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%
110.012473292480352464552471062488512475550.38
210.012460302463842462070.11
单位质量响应值RSD%判断
24730.7724596.100.39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%
5min153222-5322235.42535.101.7335.4235.101.72
251321-5132134.16034.16
353039-5303935.30335.30
452607-5260735.01635.02
553980-5398035.92935.93
652262-5226234.78634.79
10min176705-7670551.05551.092.6751.4551.482.66
274349-7434949.48749.87
376872-7687251.16651.56
479145-7914552.67953.07
578883-7888352.50552.90
674550-7455049.62150.01
15min190596-9059660.30159.652.4361.2660.612.42
286408-8640857.51458.44
387990-8799058.56759.53
491496-9149660.90061.87
592070-9207061.28262.26
689167-8916759.35060.29
20min197670-9767065.01065.191.9766.6466.811.97
295603-9560363.63465.20
397183-9718364.68666.30
4100910-10091067.16668.82
599472-9947266.20967.87
696823-9682364.44666.04
30min1106741-10674171.04770.491.0173.4072.831.02
2104723-10472369.70471.98
3104402-10440269.49171.82
4106846-10684671.11773.51
5106340-10634070.78173.18
6106367-10636770.79873.11
45min1108144-10814471.98174.303.0275.1277.422.92
2110609-11060973.62276.67
3109636-10963672.97476.08
4116939-11693977.83581.02
5109896-10989673.14776.33
6114529-11452976.23179.33
60min1109431-10943172.83876.063.5176.7880.013.39
2112975-11297575.19779.06
3111436-11143674.17278.09
4120030-12003079.89383.95
5113787-11378775.73779.74
6117938-11793878.50082.45
90min1114974-11497476.52779.324.8881.2884.124.68
2117969-11796978.52183.22
3113046-11304675.24479.98
4129133-12913385.95290.89
5117558-11755878.24783.09
6122360-12236081.44486.26
极限1117955-11795578.51280.794.6484.1186.474.47
2117721-11772178.35683.93
3116891-11689177.80383.38
4131892-13189287.78893.68
5120995-12099580.53586.24
6122817-12281781.74887.47
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%
110.019803798517984939806398297982810.24
210.019782798189980080.27
单位质量响应值RSD%判断
9818.289791.010.20数据可信
供试品溶液-24110702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%
5min111988-1198820.07217.987.4620.0717.987.44
29733-973316.29616.30
311331-1133118.97218.97
410555-1055517.67217.67
510552-1055217.66717.67
610282-1028217.21517.22
10min122044-2204436.90934.774.8037.1334.984.79
220172-2017233.77433.96
321508-2150836.01136.22
419352-1935232.40132.60
521224-2122435.53635.73
620316-2031634.01534.21
15min129243-2924348.96247.012.9549.6047.602.97
228009-2800946.89647.45
328664-2866447.99248.60
427004-2700445.21345.77
528202-2820247.21947.81
627344-2734445.78246.35
20min133897-3389756.75455.262.5857.9356.372.61
232652-3265254.67055.75
333885-3388556.73457.88
431873-3187353.36554.42
533404-3340455.92957.04
632311-3231154.09955.18
30min140021-4002167.00866.551.8868.8268.271.91
239554-3955466.22667.91
340760-4076068.24570.02
438887-3888765.10966.76
540286-4028667.45169.19
638973-3897365.25366.93
45min146025-4602577.06076.442.2279.6178.902.22
246176-4617677.31379.73
346794-4679478.34880.88
444515-4451574.53276.91
546140-4614077.25379.74
644291-4429174.15776.56
60min148166-4816680.64581.191.9784.0584.501.95
248739-4873981.60484.88
349296-4929682.53785.94
448542-4854281.27484.48
549415-4941582.73686.08
646794-4679478.34881.58
90min151959-5195986.99682.345.2591.3086.565.06
248143-4814380.60684.79
352297-5229787.56191.88
449697-4969783.20887.31
546444-4644477.76282.03
646542-4654277.92682.02
极限152271-5227187.51887.332.0092.7992.461.99
252447-5244787.81392.89
353326-5332689.28494.58
450546-5054684.63089.66
552997-5299788.73393.86
651354-5135485.98390.95
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%
110.012455492462922463462458742465312461180.17
210.012452342462312457320.29
单位质量响应值RSD%判断
24587.2124548.650.12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%
5min170575-7057547.15748.772.6347.1648.782.64
271656-7165647.88047.88
376007-7600750.78750.79
472257-7225748.28148.28
573909-7390949.38549.39
673562-7356249.15349.15
10min193027-9302762.16064.392.0962.6864.932.10
295486-9548663.80364.33
399098-9909866.21666.78
496749-9674964.64765.18
596724-9672464.63065.18
697101-9710164.88265.43
15min1105173-10517370.27571.671.4071.4972.921.41
2106233-10623370.98472.22
3108461-10846172.47273.77
4106449-10644971.12872.38
5108600-10860072.56573.83
6108632-10863272.58773.85
20min1111978-11197874.82275.431.2676.8277.481.27
2110733-11073373.99176.02
3113985-11398576.16378.27
4112349-11234975.07077.12
5113958-11395876.14578.22
6114291-11429176.36878.44
30min1117741-11774178.67379.790.9981.5082.680.97
2120800-12080080.71783.57
3118991-11899179.50882.46
4118581-11858179.23482.11
5119971-11997180.16383.08
6120392-12039280.44583.37
45min1121173-12117380.96681.640.7484.6785.420.75
2122250-12225081.68685.43
3123127-12312782.27286.11
4121606-12160681.25685.02
5121604-12160481.25485.06
6123366-12336682.43286.25
60min1121698-12169881.31782.421.2185.9287.111.19
2121999-12199981.51886.17
3123522-12352282.53687.29
4124270-12427083.03687.70
5122922-12292282.13586.85
6125690-12569083.98588.72
90min1122517-12251781.86483.081.5687.3788.681.51
2123002-12300282.18987.75
3124453-12445383.15888.82
4125266-12526683.70189.29
5123085-12308582.24487.87
6127670-12767085.30890.97
极限1124480-12448083.17684.380.9889.5990.910.94
2126628-12662884.61191.09
3126927-12692784.81191.40
4128120-12812085.60892.12
5125872-12587284.10690.65
6125708-12570883.99790.61
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%
110.019733497632976839754997667975730.15
210.019727297255972640.02
单位质量响应值RSD%判断
9747.559716.680.23数据可信
供试品溶液-24110702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%
5min124943-2494342.07436.478.0142.0736.478.00
220629-2062934.79734.80
320979-2097935.38735.39
420897-2089735.24935.25
520258-2025834.17134.17
622017-2201737.13837.14
10min133831-3383157.06656.673.2957.5357.083.29
232960-3296055.59755.98
333897-3389757.17757.57
432713-3271355.18055.57
532628-3262855.03755.42
635553-3555359.97060.38
15min140958-4095869.08868.872.0870.1969.902.09
240922-4092269.02770.03
341490-4149069.98571.01
439611-3961166.81567.82
540106-4010667.65068.64
641883-4188370.64871.73
20min145850-4585077.33976.681.2779.2178.481.29
245113-4511376.09677.87
345605-4560576.92678.73
444457-4445774.99076.74
545752-4575277.17478.92
645986-4598677.56979.43
30min150999-5099986.02585.171.4188.7587.821.41
250949-5094985.94088.56
351179-5117986.32888.99
449323-4932383.19885.78
550040-5004084.40787.01
650472-5047285.13687.86
45min154693-5469392.25691.401.2795.9495.001.27
254529-5452991.97995.55
354695-5469592.25995.88
452886-5288689.20892.71
554093-5409391.24494.78
654229-5422991.47395.14
60min155816-5581694.15095.613.5798.86100.223.46
256461-5646195.23899.83
356627-5662795.518100.16
454895-5489592.59697.09
555672-5567293.90798.46
660613-60613102.241106.93
90min156682-5668295.61196.240.99101.37101.920.97
258047-5804797.913103.57
357286-5728696.629102.34
456516-5651695.331100.86
556702-5670295.644101.24
657083-5708396.287102.11
极限157306-5730696.66396.640.68103.48103.390.69
257287-5728796.631103.37
357711-5771197.346104.13
456595-5659595.464102.05
557578-5757897.122103.78
657278-5727896.616103.51
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