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%
19.801894318916189741888718963189370.19
29.861884918983189160.51
单位质量响应值RSD%判断
1932.351918.460.52数据可信
供试品溶液-25102201批-培哚普利-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120800-2080092.17288.849.1492.1788.849.14
220551-2055191.06891.07
320979-2097992.96592.97
416321-1632172.32472.32
520774-2077492.05792.06
620858-2085892.42992.43
10min121690-2169096.11696.630.8497.1497.610.78
221538-2153895.44296.45
321830-2183096.73697.77
422065-2206597.77798.58
521785-2178596.53797.56
621924-2192497.15398.18
15min121467-2146795.12896.491.3697.2298.551.27
221497-2149795.26097.33
321654-2165495.95698.06
422235-2223598.531100.42
521843-2184396.79498.89
621946-2194697.25099.36
20min121301-2130194.39296.271.4697.5499.401.38
221477-2147795.17298.30
321593-2159395.68698.86
422134-2213498.083101.07
521926-2192697.162100.33
621912-2191297.099100.29
30min120834-2083492.32394.162.2096.5298.362.05
221043-2104393.24997.44
320881-2088192.53196.77
422097-2209797.919101.99
521374-2137494.71598.97
621266-2126694.23798.50
45min121008-2100893.09493.840.7598.3299.090.69
221174-2117493.82999.05
321065-2106593.34698.61
421407-2140794.862100.02
521323-2132394.48999.79
621081-2108193.41798.73
极限120997-2099793.04594.071.9299.30100.361.78
221003-2100393.07199.34
320889-2088992.56698.87
421965-2196597.334103.55
521430-2143094.964101.32
621085-2108593.43599.79
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%
113.957987979743795157970779826797340.18
214.188010380086800940.02
单位质量响应值RSD%判断
5715.705648.380.84数据可信
供试品溶液-25102201批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163835-6383572.83069.698.4872.8369.688.48
262489-6248971.29571.29
364172-6417273.21573.21
450608-5060857.74057.74
562760-6276071.60471.60
662617-6261771.44171.44
10min177720-7772088.67286.661.9889.4887.432.00
274053-7405384.48885.28
375742-7574286.41587.23
474789-7478985.32885.97
575708-7570886.37787.17
677706-7770688.65689.45
15min178640-7864089.72288.032.2691.5289.772.23
274727-7472785.25786.99
376181-7618186.91688.69
477620-7762088.55890.15
576348-7634887.10788.86
679435-7943590.62992.41
20min178495-7849589.55688.171.3592.3590.881.33
275794-7579486.47589.15
376223-7622386.96489.70
477881-7788188.85691.43
577674-7767488.62091.34
677597-7759788.53291.32
30min175826-7582686.51186.531.9890.3090.221.88
274373-7437384.85388.49
374170-7417084.62288.33
478075-7807589.07792.64
575647-7564786.30790.01
676962-7696287.80791.58
45min177601-7760188.53687.111.2493.2891.761.23
275658-7565886.32090.90
374914-7491485.47190.12
476381-7638187.14491.70
576778-7677887.59792.26
676756-7675687.57292.32
极限179536-7953690.74490.981.8796.4896.601.73
279170-7917090.32695.87
377760-7776088.71894.31
482299-8229993.89699.42
580119-8011991.40997.05
679572-7957290.78596.50
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%
19.801911019006188871897419040190030.44
29.861907519249191620.65
单位质量响应值RSD%判断
1939.081943.410.16数据可信
供试品溶液-25102301批-培哚普利-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121262-2126293.44990.115.5393.4590.105.54
220997-2099792.28492.28
318339-1833980.60280.60
420746-2074691.18191.18
521401-2140194.06094.06
620263-2026389.05889.06
10min122178-2217897.47596.722.4498.5197.722.46
222098-2209897.12398.15
321230-2123093.30894.20
421933-2193396.39897.41
522853-22853100.442101.49
621747-2174795.58196.57
15min122254-2225497.80996.721.9199.9398.801.94
222131-2213197.26899.37
321442-2144294.24096.17
421766-2176695.66497.75
522629-2262999.457101.62
621815-2181595.88097.93
20min121950-2195096.47396.151.6599.6899.301.69
222003-2200396.70699.89
321202-2120293.18596.16
421851-2185196.03899.18
522275-2227597.901101.17
621977-2197796.59299.71
30min121813-2181395.87194.831.95100.1599.051.95
221745-2174595.57299.83
321084-2108492.66796.68
421027-2102792.41696.63
522043-2204396.882101.24
621749-2174995.59099.78
45min121605-2160594.95794.261.57100.3099.541.60
221424-2142494.16199.48
320973-2097392.17997.22
421139-2113992.90998.15
521842-2184295.998101.43
621700-2170095.374100.63
极限121603-2160394.94894.111.25101.35100.441.30
221518-2151894.574100.94
320925-2092591.96898.04
421284-2128493.54699.82
521532-2153294.636101.13
621618-2161895.014101.33
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%
113.958029280513802118004079965802040.27
214.188093380726808300.19
单位质量响应值RSD%判断
5749.395700.280.61数据可信
供试品溶液-25102301批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162801-6280171.11469.086.5171.1169.086.51
263135-6313571.49271.49
353742-5374260.85660.86
461554-6155469.70269.70
565065-6506573.67873.68
659758-5975867.66867.67
10min178280-7828088.64286.672.9989.4387.443.01
278068-7806888.40289.20
373306-7330683.00983.69
474277-7427784.10984.88
578815-7881589.24890.07
676490-7649086.61587.37
15min181049-8104991.77788.542.7793.5590.272.79
279560-7956090.09191.87
375641-7564185.65487.25
475788-7578885.82087.53
579176-7917689.65691.47
677906-7790688.21889.93
20min180643-8064391.31888.392.5794.1191.102.59
279152-7915289.62992.41
375050-7505084.98487.53
476478-7647886.60189.26
578803-7880389.23492.04
678223-7822388.57791.27
30min180430-8043091.07687.672.7794.8991.362.77
278520-7852088.91492.69
374912-7491284.82888.32
474978-7497884.90388.53
577843-7784388.14791.94
677826-7782688.12891.81
45min179115-7911589.58787.162.4094.4191.832.41
276727-7672786.88391.64
374828-7482884.73389.17
474791-7479184.69189.26
578048-7804888.37993.16
678329-7832988.69793.36
极限181699-8169992.51390.531.8598.3396.171.89
279501-7950190.02595.75
377480-7748087.73693.11
479499-7949990.02295.53
580691-8069191.37297.13
680810-8081091.50797.15
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%
19.801914419168193131923919205192140.35
29.861906319018190400.17
单位质量响应值RSD%判断
1960.611931.031.08数据可信
供试品溶液-25102302批-培哚普利-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121111-2111192.57288.734.3992.5788.744.39
220328-2032889.13989.14
321048-2104892.29692.30
420250-2025088.79788.80
520009-2000987.74087.74
618668-1866881.86081.86
10min121623-2162394.81794.331.0195.8595.311.00
221283-2128393.32794.32
321480-2148094.19095.22
421256-2125693.20894.19
521823-2182395.69496.67
621601-2160194.72195.63
15min121616-2161694.78793.981.1996.8796.011.17
221094-2109492.49894.53
321234-2123493.11295.18
421329-2132993.52895.55
521770-2177095.46297.50
621544-2154494.47196.43
20min121185-2118592.89793.210.8896.0396.290.86
221147-2114792.73095.79
321257-2125793.21396.32
421062-2106292.35795.42
521601-2160194.72197.82
621287-2128793.34496.36
30min121560-2156094.54193.610.9498.7197.720.91
221110-2111092.56896.65
321133-2113392.66996.81
421279-2127993.30997.40
521517-2151794.35398.50
621483-2148394.20498.25
45min120898-2089891.63892.441.9396.8697.601.80
220929-2092991.77496.89
320902-2090291.65696.83
421047-2104792.29297.42
520811-2081191.25796.46
621895-2189596.010101.11
极限120933-2093391.79291.781.2798.0397.961.20
220511-2051189.94196.08
320811-2081191.25797.45
420947-2094791.85398.00
521066-2106692.37598.59
621308-2130893.43699.60
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%
113.958086580950806838079780484807560.23
214.188050980259803840.22
单位质量响应值RSD%判断
5788.965668.831.49数据可信
供试品溶液-25102302批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165836-6583674.50571.595.5874.5071.595.58
262778-6277871.04471.04
367290-6729076.15076.15
463539-6353971.90571.91
563094-6309471.40271.40
657009-5700964.51564.52
10min175215-7521585.11982.792.7785.9583.592.79
272497-7249782.04382.83
374788-7478884.63585.48
471985-7198581.46382.26
574479-7447984.28685.08
669993-6999379.20979.93
15min175508-7550885.45083.322.5087.2285.042.52
272520-7252082.06983.77
375057-7505784.94086.73
473079-7307982.70184.41
574838-7483884.69286.42
670758-7075880.07581.67
20min174996-7499684.87183.192.9587.5985.842.94
272849-7284982.44185.05
375857-7585785.84588.58
470463-7046379.74182.36
575191-7519185.09187.76
671735-7173581.18083.67
30min175696-7569685.66384.541.8689.3388.111.91
273855-7385583.58087.11
376361-7636186.41690.10
474083-7408383.83887.35
575544-7554485.49189.11
672677-7267782.24685.64
45min174716-7471684.55484.451.5189.1788.961.49
273528-7352883.20987.67
376580-7658086.66391.31
474016-7401683.76288.20
573810-7381083.52988.09
675102-7510284.99189.29
极限178060-7806088.33888.251.1993.9093.691.04
276902-7690287.02892.41
377310-7731087.48993.10
478717-7871789.08294.45
577528-7752887.73693.23
679366-7936689.81695.06
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