达格列净片项目信息
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1000
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%
112.311985191979731982381982121974821980850.20
212.271988501984341986420.15
单位质量响应值RSD%判断
16091.3916189.240.43数据可信
供试品溶液-WA3063批-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%
5min1146595-14659573.02470.298.6373.0270.298.63
2141733-14173370.60270.60
3150389-15038974.91474.91
4146048-14604872.75272.75
5144961-14496172.21072.21
6116917-11691758.24158.24
10min1179825-17982589.57786.283.1689.6986.393.16
2174221-17422186.78686.89
3176250-17625087.79687.91
4171306-17130685.33485.44
5173977-17397786.66486.77
6163666-16366681.52881.62
15min1185339-18533992.32490.082.0992.5790.322.10
2181702-18170290.51290.75
3183184-18318491.25191.49
4177698-17769888.51888.75
5182032-18203290.67790.92
6175047-17504787.19787.41
20min1187116-18711693.20991.741.5393.5992.111.55
2184148-18414891.73192.10
3186286-18628692.79693.18
4183149-18314991.23391.60
5185105-18510592.20792.58
6179210-17921089.27189.61
30min1191292-19129295.28993.821.4395.8194.321.44
2188509-18850993.90394.41
3188969-18896994.13294.65
4187586-18758693.44393.95
5190136-19013694.71495.23
6183513-18351391.41491.89
45min1194451-19445196.86395.661.3697.5396.311.37
2191049-19104995.16895.82
3193602-19360296.44097.10
4190944-19094495.11695.76
5194414-19441496.84597.50
6187804-18780493.55294.16
60min1196684-19668497.97596.571.1698.7997.371.17
2193058-19305896.16996.96
3194374-19437496.82597.63
4192681-19268195.98196.77
5195854-19585497.56298.36
6190580-19058094.93595.69
极限1198259-19825998.76097.921.2299.7298.861.20
2193107-19310796.19497.13
3197084-19708498.17599.13
4194306-19430696.79197.72
5197421-19742198.34399.29
6199316-19931699.286100.18
达格列净片项目信息
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1000
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%
112.311978561988631980531965651977411978160.42
212.271979161994031986600.53
单位质量响应值RSD%判断
16069.5416190.710.54数据可信
供试品溶液-WC2484批-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%
5min198158-9815848.92754.4311.7348.9354.4311.72
295250-9525047.47847.48
3121798-12179860.71160.71
4100951-10095150.31950.32
5125133-12513362.37362.37
6113888-11388856.76856.77
10min1148113-14811373.82783.796.0173.9083.886.01
2170164-17016484.81984.89
3176024-17602487.74087.83
4169956-16995684.71584.79
5173801-17380186.63286.73
6170599-17059985.03685.12
15min1159202-15920279.35588.005.0079.5488.215.00
2176739-17673988.09688.29
3183901-18390191.66691.89
4180033-18003389.73889.94
5180416-18041689.92990.15
6179001-17900189.22489.44
20min1164168-16416881.83090.044.7182.1390.384.72
2179610-17961089.52789.86
3187327-18732793.37493.73
4185775-18577592.60092.94
5182557-18255790.99691.35
6184453-18445391.94192.29
30min1168733-16873384.10691.964.4984.5392.434.50
2183305-18330591.36991.83
3190736-19073695.07395.57
4191217-19121795.31395.79
5185641-18564192.53393.03
6187286-18728693.35393.84
45min1172184-17218485.82693.864.5886.3894.474.58
2187046-18704693.23493.84
3193147-19314796.27596.92
4196662-19666298.02798.65
5188409-18840993.91394.55
6192328-19232895.86796.49
60min1176958-17695888.20595.124.0888.8995.874.09
2188727-18872794.07294.81
3194623-19462397.01097.80
4199689-19968999.536100.30
5190478-19047894.94495.72
6194463-19446396.93197.70
极限1196791-19679198.09198.261.1998.9099.151.18
2197791-19779198.59099.47
3196517-19651797.95598.89
4200867-200867100.123101.04
5193620-19362096.51197.43
6197141-19714198.26699.18
达格列净片项目信息
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1000
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%
112.311983851988191974761990891977451983030.35
212.271993471994271993870.03
单位质量响应值RSD%判断
16109.1016249.960.62数据可信
供试品溶液-WK2927批-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%
5min1146155-14615572.62962.6921.6472.6362.6921.64
2142648-14264870.88770.89
391478-9147845.45845.46
4140620-14062069.87969.88
590547-9054744.99645.00
6145435-14543572.27272.27
10min1173995-17399586.46485.895.3786.5785.985.38
2173391-17339186.16486.27
3154688-15468876.87076.94
4180222-18022289.55889.66
5176020-17602087.47087.54
6178695-17869588.80088.91
15min1183304-18330491.09091.153.4691.3391.383.47
2181370-18137090.12990.36
3172000-17200085.47385.66
4189144-18914493.99294.23
5186323-18632392.59092.79
6188429-18842993.63793.88
20min1186235-18623592.54692.593.1892.9292.953.19
2185206-18520692.03592.41
3175238-17523887.08287.39
4190857-19085794.84395.22
5189952-18995294.39494.73
6190488-19048894.66095.04
30min1191001-19100194.91594.263.1595.4394.763.16
2187079-18707992.96693.47
3178776-17877688.84089.28
4194090-19409096.45096.97
5193042-19304295.92996.41
6194126-19412696.46896.99
45min1192604-19260495.71195.273.2596.3795.913.26
2191330-19133095.07895.73
3179610-17961089.25489.83
4196254-19625497.52598.19
5195714-19571497.25797.88
6194742-19474296.77497.44
60min1194232-19423296.52095.922.7197.3296.702.72
2192423-19242395.62196.41
3182923-18292390.90191.61
4195495-19549597.14897.96
5197438-19743898.11498.88
6195666-19566697.23398.05
极限1194290-19429096.54997.500.9197.4998.420.92
2195971-19597197.38598.32
3194296-19429696.55297.40
4197239-19723998.01598.97
5198925-19892598.85399.77
6196446-19644697.62198.58
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