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%
19.972316792314132334622313352328852321550.42
29.992329402326662328030.09
单位质量响应值RSD%判断
23285.3623303.600.06数据可信
供试品溶液-24112102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%
5min180315-8031556.59957.190.8956.6057.190.89
281783-8178357.63457.63
381445-8144557.39657.40
480813-8081356.95056.95
582083-8208357.84557.85
680500-8050056.73056.73
10min1101942-10194271.84072.101.0672.4772.731.05
2102950-10295072.55173.19
3103966-10396673.26773.90
4102479-10247972.21972.85
5100866-10086671.08271.72
6101655-10165571.63872.27
15min1112268-11226879.11779.401.0980.5480.841.07
2110778-11077878.06779.51
3114299-11429980.54882.00
4113581-11358180.04281.48
5112273-11227379.12180.55
6112849-11284979.52780.95
20min1115316-11531681.26581.970.8683.5784.280.85
2116910-11691082.38884.70
3117474-11747482.78685.13
4117005-11700582.45584.78
5116205-11620581.89284.20
6114971-11497181.02283.33
30min1118404-11840483.44184.881.0586.6588.111.03
2120898-12089885.19988.43
3122096-12209686.04389.31
4121155-12115585.38088.62
5120122-12012284.65287.87
6120007-12000784.57187.78
45min1120637-12063785.01586.061.2589.1590.231.21
2123682-12368287.16191.34
3122913-12291386.61990.84
4122951-12295186.64690.83
5119820-11982084.43988.60
6122729-12272986.48990.64
60min1120776-12077685.11387.021.3090.1992.151.26
2123423-12342386.97892.12
3125596-12559688.51093.69
4122964-12296486.65591.81
5123955-12395587.35392.45
6124194-12419487.52292.63
90min1122065-12206586.02186.780.7892.0592.880.77
2122495-12249586.32492.44
3124745-12474587.91094.08
4123638-12363887.13093.24
5123173-12317386.80292.87
6122727-12272786.48892.57
极限1120078-12007884.62186.661.7391.6093.721.63
2124197-12419787.52494.59
3122584-12258486.38793.53
4126094-12609488.86195.94
5121404-12140485.55592.59
6123504-12350487.03594.08
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%
19.972337002337502334912325602326532332310.25
29.992311432279562295500.99
单位质量响应值RSD%判断
23393.2822977.981.27数据可信
供试品溶液-24112102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%
5min177774-7777455.07054.360.8055.0754.360.80
276645-7664554.27154.27
376498-7649854.16754.17
476858-7685854.42254.42
576957-7695754.49254.49
675920-7592053.75853.76
10min1100637-10063771.25970.760.8771.8771.360.86
2100785-10078571.36471.97
399490-9949070.44771.05
499255-9925570.28170.89
598772-9877269.93970.54
6100628-10062871.25371.85
15min1110177-11017778.01477.961.2979.4279.341.27
2109487-10948777.52678.92
3108547-10854776.86078.24
4108908-10890877.11678.50
5111243-11124378.76980.15
6112212-11221279.45580.84
20min1115565-11556581.82981.301.4784.1083.561.44
2116589-11658982.55584.81
3111909-11190979.24181.48
4114745-11474581.24983.49
5114062-11406280.76583.02
6116036-11603682.16384.43
30min1117590-11759083.26383.271.2686.4486.421.24
2117584-11758483.25986.43
3114915-11491581.36984.49
4117538-11753883.22686.37
5118931-11893184.21387.37
6119009-11900984.26887.45
45min1120515-12051585.33485.601.3889.4489.691.34
2121757-12175786.21490.31
3119302-11930284.47688.50
4119625-11962584.70488.77
5120383-12038385.24189.33
6123798-12379887.65991.78
60min1120488-12048885.31585.761.0890.3790.791.05
2122052-12205286.42391.48
3121080-12108085.73590.70
4120455-12045585.29290.30
5119465-11946584.59189.63
6123123-12312387.18192.28
90min1122856-12285686.99286.571.3392.9992.561.29
2123340-12334087.33593.35
3120212-12021285.12091.03
4120288-12028885.17491.13
5122824-12282486.96992.95
6124031-12403187.82493.89
极限1124032-12403287.82587.580.9394.7994.530.92
2123739-12373987.61794.61
3122022-12202286.40293.26
4122655-12265586.85093.75
5124877-12487788.42395.37
6124756-12475688.33795.38
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%
19.972239872240342227182230492246182236810.35
29.992244202257612250900.43
单位质量响应值RSD%判断
22435.4122531.530.31数据可信
供试品溶液-24112102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%
5min178796-7879657.53257.612.9157.5357.612.91
281418-8141859.44759.45
379012-7901257.69057.69
481493-8149359.50159.50
575982-7598255.47755.48
676741-7674156.03256.03
10min1103348-10334875.45874.800.9176.1075.440.91
2103832-10383275.81276.47
3101989-10198974.46675.11
4101953-10195374.44075.10
5101472-10147274.08974.71
6102079-10207974.53275.15
15min1111778-11177881.61481.651.1883.0983.121.17
2112894-11289482.42883.93
3109873-10987380.22381.69
4112477-11247782.12483.61
5113241-11324182.68284.12
6110681-11068180.81382.26
20min1115941-11594184.65384.540.7187.0486.920.70
2116928-11692885.37487.79
3116361-11636184.96087.32
4115013-11501383.97686.38
5114741-11474183.77786.14
6115749-11574984.51386.86
30min1118831-11883186.76387.300.4090.0990.620.40
2119931-11993187.56690.93
3119154-11915486.99990.30
4120030-12003087.63990.97
5119822-11982287.48790.78
6119639-11963987.35390.64
45min1120875-12087588.25688.001.1992.5492.291.15
2120825-12082588.21992.56
3118915-11891586.82591.09
4121938-12193889.03293.34
5121943-12194389.03593.30
6118693-11869386.66290.92
60min1121873-12187388.98489.030.3694.2594.290.35
2122233-12223389.24794.57
3121421-12142188.65493.89
4121985-12198589.06694.36
5121501-12150188.71393.96
6122561-12256189.48794.71
90min1120414-12041487.91989.411.2894.1895.671.22
2124112-12411290.61996.93
3120763-12076388.17494.39
4123779-12377990.37696.66
5123224-12322489.97196.21
6122477-12247789.42595.64
极限1122711-12271189.59689.681.2296.8396.921.15
2122733-12273389.61296.93
3120136-12013687.71694.92
4124618-12461890.98998.28
5123123-12312389.89797.13
6123603-12360390.24797.46
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%
19.972340222340952333052338162329932336460.21
29.992312012325542318780.42
单位质量响应值RSD%判断
23434.9023211.010.68数据可信
供试品溶液-24112102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%
5min178328-7832855.13354.661.9555.1354.661.95
279095-7909555.67355.67
378207-7820755.04855.05
478812-7881255.47455.47
575521-7552153.15753.16
676006-7600653.49853.50
10min199883-9988370.30570.340.9770.9270.940.98
2101387-10138771.36371.98
3100034-10003470.41171.02
4100320-10032070.61271.23
598445-9844569.29369.88
699505-9950570.03970.63
15min1107224-10722475.47276.961.4276.8778.351.41
2110538-11053877.80579.22
3111228-11122878.29079.68
4110169-11016977.54578.95
5108718-10871876.52477.88
6108155-10815576.12777.50
20min1113897-11389780.16979.880.6182.4082.120.62
2114329-11432980.47382.75
3113661-11366180.00382.27
4113574-11357479.94282.20
5113063-11306379.58281.79
6112357-11235779.08581.30
30min1117476-11747682.68882.631.5285.8185.761.50
2118649-11864983.51486.68
3117974-11797483.03986.19
4119599-11959984.18287.33
5114760-11476080.77683.87
6115920-11592081.59384.69
45min1119083-11908383.81985.121.1187.8689.161.08
2123053-12305386.61490.71
3120278-12027884.66088.74
4121349-12134985.41489.50
5120434-12043484.77088.76
6121348-12134885.41389.42
60min1121008-12100885.17485.150.8890.1590.140.84
2122220-12222086.02791.09
3119022-11902283.77688.79
4121226-12122685.32890.36
5121329-12132985.40090.33
6121032-12103285.19190.14
90min1118897-11889783.68885.611.1889.6191.551.13
2122261-12226186.05692.07
3122602-12260286.29692.24
4122752-12275286.40292.39
5121867-12186785.77991.66
6121361-12136185.42391.32
极限1121563-12156385.56585.891.3992.4192.791.34
2123523-12352386.94493.92
3120776-12077685.01191.92
4124677-12467787.75794.70
5121239-12123985.33792.17
6120409-12040984.75391.60
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