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%
110.204223031421024942153264222349421321142168330.14
210.274296896429475342958240.04
单位质量响应值RSD%判断
413415.00418288.610.83数据可信
中间条件6月-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%
5min1178317-1783174.2884.215.984.294.215.99
2188586-1885864.5354.54
3173778-1737784.1794.18
4173963-1739634.1834.18
5178236-1782364.2864.29
6156596-1565963.7663.77
10min1337124-3371248.1078.293.178.138.313.18
2359420-3594208.6438.67
3352878-3528788.4868.51
4331621-3316217.9758.00
5349564-3495648.4068.43
6336925-3369258.1028.12
15min1484811-48481111.65911.833.7811.7211.893.78
2487119-48711911.71411.78
3494407-49440711.88911.95
4483219-48321911.62011.68
5527062-52706212.67512.74
6473813-47381311.39411.45
20min1597603-59760314.37114.631.3214.4914.761.32
2609714-60971414.66214.79
3617099-61709914.84014.96
4613688-61368814.75814.88
5613222-61322214.74714.87
6599623-59962314.42014.54
30min1801151-80115119.26619.411.6019.4619.611.61
2816370-81637019.63219.83
3796315-79631519.15019.35
4809900-80990019.47619.67
5826514-82651419.87620.08
6792794-79279419.06519.25
45min11043753-104375325.10025.602.0525.3925.892.05
21066357-106635725.64425.94
31097632-109763226.39626.69
41060800-106080025.51025.80
51079161-107916125.95226.25
61039617-103961725.00125.28
60min11250811-125081130.07930.271.3730.4930.691.37
21265902-126590230.44230.87
31264535-126453530.40930.83
41264494-126449430.40830.83
51278500-127850030.74531.17
61228717-122871729.54829.96
120min11865321-186532144.85745.601.3645.4246.171.36
21905772-190577245.83046.41
31889077-188907745.42846.00
41920825-192082546.19246.76
51926830-192683046.33646.92
61870172-187017244.97445.53
180min12340225-234022556.27756.840.9957.0757.640.98
22343843-234384356.36457.17
32371398-237139857.02757.83
42399053-239905357.69258.49
52379342-237934257.21858.03
62349048-234904856.49057.27
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12709596-270959665.16065.790.9966.2366.870.99
22749288-274928866.11467.20
32743220-274322065.96967.06
42756926-275692666.29867.39
52760208-276020866.37767.48
62695102-269510264.81165.88
360min13269799-326979978.63278.831.1480.0380.241.14
23260392-326039278.40579.82
33288186-328818679.07480.49
43318063-331806379.79281.21
53312785-331278579.66581.10
63217922-321792277.38478.77
480min13569161-356916185.83187.191.2187.6288.991.20
23631111-363111187.32089.13
33624047-362404787.15188.96
43699856-369985688.97490.79
53631168-363116887.32289.15
63597707-359770786.51788.29
600min13760481-376048190.43191.080.9592.6593.330.95
23756481-375648190.33592.58
33785866-378586691.04293.29
43849525-384952592.57394.84
53807509-380750991.56293.83
63766108-376610890.56792.77
720min13875542-387554293.19893.750.7795.8796.450.77
23937896-393789694.69897.40
33880279-388027993.31296.02
43927621-392762194.45197.18
53905173-390517393.91196.64
63865304-386530492.95295.61
极限13854834-385483492.70093.310.7595.8496.480.72
23888820-388882093.51896.69
33859906-385990692.82295.99
43852943-385294392.65595.85
53902966-390296693.85897.05
63922790-392279094.33597.46
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%
112.611562415724156221572115558156500.46
212.741585715680157680.80
单位质量响应值RSD%判断
1241.081237.680.20数据可信
中间条件6月-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%
5min118462-184620.4790.462.690.480.462.88
217669-176690.4580.46
317876-178760.4640.46
417761-177610.4610.46
518102-181020.4700.47
617036-170360.4420.44
10min118128-181280.4700.471.570.470.481.77
218223-182230.4730.48
318371-183710.4770.48
417561-175610.4560.46
518222-182220.4730.48
618231-182310.4730.48
15min118461-184610.4790.481.160.480.481.32
218441-184410.4790.48
318543-185430.4810.49
417957-179570.4660.47
518297-182970.4750.48
618224-182240.4730.48
20min118282-182820.4740.470.920.480.480.85
218101-181010.4700.48
318236-182360.4730.48
418272-182720.4740.48
518615-186150.4830.49
618260-182600.4740.48
30min118656-186560.4840.481.560.490.491.55
218395-183950.4770.49
318015-180150.4670.48
418322-183220.4750.48
518643-186430.4840.49
618771-187710.4870.50
45min118239-182390.4730.482.120.490.492.10
218214-182140.4730.48
318536-185360.4810.49
418410-184100.4780.49
519261-192610.5000.51
618739-187390.4860.50
60min118300-183000.4750.470.990.490.490.84
218273-182730.4740.49
318310-183100.4750.49
417880-178800.4640.48
518161-181610.4710.49
618369-183690.4770.49
120min118161-181610.4710.481.190.490.501.11
218143-181430.4710.49
318454-184540.4790.50
418595-185950.4830.50
518526-185260.4810.50
618147-181470.4710.49
180min118254-182540.4740.471.210.490.490.84
217782-177820.4610.48
318336-183360.4760.49
418298-182980.4750.49
518268-182680.4740.49
618290-182900.4750.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118298-182980.4750.471.570.500.491.66
217770-177700.4610.48
318599-185990.4830.50
418432-184320.4780.50
518228-182280.4730.49
618142-181420.4710.49
360min118502-185020.4800.471.970.500.501.65
217581-175810.4560.48
318406-184060.4780.50
418479-184790.4800.50
518438-184380.4780.50
618201-182010.4720.50
480min117910-179100.4650.471.550.490.501.65
217803-178030.4620.49
318170-181700.4710.50
418615-186150.4830.51
518152-181520.4710.50
618021-180210.4680.49
600min117954-179540.4660.462.430.490.492.71
217214-172140.4470.47
317667-176670.4580.49
417891-178910.4640.49
518154-181540.4710.50
618496-184960.4800.51
720min117751-177510.4610.460.610.490.490.84
217562-175620.4560.49
317842-178420.4630.49
417797-177970.4620.49
517750-177500.4610.49
617895-178950.4640.50
极限117898-178980.4640.461.450.500.491.66
217326-173260.4500.48
317831-178310.4630.50
417589-175890.4560.49
517734-177340.4600.49
618086-180860.4690.50
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%
110.204205778419547442089054208736421179542061380.16
210.274227124424637642367500.33
单位质量响应值RSD%判断
412366.47412536.510.03数据可信
中间条件6月-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%
5min1178991-1789914.3404.282.914.344.282.91
2182847-1828474.4334.43
3175931-1759314.2654.27
4171871-1718714.1674.17
5169236-1692364.1034.10
6179762-1797624.3584.36
10min1356086-3560868.6338.501.768.668.531.78
2343507-3435078.3288.35
3346051-3460518.3908.41
4347637-3476378.4298.45
5359447-3594478.7158.74
6351605-3516058.5258.55
15min1493413-49341311.96312.032.2212.0312.102.19
2487303-48730311.81511.88
3496955-49695512.04912.11
4515876-51587612.50812.57
5485116-48511611.76211.83
6498814-49881412.09412.16
20min1613856-61385614.88314.820.8715.0114.940.88
2602659-60265914.61214.73
3615590-61559014.92515.05
4610187-61018714.79414.92
5608787-60878714.76014.88
6616914-61691414.95715.08
30min1830233-83023320.12919.771.1220.3319.961.12
2804282-80428219.50019.70
3807447-80744719.57719.77
4818584-81858419.84720.05
5815263-81526319.76619.96
6815804-81580419.77919.98
45min11064064-106406425.79925.761.0226.1026.061.01
21052982-105298225.53025.82
31080520-108052026.19826.49
41062677-106267725.76526.06
51049860-104986025.45425.75
61064392-106439225.80626.11
60min11298812-129881231.49030.751.4131.9231.181.40
21255354-125535430.43630.86
31267432-126743230.72931.16
41254136-125413630.40730.83
51255509-125550930.44030.86
61279295-127929531.01731.44
120min11923703-192370346.64146.220.7947.2346.800.79
21883594-188359445.66846.24
31906100-190610046.21446.79
41905784-190578446.20646.79
51921333-192133346.58347.16
61897125-189712545.99646.58
180min12383107-238310757.77957.870.9058.6058.680.89
22353379-235337957.05857.86
32418053-241805358.62659.44
42392658-239265858.01158.82
52395902-239590258.08958.90
62378920-237892057.67858.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12748640-274864066.64266.700.8267.7567.800.81
22722297-272229766.00367.09
32777770-277777067.34868.45
42739595-273959566.42267.52
52739917-273991766.43067.53
62777568-277756867.34368.44
360min13287045-328704579.69579.580.5481.1481.020.53
23275679-327567979.42080.84
33289514-328951479.75581.20
43267813-326781379.22980.66
53262757-326275779.10680.54
63310816-331081680.27281.71
480min13685809-368580989.36373.4248.9191.2075.2547.73
23599427-359942787.26989.08
33648508-364850888.45990.30
43612616-361261687.58989.42
55723-57230.1391.96
63617785-361778587.71489.55
600min13792328-379232891.94692.100.5394.2394.300.44
23783763-378376391.73893.99
33824334-382433492.72295.00
43778085-377808591.60193.87
53822304-382230492.67394.50
63791293-379129391.92194.20
720min14029694-402969497.70179.4648.92100.4582.1147.29
23917504-391750494.98197.69
36419-64190.1562.90
43884410-388441094.17996.90
53906386-390638694.71197.00
63918488-391848895.00597.74
极限13894344-389434494.41994.740.6697.6597.790.74
23903681-390368194.64697.83
33885116-388511694.19696.94
43956336-395633695.92299.12
53911805-391180594.84397.61
63892887-389288794.38497.60
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%
112.611568415687158291563315695157060.47
212.741607216189161300.52
单位质量响应值RSD%判断
1245.521266.091.16数据可信
中间条件6月-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%
5min117591-175910.4510.461.780.450.461.95
217893-178930.4580.46
318278-182780.4680.47
418391-183910.4710.47
517631-176310.4520.45
618013-180130.4610.46
10min118903-189030.4840.481.440.490.482.06
218332-183320.4690.47
318379-183790.4710.47
418583-185830.4760.48
518927-189270.4850.49
618421-184210.4720.47
15min118273-182730.4680.481.280.470.481.69
218719-187190.4790.48
318827-188270.4820.49
418856-188560.4830.49
518625-186250.4770.48
618923-189230.4850.49
20min118612-186120.4770.471.300.480.481.32
218493-184930.4740.48
318110-181100.4640.47
418333-183330.4700.48
518468-184680.4730.48
618815-188150.4820.49
30min119172-191720.4910.481.960.500.491.54
218696-186960.4790.49
318241-182410.4670.48
418634-186340.4770.49
519229-192290.4920.50
618880-188800.4840.49
45min118744-187440.4800.471.160.490.481.07
218103-181030.4640.48
318277-182770.4680.48
418509-185090.4740.49
518465-184650.4730.48
618448-184480.4720.48
60min118759-187590.4800.481.050.490.491.54
218677-186770.4780.49
318476-184760.4730.49
418338-183380.4700.48
518786-187860.4810.50
618840-188400.4830.50
120min118861-188610.4830.481.780.500.492.10
218207-182070.4660.48
318359-183590.4700.49
418490-184900.4740.49
519098-190980.4890.51
618648-186480.4780.49
180min118469-184690.4730.480.650.490.501.04
218426-184260.4720.49
318716-187160.4790.50
418662-186620.4780.50
518621-186210.4770.50
618691-186910.4790.50
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118518-185180.4740.471.410.500.501.04
218164-181640.4650.49
318501-185010.4740.50
418297-182970.4690.49
518749-187490.4800.50
618851-188510.4830.50
360min118426-184260.4720.471.700.500.501.70
218176-181760.4660.49
318129-181290.4640.49
418305-183050.4690.49
518040-180400.4620.49
618887-188870.4840.51
480min118704-187040.47915.69237.620.5115.72237.19
218186-181860.4660.49
318019-180190.4610.49
418439-184390.4720.50
53583918-358391891.78791.81
618419-184190.4720.50
600min118376-183760.4710.470.990.500.5733.29
217988-179880.4610.49
318124-181240.4640.49
418231-182310.4670.50
518459-184590.4730.96
618105-181050.4640.49
720min118856-188560.48317.03238.200.5117.13236.52
217868-178680.4580.49
33897110-389711099.80899.84
418102-181020.4640.49
518251-182510.4670.95
618556-185560.4750.51
极限118102-181020.4640.461.160.500.6637.27
217906-179060.4590.49
317737-177370.4540.98
418199-181990.4660.50
518303-183030.4690.96
618069-180690.4630.50
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