阿齐沙坦氨氯地平片项目信息
介质体积(ml) 900 取样体积(ml)5补液体积(ml)0
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.632768122769012771182766412771832769310.09
210.692773622772422773020.04
单位质量响应值RSD%判断
26051.8325940.320.31数据可信
供试品溶液-2026050921批-阿齐沙坦-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%
5min1162807-16280756.19652.0022.1256.2052.0022.12
2100456-10045634.67434.67
3120718-12071841.66841.67
4177265-17726561.18661.19
5156747-15674754.10454.10
6185843-18584364.14764.15
10min1265246-26524691.55586.997.1591.8787.287.19
2230219-23021979.46479.66
3231907-23190780.04780.28
4267100-26710092.19592.53
5247718-24771885.50585.81
6269892-26989293.15893.51
15min1271995-27199593.88490.905.3094.7191.675.36
2248280-24828085.69986.33
3245476-24547684.73185.41
4277021-27702195.61996.47
5261307-26130790.19590.97
6275971-27597195.25796.13
20min1266919-26691992.13291.793.8393.4793.063.90
2259221-25922189.47590.59
3250600-25060086.49987.65
4276197-27619795.33596.72
5265252-26525291.55792.83
6277326-27732695.72497.13
30min1270347-27034793.31592.513.3195.1794.303.38
2264137-26413791.17292.78
3253463-25346387.48889.12
4276124-27612495.30997.22
5266495-26649591.98693.77
6277579-27757995.81297.75
45min1270835-27083593.48493.012.8195.8695.312.89
2265751-26575191.72993.84
3257071-25707188.73390.85
4278588-27858896.16098.60
5269275-26927592.94595.24
6275215-27521594.99697.46
60min1271653-27165393.76692.932.5696.6695.752.61
2272026-27202693.89596.52
3256017-25601788.36990.98
4275345-27534595.04198.02
5268063-26806392.52795.34
6272307-27230793.99296.99
极限1276532-27653295.45095.830.7798.8699.160.80
2277456-27745695.76998.91
3278515-27851596.13599.23
4279627-27962796.519100.02
5274084-27408494.60597.93
6279546-27954696.491100.01
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml) 5补液体积(ml)0
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(%) 99.90对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.516877368965689566879568538688050.26
214.556907469091690820.02
单位质量响应值RSD%判断
4741.904747.900.09数据可信
供试品溶液-2026050921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%
5min156859-5685977.69273.6811.8877.6973.6811.88
250651-5065169.20969.21
342639-4263958.26258.26
456913-5691377.76677.77
560707-6070782.95082.95
655747-5574776.17276.17
10min164995-6499588.80986.796.2489.2487.206.26
266451-6645190.79891.18
356105-5610576.66276.99
464542-6454288.19088.62
566715-6671591.15991.62
662300-6230085.12685.55
15min167563-6756392.31890.384.1793.2491.274.20
268637-6863793.78594.67
361079-6107983.45884.21
465216-6521689.11190.03
567903-6790392.78293.75
666466-6646690.81991.71
20min165410-6541089.37691.205.4090.8192.595.37
273524-73524100.463101.87
362826-6282685.84587.06
466278-6627890.56291.98
566931-6693191.45492.94
665498-6549889.49690.90
30min167830-6783092.68391.922.8594.6293.822.86
269877-6987795.48097.45
365235-6523589.13790.83
464803-6480388.54790.47
567735-6773592.55394.54
668168-6816893.14495.04
45min167517-6751792.25591.874.5794.7094.284.52
271975-7197598.346100.84
365694-6569489.76491.95
464542-6454288.19090.60
569545-6954595.02697.53
664153-6415387.65890.07
60min167703-6770392.50990.414.1595.4793.334.08
270984-7098496.992100.04
365066-6506688.90691.59
465416-6541689.38492.29
564150-6415087.65490.69
663676-6367687.00789.91
极限165326-6532689.26190.652.8592.7494.082.84
267771-6777192.60296.19
365437-6543789.41392.59
465186-6518689.07092.47
569532-6953295.00898.53
664798-6479888.54091.93
阿齐沙坦氨氯地平片项目信息
介质体积(ml) 900 取样体积(ml)5补液体积(ml)0
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.632755692758272759242761212760392758960.08
210.692751872758912755390.19
单位质量响应值RSD%判断
25954.4725775.400.49数据可信
供试品溶液-2026050921批-阿齐沙坦-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%
5min1156548-15654854.31045.2320.4254.3145.2320.42
2120721-12072141.88141.88
3140685-14068548.80748.81
4160399-16039955.64655.65
593690-9369032.50332.50
6110162-11016238.21838.22
10min1267050-26705092.64587.383.8692.9587.633.87
2241826-24182683.89584.13
3242934-24293484.27984.55
4255442-25544288.61888.93
5256880-25688089.11789.30
6247063-24706385.71285.92
15min1274487-27448795.22691.832.7896.0492.572.78
2256404-25640488.95289.65
3258835-25883589.79590.53
4264283-26428391.68692.49
5272533-27253394.54895.22
6261710-26171090.79391.48
20min1273253-27325394.79792.512.3896.1493.752.38
2257956-25795689.49190.68
3264036-26403691.60092.84
4266721-26672192.53193.84
5274632-27463295.27696.48
6263299-26329991.34492.54
30min1272744-27274494.62193.512.3596.4995.272.32
2260351-26035190.32192.01
3265737-26573792.19093.94
4266578-26657892.48294.31
5276730-27673096.00497.73
6275076-27507695.43097.13
45min1270058-27005893.68992.942.0596.0995.222.02
2263339-26333991.35893.55
3261734-26173490.80193.06
4264757-26475791.85094.19
5275792-27579295.67897.94
6271793-27179394.29196.52
60min1274503-27450395.23193.042.3798.1595.842.35
2262049-26204990.91093.61
3267735-26773592.88395.65
4267217-26721792.70395.55
5276591-27659195.95598.75
6261000-26100090.54793.30
极限1276757-27675796.01396.242.2999.4699.552.24
2265314-26531492.04395.25
3278665-27866596.67599.95
4279105-27910596.828100.19
5281669-28166997.717101.05
6282966-28296698.167101.42
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml) 5补液体积(ml)0
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(%) 99.90对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.516862968863686666861868736687020.15
214.556848368745686140.28
单位质量响应值RSD%判断
4734.804715.740.29数据可信
供试品溶液-2026050921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%
5min158733-5873380.58673.9310.5180.5973.9310.52
250407-5040769.16269.16
359262-5926281.31281.31
458749-5874980.60880.61
546562-4656263.88763.89
649578-4957868.02568.02
10min168753-6875394.33485.589.9994.7885.999.97
266158-6615890.77491.16
368567-6856794.07994.53
459492-5949281.62882.08
554827-5482775.22775.58
656431-5643177.42877.81
15min169512-6951295.37688.268.8996.3589.148.88
268980-6898094.64695.53
366929-6692991.83292.81
465792-6579290.27291.17
559479-5947981.61082.38
655248-5524875.80576.61
20min165514-6551489.89087.557.3591.3988.927.36
269089-6908994.79596.21
368293-6829393.70395.19
463123-6312386.61088.01
558552-5855280.33881.56
658262-5826279.94081.17
30min169745-6974595.69690.195.2997.7092.055.29
269611-6961195.51297.45
363095-6309586.57188.58
466426-6642691.14293.03
564174-6417488.05289.72
661330-6133084.14985.82
45min170188-7018896.30389.256.6498.8491.626.64
268035-6803593.34995.82
368351-6835193.78396.27
462633-6263385.93788.33
560967-6096783.65185.81
660119-6011982.48884.63
60min168059-6805993.38290.536.0296.4593.396.02
268673-6867394.22597.21
369230-6923094.98998.00
466385-6638591.08593.95
564985-6498589.16491.79
658537-5853780.31782.92
极限170482-7048296.70794.364.19100.2997.724.01
267588-6758892.73696.25
367656-6765692.82996.36
466409-6640991.11894.49
573845-73845101.321104.44
666635-6663591.42894.47
阿齐沙坦氨氯地平片项目信息
介质体积(ml) 900 取样体积(ml)5补液体积(ml)0
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.632760782762632762102763832759432761750.07
210.692767842769552768700.05
单位质量响应值RSD%判断
25980.7125899.910.23数据可信
供试品溶液-2026050921批-阿齐沙坦-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%
5min1229179-22917979.27582.038.6779.2882.038.67
2214020-21402074.03274.03
3246668-24666885.32585.33
4269185-26918593.11493.11
5218801-21880175.68675.69
6244924-24492484.72284.72
10min1284324-28432498.35198.620.7298.7999.070.73
2285522-28552298.76599.18
3285935-28593598.90899.38
4287476-28747699.44199.96
5285825-28582598.87099.29
6281465-28146597.36297.83
15min1284837-28483798.52899.050.6999.51100.050.70
2287673-28767399.509100.47
3287553-28755399.468100.49
4288776-28877699.891100.96
5285562-28556298.77999.75
6283614-28361498.10599.12
20min1282936-28293697.87098.820.6399.40100.370.63
2286655-28665599.157100.67
3287615-28761599.489101.07
4285496-28549698.756100.38
5284368-28436898.36699.88
6287034-28703499.288100.84
30min1279016-27901696.51598.051.1098.59100.151.11
2284593-28459398.444100.51
3287336-28733699.392101.52
4286075-28607598.956101.13
5281476-28147697.36599.43
6282160-28216097.60299.71
45min1280827-28082797.14197.490.8299.76100.140.81
2285142-28514298.634101.24
3282185-28218597.611100.29
4283702-28370298.135100.86
5280170-28017096.91499.52
6279039-27903996.52299.17
60min1279548-27954896.69996.122.2799.8599.302.20
2281067-28106797.224100.38
3266457-26645792.17095.39
4284420-28442098.384101.65
5275382-27538295.25798.40
6280333-28033396.970100.16
极限1275245-27524595.21096.290.5998.90100.010.58
2279670-27967096.741100.44
3279380-27938096.640100.38
4278877-27887796.466100.28
5279018-27901896.515100.19
6277972-27797296.15399.88
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml) 5补液体积(ml)0
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(%) 99.90对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.516882668858689296883068626688140.17
214.556879968662687300.15
单位质量响应值RSD%判断
4742.524723.710.29数据可信
供试品溶液-2026050921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%
5min139910-3991054.66965.5210.1154.6765.5210.10
253225-5322572.90872.91
348205-4820566.03166.03
451877-5187771.06171.06
545071-4507161.73861.74
648682-4868266.68566.68
10min161755-6175584.59280.779.8684.9081.139.82
263228-6322886.61087.01
360741-6074183.20383.57
462694-6269485.87886.27
557526-5752678.79979.14
647843-4784365.53565.91
15min165508-6550889.73388.014.5190.5188.824.50
266305-6630590.82591.71
366457-6645791.03391.86
465346-6534689.51190.38
558929-5892980.72181.50
662960-6296086.24386.98
20min166811-6681191.51887.943.6492.7989.243.58
262509-6250985.62587.02
362278-6227885.30986.64
465703-6570390.00091.37
566350-6635090.88692.12
661557-6155784.32185.53
30min167390-6739092.31186.216.5594.0988.006.47
267712-6771292.75294.62
363381-6338186.81988.63
462377-6237785.44487.31
558292-5829279.84981.58
658452-5845280.06881.75
45min165303-6530389.45289.804.9591.7592.074.87
269989-6998995.87198.25
361744-6174484.57786.87
467572-6757292.56094.90
561984-6198484.90687.08
666743-6674391.42593.55
60min168211-6821193.43688.326.3296.2391.086.19
269061-6906194.60097.51
358094-5809479.57782.34
465143-6514389.23392.09
564446-6444688.27890.93
661888-6188884.77487.41
极限167206-6720692.05991.901.8395.3795.161.86
267695-6769592.72996.17
367212-6721292.06795.27
468659-6865994.04997.40
564959-6495988.98192.12
666795-6679591.49694.60
阿齐沙坦氨氯地平片项目信息
介质体积(ml) 900 取样体积(ml)5补液体积(ml)0
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.632770472765092764152766922769092767140.10
210.692769772774052771910.11
单位质量响应值RSD%判断
26031.4225929.930.28数据可信
供试品溶液-2026050921批-阿齐沙坦-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%
5min1275345-27534595.09789.337.3695.1089.337.36
2267609-26760992.42592.43
3276372-27637295.45295.45
4237383-23738381.98681.99
5262377-26237790.61890.62
6232769-23276980.39280.39
10min1292845-292845101.141100.291.31101.67100.781.29
2285360-28536098.55699.07
3288049-28804999.484100.01
4294589-294589101.743102.20
5287733-28773399.37599.88
6293676-293676101.428101.87
15min1293128-293128101.23999.721.30102.33100.781.28
2285339-28533998.54899.61
3283701-28370197.98399.07
4290136-290136100.205101.23
5288025-28802599.476100.53
6292086-292086100.879101.89
20min1289370-28937099.94199.291.26101.59100.901.23
2282521-28252197.57599.18
3284234-28423498.16799.79
4289364-28936499.939101.52
5287156-28715699.176100.78
6292295-292295100.951102.52
30min1287700-28770099.36498.680.97101.57100.840.95
2281217-28121797.12599.28
3284472-28447298.249100.42
4286184-28618498.840100.97
5285555-28555598.623100.78
6289156-28915699.867102.00
45min1286636-28663698.99698.511.77101.76101.221.72
2280375-28037596.83499.52
3281446-28144697.20499.92
4293857-293857101.490104.17
5282097-28209797.429100.14
6286977-28697799.114101.80
60min1286472-28647298.94097.940.95102.25101.200.94
2280711-28071196.950100.18
3281936-28193697.373100.63
4287295-28729599.224102.47
5281931-28193197.371100.62
6283119-28311997.782101.02
极限1287123-28712399.16597.431.47103.02101.231.43
2276494-27649495.49499.26
3279543-27954396.547100.35
4283464-28346497.901101.70
5279961-27996196.691100.48
6286039-28603998.790102.57
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml) 5补液体积(ml)0
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(%) 99.90对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.516873368778684776896968557687030.29
214.556890668642687740.28
单位质量响应值RSD%判断
4734.874726.740.13数据可信
供试品溶液-2026050921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%
5min141433-4143356.78364.8110.4856.7864.8110.48
251381-5138170.41670.42
343231-4323159.24759.25
453013-5301372.65372.65
550691-5069169.47069.47
643997-4399760.29660.30
10min163538-6353887.07785.305.4987.3985.665.47
261699-6169984.55684.95
356688-5668877.68978.02
465271-6527189.45289.86
560414-6041482.79583.18
665846-6584690.24090.57
15min163150-6315086.54587.395.5787.3488.235.56
266070-6607090.54791.41
357092-5709278.24379.00
465129-6512989.25790.16
564141-6414187.90388.75
667036-6703691.87192.71
20min166707-6670791.42089.575.5792.7090.885.56
266880-6688091.65793.02
357943-5794379.40980.60
466862-6686291.63293.03
567167-6716792.05093.38
666567-6656791.22892.57
30min166587-6658791.25590.524.3593.0492.344.34
264093-6409387.83789.71
361785-6178584.67486.31
469567-6956795.33997.24
565702-6570290.04291.89
668562-6856293.96295.82
45min168004-6800493.19791.474.5095.4993.794.48
264821-6482188.83591.20
362698-6269885.92688.03
469496-6949695.24297.68
565084-6508489.19691.54
670352-7035296.41598.79
60min170014-7001495.95293.184.4698.7696.014.44
269566-6956695.33898.19
362371-6237185.47788.06
470299-7029996.34399.31
568957-6895794.50397.34
666751-6675191.48094.39
极限169664-6966495.47291.655.0698.8295.004.98
265209-6520989.36792.75
362886-6288686.18389.24
469343-6934395.03298.53
563586-6358687.14390.51
670576-7057696.722100.14
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