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对照品来源分装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400
标示量(mg)25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%
110.121438028143625914366871436865143587914367440.06
210.271434012143479714344040.04
单位质量响应值RSD%判断
141970.75139669.331.16数据可信
供试品溶液-E78779批-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%
5min1890190-89019056.32255.284.1756.3255.284.17
2892299-89229956.45656.46
3894605-89460556.60256.60
4909590-90959057.55057.55
5830293-83029352.53352.53
6824907-82490752.19252.19
10min11321927-132192783.63881.281.8083.7381.371.80
21281871-128187181.10481.20
31299576-129957682.22482.32
41255994-125599479.46779.56
51275396-127539680.69480.78
61273237-127323780.55880.64
15min11404055-140405588.83587.300.9989.0787.531.00
21371809-137180986.79487.02
31388268-138826887.83688.07
41370657-137065786.72286.95
51371412-137141286.76986.99
61372548-137254886.84187.06
20min11425695-142569590.20488.880.8390.5989.260.83
21394543-139454388.23388.61
31410374-141037489.23489.61
41398773-139877388.50088.87
51397932-139793288.44788.81
61401484-140148488.67289.04
30min11435218-143521890.80689.580.7691.3490.100.77
21406887-140688789.01489.53
31420697-142069789.88890.41
41412853-141285389.39189.91
51407507-140750789.05389.57
61411716-141171689.31989.83
45min11432115-143211590.61089.480.6591.2990.140.65
21407536-140753689.05589.72
31415123-141512389.53590.21
41409596-140959689.18589.85
51409174-140917489.15989.82
61411670-141167089.31689.98
60min11411912-141191289.33289.220.2890.1790.040.28
21415219-141521989.54190.36
31407431-140743189.04889.87
41412607-141260789.37690.19
51408986-140898689.14789.96
61404772-140477288.88089.69
极限11525845-152584596.54096.270.5897.5297.240.57
21512983-151298395.72796.69
31523128-152312896.36897.34
41527862-152786296.66897.63
51509005-150900595.47596.43
61530938-153093896.86397.82
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对照品来源分装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400
标示量(mg)25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%
110.121417934141962914173811417726141753514180410.07
210.271437770143685914373140.05
单位质量响应值RSD%判断
140122.63139952.680.09数据可信
供试品溶液-E78779批-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%
5min1775462-77546249.33451.1013.4949.3351.1013.50
2947282-94728260.26560.27
3764250-76425048.62148.62
4902800-90280057.43657.44
5643728-64372840.95440.95
6785886-78588649.99850.00
10min11154549-115454973.45275.195.3073.5375.275.31
21245920-124592079.26579.37
31162056-116205673.92974.01
41266937-126693780.60280.70
51100382-110038270.00670.07
61161192-116119273.87473.96
15min11266824-126682480.59582.394.0980.8082.604.10
21323245-132324584.18484.42
31274044-127404481.05481.26
41378819-137881987.72087.95
51224900-122490077.92778.11
61302191-130219182.84583.05
20min11325652-132565284.33785.603.3584.6885.953.35
21346031-134603185.63486.01
31326553-132655384.39484.73
41424188-142418890.60690.98
51291137-129113782.14182.46
61359562-135956286.49486.84
30min11379302-137930287.75088.382.4988.2388.872.49
21359338-135933886.48087.00
31364949-136494986.83787.32
41449312-144931292.20492.73
51371679-137167987.26587.72
61410399-141039989.72990.22
45min11394807-139480788.73790.171.2089.3690.801.20
21400789-140078989.11789.78
31418934-141893490.27290.90
41439083-143908391.55492.23
51419699-141969990.32090.92
61430330-143033090.99791.63
60min11406407-140640789.47590.412.6290.2591.202.61
21374302-137430287.43288.24
31392878-139287888.61489.39
41476725-147672593.94894.78
51435577-143557791.33092.08
61440915-144091591.67092.46
极限11462058-146205893.01594.630.8793.9495.570.87
21494908-149490895.10596.06
31494816-149481695.09996.02
41495472-149547295.14196.13
51490173-149017394.80495.70
61487071-148707194.60695.55
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对照品来源分装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400
标示量(mg)25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%
110.121414295141447214139971413324141271414137600.06
210.271426780142646814266240.02
单位质量响应值RSD%判断
139699.60138911.780.40数据可信
供试品溶液-24032501批-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%
5min1926394-92639459.24752.9516.4259.2552.9516.42
2704483-70448345.05545.05
31012855-101285564.77664.78
4831206-83120653.15953.16
5846294-84629454.12454.12
6646676-64667641.35841.36
10min11327762-132776284.91680.007.9485.0180.087.95
21230713-123071378.70978.78
31393978-139397889.15189.26
41187114-118711475.92176.01
51249907-124990779.93780.03
61115419-111541971.33671.40
15min11443461-144346192.31588.344.9992.5688.565.01
21358521-135852186.88387.09
31482623-148262394.82095.08
41344816-134481686.00786.22
51362968-136296887.16787.39
61295353-129535382.84383.03
20min11475119-147511994.34091.143.4994.7391.513.50
21393942-139394289.14889.50
31499050-149905095.87096.28
41390711-139071188.94289.30
51411178-141117890.25190.62
61380531-138053188.29188.62
30min11503812-150381296.17593.423.1596.7393.953.17
21451690-145169092.84293.34
31530225-153022597.86498.44
41422905-142290591.00191.51
51438330-143833091.98792.51
61417880-141788090.67991.15
45min11519081-151908197.15194.422.9597.8695.102.97
21467089-146708993.82694.48
31541227-154122798.56899.31
41434244-143424491.72692.38
51450497-145049792.76593.44
61446161-144616192.48893.11
60min11535818-153581898.22295.033.0499.1095.873.06
21476926-147692694.45595.27
31547727-154772798.98399.89
41438185-143818591.97892.79
51462483-146248393.53294.36
61454692-145469293.03493.81
极限11569969-1569969100.40698.851.98101.4499.842.00
21505968-150596896.31397.28
31583033-1583033101.241102.31
41513507-151350796.79597.76
51552278-155227899.275100.26
61549158-154915899.075100.01
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对照品来源分装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400
标示量(mg)25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%
110.121416981141754814165911417082141744714171300.03
210.271417097141792714175120.05
单位质量响应值RSD%判断
140032.61138024.541.03数据可信
供试品溶液-24032501批-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%
5min1899711-89971157.65758.208.2657.6658.218.27
2938872-93887260.16760.17
3964799-96479961.82961.83
4983627-98362763.03563.04
5774738-77473849.64949.65
6887764-88776456.89256.89
10min11359003-135900387.09184.094.8587.1984.194.85
21300305-130030583.32983.43
31353538-135353886.74186.84
41331428-133142885.32485.43
51189472-118947276.22776.31
61339456-133945685.83885.93
15min11454899-145489993.23690.693.5793.4890.933.57
21398341-139834189.61289.85
31438577-143857792.19092.44
41417701-141770190.85391.10
51323364-132336484.80785.02
61458314-145831493.45593.69
20min11473561-147356194.43293.002.7194.8393.382.72
21439829-143982992.27192.66
31465462-146546293.91394.31
41444081-144408192.54392.94
51384245-138424588.70989.06
61499668-149966896.10596.50
30min11478901-147890194.77594.802.2995.3395.352.29
21469596-146959694.17894.72
31490253-149025395.50296.06
41465321-146532193.90494.46
51435143-143514391.97092.47
61537034-153703498.50099.05
45min11483954-148395495.09895.652.5795.8196.352.57
21479492-147949294.81295.51
31511962-151196296.89397.61
41477510-147751094.68595.39
51444957-144495792.59993.25
61557372-155737299.803100.52
60min11487104-148710495.30095.882.8196.1796.742.81
21480678-148067894.88895.75
31518047-151804797.28398.16
41478245-147824594.73295.60
51445060-144506092.60693.41
61567502-1567502100.452101.34
极限11539416-153941698.65398.261.3799.6899.281.38
21526054-152605497.79698.81
31541162-154116298.76499.81
41513016-151301696.96197.99
51511997-151199796.89597.86
61567628-1567628100.461101.51
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