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%
112.002869932869392869192870472871982870190.04
212.042869082867872868480.03
单位质量响应值RSD%判断
23918.2523824.580.28数据可信
供试品溶液-20220124批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14251-42511.5981.6939.721.601.7039.65
27175-71752.6972.70
35985-59852.2502.25
44233-42331.5911.59
52494-24940.9370.94
62915-29151.0961.10
10min162570-6257023.51921.9320.9523.5321.9420.95
279358-7935829.83029.84
360368-6036822.69222.70
449375-4937518.56018.57
553492-5349220.10720.11
644941-4494116.89316.90
15min1144092-14409254.16350.759.0254.3050.889.05
2149600-14960056.23356.41
3141358-14135853.13553.27
4119628-11962844.96745.08
5133298-13329850.10550.22
6122116-12211645.90246.00
20min1190524-19052471.61668.595.5072.0669.005.54
2196939-19693974.02774.52
3183462-18346268.96269.40
4169840-16984063.84164.20
5178922-17892267.25567.65
6175092-17509265.81566.17
30min1232124-23212487.25385.133.5088.0985.923.54
2238559-23855989.67290.58
3225368-22536884.71485.53
4216199-21619981.26781.98
5221361-22136183.20783.98
6225169-22516984.63985.36
45min1258045-25804596.99795.231.9398.3296.501.98
2259350-25935097.48798.89
3250532-25053294.17395.46
4247083-24708392.87694.04
5250031-25003193.98495.22
6255077-25507795.88197.07
60min1272918-272918102.587100.391.75104.45102.181.74
2267917-267917100.707102.65
3260242-26024297.82299.63
4264093-26409399.270100.95
5266045-266045100.004101.76
6271219-271219101.949103.67
极限1274806-274806103.297101.501.55105.73103.861.57
2273002-273002102.619105.12
3264383-26438399.379101.73
4267753-267753100.646102.88
5267070-267070100.389102.70
6273160-273160102.678104.97
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%
115.127363473418736337381973897736800.26
215.147394173589737650.34
单位质量响应值RSD%判断
4873.024872.190.02数据可信
供试品溶液-20220124批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122964-2296430.55630.9947.9030.5631.0047.90
242048-4204855.94855.95
319098-1909825.41125.41
422155-2215529.47929.48
57642-764210.16810.17
625851-2585134.39734.40
10min163834-6383484.93780.9618.0185.1181.1418.05
268929-6892991.71692.03
354973-5497373.14673.29
467809-6780990.22690.39
541190-4119054.80754.86
668354-6835490.95191.14
15min170905-7090594.34593.852.3794.9994.472.47
270816-7081694.22795.05
368207-6820790.75591.30
472480-7248096.44197.11
568903-6890391.68192.04
671878-7187895.64096.34
20min171885-7188595.64995.251.9196.8196.401.82
269478-6947892.44693.79
370470-7047093.76694.82
473032-7303297.17598.38
572724-7272496.76597.64
671929-7192995.70896.94
30min169877-6987792.97794.851.5494.6796.531.45
270127-7012793.31095.17
371098-7109894.60296.17
472205-7220596.07597.82
572359-7235996.28097.69
672058-7205895.87997.64
45min169605-6960592.61593.601.9594.8395.801.81
268003-6800390.48492.86
370421-7042193.70195.80
470982-7098294.44896.72
571716-7171695.42497.37
671347-7134794.93397.23
60min169772-6977292.83894.052.2995.5796.772.15
268676-6867691.37994.26
369633-6963392.65395.27
471089-7108994.59097.39
572998-7299897.13099.60
671922-7192295.69898.52
极限169152-6915292.01393.061.4395.2696.301.33
268904-6890491.68395.07
369135-6913591.99095.12
470569-7056993.89897.22
571246-7124694.79997.81
670640-7064093.99297.34
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%
112.002869482868692873582868312869212869850.08
212.042864042864882864460.03
单位质量响应值RSD%判断
23915.4223791.200.37数据可信
供试品溶液-20220124批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14242-42421.5961.9975.061.601.9974.97
24498-44981.6921.69
313289-132894.9995.00
43874-38741.4571.46
52710-27101.0191.02
63154-31541.1861.19
10min156382-5638221.21021.0919.8421.2221.1019.80
265740-6574024.73024.74
334785-3478513.08513.11
461625-6162523.18223.19
555380-5538020.83320.84
662404-6240423.47523.48
15min1137237-13723751.62549.7211.3851.7549.8511.38
2142085-14208553.44953.60
3102025-10202538.37938.48
4139615-13961552.52052.66
5133489-13348950.21550.34
6138544-13854452.11752.25
20min1188335-18833570.84767.167.7371.2667.567.75
2188251-18825170.81671.26
3153244-15324457.64757.96
4183914-18391469.18469.61
5171962-17196264.68865.09
6185498-18549869.78070.21
30min1231161-23116186.95784.004.7587.7684.784.79
2230779-23077986.81487.65
3205913-20591377.46078.09
4228132-22813285.81886.63
5214354-21435480.63581.39
6229509-22950986.33687.15
45min1258697-25869797.31694.284.1398.6195.534.17
2254754-25475495.83397.15
3234421-23442188.18489.25
4256735-25673596.57897.87
5240901-24090190.62191.83
6258292-25829297.16398.46
60min1271232-271232102.031100.722.51103.86102.492.54
2264461-26446199.484101.34
3261355-26135598.31699.87
4271767-271767102.232104.06
5260427-26042797.96799.68
6277317-277317104.320106.15
极限1272485-272485102.503101.022.23104.90103.352.29
2267700-267700100.703103.11
3261154-26115498.240100.34
4272686-272686102.578104.97
5261896-26189698.519100.77
6275394-275394103.597106.01
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)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%
115.127348073680734477355673671735670.15
215.147335573418733860.07
单位质量响应值RSD%判断
4865.544847.160.27数据可信
供试品溶液-20220124批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124257-2425732.38426.1750.5132.3826.1750.50
221247-2124728.36628.37
3-0.0000.00
421190-2119028.29028.29
523211-2321130.98830.99
627722-2772237.01037.01
10min163679-6367985.01485.105.2585.1985.255.31
264874-6487486.61086.77
358362-5836277.91677.92
466719-6671989.07389.23
561594-6159482.23182.40
667237-6723789.76489.97
15min172303-7230396.52895.001.5997.1895.621.67
271141-7114194.97695.61
369407-6940792.66193.09
470608-7060894.26594.92
571029-7102994.82795.46
672458-7245896.73497.44
20min172229-7222996.42995.831.3597.6296.971.35
271914-7191496.00897.17
372057-7205796.19997.15
471500-7150095.45696.63
570049-7004993.51894.67
672924-7292497.35798.60
30min171299-7129995.18795.631.6796.9197.301.61
271805-7180595.86397.56
372964-7296497.41098.89
471375-7137595.28996.99
569634-6963492.96494.64
672696-7269697.05298.83
45min170199-7019993.71994.011.4095.9796.221.42
270321-7032193.88196.11
370350-7035093.92095.94
470461-7046194.06896.30
569054-6905492.19094.38
672122-7212296.28698.61
60min171222-7122295.08495.651.5997.8698.381.53
270403-7040393.99196.74
373148-7314897.656100.20
471154-7115494.99497.75
570962-7096294.73797.44
672985-7298597.438100.29
极限170504-7050494.12693.081.1997.4396.341.20
269123-6912392.28295.56
369909-6990993.33196.42
469309-6930992.53095.82
568669-6866991.67694.91
670792-7079294.51097.91
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%
112.002863942870892867602867822872392868530.12
212.042869102869302869200.01
单位质量响应值RSD%判断
23904.4223830.560.22数据可信
供试品溶液-20220126批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15728-57282.1533.0070.902.153.0070.91
213100-131004.9254.92
316910-169106.3576.36
42633-26330.9900.99
54340-43401.6321.63
65227-52271.9651.97
10min165961-6596124.79819.9321.1624.8119.9521.10
234114-3411412.82512.85
346896-4689617.63117.67
455074-5507420.70520.71
560466-6046622.73222.74
655608-5560820.90620.92
15min1142397-14239753.53448.0811.7053.6848.2111.70
2101146-10114638.02638.12
3123698-12369846.50446.64
4132109-13210949.66749.79
5140426-14042652.79352.93
6127627-12762747.98248.11
20min1184024-18402469.18464.887.2769.6365.287.30
2151971-15197157.13457.44
3167103-16710362.82363.21
4173293-17329365.15065.55
5186728-18672870.20170.63
6172344-17234464.79365.19
30min1228640-22864085.95881.934.3086.7982.694.35
2203962-20396276.68077.31
3215366-21536680.96781.71
4213199-21319980.15380.91
5227925-22792585.68986.51
6218467-21846782.13382.89
45min1254237-25423795.58192.073.4996.8993.283.54
2232310-23231087.33788.39
3245693-24569392.36993.56
4239324-23932489.97491.18
5254156-25415695.55096.85
6243676-24367691.61092.82
60min1264214-26421499.33297.482.20101.1799.202.26
2252661-25266194.98896.53
3259738-25973897.64999.35
4253146-25314695.17196.87
5266777-266777100.295102.12
6259144-25914497.42699.14
极限1269096-269096101.16799.341.88103.56101.611.94
2259764-25976497.65999.72
3264360-26436099.387101.63
4260535-26053597.949100.18
5271346-271346102.013104.40
6260393-26039397.895100.16
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%
115.127367073810736287354573796736900.16
215.147349273329734100.16
单位质量响应值RSD%判断
4873.684848.750.37数据可信
供试品溶液-20220126批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134312-3431245.76222.2382.8445.7622.2382.84
2-0.0000.00
3-0.0000.00
422669-2266930.23430.23
522805-2280530.41530.42
620238-2023826.99226.99
10min162259-6225983.03680.322.8983.2980.452.96
257756-5775677.03077.03
360765-6076581.04381.04
461040-6104081.41081.58
561088-6108881.47481.64
658450-5845077.95578.11
15min168456-6845691.30191.951.2092.0292.521.20
268229-6822990.99891.43
369518-6951892.71793.17
470213-7021393.64494.26
569128-6912892.19792.82
668132-6813290.86891.45
20min169161-6916192.24193.681.3193.4694.761.24
271208-7120894.97195.90
370329-7032993.79994.76
471149-7114994.89296.03
570444-7044493.95295.09
669131-6913192.20193.29
30min168330-6833091.13393.232.2692.8794.832.11
272430-7243096.60198.06
371109-7110994.83996.33
468637-6863791.54293.21
569253-6925392.36494.02
669664-6966492.91294.51
45min167715-6771590.31291.611.2192.5593.731.09
269490-6949092.68094.68
369898-6989893.22495.24
468276-6827691.06093.24
568394-6839491.21893.39
668362-6836291.17593.29
60min167588-6758890.14391.892.0692.8994.521.91
271476-7147695.32897.84
369517-6951792.71695.25
468325-6832591.12693.81
568033-6803390.73693.41
668458-6845891.30393.93
极限167536-6753690.07491.241.0193.3294.380.91
269589-6958992.81295.85
368333-6833391.13794.18
468383-6838391.20394.39
568594-6859491.48594.66
668026-6802690.72793.86
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%
112.002858992860222859812861692858832859910.05
212.042865102867312866200.06
单位质量响应值RSD%判断
23832.5823805.650.08数据可信
供试品溶液-20220126批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14636-46361.7461.4919.761.751.4919.76
24489-44891.6911.69
32761-27611.0401.04
44104-41041.5461.55
54489-44891.6911.69
63207-32071.2081.21
10min159361-5936122.36222.935.1422.3722.945.13
265938-6593824.84024.85
359686-5968622.48522.49
461070-6107023.00623.01
556744-5674421.37621.39
662407-6240723.51023.52
15min1137239-13723951.70051.345.6251.8351.475.61
2142420-14242053.65253.80
3121194-12119445.65645.79
4140128-14012852.78852.92
5137015-13701551.61651.74
6139673-13967352.61752.75
20min1186282-18628270.17569.362.5870.6069.782.59
2187766-18776670.73471.18
3175100-17510065.96366.35
4184212-18421269.39569.82
5187688-18768870.70571.12
6183632-18363269.17769.61
30min1229591-22959186.49086.022.1487.3086.822.15
2233303-23330387.88988.73
3219846-21984682.81983.57
4225943-22594385.11685.93
5231998-23199887.39788.20
6229367-22936786.40687.22
45min1255555-25555596.27195.921.9497.5697.201.94
2252972-25297295.29896.62
3248464-24846493.60094.81
4256421-25642196.59797.89
5262806-26280699.003100.30
6251519-25151994.75196.04
60min1264164-26416499.514100.360.88101.34102.180.89
2269015-269015101.342103.20
3263835-26383599.390101.12
4266232-266232100.293102.12
5265864-265864100.155102.00
6269310-269310101.453103.27
极限1265221-26522199.913101.061.23102.29103.441.22
2266608-266608100.435102.85
3264902-26490299.792102.08
4273355-273355102.977105.36
5270110-270110101.754104.15
6269415-269415101.492103.88
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)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%
115.127296972971728697276372862728870.12
215.147349073154733220.33
单位质量响应值RSD%判断
4820.574842.930.33数据可信
供试品溶液-20220126批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122396-2239630.05231.4611.0730.0531.4611.08
221517-2151728.87228.87
324421-2442132.76932.77
420564-2056427.59427.59
523954-2395432.14232.14
627839-2783937.35637.36
10min161652-6165282.72786.223.0282.8986.393.02
264653-6465386.75486.91
363603-6360385.34585.53
466004-6600488.56788.72
562837-6283784.31784.50
666765-6676589.58889.80
15min169762-6976293.61095.141.7494.2495.791.74
271310-7131095.68796.33
369121-6912192.74993.41
471222-7122295.56996.21
571534-7153495.98796.63
672458-7245897.22797.93
20min171553-7155396.01396.061.0897.1697.241.08
272116-7211696.76897.94
370283-7028394.30995.48
471132-7113295.44896.62
572201-7220196.88298.06
672222-7222296.91098.16
30min170808-7080895.01395.531.2896.6997.251.28
272333-7233397.05998.77
370045-7004593.98995.68
470826-7082695.03796.74
570910-7091095.15096.87
672257-7225796.95798.74
45min169892-6989293.78494.140.9895.9996.380.95
269343-6934393.04795.30
369922-6992293.82496.04
470990-7099095.25797.49
570998-7099895.26897.52
669777-6977793.63095.95
60min169470-6947093.21894.040.8195.9596.810.81
270748-7074894.93397.70
370006-7000693.93796.68
469377-6937793.09395.86
570458-7045894.54397.32
670433-7043394.51097.35
极限168210-6821091.52792.851.1394.7796.141.12
268924-6892492.48595.78
368536-6853691.96495.23
469389-6938993.10996.39
570111-7011194.07897.38
670003-7000393.93397.30
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%
112.002861752862422859942863732865192862610.07
212.042864602865942865270.04
单位质量响应值RSD%判断
23855.0823797.920.17数据可信
供试品溶液-20220127批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17540-75402.8402.2563.602.842.2563.60
213016-130164.9024.90
34277-42771.6111.61
42642-26420.9950.99
53894-38941.4661.47
64537-45371.7091.71
10min178659-7865929.62322.3125.0729.6422.3325.04
234225-3422512.88912.92
361732-6173223.24823.26
453069-5306919.98619.99
561417-6141723.13023.14
666379-6637924.99825.01
15min1143625-14362554.08950.1912.4254.2750.3212.43
2100346-10034637.79037.89
3142211-14221153.55653.69
4133387-13338750.23350.35
5138159-13815952.03052.17
6141844-14184453.41853.57
20min1196828-19682874.12568.188.5874.6168.598.61
2152317-15231757.36257.67
3188944-18894471.15671.59
4177064-17706466.68267.08
5183038-18303868.93269.36
6187997-18799770.79971.24
30min1236786-23678689.17384.195.4390.0784.995.48
2202557-20255776.28376.91
3231281-23128187.10087.93
4219086-21908682.50783.27
5222038-22203883.61984.43
6229636-22963686.48087.32
45min1259928-25992897.88894.954.0099.2896.214.06
2234522-23452288.32189.37
3262130-26213098.718100.03
4247168-24716893.08394.31
5253822-25382295.58996.86
6255136-25513696.08497.40
60min1269735-269735101.58299.263.38103.51101.053.44
2249440-24944093.93995.48
3275084-275084103.596105.46
4259045-25904597.55699.30
5265475-26547599.977101.78
6262599-26259998.894100.75
极限1268533-268533101.129101.683.22103.63104.023.22
2258826-25882697.47399.54
3275109-275109103.605106.04
4267192-267192100.624102.91
5284156-284156107.013109.37
6266178-266178100.242102.64
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%
115.127346373598732837320373143733380.26
215.147343673171733040.26
单位质量响应值RSD%判断
4850.404841.740.13数据可信
供试品溶液-20220127批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140571-4057154.27924.9275.3654.2824.9275.37
2-0.0000.00
322617-2261730.25930.26
47146-71469.5609.56
520654-2065427.63227.63
620760-2076027.77427.77
10min168179-6817991.21580.2916.7891.5280.4316.84
257638-5763877.11277.11
362089-6208983.06783.24
440878-4087854.68954.74
566169-6616988.52688.68
665119-6511987.12187.28
15min169130-6913092.48792.751.4493.3093.341.52
267680-6768090.54790.98
369832-6983293.42694.06
469030-6903092.35392.71
569659-6965993.19593.84
670641-7064194.50995.15
20min169191-6919192.56994.581.2793.8995.681.17
270771-7077194.68295.61
370307-7030794.06295.21
471289-7128995.37596.25
570778-7077894.69295.85
671810-7181096.07297.24
30min168942-6894292.23594.251.3494.0795.871.20
271450-7145095.59197.05
370248-7024893.98395.65
470974-7097494.95496.35
569878-6987893.48895.18
671180-7118095.23096.93
45min168052-6805291.04593.281.2293.3995.431.07
270274-7027494.01896.01
370016-7001693.67295.87
470339-7033994.10496.03
569758-6975893.32795.54
669881-6988193.49295.72
60min168479-6847991.61693.061.0994.4795.720.92
270159-7015993.86496.37
370118-7011893.80996.52
470332-7033294.09596.55
569197-6919792.57795.30
669046-6904692.37595.12
极限167494-6749490.29892.792.0793.6695.981.92
269031-6903192.35595.39
369266-6926692.66995.90
470905-7090594.86297.83
571146-7114695.18498.43
668316-6831691.39894.66
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%
112.002865102865542863422864052861602863940.06
212.042871002868292869640.07
单位质量响应值RSD%判断
23866.1723834.220.10数据可信
供试品溶液-20220127批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13079-30791.1581.5638.511.161.5738.60
26366-63662.3952.40
35888-58882.2152.22
44030-40301.5161.52
52664-26641.0021.00
62920-29201.0991.10
10min162361-6236123.46220.5512.1423.4720.5612.14
256032-5603221.08121.09
359703-5970322.46222.47
449413-4941318.59018.60
555793-5579320.99121.00
644450-4445016.72316.73
15min1136676-13667651.42148.827.0251.5648.947.03
2134975-13497550.78150.91
3138808-13880852.22352.36
4115776-11577643.55843.67
5130369-13036949.04849.17
6121893-12189345.85945.96
20min1182135-18213568.52366.414.3768.9566.814.39
2186758-18675870.26370.68
3179788-17978867.64068.07
4165899-16589962.41562.77
5171439-17143964.49964.89
6173097-17309765.12365.48
30min1228673-22867386.03283.593.1286.8484.353.11
2228901-22890186.11886.92
3221888-22188883.47984.28
4221431-22143183.30884.01
5209900-20990078.96979.72
6222258-22225883.61984.33
45min1251643-25164394.67493.902.6595.9695.132.64
2256959-25695996.67497.96
3246634-24663492.79094.06
4249102-24910293.71894.88
5238450-23845089.71190.90
6254715-25471595.83097.01
60min1269079-269079101.23498.063.06103.0499.813.04
2263263-26326399.046100.86
3257029-25702996.70098.48
4255902-25590296.27697.96
5249304-24930493.79495.48
6269294-269294101.315103.03
极限1269971-269971101.569100.430.97103.94102.721.00
2266895-266895100.412102.78
3267690-267690100.711103.03
4264005-26400599.325101.54
5263846-26384699.265101.48
6269275-269275101.308103.58
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%
115.127333173050731217303872822730720.26
215.147314973082731160.07
单位质量响应值RSD%判断
4832.804829.330.06数据可信
供试品溶液-20220127批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127474-2747436.87131.0513.8136.8731.0513.81
224223-2422332.50832.51
318593-1859324.95224.95
420893-2089328.03928.04
522347-2234729.99029.99
625305-2530533.96033.96
10min166850-6685089.71484.538.0789.9284.708.07
261481-6148182.50982.69
354213-5421372.75572.89
467642-6764290.77790.93
561462-6146282.48482.65
666274-6627488.94189.13
15min170694-7069494.87393.152.5195.5893.792.55
270237-7023794.26094.90
366104-6610488.71389.26
469819-6981993.69994.36
568984-6898492.57893.20
670621-7062194.77595.46
20min171448-7144895.88594.861.6297.1296.021.66
271625-7162596.12397.29
368694-6869492.18993.22
471462-7146295.90497.08
570024-7002493.97495.11
670833-7083395.06096.27
30min172143-7214396.81894.452.4698.5896.142.46
269800-6980093.67395.37
369820-6982093.70095.25
472307-7230797.03898.75
567648-6764890.78592.45
670561-7056194.69596.43
45min169547-6954793.33493.281.8595.6395.501.87
269514-6951493.29095.51
368324-6832491.69393.76
471092-7109295.40797.66
567836-6783691.03893.20
670745-7074594.94297.21
60min170406-7040694.48792.721.9397.3195.451.94
269202-6920292.87195.61
368443-6844391.85294.43
468229-6822991.56594.35
567407-6740790.46293.13
670855-7085595.08997.88
极限169907-6990793.81792.700.9397.1695.940.93
268420-6842091.82195.07
369438-6943893.18896.28
469347-6934793.06596.36
568238-6823891.57794.75
669084-6908492.71296.03
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