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%
110.204288813428747242806614282168430276842883760.21
210.274358862434220443505330.28
单位质量响应值RSD%判断
420429.02423615.680.54数据可信
加速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%
5min1193505-1935054.5854.817.334.594.817.32
2195385-1953854.6304.63
3206750-2067504.8994.90
4193572-1935724.5874.59
5231628-2316285.4895.49
6197156-1971564.6724.67
10min1380963-3809639.0279.195.809.059.225.81
2359200-3592008.5128.53
3401789-4017899.5219.55
4406209-4062099.6259.65
5366100-3661008.6758.70
6413539-4135399.7999.82
15min1536649-53664912.71612.393.3812.7812.463.39
2494545-49454511.71911.78
3543298-54329812.87412.95
4530703-53070312.57512.65
5518125-51812512.27712.35
6514938-51493812.20212.27
20min1653574-65357415.48715.313.1215.6215.443.11
2627383-62738314.86614.99
3683578-68357816.19816.33
4638112-63811215.12115.25
5638090-63809015.12015.25
6636755-63675515.08815.22
30min1853492-85349220.22420.121.9520.4320.331.94
2846659-84665920.06220.26
3878908-87890820.82621.04
4831622-83162219.70619.92
5847537-84753720.08320.29
6837029-83702919.83420.04
45min11123496-112349626.62226.332.2426.9326.642.23
21115840-111584026.44126.74
31153005-115300527.32127.64
41095221-109522125.95226.26
51091128-109112825.85526.16
61088486-108848625.79326.10
60min11352208-135220832.04231.522.0832.4831.962.07
21330524-133052431.52831.96
31368396-136839632.42532.88
41303727-130372730.89331.33
51330109-133010931.51831.96
61296165-129616530.71431.15
120min11991699-199169947.19547.542.2447.8048.142.23
22040079-204007948.34148.93
32064002-206400248.90849.53
41942529-194252946.03046.62
52024855-202485547.98048.58
61975014-197501446.79947.39
180min12475102-247510258.64958.702.2159.4959.542.20
22543500-254350060.27061.10
32524566-252456659.82260.69
42413078-241307857.18058.00
52493302-249330259.08159.92
62414620-241462057.21658.04
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12796274-279627466.26067.541.4167.3968.671.40
22885763-288576368.38069.51
32873746-287374668.09669.26
42807922-280792266.53667.64
52888748-288874868.45169.58
62849745-284974567.52768.64
360min13360615-336061579.63279.222.5381.1080.692.51
23399049-339904980.54382.02
33438709-343870981.48382.99
43205220-320522075.95077.39
53370849-337084979.87581.35
63285809-328580977.86079.31
480min13663238-366323886.80386.981.3988.6788.851.39
23746456-374645688.77590.65
33687602-368760287.38189.29
43588588-358858885.03486.86
53679046-367904687.17889.05
63659793-365979386.72288.56
600min13845255-384525591.11691.092.3893.4193.392.36
23955485-395548593.72896.05
33880161-388016191.94394.29
43681606-368160687.23889.48
53878302-387830291.89994.21
63824304-382430490.62092.89
720min13978614-397861494.27692.602.4797.0395.352.44
23953882-395388293.69096.48
33939031-393903193.33896.15
43725451-372545188.27790.96
53972223-397222394.12596.89
63877708-387770891.88594.61
极限13956429-395642993.75192.221.9296.9795.431.90
23943740-394374093.45096.71
33895776-389577692.31395.59
43781237-378123789.59992.72
53952435-395243593.65696.89
63820983-382098390.54193.72
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%
112.611654316503163391633016405164240.59
212.741679116800167960.04
单位质量响应值RSD%判断
1302.461318.370.86数据可信
加速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%
5min119163-191630.4700.462.970.470.462.95
217907-179070.4390.44
319513-195130.4790.48
419003-190030.4660.47
518564-185640.4560.46
618779-187790.4610.46
10min119526-195260.4790.472.530.480.472.50
218137-181370.4450.45
319258-192580.4730.48
419114-191140.4690.47
518803-188030.4610.46
618960-189600.4650.47
15min119609-196090.4810.472.340.490.482.21
218360-183600.4510.46
319465-194650.4780.48
419378-193780.4760.48
519056-190560.4680.47
618986-189860.4660.47
20min119488-194880.4780.471.530.490.481.87
218783-187830.4610.47
319567-195670.4800.49
419294-192940.4740.48
519027-190270.4670.47
619099-190990.4690.48
30min119349-193490.4750.470.830.480.480.86
219010-190100.4670.48
319287-192870.4730.48
418947-189470.4650.47
519239-192390.4720.48
619068-190680.4680.48
45min119484-194840.4780.471.260.490.481.07
218897-188970.4640.48
319313-193130.4740.49
419139-191390.4700.48
518959-189590.4650.48
618912-189120.4640.48
60min119505-195050.4790.471.230.490.481.07
218889-188890.4640.48
319031-190310.4670.48
419329-193290.4740.49
519035-190350.4670.48
618989-189890.4660.48
120min119400-194000.4760.470.990.490.491.30
219013-190130.4670.48
319597-195970.4810.50
419219-192190.4720.49
519400-194000.4760.49
619339-193390.4750.49
180min119281-192810.4730.470.570.490.490.00
219325-193250.4740.49
319215-192150.4720.49
419376-193760.4760.49
519215-192150.4720.49
619063-190630.4680.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min119025-190250.4670.471.590.490.501.11
218968-189680.4660.49
318995-189950.4660.49
419581-195810.4810.50
519499-194990.4790.50
619559-195590.4800.50
360min119143-191430.4700.461.390.490.491.55
218579-185790.4560.48
319320-193200.4740.50
418986-189860.4660.49
518853-188530.4630.49
618779-187790.4610.48
480min118889-188890.4640.461.290.490.491.30
218630-186300.4570.48
319010-190100.4670.49
419344-193440.4750.50
518822-188220.4620.49
618924-189240.4640.49
600min118898-188980.4640.460.430.490.490.00
218869-188690.4630.49
318916-189160.4640.49
418682-186820.4590.49
518924-189240.4640.49
618819-188190.4620.49
720min119161-191610.4700.461.950.500.491.83
218269-182690.4480.48
319119-191190.4690.50
418488-184880.4540.48
518895-188950.4640.49
618551-185510.4550.49
极限119186-191860.4710.462.020.500.491.83
218352-183520.4500.48
318422-184220.4520.49
418444-184440.4530.49
518840-188400.4620.50
618173-181730.4460.48
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%
110.204299428430034443007514302942430386043014650.05
210.274313801431318143134910.02
单位质量响应值RSD%判断
421712.25420008.860.29数据可信
加速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%
5min1220322-2203225.2355.496.635.245.496.61
2226566-2265665.3835.38
3251671-2516715.9805.98
4247949-2479495.8925.89
5226014-2260145.3705.37
6213720-2137205.0785.08
10min1423199-42319910.0569.565.4510.089.595.42
2409715-4097159.7359.76
3424670-42467010.09110.12
4369010-3690108.7688.80
5403232-4032329.5819.61
6384969-3849699.1479.17
15min1559170-55917013.28612.892.7213.3612.962.69
2550877-55087713.08913.16
3542978-54297812.90212.98
4518199-51819912.31312.39
5533540-53354012.67712.75
6550551-55055113.08213.15
20min1692259-69225916.44915.812.3016.5915.952.30
2666220-66622015.83015.97
3667765-66776515.86716.01
4647210-64721015.37815.51
5664710-66471015.79415.93
6655025-65502515.56415.70
30min1885262-88526221.03520.822.0821.2621.042.08
2902243-90224321.43821.66
3882008-88200820.95721.18
4849987-84998720.19620.41
5875927-87592720.81321.03
6863173-86317320.51020.72
45min11173057-117305727.87327.112.8828.2027.442.87
21160180-116018027.56727.89
31152671-115267127.38927.72
41079015-107901525.63825.95
51138789-113878927.05927.38
61143102-114310227.16127.48
60min11411142-141114233.53032.322.8734.0032.782.86
21397268-139726833.20033.67
31373654-137365432.63933.11
41326729-132672931.52431.97
51331135-133113531.62932.09
61321414-132141431.39831.85
120min12027891-202789148.18547.962.4848.8248.582.48
22063735-206373549.03649.67
32049117-204911748.68949.32
41926690-192669045.78046.38
52044360-204436048.57649.19
61999578-199957847.51248.12
180min12528648-252864860.08359.311.4260.9660.181.43
22516688-251668859.79960.68
32515113-251511359.76160.63
42429967-242996757.73858.57
52494337-249433759.26860.13
62492814-249281459.23260.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12925960-292596069.52469.002.5270.7070.162.50
23017660-301766071.70272.88
32881211-288121168.46069.63
42794611-279461166.40367.52
52920462-292046269.39370.55
62883130-288313068.50669.65
360min13462008-346200882.26181.232.2683.7982.732.25
23454649-345464982.08683.62
33448580-344858081.94183.46
43262650-326265077.52478.97
53448626-344862681.94383.44
63435690-343569081.63583.12
480min13840270-384027091.24889.041.9093.1990.951.89
23723200-372320088.46790.41
33771276-377127689.60991.53
43627883-362788386.20288.04
53780616-378061689.83191.74
63741737-374173788.90790.80
600min14036374-403637495.90893.652.1398.3096.002.12
23939732-393973293.61296.00
34000202-400020295.04997.42
43791613-379161390.09292.36
53938833-393883393.59095.95
63940647-394064793.63395.97
720min14082679-408267997.00895.032.2999.8897.852.26
24121278-412127897.925100.78
33968613-396861394.29897.14
43904772-390477292.78195.50
54017000-401700095.44898.28
63901034-390103492.69295.50
极限13997181-399718194.97794.971.5598.3498.271.55
24095377-409537797.310100.65
33989210-398921094.78798.11
43913328-391332892.98496.17
54027813-402781395.70599.01
63959146-395914694.07397.34
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%
112.611636016249162921646216491163710.65
212.741656616573165700.03
单位质量响应值RSD%判断
1298.261300.630.13数据可信
加速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%
5min119070-190700.4720.482.020.470.482.17
219493-194930.4820.48
319827-198270.4910.49
419248-192480.4760.48
519464-194640.4820.48
618723-187230.4630.46
10min119320-193200.4780.481.330.480.481.57
219007-190070.4700.47
319689-196890.4870.49
419129-191290.4730.48
519524-195240.4830.49
619418-194180.4810.48
15min119254-192540.4770.481.120.480.491.55
219862-198620.4920.50
319700-197000.4880.49
419502-195020.4830.49
519381-193810.4800.48
619616-196160.4850.49
20min119521-195210.4830.480.790.490.491.07
219488-194880.4820.49
319622-196220.4860.49
419242-192420.4760.48
519401-194010.4800.49
619285-192850.4770.48
30min118979-189790.4700.481.950.480.492.00
219934-199340.4930.50
319771-197710.4890.50
419684-196840.4870.50
519430-194300.4810.49
619064-190640.4720.48
45min119439-194390.4810.481.120.490.491.54
219545-195450.4840.50
319351-193510.4790.49
419055-190550.4720.48
519448-194480.4810.49
619717-197170.4880.50
60min119434-194340.4810.481.660.500.501.70
219589-195890.4850.50
319692-196920.4870.50
419558-195580.4840.50
518925-189250.4680.48
619037-190370.4710.49
120min119260-192600.4770.481.170.490.501.11
219694-196940.4870.50
319608-196080.4850.50
419115-191150.4730.49
519335-193350.4790.50
619202-192020.4750.49
180min119358-193580.4790.480.450.500.500.82
219195-191950.4750.49
319437-194370.4810.50
419397-193970.4800.50
519376-193760.4800.50
619379-193790.4800.50
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min119164-191640.4740.482.140.500.501.66
220273-202730.5020.52
319367-193670.4790.50
419432-194320.4810.50
519596-195960.4850.51
619193-191930.4750.50
360min119236-192360.4760.481.270.500.501.66
219573-195730.4840.51
319540-195400.4840.51
418947-189470.4690.49
519436-194360.4810.51
619570-195700.4840.51
480min119408-194080.4800.481.050.510.501.03
219247-192470.4760.50
319704-197040.4880.51
419343-193430.4790.50
519154-191540.4740.50
619232-192320.4760.50
600min119262-192620.4770.481.600.510.502.08
219427-194270.4810.51
319715-197150.4880.52
418783-187830.4650.49
519221-192210.4760.50
619163-191630.4740.50
720min119303-193030.4780.482.190.510.512.04
219852-198520.4910.52
319376-193760.4800.51
419126-191260.4730.50
519266-192660.4770.51
618542-185420.4590.49
极限118717-187170.4630.471.740.500.501.66
219630-196300.4860.52
318949-189490.4690.50
418999-189990.4700.50
519192-191920.4750.51
618825-188250.4660.50
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