达格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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10000
标示量(mg)10供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.411508681508061508361507521507841508090.03
212.361517051518991518020.10
单位质量响应值RSD%判断
12152.2212281.720.75数据可信
供试品溶液-24090301批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min171690-7169042.58849.5610.2242.5949.5610.21
276483-7648345.43645.44
396124-9612457.10457.10
484542-8454250.22350.22
584760-8476050.35350.35
686976-8697651.66951.67
5min182195-8219548.82968.8318.3749.0769.1118.32
2127297-12729775.62375.87
3125484-12548474.54674.86
496345-9634557.23557.51
5134163-13416379.70179.98
6129729-12972977.06777.35
10min1141858-14185884.27369.6520.0884.7870.3119.85
2105950-10595062.94163.61
3109633-10963365.12965.86
4114262-11426267.87968.48
5147238-14723887.46988.19
684516-8451650.20850.92
15min1143865-14386585.46577.9713.9286.4479.0213.72
296599-9659957.38658.41
3144392-14439285.77886.87
4133344-13334479.21580.19
5127345-12734575.65176.86
6141949-14194984.32785.32
20min1141386-14138683.99282.6916.5985.4484.1716.33
2146826-14682687.22488.57
3125941-12594174.81776.39
4100210-10021059.53160.95
5162190-16219096.35197.98
6158576-15857694.20495.67
30min1146380-14638086.95980.657.0888.8882.596.91
2139923-13992383.12384.95
3145239-14523986.28188.27
4124428-12442873.91875.66
5125422-12542274.50976.67
6133189-13318979.12381.11
极限1152246-15224690.44483.899.7492.8486.289.61
2129670-12967077.03279.32
3150716-15071689.53592.00
4126744-12674475.29477.45
5157657-15765793.65896.24
6130285-13028577.39879.82
达格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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10000
标示量(mg)10供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.411515581516531516701516521516321516330.03
212.361507261507381507320.01
单位质量响应值RSD%判断
12218.6112195.150.14数据可信
供试品溶液-24090301批-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%
2min188570-8857052.65857.337.2152.6657.337.21
2108804-10880464.68864.69
398115-9811558.33358.33
493950-9395055.85755.86
592260-9226054.85254.85
696861-9686157.58857.59
5min1137343-13734381.65680.703.5681.9581.023.55
2139400-13940082.87983.24
3135352-13535280.47280.80
4139400-13940082.87983.19
5136417-13641781.10581.41
6126456-12645675.18375.50
10min1142613-14261384.78983.263.2485.5484.023.23
2143534-14353485.33786.16
3135487-13548780.55281.32
4142210-14221084.54985.32
5143274-14327485.18285.94
6133107-13310779.13779.87
15min1139371-13937182.86183.192.9584.0884.422.94
2145486-14548686.49787.79
3135467-13546780.54081.76
4140524-14052483.54784.79
5143381-14338185.24686.47
6135298-13529880.44081.62
20min1138828-13882882.53982.902.4084.2284.592.38
2140084-14008483.28585.06
3135519-13551980.57182.24
4140749-14074983.68185.39
5144870-14487086.13187.83
6136514-13651481.16382.79
30min1139642-13964283.02383.192.6485.1685.342.64
2142843-14284384.92687.16
3136191-13619180.97183.08
4140744-14074483.67885.85
5144823-14482386.10388.28
6135344-13534480.46782.54
极限1143595-14359585.37384.652.7787.9787.262.66
2143813-14381385.50288.21
3145240-14524086.35188.91
4144681-14468186.01888.65
5134620-13462080.03782.70
6142341-14234184.62787.15
达格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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10000
标示量(mg)10供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.411514871515901518311516171516741516400.09
212.361515981517331516660.07
单位质量响应值RSD%判断
12219.1812270.710.30数据可信
供试品溶液-24090301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%
2min184015-8401549.79554.677.3649.8054.677.36
2100763-10076359.72159.72
397074-9707457.53557.54
490158-9015853.43653.44
585354-8535450.58950.59
696093-9609356.95456.95
5min1133151-13315178.91878.532.8579.1978.832.84
2132676-13267678.63678.97
3126035-12603574.70075.02
4136831-13683181.09981.40
5130993-13099377.63977.92
6135280-13528080.17980.50
10min1144825-14482585.83781.593.4986.5582.333.44
2134891-13489179.94980.72
3130985-13098577.63478.37
4140434-14043483.23483.98
5138727-13872782.22282.93
6136069-13606980.64781.41
15min1140064-14006483.01580.642.8884.2181.842.86
2137280-13728081.36582.58
3130167-13016777.14978.31
4139802-13980282.86084.07
5136249-13624980.75481.92
6132825-13282578.72479.93
20min1138659-13865982.18281.152.4483.8482.802.42
2135829-13582980.50582.17
3130947-13094777.61179.21
4140710-14071083.39885.07
5138018-13801881.80283.42
6137371-13737181.41983.07
30min1140194-14019483.09283.684.4185.2085.774.28
2139975-13997582.96285.07
3152846-15284690.59192.62
4141695-14169583.98286.12
5137817-13781781.68383.76
6134580-13458079.76581.86
极限1147356-14735687.33787.611.0189.9190.170.96
2148907-14890788.25690.83
3148804-14880488.19590.72
4145430-14543086.19588.80
5147058-14705887.16089.69
6149332-14933288.50891.05
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