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%
110.091214770121443512137901214943121427012144420.04
29.901204425120609112052580.10
单位质量响应值RSD%判断
120360.95121743.230.81数据可信
供试品溶液-24052301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%
5min1119783-11978316.24415.823.2916.2415.823.28
2119562-11956216.21416.21
3120021-12002116.27716.28
4115586-11558615.67515.68
5110586-11058614.99715.00
6114213-11421315.48915.49
10min1192792-19279226.14625.364.4926.3325.544.49
2194164-19416426.33226.51
3195828-19582826.55726.74
4179248-17924824.30924.48
5176040-17604023.87424.04
6183924-18392424.94325.12
15min1245629-24562933.31131.644.8733.7832.104.85
2240555-24055532.62333.10
3242976-24297632.95133.43
4222964-22296430.23730.68
5218454-21845429.62630.06
6229089-22908931.06831.52
20min1287384-28738438.97436.375.7339.8137.185.70
2276703-27670337.52538.36
3280907-28090738.09538.94
4253025-25302534.31435.09
5251709-25170934.13634.90
6259525-25952535.19635.99
30min1353181-35318147.89743.486.1249.1744.696.07
2326539-32653944.28445.54
3328429-32842944.54045.81
4300203-30020340.71241.87
5305348-30534841.41042.55
6309930-30993042.03143.22
45min1417574-41757456.62950.636.9458.4452.326.87
2374654-37465450.80952.55
3386183-38618352.37254.13
4346266-34626646.95948.57
5358739-35873948.65150.25
6356532-35653248.35150.00
60min1464776-46477663.03154.898.3865.4757.158.24
2403234-40323454.68556.99
3417011-41701156.55358.90
4371307-37130750.35552.49
5395454-39545453.63055.77
6376834-37683451.10553.29
90min1525701-52570171.29361.069.2774.4363.939.08
2437920-43792059.38962.31
3453646-45364661.52164.49
4409976-40997655.59958.29
5457931-45793162.10364.84
6416189-41618956.44259.20
极限1579500-57950078.58972.275.3082.5275.825.33
2535659-53565972.64476.22
3538786-53878673.06876.72
4504617-50461768.43471.75
5536804-53680472.79976.23
6502128-50212868.09671.48
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%
110.091212570121256012119951212658121165412122870.04
29.901205706120626512059860.04
单位质量响应值RSD%判断
120147.37121816.770.98数据可信
供试品溶液-24052302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%
5min188042-8804211.94711.823.4511.9511.823.44
284199-8419911.42511.43
392565-9256512.56112.56
486873-8687311.78811.79
585295-8529511.57411.57
685528-8552811.60611.61
10min1129084-12908417.51617.914.8717.6518.044.86
2126184-12618417.12317.25
3144362-14436219.58919.73
4130720-13072017.73817.87
5132376-13237617.96318.09
6128983-12898317.50217.63
15min1160221-16022121.74122.046.3922.0722.386.34
2158033-15803321.44421.76
3183258-18325824.86725.22
4158002-15800221.44021.77
5160193-16019321.73822.07
6155003-15500321.03321.36
20min1182873-18287324.81525.117.3125.3825.687.27
2179638-17963824.37624.93
3212361-21236128.81729.45
4177946-17794624.14724.71
5180397-18039724.47925.05
6177139-17713924.03724.59
30min1212375-21237528.81829.838.8629.6630.698.76
2221471-22147130.05330.88
3258056-25805635.01735.97
4208129-20812928.24229.08
5213084-21308428.91529.76
6205952-20595227.94728.77
45min1250354-25035433.97235.2910.0635.1436.479.93
2266851-26685136.21137.37
3309875-30987542.04943.39
4242889-24288932.95934.11
5250250-25025033.95835.12
6239961-23996132.56233.70
60min1275686-27568637.40938.8311.5938.9540.4011.41
2301535-30153540.91742.48
3346384-34638447.00348.81
4264177-26417735.84837.36
5271616-27161636.85738.40
6257464-25746434.93736.43
90min1320471-32047143.48744.8613.3245.4446.8713.09
2355652-35565248.26150.28
3407587-40758755.30857.64
4303999-30399941.25143.16
5308127-30812741.81243.76
6287930-28793039.07140.96
极限1451149-45114961.21961.546.4263.6664.056.51
2473573-47357364.26266.82
3501121-50112168.00070.95
4438837-43883759.54861.92
5433821-43382158.86861.28
6422713-42271357.36059.68
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