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%
110.091210021121022412089381210353121045012099970.06
29.901202865120298512029250.01
单位质量响应值RSD%判断
119920.42121507.580.93数据可信
供试品溶液-22FA458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%
5min122816-228163.1034.3917.743.104.3917.79
238569-385695.2455.25
331781-317814.3224.32
433105-331054.5024.50
537560-375605.1085.11
629840-298404.0584.06
10min173350-733509.97511.347.2110.0111.397.25
288103-8810311.98212.04
386859-8685911.81311.86
482253-8225311.18611.24
589353-8935312.15212.21
680476-8047610.94410.99
15min1112137-11213715.25016.394.3615.4016.564.40
2121928-12192816.58216.77
3123811-12381116.83817.02
4118525-11852516.11916.29
5127509-12750917.34117.53
6119185-11918516.20916.38
20min1140657-14065719.12920.414.0919.4420.764.12
2147287-14728720.03120.41
3155188-15518821.10521.47
4147757-14775720.09420.45
5157651-15765121.44021.82
6151800-15180020.64420.99
30min1186931-18693125.42226.794.0025.9527.384.01
2188904-18890425.69026.29
3202751-20275127.57328.17
4196504-19650426.72427.30
5207090-20709028.16428.79
6199870-19987027.18227.76
45min1236878-23687832.21533.344.3733.0234.224.34
2230225-23022531.31032.19
3252910-25291034.39535.30
4240727-24072732.73833.61
5256582-25658234.89435.83
6253524-25352434.47835.36
60min1274227-27422737.29438.494.8238.4639.744.76
2261088-26108835.50736.74
3290655-29065539.52840.82
4282205-28220538.37939.62
5298382-29838240.57941.90
6291633-29163339.66140.92
90min1325303-32530344.24045.945.7045.8247.625.62
2306029-30602941.61943.25
3349297-34929747.50349.23
4337772-33777245.93647.60
5357008-35700848.55250.33
6351463-35146347.79849.50
极限1380661-38066151.76953.494.1853.8455.684.18
2368691-36869150.14152.23
3401270-40127054.57156.83
4392128-39212853.32855.50
5413460-41346056.22958.54
6403866-40386654.92457.16
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%
110.091203319120289912022501202691120267012027660.04
29.901191328119063211909800.05
单位质量响应值RSD%判断
119203.77120301.010.65数据可信
供试品溶液-22FA458批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13091-30910.4240.9745.770.420.9745.80
25536-55360.7590.76
312567-125671.7231.72
47111-71110.9750.97
58660-86601.1871.19
65667-56670.7770.78
10min14260-42600.5841.5457.450.591.5657.40
25357-53570.7340.74
322025-220253.0193.04
410584-105841.4511.46
511083-110831.5191.53
614303-143031.9611.97
15min15775-57750.7922.3260.960.802.3460.87
27040-70400.9650.98
333421-334214.5824.63
414551-145511.9952.02
518324-183242.5122.54
622338-223383.0623.09
20min17319-73191.0033.1361.101.023.1860.99
28835-88351.2111.24
344135-441356.0506.15
419710-197102.7022.75
526409-264093.6203.68
630422-304224.1704.23
30min110203-102031.3994.7058.071.434.7958.08
212272-122721.6821.72
360290-602908.2658.44
432843-328434.5024.58
543251-432515.9296.03
646946-469466.4366.55
45min115279-152792.0956.9053.422.147.0453.46
218634-186342.5542.61
378993-7899310.82911.09
456512-565127.7477.88
563646-636468.7258.89
668730-687309.4229.60
60min121720-217202.9788.7048.883.058.9248.97
226831-268313.6783.77
392689-9268912.70613.09
473778-7377810.11410.33
580362-8036211.01611.28
685406-8540611.70811.99
90min139291-392915.38612.0839.345.4912.4039.65
248763-487636.6856.81
3117261-11726116.07516.60
4102015-10201513.98514.31
5108739-10873914.90715.29
6112805-11280515.46415.88
极限165952-659529.04114.7627.199.2015.2027.81
274927-7492710.27110.47
3132881-13288118.21618.92
4119767-11976716.41816.90
5124930-12493017.12617.68
6127397-12739717.46418.05
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%
110.091197010119704911968221196962119556711966820.06
29.901187776118582011867980.12
单位质量响应值RSD%判断
118600.79119878.590.76数据可信
供试品溶液-22FA458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%
5min120854-208542.8711.04117.092.871.04117.10
2-0.0000.00
312266-122661.6891.69
412299-122991.6931.69
5-0.0000.00
6-0.0000.00
10min172015-720159.9154.2294.249.954.2494.28
26522-65220.8980.90
348695-486956.7046.72
446542-465426.4086.43
54630-46300.6370.64
65597-55970.7710.77
15min1127926-12792617.6127.8795.1017.757.9295.12
210761-107611.4821.49
388824-8882412.22912.32
499305-9930513.67213.76
57448-74481.0251.03
68625-86251.1871.20
20min1165146-16514622.73710.7893.4523.0710.9293.48
215216-152162.0952.12
3128255-12825517.65817.89
4139108-13910819.15219.39
510117-101171.3931.41
611949-119491.6451.67
30min1212083-21208329.19915.0388.9329.7915.2989.04
224862-248623.4233.47
3190655-19065526.24926.67
4189532-18953226.09426.55
516699-166992.2992.33
621091-210912.9042.94
45min1254456-25445635.03319.2284.3935.9519.6684.55
241636-416365.7325.82
3248355-24835534.19334.91
4238143-23814332.78733.53
526343-263433.6273.69
628846-288463.9714.04
60min1277640-27764038.22422.4975.3739.5323.1475.73
262733-627338.6378.79
3280944-28094438.67939.78
4267956-26795636.89138.00
538918-389185.3585.46
652143-521437.1797.30
90min1329042-32904245.30129.7555.6247.0330.6556.47
2113541-11354115.63215.88
3329983-32998345.43146.96
4316431-31643143.56545.08
585177-8517711.72711.89
6122447-12244716.85817.05
极限1406381-40638155.94943.0332.5258.1844.2633.74
2205640-20564028.31228.73
3408372-40837256.22358.25
4399388-39938854.98656.99
5215820-21582029.71330.00
6239670-23967032.99733.38
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