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%
110.371166109116691611673291166938116677811668140.04
210.371165906116778211668440.12
单位质量响应值RSD%判断
112518.23112521.120.01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%
5min1-0.0000.8059.040.000.8058.90
24380-43800.6390.64
39490-94901.3851.38
45405-54050.7890.79
57796-77961.1371.14
66012-60120.8770.88
10min16235-62350.9102.2547.490.912.2647.60
212161-121611.7741.78
326941-269413.9313.95
411879-118791.7331.74
520674-206743.0163.03
614696-146962.1442.15
15min112535-125351.8293.8736.411.843.9036.50
222917-229173.3433.37
339200-392005.7195.78
421236-212363.0983.13
534519-345195.0365.08
628711-287114.1894.22
20min120722-207223.0235.4128.273.055.4828.51
234272-342725.0005.06
350130-501307.3147.44
432014-320144.6714.73
545444-454446.6306.73
639772-397725.8035.88
30min137540-375405.4777.8917.555.548.0317.75
254512-545127.9538.07
355580-555808.1098.31
452114-521147.6037.72
566370-663709.6839.86
658527-585278.5398.68
45min165786-657869.59811.8212.029.7212.0412.31
281717-8171711.92212.13
393303-9330313.61213.91
475875-7587511.07011.27
588972-8897212.98113.26
680434-8043411.73511.97
60min188556-8855612.92014.598.5513.1514.958.84
2101307-10130714.78015.12
3111502-11150216.26816.71
494317-9431713.76014.08
5107641-10764115.70416.13
696838-9683814.12814.50
90min1119632-11963217.45418.676.5717.8319.196.76
2134740-13474019.65820.16
3139708-13970820.38321.01
4119278-11927817.40217.88
5130700-13070019.06819.67
6123859-12385918.07018.60
极限1136346-13634619.89220.604.4420.4621.334.67
2144273-14427321.04921.77
3149911-14991121.87122.72
4135650-13565019.79120.46
5145833-14583321.27622.09
6135317-13531719.74220.47
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%
110.371167162116733111682641166750117021411679440.12
210.371164054116409111640720.01
单位质量响应值RSD%判断
112627.19112253.810.24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%
5min16716-67160.9812.7465.580.982.7465.63
27950-79501.1611.16
37964-79641.1631.16
429003-290034.2344.23
530764-307644.4914.49
630111-301114.3964.40
10min121389-213893.1238.8160.413.138.8460.43
232174-321744.6974.71
328112-281124.1044.12
495189-9518913.89713.94
591703-9170313.38813.44
693379-9337913.63313.68
15min146779-467796.83014.9344.026.8815.0644.17
276149-7614911.11811.18
363564-635649.2809.34
4147165-14716521.48621.69
5137052-13705220.00920.21
6142849-14284920.85621.06
20min181267-8126711.86520.6631.7711.9920.9532.03
2123149-12314917.97918.17
3102487-10248714.96315.12
4183653-18365326.81327.25
5178651-17865126.08326.50
6179674-17967426.23226.66
30min1150906-15090622.03230.3818.6822.2930.9119.06
2201248-20124829.38229.77
3175272-17527225.58925.92
4244533-24453335.70136.44
5237667-23766734.69935.41
6239016-23901634.89635.62
45min1232395-23239533.92941.2411.9034.4342.1012.32
2280625-28062540.97141.69
3252436-25243636.85537.47
4307765-30776544.93346.07
5310434-31043445.32346.42
6310967-31096745.40046.51
60min1291090-29109042.49848.518.7143.3749.839.14
2333462-33346248.68549.85
3302734-30273444.19845.22
4357429-35742952.18453.82
5354476-35447651.75353.35
6354360-35436051.73653.35
90min1370295-37029554.06259.686.7555.4161.547.16
2412437-41243760.21561.93
3378776-37877655.30056.81
4432171-43217163.09665.31
5431173-43117362.95065.13
6427722-42772262.44664.64
极限1416463-41646360.80366.306.0362.7568.836.42
2451074-45107465.85668.24
3427047-42704762.34864.48
4475109-47510969.36572.28
5482101-48210170.38673.26
6473045-47304569.06371.95
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