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)1.5补液体积(ml)1.5
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1250
标示量(mg)10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%
112.701638171635781638971634421632611635990.17
212.781634621635941635280.06
单位质量响应值RSD%判断
12881.8112795.620.48数据可信
供试品溶液-25041503批-达格列净-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%
5min1102275-10227551.23949.9110.8951.2449.9110.89
290645-9064545.41245.41
392072-9207246.12746.13
4110356-11035655.28755.29
5113898-11389857.06257.06
688483-8848344.32944.33
10min1189588-18958894.98294.123.0395.0694.203.03
2178892-17889289.62389.69
3190116-19011695.24695.32
4195013-19501397.70097.78
5189921-18992195.14995.23
6183702-18370292.03392.10
15min1200158-200158100.27798.721.85100.5098.941.85
2191667-19166796.02396.23
3199063-19906399.72999.94
4200186-200186100.291100.52
5193459-19345996.92197.15
6197798-19779899.09599.30
20min1200589-200589100.49399.621.77100.8699.981.77
2193693-19369397.03897.38
3200990-200990100.694101.06
4201958-201958101.179101.56
5195073-19507397.73098.10
6200740-200740100.569100.92
30min1201015-201015100.707100.701.72101.23101.211.72
2196898-19689898.64499.14
3203759-203759102.081102.59
4203699-203699102.051102.58
5196634-19663498.51299.03
6203955-203955102.179102.68
45min1201873-201873101.136100.931.93101.81101.601.92
2197853-19785399.12299.76
3202961-202961101.682102.35
4205503-205503102.955103.64
5195802-19580298.09598.76
6204809-204809102.607103.26
60min1202072-202072101.236100.891.96102.06101.701.96
2197536-19753698.96499.75
3203048-203048101.725102.54
4204352-204352102.378103.22
5195647-19564798.01798.83
6205615-205615103.011103.82
120min1211753-211753106.086105.162.04107.06106.132.04
2206524-206524103.467104.40
3210759-210759105.588106.56
4212360-212360106.390107.38
5203182-203182101.792102.75
6214875-214875107.650108.62
180min1209831-209831105.123104.662.11106.26105.782.10
2204578-204578102.492103.58
3210532-210532105.475106.60
4212081-212081106.251107.40
5202576-202576101.489102.60
6213845-213845107.134108.26
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1209459-209459104.937104.462.21106.23105.742.19
2204209-204209102.307103.55
3210467-210467105.442106.73
4211247-211247105.833107.14
5201762-201762101.081102.35
6213906-213906107.165108.45
360min1207100-207100103.755103.582.04105.20105.022.03
2202773-202773101.587102.99
3208381-208381104.397105.84
4209845-209845105.130106.60
5200747-200747100.572101.99
6211682-211682106.051107.50
480min1205403-205403102.905102.642.22104.51104.242.21
2200463-200463100.430101.98
3207207-207207103.809105.41
4208697-208697104.555106.18
5198257-19825799.325100.89
6209261-209261104.838106.45
600min1204799-204799102.602102.042.39104.36103.782.38
2199162-19916299.778101.48
3205215-205215102.811104.57
4207201-207201103.806105.59
5196482-19648298.436100.15
6209140-209140104.777106.54
720min1202921-202921101.661101.202.16103.57103.102.15
2197468-19746898.930100.78
3203760-203760102.082103.99
4204697-204697102.551104.49
5195964-19596498.176100.04
6207137-207137103.774105.70
极限1201585-201585100.992100.992.18103.06103.042.17
2197700-19770099.046101.05
3202430-202430101.415103.48
4204343-204343102.374104.47
5195657-19565798.022100.04
6207719-207719104.065106.14
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)1.5补液体积(ml)1.5
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(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.991146473114552911466521145431114700011462170.07
29.961144503114485511446790.03
单位质量响应值RSD%判断
114736.44114927.610.12数据可信
供试品溶液-25041503批-二甲双胍-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%
5min132388-323882.8203.5620.072.823.5620.07
240313-403133.5113.51
335608-356083.1013.10
441069-410693.5763.58
556169-561694.8914.89
639485-394853.4393.44
10min189305-893057.7778.7612.157.788.7612.17
294180-941808.2028.21
394332-943328.2158.22
4113954-1139549.9249.93
5118150-11815010.28910.30
693399-933998.1348.14
15min1159501-15950113.89013.154.0513.9113.164.07
2145979-14597912.71212.73
3146272-14627212.73812.75
4155489-15548913.54113.56
5153718-15371813.38613.41
6144763-14476312.60712.62
20min1181713-18171315.82416.533.1215.8616.573.12
2188161-18816116.38616.42
3189704-18970416.52016.56
4196854-19685417.14317.18
5196481-19648117.11017.15
6186267-18626716.22116.26
30min1247039-24703921.51322.553.0221.5722.613.03
2257201-25720122.39822.46
3266548-26654823.21223.27
4263899-26389922.98123.05
5265586-26558623.12823.20
6253175-25317522.04722.11
45min1324690-32469028.27529.633.5328.3729.733.53
2338329-33832929.46329.56
3338915-33891529.51429.61
4360014-36001431.35131.45
5346270-34627030.15530.26
6333445-33344529.03829.13
60min1388656-38865633.84635.122.1033.9835.262.11
2403205-40320535.11335.25
3407297-40729735.46935.61
4409196-40919635.63435.78
5412035-41203535.88236.03
6399353-39935334.77734.91
120min1603256-60325652.53453.801.3952.7254.001.40
2619689-61968953.96554.16
3622558-62255854.21554.41
4619847-61984753.97954.18
5628055-62805554.69354.90
6613605-61360553.43553.62
180min1730995-73099563.65865.991.9363.9266.261.94
2761114-76111466.28166.55
3767558-76755866.84267.12
4760694-76069466.24466.53
5772543-77254367.27667.56
6753601-75360165.62665.90
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1836678-83667872.86175.131.8273.2275.501.83
2860091-86009174.90075.27
3876755-87675576.35176.73
4863264-86326475.17675.56
5880916-88091676.71377.10
6858774-85877474.78575.15
360min1980695-98069585.40388.181.8685.8788.671.86
21010552-101055288.00388.49
31028605-102860589.57590.06
41012478-101247888.17088.66
51034482-103448290.08790.59
61008972-100897287.86588.35
480min11073886-107388693.51896.311.7294.1296.931.72
21099362-109936295.73796.35
31121021-112102197.62398.25
41109114-110911496.58697.21
51128158-112815898.24498.88
61104236-110423696.16196.77
600min11128628-112862898.285100.481.3899.02101.241.38
21147109-114710999.895100.65
31165051-1165051101.457102.23
41155350-1155350100.612101.38
51174753-1174753102.302103.08
61152078-1152078100.327101.08
720min11143536-114353699.583102.081.60100.47103.001.61
21163791-1163791101.347102.26
31183075-1183075103.027103.95
41172676-1172676102.121103.04
51199504-1199504104.457105.39
61170782-1170782101.956102.86
极限11143332-114333299.566102.081.53100.60103.151.54
21168866-1168866101.789102.85
31179095-1179095102.680103.76
41173660-1173660102.207103.28
51198800-1198800104.396105.49
61169654-1169654101.858102.92
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