缬沙坦片项目信息
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%
115.444479787448653144874244484790448378044844620.07
215.394471011447155544712830.01
单位质量响应值RSD%判断
290444.43290531.710.03数据可信
供试品溶液-24072501-1SP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%
5min11197641-119764122.98220.4124.3622.9820.4024.36
21321715-132171525.36325.36
31206070-120607023.14423.14
4813558-81355815.61215.61
5668549-66854912.82912.83
61172832-117283222.50622.51
10min11958250-195825037.57834.3320.8337.6234.3720.83
22126630-212663040.80940.85
31995812-199581238.29938.34
41441904-144190427.67027.70
51205337-120533723.13023.15
62006218-200621838.49938.54
15min12589001-258900149.68245.9718.4749.7846.0618.48
22765944-276594453.07853.19
32631646-263164650.50050.60
41997992-199799238.34138.41
51689870-168987032.42832.49
62699313-269931351.79951.90
20min13102632-310263259.53954.2417.2059.7254.4017.21
23278442-327844262.91263.11
32844202-284420254.57954.77
42438694-243869446.79846.93
52062063-206206339.57039.68
63232383-323238362.02862.22
30min13823927-382392773.38067.8516.6373.6668.1116.63
23974398-397439876.26776.57
33837800-383780073.64673.92
43020821-302082157.96958.18
52585132-258513249.60849.79
63973565-397356576.25176.54
45min14451939-445193985.43178.8915.8485.8479.2615.85
24553617-455361787.38287.81
34453241-445324185.45685.86
43525615-352561567.65567.97
53065633-306563358.82959.09
64616232-461623288.58489.00
60min14774947-477494791.63084.6815.0292.1885.1815.04
24848709-484870993.04593.62
34795638-479563892.02792.57
43801610-380161072.95273.38
53355878-335587864.39864.76
64899591-489959194.02294.59
90min15000255-500025595.95389.5813.1496.6590.2213.17
25070944-507094497.31098.04
35059781-505978197.09697.79
44104021-410402178.75579.30
53687707-368770770.76671.23
65084963-508496397.57998.30
120min15041720-504172096.74991.8110.9597.6192.6011.00
25128066-512806698.40699.30
35150643-515064398.83999.70
44333609-433360983.16183.84
53927446-392744675.36675.95
65123943-512394398.32799.21
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15050123-505012396.91096.233.4297.9397.183.53
25139509-513950998.62699.68
35159974-515997499.018100.04
44865243-486524393.36294.18
54744754-474475491.05091.76
65129203-512920398.42899.48
缬沙坦片项目信息
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%
115.444490674448952444893844489281449059444898910.02
215.394497136449850044978180.03
单位质量响应值RSD%判断
290796.05292255.880.36数据可信
供试品溶液-24072501-2SP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%
5min11765745-176574533.76435.095.0233.7635.095.02
21786022-178602234.15134.15
31795382-179538234.33034.33
41975428-197542837.77337.77
51926612-192661236.84036.84
61761468-176146833.68233.68
10min12606894-260689449.84850.673.5749.9050.733.57
22550839-255083948.77648.83
32615387-261538750.01050.07
42804548-280454853.62753.69
52722225-272222552.05352.11
62599554-259955449.70749.76
15min13225071-322507161.66861.953.2161.8162.093.21
23100073-310007359.27859.42
33204353-320435361.27261.41
43398073-339807364.97665.13
53315692-331569263.40163.55
63195333-319533361.10061.24
20min13677905-367790570.32770.132.6770.5770.372.67
23535633-353563367.60767.84
33629643-362964369.40469.65
43816923-381692372.98573.25
53728465-372846571.29471.55
63615980-361598069.14369.38
30min14254855-425485581.35980.422.1381.7280.792.13
24080010-408001078.01678.37
34162328-416232879.59079.95
44333172-433317282.85783.24
54244962-424496281.17081.54
64159854-415985479.54379.90
45min14674173-467417389.37787.861.4489.8788.361.44
24513878-451387886.31286.79
34579897-457989787.57488.07
44673860-467386089.37189.89
54577617-457761787.53188.04
64548761-454876186.97987.47
60min14838696-483869692.52390.591.4093.1791.231.40
24702045-470204589.91090.53
34668834-466883489.27589.91
44798336-479833691.75192.42
54715386-471538690.16590.82
64700847-470084789.88790.52
90min14941393-494139394.48792.231.5095.2893.021.49
24833280-483328092.42093.19
34735471-473547190.54991.34
44859061-485906192.91293.73
54783430-478343091.46692.27
64787715-478771591.54892.33
120min14963426-496342694.90892.601.5995.8693.551.58
24861602-486160292.96193.89
34742848-474284890.69091.63
44879885-487988593.31194.29
54801365-480136591.80992.77
64806513-480651391.90892.84
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14957980-495798094.80492.441.5695.9293.541.56
24851791-485179192.77393.86
34740404-474040490.64491.73
44864207-486420793.01194.14
54793174-479317491.65392.76
64797053-479705391.72792.82
缬沙坦片项目信息
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%
115.444475667447552544737924473751447383544745140.03
215.394458457445484344566500.06
单位质量响应值RSD%判断
289800.13289580.900.06数据可信
供试品溶液-24072501-3SP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%
5min11968843-196884337.88635.784.7937.8935.784.79
21845055-184505535.50435.50
31808505-180850534.80034.80
41752257-175225733.71833.72
51816545-181654534.95534.95
61966255-196625537.83637.84
10min12784927-278492753.58950.884.4753.6550.944.47
22620852-262085250.43250.49
32542584-254258448.92648.98
42539209-253920948.86148.92
52579867-257986749.64349.70
62798976-279897653.85953.92
15min13361301-336130164.68062.443.7164.8362.583.71
23269720-326972062.91863.06
33131617-313161760.26060.40
43139459-313945960.41160.55
53158075-315807560.76960.91
63408234-340823465.58365.74
20min13780801-378080172.75270.833.1773.0171.083.18
23723028-372302871.64071.89
33580587-358058768.90069.14
43581247-358124768.91269.15
53578410-357841068.85869.10
63841408-384140873.91874.18
30min14295029-429502982.64781.112.3683.0381.482.37
24282206-428220682.40082.77
34135408-413540879.57679.93
44131572-413157279.50279.86
54110954-411095479.10579.46
64335068-433506883.41883.80
45min14649304-464930489.46488.141.9489.9888.641.95
24679686-467968690.04990.55
34498467-449846786.56287.05
44493555-449355586.46786.95
54508213-450821386.74987.24
64653416-465341689.54390.07
60min14769995-476999591.78790.791.5692.4691.441.57
24775196-477519691.88792.54
34636663-463666389.22189.85
44643515-464351589.35389.98
54680094-468009490.05790.69
64804365-480436592.44893.12
90min14839878-483987893.13192.461.3493.9593.261.35
24851732-485173293.36094.17
34725899-472589990.93891.72
44727824-472782490.97591.75
54809819-480981992.55393.34
64874648-487464893.80194.63
120min14889246-488924694.08192.991.4295.0693.941.43
24862836-486283693.57394.54
34745125-474512591.30892.24
44752240-475224091.44592.38
54839394-483939493.12294.06
64905037-490503794.38595.37
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14861915-486191593.55692.731.4094.6993.841.41
24859187-485918793.50394.62
34736747-473674791.14792.23
44739708-473970891.20492.29
54818905-481890592.72893.82
64897606-489760694.24295.38
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