缬沙坦左氨氯地平片项目信息
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4000
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%
114.07 1158101157981159711155671154091157110.20
214.091153691151041152360.17
单位质量响应值RSD%判断
8223.958178.570.40数据可信
供试品溶液-2024082121批-左氨氯地平-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%
5min175956-7595658.47649.8321.5758.4849.8321.58
243271-4327133.31333.31
351006-5100639.26839.27
475088-7508857.80757.81
570980-7098054.64554.64
672027-7202755.45155.45
10min184600-8460065.13063.611.7165.2363.701.70
283478-8347864.26764.32
382492-8249263.50863.57
483000-8300063.89963.99
580632-8063262.07662.17
681566-8156662.79562.89
15min189528-8952868.92467.252.3469.1367.442.33
288928-8892868.46268.63
388314-8831467.99068.16
487431-8743167.31067.51
584148-8414864.78264.98
685786-8578666.04366.24
20min191892-9189270.74469.421.7471.0769.721.73
291562-9156270.49070.77
390984-9098470.04570.33
489904-8990469.21469.53
588180-8818067.88768.19
688524-8852468.15168.46
30min196412-9641274.22471.074.0174.6671.493.99
295666-9566673.65074.04
387398-8739867.28467.69
488421-8842168.07268.50
592849-9284971.48171.90
693163-9316371.72372.14
45min1100639-10063977.47875.891.6978.0476.431.67
299875-9987576.89077.41
399642-9964276.71177.22
497308-9730874.91475.46
597213-9721374.84175.38
696792-9679274.51775.06
60min1103647-10364779.79478.181.4680.4978.841.45
2102804-10280479.14579.79
3101934-10193478.47579.12
4100056-10005677.02977.70
5100575-10057577.42978.09
6100280-10028077.20277.87
90min1108744-10874483.71881.851.7584.5482.641.74
2108031-10803183.16983.95
3106805-10680582.22583.00
4105219-10521981.00481.80
5105122-10512280.93081.72
6103970-10397080.04380.84
120min1110797-11079785.29983.961.3386.2684.891.32
2109815-10981584.54285.46
3109887-10988784.59885.51
4108664-10866483.65684.59
5108536-10853683.55884.48
6106664-10666482.11783.04
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1113271-11327187.20386.162.0588.3187.222.03
2112314-11231486.46687.52
3112143-11214386.33587.38
4110076-11007684.74385.81
5115060-11506088.58089.64
6108606-10860683.61284.68
缬沙坦左氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.944754550475007047463424741273473611647456700.16
215.954682364468281546825900.01
单位质量响应值RSD%判断
297720.83293579.311.00数据可信
供试品溶液-2024082121批-缬沙坦-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%
5min1331591-3315916.2526.638.746.256.638.73
2385511-3855117.2697.27
3395082-3950827.4497.45
4343004-3430046.4686.47
5330854-3308546.2386.24
6323880-3238806.1076.11
10min1622663-62266311.74111.982.1911.7512.002.21
2656848-65684812.38512.40
3640930-64093012.08512.10
4643578-64357812.13512.15
5625680-62568011.79811.81
6623024-62302411.74711.76
15min1858272-85827216.18316.462.4616.2116.492.46
2904262-90426217.05017.08
3886166-88616616.70916.74
4883613-88361316.66116.69
5851817-85181716.06116.09
6853887-85388716.10116.13
20min11044960-104496019.70319.981.6819.7620.031.68
21072034-107203420.21420.27
31078243-107824320.33120.39
41075891-107589120.28720.35
51043919-104391919.68419.74
61041246-104124619.63319.69
30min11334724-133472425.16725.432.0325.2625.522.02
21378231-137823125.98726.08
31387104-138710426.15526.25
41320413-132041324.89724.99
51336535-133653525.20125.29
61333624-133362425.14625.24
45min11681417-168141731.70431.941.1631.8432.081.17
21713431-171343132.30832.45
31723594-172359432.49932.64
41685271-168527131.77731.91
51683373-168337331.74131.87
61676522-167652231.61231.74
60min11942946-194294636.63536.921.0236.8237.101.02
21981931-198193137.37037.56
31982866-198286637.38837.58
41940882-194088236.59636.78
51957010-195701036.90137.09
61941698-194169836.61236.80
90min12382155-238215544.91744.951.1745.1645.201.17
22413325-241332545.50545.76
32414212-241421245.52145.78
42384426-238442644.96045.21
52368702-236870244.66344.91
62341205-234120544.14544.39
120min12679833-267983350.53050.861.2950.8551.181.29
22716047-271604751.21351.54
32738341-273834151.63351.96
42713534-271353451.16551.49
52696950-269695050.85351.17
62638698-263869849.75450.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12916166-291616654.98655.391.8355.3955.801.82
22950414-295041455.63256.05
32957465-295746555.76556.18
42892175-289217554.53454.94
53027506-302750657.08557.49
62880860-288086054.32054.72
缬沙坦左氨氯地平片项目信息
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4000
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%
114.07 1148431147861145751146011141021145810.26
214.091142551139581141060.19
单位质量响应值RSD%判断
8143.648098.370.40数据可信
供试品溶液-2024082121批-左氨氯地平-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%
5min179616-7961661.89961.781.6761.9061.781.66
276887-7688759.77759.78
379657-7965761.93161.93
480214-8021462.36462.36
579739-7973961.99561.99
680638-8063862.69462.69
10min190135-9013570.07769.071.3570.1869.171.35
286765-8676567.45767.56
389508-8950869.59069.69
488437-8843768.75768.86
588648-8864868.92169.02
689542-8954269.61669.72
15min194716-9471673.63972.321.5373.8672.531.53
290436-9043670.31170.52
393708-9370872.85573.07
492950-9295072.26672.48
593300-9330072.53872.76
692984-9298472.29272.51
20min197932-9793276.13974.801.3376.4875.141.33
294001-9400173.08373.41
396643-9664375.13775.48
496189-9618974.78475.12
596086-9608674.70475.04
696419-9641974.96375.30
30min1102719-10271979.86178.381.2980.3378.841.29
298854-9885476.85677.31
3101313-10131378.76879.23
4100159-10015977.87178.33
5100558-10055878.18178.64
6101307-10130778.76379.23
45min1105071-10507181.69081.471.3582.2982.061.34
2104805-10480581.48382.06
3104023-10402380.87581.47
4105071-10507181.69082.28
5102742-10274279.87980.47
6107035-10703583.21783.81
60min1108236-10823684.15084.071.1684.8984.801.15
2108227-10822784.14384.86
3107828-10782883.83384.57
4108320-10832084.21684.95
5106133-10613382.51583.24
6110030-11003085.54586.28
90min1112386-11238687.37787.570.9888.2688.440.97
2112606-11260687.54888.40
3112248-11224887.27088.14
4112991-11299187.84788.72
5111092-11109286.37187.24
6114452-11445288.98389.86
120min1115489-11548989.78989.980.8890.8190.990.88
2115883-11588390.09691.10
3115751-11575189.99391.01
4116191-11619190.33591.35
5113988-11398888.62289.63
6117083-11708391.02992.06
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1117208-11720891.12691.240.7292.3092.400.72
2117352-11735291.23892.39
3117320-11732091.21392.38
4117510-11751091.36192.53
5116037-11603790.21591.37
6118671-11867192.26393.44
缬沙坦左氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.944723507472163647179804712814469124747134370.28
215.954670170466679546684820.06
单位质量响应值RSD%判断
295698.68292694.800.73数据可信
供试品溶液-2024082121批-缬沙坦-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%
5min1250982-2509824.7564.973.184.764.983.14
2256779-2567794.8664.87
3264615-2646155.0145.01
4265205-2652055.0255.03
5261920-2619204.9634.96
6275562-2755625.2215.22
10min1531194-53119410.0659.832.3610.079.832.34
2497230-4972309.4229.43
3515673-5156739.7719.78
4518926-5189269.8339.84
5518676-5186769.8289.84
6529640-52964010.03610.04
15min1795292-79529215.06914.373.1015.0914.403.08
2723642-72364213.71213.74
3745872-74587214.13314.16
4760825-76082514.41614.44
5762712-76271214.45214.48
6761648-76164814.43214.46
20min11026196-102619619.44518.333.5619.4918.383.54
2921633-92163317.46317.51
3949830-94983017.99818.05
4971599-97159918.41018.46
5971054-97105418.40018.45
6964865-96486518.28318.33
30min11396067-139606726.45324.783.6826.5424.863.68
21251320-125132023.71023.79
31284974-128497424.34824.43
41307231-130723124.77024.85
51304108-130410824.71124.79
61303676-130367624.70224.78
45min11698885-169888532.19132.413.8832.3232.533.87
21711761-171176132.43532.55
31706881-170688132.34232.46
41672314-167231431.68731.81
51638875-163887531.05431.17
61833865-183386534.74934.87
60min12014594-201459438.17338.503.3638.3538.683.35
22032293-203229338.50838.68
32034852-203485238.55738.73
41992357-199235737.75237.93
51959073-195907337.12137.29
62158741-215874140.90441.08
90min12475588-247558846.90847.492.8147.1547.732.80
22500552-250055247.38147.61
32513832-251383247.63347.87
42472599-247259946.85147.09
52435920-243592046.15646.39
62638926-263892650.00350.25
120min12830382-283038253.63154.182.5353.9554.502.53
22858779-285877954.16954.48
32872434-287243454.42854.74
42821338-282133853.45953.77
52782134-278213452.71753.03
62992511-299251156.70357.03
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限13050802-305080257.80758.311.9258.2258.711.92
23075145-307514558.26958.67
33092648-309264858.60059.01
43034356-303435657.49657.90
53024234-302423457.30457.70
63185342-318534260.35760.78
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