缬沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)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%
114.332530292525472526002522752521592525220.14
214.372524012525922524960.06
单位质量响应值RSD%判断
17621.9117571.050.21数据可信
长期24月-供试品溶液-BDJL7批-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%
5min156779-5677920.91725.7611.8120.9225.7611.79
265814-6581424.24624.25
376968-7696828.35528.35
475936-7593627.97527.97
577342-7734228.49328.49
666741-6674124.58724.59
10min1156113-15611357.51259.905.3157.5559.945.31
2156303-15630357.58257.62
3165273-16527360.88660.93
4171973-17197363.35563.40
5172824-17282463.66863.72
6153100-15310056.40256.44
15min1196408-19640872.35673.592.5772.4973.732.58
2195622-19562272.06772.20
3198204-19820473.01873.17
4204141-20414175.20575.36
5208035-20803576.64076.79
6196115-19611572.24972.38
20min1213263-21326378.56679.842.2778.8280.112.27
2213177-21317778.53478.79
3219172-21917280.74381.01
4218874-21887480.63380.91
5224333-22433382.64482.93
6211536-21153677.93078.19
30min1222845-22284582.09684.332.6982.4884.732.69
2222653-22265382.02582.41
3233519-23351986.02886.43
4232242-23224285.55885.97
5237059-23705987.33287.75
6225171-22517182.95383.34
45min1232669-23266985.71587.002.1586.2387.542.16
2231885-23188585.42685.95
3237210-23721087.38887.94
4238668-23866887.92588.48
5244646-24464690.12790.69
6231865-23186585.41985.94
60min1233793-23379386.12987.932.2486.7988.622.24
2235887-23588786.90187.57
3242315-24231589.26989.96
4241165-24116588.84589.55
5246178-24617890.69291.41
6232812-23281285.76886.43
极限1232992-23299285.83489.282.8686.6490.102.86
2238753-23875387.95688.77
3250514-25051492.28993.13
4243773-24377389.80690.65
5249685-24968591.98492.85
6238289-23828987.78588.59
缬沙坦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%
116.304697812469284446943434691222469294546938330.06
216.084709071471418347116270.08
单位质量响应值RSD%判断
287965.21293011.631.23数据可信
长期24月-供试品溶液-BDJL7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%
5min13558477-355847768.29174.905.7268.2974.915.73
23836624-383662473.62973.63
33995034-399503476.66976.67
44129887-412988779.25779.26
54125190-412519079.16779.17
63773447-377344772.41772.42
10min14740767-474076790.98194.573.0691.0994.693.07
24840681-484068192.89893.02
35044984-504498496.81996.95
45010377-501037796.15596.29
55119319-511931998.24598.38
64810172-481017292.31392.43
15min14936898-493689894.74597.692.7095.0197.982.70
25020135-502013596.34296.62
35209527-520952799.977100.27
45146466-514646698.76699.06
55268541-5268541101.109101.40
64961921-496192195.22595.50
20min14972997-497299795.43798.102.5895.8698.552.59
25040692-504069296.73697.17
35229773-5229773100.365100.82
45158292-515829298.99399.45
55285526-5285526101.435101.90
64984035-498403595.64996.08
30min14976829-497682995.51198.082.4996.0998.692.50
25037767-503776796.68097.28
35221943-5221943100.215100.84
45159927-515992799.02599.65
55278731-5278731101.305101.94
64989795-498979595.76096.35
45min14978032-497803295.53498.032.5296.2898.802.52
25032327-503232796.57697.34
35222186-5222186100.220101.01
45154509-515450998.92199.71
55278425-5278425101.299102.10
64982562-498256295.62196.37
60min15024577-502457796.42798.852.4997.3399.782.50
25074995-507499597.39598.32
35267373-5267373101.087102.04
45199335-519933599.781100.73
55316913-5316913102.037103.01
65021087-502108796.36097.27
极限15110697-511069798.08099.502.3399.14100.602.33
25089917-508991797.68198.76
35297680-5297680101.668102.79
45216312-5216312100.107101.22
55345256-5345256102.581103.72
65048656-504865696.88997.96
缬沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)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%
114.332520722520982519242520032526102521410.11
214.372531942530652531300.04
单位质量响应值RSD%判断
17595.3217615.170.08数据可信
长期24月-供试品溶液-BDJL7批-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%
5min174412-7441227.40026.635.3027.4026.625.31
271552-7155226.34726.35
374601-7460127.46927.47
467229-6722924.75524.75
577295-7729528.46128.46
668776-6877625.32425.32
10min1164983-16498360.74959.913.4560.7959.963.46
2158226-15822658.26158.31
3166947-16694761.47261.52
4154075-15407556.73356.77
5169009-16900962.23262.28
6162990-16299060.01560.06
15min1205301-20530175.59573.441.9375.7473.581.93
2194758-19475871.71371.85
3201694-20169474.26774.41
4196618-19661872.39872.53
5197694-19769472.79472.95
6200661-20066173.88674.03
20min1216162-21616279.59478.641.2079.8778.911.20
2211550-21155077.89678.16
3216734-21673479.80580.08
4211162-21116277.75378.01
5211336-21133677.81778.09
6214533-21453378.99479.26
30min1234483-23448386.34084.201.7286.7584.601.72
2224699-22469982.73883.13
3230795-23079584.98285.39
4224050-22405082.49982.88
5228230-22823084.03884.44
6229769-22976984.60485.00
45min1243841-24384189.78686.662.2390.3487.202.22
2234047-23404786.18086.71
3238515-23851587.82588.37
4230152-23015284.74585.27
5230242-23024284.77985.32
6235393-23539386.67587.21
60min1242215-24221589.18787.572.0489.8988.262.04
2231731-23173185.32786.00
3243190-24319089.54690.24
4233895-23389586.12486.79
5235095-23509586.56587.25
6240825-24082588.67589.36
极限1248879-24887991.64189.562.1192.4990.392.10
2233731-23373186.06386.88
3245971-24597190.57091.41
4242970-24297089.46590.27
5243517-24351789.66790.49
6244298-24429889.95490.78
缬沙坦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%
116.304696747470262146999934702729470883147021840.10
216.084723930472577947248540.03
单位质量响应值RSD%判断
288477.55293834.201.31数据可信
长期24月-供试品溶液-BDJL7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%
5min13937576-393757675.39475.862.3175.3975.862.31
23840885-384088573.54373.54
33968055-396805575.97875.98
43928015-392801575.21175.21
54119949-411994978.88678.89
63977127-397712776.15176.15
10min15023910-502391096.19494.681.5496.3294.811.54
24830060-483006092.48392.61
34995453-499545395.64995.78
44877655-487765593.39493.52
54949407-494940794.76894.90
64993462-499346295.61195.74
15min15199439-519943999.55598.001.4599.8498.291.44
24994969-499496995.64095.92
35153152-515315298.66998.95
45141008-514100898.43698.72
55068664-506866497.05197.34
65152961-515296198.66598.95
20min15221337-522133799.97498.051.51100.4398.501.51
25024603-502460396.20896.64
35168237-516823798.95899.41
45048981-504898196.67497.12
55095186-509518697.55998.01
65167814-516781498.95099.40
30min15229480-5229480100.13098.091.61100.7598.701.61
25021679-502167996.15296.75
35168784-516878498.96899.58
45048093-504809396.65797.26
55089524-508952497.45198.06
65180364-518036499.19099.81
45min15230665-5230665100.15397.981.61100.9498.761.61
25011836-501183695.96396.72
35159310-515931098.78799.57
45053927-505392796.76997.54
55080673-508067397.28198.06
65167726-516772698.94899.73
60min15264887-5264887100.80898.861.65101.7699.801.65
25052409-505240996.74097.66
35218376-521837699.918100.86
45095609-509560997.56798.50
55120653-512065398.04798.98
65228272-5228272100.107101.05
极限15280246-5280246101.10299.181.76102.22100.281.76
25047269-504726996.64297.72
35239370-5239370100.320101.43
45123816-512381698.10799.20
55136758-513675898.35599.46
65251849-5251849100.559101.67
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