达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354261574425160742542474251035425693542550800.11
210.374268021426762942678250.01
单位质量响应值RSD%判断
411118.84411554.970.08数据可信
供试品溶液-2025081821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%
5min1168368-1683684.0934.5212.604.094.5212.60
2196217-1962174.7704.77
3221833-2218335.3935.39
4166465-1664654.0474.05
5163829-1638293.9833.98
6199073-1990734.8404.84
10min1394141-3941419.5828.855.449.608.875.42
2363416-3634168.8358.86
3376241-3762419.1479.17
4346328-3463288.4208.44
5339800-3398008.2618.28
6364518-3645188.8628.89
15min1499072-49907212.13312.344.2312.2012.404.24
2507795-50779512.34512.41
3533888-53388812.97913.05
4487552-48755211.85311.92
5484657-48465711.78211.84
6532215-53221512.93913.01
20min1628364-62836415.27615.262.3415.4115.392.37
2636612-63661215.47715.61
3647931-64793115.75215.89
4609296-60929614.81314.93
5612338-61233814.88715.01
6631538-63153815.35315.49
30min1867249-86724921.08420.463.3121.2920.663.31
2851771-85177120.70720.91
3876512-87651221.30921.53
4821712-82171219.97720.17
5807261-80726119.62519.82
6824201-82420120.03720.25
45min11083521-108352126.34126.501.4726.6526.811.49
21094546-109454626.60926.92
31118010-111801027.18027.50
41077464-107746426.19426.49
51073752-107375226.10426.40
61093686-109368626.58926.90
60min11299458-129945831.59131.801.1832.0332.241.19
21320193-132019332.09532.54
31328501-132850132.29732.76
41301102-130110231.63132.06
51311949-131194931.89532.32
61286169-128616931.26831.71
120min11971992-197199247.94148.211.0348.5448.811.02
22006541-200654148.78149.39
31996211-199621148.53049.15
41995830-199583048.52149.11
51974932-197493248.01348.60
61951851-195185147.45148.05
180min12445016-244501659.44159.241.4660.2860.081.45
22480400-248040060.30161.15
32458352-245835259.76560.63
42448334-244833459.52160.35
52396547-239654758.26259.09
62391195-239119558.13258.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12777608-277760867.52668.601.4968.6669.741.47
22860740-286074069.54770.70
32815302-281530268.44369.60
42878743-287874369.98571.11
52821288-282128868.58869.70
62776911-277691167.50968.64
360min13326581-332658180.87281.420.9982.3582.900.97
23312054-331205480.51982.02
33366191-336619181.83583.34
43405670-340567082.79584.27
53344836-334483681.31682.77
63339332-333933281.18282.65
480min13671209-367120989.25189.740.5991.1391.620.59
23710521-371052190.20692.11
33696455-369645589.86491.78
43699766-369976689.94591.83
53710982-371098290.21892.08
63657918-365791888.92890.80
600min13913115-391311595.13294.801.1497.4697.141.11
23932178-393217895.59597.95
33841000-384100093.37895.74
43936713-393671395.70598.04
53928890-392889095.51597.83
63845540-384554093.48995.80
720min13996232-399623297.15297.001.0099.9599.810.97
23986172-398617296.90899.74
33975344-397534496.64599.47
44018188-401818897.686100.50
54040030-404003098.217101.01
63924900-392490095.41898.20
极限13909799-390979995.05195.461.6698.3498.751.62
23939142-393914295.76499.08
34028117-402811797.927101.24
43911866-391186695.10198.41
53942832-394283295.85499.14
63827164-382716493.04296.30
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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6250
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.481569615904156511582215808157760.65
222.541568315556156200.58
单位质量响应值RSD%判断
701.78692.990.90数据可信
供试品溶液-2025081821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%
5min117270-17270159.288165.332.76159.29165.332.76
217629-17629162.599162.60
318461-18461170.273170.27
417975-17975165.791165.79
517692-17692163.180163.18
618523-18523170.845170.84
10min118570-18570171.278173.601.62172.07174.421.63
218481-18481170.458171.27
319059-19059175.789176.64
418863-18863173.981174.81
518681-18681172.302173.12
619275-19275177.781178.64
15min118279-18279168.594173.062.08170.25174.762.08
218316-18316168.936170.60
319252-19252177.569179.30
418792-18792173.326175.02
518996-18996175.208176.89
618944-18944174.728176.47
20min118410-18410169.803173.731.39172.30176.291.40
218672-18672172.219174.73
318911-18911174.424177.04
418845-18845173.815176.38
519063-19063175.826178.38
619113-19113176.287178.90
30min118759-18759173.022173.570.72176.37177.000.73
218590-18590171.463174.83
318957-18957174.848178.34
418937-18937174.663178.10
518822-18822173.603177.04
618843-18843173.796177.29
45min118372-18372169.452172.382.70173.66176.672.66
217815-17815164.315168.54
318899-18899174.313178.68
418908-18908174.396178.70
518976-18976175.023179.32
619165-19165176.766181.13
60min118303-18303168.816173.442.43173.87178.602.39
218329-18329169.056174.11
318768-18768173.105178.34
419004-19004175.281180.46
519518-19518180.022185.20
618905-18905174.368179.62
120min118606-18606171.610174.581.72177.51180.601.70
218614-18614171.684177.58
318756-18756172.994179.10
419282-19282177.846183.90
519337-19337178.353184.43
618971-18971174.977181.10
180min118549-18549171.085171.910.75177.84178.800.75
218546-18546171.057177.81
318625-18625171.786178.75
418909-18909174.405181.35
518560-18560171.186178.15
618640-18640171.924178.92
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118283-18283168.631172.742.04176.25180.502.00
218329-18329169.056176.66
318627-18627171.804179.63
419220-19220177.274185.09
518880-18880174.138181.96
619031-19031175.530183.39
360min117762-17762163.826170.232.93172.28178.852.86
217829-17829164.444172.90
318496-18496170.596179.28
418985-18985175.106183.81
518935-18935174.645183.34
618731-18731172.763181.50
480min118083-18083166.787171.071.80176.06180.541.79
218222-18222168.069177.35
318546-18546171.057180.59
418896-18896174.285183.86
518856-18856173.916183.48
618681-18681172.302181.90
600min118378-18378169.508170.982.14179.62181.312.09
218096-18096166.907177.02
318130-18130167.220177.61
419014-19014175.374185.82
518927-18927174.571185.01
618683-18683172.321182.78
720min118069-18069166.658169.861.84177.62181.041.80
218144-18144167.349178.30
318319-18319168.963180.19
418883-18883174.165185.49
518782-18782173.234184.54
618300-18300168.788180.11
极限117866-17866164.785167.851.36176.58179.891.36
217937-17937165.440177.23
318478-18478170.430182.50
418299-18299168.779180.98
518392-18392169.637181.81
618220-18220168.050180.22
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354239141424509042436634242346424111042422700.06
210.374329374433066643300200.03
单位质量响应值RSD%判断
409881.16417552.561.32数据可信
供试品溶液-2025081821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%
5min1200793-2007934.8544.4812.924.854.4812.89
2221487-2214875.3545.35
3164655-1646553.9803.98
4168355-1683554.0704.07
5162585-1625853.9303.93
6194754-1947544.7084.71
10min1373665-3736659.0338.795.619.068.815.61
2376176-3761769.0939.12
3343483-3434838.3038.32
4390992-3909929.4529.47
5338327-3383278.1788.20
6359030-3590308.6798.70
15min1528364-52836412.77212.264.3112.8412.324.31
2534128-53412812.91212.98
3486799-48679911.76711.83
4493433-49343311.92812.00
5484120-48412011.70311.76
6515803-51580312.46912.54
20min1632356-63235615.28615.142.3315.4215.272.34
2645022-64502215.59215.73
3607514-60751414.68614.81
4625640-62564015.12415.25
5611843-61184314.79014.91
6636679-63667915.39115.52
30min1820850-82085019.84320.283.0520.0520.483.05
2869689-86968921.02321.24
3821107-82110719.84920.04
4861588-86158820.82721.03
5807637-80763719.52319.72
6852037-85203720.59620.80
45min11087162-108716226.28026.321.3526.5926.621.38
21115988-111598826.97727.30
31080574-108057426.12126.41
41083727-108372726.19726.50
51073661-107366125.95426.24
61091401-109140126.38326.69
60min11290667-129066731.20031.581.0231.6432.021.02
21329304-132930432.13432.59
31299899-129989931.42331.85
41300450-130045031.43631.87
51308710-130871031.63632.06
61310459-131045931.67832.12
120min11946652-194665247.05747.851.0647.6548.441.05
21981600-198160047.90248.52
31978011-197801147.81548.40
41980155-198015547.86748.46
51976890-197689047.78848.37
62012763-201276348.65549.25
180min12414160-241416058.35859.171.1259.1960.011.11
22456867-245686759.39060.25
32415995-241599558.40259.22
42481064-248106459.97560.81
52453251-245325159.30360.12
62466299-246629959.61860.46
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12774477-277447767.06868.211.0868.1969.331.07
22823014-282301468.24169.39
32836535-283653568.56869.68
42865049-286504969.25770.39
52805903-280590367.82868.94
62824207-282420768.27069.41
360min13338117-333811780.69380.890.8482.1582.360.83
23390292-339029281.95483.45
33354273-335427381.08482.54
43306613-330661379.93181.41
53333395-333339580.57982.03
63354487-335448781.08982.57
480min13671083-367108388.74289.070.5390.6090.940.52
23668534-366853488.68090.58
33688107-368810789.15391.01
43720372-372037289.93391.81
53671957-367195788.76390.62
63687750-368775089.14591.03
600min13840397-384039792.83593.400.3495.1495.720.35
23872678-387267893.61595.96
33862664-386266493.37395.68
43877045-387704593.72196.05
53859485-385948593.29695.60
63869693-386969393.54395.88
720min13929272-392927294.98396.350.8997.7599.140.87
24002035-400203596.74299.56
34032899-403289997.488100.26
43965402-396540295.85698.66
53989860-398986096.44899.21
63995833-399583396.59299.39
极限13857586-385758693.25094.981.5296.5098.251.48
23897465-389746594.21497.51
33958622-395862295.69398.95
43920456-392045694.77098.05
53909851-390985194.51497.76
64031088-403108897.444100.73
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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6250
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.481579415706159081573016018158310.83
222.541643715828161322.67
单位质量响应值RSD%判断
704.23715.711.15数据可信
供试品溶液-2025081821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%
5min118657-18657169.036163.483.04169.04163.493.04
218733-18733169.724169.72
317772-17772161.018161.02
417432-17432157.937157.94
517601-17601159.468159.47
618071-18071163.727163.73
10min119155-19155173.548169.881.98174.39170.701.98
219163-19163173.620174.47
318813-18813170.449171.25
418700-18700169.425170.22
518344-18344166.200167.00
618329-18329166.064166.88
15min119444-19444176.166172.262.06177.88173.922.06
219560-19560177.217178.93
318760-18760169.969171.63
418611-18611168.619170.26
518880-18880171.056172.68
618820-18820170.513172.16
20min119201-19201173.965171.591.44176.56174.121.44
219178-19178173.756176.36
318869-18869170.957173.46
418701-18701169.435171.91
519128-19128173.303175.79
618556-18556168.121170.62
30min118865-18865170.920170.380.89174.38173.770.90
219017-19017172.298175.77
318914-18914171.364174.73
418536-18536167.940171.27
518763-18763169.996173.35
618738-18738169.770173.11
45min119271-19271174.599170.571.95178.92174.811.93
218861-18861170.884175.22
319154-19154173.539177.76
418520-18520167.795171.96
518847-18847170.757174.96
618305-18305165.847170.04
60min119014-19014172.270171.152.42177.46176.242.37
218912-18912171.346176.53
319123-19123173.258178.34
418525-18525167.840172.85
519532-19532176.964182.02
618237-18237165.231170.25
120min118971-18971171.881170.921.29177.93176.861.27
218847-18847170.757176.80
319106-19106173.104179.06
418751-18751169.888175.73
519062-19062172.705178.64
618452-18452167.179173.02
180min118822-18822170.531169.531.17177.44176.331.15
218961-18961171.790178.69
318721-18721169.616176.43
418576-18576168.302175.00
518352-18352166.273173.07
618835-18835170.649177.33
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118912-18912171.346169.761.88179.11177.411.84
219028-19028172.397180.15
319162-19162173.611181.28
418322-18322166.001173.54
518366-18366166.399174.03
618634-18634168.827176.36
360min118870-18870170.966168.092.92179.59176.582.84
219327-19327175.106183.73
318753-18753169.906178.44
417835-17835161.588169.95
518126-18126164.225172.69
618403-18403166.735175.11
480min118811-18811170.431167.671.46179.91177.011.45
218588-18588168.411177.91
318810-18810170.422179.81
418187-18187164.778173.95
518321-18321165.992175.28
618319-18319165.974175.19
600min118581-18581168.347166.441.59178.68176.611.58
218645-18645168.927179.26
318592-18592168.447178.68
417893-17893162.114172.11
518271-18271165.539175.66
618238-18238165.240175.28
720min118635-18635168.837167.352.51180.01178.362.42
218972-18972171.890183.07
318865-18865170.920182.00
417883-17883162.023172.83
517935-17935162.494173.44
618536-18536167.940178.81
极限118330-18330166.073164.992.05178.09176.841.97
218350-18350166.254178.30
318536-18536167.940179.87
417712-17712160.474172.09
517781-17781161.099172.86
618556-18556168.121179.83
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354326718432539443285614332843433465643296340.10
210.374318510432194243202260.06
单位质量响应值RSD%判断
418322.13416608.100.30数据可信
供试品溶液-2025081922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%
5min1176673-1766734.2324.414.544.234.424.55
2178269-1782694.2704.27
3178558-1785584.2774.28
4187883-1878834.5014.50
5198670-1986704.7594.76
6185706-1857064.4484.45
10min1361286-3612868.6548.613.898.688.633.89
2366120-3661208.7708.79
3337823-3378238.0928.11
4351647-3516478.4238.45
5379299-3792999.0869.11
6360675-3606758.6408.66
15min1504106-50410612.07512.013.5812.1412.073.57
2500153-50015311.98112.05
3469903-46990311.25611.32
4497963-49796311.92811.99
5511606-51160612.25512.32
6523598-52359812.54212.61
20min1622176-62217614.90414.842.3715.0314.962.37
2633657-63365715.17915.30
3593667-59366714.22114.34
4613619-61361914.69914.82
5632189-63218915.14415.27
6621563-62156314.88915.02
30min1835190-83519020.00619.871.5820.2120.071.59
2837335-83733520.05820.26
3803288-80328819.24219.43
4834151-83415119.98120.18
5836194-83619420.03020.24
6831663-83166319.92220.12
45min11072791-107279125.69825.841.5026.0026.141.51
21104778-110477826.46426.77
31060602-106060225.40625.69
41065009-106500925.51125.81
51086452-108645226.02526.33
61081570-108157025.90826.21
60min11288015-128801530.85330.830.8031.2831.260.82
21293436-129343630.98331.42
31266548-126654830.33930.75
41291064-129106430.92631.35
51292178-129217830.95331.39
61291438-129143830.93531.37
120min11938903-193890346.44546.420.7447.0347.000.74
21959556-195955646.94047.53
31927671-192767146.17646.74
41921658-192165846.03246.61
51931143-193114346.25946.85
61949063-194906346.68847.27
180min12385171-238517157.13557.870.8457.9558.680.83
22405833-240583357.63058.45
32410314-241031457.73758.53
42419509-241950957.95758.77
52439604-243960458.43959.26
62434892-243489258.32659.15
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12742206-274220665.68766.821.3366.7967.921.31
22829877-282987767.78768.90
32792717-279271766.89767.98
42746964-274696465.80166.90
52806535-280653567.22868.34
62818410-281841067.51368.62
360min13283909-328390978.66379.351.5880.0980.791.56
23394220-339422081.30682.76
33284191-328419178.67080.09
43307538-330753879.22980.66
53252309-325230977.90679.36
63353934-335393480.34181.79
480min13582581-358258185.81887.030.9487.6488.860.93
23651371-365137187.46689.32
33654463-365446387.54089.35
43637132-363713287.12588.95
53602400-360240086.29388.13
63671399-367139987.94589.80
600min13778084-377808490.50191.391.0792.7593.661.06
23877893-387789392.89295.19
33783552-378355290.63292.88
43828038-382803891.69893.96
53782975-378297590.61892.89
63841467-384146792.01994.31
720min13892387-389238793.23993.090.9295.9495.820.88
23896546-389654693.33996.10
33932374-393237494.19796.90
43907484-390748493.60196.32
53848956-384895692.19994.92
63839417-383941791.97094.72
极限13916378-391637893.81493.461.5596.9896.651.50
23978416-397841695.30098.53
33950223-395022394.62497.80
43843876-384387692.07795.26
53898976-389897693.39796.58
63821664-382166491.54594.76
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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6250
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.481594016073161561616016139160940.58
222.541606116199161300.61
单位质量响应值RSD%判断
715.93715.620.04数据可信
供试品溶液-2025081922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%
5min117738-17738159.396160.561.72159.40160.561.72
217818-17818160.115160.11
317472-17472157.005157.01
418371-18371165.084165.08
518041-18041162.119162.12
617768-17768159.665159.67
10min118234-18234163.853165.311.94164.65166.111.94
218164-18164163.224164.02
318034-18034162.056162.84
419026-19026170.970171.80
518553-18553166.719167.53
618366-18366165.039165.84
15min118145-18145163.053165.932.23164.67167.552.22
218844-18844169.334170.95
317893-17893160.789162.38
418978-18978170.538172.22
518513-18513166.360168.00
618415-18415165.479167.10
20min117992-17992161.678164.281.63164.11166.741.63
218218-18218163.709166.17
318169-18169163.269165.67
418771-18771168.678171.21
518495-18495166.198168.67
618042-18042162.127164.58
30min117947-17947161.274164.711.85164.51167.991.84
218128-18128162.900166.18
318219-18219163.718166.93
418936-18936170.161173.54
518369-18369165.066168.37
618376-18376165.129168.39
45min117828-17828160.204166.122.17164.25170.222.14
218729-18729168.301172.40
318384-18384165.201169.23
418538-18538166.585170.81
519024-19024170.952175.08
618412-18412165.452169.54
60min117955-17955161.346163.371.44166.19168.301.44
218028-18028162.002166.94
318239-18239163.898168.76
418678-18678167.843172.90
518112-18112162.757167.74
618070-18070162.379167.29
120min118015-18015161.885165.792.01167.54171.541.98
218506-18506166.297172.04
318572-18572166.890172.57
419086-19086171.509177.41
518240-18240163.907169.71
618277-18277164.239169.97
180min117774-17774159.719164.842.08166.18171.422.05
218117-18117162.801169.38
318443-18443165.731172.25
418905-18905169.883176.64
518496-18496166.207172.83
618329-18329164.707171.25
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min117952-17952161.319165.361.70168.58172.761.68
218182-18182163.386170.78
318364-18364165.021172.36
418654-18654167.627175.23
518812-18812169.047176.50
618446-18446165.758173.13
360min117906-17906160.905165.202.09168.97173.432.04
218282-18282164.284172.49
318449-18449165.785173.95
418894-18894169.784178.23
518047-18047162.172170.47
618726-18726168.274176.47
480min117866-17866160.546163.601.41169.42172.661.39
217962-17962161.409170.44
318418-18418165.506174.50
418523-18523166.450175.74
518191-18191163.466172.57
618278-18278164.248173.29
600min117553-17553157.733161.981.95167.41171.861.92
217910-17910160.941170.78
318109-18109162.730172.55
418625-18625167.366177.49
517915-17915160.986170.91
618044-18044162.145172.01
720min117799-17799159.944161.352.24170.41172.042.18
217534-17534157.563168.21
318137-18137162.981173.62
418668-18668167.753178.72
517886-17886160.726171.46
617710-17710159.144169.82
极限117916-17916160.995161.491.86172.26172.981.75
218343-18343164.832176.26
318078-18078162.451173.90
418158-18158163.170174.97
517962-17962161.409172.94
617367-17367156.062167.53
点击查看处理图标(人工保存)
 
原始图谱下载图谱(刘齐慧子 于 2025-09-21 15:57:15 完成)
生成报告数据部分(等待生成报告)
Current page cost:1.152 s