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10000
标示量(mg)1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%
110.252428822432912428512428522429192429590.08
210.162410922408922409920.06
单位质量响应值RSD%判断
23703.3223719.690.05数据可信
供试品溶液-24072201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%
5min147020-4702032.55332.572.6532.5532.572.65
248856-4885633.82433.82
347487-4748732.87632.88
445995-4599531.84331.84
547562-4756232.92832.93
645340-4534031.39031.39
10min176658-7665853.07252.901.7353.4353.271.74
278288-7828854.20154.58
376688-7668853.09353.46
476137-7613752.71153.07
576528-7652852.98253.35
674180-7418051.35651.71
15min193637-9363764.82763.821.7865.7864.771.79
294019-9401965.09166.07
391689-9168963.47864.43
491583-9158363.40564.34
592645-9264564.14065.09
689511-8951161.97062.89
20min1103148-10314871.41270.251.2373.0871.911.23
2102286-10228670.81572.52
3101453-10145370.23871.90
4101145-10114570.02571.67
5101325-10132570.15071.82
699445-9944568.84870.46
30min1112897-11289778.16177.061.4780.6379.501.47
2112749-11274978.05980.55
3111274-11127477.03779.48
4110347-11034776.39678.82
5111930-11193077.49279.94
6108601-10860175.18777.56
45min1118043-11804381.72480.471.7285.0683.771.72
2118621-11862182.12485.48
3116491-11649180.64983.95
4114714-11471479.41982.69
5116217-11621780.46083.77
6113305-11330578.44481.65
60min1120135-12013583.17281.571.5187.4185.761.51
2119055-11905582.42486.69
3117074-11707481.05385.25
4117759-11775981.52785.68
5117997-11799781.69285.89
6114932-11493279.57083.65
90min1121501-12150184.11882.831.0789.2887.921.08
2119608-11960882.80787.99
3120013-12001383.08888.18
4119556-11955682.77187.83
5119629-11962982.82287.93
6117534-11753481.37186.34
极限1120104-12010483.15182.911.0189.2588.921.02
2120378-12037883.34089.44
3119248-11924882.55888.57
4120392-12039283.35089.33
5120848-12084883.66689.70
6117545-11754581.37987.25
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10000
标示量(mg)1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%
110.252424412423102422362423712405962419910.33
210.162412622410082411350.08
单位质量响应值RSD%判断
23608.8823733.760.38数据可信
供试品溶液-24072202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%
5min149253-4925334.15733.924.8734.1633.924.87
249896-4989634.60334.60
352308-5230836.27636.28
448763-4876333.81733.82
545014-4501431.21731.22
648201-4820133.42833.43
10min176302-7630252.91652.373.1153.3052.753.13
276817-7681753.27353.66
377522-7752253.76254.16
476048-7604852.73953.12
570940-7094049.19749.54
675478-7547852.34452.72
15min191466-9146663.43262.282.7464.4063.242.75
291633-9163363.54864.52
391747-9174763.62764.63
488907-8890761.65762.62
585387-8538759.21660.11
689693-8969362.20263.16
20min1101255-10125570.22168.403.1971.8970.053.17
2101963-10196370.71272.39
398292-9829268.16669.87
498986-9898668.64770.29
593078-9307864.55066.10
698210-9821068.10969.75
30min1109801-10980176.14775.012.5078.6077.422.52
2110719-11071976.78479.25
3108485-10848575.23577.70
4108392-10839275.17077.58
5102978-10297871.41573.68
6108576-10857675.29877.70
45min1116486-11648680.78379.292.0584.0882.532.08
2116250-11625080.62083.94
3115632-11563280.19183.49
4113893-11389378.98582.23
5110295-11029576.49079.55
6113410-11341078.65081.89
60min1116795-11679580.99880.251.8685.1984.381.90
2118125-11812581.92086.14
3116952-11695281.10685.30
4116044-11604480.47784.60
5112225-11222577.82881.74
6114193-11419379.19383.30
90min1118291-11829182.03581.621.6487.1386.641.68
2120605-12060583.64088.77
3118338-11833882.06887.16
4116747-11674780.96485.98
5114815-11481579.62484.40
6117372-11737281.39886.39
极限1118957-11895782.49782.231.0288.5088.161.11
2120268-12026883.40689.46
3119009-11900982.53388.54
4118756-11875682.35888.27
5116742-11674280.96186.62
6117737-11773781.65187.55
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10000
标示量(mg)1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%
110.252418002414192415792411562411462414200.12
210.162399512399432399470.01
单位质量响应值RSD%判断
23553.1723616.830.20数据可信
供试品溶液-24072203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%
5min147445-4744533.02332.784.3233.0232.784.32
248648-4864833.86133.86
348859-4885934.00834.01
445946-4594631.98031.98
548122-4812233.49533.49
643548-4354830.31130.31
10min176292-7629253.10253.251.5453.4753.621.56
277614-7761454.02254.40
378094-7809454.35654.73
475773-7577352.74153.10
576396-7639653.17453.55
674897-7489752.13152.47
15min192621-9262164.46864.590.6865.4265.540.69
292516-9251664.39565.37
393682-9368265.20666.19
492134-9213464.12965.07
593449-9344965.04466.01
692374-9237464.29665.21
20min1102924-10292471.63971.510.2173.3173.180.21
2102708-10270871.48973.18
3102682-10268271.47073.18
4102360-10236071.24672.90
5102901-10290171.62373.31
6102819-10281971.56673.20
30min1111729-11172977.76877.620.5480.2480.090.52
2111707-11170777.75280.24
3111173-11117377.38179.88
4110491-11049176.90679.35
5111859-11185977.85880.34
6112136-11213678.05180.48
45min1116538-11653881.11580.820.5484.4584.150.52
2115298-11529880.25283.60
3116425-11642581.03684.40
4115344-11534480.28483.58
5116468-11646881.06684.41
6116624-11662481.17584.47
60min1118532-11853282.50382.150.5386.7486.380.50
2117347-11734781.67885.92
3117505-11750581.78886.05
4118169-11816982.25086.44
5118897-11889782.75787.00
6117679-11767981.90986.10
90min1119575-11957583.22983.220.8088.3888.370.75
2118911-11891182.76687.92
3119071-11907182.87888.05
4118697-11869782.61787.72
5119859-11985983.42688.59
6121304-12130484.43289.54
极限1119843-11984383.41582.820.7589.4988.890.72
2117997-11799782.13088.20
3119602-11960283.24789.34
4119054-11905482.86688.89
5119654-11965483.28489.38
6117808-11780881.99988.04
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10000
标示量(mg)1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%
110.252404722400582401982396502404012401560.14
210.162389402386062387730.10
单位质量响应值RSD%判断
23429.8523501.280.22数据可信
供试品溶液-24072204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%
5min146288-4628832.38232.291.7532.3832.291.74
246927-4692732.82932.83
345567-4556731.87831.88
444898-4489831.41031.41
546976-4697632.86332.86
646286-4628632.38132.38
10min174085-7408551.82852.311.5452.1952.671.54
275768-7576853.00653.37
373311-7331151.28751.64
473889-7388951.69152.04
576045-7604553.20053.56
675539-7553952.84653.21
15min191648-9164864.11563.851.6965.0564.781.69
291808-9180864.22765.18
388482-8848261.90062.82
490780-9078063.50864.43
593032-9303265.08366.04
691833-9183364.24565.19
20min1100353-10035370.20569.892.1671.8571.542.14
2101053-10105370.69572.36
395689-9568966.94268.55
499877-9987769.87271.50
5101655-10165571.11672.80
6100787-10078770.50972.17
30min1110403-11040377.23677.212.1779.6679.632.14
2109720-10972076.75879.21
3107555-10755575.24377.60
4108478-10847875.88978.29
5114145-11414579.85482.32
6111892-11189278.27780.72
45min1117344-11734482.09281.971.3185.3885.251.33
2116398-11639881.43084.74
3115010-11501080.45983.65
4116577-11657781.55584.80
5119385-11938583.51986.88
6118279-11827982.74686.06
60min1119352-11935283.49683.431.5387.6987.621.54
2119623-11962383.68687.90
3116726-11672681.65985.74
4117680-11768082.32786.48
5121769-12176985.18789.47
6120374-12037484.21188.44
90min1120057-12005783.98984.631.7889.1289.761.77
2120833-12083384.53289.67
3118736-11873683.06588.06
4119564-11956483.64588.71
5124767-12476787.28492.52
6121904-12190485.28290.45
极限1120935-12093584.60484.171.9190.6690.231.88
2120309-12030984.16690.25
3118226-11822682.70988.62
4117196-11719681.98887.99
5123437-12343786.35492.56
6121768-12176885.18691.30
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