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%
112.701660761664731664241657691664171662320.19
212.781707641699171703400.36
单位质量响应值RSD%判断
13089.1313328.641.29数据可信
供试品溶液-25041503批-达格列净-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1124135-12413560.45268.0412.6960.4568.0412.69
2112646-11264654.85754.86
3157712-15771276.80376.80
4154535-15453575.25675.26
5145773-14577370.98970.99
6143465-14346569.86569.87
10min1198483-19848396.65896.803.6796.7596.903.68
2189255-18925592.16492.25
3211710-211710103.100103.21
4195990-19599095.44495.56
5198581-19858196.70696.81
6198564-19856496.69896.80
15min1203780-20378099.23898.953.5699.4799.203.56
2197709-19770996.28196.50
3217048-217048105.699105.97
4197514-19751496.18696.44
5201123-20112397.94498.20
6202014-20201498.37898.63
20min1204646-20464699.66099.273.18100.0499.673.17
2199766-19976697.28397.65
3215687-215687105.036105.46
4196916-19691695.89596.30
5202030-20203098.38698.78
6204088-20408899.38899.79
30min1207312-207312100.95899.833.02101.49100.373.02
2202324-20232498.52999.04
3215870-215870105.125105.71
4197698-19769896.27696.82
5202567-20256798.64799.19
6204209-20420999.44799.99
45min1206686-206686100.653100.423.00101.34101.113.00
2203741-20374199.21999.88
3216483-216483105.424106.17
4198519-19851996.67697.36
5202747-20274798.73599.43
6209041-209041101.800102.50
60min1206516-206516100.57099.912.96101.41100.762.96
2203673-20367399.18699.99
3216067-216067105.221106.12
4197784-19778496.31897.15
5202688-20268898.70699.55
6204280-20428099.481100.33
120min1207109-207109100.859100.083.06101.85101.083.06
2204595-20459599.635100.59
3216751-216751105.554106.61
4197910-19791096.37997.36
5202866-20286698.79399.78
6203882-20388299.287100.29
180min1214621-214621104.517103.753.04105.66104.903.04
2211748-211748103.118104.22
3224462-224462109.310110.53
4204888-20488899.777100.90
5210444-210444102.483103.62
6212113-212113103.296104.44
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1213637-213637104.038103.403.02105.33104.703.02
2211606-211606103.049104.31
3223803-223803108.989110.37
4204523-20452399.600100.87
5209429-209429101.989103.28
6210961-210961102.735104.04
360min1212360-212360103.416102.632.88104.87104.082.89
2209713-209713102.127103.54
3221518-221518107.876109.42
4203211-20321198.961100.38
5208425-208425101.500102.94
6209243-209243101.898103.35
480min1211006-211006102.757102.062.83104.36103.672.83
2209184-209184101.869103.44
3220204-220204107.236108.94
4202622-20262298.674100.24
5206818-206818100.717102.31
6207663-207663101.129102.74
600min1208468-208468101.521101.312.87103.28103.072.87
2207651-207651101.123102.84
3218718-218718106.512108.38
4200377-20037797.58199.30
5206182-206182100.408102.16
6206769-206769100.693102.45
720min1208325-208325101.451100.632.95103.36102.542.95
2206034-206034100.335102.21
3217254-217254105.799107.83
4198866-19886696.84598.71
5204113-20411399.400101.30
6205222-20522299.940101.85
极限1207968-207968101.277100.672.98103.34102.742.98
2206376-206376100.502102.53
3217461-217461105.900108.09
4198658-19865896.74398.75
5204498-20449899.587101.64
6205397-205397100.025102.09
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%
19.991073724107775710801541075806107981410774510.26
29.961097648109309710953720.30
单位质量响应值RSD%判断
107852.95109977.111.38数据可信
供试品溶液-25041503批-二甲双胍-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min142521-425213.9043.538.073.903.528.07
238901-389013.5723.57
340884-408843.7543.75
437747-377473.4663.47
536623-366233.3633.36
633810-338103.1053.10
10min198068-980689.0059.2111.349.019.2111.32
291389-913898.3928.40
3101481-1014819.3189.32
4122267-12226711.22711.23
595468-954688.7668.77
692936-929368.5348.54
15min1148629-14862913.64813.8811.7913.6713.9011.77
2138719-13871912.73812.76
3186042-18604217.08317.10
4151733-15173313.93313.95
5141845-14184513.02513.04
6140107-14010712.86512.88
20min1189296-18929617.38217.063.3717.4217.103.36
2177391-17739116.28916.33
3193411-19341117.76017.80
4190298-19029817.47417.52
5180366-18036616.56216.60
6183717-18371716.87016.91
30min1260721-26072123.94022.843.7224.0122.903.72
2242230-24223022.24222.30
3255785-25578523.48723.56
4253901-25390123.31423.38
5241714-24171422.19522.26
6238032-23803221.85721.92
45min1331502-33150230.44029.733.0430.5429.833.05
2319499-31949929.33729.43
3332447-33244730.52630.63
4333389-33338930.61330.72
5315020-31502028.92629.02
6311082-31108228.56528.66
60min1394838-39483836.25535.343.0236.4035.483.03
2381769-38176935.05535.19
3395332-39533236.30136.45
4393854-39385436.16536.32
5375000-37500034.43434.57
6368176-36817633.80733.94
120min1577532-57753253.03151.893.0353.2352.093.03
2563539-56353951.74651.94
3579725-57972553.23253.44
4579608-57960853.22253.43
5552056-55205650.69250.88
6538475-53847549.44549.63
180min1726268-72626866.68865.472.8866.9765.742.88
2710240-71024065.21765.49
3731116-73111667.13467.42
4732357-73235767.24867.53
5694216-69421663.74564.01
6683623-68362362.77363.04
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1821647-82164775.44674.372.8575.8374.742.86
2808896-80889674.27674.64
3829781-82978176.19376.58
4834200-83420076.59976.98
5787494-78749472.31072.67
6777747-77774771.41571.77
360min1955433-95543387.73186.832.7388.2387.322.73
2939928-93992886.30786.79
3972652-97265289.31289.81
4972270-97227089.27789.78
5923012-92301284.75485.23
6910556-91055683.61084.07
480min11038715-103871595.37894.562.2796.0095.182.27
21026916-102691694.29594.90
31048871-104887196.31196.95
41058135-105813597.16297.80
51008139-100813992.57193.17
6998304-99830491.66892.26
600min11085723-108572399.69599.061.80100.4699.811.81
21076321-107632198.83199.58
31095703-1095703100.611101.39
41101091-1101091101.106101.89
51063198-106319897.62698.36
61050667-105066796.47697.20
720min11107563-1107563101.700100.981.66102.62101.891.67
21094361-1094361100.488101.39
31114423-1114423102.330103.26
41122262-1122262103.050103.98
51084707-108470799.602100.48
61075089-107508998.71899.59
极限11108237-1108237101.762101.251.52102.83102.301.53
21100200-1100200101.024102.07
31116772-1116772102.546103.63
41122688-1122688103.089104.17
51089347-1089347100.028101.06
61078677-107867799.048100.07
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