左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.647693776620765277630676205765190.38
216.757568275333755080.33
单位质量响应值RSD%判断
4598.504507.941.41数据可信
供试品溶液-2024092121批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144643-4464349.52947.074.2149.5347.074.21
243104-4310447.82147.82
341630-4163046.18646.19
444036-4403648.85548.86
540993-4099345.47945.48
640138-4013844.53144.53
10min167139-6713974.48772.371.8674.5772.451.86
265594-6559472.77372.85
365471-6547172.63672.71
465132-6513272.26072.34
564576-6457671.64371.72
663487-6348770.43570.51
15min177889-7788986.41382.832.5786.6283.032.57
273926-7392682.01782.22
372683-7268380.63880.84
475936-7593684.24784.45
574129-7412982.24282.44
673409-7340981.44381.63
20min180439-8043989.24286.941.9589.5987.281.95
279108-7910887.76688.10
378056-7805686.59986.93
478785-7878587.40787.75
577959-7795986.49186.82
675861-7586184.16384.49
30min185292-8529294.62790.872.2195.1391.352.21
281368-8136890.27390.76
381397-8139790.30590.78
482233-8223391.23391.72
580002-8000288.75889.23
681142-8114290.02290.49
45min186948-8694896.46493.512.1897.1294.152.18
285553-8555394.91695.55
382819-8281991.88392.51
484430-8443093.67094.31
584146-8414693.35593.98
681840-8184090.79791.41
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.169803098110982699830198062981540.13
216.229818497830980070.26
单位质量响应值RSD%判断
6073.896042.360.37数据可信
供试品溶液-2024092121批-叶酸-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113832-11383296.39395.812.9096.3995.812.90
2118673-118673100.493100.49
3111786-11178694.66194.66
4109466-10946692.69692.70
5114349-11434996.83196.83
6110752-11075293.78593.79
10min1117434-11743499.44398.732.9799.6098.892.97
2122352-122352103.608103.78
3114800-11480097.21397.37
4112627-11262795.37395.53
5118011-11801199.932100.09
6114349-11434996.83196.99
15min1118001-11800199.92499.253.02100.2599.583.02
2123008-123008104.164104.50
3115545-11554597.84498.16
4112932-11293295.63195.94
5118765-118765100.571100.90
6114998-11499897.38197.70
20min1118496-118496100.34399.393.11100.8499.883.11
2123432-123432104.523105.04
3115708-11570897.98298.46
4113153-11315395.81896.29
5118619-118619100.447100.94
6114841-11484197.24897.73
30min1118551-118551100.38999.413.09101.05100.073.09
2123387-123387104.484105.17
3115857-11585798.10898.75
4112936-11293695.63596.27
5118485-118485100.333101.00
6115185-11518597.53998.18
45min1118969-118969100.74399.613.19101.57100.433.19
2123785-123785104.822105.68
3116034-11603498.25899.07
4112966-11296695.66096.45
5118678-118678100.497101.33
6115367-11536797.69398.50
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.647651976376761507614976245762880.21
216.757553875870757040.32
单位质量响应值RSD%判断
4584.624519.641.01数据可信
供试品溶液-2024092121批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150320-5032055.83854.984.4655.8454.984.46
252731-5273158.51358.51
349029-4902954.40554.41
447993-4799353.25653.26
550754-5075456.31956.32
646469-4646951.56551.56
10min167182-6718274.54974.601.4774.6474.701.47
267696-6769675.11975.22
367227-6722774.59974.69
465353-6535372.51972.61
568141-6814175.61375.71
667783-6778375.21675.30
15min174586-7458682.76583.363.4182.9883.573.40
277859-7785986.39786.62
374900-7490083.11383.33
470822-7082278.58878.80
577637-7763786.15086.37
674913-7491383.12883.34
20min178004-7800486.55887.932.3086.9188.282.30
281010-8101089.89390.26
378601-7860187.22087.57
477151-7715185.61185.95
581872-8187290.85091.21
678820-7882087.46387.81
30min181068-8106889.95890.432.3490.4690.932.34
284509-8450993.77694.29
380786-8078689.64590.14
478688-7868887.31787.80
582174-8217491.18591.70
681712-8171290.67291.17
45min182543-8254391.59493.293.2592.2493.943.24
285952-8595295.37796.05
384838-8483894.14194.79
479440-7944088.15188.78
587055-8705596.60197.27
684614-8461493.89294.54
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.169788697947980799797998040979860.08
216.229640996213963110.15
单位质量响应值RSD%判断
6063.495937.791.49数据可信
供试品溶液-2024092121批-叶酸-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1112162-11216295.89999.462.4395.9099.462.43
2116220-11622099.36899.37
3119804-119804102.433102.43
4118941-118941101.695101.69
5114417-11441797.82797.83
6116411-11641199.53299.53
10min1114582-11458297.968101.802.6598.13101.962.65
2119327-119327102.025102.19
3122472-122472104.714104.88
4122435-122435104.682104.85
5116534-11653499.63799.80
6119011-119011101.755101.92
15min1116253-11625399.397102.082.2299.72102.412.22
2119505-119505102.177102.51
3122544-122544104.775105.12
4122340-122340104.601104.94
5116887-11688799.939100.27
6118790-118790101.566101.90
20min1115827-11582799.032101.722.2599.52102.222.25
2119508-119508102.180102.69
3121443-121443103.834104.35
4122435-122435104.682105.20
5116383-11638399.508100.00
6118218-118218101.077101.58
30min1114761-11476198.121101.472.4598.77102.142.45
2118685-118685101.476102.15
3121837-121837104.171104.86
4122047-122047104.350105.04
5116392-11639299.515100.18
6118364-118364101.202101.87
45min1114565-11456597.953101.192.4798.77102.032.47
2118708-118708101.496102.34
3121552-121552103.927104.79
4121534-121534103.912104.78
5115557-11555798.80299.63
6118161-118161101.028101.87
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.647619775975758987590275668759280.25
216.757525075267752580.02
单位质量响应值RSD%判断
4562.984493.011.10数据可信
供试品溶液-2024092121批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133251-3325137.09433.9415.9837.0933.9415.98
233884-3388437.80037.80
330448-3044833.96733.97
432573-3257336.33836.34
531564-3156435.21235.21
620824-2082423.23123.23
10min152037-5203758.05154.0211.4058.1154.0811.41
252066-5206658.08458.15
349115-4911554.79254.85
449802-4980255.55855.62
550100-5010055.89155.95
637430-3743041.75641.79
15min161198-6119868.27165.266.6068.4365.406.61
260953-6095367.99868.16
360772-6077267.79667.94
460183-6018367.13967.29
556341-5634162.85363.00
651541-5154157.49857.61
20min166550-6655074.24271.874.7474.5172.124.76
264963-6496372.47172.74
365977-6597773.60373.86
463845-6384571.22471.49
566611-6661174.31074.57
658575-5857565.34565.55
30min170181-7018178.29277.262.6978.6977.642.71
270160-7016078.26978.66
368945-6894576.91477.30
467968-6796875.82476.21
571772-7177280.06780.45
666512-6651274.19974.51
45min174301-7430182.88982.243.0083.4282.753.01
274465-7446583.07283.60
372520-7252080.90281.41
473356-7335681.83482.34
577150-7715086.06786.58
670541-7054178.69479.13
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.169606596201960559591395800960070.17
216.229636295827960940.40
单位质量响应值RSD%判断
5941.035924.410.20数据可信
供试品溶液-2024092121批-叶酸-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1118684-118684102.62694.0111.56102.6394.0111.56
2113304-11330497.97497.97
3114169-11416998.72298.72
4112669-11266997.42597.42
5109713-10971394.86994.87
683758-8375872.42572.43
10min1120921-120921104.560101.503.52104.73101.663.53
2117267-117267101.401101.56
3121747-121747105.274105.44
4119367-119367103.216103.38
5113503-11350398.14698.30
6111492-11149296.40796.53
15min1121400-121400104.974103.581.78105.32103.911.78
2117461-117461101.568101.90
3122056-122056105.542105.88
4119631-119631103.445103.78
5117036-117036101.201101.52
6121150-121150104.758105.04
20min1122007-122007105.499103.302.67106.02103.802.66
2117261-117261101.395101.90
3121782-121782105.305105.82
4120011-120011103.773104.28
5114095-11409598.65899.15
6121642-121642105.184105.64
30min1121357-121357104.937103.272.61105.63103.942.60
2117599-117599101.688102.36
3122195-122195105.662106.35
4119607-119607103.424104.10
5114097-11409798.65999.31
6121712-121712105.244105.88
45min1120986-120986104.616102.662.69105.49103.502.68
2116745-116745100.949101.79
3121898-121898105.405106.27
4117509-117509101.610102.46
5113877-11387798.46999.29
6121340-121340104.922105.73
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