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%
19.831916419187191201917119246191780.24
29.901902719276191520.92
单位质量响应值RSD%判断
1950.971934.550.60数据可信
供试品溶液-25102201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%
5min121984-2198496.54999.202.3696.5599.202.36
221938-2193896.34796.35
322753-2275399.92699.93
423324-23324102.434102.43
522774-22774100.018100.02
622755-2275599.93599.93
10min122411-2241198.424100.231.4099.50101.341.39
223001-23001101.015102.09
322548-2254899.026100.14
423297-23297102.315103.45
522871-22871100.444101.56
622810-22810100.176101.29
15min122164-2216497.33999.641.4899.51101.861.48
222844-22844100.326102.52
322676-2267699.588101.80
423182-23182101.810104.09
522702-2270299.702101.93
622558-2255899.070101.29
20min122052-2205296.84798.721.71100.10102.051.69
222618-2261899.333102.64
322078-2207896.962100.28
422990-22990100.967104.37
522353-2235398.169101.50
622786-22786100.071103.40
30min121685-2168595.23697.321.2899.56101.741.28
222226-2222697.612102.02
322168-2216897.357101.75
422547-2254799.021103.55
522071-2207196.931101.36
622264-2226497.779102.21
45min121760-2176095.56596.871.46100.95102.381.46
222112-2211297.111102.61
321857-2185795.991101.47
422661-2266199.522105.15
521911-2191196.228101.73
622048-2204896.830102.35
极限121358-2135893.80095.231.31100.24101.801.31
221834-2183495.890102.47
321401-2140193.988100.53
422100-2210097.058103.79
521610-2161094.906101.48
621796-2179695.723102.32
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%
113.898069280487806598066780361805730.18
214.088055880460805090.09
单位质量响应值RSD%判断
5800.795717.971.02数据可信
供试品溶液-25102201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%
5min182856-8285693.26496.272.6193.2696.272.61
282867-8286793.27693.28
385555-8555596.30296.30
488179-8817999.25699.26
586813-8681397.71897.72
686879-8687997.79297.79
10min185978-8597896.77898.601.7697.8199.671.76
288293-8829399.384100.42
385857-8585796.64297.71
489947-89947101.246102.35
587946-8794698.993100.08
687554-8755498.55299.64
15min184748-8474895.39497.571.4297.5199.731.42
287226-8722698.183100.32
386551-8655197.42399.57
488510-8851099.628101.86
586401-8640197.25499.44
686633-8663397.51599.70
20min184522-8452295.13996.371.8598.3199.621.83
285650-8565096.40999.64
383716-8371694.23297.46
488150-8815099.223102.56
585077-8507795.76499.03
686592-8659297.469100.73
30min183256-8325693.71495.211.2597.9499.531.26
285013-8501395.69299.99
383860-8386094.39498.67
486318-8631897.161101.60
584354-8435494.95099.28
684717-8471795.35999.71
45min182939-8293993.35794.691.4498.63100.071.44
284667-8466795.302100.67
382992-8299293.41798.74
486177-8617797.002102.52
584085-8408594.647100.03
683890-8389094.42899.84
极限181675-8167591.93593.301.4698.2499.731.46
283872-8387294.408100.83
381325-8132591.54197.90
484401-8440195.003101.60
582788-8278893.18799.62
683263-8326393.722100.18
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%
19.831916619175190231918119212191510.39
29.901920719119191630.33
单位质量响应值RSD%判断
1948.221935.660.46数据可信
供试品溶液-25102301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%
5min122937-22937100.77698.123.10100.7898.123.10
222694-2269499.70899.71
322214-2221497.59997.60
422309-2230998.01798.02
522800-22800100.174100.17
621045-2104592.46392.46
10min122932-22932100.75499.470.97101.87100.560.95
222427-2242798.53599.64
322405-2240598.43899.52
422645-2264599.493100.58
522580-2258099.207100.32
622856-22856100.420101.45
15min122813-22813100.23198.831.52102.47101.031.48
222463-2246398.693100.90
322091-2209197.05999.24
422499-2249998.851101.05
522156-2215697.34499.56
622944-22944100.807102.95
20min122422-2242298.51397.231.27101.87100.521.24
222056-2205696.905100.20
321712-2171295.39498.65
422269-2226997.841101.13
521930-2193096.35299.65
622387-2238798.359101.62
30min122456-2245698.66396.871.30103.11101.251.28
221954-2195496.457100.83
321711-2171195.38999.71
421877-2187796.119100.50
521958-2195896.475100.84
622337-2233798.140102.50
45min122110-2211097.14295.660.92102.69101.120.93
221721-2172195.433100.88
321492-2149294.42799.80
421805-2180595.802101.25
521724-2172495.446100.89
621790-2179095.736101.18
极限121951-2195196.44494.481.58103.07101.001.53
221388-2138893.970100.48
321104-2110492.72299.15
421740-2174095.517102.03
521163-2116392.98299.48
621680-2168095.253101.76
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%
113.897976579725798068004879897798480.17
214.088017580306802400.12
单位质量响应值RSD%判断
5748.605698.860.62数据可信
供试品溶液-25102301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%
5min184901-8490196.15895.644.3196.1695.644.31
287330-8733098.90998.91
385066-8506696.34596.34
485147-8514796.43796.44
586902-8690298.42498.42
677337-7733787.59187.59
10min186303-8630397.74698.200.7298.8199.260.69
286118-8611897.53698.64
386169-8616997.59498.66
487499-8749999.100100.17
586720-8672098.21899.31
687427-8742799.01999.99
15min185461-8546196.79297.661.6398.9599.821.57
286053-8605397.46399.65
384605-8460595.82397.98
487490-8749099.090101.26
585435-8543596.76398.95
688322-88322100.033102.11
20min184138-8413895.29496.241.1698.5299.471.13
285378-8537896.69899.96
383556-8355694.63597.85
486051-8605197.460100.73
584854-8485496.10599.36
685840-8584097.221100.41
30min183993-8399395.13095.491.3699.4299.801.30
284335-8433595.51799.86
382795-8279593.77398.04
483915-8391595.04199.40
584525-8452595.732100.06
686300-8630097.742102.01
45min182990-8299093.99494.220.9899.3499.590.95
282740-8274093.71099.11
381872-8187292.72798.04
483953-8395395.084100.50
583820-8382094.934100.33
683761-8376194.867100.22
极限181899-8189992.75892.941.2099.1599.361.15
282106-8210692.99299.43
380848-8084891.56897.91
483349-8334994.400100.87
581181-8118191.94598.39
682998-8299894.003100.41
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%
19.831920419226194001933219217192760.45
29.901920619428193170.82
单位质量响应值RSD%判断
1960.941951.210.36数据可信
供试品溶液-25102302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%
5min122434-2243497.85399.621.3397.8599.621.33
222612-2261298.63098.63
323070-23070100.627100.63
423221-23221101.286101.29
522996-22996100.305100.30
622701-2270199.01899.02
10min122501-2250198.14599.492.1599.23100.602.13
222103-2210396.40997.51
322960-22960100.148101.27
423508-23508102.538103.66
522693-2269398.983100.10
623087-23087100.701101.80
15min122296-2229697.25198.621.6599.43100.841.64
222104-2210496.41498.58
322557-2255798.390100.62
423119-23119100.841103.11
522746-2274699.214101.43
622840-2284099.624101.84
20min122184-2218496.76397.371.64100.02100.671.64
221787-2178795.03198.27
322363-2236397.543100.87
422919-2291999.969103.35
522309-2230997.308100.62
622372-2237297.583100.91
30min121417-2141793.41796.012.1497.75100.402.11
221494-2149493.75398.05
322232-2223296.972101.38
422637-2263798.739103.23
522109-2210996.436100.83
622182-2218296.754101.16
45min121556-2155694.02495.411.5799.39100.861.58
221518-2151893.85899.19
321843-2184395.275100.76
422446-2244697.906103.50
521828-2182895.210100.68
622049-2204996.174101.66
极限121137-2113792.19694.461.7198.61100.981.71
221315-2131592.97299.35
321788-2178895.035101.58
422146-2214696.597103.28
521697-2169794.639101.17
621853-2185395.319101.87
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%
113.898087681003809418098580996809600.07
214.088072480861807920.12
单位质量响应值RSD%判断
5828.655738.071.11数据可信
供试品溶液-25102302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%
5min184527-8452794.75196.541.8494.7596.541.84
284891-8489195.15995.16
387832-8783298.45698.46
487651-8765198.25398.25
587156-8715697.69897.70
684659-8465994.89994.90
10min185628-8562895.98597.371.4797.0498.441.48
285282-8528295.59896.65
387717-8771798.32799.42
488600-8860099.317100.41
587395-8739597.96699.05
686578-8657897.05098.10
15min184497-8449794.71896.431.1596.8498.581.16
285416-8541695.74897.87
386038-8603896.44598.63
487174-8717497.71899.91
586953-8695397.47199.64
686058-8605896.46798.60
20min183301-8330193.37795.131.4496.5598.351.44
284045-8404594.21197.39
385244-8524495.55598.81
486796-8679697.295100.58
585343-8534395.66698.92
684443-8444394.65797.86
30min181227-8122791.05293.571.9795.2697.851.95
282241-8224192.18996.42
384207-8420794.39398.71
485628-8562895.985100.35
584652-8465294.89199.21
682874-8287492.89897.15
45min181328-8132891.16592.551.4696.3997.871.45
281445-8144591.29696.55
382558-8255892.54497.91
484627-8462794.863100.29
582426-8242692.39697.77
682999-8299993.03898.33
极限179889-7988989.55291.521.3995.7997.871.39
280872-8087290.65496.92
382274-8227492.22698.62
482957-8295792.99199.47
582401-8240192.36898.77
681466-8146691.32097.64
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