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%
116.014686432468503646845634685374468580546854420.02
215.994676081467641046762460.01
单位质量响应值RSD%判断
292657.21292448.160.06数据可信
供试品溶液-AR7108E批-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%
5min1211735-2117354.0304.498.534.034.498.54
2249053-2490534.7414.74
3242864-2428644.6234.62
4212397-2123974.0434.04
5237528-2375284.5214.52
6261580-2615804.9794.98
10min1463824-4638248.8299.294.558.849.294.53
2509268-5092689.6949.70
3510283-5102839.7139.72
4459168-4591688.7408.75
5486725-4867259.2659.27
6497682-4976829.4739.48
15min1689732-68973213.12913.563.7613.1513.583.76
2734551-73455113.98214.01
3739631-73963114.07914.10
4673303-67330312.81612.84
5707146-70714613.46113.48
6728923-72892313.87513.90
20min1882829-88282916.80517.102.8716.8517.152.87
2920120-92012017.51517.56
3930823-93082317.71817.77
4859098-85909816.35316.40
5896695-89669517.06917.11
6901428-90142817.15917.21
30min11185494-118549422.56622.882.4322.6422.952.43
21224374-122437423.30623.38
31238968-123896823.58423.66
41156862-115686222.02122.09
51196741-119674122.78022.85
61208813-120881323.01023.09
45min11522358-152235828.97829.301.8729.0929.411.87
21567500-156750029.83729.95
31572390-157239029.93030.05
41495380-149538028.46528.57
51538886-153888629.29329.40
61538340-153834029.28229.40
60min11786411-178641134.00434.392.0434.1634.552.04
21824741-182474134.73434.90
31843763-184376335.09635.26
41744804-174480433.21233.37
51835383-183538334.93735.10
61805072-180507234.36034.52
90min12150915-215091540.94341.381.4141.1641.601.42
22196764-219676441.81542.04
32212477-221247742.11542.34
42128304-212830440.51240.72
52181226-218122641.52041.74
62175183-217518341.40541.62
120min12436540-243654046.38046.651.2946.6646.941.29
22469064-246906446.99947.29
32494955-249495547.49247.79
42406591-240659145.81046.09
52463847-246384746.89947.19
62432918-243291846.31146.60
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12591035-259103549.32049.960.8949.6850.320.90
22646072-264607250.36850.74
32656106-265610650.55950.93
42615985-261598549.79550.15
52617996-261799649.83450.20
62619843-261984349.86950.24
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%
116.014676940468188746826214678797468302246806530.06
215.994711500471431947129100.05
单位质量响应值RSD%判断
292358.09294741.090.58数据可信
供试品溶液-AR7108E批-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%
5min1219730-2197304.1683.936.644.173.936.66
2226665-2266654.3004.30
3203586-2035863.8623.86
4192368-1923683.6493.65
5194091-1940913.6823.68
6205500-2055003.8983.90
10min1470875-4708758.9338.624.958.948.634.94
2491104-4911049.3179.32
3449565-4495658.5298.54
4435211-4352118.2568.26
5432586-4325868.2068.21
6448492-4484928.5088.51
15min1688706-68870613.06512.734.0013.0912.764.01
2715541-71554113.57413.60
3662154-66215412.56212.58
4651161-65116112.35312.37
5642514-64251412.18912.21
6667102-66710212.65512.68
20min1867327-86732716.45416.233.8616.5016.283.86
2912814-91281417.31717.36
3840197-84019715.93915.98
4836307-83630715.86515.91
5818093-81809315.52015.56
6859389-85938916.30316.34
30min11159628-115962821.99921.863.3722.0721.933.38
21220681-122068123.15723.23
31133871-113387121.51021.58
41138969-113896921.60721.67
51104604-110460420.95521.02
61156119-115611921.93222.00
45min11490057-149005728.26728.242.8328.3828.352.84
21557489-155748929.54729.66
31469128-146912827.87027.97
41481810-148181028.11128.21
51430315-143031527.13427.23
61504163-150416328.53528.64
60min11739729-173972933.00433.122.6833.1633.272.68
21821527-182152734.55634.72
31718204-171820432.59632.75
41750643-175064333.21133.36
51682319-168231931.91532.06
61762500-176250033.43633.59
90min12090777-209077739.66440.262.8439.8740.462.84
22199276-219927641.72241.94
32091057-209105739.66939.87
42113658-211365840.09840.30
52047872-204787238.85039.05
62189623-218962341.53941.75
120min12370790-237079044.97645.452.3645.2545.722.36
22471432-247143246.88547.17
32364294-236429444.85245.12
42406032-240603245.64445.92
52317933-231793343.97344.24
62444588-244458846.37646.65
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12545990-254599048.29948.542.3348.6548.892.33
22650715-265071550.28650.65
32520167-252016747.80948.15
42569436-256943648.74449.09
52477477-247747746.99947.34
62587264-258726449.08249.44
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100651-202006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%
116.014768287477102747754014779798477881347746650.11
215.994687335468947246884040.04
单位质量响应值RSD%判断
298230.17293208.511.21数据可信
供试品溶液-AR7108E批-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%
5min11655210-165521031.17231.277.3731.1731.277.37
21624255-162425530.58930.59
31668006-166800631.41331.41
41527917-152791728.77528.77
51599521-159952130.12330.12
61888941-188894135.57435.57
10min12730872-273087251.42951.565.7651.4851.615.76
22660189-266018950.09850.15
32725179-272517951.32251.37
42573273-257327348.46148.51
52699767-269976750.84450.89
63036574-303657457.18657.25
15min13389857-338985763.84063.565.4963.9863.705.49
23257714-325771461.35161.49
33328661-332866162.68762.83
43199151-319915160.24860.38
53347805-334780563.04863.18
63726655-372665570.18270.34
20min13814763-381476371.84271.515.7072.0971.765.70
23663711-366371168.99769.23
33726409-372640970.17870.42
43607787-360778767.94468.17
53757998-375799870.77371.01
64213388-421338879.34979.62
30min14317936-431793681.31880.544.0981.6880.904.09
24162551-416255178.39178.74
34192736-419273678.96079.32
44122563-412256377.63877.98
54259581-425958180.21980.58
64602945-460294586.68587.09
45min14682117-468211788.17687.182.8088.6887.682.81
24536036-453603685.42585.91
34546563-454656385.62386.11
44514294-451429485.01685.49
54639283-463928387.37087.86
64857391-485739191.47792.03
60min14846664-484666491.27589.902.2591.9290.542.26
24687561-468756188.27988.90
34691099-469109988.34588.98
44679372-467937288.12588.74
54793504-479350490.27490.91
64942721-494272193.08493.78
90min14938050-493805092.99691.192.1393.7991.982.15
24765555-476555589.74890.52
34740932-474093289.28490.06
44757674-475767489.59990.36
54866760-486676091.65492.44
64983794-498379493.85894.71
120min14950873-495087393.23891.742.1494.1992.682.15
24793073-479307390.26691.19
34763061-476306189.70190.63
44785972-478597290.13291.04
54921222-492122292.67993.62
65012816-501281694.40495.42
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15192752-519275297.79395.831.7898.9096.921.79
24998218-499821894.12995.20
35045869-504586995.02796.11
44984107-498410793.86394.92
55147227-514722796.93598.03
65162427-516242797.22298.39
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%
116.014703166470603047081854708318471076347072920.07
215.994760503476162147610620.02
单位质量响应值RSD%判断
294021.99297752.470.90数据可信
供试品溶液-AR7108E批-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%
5min11618367-161836730.46032.737.9530.4632.737.96
21753396-175339633.00133.00
31650803-165080331.07031.07
41750570-175057032.94832.95
51661920-166192031.27931.28
61997637-199763737.59837.60
10min12674477-267447750.33752.595.4650.3952.655.46
22818379-281837953.04553.10
32699875-269987550.81550.87
42759149-275914951.93151.99
52725315-272531551.29451.35
63088031-308803158.12158.18
15min13306410-330641062.23164.314.2862.3764.454.28
23417970-341797064.33164.47
33322606-332260662.53662.67
43375019-337501963.52263.66
53376062-337606263.54263.68
63703531-370353169.70569.86
20min13715694-371569469.93472.073.7270.1772.323.72
23849401-384940172.45172.70
33739226-373922670.37770.62
43763136-376313670.82771.07
53804505-380450571.60671.85
64102208-410220877.20977.48
30min14231763-423176379.64781.382.6780.0081.752.68
24388112-438811282.59082.96
34241988-424198879.84080.20
44234112-423411279.69180.06
54325569-432556981.41381.78
64521443-452144385.09985.50
45min14594606-459460686.47687.821.8786.9688.331.88
24764927-476492789.68290.19
34608698-460869886.74287.23
44577770-457777086.15986.66
54676771-467677188.02388.52
64774268-477426889.85890.40
60min14750388-475038889.40890.361.6790.0491.001.67
24929852-492985292.78693.44
34761820-476182089.62390.26
44704371-470437188.54289.18
54818380-481838090.68891.33
64839498-483949891.08591.78
90min14811994-481199490.56891.651.8691.3592.461.86
25017311-501731194.43295.25
34828608-482860890.88191.67
44759442-475944289.57990.37
54910141-491014192.41593.21
64890213-489021392.04092.89
120min14842738-484273891.14691.461.9292.0892.421.91
25034517-503451794.75695.73
34839589-483958991.08792.02
44757679-475767989.54690.48
54821180-482118090.74191.69
64861865-486186591.50692.51
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15043664-504366494.92895.521.3096.0196.621.29
25195569-519556997.78798.92
35036428-503642894.79295.88
45081828-508182895.64696.73
55084860-508486095.70396.81
65007584-500758494.24995.40
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