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(%)96.5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%
115.301318991322011319131319321319931319880.10
215.351314621315161314890.03
单位质量响应值RSD%判断
8626.678566.060.50数据可信
长期12月-供试品溶液-2024082021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%
5min170443-7044351.31451.301.4851.3151.301.48
268723-6872350.06150.06
370845-7084551.60751.61
471839-7183952.33152.33
569971-6997150.97050.97
670731-7073151.52451.52
10min1101160-10116073.68973.161.1373.7773.251.12
2101655-10165574.05074.13
398485-9848571.74171.83
4101033-10103373.59773.68
5100161-10016172.96273.05
6100144-10014472.94973.04
15min1110731-11073180.66181.701.6480.8781.911.63
2115324-11532484.00784.21
3110474-11047480.47480.68
4111047-11104780.89181.10
5112533-11253381.97482.18
6112875-11287582.22382.43
20min1115069-11506983.82185.821.8084.1686.161.80
2119110-11911086.76587.11
3116354-11635484.75785.10
4116725-11672585.02885.37
5118809-11880986.54686.89
6120793-12079387.99188.34
30min1120515-12051587.78888.471.6388.2788.961.62
2123373-12337389.87090.36
3117913-11791385.89386.37
4122554-12255489.27489.76
5122006-12200688.87489.36
6122348-12234889.12489.61
45min1118286-11828686.16587.371.2886.7988.001.28
2122461-12246189.20689.85
3118465-11846586.29586.92
4120542-12054287.80888.44
5119736-11973687.22187.86
6120158-12015887.52888.17
60min1118273-11827386.15587.641.6486.9388.421.63
2123155-12315589.71190.50
3119660-11966087.16687.93
4120797-12079787.99488.78
5121764-12176488.69889.48
6118248-11824886.13786.92
极限1124585-12458590.75390.420.6991.6791.340.69
2124970-12497091.03491.97
3123238-12323889.77290.69
4124619-12461990.77891.71
5124457-12445790.66091.59
6122865-12286589.50090.43
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%
116.104672864467052346701724670193466851746704540.04
216.114689964468964446898040.01
单位质量响应值RSD%判断
290090.31291111.360.25数据可信
长期12月-供试品溶液-2024082021批-缬沙坦-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%
5min14442140-444214085.21084.681.4185.2184.681.40
24302349-430234982.52982.53
34391590-439159084.24184.24
44469992-446999285.74585.74
54419555-441955584.77784.78
64461054-446105485.57385.57
10min15032826-503282696.54196.440.7896.6896.580.78
25012292-501229296.14796.28
34966194-496619495.26395.40
45047083-504708396.81596.96
55022491-502249196.34396.48
65083758-508375897.51897.66
15min15102883-510288397.88598.030.8698.1998.330.85
25132707-513270798.45798.75
35042623-504262396.72997.03
45126285-512628598.33498.64
55087685-508768597.59397.90
65169856-516985699.17099.47
20min15104294-510429497.91298.100.8898.3898.560.88
25143995-514399598.67499.14
35041908-504190896.71597.18
45129415-512941598.39498.86
55093878-509387897.71298.18
65170609-517060999.18499.65
30min15101414-510141497.85798.130.7998.4998.760.79
25148214-514821498.75599.38
35055852-505585296.98397.60
45129096-512909698.38899.02
55093639-509363997.70898.34
65166098-516609899.09899.73
45min15162051-516205199.02098.340.9499.8199.140.94
25155417-515541798.89399.68
35046893-504689396.81197.59
45130877-513087798.42299.22
55094320-509432097.72198.51
65171553-517155399.202100.00
60min15105130-510513097.92898.220.8398.8999.180.83
25152723-515272398.84199.80
35043862-504386296.75397.70
45122799-512279998.26799.23
55141452-514145298.62599.58
65156757-515675798.91899.88
极限15112592-511259298.07198.360.8999.1999.480.89
25189439-518943999.545100.67
35060314-506031497.06898.17
45141479-514147998.62599.75
55104663-510466397.91999.04
65158175-515817598.946100.08
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(%)96.5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%
115.301311211315591314301315331316751314640.17
215.351314201312431313320.10
单位质量响应值RSD%判断
8592.428555.830.31数据可信
长期12月-供试品溶液-2024082021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%
5min173104-7310453.39051.782.6153.3951.782.61
272152-7215252.69552.69
368225-6822549.82749.83
472124-7212452.67452.67
569870-6987051.02851.03
669942-6994251.08151.08
10min1103572-10357275.64175.201.5075.7375.281.50
2104672-10467276.44576.53
3104297-10429776.17176.25
4102416-10241674.79774.88
5102335-10233574.73874.82
6100491-10049173.39173.48
15min1117676-11767685.94283.092.3586.1683.302.35
2115115-11511584.07284.29
3115391-11539184.27384.48
4111031-11103181.08981.30
5111541-11154181.46181.67
6111898-11189881.72281.93
20min1123432-12343290.14687.252.3990.5087.602.39
2122334-12233489.34489.70
3119678-11967887.40487.75
4116865-11686585.35085.70
5117148-11714885.55685.90
6117317-11731785.68086.02
30min1123418-12341890.13588.782.2490.6489.272.24
2125322-12532291.52692.03
3122922-12292289.77390.27
4119607-11960787.35287.84
5118378-11837886.45586.94
6119699-11969987.41987.91
45min1123737-12373790.36888.052.5891.0388.692.57
2123134-12313489.92890.58
3122831-12283189.70790.35
4119668-11966887.39788.03
5116678-11667885.21385.85
6117311-11731185.67586.31
60min1126625-12662592.47887.903.6393.2988.693.62
2122458-12245889.43490.24
3121974-12197489.08189.88
4119937-11993787.59388.37
5114372-11437283.52984.30
6116775-11677585.28486.06
极限1126754-12675492.57290.541.3893.5491.481.38
2123390-12339090.11591.07
3125355-12535591.55092.49
4123138-12313889.93190.86
5122785-12278589.67390.59
6122439-12243989.42090.34
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%
116.104696464469298046921684702587471044446989290.17
216.114701544470389547027200.04
单位质量响应值RSD%判断
291858.94291913.100.02数据可信
长期12月-供试品溶液-2024082021批-缬沙坦-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%
5min14597477-459747787.80285.232.1687.8085.232.16
24546132-454613286.82186.82
34452192-445219285.02785.03
44460188-446018885.18085.18
54364409-436440983.35183.35
64355657-435565783.18383.18
10min15181410-518141098.95396.651.5599.1096.801.55
25103188-510318897.46097.60
35078797-507879796.99497.14
45043416-504341696.31896.46
54967260-496726094.86495.00
64992215-499221595.34095.48
15min15262972-5262972100.51197.961.63100.8298.261.63
25163040-516304098.60398.91
35148261-514826198.32098.62
45109110-510911097.57397.88
55020741-502074195.88596.18
65072834-507283496.88097.18
20min15285301-5285301100.93898.051.78101.4298.511.78
25163431-516343198.61099.08
35151001-515100198.37398.84
45106738-510673897.52797.99
55017587-501758795.82596.28
65079261-507926197.00397.46
30min15272747-5272747100.69898.041.69101.3498.671.69
25168521-516852198.70799.34
35151714-515171498.38699.02
45112541-511254197.63898.27
55022156-502215695.91296.53
65074045-507404596.90397.52
45min15285068-5285068100.93398.111.70101.7598.901.70
25155503-515550398.45999.26
35154216-515421698.43499.23
45121518-512151897.81098.60
55029510-502951096.05296.83
65076857-507685796.95797.74
60min15275049-5275049100.74298.001.69101.7298.951.69
25149273-514927398.34099.30
35155100-515510098.45199.41
45113216-511321697.65198.60
55021214-502121495.89496.83
65074309-507430996.90897.85
极限15265560-5265560100.56197.801.67101.7198.921.67
25139043-513904398.14499.27
35144834-514483498.25599.38
45099042-509904297.38098.50
55020982-502098295.89096.99
65057677-505767796.59097.70
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(%)96.5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%
115.301307951309861309231307371308941308670.08
215.351315561314971315260.04
单位质量响应值RSD%判断
8553.408568.470.13数据可信
长期12月-供试品溶液-2024082121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%
5min174501-7450154.49455.552.5654.4955.552.56
274918-7491854.79954.80
379455-7945558.11758.12
476372-7637255.86255.86
574181-7418154.26054.26
676212-7621255.74555.75
10min1105617-10561777.25377.371.3377.3477.461.33
2105703-10570377.31677.41
3107027-10702778.28578.38
4103131-10313175.43575.53
5106592-10659277.96778.06
6106561-10656177.94478.04
15min1115252-11525284.30183.860.8384.5284.080.82
2115625-11562584.57484.79
3114537-11453783.77884.01
4113879-11387983.29783.52
5115361-11536184.38184.60
6113233-11323382.82483.05
20min1118512-11851286.68687.470.8687.0587.830.85
2120003-12000387.77688.14
3119394-11939487.33187.70
4118700-11870086.82387.18
5121325-12132588.74389.10
6119539-11953987.43787.80
30min1118080-11808086.37087.441.2786.8787.941.26
2118867-11886786.94587.45
3119583-11958387.46987.98
4118511-11851186.68587.19
5122308-12230889.46289.97
6119890-11989087.69388.20
45min1120142-12014287.87887.682.0188.5388.342.00
2115160-11516084.23484.89
3120557-12055788.18188.84
4120607-12060788.21888.86
5122103-12210389.31289.97
6120690-12069088.27988.93
60min1120039-12003987.80288.251.2288.6089.051.21
2121139-12113988.60789.40
3122572-12257289.65590.46
4120897-12089788.43089.22
5121087-12108788.56989.38
6118159-11815986.42787.23
极限1125754-12575491.98392.240.8292.9293.180.81
2127344-12734493.14694.09
3125839-12583992.04593.00
4126501-12650192.52993.47
5124380-12438090.97891.93
6126792-12679292.74293.69
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%
116.104687944469042346906234691193469420046908770.05
216.114710980471091747109480.01
单位质量响应值RSD%判断
291358.82292423.840.26数据可信
长期12月-供试品溶液-2024082121批-缬沙坦-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%
5min14621764-462176488.26488.840.9288.2688.840.92
24659773-465977388.99088.99
34733584-473358490.40090.40
44625578-462557888.33788.34
54643229-464322988.67488.67
64627160-462716088.36788.37
10min15072042-507204296.86397.710.7397.0197.850.73
25111064-511106497.60997.76
35161280-516128098.56898.72
45074848-507484896.91797.06
55132357-513235798.01598.16
65145299-514529998.26298.41
15min15103147-510314797.45798.830.9297.7799.140.92
25148043-514804398.31598.63
35245547-5245547100.177100.49
45177298-517729898.87399.18
55188135-518813599.08099.39
65187720-518772099.07299.38
20min15102805-510280597.45198.550.7697.9299.030.76
25149435-514943598.34198.82
35202557-520255799.35699.84
45132265-513226598.01398.49
55187900-518790099.07699.55
65187742-518774299.07399.55
30min15113302-511330297.65198.890.9598.2899.530.95
25158251-515825198.51099.15
35213386-521338699.563100.21
45142836-514283698.21598.85
55195485-519548599.22199.86
65245660-5245660100.179100.82
45min15109662-510966297.58298.670.7398.3899.480.73
25149728-514972898.34799.15
35209321-520932199.485100.30
45149970-514997098.35299.15
55179641-517964198.91899.72
65202491-520249199.355100.16
60min15101427-510142797.42498.540.7898.3899.510.78
25148668-514866898.32799.29
35205197-520519799.406100.39
45133990-513399098.04699.01
55169738-516973898.72999.70
65199980-519998099.307100.28
极限15109887-510988797.58698.870.8798.71100.000.86
25170597-517059798.74599.88
35213098-521309899.557100.70
45186780-518678099.055100.18
55148161-514816198.31799.45
65233087-523308799.939101.08
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(%)96.5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%
115.301318641322001330381335911336271328640.61
215.351317011321601319300.25
单位质量响应值RSD%判断
8683.928594.790.73数据可信
长期12月-供试品溶液-2024082121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%
5min173564-7356453.32153.232.8853.3253.232.88
273313-7331353.13953.14
375397-7539754.65054.65
469408-6940850.30950.31
574269-7426953.83253.83
674650-7465054.10854.11
10min1104042-10404275.41376.451.7675.5076.541.76
2105950-10595076.79676.88
3105830-10583076.70976.80
4102928-10292874.60574.69
5105764-10576476.66176.75
6108319-10831978.51378.60
15min1113685-11368582.40283.931.8682.6284.151.86
2114794-11479483.20683.42
3114251-11425182.81283.03
4116173-11617384.20684.41
5116213-11621384.23584.45
6119668-11966886.73986.96
20min1119679-11967986.74787.700.9287.1088.060.92
2120417-12041787.28287.64
3120166-12016687.10087.46
4121269-12126987.89988.25
5121804-12180488.28788.64
6122633-12263388.88889.25
30min1119627-11962786.70987.182.1987.2187.692.18
2122690-12269088.92989.43
3117586-11758685.23085.73
4119811-11981186.84287.34
5117852-11785285.42385.93
6124128-12412889.97290.49
45min1120623-12062387.43188.771.5388.0789.421.53
2124896-12489690.52891.18
3121674-12167488.19388.84
4120777-12077787.54388.18
5122271-12227188.62689.27
6124597-12459790.31190.98
60min1120952-12095287.66988.671.9288.4689.461.91
2122633-12263388.88889.69
3120395-12039587.26688.06
4119857-11985786.87687.66
5124529-12452990.26291.06
6125594-12559491.03491.85
极限1125580-12558091.02488.814.1091.9689.754.06
2123248-12324889.33490.28
3123634-12363489.61390.55
4112472-11247281.52382.45
5125390-12539090.88691.83
6124812-12481290.46791.43
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%
116.104724158474530447707944791014479038247643300.62
216.114717217474271947299680.39
单位质量响应值RSD%判断
295921.12293604.470.56数据可信
长期12月-供试品溶液-2024082121批-缬沙坦-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%
5min14641584-464158487.78085.923.4387.7885.923.43
24616141-461614187.29987.30
34641375-464137587.77687.78
44236371-423637180.11780.12
54530829-453082985.68685.69
64593038-459303886.86286.86
10min15090999-509099996.27995.991.0696.4396.131.07
25111786-511178696.67296.82
35092340-509234096.30596.45
44995716-499571694.47794.61
55025788-502578895.04695.19
65136712-513671297.14497.29
15min15141790-514179097.24097.210.6797.5597.510.67
25149620-514962097.38897.69
35136987-513698797.14997.46
45147674-514767497.35197.64
55079134-507913496.05596.36
65184604-518460498.05098.36
20min15153648-515364897.46497.680.4197.9398.140.41
25161990-516199097.62298.09
35133088-513308897.07597.54
45173037-517303797.83198.28
55173108-517310897.83298.29
65194872-519487298.24498.71
30min15155909-515590997.50797.580.5598.1498.210.54
25165184-516518497.68298.31
35146379-514637997.32797.96
45183977-518397798.03898.65
55115071-511507196.73597.36
65192926-519292698.20798.84
45min15152114-515211497.43597.510.3598.2398.300.34
25154607-515460797.48298.28
35147108-514710897.34098.13
45180491-518049197.97298.75
55130596-513059697.02897.81
65170027-517002797.77498.57
60min15149672-514967297.38997.430.2698.3598.380.25
25145782-514578297.31598.27
35142412-514241297.25298.21
45169869-516986997.77198.71
55137683-513768397.16298.11
65166256-516625697.70398.66
极限15156465-515646597.51797.330.3898.6498.440.37
25138393-513839397.17698.29
35128343-512834396.98698.10
45176691-517669197.90099.01
55126513-512651396.95198.06
65151700-515170097.42798.55
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