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%
110.372228012230732234092220692228572228420.23
210.372220352221692221020.05
单位质量响应值RSD%判断
21489.1021417.740.24数据可信
供试品溶液-AM221354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%
5min130817-3081723.58120.6712.0823.5820.6712.08
230119-3011923.04723.05
324845-2484519.01119.01
425973-2597319.87419.87
528005-2800521.42921.43
622295-2229517.06017.06
10min147307-4730736.19936.952.5436.4637.182.53
249404-4940437.80438.06
346606-4660635.66335.87
447776-4777636.55836.78
549249-4924937.68537.92
649424-4942437.81938.01
15min167656-6765651.77052.621.7752.4353.261.77
269527-6952753.20253.88
367234-6723451.44752.05
468924-6892452.74053.37
570539-7053953.97654.63
668684-6868452.55753.17
20min181164-8116462.10663.471.9163.3564.701.91
283494-8349463.88965.16
382090-8209062.81563.99
483319-8331963.75564.97
585640-8564065.53166.79
681994-8199462.74163.94
30min196827-9682774.09275.842.0576.0277.772.02
298487-9848775.36277.34
397683-9768374.74776.62
499176-9917675.88977.81
5102610-10261078.51780.50
699899-9989976.44278.33
45min1110174-11017484.30584.981.4287.0687.761.40
2109358-10935883.68086.49
3109716-10971683.95486.66
4111796-11179685.54688.31
5113406-11340686.77889.63
6111917-11191785.63888.38
60min1112482-11248286.07187.781.3789.7691.491.35
2113475-11347586.83090.57
3114494-11449487.61091.25
4115057-11505788.04191.76
5116589-11658989.21393.03
6116177-11617788.89892.59
90min1119983-11998391.81092.031.1896.4696.731.18
2118948-11894891.01895.73
3118467-11846790.65095.26
4120858-12085892.48097.17
5122196-12219693.50498.32
6121198-12119892.74097.42
极限1119857-11985791.71491.340.9997.3897.060.91
2117424-11742489.85295.57
3119685-11968591.58297.20
4119382-11938291.35097.07
5118913-11891390.99296.84
6120961-12096192.55998.27
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%
110.372210472213892211772210002210152211260.08
210.372198822202952200880.14
单位质量响应值RSD%判断
21323.6321223.530.34数据可信
供试品溶液-AM221354批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111698-116989.0278.575.269.038.575.27
211626-116268.9718.97
310957-109578.4558.46
410677-106778.2398.24
511425-114258.8168.82
610227-102277.8927.89
10min119117-1911714.75214.994.1814.8515.094.19
220074-2007415.49015.59
320026-2002615.45315.55
418985-1898514.65014.74
520218-2021815.60215.70
618163-1816314.01614.10
15min127059-2705920.88121.653.6021.1421.913.60
228388-2838821.90622.18
328587-2858722.06022.33
428634-2863422.09622.35
529091-2909122.44922.72
626542-2654220.48220.72
20min133639-3363925.95827.123.5626.4527.623.56
235792-3579227.61928.13
335579-3557927.45527.97
435731-3573127.57228.07
536579-3657928.22728.75
633549-3354925.88926.36
30min143241-4324133.36835.153.5234.1535.953.51
245930-4593035.44336.26
346455-4645535.84836.66
446347-4634735.76436.57
547365-4736536.55037.38
643934-4393433.90234.66
45min154166-5416641.79843.673.4542.9544.863.44
256538-5653843.62844.84
356371-5637143.50044.71
457882-5788244.66645.87
559579-5957945.97547.22
655018-5501842.45643.59
60min161699-6169947.61149.812.8649.2351.492.86
264577-6457749.83251.53
365413-6541350.47752.17
465319-6531950.40452.10
566978-6697851.68553.44
663297-6329748.84450.45
90min171560-7156055.22057.823.1257.3760.053.12
274772-7477257.69959.95
376342-7634258.91161.17
476068-7606858.69960.96
577873-7787360.09262.42
672937-7293756.28358.43
极限175398-7539858.18259.992.2960.9462.862.31
276381-7638158.94161.84
379002-7900260.96363.88
478274-7827460.40163.31
580236-8023661.91564.91
677119-7711959.51062.29
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%
110.372197342197622197722200692196362197950.08
210.372189362187732188540.06
单位质量响应值RSD%判断
21195.2721104.530.31数据可信
供试品溶液-AM221354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%
5min133797-3379726.23227.318.2026.2327.318.21
233830-3383026.25826.26
335285-3528527.38727.39
433220-3322025.78525.78
534059-3405926.43626.44
640904-4090431.74931.75
10min158144-5814445.13045.173.3445.4245.483.35
255414-5541443.01143.30
360435-6043546.90847.21
457824-5782444.88245.17
557039-5703944.27244.57
660338-6033846.83347.19
15min179061-7906161.36562.172.5862.1662.982.58
276901-7690159.68960.46
383023-8302364.44165.27
481219-8121963.04063.83
579858-7985861.98462.77
680526-8052662.50263.38
20min193416-9341672.50773.671.8473.9875.161.84
292255-9225571.60673.04
395838-9583874.38775.93
496981-9698175.27476.76
595424-9542474.06675.54
695560-9556074.17275.74
30min1108647-10864784.32985.121.4786.6187.441.48
2106853-10685382.93785.17
3110750-11075085.96288.33
4110841-11084186.03288.35
5110274-11027485.59287.89
6110650-11065085.88488.28
45min1115328-11532889.51591.791.5792.7395.051.57
2116634-11663490.52993.68
3119607-11960792.83696.16
4119083-11908392.43095.71
5120011-12001193.15096.40
6118906-11890692.29295.64
60min1118428-11842891.92194.121.2496.1398.401.24
2121089-12108993.98798.14
3121300-12130094.15098.50
4122160-12216094.81899.12
5121975-12197594.67498.96
6122641-12264195.19199.56
90min1121003-12100393.92095.751.2899.15101.071.29
2121946-12194694.65299.85
3125122-12512297.117102.52
4124391-12439196.549101.91
5123605-12360595.939101.27
6124085-12408596.312101.74
极限1120350-12035093.41394.820.9499.69101.200.97
2121148-12114894.032100.28
3122987-12298795.460101.94
4123216-12321695.637102.07
5122578-12257895.142101.54
6122663-12266395.208101.71
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