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%
110.012429732424302430642425532428942427830.12
210.012424642426752425700.07
单位质量响应值RSD%判断
24254.0524232.770.07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%
5min174541-7454150.47449.101.9650.4749.101.95
273523-7352349.78549.78
372411-7241149.03249.03
472151-7215148.85648.86
570378-7037847.65547.66
672078-7207848.80648.81
10min197220-9722065.83165.451.0666.3966.001.06
298272-9827266.54367.10
395752-9575264.83765.38
495794-9579464.86565.41
595916-9591664.94865.48
697022-9702265.69766.24
15min1107456-10745672.76273.241.0674.0574.511.04
2109596-10959674.21175.50
3107158-10715872.56073.83
4106956-10695672.42373.69
5109377-10937774.06375.31
6108434-10843473.42474.70
20min1113895-11389577.12277.260.7479.2279.340.72
2114653-11465377.63579.75
3112917-11291776.46078.53
4113693-11369376.98579.05
5115352-11535278.10980.18
6114053-11405377.22979.32
30min1120426-12042681.54481.871.4984.5084.811.45
2122189-12218982.73885.72
3117463-11746379.53882.46
4121651-12165182.37485.30
5122029-12202982.63085.57
6121673-12167382.38985.33
45min1124899-12489984.57384.631.1788.4488.491.15
2125881-12588185.23889.14
3122180-12218082.73286.54
4125937-12593785.27689.11
5126036-12603685.34389.20
6124980-12498084.62888.49
60min1125034-12503484.66585.521.8189.4790.311.75
2128579-12857987.06591.91
3122404-12240482.88487.61
4127865-12786586.58291.37
5127582-12758286.39091.20
6126278-12627885.50790.31
90min1125532-12553285.00286.151.4090.7591.901.36
2128928-12892887.30193.11
3124764-12476484.48290.13
4128408-12840886.94992.70
5128789-12878987.20792.98
6126953-12695385.96491.72
极限1126056-12605685.35786.281.2792.0592.981.25
2128742-12874287.17593.96
3125031-12503184.66391.25
4128252-12825286.84493.56
5129170-12917087.46594.20
6127280-12728086.18592.89
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%
110.019755597468972149742697519974360.14
210.019710397331972170.17
单位质量响应值RSD%判断
9733.879711.990.16数据可信
供试品溶液-24111402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%
5min118340-1834030.96533.254.5430.9633.254.54
219526-1952632.96732.97
319040-1904032.14732.15
420694-2069434.93934.94
520201-2020134.10734.11
620355-2035534.36734.37
10min130230-3023051.04052.452.8951.3852.822.90
231200-3120052.67853.04
330393-3039351.31551.67
431108-3110852.52252.91
532722-3272255.24755.63
630732-3073251.88752.27
15min137292-3729262.96363.522.0363.8764.482.03
236849-3684962.21563.17
337408-3740863.15964.09
437464-3746463.25464.23
539079-3907965.98066.97
637654-3765463.57464.53
20min141753-4175370.49570.342.2372.1172.002.22
240620-4062068.58270.22
341469-4146970.01671.64
441524-4152470.10871.78
543382-4338273.24574.97
641212-4121269.58271.25
30min145790-4579077.31178.331.6779.7180.771.67
245708-4570877.17379.58
346861-4686179.11981.53
445844-4584477.40279.86
547671-4767180.48783.03
646475-4647578.46880.91
45min148939-4893982.62883.862.2785.8887.172.26
248670-4867082.17485.44
349612-4961283.76487.05
449540-4954083.64286.96
551841-5184187.52790.96
649414-4941483.43086.74
60min150765-5076585.71187.021.7689.8891.261.77
250590-5059085.41589.59
351549-5154987.03491.25
451733-5173387.34591.59
553134-5313489.71194.12
651457-5145786.87991.12
90min152103-5210387.97089.041.5593.0994.251.57
251774-5177487.41492.54
352876-5287689.27594.46
452476-5247688.60093.81
554064-5406491.28196.68
653129-5312989.70294.90
极限152057-5205787.89288.751.5693.9994.951.56
251270-5127086.56392.66
353069-5306989.60195.78
452928-5292889.36395.56
553572-5357290.45096.87
652486-5248688.61694.82
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%
110.012426262422312421962429972425892425280.14
210.012419962423252421600.10
单位质量响应值RSD%判断
24228.5724191.810.11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%
5min151449-5144934.88635.243.1034.8935.243.10
253420-5342036.22236.22
350355-5035534.14434.14
453345-5334536.17136.17
553365-5336536.18536.18
649936-4993633.86033.86
10min179735-7973554.06554.202.3754.4554.602.37
282963-8296356.25456.66
378490-7849053.22153.60
480831-8083154.80855.21
580082-8008254.30154.70
677544-7754452.58052.96
15min195736-9573664.91564.371.9665.9065.361.95
297566-9756666.15667.18
391972-9197262.36363.33
494840-9484064.30765.32
594100-9410063.80664.81
695358-9535864.65965.62
20min1103321-10332170.05870.411.2971.7772.121.29
2105385-10538571.45873.22
3101572-10157268.87270.54
4104336-10433670.74672.47
5103667-10366770.29372.01
6104739-10473971.02072.70
30min1113864-11386477.20776.961.2079.6979.451.21
2115629-11562978.40480.96
3112159-11215976.05178.48
4114061-11406177.34079.85
5111965-11196575.91978.41
6113301-11330176.82579.29
45min1120511-12051181.71481.700.6785.0685.050.70
2121800-12180082.58886.02
3119443-11944380.99084.26
4120476-12047681.69085.06
5119939-11993981.32684.67
6120815-12081581.92085.24
60min1124239-12423984.24284.751.0988.5089.001.05
2125732-12573285.25489.60
3124435-12443584.37588.55
4124124-12412484.16488.44
5123931-12393184.03388.28
6127436-12743686.41090.64
90min1127336-12733686.34285.320.6691.5390.520.63
2126137-12613785.52990.82
3125679-12567985.21890.33
4124989-12498984.75089.96
5125451-12545185.06490.24
6125421-12542185.04390.24
极限1125238-12523884.91985.531.5991.0791.681.50
2127153-12715386.21892.46
3126663-12666385.88591.94
4127127-12712786.20092.36
5122538-12253883.08889.21
6128117-12811786.87193.01
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%
110.019727797316975159751697433974110.12
210.019743397570975020.10
单位质量响应值RSD%判断
9731.379740.460.07数据可信
供试品溶液-24111402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%
5min113949-1394923.52024.723.5623.5224.723.57
214583-1458324.58924.59
314813-1481324.97724.98
414233-1423323.99924.00
514981-1498125.26025.26
615395-1539525.95825.96
10min119664-1966433.15641.6510.0733.4241.9210.01
226089-2608943.98944.26
325572-2557243.11843.40
425286-2528642.63542.90
526012-2601243.86044.14
625569-2556943.11343.40
15min132129-3212954.17455.215.2754.8055.955.21
234311-3431157.85358.61
333350-3335056.23256.99
433313-3331356.17056.91
533824-3382457.03257.80
629552-2955249.82850.60
20min137407-3740763.07363.791.8964.3065.141.90
238707-3870765.26566.67
338304-3830464.58565.97
436678-3667861.84463.21
538058-3805864.17165.57
637842-3784263.80665.13
30min141839-4183970.54671.271.5672.4873.331.53
241521-4152170.01072.14
342144-4214471.06073.16
441983-4198370.78972.84
543187-4318772.81974.93
642950-4295072.41974.45
45min148167-4816781.21679.792.8883.9382.642.78
248701-4870182.11685.02
346915-4691579.10581.99
444868-4486875.65378.49
547978-4797880.89783.82
647297-4729779.74982.58
60min149020-4902082.65483.531.2486.2787.271.26
250098-5009884.47288.29
350172-5017284.59688.36
448625-4862581.98885.67
549756-4975683.89587.72
649583-4958383.60387.32
90min147213-4721379.60785.903.7584.1490.573.63
251903-5190387.51592.27
351729-5172987.22291.93
450883-5088385.79590.39
551451-5145186.75391.51
652506-5250688.53293.18
极限151164-5116486.26987.190.8591.6992.810.86
251344-5134486.57392.30
352430-5243088.40494.08
451793-5179387.33092.87
551771-5177187.29393.01
651764-5176487.28192.91
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