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10000
标示量(mg)1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%
110.062481132478182479612473132472642476940.16
210.102474412464902469660.28
单位质量响应值RSD%判断
24621.6724452.080.49数据可信
供试品溶液-24121701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%
5min168481-6848145.81746.443.7645.8246.453.76
272904-7290448.77648.78
371320-7132047.71647.72
465808-6580844.02844.03
570404-7040447.10347.10
667597-6759745.22545.23
10min186797-8679758.07156.611.8058.5857.121.79
285533-8553357.22557.77
383421-8342155.81256.34
483621-8362155.94656.44
585367-8536757.11457.64
682910-8291055.47055.97
15min188387-8838759.13559.541.9060.2960.691.88
291436-9143661.17562.35
388149-8814958.97560.13
489501-8950159.88060.99
589959-8995960.18661.34
686557-8655757.91059.03
20min190350-9035060.44860.451.7662.2662.251.75
292717-9271762.03263.89
388253-8825359.04560.85
491046-9104660.91462.69
590765-9076560.72662.55
688964-8896459.52161.28
30min190127-9012760.29961.112.1362.7863.592.10
294433-9443363.18065.73
389499-8949959.87962.34
492473-9247361.86864.32
591886-9188661.47663.98
689658-8965859.98562.41
45min192377-9237761.80461.861.8364.9665.021.81
294370-9437063.13766.39
390826-9082660.76663.89
494225-9422563.04066.18
592712-9271262.02865.21
690276-9027660.39863.49
60min192454-9245461.85662.432.2565.7066.282.20
296348-9634864.46168.41
392177-9217761.67065.47
495464-9546463.86967.71
592411-9241161.82765.70
691029-9102960.90264.66
90min191234-9123461.03962.052.2765.5766.582.22
295633-9563363.98268.65
390763-9076360.72465.21
494709-9470963.36467.91
593216-9321662.36566.93
690875-9087560.79965.24
极限191703-9170361.35362.692.5466.5667.922.47
296255-9625564.39969.78
391786-9178661.40966.57
495315-9531563.77069.02
595988-9598864.22069.47
691191-9119161.01166.12
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10000
标示量(mg)1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%
110.062463972456162454242458292458422458220.15
210.102457902449012453460.26
单位质量响应值RSD%判断
24435.5924291.680.42数据可信
供试品溶液-24121703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%
5min179687-7968753.69351.792.3553.6951.792.35
276830-7683051.76851.77
375561-7556150.91350.91
478252-7825252.72652.73
574953-7495350.50350.50
675869-7586951.12051.12
10min189812-8981260.51559.532.0661.1160.102.05
288576-8857659.68260.26
385759-8575957.78458.35
487315-8731558.83359.42
587767-8776759.13759.70
690840-9084061.20861.78
15min194128-9412863.42362.332.1564.6963.562.12
291955-9195561.95963.20
390084-9008460.69861.91
490321-9032160.85862.10
594181-9418163.45964.68
694325-9432563.55664.80
20min194741-9474163.83662.832.0365.8164.762.01
292642-9264262.42264.35
391916-9191661.93363.81
490772-9077261.16263.08
593441-9344162.96064.88
695952-9595264.65266.61
30min192879-9287962.58262.712.1665.2665.342.11
291558-9155861.69264.31
391743-9174361.81664.39
491427-9142761.60364.20
594353-9435363.57566.20
696483-9648365.01067.68
45min194341-9434163.56763.432.7366.9566.762.66
294450-9445063.64066.95
390802-9080261.18264.44
491738-9173861.81365.09
595721-9572164.49767.83
697789-9778965.89069.28
60min194779-9477963.86263.512.3767.9567.542.33
294563-9456363.71667.73
391488-9148861.64465.58
492103-9210362.05966.03
594922-9492263.95868.00
697679-9767965.81669.94
90min195144-9514464.10864.302.8068.9069.042.72
294650-9465063.77568.50
393080-9308062.71767.34
492852-9285262.56367.22
596904-9690465.29470.05
699958-9995867.35172.21
极限196118-9611864.76464.672.2970.2770.122.25
295082-9508264.06669.50
394526-9452663.69169.01
493126-9312662.74868.10
598126-9812666.11771.60
698877-9887766.62372.23
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10000
标示量(mg)1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%
110.062493532489602494472493282492642492700.08
210.102490222487392488800.09
单位质量响应值RSD%判断
24778.3324641.580.40数据可信
供试品溶液-24121702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%
5min175360-7536050.06649.503.2350.0749.503.23
276846-7684651.05351.05
375950-7595050.45850.46
471732-7173247.65547.66
575953-7595350.46050.46
671214-7121447.31147.31
10min188020-8802058.47658.653.4359.0359.203.42
292133-9213361.20961.78
389903-8990359.72760.29
484278-8427855.99056.52
590037-9003759.81660.38
685289-8528956.66257.19
15min191954-9195461.09061.733.5362.3062.943.52
297254-9725464.61165.86
394475-9447562.76563.99
489328-8932859.34560.50
595224-9522463.26264.49
689292-8929259.32160.48
20min193750-9375062.28362.963.5064.1764.843.48
299643-9964366.19868.16
394531-9453162.80264.72
492192-9219261.24863.06
597600-9760064.84166.77
690863-9086360.36562.18
30min194917-9491763.05863.093.3465.6465.683.34
299858-9985866.34169.04
395504-9550463.44866.07
491766-9176660.96563.46
596427-9642764.06266.71
691289-9128960.64863.13
45min196857-9685764.34764.323.3467.6267.613.34
2100953-10095367.06870.51
397597-9759764.83968.16
493825-9382562.33365.50
599269-9926965.95069.31
692399-9239961.38664.54
60min195413-9541363.38863.922.9167.3867.922.92
299794-9979466.29870.48
397142-9714264.53768.58
494584-9458462.83766.70
598330-9833065.32669.42
692022-9202261.13564.98
90min195743-9574363.60764.372.6668.3069.082.69
2101274-10127467.28272.20
397183-9718364.56469.33
496021-9602163.79268.35
597569-9756964.82069.64
693526-9352662.13466.65
极限197666-9766664.88564.812.8770.2970.242.83
2102334-10233467.98673.65
397774-9777464.95670.44
497721-9772164.92170.19
595908-9590863.71769.26
693887-9388762.37467.58
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10000
标示量(mg)1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%
110.062486772486092488972488832483802486890.09
210.102480532474822477680.17
单位质量响应值RSD%判断
24720.5824531.490.55数据可信
供试品溶液-24121601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%
5min188696-8869659.12758.841.1259.1358.841.12
287525-8752558.34658.35
389688-8968859.78859.79
488514-8851459.00559.01
588317-8831758.87458.87
686853-8685357.89857.90
10min1105616-10561670.40671.521.2671.0672.181.26
2106876-10687671.24671.89
3109344-10934472.89173.56
4106486-10648670.98671.64
5108374-10837472.24472.90
6107035-10703571.35272.00
15min1111839-11183974.55476.491.8075.9977.941.78
2113969-11396975.97477.41
3118002-11800278.66380.14
4115560-11556077.03578.48
5115142-11514276.75678.21
6113923-11392375.94477.38
20min1116677-11667777.77978.151.4980.0580.451.48
2114781-11478176.51578.80
3119844-11984479.89182.24
4116856-11685677.89980.20
5118499-11849978.99481.30
6116728-11672877.81380.09
30min1115280-11528076.84879.332.2879.9882.502.24
2117236-11723678.15281.29
3123118-12311882.07385.31
4118692-11869279.12382.29
5120645-12064580.42583.61
6119070-11907079.37582.52
45min1118505-11850578.99881.292.4482.9885.342.39
2120836-12083680.55284.55
3127305-12730584.86489.01
4120473-12047380.31084.35
5122152-12215281.42985.51
6122401-12240181.59585.62
60min1118373-11837378.91081.382.5383.7786.342.47
2120285-12028580.18585.08
3126833-12683384.55089.64
4120100-12010080.06185.00
5123707-12370782.46687.45
6123209-12320982.13487.07
90min1120025-12002580.01182.612.9885.7588.462.90
2121079-12107980.71486.50
3130348-13034886.89392.92
4123497-12349782.32688.15
5125530-12553083.68189.58
6123062-12306282.03687.88
极限1120728-12072880.48082.972.4687.1189.752.42
2123052-12305282.02988.71
3129719-12971986.47393.47
4123746-12374682.49289.23
5125869-12586983.90790.74
6123702-12370282.46289.22
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