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%
110.204265861427053942719444273007427153242705770.07
210.274312573431045543115140.04
单位质量响应值RSD%判断
418684.02419816.360.20数据可信
长期6月-供试品溶液-2025081921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%
5min1177577-1775774.2364.747.914.244.747.86
2220104-2201045.2505.25
3188123-1881234.4874.49
4203847-2038474.8624.86
5211027-2110275.0335.03
6192327-1923274.5874.59
10min1338012-3380128.0628.767.288.088.787.27
2414451-4144519.8869.91
3359523-3595238.5758.60
4370695-3706958.8428.87
5347707-3477078.2948.32
6372520-3725208.8858.91
15min1465386-46538611.10011.924.5011.1611.994.50
2525096-52509612.52512.60
3496299-49629911.83811.90
4510238-51023812.17012.24
5484354-48435411.55311.62
6518054-51805412.35712.42
20min1583034-58303413.90715.024.1914.0215.154.19
2640836-64083615.28515.42
3661412-66141215.77615.90
4631984-63198415.07415.20
5621622-62162214.82714.95
6639700-63970015.25815.39
30min1777959-77795918.55619.593.7318.7419.803.74
2870140-87014020.75520.97
3828186-82818619.75419.96
4811594-81159419.35819.56
5808792-80879219.29119.49
6832422-83242219.85520.06
45min11009759-100975924.08525.322.4924.3625.622.50
21068045-106804525.47525.79
31083729-108372925.84926.15
41076174-107617425.66925.97
51062694-106269425.34825.64
61068058-106805825.47525.78
60min11238701-123870129.54630.622.1129.9531.052.13
21316937-131693731.41231.86
31297141-129714130.94031.37
41292020-129202030.81731.25
51268164-126816430.24830.67
61290475-129047530.78131.21
120min11909173-190917345.53845.861.5546.0946.441.55
21972740-197274047.05447.66
31936840-193684046.19846.78
41915025-191502545.67746.26
51917511-191751145.73746.31
61884744-188474444.95545.54
180min12345613-234561355.94857.061.3356.7257.871.33
22398765-239876557.21658.05
32363993-236399356.38657.20
42397699-239769957.19058.00
52427289-242728957.89658.70
62419985-241998557.72258.53
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12666023-266602363.59065.561.5664.6566.661.56
22789961-278996166.54767.67
32755775-275577565.73166.83
42750364-275036465.60266.70
52765996-276599665.97567.07
62764548-276454865.94067.04
360min13238121-323812177.23679.061.3178.6180.481.32
23359875-335987580.14081.60
33327705-332770579.37380.80
43293727-329372778.56279.99
53328364-332836479.38980.81
63340301-334030179.67381.10
480min13572653-357265385.21586.841.2186.9788.661.22
23691410-369141088.04889.91
33683724-368372487.86589.69
43618401-361840186.30788.13
53647693-364769387.00588.82
63631095-363109586.60988.44
600min13809186-380918690.85791.681.3893.0493.931.35
23807950-380795090.82893.13
33940047-394004793.97996.24
43804292-380429290.74192.99
53865487-386548792.20094.45
63834092-383409291.45193.71
720min13914423-391442393.36793.511.3996.0196.221.37
23992761-399276195.23697.99
33966380-396638094.60797.34
43846251-384625191.74194.45
53878262-387826292.50595.22
63925103-392510393.62296.34
极限13845851-384585191.73293.260.9594.8496.440.95
23927519-392751993.68096.91
33896377-389637792.93796.14
43917100-391710093.43196.59
53915562-391556293.39596.57
63956567-395656794.37397.56
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12500
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%
112.611624116122161921623216100161770.40
212.611622516115161700.49
单位质量响应值RSD%判断
1282.871282.320.04数据可信
长期6月-供试品溶液-2025081921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%
5min118591-185910.4660.470.720.470.470.87
218955-189550.4750.48
318879-188790.4730.47
418922-189220.4740.47
518815-188150.4720.47
618935-189350.4750.47
10min118515-185150.4640.472.090.470.482.17
219216-192160.4820.48
318318-183180.4590.46
419060-190600.4780.48
519281-192810.4830.49
618960-189600.4750.48
15min118466-184660.4630.471.470.470.481.72
219125-191250.4800.48
318750-187500.4700.47
419161-191610.4800.49
519016-190160.4770.48
618690-186900.4690.47
20min118714-187140.4690.481.550.480.481.13
219264-192640.4830.49
318688-186880.4690.48
419334-193340.4850.49
519278-192780.4830.49
618895-188950.4740.48
30min118787-187870.4710.481.350.480.491.55
219101-191010.4790.49
318975-189750.4760.49
419109-191090.4790.49
519387-193870.4860.50
618678-186780.4680.48
45min118681-186810.4680.471.470.480.481.73
218769-187690.4710.48
318819-188190.4720.48
419063-190630.4780.49
519421-194210.4870.50
618782-187820.4710.48
60min118950-189500.4750.481.500.490.501.70
219141-191410.4800.49
319100-191000.4790.49
419570-195700.4910.51
519413-194130.4870.50
618835-188350.4720.49
120min119367-193670.4860.482.020.500.492.10
219247-192470.4830.50
318675-186750.4680.48
419252-192520.4830.50
519276-192760.4830.50
618469-184690.4630.48
180min119113-191130.4790.482.250.500.502.12
218925-189250.4750.49
318386-183860.4610.48
419362-193620.4850.50
519599-195990.4910.51
618761-187610.4700.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118464-184640.4630.471.790.480.491.83
218793-187930.4710.49
318473-184730.4630.48
419275-192750.4830.50
519140-191400.4800.50
618716-187160.4690.49
360min118932-189320.4750.481.000.500.501.27
218972-189720.4760.50
318910-189100.4740.50
419074-190740.4780.50
519182-191820.4810.51
618608-186080.4670.49
480min118801-188010.4710.470.810.500.500.82
218854-188540.4730.50
318798-187980.4710.50
418922-189220.4740.50
518986-189860.4760.50
618530-185300.4650.49
600min118777-187770.4710.471.690.500.502.12
218191-181910.4560.48
319101-191010.4790.51
418564-185640.4650.49
518863-188630.4730.50
618584-185840.4660.49
720min118880-188800.4730.471.200.500.500.82
218842-188420.4720.50
318833-188330.4720.50
418691-186910.4690.50
518644-186440.4670.50
618264-182640.4580.49
极限118694-186940.4690.471.320.500.501.27
218423-184230.4620.50
318297-182970.4590.49
418941-189410.4750.51
518765-187650.4710.50
618457-184570.4630.50
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%
110.204310468431075543126264307245430858243099350.05
210.274345980434752643467530.03
单位质量响应值RSD%判断
422542.65423247.610.12数据可信
长期6月-供试品溶液-2025081921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%
5min1195155-1951554.6154.695.574.614.695.61
2201713-2017134.7704.77
3180711-1807114.2734.27
4208731-2087314.9364.94
5194251-1942514.5934.59
6210683-2106834.9824.98
10min1358337-3583378.4738.643.008.508.662.99
2376584-3765848.9058.93
3348848-3488488.2498.27
4377536-3775368.9278.95
5364233-3642338.6138.64
6365746-3657468.6498.67
15min1499065-49906511.80111.813.1711.8711.883.14
2485026-48502611.46911.54
3486540-48654011.50511.57
4528756-52875612.50312.57
5501820-50182011.86611.93
6496619-49661911.74311.81
20min1620662-62066214.67714.801.2314.8014.921.22
2612956-61295614.49414.62
3626442-62644214.81314.93
4633586-63358614.98215.11
5630795-63079514.91615.04
6629648-62964814.88915.02
30min1818399-81839919.35219.461.5019.5519.661.48
2808882-80888219.12719.33
3819547-81954719.37919.57
4825177-82517719.51319.72
5845425-84542519.99120.19
6819366-81936619.37519.58
45min11088567-108856725.74125.451.9726.0425.741.95
21068140-106814025.25825.55
31048982-104898224.80525.10
41110535-111053526.26026.56
51073265-107326525.37925.68
61066869-106686925.22825.53
60min11261184-126118429.82330.032.0830.2530.452.04
21319598-131959831.20431.62
31263488-126348829.87730.29
41262666-126266629.85830.29
51271499-127149930.06730.49
61241050-124105029.34729.77
120min11924953-192495345.51845.361.1546.0945.941.13
21919504-191950445.39045.97
31939376-193937645.86046.42
41941412-194141245.90846.49
51898631-189863144.89645.47
61886751-188675144.61545.19
180min12379680-237968056.27155.881.8357.0756.681.79
22406658-240665856.90957.71
32353656-235365655.65656.45
42282500-228250053.97354.79
52384368-238436856.38257.18
62372759-237275956.10856.90
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12757086-275708665.19665.511.6466.2866.601.62
22862042-286204267.67768.77
32754778-275477865.14166.21
42741251-274125164.82165.91
52758717-275871765.23466.32
62749399-274939965.01466.09
360min13309470-330947078.25877.741.0579.6679.151.04
23290955-329095577.82079.25
33289749-328974977.79179.19
43329023-332902378.72080.13
53279705-327970577.55478.96
63227194-322719476.31277.71
480min13582598-358259884.71685.671.5386.5187.461.50
23601797-360179785.17086.99
33717931-371793187.91689.70
43657079-365707986.47788.28
53607025-360702585.29487.09
63570161-357016184.42286.20
600min13859881-385988191.27390.281.5793.5092.501.53
23794550-379455089.72891.97
33810545-381054590.10692.33
43773193-377319389.22391.46
53914577-391457792.56694.79
63754274-375427488.77690.98
720min13996025-399602594.49292.261.6597.1794.941.61
23812020-381202090.14192.83
33949475-394947593.39196.07
43865278-386527891.40094.08
53895721-389572192.12094.81
63891013-389101392.00994.66
极限13900105-390010592.22492.030.9795.3895.170.94
23846061-384606190.94694.09
33957766-395776693.58796.73
43895113-389511392.10695.24
53880508-388050891.76194.91
63871210-387121091.54194.65
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12500
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%
112.611654216302164471642316283163990.66
212.611633716385163610.21
单位质量响应值RSD%判断
1300.481297.460.17数据可信
长期6月-供试品溶液-2025081921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%
5min119161-191610.4740.462.620.470.462.56
218994-189940.4700.47
318425-184250.4560.46
417876-178760.4430.44
518119-181190.4490.45
618650-186500.4620.46
10min118563-185630.4600.461.230.460.461.12
218993-189930.4700.47
318719-187190.4630.47
418307-183070.4530.46
518676-186760.4620.46
618491-184910.4580.46
15min118978-189780.4700.470.790.470.470.87
218996-189960.4700.48
318811-188110.4660.47
418646-186460.4620.47
518655-186550.4620.47
618726-187260.4640.47
20min119226-192260.4760.471.610.480.481.77
219310-193100.4780.49
318715-187150.4630.47
418580-185800.4600.47
518828-188280.4660.47
618689-186890.4630.47
30min119201-192010.4750.471.190.480.480.86
219134-191340.4740.48
319137-191370.4740.48
418852-188520.4670.48
518626-186260.4610.47
618864-188640.4670.48
45min119593-195930.4850.471.770.500.482.14
219395-193950.4800.49
318843-188430.4670.48
418691-186910.4630.47
519010-190100.4710.48
618937-189370.4690.48
60min118702-187020.4630.472.680.480.482.83
219971-199710.4940.51
318821-188210.4660.48
418596-185960.4600.47
518714-187140.4630.48
618926-189260.4690.48
120min118899-188990.4680.471.550.480.491.68
219017-190170.4710.49
319551-195510.4840.50
418950-189500.4690.49
518768-187680.4650.48
618757-187570.4640.48
180min118742-187420.4640.462.350.480.482.29
219148-191480.4740.49
318601-186010.4610.48
417868-178680.4420.46
518888-188880.4680.49
618655-186550.4620.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118781-187810.4650.471.780.490.491.55
219401-194010.4800.50
318968-189680.4700.49
418405-184050.4560.48
518632-186320.4610.48
618950-189500.4690.49
360min118979-189790.4700.471.200.490.491.55
219085-190850.4730.50
318939-189390.4690.49
418644-186440.4620.48
518781-187810.4650.49
618507-185070.4580.48
480min118428-184280.4560.462.200.480.491.68
218886-188860.4680.49
319325-193250.4780.50
418592-185920.4600.49
518220-182200.4510.48
618352-183520.4540.48
600min118630-186300.4610.461.750.490.491.83
219002-190020.4700.50
318661-186610.4620.49
418110-181100.4480.48
518905-189050.4680.50
618408-184080.4560.48
720min119163-191630.4740.462.320.500.492.13
218302-183020.4530.48
318870-188700.4670.50
418162-181620.4500.48
518041-180410.4470.48
618327-183270.4540.48
极限118432-184320.4560.461.680.490.491.55
218574-185740.4600.49
318938-189380.4690.50
418221-182210.4510.48
518072-180720.4470.48
618363-183630.4550.49
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