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%
19.812360372365312366962369812364822365450.15
29.842364522363552364040.03
单位质量响应值RSD%判断
24112.6424024.800.26数据可信
供试品溶液-24042502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%
5min120172-2017213.75813.5010.0413.7613.5010.05
221006-2100614.32714.33
319728-1972813.45513.46
416113-1611310.99010.99
519826-1982613.52213.52
621936-2193614.96114.96
10min138816-3881626.47425.937.2226.6326.087.23
240078-4007827.33527.49
338267-3826726.10026.25
432764-3276422.34722.47
537902-3790225.85126.00
640263-4026327.46127.63
15min148742-4874233.24432.946.2433.6933.386.26
250234-5023434.26234.72
348151-4815132.84133.28
442821-4282129.20629.58
548207-4820732.88033.32
651661-5166135.23535.71
20min155164-5516437.62537.373.9638.4438.184.02
256366-5636638.44439.29
355047-5504737.54538.35
450671-5067134.56035.26
554783-5478337.36538.17
656743-5674338.70239.56
30min164939-6493944.29243.782.5345.5345.002.60
265462-6546244.64845.92
362445-6244542.59143.81
462614-6261442.70643.78
563339-6333943.20044.42
666369-6636945.26746.56
45min173676-7367650.25150.491.2251.9852.191.32
275100-7510051.22252.99
373963-7396350.44652.14
472968-7296849.76851.32
573322-7332250.00951.71
675096-7509651.21953.02
60min180695-8069555.03854.981.6857.3257.241.58
279445-7944554.18556.52
379769-7976954.40656.66
482345-8234556.16358.27
579268-7926854.06556.32
682109-8210956.00258.37
90min189473-8947361.02561.532.0363.9264.401.93
287667-8766759.79362.73
390157-9015761.49264.35
491869-9186962.65965.39
589371-8937160.95563.81
692716-9271663.23766.22
极限196567-9656765.86366.243.2169.4469.803.11
295630-9563065.22468.83
394489-9448964.44667.99
497607-9760766.57370.00
595355-9535565.03768.57
6103084-10308470.30874.00
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%
19.819491795035950309486294607948900.19
29.849510894911950100.15
单位质量响应值RSD%判断
9672.789655.490.13数据可信
供试品溶液-24042503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%
5min19239-923915.69414.806.6615.6914.806.64
29587-958716.28516.28
38559-855914.53914.54
48500-850014.43914.44
58093-809313.74713.75
68281-828114.06714.07
10min117366-1736629.49928.315.5229.6728.485.51
217251-1725129.30329.48
317658-1765829.99530.16
415883-1588326.98027.14
515337-1533726.05226.20
616514-1651428.05228.21
15min121654-2165436.78334.765.0437.2835.245.03
221492-2149236.50737.01
320313-2031334.50535.00
419161-1916132.54833.01
519439-1943933.02033.46
620715-2071535.18835.66
20min124764-2476442.06540.304.2842.9841.174.29
224175-2417541.06541.98
324827-2482742.17243.05
422464-2246438.15938.98
522756-2275638.65539.46
623368-2336839.69440.55
30min128632-2863248.63646.644.2850.0147.954.28
227659-2765946.98348.35
328964-2896449.20050.55
426357-2635744.77146.02
526118-2611844.36545.60
627011-2701145.88247.18
45min132595-3259555.36853.164.5257.2954.984.51
231267-3126753.11255.00
333320-3332056.59958.49
429777-2977750.58152.32
530013-3001350.98252.71
630786-3078652.29554.10
60min135368-3536860.07857.334.7462.6159.744.71
233690-3369057.22859.71
336023-3602361.19163.71
432264-3226454.80557.11
532606-3260655.38657.68
632534-3253455.26457.65
90min139322-3932266.79464.084.2970.0067.144.27
237255-3725563.28366.40
340173-4017368.24071.44
436614-3661462.19465.11
536551-3655162.08765.00
636425-3642561.87364.88
极限141739-4173970.90067.574.6974.8471.344.64
238810-3881065.92569.74
342471-4247172.14376.10
437988-3798864.52868.13
539217-3921766.61670.22
638432-3843265.28368.98
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%
19.811187255118688811868591186300118643611867480.04
29.841189361118907511892180.02
单位质量响应值RSD%判断
120973.29120855.490.07数据可信
供试品溶液-24042501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%
5min1177381-17738124.08222.838.3624.0822.838.35
2187986-18798625.52225.52
3174448-17444823.68423.68
4158369-15836921.50121.50
5150661-15066120.45520.45
6160021-16002121.72521.73
10min1292436-29243639.70338.166.2539.9738.426.25
2305361-30536141.45741.74
3287023-28702338.96839.23
4274940-27494037.32737.57
5255665-25566534.71034.94
6271042-27104236.79837.04
15min1352656-35265647.87947.065.6848.5947.745.69
2375451-37545150.97351.72
3352877-35287747.90948.60
4339208-33920846.05346.71
5315562-31556242.84243.46
6343805-34380546.67747.33
20min1396053-39605353.77052.895.3855.0154.095.40
2421007-42100757.15858.47
3396466-39646653.82655.05
4377779-37777951.28952.45
5358424-35842448.66249.75
6387695-38769552.63653.80
30min1455723-45572361.87160.975.5563.7162.765.56
2487551-48755166.19368.14
3458329-45832962.22564.05
4433615-43361558.87060.61
5413898-41389856.19357.82
6445570-44557060.49362.25
45min1507536-50753668.90667.994.9071.4370.464.93
2535922-53592272.76075.44
3508988-50898869.10371.62
4483898-48389865.69768.09
5463909-46390962.98365.24
6504498-50449868.49370.92
60min1538374-53837473.09372.654.4076.3875.864.45
2569362-56936277.30080.79
3542901-54290173.70776.99
4525684-52568471.37074.49
5497256-49725667.51070.46
6536939-53693972.89876.08
90min1578515-57851578.54278.653.9382.6582.683.99
2613586-61358683.30487.65
3582188-58218879.04183.15
4571813-57181377.63281.54
5543379-54337973.77277.48
6586449-58644979.62083.62
极限1622826-62282684.55884.292.5789.5389.192.69
2642190-64219087.18792.46
3622111-62211184.46189.44
4609361-60936182.73087.51
5597115-59711581.06885.59
6631373-63137385.71990.60
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