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2500
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%
117.833952583951523950633946683951643950610.06
217.893945633948013946820.05
单位质量响应值RSD%判断
22157.0922061.600.31数据可信
供试品溶液-24073101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%
5min1115697-115697105.728103.591.61105.73103.591.61
2113131-113131103.383103.38
3113104-113104103.358103.36
4112800-112800103.080103.08
5114929-114929105.026105.03
6110490-110490100.969100.97
10min1116183-116183106.172103.411.97107.35104.561.96
2112197-112197102.529103.68
3113261-113261103.502104.65
4112011-112011102.359103.50
5115163-115163105.240106.41
6110123-110123100.634101.76
15min1113895-113895104.081101.821.67106.44104.121.67
2110247-110247100.747103.04
3110873-110873101.319103.62
4110948-110948101.388103.67
5113398-113398103.627105.96
6109132-10913299.728101.97
20min1109472-109472100.039100.272.04103.55103.702.01
2108295-10829598.964102.37
3111090-111090101.518104.94
4110200-110200100.704104.11
5112866-112866103.141106.63
6106417-10641797.247100.60
30min1111415-111415101.81599.941.87106.44104.491.86
2108170-10817098.849103.36
3109675-109675100.225104.78
4109414-10941499.986104.51
5111439-111439101.837106.47
6106080-10608096.939101.37
45min1109561-109561100.12097.991.37105.87103.641.37
2107667-10766798.390103.99
3106736-10673697.539103.20
4107081-10708197.854103.49
5107306-10730698.060103.82
6105023-10502395.973101.48
60min1107958-10795898.65696.771.83105.52103.521.78
2107279-10727998.035104.73
3106013-10601396.878103.63
4103063-10306394.182100.91
5106995-10699597.776104.63
6104064-10406495.097101.67
90min1106545-10654597.36496.091.86105.33103.921.83
2104116-10411695.145102.93
3106649-10664997.459105.29
4103791-10379194.848102.62
5107340-10734098.091106.03
6102488-10248893.657101.29
极限1104533-10453395.52694.902.53104.57103.792.41
2102983-10298394.109102.95
3101605-10160592.850101.76
4104253-10425395.270104.10
5108462-10846299.116108.15
6101253-10125392.528101.20
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(%)91.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.8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%
116.193943913942973943583942193942873943100.02
216.173939643943573941600.08
单位质量响应值RSD%判断
24355.1624376.000.07数据可信
供试品溶液-24073101批-叶酸-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%
5min138093-3809332.08132.504.2332.0832.504.24
235615-3561529.99429.99
340274-4027433.91833.92
438862-3886232.72832.73
539649-3964933.39133.39
639026-3902632.86732.87
10min157976-5797648.82649.656.9349.1850.016.92
252088-5208843.86744.20
363112-6311253.15153.53
458039-5803948.87949.24
563074-6307453.11953.49
659451-5945150.06850.43
15min166172-6617255.72856.867.7256.6357.777.68
259133-5913349.80050.62
372123-7212360.74061.71
465959-6595955.54956.46
573812-7381262.16263.12
667872-6787257.16058.08
20min169281-6928158.34660.238.3059.8661.778.25
262396-6239652.54853.92
377634-7763465.38167.02
470580-7058059.44060.96
578501-7850166.11167.76
670698-7069859.54061.10
30min174656-7465662.87363.887.6665.0466.097.64
266513-6651356.01557.97
380791-8079168.04070.41
474491-7449162.73464.92
583165-8316570.03972.43
675460-7546063.55065.77
45min176092-7609264.08366.734.2966.9569.654.18
282276-8227669.29171.87
381853-8185368.93472.06
475712-7571263.76366.64
582796-8279669.72872.89
676674-7667464.57367.50
60min176852-7685264.72366.854.5568.3070.524.54
279165-7916566.67170.02
383117-8311769.99973.89
474939-7493963.11266.70
584187-8418770.90074.84
678006-7800665.69469.34
90min177175-7717564.99566.477.5369.2970.877.40
269914-6991458.88062.97
385013-8501371.59676.26
476455-7645564.38868.68
585920-8592072.35977.09
679055-7905566.57870.95
极限189709-8970975.55076.773.6180.5781.923.70
286282-8628272.66477.41
391940-9194077.42982.89
492021-9202177.49782.50
596311-9631181.11086.64
690685-9068576.37281.48
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2500
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%
117.833949413948043949333946823949293948580.03
217.893952043950743951390.03
单位质量响应值RSD%判断
22145.7122087.140.19数据可信
供试品溶液-24073101批-左氨氯地平-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%
5min1114103-114103104.237102.831.23104.24102.831.23
2110917-110917101.327101.33
3110836-110836101.253101.25
4113510-113510103.696103.70
5112690-112690102.947102.95
6113293-113293103.497103.50
10min1113753-113753103.918103.021.26105.08104.161.26
2111633-111633101.981103.11
3110937-110937101.345102.47
4113098-113098103.319104.47
5112358-112358102.643103.79
6114817-114817104.890106.04
15min1112713-112713102.968101.671.17105.28103.961.17
2109427-10942799.966102.22
3110298-110298100.761103.01
4111409-111409101.776104.08
5111219-111219101.603103.89
6112679-112679102.936105.25
20min1111401-111401101.769100.481.34105.23103.901.33
2107767-10776798.449101.82
3109444-10944499.981103.35
4111015-111015101.416104.85
5109050-10905099.621103.03
6111285-111285101.663105.12
30min1110659-110659101.09199.361.35105.68103.891.34
2107242-10724297.970102.43
3107556-10755698.256102.74
4109812-109812100.317104.88
5107591-10759198.288102.81
6109719-109719100.232104.82
45min1107106-10710697.84597.411.09103.56103.051.08
2104939-10493995.866101.42
3106454-10645497.250102.82
4108056-10805698.713104.39
5105754-10575496.610102.22
6107496-10749698.202103.90
60min1108507-10850799.12596.931.88105.92103.651.83
2103753-10375394.782101.40
3105068-10506895.984102.64
4108377-10837799.006105.78
5104600-10460095.556102.24
6106326-10632697.133103.93
90min1105582-10558296.45396.190.98104.35103.980.99
2104280-10428095.264102.93
3104061-10406195.064102.78
4105674-10567496.537104.41
5105256-10525696.155103.90
6106890-10689097.648105.52
极限1105061-10506195.97794.671.19104.95103.541.18
2102546-10254693.680102.41
3102118-10211893.289102.07
4104230-10423095.218104.16
5103053-10305394.143102.96
6104776-10477695.717104.67
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(%)91.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.8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%
116.193956303950303951843954503946513951890.10
216.173944103945763944930.03
单位质量响应值RSD%判断
24409.4524396.600.04数据可信
供试品溶液-24073101批-叶酸-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%
5min153957-5395745.37144.851.9945.3744.851.99
252150-5215043.85243.85
352696-5269644.31144.31
454962-5496246.21646.22
553727-5372745.17845.18
652556-5255644.19344.19
10min175665-7566563.62563.372.4464.1363.872.43
272865-7286561.27161.76
374391-7439162.55463.05
478443-7844365.96166.47
575534-7553463.51564.02
675280-7528063.30163.79
15min185089-8508971.55070.353.2772.7671.553.24
279878-7987867.16868.34
382568-8256869.43070.62
487750-8775073.78775.03
584523-8452371.07472.28
682172-8217269.09770.29
20min188693-8869374.58073.213.9076.5975.203.86
282071-8207169.01270.93
386266-8626672.53974.50
492199-9219977.52879.59
587690-8769073.73775.73
685475-8547571.87473.84
30min192235-9223577.55975.723.9680.3978.513.92
285053-8505371.51974.20
388606-8860674.50777.27
495407-9540780.22683.15
590553-9055376.14478.96
688415-8841574.34677.11
45min195936-9593680.67177.893.9984.3781.533.95
288083-8808374.06777.54
391278-9127876.75480.35
498012-9801282.41686.24
592121-9212177.46381.13
690317-9031775.94679.53
60min1104538-10453887.90481.866.3692.5086.376.19
291146-9114676.64380.94
393770-9377078.84983.29
4104400-10440087.78892.52
598931-9893183.18987.71
691343-9134376.80881.24
90min1108167-10816790.95587.424.7796.5292.834.69
2100950-10095084.88790.04
3102428-10242886.13091.45
4110055-11005592.54398.25
5105563-10556388.76694.21
696603-9660381.23186.52
极限1110125-11012592.60289.143.5299.1895.533.53
2102905-10290586.53192.62
3105190-10519088.45294.73
4110287-11028792.73899.48
5106403-10640389.47295.91
6101153-10115385.05791.24
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