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)5
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%
110.652776372775482773162779202778582776560.09
210.682779712778152778930.04
单位质量响应值RSD%判断
26070.9926019.940.14数据可信
长期24月-供试品溶液-2023101221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%
5min193342-9334232.15829.3129.7732.1629.3129.76
292742-9274231.95131.95
389604-8960430.87030.87
461076-6107621.04121.04
5122064-12206442.05342.05
651690-5169017.80817.81
10min1268164-26816492.38691.033.8092.5691.193.84
2269663-26966392.90293.08
3269922-26992292.99293.16
4247690-24769085.33285.45
5273640-27364094.27394.51
6256226-25622688.27388.37
15min1288893-28889399.52799.161.85100.2299.831.83
2291883-291883100.558101.25
3284110-28411097.88098.57
4295464-295464101.791102.38
5285720-28572098.43499.19
6280962-28096296.79597.38
20min1291272-291272100.34799.801.50101.59101.021.50
2293552-293552101.133102.38
3287012-28701298.879100.11
4293873-293873101.243102.40
5289817-28981799.846101.15
6282541-28254197.33998.47
30min1285306-28530698.29298.671.80100.09100.441.75
2290230-29023099.988101.80
3284234-28423497.92299.70
4294809-294809101.566103.28
5281230-28123096.88798.75
6282598-28259897.35999.03
45min1287212-28721298.94898.871.45101.30101.201.44
2286829-28682998.816101.19
3287968-28796899.209101.53
4293579-293579101.142103.43
5285728-28572898.437100.83
6280674-28067496.69698.90
60min1285882-28588298.49098.991.67101.39101.861.63
2291091-291091100.285103.20
3285830-28583098.472101.35
4295040-295040101.645104.49
5283266-28326697.589100.53
6282906-28290697.465100.21
极限1282459-28245997.31198.601.78100.76102.021.69
2287414-28741499.018102.49
3280769-28076996.729100.15
4293919-293919101.259104.67
5282773-28277397.419100.91
6289866-28986699.863103.15
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)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%
114.917031470347700557037770271702730.19
214.877039369919701560.48
单位质量响应值RSD%判断
4713.154717.960.08数据可信
长期24月-供试品溶液-2023101221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%
5min142504-4250458.43961.304.5058.4461.294.49
247941-4794165.91465.91
343910-4391060.37260.37
445751-4575162.90362.90
542971-4297159.08159.08
644412-4441261.06261.06
10min168559-6855994.26287.664.3694.5988.004.34
262054-6205485.31885.68
362372-6237285.75586.09
465466-6546690.00990.36
561053-6105383.94284.27
663046-6304686.68287.02
15min169832-6983296.01291.013.8796.8691.843.85
264166-6416688.22289.06
365873-6587390.56991.38
468726-6872694.49195.34
563396-6339687.16387.96
665187-6518789.62690.45
20min169520-6952095.58392.243.0996.9693.573.08
264647-6464788.88390.21
367348-6734892.59793.91
469503-6950395.56096.93
565548-6554890.12291.40
665966-6596690.69792.02
30min169341-6934195.33792.273.1897.2594.123.17
265502-6550290.05991.88
367516-6751692.82894.66
469679-6967995.80297.71
564340-6434088.46190.24
666297-6629791.15292.97
45min169729-6972995.87092.752.9498.3195.102.94
265385-6538589.89892.22
368414-6841494.06296.41
469472-6947295.51797.95
565541-6554190.11292.38
666210-6621091.03293.36
60min169994-6999496.23593.842.9299.2196.722.92
266843-6684391.90294.73
368716-6871694.47897.35
470961-7096197.564100.53
565758-6575890.41193.18
667247-6724792.45895.29
极限169091-6909194.99392.382.8998.5095.772.87
265618-6561890.21893.55
365382-6538289.89493.29
469843-6984396.02799.54
565672-6567290.29293.57
667525-6752592.84096.19
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)5
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%
110.652778822772412774352773442771982774200.10
210.682778572776032777300.07
单位质量响应值RSD%判断
26048.8326004.680.12数据可信
长期24月-供试品溶液-2024010621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%
5min1153743-15374353.00551.2614.8653.0051.2614.86
2168633-16863358.13858.14
3144070-14407049.67049.67
4112735-11273538.86738.87
5173529-17352959.82659.83
6139453-13945348.07848.08
10min1295699-295699101.94599.261.41102.2499.551.41
2287963-28796399.27899.60
3286830-28683098.88899.16
4284966-28496698.24598.46
5284580-28458098.11298.44
6287504-28750499.12099.39
15min1300448-300448103.583100.931.36104.44101.771.35
2292224-292224100.747101.62
3291942-291942100.650101.48
4291542-291542100.512101.27
5288871-28887199.591100.47
6291515-291515100.503101.32
20min1297832-297832102.681100.671.19104.12102.071.18
2293636-293636101.234102.67
3290313-290313100.089101.47
4291345-291345100.444101.76
5287641-28764199.167100.60
6291314-291314100.434101.81
30min1300743-300743103.68499.952.23105.69101.902.22
2294903-294903101.671103.67
3285118-28511898.298100.24
4286419-28641998.746100.62
5285063-28506398.279100.26
6287183-28718399.009100.94
45min1297617-297617102.60799.541.82105.19102.051.80
2288663-28866399.520102.08
3288756-28875699.552102.04
4285932-28593298.578101.00
5281704-28170497.12199.65
6289679-28967999.870102.35
60min1295783-295783101.97499.651.34105.13102.711.35
2289424-28942499.782102.90
3288795-28879599.565102.60
4284672-28467298.144101.12
5286017-28601798.607101.67
6289494-28949499.806102.85
极限1291940-291940100.64999.121.29104.37102.741.30
2291622-291622100.540104.21
3288386-28838699.424103.02
4285458-28545898.415101.93
5283455-28345597.724101.34
6284234-28423497.993101.59
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)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%
114.917029170412708807021870146703890.42
214.877034570135702400.22
单位质量响应值RSD%判断
4720.934723.600.04数据可信
长期24月-供试品溶液-2024010621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%
5min151835-5183571.16768.758.6171.1768.758.61
253297-5329773.17473.17
347583-4758365.32965.33
442618-4261858.51258.51
550962-5096269.96869.97
654171-5417174.37474.37
10min164850-6485089.03586.803.5289.4387.183.53
266198-6619890.88691.29
362173-6217385.36085.72
460335-6033582.83783.16
561570-6157084.53284.92
664204-6420488.14988.56
15min166796-6679691.70789.782.2692.6090.642.28
267461-6746192.62093.53
364914-6491489.12389.96
463838-6383887.64688.43
563986-6398687.84988.71
665363-6536389.74090.64
20min166830-6683091.75490.962.2793.1592.322.28
268507-6850794.05695.48
365343-6534389.71291.04
465233-6523389.56190.83
564464-6446488.50689.85
667120-6712092.15293.55
30min168230-6823093.67691.623.0695.5993.493.06
270074-7007496.20898.16
365351-6535189.72391.55
465240-6524089.57191.34
564952-6495289.17691.01
666549-6654991.36893.28
45min168235-6823593.68392.022.7296.1194.402.72
268790-6879094.44596.93
367364-6736492.48794.82
465280-6528089.62691.89
564296-6429688.27590.61
668187-6818793.61796.04
60min168879-6887994.56793.171.8797.5296.061.89
268554-6855494.12197.13
368131-6813193.54096.38
466057-6605790.69393.46
566533-6653391.34694.17
669034-6903494.78097.72
极限168223-6822393.66692.671.6197.1496.071.63
268711-6871194.33697.87
368314-6831493.79197.15
466314-6631491.04594.31
566185-6618590.86894.20
667221-6722192.29195.76
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)5
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%
110.652776462778032781642783632780572780070.11
210.682779182777202778190.06
单位质量响应值RSD%判断
26103.9426013.010.25数据可信
长期24月-供试品溶液-2024010721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%
5min1141205-14120548.62348.9218.0748.6248.9218.07
2149481-14948151.47351.47
3118274-11827440.72740.73
4107521-10752137.02437.02
5176288-17628860.70360.70
6159569-15956954.94654.95
10min1291436-291436100.35498.601.97100.6298.872.00
2284151-28415197.84598.13
3286966-28696698.81499.04
4277792-27779295.65595.86
5293423-293423101.038101.38
6284285-28428597.89198.20
15min1297216-297216102.344100.231.86103.17101.051.87
2287108-28710898.86399.69
3292700-292700100.789101.56
4285611-28561198.34899.08
5297342-297342102.387103.29
6286544-28654498.66999.52
20min1294988-294988101.57799.871.71102.97101.241.73
2285972-28597298.47299.85
3291027-291027100.213101.55
4285345-28534598.25699.54
5296602-296602102.133103.60
6286188-28618898.54799.94
30min1294794-294794101.51099.341.92103.47101.271.93
2283289-28328997.54899.47
3291647-291647100.426102.32
4282842-28284297.39499.22
5293816-293816101.173103.21
6284591-28459197.99799.94
45min1290838-290838100.14899.662.65102.67102.142.65
2282741-28274197.36099.83
3287496-28749698.997101.45
4280331-28033196.53098.90
5301274-301274103.741106.34
6293801-293801101.168103.66
60min1298749-298749102.87298.512.78105.95101.542.75
2278435-27843595.87798.89
3289697-28969799.755102.75
4277296-27729695.48598.39
5287881-28788199.130102.30
6284366-28436697.919100.97
极限1284980-28498098.13196.501.70101.78100.091.74
2277461-27746195.54199.08
3280974-28097496.751100.31
4272569-27256993.85797.29
5285109-28510998.175101.90
6280424-28042496.562100.16
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)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%
114.917045770568704357089970496705710.27
214.877076070484706220.28
单位质量响应值RSD%判断
4733.134749.290.25数据可信
长期24月-供试品溶液-2024010721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%
5min152300-5230071.51871.667.1071.5271.667.10
251772-5177270.79670.80
345704-4570462.49862.50
453271-5327172.84672.85
554777-5477774.90574.91
656589-5658977.38377.38
10min164983-6498388.86287.761.5189.2688.161.52
264404-6440488.07088.46
362634-6263485.65086.00
464749-6474988.54288.95
564944-6494488.80889.22
663368-6336886.65387.08
15min166264-6626490.61490.141.3991.5091.031.39
265726-6572689.87890.76
365126-6512689.05789.88
466900-6690091.48392.38
566842-6684291.40492.31
664665-6466588.42789.34
20min166089-6608990.37490.411.8391.7791.801.81
266185-6618590.50591.89
365948-6594890.18191.50
467188-6718891.87793.28
567315-6731592.05193.47
663959-6395987.46288.86
30min165840-6584090.03490.931.4691.9392.821.42
265919-6591990.14292.03
367209-6720991.90693.72
468139-6813993.17795.09
566125-6612590.42392.35
665750-6575089.91191.80
45min166637-6663791.12491.531.0393.5293.920.99
267368-6736892.12394.51
367552-6755292.37594.70
467187-6718791.87694.31
567167-6716791.84894.28
665683-6568389.81992.21
60min169016-6901694.37792.411.9297.2895.311.84
267290-6729092.01794.91
369090-6909094.47897.32
467700-6770092.57795.52
566026-6602690.28893.23
666336-6633690.71293.60
极限166323-6632390.69491.110.4794.1294.530.47
267067-6706791.71295.12
366365-6636590.75294.12
466692-6669291.19994.66
566903-6690391.48794.93
666429-6642990.83994.23
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)5
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%
110.652781622779792781062774912776362778750.11
210.682777562778352777960.03
单位质量响应值RSD%判断
26091.5526010.860.22数据可信
长期24月-供试品溶液-2024010921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%
5min1175275-17527560.37154.2917.1260.3754.3017.12
2129682-12968244.66744.67
3176090-17609060.65260.65
4188855-18885565.04965.05
5122835-12283542.30942.31
6153052-15305252.71752.72
10min1290447-290447100.041100.902.71100.38101.202.70
2293415-293415101.063101.31
3290328-290328100.000100.34
4290652-290652100.112100.47
5284761-28476198.08298.32
6308070-308070106.111106.40
15min1293071-293071100.945101.041.02101.84101.911.01
2298717-298717102.889103.70
3292497-292497100.747101.64
4293765-293765101.184102.10
5289639-28963999.763100.54
6292473-292473100.739101.62
20min1298862-298862102.939101.610.86104.39103.040.85
2296904-296904102.265103.65
3291780-291780100.500101.95
4293605-293605101.129102.61
5293856-293856101.215102.55
6295035-295035101.621103.06
30min1288060-28806099.219100.230.87101.24102.220.85
2294939-294939101.588103.54
3290758-290758100.148102.16
4291125-291125100.274102.32
5288726-28872699.448101.34
6292386-292386100.709102.72
45min1285996-28599698.50898.981.54101.08101.521.51
2294332-294332101.379103.89
3286429-28642998.657101.22
4286070-28607098.533101.13
5281291-28129196.88799.34
6290039-29003999.900102.47
60min1283024-28302497.48498.781.55100.61101.881.51
2294756-294756101.525104.60
3286103-28610398.545101.66
4286395-28639598.645101.79
5282547-28254797.320100.31
6287978-28797899.191102.31
极限1276968-27696895.39897.401.3499.06101.051.32
2284826-28482698.105101.75
3284241-28424197.903101.57
4284469-28446997.982101.68
5279365-27936596.22499.75
6286876-28687698.811102.48
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)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%
114.916984270045700626989170061699800.16
214.877058870255704220.34
单位质量响应值RSD%判断
4693.494735.840.64数据可信
长期24月-供试品溶液-2024010921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%
5min151670-5167071.05672.163.5971.0672.163.59
250402-5040269.31269.31
354475-5447574.91374.91
453556-5355673.64973.65
550424-5042469.34269.34
654313-5431374.69074.69
10min161931-6193185.16786.011.7485.5686.411.73
262663-6266386.17386.56
363884-6388487.85288.27
461033-6103383.93284.34
563645-6364587.52487.91
662112-6211285.41585.83
15min164024-6402488.04587.601.9888.9188.471.96
263868-6386887.83088.69
364598-6459888.83489.74
462551-6255186.01986.89
565246-6524689.72590.60
661898-6189885.12186.01
20min165651-6565190.28288.712.5891.6490.072.55
263600-6360087.46288.81
365999-6599990.76192.16
462876-6287686.46687.82
566292-6629291.16492.53
662620-6262086.11487.48
30min164162-6416288.23588.752.7590.0990.612.72
265049-6504989.45491.29
366502-6650291.45393.35
463031-6303186.67988.51
566358-6635891.25593.13
662123-6212385.43187.27
45min164998-6499889.38489.012.4091.7391.362.38
265343-6534389.85992.19
366081-6608190.87493.28
463073-6307386.73789.05
566287-6628791.15793.54
662582-6258286.06288.38
60min165182-6518289.63789.642.1592.4892.492.13
265980-6598090.73593.57
366436-6643691.36294.28
463658-6365887.54290.34
566525-6652591.48494.37
663327-6332787.08689.88
极限163419-6341987.21389.091.9290.5692.431.90
264381-6438188.53691.87
365886-6588690.60594.03
464008-6400888.02391.31
566693-6669391.71595.11
664313-6431388.44291.72
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