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%
19.951963919614197351949619603196170.44
29.981962619477195520.54
单位质量响应值RSD%判断
1971.561959.120.45数据可信
长期12月-供试品溶液-2022081601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%
5min123045-23045100.04599.431.21100.0499.421.20
222787-2278798.92598.92
323326-23326101.265101.26
422612-2261298.16598.17
522637-2263798.27498.27
623008-2300899.88499.88
10min123312-23312101.204100.240.99102.32101.340.98
222868-2286899.276100.38
323336-23336101.308102.43
422902-2290299.424100.51
523230-23230100.848101.94
622885-2288599.350100.46
15min123056-23056100.09399.451.08102.33101.681.07
222596-2259698.096100.30
323269-23269101.017103.27
422683-2268398.473100.67
522911-2291199.463101.68
622939-2293999.585101.80
20min122559-2255997.93598.791.16101.28102.121.15
222565-2256597.961101.25
323250-23250100.935104.31
422688-2268898.495101.78
522631-2263198.248101.57
622849-2284999.194102.51
30min122013-2201395.56595.110.90100.0099.530.88
221627-2162793.88998.27
321948-2194895.28299.78
421859-2185994.89699.28
522203-2220396.389100.80
621801-2180194.64499.07
45min121784-2178494.57094.370.92100.0799.840.90
221570-2157093.64199.07
321988-2198895.456101.01
421581-2158193.68999.13
521549-2154993.55099.03
621949-2194995.287100.76
极限121734-2173494.35394.101.07100.90100.621.03
221253-2125392.26598.73
321806-2180694.666101.28
421885-2188595.009101.49
521573-2157393.654100.17
621797-2179794.627101.16
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%
113.951584731587491585591587971584331586020.11
214.011585771587861586820.10
单位质量响应值RSD%判断
11369.3211326.340.27数据可信
长期12月-供试品溶液-2022081601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%
5min1174906-17490699.91699.121.0899.9299.121.08
2174384-17438499.61899.62
3175042-17504299.99499.99
4170029-17002997.13097.13
5173251-17325198.97198.97
6173470-17347099.09699.10
10min1178206-178206101.802100.551.08102.91101.651.08
2176617-176617100.894102.00
3176952-176952101.085102.20
4172641-17264198.62299.70
5176235-176235100.676101.78
6175414-175414100.207101.31
15min1174495-17449599.68299.421.85101.92101.641.83
2175012-17501299.977102.20
3175336-175336100.162102.40
4167599-16759995.74297.92
5176345-176345100.738102.96
6175476-175476100.242102.46
20min1171773-17177398.12799.100.87101.48102.420.87
2173301-17330199.000102.34
3175125-175125100.042103.39
4171597-17159798.026101.26
5174420-17442099.639102.98
6174609-17460999.747103.08
30min1167179-16717995.50294.900.6599.9499.320.65
2166668-16666895.21099.65
3164922-16492294.21398.67
4164976-16497694.24498.57
5167302-16730295.573100.02
6165692-16569294.65399.09
45min1163997-16399793.68594.250.5099.1899.730.50
2165730-16573094.675100.17
3165414-16541494.494100.00
4164216-16421693.81099.18
5164626-16462694.04499.55
6165957-16595794.804100.29
极限1163571-16357193.44193.560.2999.98100.080.23
2163372-16337293.32899.88
3163301-16330193.28799.84
4164582-16458294.019100.44
5163903-16390393.631100.18
6163915-16391593.638100.18
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%
19.951937119573197261957719700195890.72
29.981952519662195940.50
单位质量响应值RSD%判断
1968.741963.330.20数据可信
长期12月-供试品溶液-2022081701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%
5min122999-2299999.80999.571.5699.8199.571.56
222783-2278398.87298.87
322514-2251497.70497.70
422660-2266098.33898.34
523314-23314101.176101.18
623393-23393101.519101.52
10min123146-23146100.447100.121.08101.56101.221.08
222769-2276998.81199.91
322767-2276798.80299.89
423291-23291101.076102.17
523336-23336101.271102.40
623109-23109100.286101.41
15min123121-23121100.33899.881.08102.56102.101.06
222742-2274298.694100.89
323026-2302699.926102.11
423116-23116100.317102.53
523367-23367101.406103.66
622726-2272698.624100.87
20min122892-2289299.34598.291.24102.68101.621.23
222468-2246897.505100.80
322283-2228396.702100.00
422668-2266898.372101.70
523041-2304199.991103.37
622539-2253997.813101.15
30min122185-2218596.27695.960.53100.72100.380.52
222231-2223196.476100.85
321898-2189895.03199.40
422141-2214196.085100.51
522085-2208595.842100.33
622127-2212796.025100.45
45min121702-2170294.18095.031.2799.69100.521.24
221763-2176394.44599.89
321704-2170494.18999.61
421812-2181294.658100.15
522425-2242597.318102.87
621980-2198095.387100.88
极限121555-2155593.54293.461.90100.10100.001.80
220752-2075290.05896.56
321522-2152293.39999.87
421869-2186994.905101.45
521816-2181694.675101.31
621700-2170094.172100.72
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%
113.951588221586161586911587031587761587220.06
214.011584071589121586600.23
单位质量响应值RSD%判断
11377.9211324.770.34数据可信
长期12月-供试品溶液-2022081701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%
5min1171379-17137997.87198.431.3297.8798.421.32
2170789-17078997.53497.53
3171205-17120597.77297.77
4170630-17063097.44497.44
5173749-17374999.22599.22
6176363-176363100.718100.72
10min1174606-17460699.71499.990.42100.80101.080.41
2176035-176035100.530101.61
3173947-17394799.338100.42
4175447-175447100.195101.28
5175207-175207100.058101.16
6175247-175247100.080101.20
15min1173707-17370799.20199.330.67101.40101.540.65
2172389-17238998.448100.65
3174646-17464699.737101.93
4175222-175222100.066102.26
5174869-17486999.865102.08
6172802-17280298.684100.92
20min1171661-17166198.03297.920.58101.33101.230.58
2170469-17046997.352100.65
3170078-17007897.128100.43
4171785-17178598.103101.41
5172712-17271298.633101.96
6172041-17204198.249101.58
30min1165524-16552494.52894.830.7598.9199.230.71
2166556-16655695.11799.49
3165241-16524194.36698.74
4168353-16835396.143100.54
5165047-16504794.25598.68
6165649-16564994.59999.02
45min1163127-16312793.15993.840.5998.6099.290.57
2164652-16465294.03099.46
3163295-16329593.25598.68
4164789-16478994.10899.57
5164338-16433893.85099.32
6165693-16569394.624100.09
极限1161700-16170092.34492.810.7298.8299.300.69
2162184-16218492.62099.10
3161679-16167992.33298.79
4164543-16454393.968100.48
5161717-16171792.35498.86
6163294-16329493.25499.78
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%
19.951954819715195581964019753196430.47
29.981952219431194760.34
单位质量响应值RSD%判断
1974.171951.500.82数据可信
长期12月-供试品溶液-2022081801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%
5min122785-2278599.04498.180.9999.0498.180.98
222491-2249197.76697.77
322190-2219096.45896.46
422626-2262698.35398.35
522651-2265198.46298.46
622771-2277198.98498.98
10min122727-2272798.79298.380.9799.8999.470.97
222535-2253597.95899.04
322244-2224496.69397.76
422670-2267098.54599.64
522764-2276498.953100.05
622858-2285899.362100.46
15min122620-2262098.32798.430.75100.53100.620.74
222745-2274598.871101.05
322516-2251697.875100.02
422610-2261098.284100.47
522454-2245497.60699.80
622923-2292399.644101.85
20min122412-2241297.42396.541.27100.7199.821.25
222423-2242397.471100.74
321701-2170194.33297.57
422074-2207495.95499.23
522253-2225396.732100.01
622388-2238897.319100.63
30min121939-2193995.36795.830.9499.74100.180.92
222121-2212196.158100.51
321969-2196995.49799.78
421744-2174494.51998.87
522151-2215196.289100.64
622343-2234397.123101.52
45min121562-2156293.72894.361.0699.1699.771.03
221848-2184894.971100.40
321366-2136692.87698.22
421656-2165694.13799.53
522009-2200995.671101.09
621801-2180194.767100.24
极限121386-2138692.96393.961.7599.44100.421.67
221583-2158393.819100.30
321246-2124692.35598.73
421475-2147593.35099.79
522323-2232397.036103.52
621680-2168094.241100.77
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%
113.951591781585611584741587181586431587150.18
214.011586981590641588810.17
单位质量响应值RSD%判断
11377.4211340.540.23数据可信
长期12月-供试品溶液-2022081801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%
5min1170907-17090797.53695.841.4897.5495.841.48
2164384-16438493.81393.81
3166322-16632294.91994.92
4168128-16812895.95095.95
5170428-17042897.26397.26
6167465-16746595.57295.57
10min1170421-17042197.25996.901.2398.3497.971.23
2168057-16805795.91096.95
3166510-16651095.02796.08
4170554-17055497.33598.40
5171833-17183398.06499.15
6171399-17139997.81798.88
15min1170348-17034897.21796.630.6599.3898.760.66
2168103-16810395.93698.04
3168012-16801295.88497.99
4169191-16919196.55798.70
5169673-16967396.83299.00
6170543-17054397.32899.48
20min1168325-16832596.06295.000.8199.3198.220.81
2166278-16627894.89498.07
3164319-16431993.77696.95
4165912-16591294.68597.91
5166913-16691395.25798.50
6167077-16707795.35098.58
30min1165452-16545294.42394.261.1498.7398.541.12
2164060-16406093.62897.86
3164104-16410493.65497.87
4162762-16276292.88897.16
5167260-16726095.45599.76
6167409-16740995.54099.83
45min1163360-16336093.22991.983.2498.5997.303.10
2151217-15121786.29991.57
3160405-16040591.54396.80
4162263-16226392.60397.91
5165970-16597094.718100.08
6163840-16384093.50398.85
极限1157980-15798090.15991.801.6796.5698.141.60
2159665-15966591.12097.35
3158751-15875190.59996.87
4161673-16167392.26698.60
5165374-16537494.378100.80
6161735-16173592.30298.69
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