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%
114.631211071210591210361209901209641210310.05
214.601210031209591209810.03
单位质量响应值RSD%判断
8272.808286.370.12数据可信
供试品溶液-24080802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%
5min150257-5025738.32537.095.2138.3237.095.21
246296-4629635.30435.30
347020-4702035.85635.86
446991-4699135.83435.83
548340-4834036.86336.86
652939-5293940.37040.37
10min164802-6480249.41647.294.2449.4847.354.24
261073-6107346.57346.63
360089-6008945.82245.88
461820-6182047.14247.20
558814-5881444.85044.91
665447-6544749.90849.98
15min174747-7474757.00054.153.1357.1554.293.13
269585-6958553.06453.20
369231-6923152.79452.93
471034-7103454.16954.31
569112-6911252.70352.84
672352-7235255.17455.32
20min182071-8207162.58559.853.6762.8360.083.67
277108-7710858.80159.03
376183-7618358.09558.32
478464-7846459.83560.06
575268-7526857.39757.62
681792-8179262.37362.61
30min190469-9046968.98965.663.7669.3365.983.76
284662-8466264.56164.88
385008-8500864.82565.15
484249-8424964.24664.57
582462-8246262.88363.20
689741-8974168.43468.78
45min199805-9980576.10973.083.6476.5773.523.64
291805-9180570.00870.44
394839-9483972.32272.75
495584-9558472.89073.33
592848-9284870.80471.23
6100146-10014676.36976.83
60min1107826-10782682.22579.013.5082.8179.573.50
2101048-10104877.05777.60
3103551-10355178.96579.51
4101588-10158877.46878.03
599507-9950775.88276.42
6108116-10811682.44783.03
90min1115265-11526587.89884.363.2188.6285.063.21
2107638-10763882.08282.76
3110167-11016784.01184.69
4109359-10935983.39484.08
5106766-10676681.41782.09
6114590-11459087.38388.11
120min1117882-11788289.89487.503.2290.7688.333.23
2112595-11259585.86286.67
3115491-11549188.07188.89
4113170-11317086.30187.13
5109615-10961583.59084.39
6119682-11968291.26692.14
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1119705-11970591.28488.983.3092.3089.963.30
2114117-11411787.02387.98
3116528-11652888.86189.83
4114449-11444987.27688.24
5112601-11260185.86786.81
6122735-12273593.59594.62
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100651-202006对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0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%
115.86 4728831473500847343904733312473148847326060.06
215.954721435472174847215920.01
单位质量响应值RSD%判断
298398.87296024.580.57数据可信
供试品溶液-24080802批-缬沙坦-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%
5min1960350-96035017.99418.103.8917.9918.093.89
21016951-101695119.05519.05
31007947-100794718.88618.89
4937938-93793817.57417.57
5933461-93346117.49017.49
6937783-93778317.57117.57
10min11567318-156731829.36729.403.8529.4029.433.86
21646281-164628130.84630.88
31640724-164072430.74230.77
41519112-151911228.46428.49
51518967-151896728.46128.49
61522800-152280028.53328.56
15min12034834-203483438.12738.093.5838.2138.173.59
22126079-212607939.83639.92
32116884-211688439.66439.75
41976095-197609537.02637.10
51975093-197509337.00737.08
61968612-196861236.88636.96
20min12395720-239572044.88845.273.3145.0345.413.31
22509559-250955947.02147.17
32502217-250221746.88447.03
42429245-242924545.51745.66
52331931-233193143.69343.83
62326656-232665643.59443.73
30min12983901-298390155.90955.823.2456.1356.043.24
23100998-310099858.10358.33
33091227-309122757.92058.15
42902219-290221954.37954.59
52906971-290697154.46854.68
62890852-289085254.16654.38
45min13573719-357371966.96167.313.0067.2767.623.01
23735148-373514869.98570.31
33718947-371894769.68270.01
43520037-352003765.95566.26
53513311-351331165.82966.13
63493459-349345965.45765.76
60min13995067-399506774.85575.442.7275.2875.862.72
24172020-417202078.17178.61
34155789-415578977.86778.31
43943289-394328973.88574.30
53964054-396405474.27474.69
63926796-392679673.57673.99
90min14482508-448250883.98884.992.4284.5485.542.42
24690514-469051487.88688.46
34661665-466166587.34587.91
44459122-445912283.55084.09
54474280-447428083.83484.37
64449206-444920683.36583.90
120min14732956-473295688.68189.892.3389.3790.582.33
24948417-494841792.71893.44
34932904-493290492.42893.14
44713289-471328988.31388.99
54737954-473795488.77589.45
64719265-471926588.42589.10
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14852855-485285590.92892.282.1191.7693.122.12
25081691-508169195.21596.09
35030662-503066294.25995.13
44841122-484112290.70891.53
54882083-488208391.47592.30
64861263-486126391.08591.90
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%
114.631208861208901208071208001207831208330.05
214.601222231216701219460.33
单位质量响应值RSD%判断
8259.268352.470.80数据可信
供试品溶液-24080804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%
5min151641-5164139.25739.928.6839.2639.928.68
257406-5740643.63943.64
356346-5634642.83342.83
445680-4568034.72534.73
549079-4907937.30937.31
654965-5496541.78441.78
10min169245-6924552.63950.835.7552.7050.905.75
270003-7000353.21553.29
368696-6869652.22252.29
459736-5973645.41045.47
565330-6533049.66349.73
668203-6820351.84751.92
15min179188-7918860.19858.205.1360.3558.355.13
278435-7843559.62559.79
378769-7876959.87960.04
468921-6892152.39352.53
575861-7586157.66857.81
678203-7820359.44959.60
20min184864-8486464.51263.485.2164.7763.735.22
286667-8666765.88366.14
386217-8621765.54165.80
474998-7499857.01257.23
583087-8308763.16263.40
685197-8519764.76665.02
30min193454-9345471.04269.124.8671.4069.474.86
292212-9221270.09870.47
393700-9370071.22971.60
482055-8205562.37762.69
591607-9160769.63869.98
692511-9251170.32670.69
45min1102989-10298978.29176.483.1578.7776.953.16
2100762-10076276.59877.09
3102522-10252277.93678.42
494452-9445271.80172.22
5102269-10226977.74378.21
6100616-10061676.48776.97
60min1107730-10773081.89580.891.9782.5081.481.98
2106133-10613380.68181.30
3107784-10778481.93682.55
4102836-10283678.17478.71
5108513-10851382.49083.08
6105422-10542280.14080.75
90min1112934-11293485.85184.681.7186.6085.411.71
2110677-11067784.13584.88
3112805-11280585.75386.51
4109859-10985983.51384.18
5113339-11333986.15986.89
6108748-10874882.66983.41
120min1113630-11363086.38082.763.7587.2783.633.71
2110609-11060984.08384.97
3110126-11012683.71684.61
4111132-11113284.48185.29
5103485-10348578.66879.54
6104210-10421079.21980.10
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1115572-11557287.85686.064.0988.8987.074.05
2113109-11310985.98487.01
3117549-11754989.35990.39
4110872-11087284.28385.23
5116902-11690288.86789.87
6105257-10525780.01581.03
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100651-202006对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0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%
115.86 4719030472093847203274719551471949947198690.02
215.954782940476205747724980.31
单位质量响应值RSD%判断
297595.78299216.180.39数据可信
供试品溶液-24080804批-缬沙坦-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%
5min11292010-129201024.11124.066.8324.1124.066.82
21275532-127553223.80423.80
31370554-137055425.57725.58
41125095-112509520.99621.00
51320417-132041724.64124.64
61352082-135208225.23225.23
10min12131708-213170839.78138.625.0739.8238.665.07
22094930-209493039.09539.13
32069694-206969438.62438.67
41862601-186260134.75934.79
52141058-214105839.95640.00
62118450-211845039.53439.58
15min12721926-272192650.79649.424.8450.9049.534.84
22693621-269362150.26850.37
32672789-267278949.87949.99
42389094-238909444.58544.68
52700299-270029950.39250.50
62712625-271262550.62250.73
20min13170931-317093159.17557.714.9059.3757.904.90
23148647-314864758.75958.95
33124765-312476558.31458.50
42785470-278547051.98252.15
53153543-315354358.85159.04
63171440-317144059.18559.38
30min13814449-381444971.18469.334.7071.4769.614.70
23770733-377073370.36970.66
33767070-376707070.30070.59
43362357-336235762.74863.00
53762393-376239370.21370.50
63813822-381382271.17371.46
45min14401949-440194982.14880.522.9482.5680.922.95
24355897-435589781.28981.69
34352500-435250081.22581.63
44061380-406138075.79376.15
54328190-432819080.77281.18
64387733-438773381.88382.29
60min14734067-473406788.34687.171.8988.8987.701.91
24697467-469746787.66388.20
34705113-470511387.80688.35
44496543-449654383.91484.40
54669977-466997787.15087.69
64722759-472275988.13588.68
90min15046419-504641994.17593.431.0094.8794.101.01
24991410-499141093.14993.83
35055710-505571094.34995.03
44917491-491749191.76992.39
55009087-500908793.47994.17
65017585-501758593.63794.33
120min15137696-513769695.87994.690.6796.7395.520.68
25067618-506761894.57195.41
35069734-506973494.61095.45
45044319-504431994.13694.91
55049038-504903894.22495.07
65074111-507411194.69295.54
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15189843-518984396.85295.500.8797.8696.490.87
25128313-512831395.70496.70
35138500-513850095.89496.89
45094626-509462695.07596.01
55082660-508266094.85295.85
65069377-506937794.60495.61
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