培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.942054620648206082052520659205970.30
29.962058320547205650.13
单位质量响应值RSD%判断
2072.132064.760.26数据可信
长期6月-供试品溶液-2022081701批-培哚普利-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123570-2357097.22398.231.0697.2298.231.06
224013-2401399.05099.05
324138-2413899.56699.57
423486-2348696.87696.88
523821-2382198.25898.26
623860-2386098.41998.42
10min123606-2360697.37198.671.6798.4599.761.66
223554-2355497.15798.26
324197-2419799.809100.92
423535-2353597.07898.15
524404-24404100.663101.75
624236-2423699.970101.06
15min123236-2323695.84597.411.7298.0199.601.70
223448-2344896.71998.90
323964-2396498.848101.06
423136-2313695.43397.59
524134-2413499.549101.76
623769-2376998.044100.25
20min122997-2299794.85996.321.9098.0999.591.88
223005-2300594.89298.15
323860-2386098.419101.73
422967-2296794.73597.95
523921-2392198.671101.99
623350-2335096.31599.61
30min122966-2296694.73195.201.7199.0199.541.69
222716-2271693.70098.01
323503-2350396.946101.35
422680-2268093.55297.82
523611-2361197.392101.80
623006-2300694.89699.26
45min122648-2264893.42093.811.6598.7599.211.63
222510-2251092.85098.20
323296-2329696.092101.58
422294-2229491.95997.27
523082-2308295.210100.70
622629-2262993.34198.76
极限122460-2246092.64492.701.3199.0299.141.31
222413-2241392.45098.83
322885-2288594.397100.95
422064-2206491.01197.34
522713-2271393.688100.24
622301-2230191.98898.44
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.061671181675971669751670721668501671220.18
214.201665891664051664970.08
单位质量响应值RSD%判断
11886.3411725.140.97数据可信
长期6月-供试品溶液-2022081701批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1172724-17272494.84795.151.1794.8595.151.17
2176785-17678597.07797.08
3174093-17409395.59995.60
4173209-17320995.11395.11
5171789-17178994.33394.33
6171096-17109693.95393.95
10min1176398-17639896.86497.740.7397.9298.800.72
2177917-17791797.69898.78
3178026-17802697.75898.82
4176837-17683797.10598.16
5178846-17884698.20999.26
6179929-17992998.80399.85
15min1174148-17414895.62996.500.8197.7698.640.79
2175765-17576596.51798.68
3177254-17725497.33499.48
4174635-17463595.89698.03
5177571-17757197.50899.65
6175004-17500496.09998.24
20min1173610-17361095.33395.860.8898.5399.080.86
2174254-17425495.68798.92
3175296-17529696.25999.49
4172998-17299894.99798.20
5177300-17730097.360100.58
6174003-17400395.54998.76
30min1169631-16963193.14894.191.0697.4098.471.04
2171686-17168694.27798.58
3173166-17316695.09099.39
4169303-16930392.96897.23
5173801-17380195.43899.74
6171592-17159294.22598.50
45min1168914-16891492.75593.281.0198.0498.600.99
2170636-17063693.70099.05
3171126-17112693.96999.33
4168034-16803492.27197.56
5172229-17222994.57599.94
6168241-16824192.38597.70
极限1166340-16634091.34192.060.7997.6698.420.78
2169092-16909292.85299.24
3168329-16832992.43398.83
4166750-16675091.56697.88
5169026-16902692.81699.23
6166309-16630991.32497.67
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.942057120606207492056020575206120.39
29.962051320487205000.09
单位质量响应值RSD%判断
2073.642058.230.53数据可信
长期6月-供试品溶液-2022081801批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123885-2388598.64399.040.9398.6499.040.93
224386-24386100.712100.71
324045-2404599.30399.30
423945-2394598.89098.89
523736-2373698.02798.03
623888-2388898.65598.66
10min123730-2373098.00398.131.3599.1099.241.34
223492-2349297.02098.14
324362-24362100.613101.72
423484-2348496.98798.09
523730-2373098.00399.09
623772-2377298.17699.27
15min123219-2321995.89296.561.1498.0898.751.12
223037-2303795.14197.34
323416-2341696.70698.93
423395-2339596.61998.80
523373-2337396.52898.71
623837-2383798.444100.63
20min122965-2296594.84396.231.4298.0999.491.38
223555-2355597.280100.53
323840-2384098.457101.75
423134-2313495.54198.79
523189-2318995.76899.02
623115-2311595.46398.74
30min122821-2282194.24894.630.7398.5598.960.73
222882-2288294.50098.84
323223-2322395.909100.30
422736-2273693.89798.21
522908-2290894.60898.92
622913-2291394.62898.97
45min123590-2359097.42494.391.89102.7899.771.80
222847-2284794.35699.74
323051-2305195.198100.65
422465-2246592.77898.13
522419-2241992.58897.95
622758-2275893.98899.38
极限122329-2232992.21792.820.8998.6599.250.85
222625-2262593.43999.87
322626-2262693.44399.96
422299-2229992.09398.48
522708-2270893.782100.18
622258-2225891.92398.36
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.061665791668211670591663621667121667070.16
214.201664521664441664480.01
单位质量响应值RSD%判断
11856.8311721.690.82数据可信
长期6月-供试品溶液-2022081801批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1176142-17614296.85896.241.2596.8696.241.25
2178334-17833498.06398.06
3174574-17457495.99596.00
4175113-17511396.29296.29
5174115-17411595.74395.74
6171800-17180094.47094.47
10min1174034-17403495.69897.211.3596.7798.281.34
2178775-17877598.30599.40
3179589-17958998.75399.82
4176828-17682897.23598.30
5177501-17750197.60598.67
6173930-17393095.64196.69
15min1172657-17265794.94196.021.0497.0898.161.02
2173933-17393395.64397.82
3173808-17380895.57497.74
4176894-17689497.27199.42
5176859-17685997.25299.40
6173510-17351095.41097.52
20min1171651-17165194.38895.611.3197.5898.821.30
2175071-17507196.26999.51
3176290-17629096.939100.16
4175184-17518496.33199.56
5174526-17452695.96999.20
6170475-17047593.74196.91
30min1170275-17027593.63194.251.0897.8798.521.08
2171870-17187094.50998.82
3172198-17219894.68998.99
4173519-17351995.41599.72
5172225-17222594.70499.00
6168268-16826892.52896.74
45min1169168-16916893.02393.371.1798.3198.691.16
2172275-17227594.731100.10
3170575-17057593.79699.15
4171390-17139094.24599.61
5168379-16837992.58997.94
6166966-16696691.81297.05
极限1166115-16611591.34492.311.3197.6698.671.28
2170248-17024893.617100.03
3169353-16935393.12499.52
4168801-16880192.82199.23
5168304-16830492.54898.92
6164407-16440790.40596.67
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