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%
110.14 1004951007541008691006861004861006580.17
210.181004351004321004340.01
单位质量响应值RSD%判断
9926.829865.820.44数据可信
供试品溶液-24060303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%
5min119279-1927931.98030.856.0231.9830.856.02
218525-1852530.73030.73
319883-1988332.98232.98
419126-1912631.72631.73
516710-1671027.71927.72
618059-1805929.95729.96
10min127965-2796546.38945.772.9746.7446.122.98
227529-2752945.66546.01
327878-2787846.24446.61
428025-2802546.48846.84
525983-2598343.10143.41
628188-2818846.75947.09
15min134266-3426656.84155.913.5757.7156.763.57
234211-3421156.75057.60
333594-3359455.72656.61
434952-3495257.97958.85
531449-3144952.16852.95
633739-3373955.96756.82
20min138662-3866264.13361.473.3565.6462.943.33
237951-3795162.95464.43
337060-3706061.47662.98
436079-3607959.84861.36
535246-3524658.46759.83
637347-3734761.95263.43
30min143117-4311771.52370.815.3273.7472.965.22
245601-4560175.64477.82
341102-4110268.18170.36
445028-4502874.69376.87
540077-4007766.48068.50
641192-4119268.33070.49
45min146410-4641076.98675.615.3880.0078.555.27
247548-4754878.87381.89
343112-4311271.51574.45
449060-4906081.38184.39
543761-4376172.59175.35
643592-4359272.31175.23
60min147653-4765379.04777.225.5982.9181.005.47
248868-4886881.06384.96
343626-4362672.36776.10
449903-4990382.78086.69
544422-4442273.68877.25
644848-4484874.39478.12
90min149381-4938181.91479.935.6986.6684.575.56
250335-5033583.49688.29
344704-4470474.15678.69
451819-5181985.95890.79
546639-4663977.36581.75
646245-4624576.71281.26
极限150358-5035883.53582.483.2589.1988.003.27
250647-5064784.01489.74
347317-4731778.49083.85
451841-5184185.99591.78
548525-4852580.49485.73
649631-4963182.32987.73
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%
110.14 1002951004441001311002901003351002990.12
210.18999461003231001340.27
单位质量响应值RSD%判断
9891.429836.350.40数据可信
供试品溶液-24060304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%
5min118196-1819630.28329.132.6030.2829.132.59
217915-1791529.81529.82
317304-1730428.79828.80
417302-1730228.79528.80
517321-1732128.82728.83
616987-1698728.27128.27
10min129622-2962249.29948.151.4449.6448.471.45
228941-2894148.16648.50
328824-2882447.97148.29
428455-2845547.35747.68
529131-2913148.48248.80
628605-2860547.60647.92
15min135039-3503958.31458.684.0959.2059.544.03
235315-3531558.77459.64
334769-3476957.86558.72
438043-3804363.31464.16
534415-3441557.27658.13
633988-3398856.56557.41
20min139478-3947865.70265.504.9267.2367.014.81
238893-3889364.72866.25
338373-3837363.86365.36
438996-3899664.90066.45
543018-4301871.59373.09
637365-3736562.18563.66
30min143711-4371172.74771.301.8875.0173.541.88
243208-4320871.91074.15
342278-4227870.36272.57
443340-4334072.12974.40
542991-4299171.54873.84
641517-4151769.09571.26
45min146715-4671577.74675.242.3180.8278.272.26
245523-4552375.76278.80
344703-4470374.39877.39
445972-4597276.51079.58
544042-4404273.29876.38
644285-4428573.70276.63
60min147761-4776179.48777.601.6983.4281.471.69
246369-4636977.17081.05
345931-4593176.44180.26
447383-4738378.85882.78
546529-4652977.43781.34
645801-4580176.22579.97
90min148415-4841580.57579.861.6485.3984.591.62
248056-4805679.97884.71
348629-4862980.93285.59
448296-4829680.37785.18
548073-4807380.00684.77
646445-4644577.29781.89
极限147676-4767679.34680.121.3785.0685.731.34
248313-4831380.40686.03
348438-4843880.61486.18
449044-4904481.62287.31
548220-4822080.25185.90
647145-4714578.46283.92
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%
110.14 1254419125267512519921252666125168912526880.09
210.181251604125016712508860.09
单位质量响应值RSD%判断
123539.25122876.820.39数据可信
供试品溶液-24060301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%
5min1141934-14193418.91118.532.7318.9118.522.74
2144316-14431619.22919.23
3135867-13586718.10318.10
4139618-13961818.60318.60
5138434-13843418.44518.44
6134066-13406617.86317.86
10min1244730-24473032.60831.812.7532.8232.022.76
2247862-24786233.02533.24
3238062-23806231.71931.92
4237698-23769831.67131.88
5234060-23406031.18631.39
6230208-23020830.67330.87
15min1321981-32198142.90041.623.1243.4742.183.12
2325194-32519443.32943.91
3309721-30972141.26741.82
4311057-31105741.44542.00
5307453-30745340.96541.52
6298788-29878839.81040.35
20min1386350-38635051.47749.073.3652.5350.093.35
2379406-37940650.55251.61
3362477-36247748.29649.31
4366874-36687448.88249.90
5361816-36181648.20849.21
6352908-35290847.02148.00
30min1461439-46143961.48259.282.4663.1060.852.47
2454472-45447260.55362.18
3439938-43993858.61760.17
4436774-43677458.19559.76
5443879-44387959.14260.68
6433043-43304357.69859.20
45min1539204-53920471.84368.462.7774.1570.692.75
2514308-51430868.52670.82
3509113-50911367.83470.03
4498863-49886366.46868.68
5517927-51792769.00871.21
6503604-50360467.10069.24
60min1579202-57920277.17273.792.6980.2776.772.68
2554250-55425073.84876.91
3553568-55356873.75776.71
4540426-54042672.00674.95
5557903-55790374.33477.30
6537462-53746271.61174.50
90min1615770-61577082.04579.352.3786.0083.152.31
2584742-58474277.91081.79
3592905-59290578.99882.77
4576814-57681476.85480.60
5605636-60563680.69484.49
6597293-59729379.58383.27
极限1626744-62674483.50781.461.5888.3886.151.60
2610898-61089881.39586.14
3615205-61520581.96986.62
4597716-59771679.63984.24
5611155-61115581.43086.12
6606547-60654780.81685.39
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%
110.14 1251040124993212501981249773125077412503430.05
210.181253036124740812502220.32
单位质量响应值RSD%判断
123307.99122811.590.29数据可信
供试品溶液-24060302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%
5min1153775-15377520.51320.195.0420.5120.205.04
2150529-15052920.08020.08
3146520-14652019.54619.55
4144782-14478219.31419.31
5165491-16549122.07622.08
6147207-14720719.63719.64
10min1244914-24491432.67131.796.1832.9032.016.17
2232043-23204330.95431.18
3226228-22622830.17930.40
4227498-22749830.34830.56
5265109-26510935.36535.61
6233876-23387631.19931.42
15min1306178-30617840.84439.166.4641.4339.746.44
2286437-28643738.21038.78
3277875-27787537.06837.62
4277574-27757437.02837.58
5325883-32588343.47344.11
6287375-28737538.33638.90
20min1344548-34454845.96244.166.5847.0145.176.57
2323942-32394243.21444.21
3313463-31346341.81642.78
4309514-30951441.28942.25
5367728-36772849.05550.18
6326971-32697143.61844.61
30min1411642-41164254.91351.787.2056.4753.287.17
2382403-38240351.01252.48
3365064-36506448.69950.13
4356340-35634047.53548.96
5429939-42993957.35359.02
6383458-38345851.15352.63
45min1495235-49523566.06459.438.8268.2361.518.72
2427730-42773057.05959.10
3415302-41530255.40157.37
4399604-39960453.30755.26
5489043-48904365.23867.54
6446050-44605059.50361.55
60min1548957-54895773.23064.3510.4476.1367.0910.28
2462741-46274161.72964.40
3440476-44047658.75961.34
4423793-42379356.53459.08
5534015-53401571.23774.27
6484345-48434564.61167.32
90min1596955-59695579.63368.9410.8683.3572.3910.68
2493489-49348965.83169.19
3465897-46589762.15065.39
4456376-45637660.88064.05
5566786-56678675.60979.43
6521165-52116569.52372.95
极限1601789-60178980.27875.054.8984.8879.275.05
2557881-55788174.42178.51
3532937-53293771.09375.02
4534664-53466471.32475.17
5586191-58619178.19782.86
6562181-56218174.99479.19
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