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%
110.171002161002021000991002121002241001910.06
210.12100054999711000120.06
单位质量响应值RSD%判断
9851.629882.610.23数据可信
供试品溶液-23FA175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%
5min114854-1485424.71323.4219.7724.7123.4219.77
214479-1447924.08924.09
38488-848814.12214.12
415367-1536725.56625.57
515919-1591926.48526.48
615368-1536825.56825.57
10min125810-2581042.94044.112.9043.2244.372.85
225552-2555242.51142.78
327197-2719745.24845.40
426747-2674744.49944.78
527489-2748945.73446.03
626292-2629243.74244.03
15min131864-3186453.01354.182.4053.7654.932.39
231735-3173552.79853.54
333035-3303554.96155.62
432795-3279554.56155.34
533773-3377356.18956.99
632195-3219553.56354.33
20min135284-3528458.70260.002.2260.0461.352.21
235435-3543558.95460.28
336379-3637960.52461.79
435964-3596459.83461.22
537485-3748562.36463.79
635837-3583759.62260.99
30min139151-3915165.13665.192.2367.1367.202.17
237682-3768262.69264.67
339775-3977566.17468.12
439401-3940165.55267.60
538869-3886964.66766.79
640205-4020566.89068.92
45min141512-4151269.06469.941.5371.7872.681.53
241719-4171969.40872.09
341966-4196669.81972.50
441598-4159869.20771.99
543244-4324471.94674.78
642193-4219370.19772.97
60min142190-4219070.19271.521.5773.6875.041.59
242780-4278071.17474.62
342526-4252670.75174.20
443174-4317471.82975.38
544141-4414173.43877.08
643114-4311471.72975.28
90min143852-4385272.95773.641.6077.2277.961.60
244125-4412573.41177.65
344173-4417373.49177.73
444085-4408573.34577.69
545659-4565975.96380.42
643687-4368772.68377.03
极限144339-4433973.76774.310.6078.8479.440.66
244767-4476774.47979.54
344465-4446573.97779.03
444588-4458874.18279.34
545098-4509875.03080.33
644727-4472774.41379.57
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%
110.171001071001111000591000461000571000760.04
210.129981699781997980.03
单位质量响应值RSD%判断
9840.319861.460.16数据可信
供试品溶液-23FA175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%
5min116569-1656927.61128.282.3727.6128.282.37
217696-1769629.49029.49
316795-1679527.98827.99
417061-1706128.43128.43
517010-1701028.34628.35
616689-1668927.81127.81
10min127084-2708445.13445.972.1645.4446.292.15
228135-2813546.88647.21
328182-2818246.96447.27
428009-2800946.67646.99
526806-2680644.67144.99
627310-2731045.51145.82
15min132754-3275454.58355.100.7355.3955.930.74
233234-3323455.38356.23
333242-3324255.39656.23
433219-3321955.35856.19
532765-3276554.60155.41
633179-3317955.29156.11
20min136450-3645060.74261.293.7062.1662.733.64
239299-3929965.49066.95
336964-3696461.59963.05
436535-3653560.88462.33
535269-3526958.77460.19
636158-3615860.25661.68
30min139490-3949065.80865.801.7567.9067.921.74
239940-3994066.55868.75
339763-3976366.26368.40
440200-4020066.99169.12
538241-3824163.72765.80
639292-3929265.47867.58
45min141415-4141569.01668.971.6071.8471.821.59
241855-4185569.74972.68
341042-4104268.39471.26
442220-4222070.35873.23
540315-4031567.18369.96
641461-4146169.09371.92
60min140954-4095468.24870.772.3571.8474.392.29
242854-4285471.41475.12
343244-4324472.06475.69
443235-4323572.04975.70
541476-4147669.11872.64
643048-4304871.73775.33
90min144726-4472674.53473.771.9778.8878.181.91
244152-4415273.57778.08
345054-4505475.08079.51
444162-4416273.59478.05
542658-4265871.08775.38
644866-4486674.76779.16
极限144915-4491574.84974.761.9180.0279.981.86
244671-4467174.44279.76
345850-4585076.40781.67
445337-4533775.55280.82
543323-4332372.19677.28
645079-4507975.12280.34
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%
110.172507842511002510572509062510362509770.06
210.122496952490382493660.19
单位质量响应值RSD%判断
24678.1724640.910.11数据可信
供试品溶液-AM222092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%
5min135870-3587023.87923.136.0623.8823.136.06
231092-3109220.69820.70
336441-3644124.25924.26
434151-3415122.73522.73
536729-3672924.45124.45
634177-3417722.75222.75
10min159356-5935639.51439.213.6339.7839.473.61
260733-6073340.43040.66
360625-6062540.35840.63
455307-5530736.81837.07
559986-5998639.93340.20
657420-5742038.22538.48
15min179256-7925652.76153.122.6053.4753.822.57
282726-8272655.07155.75
380725-8072553.73954.46
480124-8012453.33954.00
579541-7954152.95153.67
676397-7639750.85851.54
20min195253-9525363.41162.712.6364.7063.992.60
297163-9716364.68265.97
395670-9567063.68865.00
494484-9448462.89964.15
592202-9220261.37962.68
690406-9040660.18461.43
30min1113833-11383375.77975.042.4277.7777.022.40
2115987-11598777.21379.22
3114582-11458276.27878.30
4112578-11257874.94476.90
5110925-11092573.84375.83
6108434-10843472.18574.10
45min1127648-12764884.97684.631.8887.8187.441.87
2129676-12967686.32689.19
3128042-12804285.23888.11
4128491-12849185.53788.32
5125973-12597383.86186.67
6122948-12294881.84784.56
60min1133751-13375189.03988.461.6592.8292.211.66
2134383-13438389.46093.29
3133719-13371989.01892.83
4133428-13342888.82492.56
5133532-13353288.89392.63
6128463-12846385.51989.14
90min1132609-13260988.27990.291.8493.0595.021.80
2138734-13873492.35697.18
3136916-13691691.14695.95
4134409-13440989.47794.20
5137681-13768191.65596.38
6133421-13342188.81993.39
极限1136569-13656990.91590.631.3596.6796.371.34
2135238-13523890.02995.88
3136882-13688291.12396.94
4137811-13781191.74297.46
5137491-13749191.52997.27
6132868-13286888.45194.01
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%
110.172516682513962513342512802512462513850.07
210.122506512509182507840.08
单位质量响应值RSD%判断
24718.2924781.030.18数据可信
供试品溶液-AM222092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%
5min136293-3629324.07323.567.1824.0723.567.19
236349-3634924.11024.11
337365-3736524.78424.78
430385-3038520.15420.15
536503-3650324.21224.21
636192-3619224.00624.01
10min160531-6053140.14939.432.4040.4239.692.37
258808-5880839.00639.27
360767-6076740.30640.58
460709-6070940.26740.49
558536-5853638.82639.09
657353-5735338.04138.31
15min177908-7790851.67551.232.1552.3951.932.12
276060-7606050.44951.15
378693-7869352.19652.92
479342-7934252.62653.30
576229-7622950.56151.26
675163-7516349.85450.54
20min192178-9217861.14060.442.1062.4361.712.07
289909-8990959.63560.90
391796-9179660.88762.19
494053-9405362.38463.64
588809-8880958.90560.17
689983-8998359.68460.93
30min1109365-10936572.54072.442.4474.5174.382.41
2107665-10766571.41273.34
3111438-11143873.91575.89
4113234-11323475.10677.06
5106494-10649470.63672.55
6107104-10710471.04072.95
45min1121802-12180280.78981.673.0483.5684.422.99
2122580-12258081.30584.02
3127478-12747884.55487.35
4127301-12730184.43787.22
5122022-12202280.93583.64
6117618-11761878.01480.71
60min1130720-13072086.70486.192.3390.3889.842.32
2128316-12831685.11088.73
3133268-13326888.39492.13
4133453-13345388.51792.24
5127692-12769284.69688.30
6126188-12618883.69887.26
90min1134855-13485589.44790.282.3594.0894.892.33
2134404-13440489.14893.71
3139912-13991292.80197.52
4140306-14030693.06397.77
5134592-13459289.27393.81
6132623-13262387.96792.46
极限1134837-13483789.43589.841.6195.0695.461.62
2134179-13417988.99994.56
3138754-13875492.03397.79
4137518-13751891.21396.95
5133281-13328188.40393.94
6134150-13415088.97994.45
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