左氨氯地平叶酸片项目信息
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(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.431973991971461973641972691971211972600.07
217.49 1966321971121968720.18
单位质量响应值RSD%判断
11317.2711256.260.39数据可信
供试品溶液-24071201批-左氨氯地平-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%
5min1107694-10769496.391100.383.1796.39100.383.17
2112233-112233100.453100.45
3109910-10991098.37498.37
4118301-118301105.885105.88
5112046-112046100.286100.29
6112698-112698100.870100.87
10min1110867-11086799.23199.560.51100.30100.680.50
2110924-11092499.282100.40
3112099-112099100.334101.43
4111172-11117299.504100.68
5110655-11065599.041100.16
6111716-11171699.991101.11
15min1110067-11006798.51597.791.25100.69100.021.21
2107083-10708395.84498.06
3110350-11035098.768100.98
4108457-10845797.07499.36
5108949-10894997.51499.73
6110659-11065999.045101.28
20min1109646-10964698.13896.600.92101.4199.910.88
2106827-10682795.61598.90
3108032-10803296.693100.00
4107109-10710995.86799.23
5107807-10780796.49299.79
6108139-10813996.789100.12
30min1105827-10582794.72094.680.3899.0899.060.39
2105603-10560394.51998.87
3105671-10567194.58098.96
4106329-10632995.16999.60
5105181-10518194.14298.51
6106093-10609394.95899.37
45min1106512-10651295.33394.600.68100.74100.040.64
2105269-10526994.22099.62
3104731-10473193.73999.17
4105298-10529894.24699.73
5106437-10643795.266100.68
6105939-10593994.820100.28
60min1104450-10445093.48793.390.9999.9699.870.93
2104765-10476593.769100.21
3102434-10243491.68398.16
4105296-10529694.245100.78
5105006-10500693.985100.46
6104072-10407293.14999.67
90min1102818-10281892.02792.230.6999.5499.750.65
2103367-10336792.518100.00
3102107-10210791.39098.88
4103497-10349792.634100.21
5104009-10400993.093100.61
6102456-10245691.70399.25
极限1101999-10199991.29491.310.6399.8399.860.60
2101628-10162890.96299.48
3101232-10123290.60799.11
4102079-10207991.36599.97
5103150-10315092.324100.88
6102039-10203991.32999.90
左氨氯地平叶酸片项目信息
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(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.431971281970461974891970061971071971550.10
217.49 1967141974041970590.25
单位质量响应值RSD%判断
11311.2411266.950.28数据可信
供试品溶液-24071202批-左氨氯地平-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%
5min1112306-112306100.49898.731.67100.5098.731.67
2110845-11084599.19099.19
3111051-11105199.37599.37
4111108-11110899.42699.43
5109649-10964998.12098.12
6107009-10700995.75895.76
10min1110291-11029198.69598.131.0299.8199.231.03
2109717-10971798.18199.28
3110547-11054798.924100.03
4110451-11045198.83899.94
5109383-10938397.88298.97
6107577-10757796.26697.33
15min1109176-10917697.69796.461.4299.9198.641.41
2109461-10946197.952100.14
3107730-10773096.40398.61
4107944-10794496.59498.80
5107207-10720795.93598.11
6105236-10523694.17196.30
20min1107060-10706095.80395.451.4799.1098.711.46
2106579-10657995.37398.65
3108917-10891797.465100.74
4107080-10708095.82199.10
5106269-10626995.09598.34
6104083-10408393.13996.32
30min1105683-10568394.57194.350.9398.9398.670.93
2105853-10585394.72399.06
3106965-10696595.718100.08
4105270-10527094.20198.54
5104573-10457393.57897.88
6104268-10426893.30597.52
45min1105854-10585494.72493.861.80100.1499.221.76
2107439-10743996.142101.54
3105640-10564094.53399.95
4104255-10425593.29398.68
5104194-10419493.23998.58
6101922-10192291.20596.46
60min1103684-10368492.78292.720.8299.2599.130.81
2104810-10481093.790100.25
3103814-10381492.89999.37
4103783-10378392.87199.29
5102177-10217791.43497.81
6103424-10342492.55098.81
90min1102248-10224891.49791.012.0998.9998.442.01
2103076-10307692.23899.74
3104551-10455193.558101.06
4101428-10142890.76398.22
5100409-10040989.85297.24
698484-9848488.12995.42
极限1102007-10200791.28290.331.2999.8098.791.28
2102031-10203191.30399.83
3101013-10101390.39298.94
4101527-10152790.85299.32
5100529-10052989.95998.35
698582-9858288.21796.49
左氨氯地平叶酸片项目信息
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(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.431970311970011972181973431966981970580.13
217.49 1973751969561971660.16
单位质量响应值RSD%判断
11305.6811273.070.21数据可信
供试品溶液-24071203批-左氨氯地平-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%
5min1109261-10926197.77098.871.5097.7798.881.50
2110308-11030898.70798.71
3112922-112922101.046101.05
4111797-111797100.040100.04
5108379-10837996.98196.98
6110304-11030498.70498.70
10min1110895-11089599.23298.961.48100.32100.061.48
2109754-10975498.21199.31
3112323-112323100.510101.63
4112485-112485100.655101.77
5108311-10831196.92098.00
6109750-10975098.20899.30
15min1109288-10928897.79497.831.1499.98100.031.13
2109034-10903497.56799.76
3110075-11007598.499100.74
4110954-11095499.285101.52
5109353-10935397.853100.01
6107237-10723795.95998.15
20min1106899-10689995.65796.611.3998.9399.891.38
2107726-10772696.39799.67
3108775-10877597.335100.67
4110509-11050998.887102.22
5106337-10633795.15498.40
6107522-10752296.21499.47
30min1105758-10575894.63695.481.5098.9799.831.48
2106003-10600394.85599.20
3108111-10811196.741101.16
4108044-10804496.681101.11
5104262-10426293.29797.60
6107999-10799996.641100.96
45min1104096-10409693.14895.392.1498.54100.822.04
2108671-10867197.242102.64
3106009-10600994.860100.35
4107182-10718295.910101.42
5104149-10414993.19698.53
6109528-10952898.009103.41
60min1104082-10408293.13693.041.5099.5699.521.45
2103442-10344292.56399.04
3105533-10553394.434100.98
4106010-10601094.861101.43
5102748-10274891.94298.31
6102063-10206391.32997.82
90min1102098-10209891.36191.451.6498.8298.961.59
2102384-10238491.61699.12
3103033-10303392.19799.79
4104717-10471793.704101.33
599805-9980589.30996.70
6101146-10114690.50998.01
极限1101122-10112290.48790.671.7298.9699.201.66
299423-9942388.96797.49
3102848-10284892.032100.65
4103909-10390992.981101.65
599878-9987889.37497.76
6100780-10078090.18198.69
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