86394884.36084.80
4844523-84452382.46382.90
5861063-86106384.07884.50
6865115-86511584.47484.90
480min1948235-94823592.59092.280.9293.1592.840.91
2939703-93970391.75792.32
3945292-94529292.30392.87
4931817-93181790.98791.55
5948046-94804692.57293.12
6957404-95740493.48694.04
600min1999278-99927897.57497.570.9698.2798.270.95
21001199-100119997.76298.47
3998925-99892597.54098.25
4983176-98317696.00296.70
5999958-99995897.64198.33
61012978-101297898.91299.61
720min11024251-1024251100.01399.921.01100.86100.761.00
21024362-1024362100.024100.87
31018635-101863599.464100.32
41007730-100773098.40099.24
51025254-1025254100.111100.95
61039400-1039400101.492102.34
极限11025647-1025647100.14999.881.07101.14100.871.06
21015379-101537999.147100.15
31018409-101840999.442100.44
41010129-101012998.63499.62
51026371-1026371100.220101.21
61041248-1041248101.672102.67
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