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2000
标示量(mg)5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%
1 10.091250160125079012512131250517125048812506340.04
2 10.041248999124897612489880.01
单位质量响应值RSD%判断
123947.87124401.200.26数据可信
供试品溶液-24102101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%
5min1114358-11435815.11814.474.7015.1214.474.71
2113317-11331714.98114.98
3102528-10252813.55413.55
4103394-10339413.66913.67
5111750-11175014.77414.77
6111249-11124914.70714.71
10min1198840-19884026.28725.192.7526.4525.352.75
2189601-18960125.06625.23
3183450-18345024.25224.40
4187253-18725324.75524.91
5191310-19131025.29125.46
6192749-19274925.48225.65
15min1258735-25873534.20532.502.8534.6732.942.85
2243478-24347832.18832.63
3237453-23745331.39231.81
4245089-24508932.40132.83
5244672-24467232.34632.79
6245651-24565132.47532.92
20min1303149-30314940.07737.673.4140.9238.483.40
2284656-28465637.63238.43
3275299-27529936.39537.16
4279203-27920336.91137.70
5281392-28139237.20038.01
6286072-28607237.81938.63
30min1361710-36171047.81944.643.6949.1045.863.67
2338561-33856144.75845.98
3328351-32835143.40844.58
4328700-32870043.45544.65
5332714-33271443.98545.20
6336088-33608844.43145.66
45min1414950-41495054.85751.703.3856.6753.413.37
2391816-39181651.79953.52
3377783-37778349.94351.60
4380948-38094850.36252.04
5387385-38738551.21352.92
6393428-39342852.01253.73
60min1445825-44582558.93956.193.0061.3658.483.01
2425514-42551456.25458.55
3411076-41107654.34556.56
4412621-41262154.54956.79
5424712-42471256.14858.42
6430569-43056956.92259.22
90min1503022-50302266.50062.743.4369.5865.663.41
2468878-46887861.98664.91
3460288-46028860.85163.67
4460944-46094460.93763.78
5471105-47110562.28165.18
6483368-48336863.90266.83
极限1548860-54886072.56069.232.6276.3872.852.62
2516393-51639368.26871.88
3525749-52574969.50573.00
4508408-50840867.21270.73
5521929-52192969.00072.59
6520885-52088568.86272.50
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2000
标示量(mg)5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%
1 10.091248807124877612490431249027125096812493240.08
2 10.041248267124840912483380.01
单位质量响应值RSD%判断
123818.04124336.450.30数据可信
供试品溶液-24102102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%
5min1107255-10725514.19013.543.5814.1913.543.60
2104708-10470813.85313.85
3103651-10365113.71413.71
496782-9678212.80512.80
5100409-10040913.28513.28
6101306-10130613.40313.40
10min1182247-18224724.11223.403.7624.2723.553.75
2181989-18198924.07824.23
3183578-18357824.28824.44
4167451-16745122.15522.30
5172461-17246122.81722.97
6173302-17330222.92923.08
15min1239030-23903031.62530.572.9732.0530.982.98
2231278-23127830.59931.02
3238894-23889431.60732.03
4221941-22194129.36429.75
5228290-22829030.20430.61
6226740-22674029.99930.40
20min1276720-27672036.61235.672.2037.3936.422.21
2268183-26818335.48236.24
3276488-27648836.58137.35
4262826-26282634.77335.49
5264238-26423834.96035.70
6269277-26927735.62736.36
30min1326226-32622643.16142.242.2244.3543.382.20
2309086-30908640.89442.05
3325026-32502643.00344.18
4317318-31731841.98343.08
5313310-31331041.45342.58
6324382-32438242.91744.05
45min1382766-38276650.64249.522.8852.3151.132.84
2362154-36215447.91549.52
3381030-38103050.41252.07
4370860-37086049.06750.63
5362062-36206247.90349.49
6386742-38674251.16852.78
60min1415869-41586955.02254.352.8457.2556.522.79
2396045-39604552.39954.54
3419004-41900455.43657.65
4408730-40873054.07756.19
5399333-39933352.83454.95
6425976-42597656.35958.54
90min1468779-46877962.02260.862.7864.8663.632.74
2445583-44558358.95361.68
3468704-46870462.01264.85
4455963-45596360.32663.04
5445703-44570358.96961.67
6475213-47521362.87365.68
极限1525234-52523469.49167.961.7173.0271.411.73
2504228-50422866.71270.09
3522483-52248369.12772.65
4507598-50759867.15870.54
5507206-50720667.10670.47
6515325-51532568.18071.68
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