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2000
标示量(mg)10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%
19.832041820391203702046220470204220.22
29.892032720351203390.09
单位质量响应值RSD%判断
2077.522056.520.72数据可信
长期9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%
5min122584-2258493.22296.603.0193.2296.603.01
223406-2340696.61596.62
324310-24310100.347100.35
423170-2317095.64195.64
524150-2415099.68699.69
622800-2280094.11494.11
10min123808-2380898.27499.061.0299.31100.141.03
223728-2372897.94499.02
324237-24237100.045101.16
423845-2384598.42799.49
524318-24318100.380101.49
624059-2405999.310100.36
15min123581-2358197.33799.091.9499.47101.261.93
223499-2349996.99999.16
324441-24441100.887103.11
423720-2372097.911100.07
524578-24578101.453103.68
624215-2421599.954102.10
20min123306-2330696.20296.771.6399.41100.041.63
223046-2304695.12998.37
324020-2402099.149102.50
423048-2304895.13798.38
523585-2358597.354100.70
623654-2365497.639100.90
30min122851-2285194.32495.431.2898.6099.781.30
222956-2295694.75899.05
323398-2339896.582101.03
422910-2291094.56898.87
523574-2357497.308101.74
623031-2303195.06799.41
45min122636-2263693.43794.611.7198.76100.021.68
222323-2232392.14597.49
322964-2296494.791100.31
423100-2310095.352100.70
523446-2344696.780102.29
623059-2305995.183100.58
极限123366-2336696.45093.942.10102.81100.402.00
222116-2211691.29097.66
322948-2294894.724101.30
422352-2235292.26498.68
523131-2313195.480102.07
622635-2263593.43299.89
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%
114.088261482603826808318383004828170.32
214.088312182911830160.18
单位质量响应值RSD%判断
5881.895896.020.17数据可信
长期9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%
5min183728-8372892.16794.393.5992.1794.393.59
285179-8517993.76493.76
389265-8926598.26298.26
485463-8546394.07794.08
589322-8932298.32598.33
681537-8153789.75589.76
10min188538-8853897.46297.730.2998.4998.780.30
289009-8900997.98099.02
388780-8878097.72898.82
488437-8843797.35198.40
589092-8909298.07299.16
688820-8882097.77298.77
15min188062-8806296.93898.441.7499.05100.581.73
288367-8836797.27499.40
391624-91624100.859103.04
487948-8794896.81398.94
590812-9081299.965102.15
689757-8975798.804100.89
20min186647-8664795.38096.192.0898.5699.412.04
286124-8612494.80598.02
390712-9071299.855103.15
485673-8567394.30897.51
587255-8725596.05099.34
687864-8786496.72099.90
30min183902-8390292.35994.621.8596.6098.911.84
285976-8597694.64298.91
388255-8825597.150101.56
484643-8464393.17497.42
587121-8712195.902100.26
685818-8581894.46898.72
45min184198-8419892.68594.051.3897.9599.391.38
283992-8399292.45897.77
386711-8671195.451100.94
485535-8553594.15699.44
586719-8671995.460100.89
685455-8545594.06899.37
极限182969-8296991.33292.661.9797.6399.051.94
282435-8243590.74497.09
386770-8677095.516102.06
483186-8318691.57197.90
585405-8540594.013100.50
684291-8429192.78799.14
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2000
标示量(mg)10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%
19.832046620485204972046920493204820.07
29.892042020403204120.06
单位质量响应值RSD%判断
2083.622063.900.68数据可信
长期9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%
5min123107-2310795.07097.001.3795.0797.001.37
223420-2342096.35896.36
323958-2395898.57298.57
423437-2343796.42896.43
523895-2389598.31298.31
623638-2363897.25597.26
10min123405-2340596.29697.941.5897.3599.021.57
223419-2341996.35497.42
324389-24389100.345101.44
423909-2390998.37099.44
523986-2398698.68799.78
623719-2371997.58898.67
15min123673-2367397.39997.172.0699.5399.342.03
222916-2291694.28596.43
324014-2401498.802101.01
424191-2419199.530101.69
523727-2372797.62199.81
623182-2318295.37997.54
20min123085-2308594.98095.491.8798.1998.741.85
222615-2261593.04696.23
323720-2372097.592100.90
423480-2348096.60599.88
523517-2351796.757100.03
622838-2283893.96497.19
30min123168-2316895.32194.402.1399.5998.702.09
222284-2228491.68495.91
323533-2353396.823101.22
423223-2322395.54899.89
523027-2302794.74199.09
622423-2242392.25696.52
45min122809-2280993.84493.351.2099.1798.701.21
222198-2219891.33096.57
322915-2291594.28099.75
422890-2289094.17899.58
522754-2275493.61899.02
622562-2256292.82898.12
极限122292-2229291.71791.741.8798.0898.131.84
221761-2176189.53295.79
322754-2275493.618100.13
422488-2248892.52498.98
522648-2264893.18299.62
621837-2183789.84596.17
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%
114.088332583125833218331083345832850.11
214.088292782877829020.05
单位质量响应值RSD%判断
5915.135887.930.33数据可信
长期9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%
5min184025-8402592.29794.261.5892.3094.261.58
286191-8619194.67794.68
387915-8791596.57096.57
484725-8472593.06693.07
586216-8621694.70494.70
685798-8579894.24594.25
10min186215-8621594.70395.731.4895.7396.781.48
286454-8645494.96696.02
389601-8960198.42299.50
486690-8669095.22596.26
587503-8750396.11897.17
686433-8643394.94395.99
15min186929-8692995.48794.511.6497.5796.631.62
284504-8450492.82494.93
387950-8795096.60998.78
486898-8689895.45397.55
585227-8522793.61895.74
684748-8474893.09295.19
20min185383-8538393.78993.311.6596.9396.471.63
283547-8354791.77294.91
387193-8719395.77799.02
485308-8530893.70796.86
584856-8485693.21096.37
683390-8339091.60094.74
30min185107-8510793.48691.921.9897.6796.121.94
282228-8222890.32494.48
385605-8560594.03398.34
484041-8404192.31596.51
583808-8380892.05996.26
681314-8131489.32093.47
45min183712-8371291.95490.841.1597.1796.061.15
281531-8153189.55894.72
383815-8381592.06797.42
482396-8239690.50895.73
582857-8285791.01496.23
681856-8185689.91595.06
极限181793-8179389.84689.191.8496.0995.421.80
279944-7994487.81593.97
383403-8340391.61497.99
480975-8097588.94795.17
581844-8184489.90296.13
679243-7924387.04593.19
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2000
标示量(mg)10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%
19.832040320397204612041720448204250.14
29.892043220387204100.16
单位质量响应值RSD%判断
2077.822063.700.49数据可信
长期9月-供试品溶液-2022082101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%
5min123759-2375997.89497.243.1997.8997.243.19
222092-2209291.02591.03
324126-2412699.40699.41
423742-2374297.82397.82
523944-2394498.65698.66
623944-2394498.65698.66
10min123564-2356497.09099.742.5598.18100.822.55
223344-2334496.18497.19
324496-24496100.930102.03
424419-24419100.613101.70
524486-24486100.889101.99
624941-24941102.764103.86
15min123406-2340696.43998.402.6898.61100.592.68
223023-2302394.86196.94
323947-2394798.668100.89
424149-2414999.500101.71
523881-2388198.396100.61
624886-24886102.537104.78
20min123252-2325295.80597.502.7399.04100.782.72
222787-2278793.88997.02
323655-2365597.465100.79
424050-2405099.093102.40
523583-2358397.168100.48
624659-24659101.602104.98
30min123108-2310895.21195.822.9199.51100.182.89
222113-2211391.11295.29
323282-2328295.928100.33
423597-2359797.226101.64
523258-2325895.829100.22
624170-2417099.587104.09
45min122498-2249892.69894.982.8798.06100.412.86
222043-2204390.82396.01
323379-2337996.328101.80
423343-2334396.179101.67
523193-2319395.561101.02
623858-2385898.301103.91
极限122219-2221991.54893.532.4997.94100.022.49
221851-2185190.03296.23
323114-2311495.236101.78
423104-2310495.195101.76
522670-2267093.40799.92
623247-2324795.784102.49
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%
114.088311283105831308323383199831560.07
214.088322183187832040.03
单位质量响应值RSD%判断
5905.975909.380.05数据可信
长期9月-供试品溶液-2022082101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%
5min187283-8728395.77694.262.8095.7894.262.80
281547-8154789.48289.48
386783-8678395.22795.23
484661-8466192.89992.90
587812-8781296.35696.36
687332-8733295.83095.83
10min187074-8707495.54797.432.1996.6198.482.18
286461-8646194.87495.87
388722-8872297.35598.41
488543-8854397.15998.19
590325-9032599.114100.18
691609-91609100.523101.59
15min186560-8656094.98396.012.2297.1198.142.21
285165-8516593.45295.50
387297-8729795.79197.93
486987-8698795.45197.56
588064-8806496.63398.80
690927-9092799.775101.96
20min185910-8591094.26994.832.4797.4598.022.45
284173-8417392.36395.45
385025-8502593.29896.50
486530-8653094.95098.12
586518-8651894.93798.18
690343-9034399.134102.42
30min184959-8495993.22693.142.4497.4597.382.43
281656-8165689.60193.71
384357-8435792.56596.81
484964-8496493.23197.46
585194-8519493.48497.78
688136-8813696.712101.10
45min183124-8312491.21292.542.3996.4897.832.38
281550-8155089.48594.59
384788-8478893.03898.31
483990-8399092.16397.43
585027-8502793.30098.64
687529-8752996.046101.51
极限181964-8196489.93991.001.8296.2297.321.84
280627-8062788.47294.58
383615-8361591.75198.05
483205-8320591.30197.59
583137-8313791.22797.60
685063-8506393.34099.87
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