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%
110.592615732621102621742626232621312621220.15
210.582632192624582628380.21
单位质量响应值RSD%判断
24751.8424842.910.26数据可信
供试品溶液-24073001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%
5min144958-4495829.76329.671.9629.7629.671.96
244903-4490329.72629.73
345624-4562430.20330.20
444520-4452029.47329.47
545626-4562630.20530.20
643258-4325828.63728.64
10min173090-7309048.38648.541.9348.7248.881.93
272114-7211447.74048.07
374440-7444049.28049.62
474122-7412249.06949.40
574899-7489949.58449.92
671299-7129947.20047.52
15min188726-8872658.73758.932.3759.6159.802.36
287772-8777258.10658.97
391230-9123060.39561.28
487643-8764358.02058.89
591948-9194860.87061.76
686744-8674457.42558.27
20min199661-9966165.97665.261.7967.5066.781.79
296898-9689864.14765.65
399887-9988766.12667.68
496778-9677864.06865.59
5100847-10084766.76168.32
697371-9737164.46065.94
30min1109762-10976272.66372.591.6474.9274.841.64
2106911-10691170.77673.00
3111582-11158273.86876.16
4109018-10901872.17174.40
5111663-11166373.92276.23
6109005-10900572.16274.36
45min1116734-11673477.27976.641.4980.3479.691.49
2112675-11267574.59277.60
3117169-11716977.56780.68
4115445-11544576.42579.46
5117210-11721077.59480.72
6115337-11533776.35479.35
60min1117326-11732677.67178.022.5681.5981.922.46
2112489-11248974.46978.30
3119985-11998579.43183.40
4119173-11917378.89382.77
5117198-11719877.58681.57
6120922-12092280.05183.90
90min1119219-11921978.92478.951.4683.7183.721.45
2116537-11653777.14881.81
3121925-12192580.71585.57
4119789-11978979.30184.06
5118696-11869678.57883.43
6119385-11938579.03483.77
极限1119507-11950779.11579.261.0984.7784.911.10
2117249-11724977.62083.14
3120966-12096680.08085.83
4120040-12004079.46785.11
5120299-12029979.63985.36
6120286-12028679.63085.24
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%
110.592646352648702641502645172642772644900.11
210.582674502675722675110.04
单位质量响应值RSD%判断
24975.4525284.590.87数据可信
供试品溶液-24073002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%
5min146869-4686930.61829.634.9130.6229.634.91
245583-4558329.77829.78
346202-4620230.18230.18
447550-4755031.06331.06
544667-4466729.17929.18
641307-4130726.98526.98
10min172658-7265847.46547.082.4447.8147.422.45
271467-7146746.68747.02
373743-7374348.17448.51
473671-7367148.12748.47
571896-7189646.96747.29
669017-6901745.08745.39
15min189938-8993858.75458.222.5559.6259.072.56
288438-8843857.77458.62
391099-9109959.51260.38
491158-9115859.55160.43
589058-8905858.17959.02
685064-8506455.57056.37
20min199883-9988365.25064.941.9666.7766.441.97
297912-9791263.96365.45
3101464-10146466.28367.81
4101486-10148666.29767.84
599043-9904364.70266.19
696636-9663663.12964.55
30min1111826-11182673.05272.201.0975.3074.431.12
2109610-10961071.60573.81
3111645-11164572.93475.20
4111057-11105772.55074.83
5110225-11022572.00674.22
6108800-10880071.07573.20
45min1119729-11972978.21578.081.4381.2781.101.44
2117534-11753476.78179.78
3121826-12182679.58582.66
4119830-11983078.28181.37
5120642-12064278.81181.82
6117553-11755376.79479.70
60min1119786-11978678.25279.372.2582.1883.262.18
2120882-12088278.96882.82
3125048-12504881.69085.65
4119292-11929277.93081.88
5124817-12481781.53985.43
6119171-11917177.85181.61
90min1121775-12177579.55281.311.4184.3586.091.34
2123238-12323880.50785.24
3126433-12643382.59587.47
4124153-12415381.10585.93
5125518-12551881.99786.79
6125699-12569982.11586.74
极限1124395-12439581.26381.042.3586.9486.722.18
2124067-12406781.04986.67
3126185-12618582.43388.22
4118365-11836577.32483.05
5125466-12546681.96387.67
6125873-12587382.22987.77
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%
110.591266623126676612671801267712126574912668060.06
210.581260272125975312600120.03
单位质量响应值RSD%判断
119622.85119093.760.32数据可信
供试品溶液-23FA408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%
5min169020-690209.4939.443.519.499.443.50
268314-683149.3969.40
364626-646268.8888.89
471904-719049.8899.89
569891-698919.6139.61
668024-680249.3569.36
10min1127386-12738617.52017.743.4117.6317.853.41
2127284-12728417.50617.61
3124208-12420817.08317.18
4136037-13603718.71018.82
5132553-13255318.23118.34
6126625-12662517.41617.52
15min1183533-18353325.24225.323.5125.5425.623.51
2182213-18221325.06125.36
3176829-17682924.32024.61
4192659-19265926.49826.82
5190813-19081326.24426.55
6178359-17835924.53124.83
20min1223680-22368030.76430.521.8831.3431.101.90
2219615-21961530.20530.78
3217371-21737129.89630.46
4228244-22824431.39232.00
5224141-22414130.82731.43
6218399-21839930.03830.61
30min1283005-28300538.92337.831.8839.8538.761.87
2268786-26878636.96837.88
3275013-27501337.82438.72
4278996-27899638.37239.33
5272807-27280737.52138.46
6271802-27180237.38338.29
45min1351001-35100148.27545.463.4449.6346.813.36
2320796-32079644.12145.44
3334400-33440045.99247.30
4330411-33041145.44346.83
5325943-32594344.82946.19
6320833-32083344.12645.45
60min1395891-39589154.44951.183.5556.3453.033.47
2365244-36524450.23452.05
3377532-37753251.92453.75
4368154-36815450.63452.53
5368000-36800050.61352.47
6358052-35805249.24551.05
90min1471991-47199164.91659.914.9667.4162.324.82
2419119-41911957.64460.02
3452285-45228562.20664.60
4421080-42108057.91460.37
5424822-42482258.42860.85
6424144-42414458.33560.69
极限1497936-49793668.48465.472.4871.7068.552.47
2462145-46214563.56266.57
3475677-47567765.42368.51
4473356-47335665.10468.20
5474379-47437965.24468.31
6472543-47254364.99268.00
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%
110.591259777126034412595261259420125834712594830.06
210.581252082125162012518510.03
单位质量响应值RSD%判断
118931.35118322.400.37数据可信
供试品溶液-23FA408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%
5min1128175-12817517.73717.6310.0317.7417.6310.03
2138345-13834519.14519.14
3138441-13844119.15819.16
4131401-13140118.18418.18
5123876-12387617.14317.14
6104051-10405114.39914.40
10min1214755-21475529.71929.518.6429.9229.708.65
2228593-22859331.63431.85
3227942-22794231.54431.76
4217791-21779130.13930.34
5211946-21194629.33029.52
6178340-17834024.67924.84
15min1267862-26786237.06837.475.4737.6037.995.52
2286818-28681839.69140.26
3283502-28350239.23239.80
4273397-27339737.83438.37
5267586-26758637.03037.55
6245295-24529533.94534.38
20min1324183-32418344.86242.484.9545.8043.424.96
2302371-30237141.84342.85
3320696-32069644.37945.38
4310010-31001042.90143.86
5302589-30258941.87442.80
6282107-28210739.03939.85
30min1352276-35227648.75049.823.7450.1951.243.78
2374841-37484151.87253.34
3371616-37161651.42652.92
4367600-36760050.87052.30
5353691-35369148.94550.34
6340235-34023547.08348.33
45min1397045-39704554.94556.703.6156.9258.673.63
2427788-42778859.19961.25
3418127-41812757.86259.93
4422977-42297758.53360.53
5395996-39599654.80056.74
6396608-39660854.88456.65
60min1424583-42458358.75661.033.2361.3563.623.21
2456408-45640863.16065.86
3441820-44182061.14163.85
4459264-45926463.55566.20
5430088-43008859.51762.06
6433753-43375360.02562.40
90min1468147-46814764.78466.942.5968.0370.212.54
2492117-49211768.10171.51
3479584-47958466.36769.75
4502276-50227669.50772.86
5473581-47358165.53668.74
6486443-48644367.31670.36
极限1571014-57101479.01980.731.3182.9884.751.32
2592791-59279182.03386.20
3585951-58595181.08685.21
4584302-58430280.85884.99
5578560-57856080.06484.00
6587775-58777581.33985.13
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