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%
19.952004520103199642004120013200330.26
29.982008719989200380.35
单位质量响应值RSD%判断
2013.372007.820.20数据可信
长期12月-供试品溶液-2022081901批-培哚普利-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min122931-2293197.30996.175.5997.3196.175.59
222963-2296397.44497.44
320106-2010685.32185.32
423310-2331098.91798.92
523381-2338199.21899.22
623279-2327998.78598.79
10min122551-2255195.69697.751.4896.7898.821.49
223177-2317798.35299.44
322746-2274696.52397.47
422982-2298297.52598.62
523333-2333399.014100.12
623415-2341599.362100.46
15min122191-2219194.16896.861.8596.3199.021.84
222977-2297797.50499.68
322549-2254995.68797.71
423094-2309498.000100.18
522770-2277096.62598.83
623378-2337899.205101.41
20min121831-2183192.64195.421.7495.8398.651.74
222507-2250795.50998.77
322276-2227694.52997.61
422847-2284796.952100.22
522872-2287297.058100.33
622581-2258195.82399.13
30min122051-2205193.57495.071.2397.7999.361.25
222260-2226094.46198.78
322245-2224594.39798.53
422810-2281096.795101.14
522608-2260895.938100.29
622447-2244795.25599.62
45min121154-2115489.76893.602.4795.0398.952.41
222533-2253395.620100.99
321700-2170092.08597.27
422559-2255995.730101.15
522110-2211093.82599.25
622290-2229094.588100.02
极限121339-2133990.55393.241.9196.8199.621.89
222151-2215193.999100.43
321743-2174392.26798.47
422107-2210793.812100.30
521908-2190892.96799.43
622581-2258195.823102.30
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4000
标示量(mg)5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%
113.958190182368825818187781981821420.39
214.018179182106819480.28
单位质量响应值RSD%判断
5888.325849.250.48数据可信
长期12月-供试品溶液-2022081901批-氨氯地平-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min184090-8409092.88594.701.8292.8894.701.83
286293-8629395.31895.32
385563-8556394.51294.51
483809-8380992.57492.57
587735-8773596.91196.91
686916-8691696.00696.01
10min183421-8342192.14694.901.6393.1895.951.62
286081-8608195.08496.14
385367-8536794.29595.35
486332-8633295.36196.39
587049-8704996.15397.23
687223-8722396.34597.41
15min182225-8222590.82591.796.4292.8893.906.27
285925-8592594.91297.03
385372-8537294.30196.40
485763-8576394.73396.82
572671-7267180.27182.42
686624-8662495.68497.82
20min180717-8071789.15993.022.3492.2296.142.27
285147-8514794.05297.22
383964-8396492.74695.89
485842-8584294.82097.96
585970-8597094.96198.00
683615-8361592.36095.56
30min181113-8111389.59692.341.5993.6596.501.56
283488-8348892.22096.43
383473-8347392.20396.38
484294-8429493.11097.30
584735-8473593.59797.69
684490-8449093.32797.55
45min180526-8052688.94891.361.6494.0096.541.62
283735-8373592.49397.73
381662-8166290.20395.40
483906-8390692.68197.91
582855-8285591.52196.65
683558-8355892.29797.56
极限179029-7902987.29490.441.8993.3396.641.85
282298-8229890.90597.17
381799-8179990.35496.56
481903-8190390.46996.73
582562-8256291.19797.35
683646-8364692.39498.68
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%
19.951995719803198992003719794198980.52
29.982003119974200020.21
单位质量响应值RSD%判断
1999.802004.210.16数据可信
长期12月-供试品溶液-2022082001批-培哚普利-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min122424-2242495.56598.542.0695.5798.542.05
222994-2299497.99497.99
323858-23858101.676101.68
423329-2332999.42299.42
523187-2318798.81798.82
622945-2294597.78697.79
10min122781-2278197.08798.331.6998.1599.421.69
222709-2270996.78097.87
323801-23801101.434102.56
423110-2311098.48999.59
523031-2303198.15299.25
622999-2299998.01699.10
15min122650-2265096.52897.451.5898.6799.631.58
222657-2265796.55898.72
323495-23495100.129102.39
423033-2303398.161100.36
522858-2285897.41599.60
622500-2250095.88998.06
20min122368-2236895.32796.712.2098.5499.982.18
222458-2245895.71098.95
323686-23686100.943104.31
422567-2256796.17599.46
522660-2266096.57199.84
622421-2242195.55298.79
30min122227-2222794.72694.992.8399.0099.342.77
221309-2130990.81395.11
323260-2326099.128103.62
422535-2253596.038100.40
522201-2220194.61598.96
622207-2220794.64098.94
45min121919-2191993.41394.631.8398.74100.031.83
221928-2192893.45198.76
322933-2293397.734103.33
422416-2241695.531100.96
522082-2208294.10899.50
621943-2194393.51598.87
极限121729-2172992.60393.891.5798.97100.341.58
221891-2189193.29499.64
322552-2255296.111102.79
422358-2235895.284101.77
521922-2192293.42699.87
621727-2172792.59598.99
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4000
标示量(mg)5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%
113.958104981117818658120481379813230.41
214.018159882095818460.43
单位质量响应值RSD%判断
5829.615841.970.15数据可信
长期12月-供试品溶液-2022082001批-氨氯地平-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min181159-8115990.15394.262.8590.1594.262.85
285452-8545294.92294.92
388586-8858698.40398.40
483782-8378293.06793.07
585206-8520694.64994.65
684952-8495294.36794.37
10min183175-8317592.39394.232.2193.3995.282.21
283816-8381693.10594.16
388147-8814797.91699.01
483309-8330992.54193.58
585184-8518494.62495.68
685333-8533394.79095.84
15min183415-8341592.65993.551.4794.6995.651.49
284584-8458493.95896.05
386574-8657496.16898.35
483448-8344892.69694.76
583799-8379993.08695.19
683489-8348992.74194.84
20min182042-8204291.13492.282.3994.1995.412.38
282661-8266191.82294.95
387049-8704996.69699.95
481762-8176290.82393.92
582763-8276391.93595.07
682165-8216591.27194.40
30min182068-8206891.16390.952.2995.2395.112.26
279277-7927788.06392.22
385052-8505294.47898.80
481115-8111590.10494.21
581636-8163690.68394.84
682103-8210391.20295.35
45min180028-8002888.89790.601.7393.9895.771.74
281027-8102790.00795.14
384177-8417793.50698.88
481605-8160590.64995.75
581597-8159790.64095.81
680932-8093289.90195.06
极限179386-7938688.18489.411.6994.2595.581.69
281167-8116790.16296.29
382900-8290092.08798.50
480305-8030589.20595.31
579514-7951488.32694.50
679659-7965988.48794.65
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