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25000
标示量(mg)0.4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%
110.251023131023971024661025881021871023900.15
210.161022841021991022420.06
单位质量响应值RSD%判断
9989.2710063.190.53数据可信
供试品溶液-24070102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%
5min117502-1750228.65728.451.9428.6628.451.93
217672-1767228.93528.93
317240-1724028.22828.23
417080-1708027.96627.97
517803-1780329.14929.15
616958-1695827.76627.77
10min129029-2902947.53046.881.9047.8547.191.88
228212-2821246.19246.51
329240-2924047.87548.19
427780-2778045.48545.80
528708-2870847.00447.33
628808-2880847.16847.48
15min133967-3396755.61556.102.0456.4656.932.01
234331-3433156.21157.05
335179-3517957.60058.45
433914-3391455.52856.34
533278-3327854.48755.33
634894-3489457.13357.97
20min137629-3762961.61162.392.0963.0863.852.06
237127-3712760.78962.25
339213-3921364.20565.69
437544-3754461.47262.90
538660-3866063.29964.75
638449-3844962.95464.42
30min140251-4025165.90468.192.5568.0570.342.51
240911-4091166.98569.12
342950-4295070.32372.52
441068-4106867.24269.36
542114-4211468.95471.11
642593-4259369.73971.91
45min143196-4319670.72673.012.3673.6175.922.32
243822-4382271.75174.63
346207-4620775.65678.64
444351-4435172.61775.48
544976-4497673.64076.56
644999-4499973.67876.62
60min144439-4443972.76175.422.6476.4379.142.58
244874-4487473.47377.15
347160-4716077.21681.04
446104-4610475.48779.16
546302-4630275.81279.55
647486-4748677.75081.51
90min144369-4436972.64776.113.1277.1280.673.03
245155-4515573.93478.43
347659-4765978.03382.71
446639-4663976.36380.87
547015-4701576.97981.56
648083-4808378.72883.35
极限150257-5025782.28782.513.8487.5787.913.68
246888-4688876.77182.09
351931-5193185.02890.57
450199-5019982.19287.55
552358-5235885.72791.16
650713-5071383.03488.53
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25000
标示量(mg)0.4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%
110.251021661020971016481019981022851020390.24
210.161020161018071019120.15
单位质量响应值RSD%判断
9955.0210030.710.54数据可信
供试品溶液-24070102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%
5min123543-2354338.67641.413.6538.6841.413.64
226085-2608542.85242.85
324942-2494240.97540.97
425937-2593742.60942.61
525271-2527141.51541.52
625471-2547141.84441.84
10min136350-3635059.71663.364.6960.1563.824.67
238863-3886363.84464.32
338611-3861163.43063.89
441793-4179368.65769.13
537987-3798762.40562.87
637806-3780662.10862.57
15min143957-4395772.21273.781.8373.3174.941.83
245858-4585875.33576.52
345959-4595975.50176.66
444807-4480773.60974.85
544443-4444373.01174.17
644429-4442972.98874.14
20min147858-4785878.62181.224.0680.5283.204.02
250481-5048182.93084.95
350009-5000982.15584.15
452671-5267186.52888.58
547350-4735077.78679.75
648269-4826979.29681.26
30min151951-5195185.34588.174.1088.1191.064.06
253681-5368188.18791.13
354851-5485190.10993.02
457295-5729594.12497.14
551144-5114484.01986.85
653114-5311487.25590.10
45min155552-5555291.26193.123.7894.9896.983.75
256967-5696793.58597.51
357868-5786895.06598.98
460110-6011098.748102.81
554006-5400688.72192.48
655594-5559491.33095.15
60min156265-5626592.43294.144.0497.1699.044.00
258364-5836495.880100.84
358577-5857796.230101.20
460369-6036999.174104.33
553692-5369288.20592.95
656577-5657792.94497.78
90min156423-5642392.69194.013.7598.4599.963.71
258518-5851896.133102.16
358356-5835695.867101.91
460063-6006398.671104.93
554182-5418289.01094.74
655812-5581291.68897.55
极限158088-5808895.42795.562.77102.22102.552.78
259353-5935397.505104.60
359327-5932797.462104.57
459652-5965297.996105.35
555624-5562491.37998.10
656959-5695993.572100.45
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25000
标示量(mg)0.4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%
110.251273253127168112745971273363127138112728550.11
210.161270049127070312703760.04
单位质量响应值RSD%判断
124180.98125037.010.49数据可信
供试品溶液-24070101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%
5min1110986-11098614.62114.984.8414.6214.984.84
2118539-11853915.61715.62
3115417-11541715.20515.21
4103843-10384313.68013.68
5115553-11555315.22315.22
6117747-11774715.51215.51
10min1191412-19141225.21725.883.5825.3826.053.59
2201036-20103626.48526.66
3201735-20173526.57726.75
4184359-18435924.28824.44
5200646-20064626.43326.60
6199483-19948326.28026.45
15min1252846-25284633.31033.472.7233.7533.922.73
2261100-26110034.39834.87
3258124-25812434.00634.47
4243663-24366332.10132.52
5248701-24870132.76433.23
6259895-25989534.23934.70
20min1293800-29380038.70639.052.3839.5239.882.40
2300320-30032039.56540.41
3297049-29704939.13439.98
4284223-28422337.44438.22
5298141-29814139.27840.10
6305055-30505540.18841.03
30min1348891-34889145.96345.992.7747.2147.252.77
2352815-35281546.48047.77
3352322-35232246.41547.69
4330610-33061043.55544.75
5351030-35103046.24547.51
6358853-35885347.27648.57
45min1402747-40274753.05953.831.8554.8155.601.84
2408658-40865853.83755.64
3408125-40812553.76755.56
4406181-40618153.51155.19
5402855-40285553.07354.85
6423145-42314555.74657.56
60min1430424-43042456.70557.372.1759.0559.742.16
2439121-43912157.85160.25
3439942-43994257.95960.35
4427125-42712556.27058.54
5425746-42574656.08858.46
6450371-45037159.33361.77
90min1480205-48020563.26363.111.5066.2466.121.53
2483421-48342163.68766.73
3477944-47794462.96566.00
4469087-46908761.79864.70
5473949-47394962.43965.43
6489558-48955864.49567.59
极限1509057-50905767.06467.541.2170.7471.251.25
2513564-51356467.65871.41
3516494-51649468.04471.78
4506084-50608466.67270.26
5508180-50818066.94870.63
6522623-52262368.85172.66
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