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 1140341138471140641139011137731139240.11
214.091153911150481152200.22
单位质量响应值RSD%判断
8096.948177.430.70数据可信
供试品溶液-2024081921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%
5min170731-7073154.88354.405.6854.8854.405.68
272785-7278556.47756.48
368028-6802852.78552.79
465710-6571050.98750.99
567066-6706652.03952.04
676328-7632859.22659.23
10min1105692-10569282.01081.732.1682.1081.822.16
2104995-10499581.47081.56
3107037-10703783.05483.14
4103785-10378580.53180.62
5102072-10207279.20279.29
6108430-10843084.13584.23
15min1121813-12181394.51992.062.3794.7592.282.37
2118927-11892792.28092.51
3121181-12118194.02994.26
4115310-11531089.47389.69
5115280-11528089.45089.67
6119330-11933092.59392.83
20min1124147-12414796.33096.121.3196.7296.501.31
2122153-12215394.78395.17
3126252-12625297.96498.35
4123111-12311195.52695.89
5122446-12244695.01095.38
6125168-12516897.12397.52
30min1130765-130765101.46699.492.42102.01100.032.41
2128120-12812099.41399.95
3131109-131109101.732102.28
4129306-129306100.333100.86
5122620-12262095.14595.67
6127431-12743198.87999.43
45min1131647-131647102.150100.211.73102.87100.911.72
2127669-12766999.06399.77
3131703-131703102.193102.91
4129757-129757100.683101.38
5127596-12759699.00799.69
6126483-12648398.14398.86
60min1127728-12772899.10999.722.3499.99100.592.33
2132186-132186102.568103.44
3131495-131495102.032102.92
4128670-12867099.840100.70
5124140-12414096.32597.17
6126844-12684498.42399.31
极限1133190-133190103.347101.341.90104.40102.381.88
2126785-12678598.37799.42
3133422-133422103.527104.58
4130567-130567101.312102.34
5130150-130150100.988102.00
6129543-129543100.517101.56
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%
115.94 4636934463619346374824637202463565846366940.02
215.954670541467133346709370.02
单位质量响应值RSD%判断
290884.19292848.710.48数据可信
供试品溶液-2024081921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%
5min14619044-461904488.22085.752.8888.2285.752.88
24582966-458296687.53187.53
34527279-452727986.46886.47
44374366-437436683.54783.55
54289635-428963581.92981.93
64543525-454352586.77886.78
10min15251952-5251952100.30898.282.10100.4698.422.10
25198857-519885799.29499.44
35262148-5262148100.503100.65
45049017-504901796.43396.57
55007583-500758395.64195.78
65103528-510352897.47497.62
15min15342729-5342729102.042100.401.83102.36100.711.83
25305706-5305706101.335101.65
35376826-5376826102.693103.01
45159545-515954598.54498.84
55179772-517977298.93099.23
65177412-517741298.88599.19
20min15346293-5346293102.110100.611.78102.59101.091.78
25319032-5319032101.590102.07
35385338-5385338102.856103.34
45173509-517350998.81099.27
55211220-521122099.53199.99
65172099-517209998.78399.26
30min15456770-5456770104.220101.122.17104.87101.762.17
25326691-5326691101.736102.39
35388334-5388334102.913103.57
45187913-518791399.08599.71
55233933-523393399.964100.59
65172844-517284498.79899.43
45min15348875-5348875102.160100.711.67102.99101.521.67
25322965-5322965101.665102.48
35376766-5376766102.692103.52
45190076-519007699.12799.92
55231159-523115999.911100.70
65168486-516848698.71499.52
60min15335044-5335044101.895100.541.66102.89101.521.66
25314851-5314851101.510102.50
35370496-5370496102.573103.57
45184233-518423399.01599.97
55216364-521636499.629100.59
65163153-516315398.61299.58
极限15350325-5350325102.187100.811.63103.36101.961.63
25313535-5313535101.485102.64
35377276-5377276102.702103.87
45263168-5263168100.523101.65
55212605-521260599.557100.68
65152254-515225498.40499.53
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 1141781140621139091139401139531140080.10
214.091150971148701149840.14
单位质量响应值RSD%判断
8102.918160.680.51数据可信
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%
5min169644-6964454.07554.774.6954.0754.774.70
268746-6874653.37753.38
368455-6845553.15153.15
467144-6714452.13352.13
575501-7550158.62258.62
673734-7373457.25057.25
10min1106716-10671682.85981.522.7882.9581.612.78
2100774-10077478.24578.33
3103350-10335080.24580.33
4103622-10362280.45780.54
5108711-10871184.40884.51
6106788-10678882.91583.01
15min1122936-12293695.45391.084.5295.6891.304.50
2118479-11847991.99292.21
3113304-11330487.97488.20
4119627-11962792.88493.10
5108716-10871684.41284.65
6120739-12073993.74793.98
20min1127419-12741998.93497.871.3499.3298.251.35
2123062-12306295.55195.92
3125232-12523297.23597.60
4126578-12657898.28198.66
5126438-12643898.17298.55
6127564-12756499.04699.44
30min1129017-129017100.17499.330.64100.7399.870.64
2126881-12688198.51699.05
3127371-12737198.89699.43
4127963-12796399.35699.90
5127647-12764799.11199.65
6128702-12870299.930100.48
45min1132528-132528102.900100.431.74103.62101.141.72
2128679-12867999.912100.61
3130904-130904101.639102.34
4129937-129937100.889101.59
5126339-12633998.09598.80
6127716-12771699.16499.89
60min1132824-132824103.130101.291.82104.02102.161.81
2131284-131284101.935102.80
3128118-12811899.476100.34
4128441-12844199.727100.60
5133423-133423103.595104.47
6128631-12863199.875100.76
极限1137795-137795106.990102.523.35108.05103.563.32
2133176-133176103.404104.44
3132059-132059102.536103.57
4128917-128917100.097101.14
5134934-134934104.769105.81
6125333-12533397.31498.37
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%
115.94 4662578465601946564354651563465086346554920.11
215.954675020468123246781260.10
单位质量响应值RSD%判断
292063.49293299.440.30数据可信
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%
5min14475609-447560985.24283.192.1485.2483.192.14
24344812-434481282.75182.75
34272196-427219681.36881.37
44250643-425064380.95880.96
54445866-444586684.67684.68
64417114-441711484.12884.13
10min15241718-524171899.83497.841.6399.9897.981.63
25144715-514471597.98698.12
35015272-501527295.52195.66
45067247-506724796.51196.65
55198086-519808699.00399.14
65153941-515394198.16298.30
15min15386591-5386591102.59399.961.46102.90100.271.46
25235355-523535599.712100.01
35160576-516057698.28898.58
45209557-520955799.22199.52
55229601-522960199.60399.91
65270020-5270020100.373100.68
20min15398812-5398812102.826100.591.48103.31101.061.48
25249648-524964899.985100.45
35188408-518840898.81899.28
45233263-523326399.673100.13
55347167-5347167101.842102.31
65271431-5271431100.399100.87
30min15403988-5403988102.924100.972.18103.57101.612.17
25246151-524615199.918100.55
35184044-518404498.73599.36
45226417-522641799.542100.17
55480923-5480923104.389105.03
65267502-5267502100.325100.96
45min15393082-5393082102.716100.541.43103.54101.341.43
25246102-524610299.917100.72
35191227-519122798.87299.66
45234226-523422699.691100.48
55344820-5344820101.797102.61
65263757-5263757100.253101.06
60min15387335-5387335102.607100.431.44103.60101.401.44
25243698-524369899.871100.84
35179929-517992998.65799.61
45229017-522901799.592100.55
55335447-5335447101.619102.60
65261454-5261454100.209101.18
极限15378238-5378238102.434100.411.39103.60101.551.39
25228038-522803899.573100.71
35171892-517189298.50499.62
45275661-5275661100.480101.61
55326482-5326482101.448102.60
65250965-5250965100.010101.15
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 1134631135211138921136851134911136100.16
214.091152191154331153260.14
单位质量响应值RSD%判断
8074.638184.950.96数据可信
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%
5min172220-7222056.09057.362.5556.0957.362.55
275801-7580158.87258.87
372681-7268156.44856.45
475978-7597859.00959.01
574733-7473358.04258.04
671715-7171555.69855.70
10min1104670-10467081.29380.352.2781.3980.442.27
2106858-10685882.99283.09
3100487-10048778.04478.14
4103869-10386980.67180.77
5103686-10368680.52980.63
6101146-10114678.55678.65
15min1117827-11782791.51290.791.5091.7491.021.50
2119533-11953392.83793.07
3115906-11590690.02090.24
4117726-11772691.43391.67
5115062-11506289.36489.60
6115311-11531189.55889.78
20min1122303-12230394.98895.501.7995.3795.881.79
2125729-12572997.64998.04
3125345-12534597.35197.72
4122982-12298295.51595.90
5121092-12109294.04794.43
6120342-12034293.46593.84
30min1125525-12552597.49096.353.2398.0396.893.22
2125572-12557297.52798.08
3126965-12696598.60999.15
4127319-12731998.88499.43
5116779-11677990.69891.23
6122161-12216194.87895.41
45min1125428-12542897.41597.282.2698.1297.982.25
2125705-12570597.63098.35
3128199-12819999.567100.27
4127935-12793599.362100.07
5123582-12358295.98196.67
6120684-12068493.73194.42
60min1126913-12691398.56896.921.8599.4397.781.83
2126329-12632998.11598.99
3125758-12575897.67198.54
4121537-12153794.39395.27
5122230-12223094.93195.78
6125992-12599297.85398.70
极限1130624-130624101.451101.911.79102.48102.941.78
2134168-134168104.203105.25
3132868-132868103.193104.22
4131310-131310101.983103.02
5131050-131050101.781102.79
6127274-12727498.84999.85
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%
115.94 4644914464670646496994653558465088646491530.08
215.954687305469163946894720.07
单位质量响应值RSD%判断
291665.81294010.780.57数据可信
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%
5min14571360-457136087.02087.851.1087.0287.851.10
24683642-468364289.15889.16
34569547-456954786.98686.99
44653133-465313388.57788.58
54639913-463991388.32588.33
64571304-457130487.01987.02
10min15145567-514556797.95198.490.9698.1098.640.96
25222880-522288099.42399.57
35189363-518936398.78598.93
45223511-522351199.43599.58
55166461-516646198.34998.50
65095277-509527796.99497.14
15min15204159-520415999.06699.731.0799.37100.041.07
25289181-5289181100.685101.00
35303554-5303554100.958101.27
45258893-5258893100.108100.42
55221257-522125799.39299.70
65155806-515580698.14698.45
20min15208077-520807799.14199.821.1699.61100.301.16
25294065-5294065100.778101.26
35317303-5317303101.220101.70
45265049-5265049100.225100.71
55225065-522506599.46499.94
65152656-515265698.08698.56
30min15217380-521738099.31899.871.1999.96100.511.19
25299894-5299894100.889101.54
35321030-5321030101.291101.94
45267669-5267669100.275100.92
55220291-522029199.373100.02
65151874-515187498.07198.70
45min15215419-521541999.28199.901.06100.08100.701.06
25294219-5294219100.781101.60
35318175-5318175101.237102.05
45265692-5265692100.238101.05
55224695-522469599.457100.27
65168006-516800698.37899.18
60min15181251-518125198.630100.001.5599.60100.981.54
25367495-5367495102.176103.16
35326656-5326656101.398102.38
45261743-5261743100.162101.14
55220266-522026699.373100.35
65162896-516289698.28199.24
极限15215465-521546599.281100.181.15100.42101.331.15
25308375-5308375101.050102.21
35322214-5322214101.314102.47
45313643-5313643101.150102.30
55237509-523750999.701100.84
65179202-517920298.59199.72
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