左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.821959201959151955521955761962521958430.15
217.841958591963041960820.17
单位质量响应值RSD%判断
10990.0710991.140.01数据可信
供试品溶液-24081901批-左氨氯地平-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%
5min1112988-112988103.854102.781.69103.85102.781.69
2112288-112288103.210103.21
3113026-113026103.888103.89
4109255-109255100.422100.42
5113709-113709104.516104.52
6109667-109667100.801100.80
10min1113368-113368104.203103.071.93105.36104.221.93
2111026-111026102.050103.20
3112231-112231103.158104.31
4110946-110946101.977103.09
5115695-115695106.342107.50
6109577-109577100.718101.84
15min1114357-114357105.112102.192.07107.42104.482.06
2110583-110583101.643103.92
3110759-110759101.805104.11
4109094-109094100.274102.52
5113536-113536104.357106.70
6108744-10874499.953102.19
20min1112221-112221103.149101.412.02106.63104.832.01
2109418-109418100.572103.98
3110528-110528101.592105.02
4108347-10834799.588102.95
5113568-113568104.387107.89
6107899-10789999.176102.53
30min1110218-110218101.307100.151.09105.93104.701.11
2108058-10805899.322103.85
3109511-109511100.658105.22
4108653-10865399.869104.34
5110092-110092101.192105.85
6107245-10724598.575103.03
45min1109721-109721100.85198.771.78106.60104.431.77
2106587-10658797.970103.60
3107500-10750098.809104.49
4106206-10620697.620103.20
5109670-109670100.804106.59
6105038-10503896.546102.09
60min1108430-10843099.66498.061.83106.54104.821.82
2105520-10552096.989103.71
3106316-10631697.721104.50
4105340-10534096.824103.49
5109694-109694100.826107.73
6104804-10480496.331102.95
90min1107676-10767698.97197.272.18106.95105.122.15
2105450-10545096.925104.72
3106920-10692098.276106.14
4103937-10393795.534103.27
5108504-10850499.732107.76
6102497-10249794.211101.90
极限1107038-10703898.38596.402.11107.46105.332.07
2103675-10367595.293104.17
3104407-10440795.966104.92
4102653-10265394.354103.16
5108145-10814599.402108.54
6103353-10335394.997103.73
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.191980471976221975431978881988561979910.27
216.171982541983771983160.05
单位质量响应值RSD%判断
12229.2212264.440.21数据可信
供试品溶液-24081901批-叶酸-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%
5min125933-2593321.72621.235.8921.7321.245.89
226052-2605221.82621.83
327181-2718122.77122.77
425733-2573321.55821.56
523058-2305819.31719.32
624110-2411020.19920.20
10min145259-4525937.91737.172.6738.1637.412.68
243680-4368036.59436.84
345470-4547038.09338.35
445167-4516737.84038.08
544248-4424837.07037.28
642409-4240935.52935.75
15min156045-5604546.95345.322.6647.6245.962.67
253918-5391845.17145.82
355063-5506346.13046.81
454505-5450545.66346.32
552094-5209443.64344.27
652914-5291444.33044.95
20min161575-6157551.58650.182.1252.7751.332.14
259350-5935049.72250.87
361212-6121251.28252.47
459945-5994550.22051.39
558881-5888149.32950.44
658430-5843048.95150.06
30min168738-6873857.58755.972.3759.3457.682.38
265719-6571955.05756.76
368321-6832157.23759.00
467538-6753856.58158.31
565169-6516954.59756.26
665363-6536354.75956.41
45min175264-7526463.05460.872.3365.4563.202.33
271601-7160159.98562.30
373927-7392761.93464.33
472463-7246360.70763.06
572142-7214260.43862.70
670545-7054559.10061.36
60min179310-7931066.44464.332.0269.5467.342.01
275770-7577063.47866.46
377089-7708964.58367.67
476451-7645164.04867.08
577355-7735564.80667.74
674782-7478262.65065.57
90min185454-8545471.59168.693.2075.4372.413.13
281068-8106867.91671.60
383739-8373970.15473.95
481256-8125668.07471.81
582603-8260369.20272.86
677816-7781665.19268.81
极限193151-9315178.03976.381.8682.6780.871.84
290616-9061675.91580.36
391521-9152176.67481.25
490040-9004075.43379.93
592912-9291277.83982.27
688800-8880074.39478.74
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.821955241961261952781953011957871956030.19
217.841958781961501960140.10
单位质量响应值RSD%判断
10976.6010987.330.07数据可信
供试品溶液-24081902批-左氨氯地平-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%
5min1114615-114615105.432103.821.02105.43103.821.02
2111913-111913102.946102.95
3112289-112289103.292103.29
4114015-114015104.880104.88
5112060-112060103.082103.08
6112287-112287103.290103.29
10min1115580-115580106.320104.371.01107.49105.521.01
2112963-112963103.912105.06
3112688-112688103.659104.81
4113945-113945104.816105.98
5112856-112856103.814104.96
6112700-112700103.670104.82
15min1113788-113788104.671102.821.23107.02105.141.23
2111821-111821102.862105.16
3110810-110810101.932104.23
4112821-112821103.782106.11
5111478-111478102.546104.85
6109966-109966101.155103.45
20min1112890-112890103.845102.011.60107.36105.461.58
2109811-109811101.013104.45
3111000-111000102.107105.54
4113142-113142104.077107.56
5109318-109318100.559104.00
6109185-109185100.437103.86
30min1112626-112626103.602100.451.97108.27105.041.93
2109935-109935101.127105.69
3108747-108747100.034104.60
4109694-109694100.905105.54
5107969-10796999.318103.87
6106220-10622097.710102.25
45min1109949-109949101.14099.201.51106.96104.911.50
2107440-10744098.832104.52
3107420-10742098.813104.49
4109633-109633100.849106.61
5106845-10684598.284103.94
6105781-10578197.306102.93
60min1109856-109856101.05498.571.45108.00105.381.44
2106695-10669598.146104.93
3106667-10666798.121104.90
4107927-10792799.280106.16
5106469-10646997.939104.69
6105350-10535096.909103.62
90min1109017-109017100.28297.831.47108.35105.741.45
2105481-10548197.030104.91
3105513-10551397.059104.93
4107499-10749998.886106.87
5105261-10526196.827104.67
6105347-10534796.906104.69
极限1107421-10742198.81496.911.71108.00105.901.67
2104175-10417595.828104.78
3103909-10390995.584104.53
4107867-10786799.225108.31
5104546-10454696.170105.08
6104162-10416295.816104.68
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.191974871980131974651970131977481975450.19
216.171975711980061977880.16
单位质量响应值RSD%判断
12201.6712231.790.18数据可信
供试品溶液-24081902批-叶酸-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%
5min123078-2307819.38218.377.5619.3818.377.56
223815-2381520.00120.00
319776-1977616.60916.61
419962-1996216.76516.76
522235-2223518.67418.67
622386-2238618.80118.80
10min141161-4116134.56832.696.4834.7832.906.48
240510-4051034.02234.24
336727-3672730.84531.03
434875-3487529.28929.48
540008-4000833.60033.81
640285-4028533.83334.04
15min150027-5002742.01440.357.2442.6140.927.23
250140-5014042.10942.71
344970-4497037.76738.29
442411-4241135.61836.13
550634-5063442.52443.10
650094-5009442.07142.66
20min155092-5509246.26844.826.3847.3345.846.38
254775-5477546.00247.07
350844-5084442.70043.65
447614-4761439.98840.90
556153-5615347.15948.21
655756-5575646.82647.88
30min162816-6281652.75550.476.8554.3451.986.84
262000-6200052.07053.65
357069-5706947.92849.35
453054-5305444.55745.91
562897-6289752.82354.40
662718-6271852.67354.25
45min167558-6755856.73755.606.5058.9057.676.49
267065-6706556.32358.48
363376-6337653.22555.18
459072-5907249.61151.46
569355-6935558.24760.41
670795-7079559.45661.61
60min171701-7170160.21759.237.2063.0161.927.16
271035-7103559.65862.44
367232-6723256.46459.01
462436-6243652.43654.83
573968-7396862.12164.93
676767-7676764.47167.29
90min177326-7732664.94164.127.7968.4167.477.70
275898-7589863.74267.19
372328-7232860.74363.92
467745-6774556.89559.88
579912-7991267.11370.61
684868-8486871.27574.81
极限188012-8801273.91573.324.9178.1077.385.01
288555-8855574.37178.53
384043-8404370.58274.43
480498-8049867.60571.22
590998-9099876.42380.67
691683-9168376.99881.33
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