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D5551-23-012对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)19.2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%
112.302014402016802015452013712013432014760.07
212.332014312012872013590.06
单位质量响应值RSD%判断
16380.1616330.820.22数据可信
供试品溶液-25021301批-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%
5min1155578-15557876.70676.954.5776.7176.964.57
2142739-14273970.37670.38
3159630-15963078.70378.70
4162437-16243780.08780.09
5155295-15529576.56676.57
6160802-16080279.28179.28
10min1170774-17077484.19883.263.5184.3183.383.51
2157898-15789877.85077.96
3170527-17052784.07684.19
4173035-17303585.31385.43
5166938-16693882.30782.42
6174091-17409185.83385.95
15min1172719-17271985.15784.313.3785.4084.553.38
2160897-16089779.32879.55
3172278-17227884.93985.18
4174987-17498786.27586.52
5168213-16821382.93583.17
6176966-17696687.25187.50
20min1174178-17417885.87685.063.3186.2585.423.32
2162082-16208279.91280.25
3175474-17547486.51586.89
4175560-17556086.55886.94
5170064-17006483.84884.21
6177722-17772287.62388.00
30min1175834-17583486.69385.623.2987.1986.123.29
2163304-16330480.51580.98
3175250-17525086.40586.91
4176840-17684087.18987.70
5171341-17134184.47784.97
6179397-17939788.44988.96
45min1177344-17734487.43786.583.2988.0787.213.29
2165398-16539881.54782.13
3178842-17884288.17688.81
4178353-17835387.93588.57
5172535-17253585.06685.68
6181206-18120689.34189.98
60min1178880-17888088.19487.013.4888.9587.773.48
2165603-16560381.64882.35
3179003-17900388.25589.02
4179928-17992888.71189.48
5173165-17316585.37786.12
6182348-18234889.90490.68
极限1196010-19601096.64096.231.0897.5397.111.09
2192337-19233794.82995.66
3198185-19818597.71298.61
4193578-19357895.44196.34
5196367-19636796.81697.69
6194554-19455495.92296.83
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D5551-23-012对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)19.2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%
112.302029852029062030362029032029992029660.03
212.332024152023572023860.03
单位质量响应值RSD%判断
16501.3016414.110.38数据可信
供试品溶液-25021701批-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%
5min1148281-14828172.65475.722.8472.6575.722.85
2152923-15292374.92974.93
3153851-15385175.38375.38
4153607-15360775.26475.26
5161273-16127379.02079.02
6157339-15733977.09277.09
10min1168581-16858182.60183.942.7182.7184.052.71
2171945-17194584.24984.36
3164672-16467280.68580.80
4170837-17083783.70683.82
5178422-17842287.42387.54
6173425-17342584.97485.09
15min1173002-17300284.76786.033.0585.0086.273.05
2176344-17634486.40486.64
3171429-17142983.99684.23
4170557-17055783.56983.81
5185134-18513490.71190.96
6176974-17697486.71386.96
20min1173791-17379185.15486.563.1985.5186.933.19
2179424-17942487.91488.28
3169841-16984183.21883.58
4171730-17173084.14484.51
5183528-18352889.92490.31
6181633-18163388.99689.37
30min1175414-17541485.94987.202.9086.4487.702.90
2180973-18097388.67389.17
3171737-17173784.14784.63
4173617-17361785.06885.56
5185000-18500090.64691.17
6181095-18109588.73289.24
45min1177085-17708586.76888.262.8687.3888.882.86
2183172-18317289.75090.38
3174521-17452185.51186.12
4175601-17560186.04086.66
5187483-18748391.86292.52
6182883-18288389.60890.25
60min1182111-18211189.23089.362.8889.9890.122.88
2184938-18493890.61591.38
3176380-17638086.42287.16
4176663-17666386.56187.31
5190094-19009493.14293.94
6184069-18406990.19090.96
极限1198098-19809897.06396.441.6497.9497.341.64
2199299-19929997.65298.56
3192624-19262494.38195.25
4194109-19410995.10995.99
5201039-20103998.50499.44
6195836-19583695.95596.86
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