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100546-202105 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%
117.16 1888341887341888551886451886551887450.06
217.031884101883031883560.05
单位质量响应值RSD%判断
10999.1311060.250.40数据可信
供试品溶液-24060601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%
5min1110991-110991101.65799.401.84101.6699.401.84
2109231-109231100.045100.05
3107325-10732598.30098.30
4105332-10533296.47496.47
5109782-109782100.550100.55
6108503-10850399.37999.38
10min1106661-10666197.69198.811.0698.8299.921.06
2108755-10875599.609100.72
3107455-10745598.41999.51
4106605-10660597.64098.71
5109314-109314100.121101.24
6108514-10851499.389100.49
15min1109327-109327100.13398.641.30102.35100.841.30
2108853-10885399.699101.92
3106777-10677797.79899.98
4105765-10576596.87199.03
5108498-10849899.374101.60
6106963-10696397.968100.18
20min1108677-10867799.53897.491.21102.87100.791.20
2106228-10622897.295100.62
3105893-10589396.988100.26
4105201-10520196.35499.59
5107128-10712898.119101.45
6105521-10552196.64799.94
30min1105040-10504096.20795.920.88100.64100.300.88
2105413-10541396.548100.96
3103513-10351394.80899.16
4103693-10369394.97399.28
5104974-10497496.146100.57
6105741-10574196.849101.22
45min1105615-10561596.73396.130.57102.24101.580.56
2104300-10430095.529101.01
3104794-10479495.981101.38
4104561-10456195.768101.13
5104678-10467895.875101.37
6105767-10576796.873102.32
60min1107082-10708298.07795.101.68104.65101.621.62
2103973-10397395.229101.77
3103316-10331694.628101.10
4101984-10198493.40899.83
5103775-10377595.048101.61
6102866-10286694.216100.74
90min1103203-10320394.52493.280.72102.19100.850.72
2102143-10214393.553101.15
3101569-10156993.028100.55
4101287-10128792.769100.23
5101454-10145492.922100.54
6101421-10142192.892100.46
极限1100138-10013891.71791.410.56100.43100.020.56
2100247-10024791.817100.46
3100321-10032191.885100.44
499021-9902190.69499.19
599873-9987391.474100.12
699229-9922990.88499.49
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(%)91.2对照品水分(%)0对照品稀释倍数20000
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%
116.03 1919551922241921701917591918431919900.11
216.071902021900621901320.06
单位质量响应值RSD%判断
11976.9211831.490.87数据可信
供试品溶液-24060601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%
5min122244-2224419.17215.6216.8619.1715.6216.86
218219-1821915.70315.70
316813-1681314.49114.49
413287-1328711.45211.45
520254-2025417.45717.46
617946-1794615.46815.47
10min125140-2514021.66823.9112.0221.8824.0811.98
230114-3011425.95626.13
326850-2685023.14223.30
423032-2303219.85219.98
531915-3191527.50827.70
629401-2940125.34125.51
15min150501-5050143.52732.1819.6143.9832.6219.44
236501-3650131.46131.92
332679-3267928.16628.58
429182-2918225.15225.50
539231-3923133.81434.31
635920-3592030.96031.41
20min158845-5884550.71936.4620.8951.6637.2520.71
240235-4023534.67935.49
336658-3665831.59632.33
433644-3364428.99829.63
543861-4386137.80438.68
640533-4053334.93635.73
30min167912-6791258.53441.6122.0260.0442.8221.82
245322-4532239.06440.26
340406-4040634.82635.91
438365-3836533.06734.02
551031-5103143.98445.28
646648-4664840.20741.39
45min176490-7649065.92846.4523.7968.0848.1223.54
248688-4868841.96543.60
344426-4442638.29139.76
442926-4292636.99838.32
561312-6131252.84654.63
649540-4954042.69944.33
60min180804-8080469.64649.6125.7372.5351.7925.40
250294-5029443.34945.45
346227-4622739.84441.74
444685-4468538.51540.24
571015-7101561.20963.58
652308-5230845.08547.19
90min180948-8094869.77052.1926.5873.4354.9326.17
251642-5164244.51147.09
347597-4759741.02443.36
446803-4680340.34042.50
580941-8094169.76472.82
655405-5540547.75450.36
极限174579-7457964.28166.8210.0668.7170.1310.04
274925-7492564.57967.65
374044-7404463.81966.61
472068-7206862.11664.72
593193-9319380.32484.15
676372-7637265.82668.96
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100546-202105 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%
117.16 1884021884651885271883931883331884240.04
217.031885801887971886880.09
单位质量响应值RSD%判断
10980.4211079.740.64数据可信
供试品溶液-24060601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%
5min1112035-112035102.61199.681.47102.6199.681.47
2108066-10806698.97698.98
3108277-10827799.16999.17
4108437-10843799.31699.32
5107705-10770598.64598.65
6108457-10845799.33499.33
10min1111545-111545102.16299.981.14103.30101.091.14
2109411-109411100.208101.31
3108121-10812199.026100.13
4108608-10860899.472100.58
5108491-10849199.365100.46
6108806-10880699.654100.76
15min1109986-109986100.73498.291.29103.01100.501.29
2106848-10684897.860100.07
3106515-10651597.55599.76
4107421-10742198.385100.59
5106956-10695697.959100.16
6106156-10615697.22799.44
20min1105119-10511996.27796.980.8899.67100.290.83
2104529-10452995.73699.04
3106088-10608897.164100.45
4105935-10593597.024100.33
5106991-10699197.991101.28
6106630-10663097.661100.95
30min1106630-10663097.66196.530.85102.13100.920.84
2105103-10510396.262100.63
3105401-10540196.535100.90
4105830-10583096.928101.31
5105485-10548596.612100.99
6103932-10393295.19099.57
45min1105638-10563896.75294.641.18102.30100.101.16
2102367-10236793.75699.19
3102963-10296394.30299.74
4103636-10363694.919100.38
5102957-10295794.29799.75
6102454-10245493.83699.27
60min1104836-10483696.01894.420.91102.64100.930.90
2102199-10219993.602100.08
3103078-10307894.408100.89
4102445-10244593.828100.34
5103165-10316594.487100.99
6102822-10282294.173100.65
90min1103668-10366894.94893.241.10102.64100.801.07
2100959-10095992.46799.98
3101964-10196493.387100.92
4100591-10059192.13099.68
5101302-10130292.781100.33
6102357-10235793.747101.27
极限1101953-10195393.37791.931.68102.12100.521.58
298852-9885290.53799.08
398897-9889790.57899.15
4102890-10289094.235102.81
5100163-10016391.738100.32
699476-9947691.10999.67
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20000
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%
116.03 1914001914861915821922561912661915980.21
216.071905831898451902140.28
单位质量响应值RSD%判断
11952.4611836.590.69数据可信
供试品溶液-24060601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%
5min137587-3758732.42331.2212.5432.4231.2212.54
238113-3811332.87632.88
333589-3358928.97428.97
438931-3893133.58233.58
540655-4065535.06935.07
628250-2825024.36924.37
10min157397-5739749.51146.1414.3349.8746.4914.32
256523-5652348.75749.12
347541-4754141.00941.33
458356-5835650.33850.71
560396-6039652.09852.49
640749-4074935.15035.42
15min166566-6656657.42052.5415.2658.3353.4015.23
263854-6385455.08155.99
352807-5280745.55146.33
467693-6769358.39259.32
568527-6852759.11260.08
646038-4603839.71240.37
20min170258-7025860.60555.7815.0362.1557.2215.01
267243-6724358.00459.52
355813-5581348.14449.43
471816-7181661.94963.53
573352-7335263.27464.90
649526-4952642.72143.82
30min176767-7676766.21959.9515.6068.4462.0215.55
272232-7223262.30764.47
359508-5950851.33253.15
477712-7771267.03569.30
578156-7815667.41869.75
652631-5263145.40046.98
45min181829-8182970.58662.1215.5573.5464.8615.50
273979-7397963.81466.67
361542-6154253.08655.48
480085-8008569.08172.10
579750-7975068.79371.87
654932-5493247.38449.47
60min183792-8379272.27964.1914.8576.0267.6114.84
276287-7628765.80569.37
363672-6367254.92457.90
481743-8174370.51274.29
583133-8313371.71175.55
657879-5787949.92752.53
90min185675-8567573.90367.6913.0078.4571.8313.10
280340-8034069.30173.60
367200-6720057.96761.56
484478-8447872.87177.44
588716-8871676.52781.17
664445-6444555.59058.75
极限1103002-10300288.85086.993.6894.2291.874.24
2100952-10095287.08192.15
397149-9714983.80188.03
4104629-10462990.25395.63
5103739-10373989.48594.97
695592-9559282.45886.24
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