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%
19.972393042385512396372418662411092400930.57
29.992408362399662404010.26
单位质量响应值RSD%判断
24081.5424064.160.06数据可信
供试品溶液-24110701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%
5min160745-6074541.42440.012.3741.4240.012.36
258508-5850839.89839.90
357038-5703838.89638.90
459173-5917340.35240.35
559319-5931940.45140.45
657285-5728539.06439.06
10min184706-8470657.76456.851.7558.2257.291.75
281321-8132155.45555.90
383046-8304656.63257.06
485132-8513258.05458.50
583726-8372657.09557.54
682253-8225356.09156.52
15min197970-9797066.80966.932.1867.9168.012.16
294623-9462364.52665.59
398245-9824566.99668.06
4100890-10089068.80069.89
599699-9969967.98869.07
697467-9746766.46667.52
20min1110232-11023275.17172.652.4377.0174.472.41
2104316-10431671.13672.91
3104976-10497671.58673.39
4108947-10894774.29476.15
5106746-10674672.79374.63
6103990-10399070.91472.71
30min1117606-11760680.19978.252.4782.8880.882.44
2110267-11026775.19477.76
3113612-11361277.47580.08
4117536-11753680.15182.83
5113558-11355877.43980.09
6115910-11591079.04381.63
45min1120922-12092282.46081.702.3286.0385.192.29
2114651-11465178.18481.59
3119187-11918781.27784.74
4122784-12278483.73087.30
5120797-12079782.37585.88
6120465-12046582.14985.61
60min1122428-12242883.48782.881.8587.9787.281.84
2117749-11774980.29784.57
3119978-11997881.81786.18
4123706-12370684.35988.86
5122365-12236583.44487.87
6122997-12299783.87588.25
90min1125832-12583285.80984.211.9391.2289.531.90
2119729-11972981.64786.81
3122955-12295583.84789.12
4124968-12496885.21990.66
5121980-12198083.18288.53
6125430-12543085.53490.84
极限1124294-12429484.76084.071.1491.1390.341.17
2121502-12150282.85688.93
3122338-12233883.42689.63
4125010-12501085.24891.64
5122368-12236883.44689.72
6124208-12420884.70190.96
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%
19.972398852384562378972379932381672384800.35
29.992388992402922395960.42
单位质量响应值RSD%判断
23919.7623983.580.19数据可信
供试品溶液-24111401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%
5min176421-7642152.37848.247.0152.3848.247.01
261509-6150942.15742.16
372722-7272249.84249.84
469870-6987047.88847.89
570986-7098648.65248.65
670831-7083148.54648.55
10min1107040-10704073.36365.588.2573.9566.128.24
282543-8254356.57357.04
398406-9840667.44668.00
495419-9541965.39865.93
596289-9628965.99566.54
694407-9440764.70565.24
15min1122542-12254283.98874.507.8885.3975.767.87
295607-9560765.52766.62
3109007-10900774.71176.01
4107776-10777673.86875.13
5107645-10764573.77875.05
6109626-10962675.13676.39
20min1127700-12770087.52379.466.4789.8581.556.50
2104175-10417571.40073.22
3114837-11483778.70780.84
4115274-11527479.00781.09
5116116-11611679.58481.68
6117516-11751680.54382.64
30min1136828-13682893.77984.156.3497.0887.136.36
2112799-11279977.31079.93
3122443-12244383.92086.93
4120835-12083582.81885.78
5122072-12207283.66686.64
6121697-12169783.40986.40
45min1143407-14340798.28888.735.71102.6392.645.75
2121357-12135783.17686.65
3127964-12796487.70491.64
4129559-12955988.79792.67
5127896-12789687.65891.57
6126568-12656886.74790.66
60min1143802-14380298.55988.605.64104.0093.505.65
2124836-12483685.56089.96
3126373-12637386.61491.53
4125080-12508085.72890.59
5126272-12627286.54491.43
6129263-12926388.59493.47
90min1147115-147115100.83090.415.72107.3696.305.71
2127890-12789087.65393.01
3129998-12999889.09894.98
4127139-12713987.13992.96
5130177-13017789.22195.06
6129192-12919288.54694.41
极限1145877-14587799.98190.305.32107.6397.195.34
2128473-12847388.05394.38
3128272-12827287.91594.78
4127739-12773987.55094.33
5129284-12928488.60995.44
6130896-13089689.71496.56
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%
19.972316272325162327572316352301652317400.44
29.992349272352532350900.10
单位质量响应值RSD%判断
23243.7323532.530.88数据可信
供试品溶液-24110701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%
5min145666-4566632.05430.183.8232.0530.183.82
241317-4131729.00129.00
343194-4319430.31930.32
442660-4266029.94429.94
543803-4380330.74630.75
641362-4136229.03329.03
10min167842-6784247.62046.082.3447.9846.422.35
263782-6378244.77045.09
366211-6621146.47546.81
466343-6634346.56846.90
565708-6570846.12246.46
664018-6401844.93645.26
15min181236-8123657.02156.011.9457.9156.861.94
277447-7744754.36255.18
381476-8147657.19058.04
480465-8046556.48057.33
578962-7896255.42556.28
679218-7921855.60556.43
20min188437-8843762.07661.752.2463.5963.222.23
285567-8556760.06161.48
389053-8905362.50864.00
491076-9107663.92865.41
586923-8692361.01362.48
686757-8675760.89762.34
30min197365-9736568.34368.492.2670.5570.642.24
294387-9438766.25268.34
3100130-10013070.28372.47
499991-9999170.18672.37
596326-9632667.61369.76
697223-9722368.24370.36
45min1105059-10505973.74374.423.0076.7177.342.95
2102615-10261572.02874.85
3108238-10823875.97578.94
4111250-11125078.08981.06
5105194-10519473.83876.74
6103794-10379472.85575.73
60min1108267-10826775.99577.444.6579.7881.184.52
2104648-10464873.45577.08
3110866-11086677.81981.63
4119028-11902883.54887.38
5112546-11254678.99882.72
6106563-10656374.79978.48
90min1111977-11197778.59980.204.0183.2384.813.91
2108895-10889576.43680.88
3114520-11452080.38485.06
4122242-12224285.80490.57
5115821-11582181.29785.89
6112116-11211678.69783.21
极限1118910-11891083.46583.072.0888.9788.572.12
2114987-11498780.71286.00
3119147-11914783.63289.20
4122249-12224985.80991.53
5118133-11813382.92088.42
6116690-11669081.90787.30
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%
19.972422462425932425002427962428882426050.11
29.992385432376102380760.28
单位质量响应值RSD%判断
24333.5023831.431.48数据可信
供试品溶液-24111401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%
5min147804-4780432.59033.302.3532.5933.302.35
248058-4805832.76332.76
350375-5037534.34234.34
449574-4957433.79633.80
549585-4958533.80433.80
647645-4764532.48132.48
10min171475-7147548.72750.422.7649.0950.792.76
272824-7282449.64650.01
376507-7650752.15752.54
475001-7500151.13151.51
575648-7564851.57251.95
672263-7226349.26449.62
15min183933-8393357.22059.132.4358.1260.062.43
285293-8529358.14759.06
388655-8865560.43961.40
487849-8784959.88960.83
589159-8915960.78361.73
685533-8553358.31159.22
20min191868-9186862.62964.732.4164.1766.322.41
293324-9332463.62265.18
397929-9792966.76168.39
495755-9575565.27966.89
596822-9682266.00767.63
694010-9401064.09065.65
30min199937-9993768.13070.163.4170.3772.473.38
2101314-10131469.06971.34
3107393-10739373.21375.59
4104493-10449371.23673.57
5105819-10581972.14074.50
698540-9854067.17869.45
45min1107384-10738473.20775.482.3276.2078.572.33
2108004-10800473.63076.67
3112991-11299177.03080.22
4112300-11230076.55879.68
5113298-11329877.23980.40
6110334-11033475.21878.23
60min1111138-11113875.76678.083.4679.5782.013.40
2109625-10962574.73578.59
3118912-11891281.06685.11
4118294-11829480.64584.62
5116765-11676579.60283.62
6112486-11248676.68580.54
90min1113484-11348477.36680.433.3082.0185.233.24
2112986-11298677.02681.71
3119286-11928681.32186.27
4121208-12120882.63187.50
5122181-12218183.29588.20
6118761-11876180.96385.67
极限1118024-11802480.46182.891.9085.9788.581.94
2120190-12019081.93787.48
3124308-12430884.74590.59
4123289-12328984.05089.84
5122675-12267583.63189.46
6121033-12103382.51288.11
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