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%
110.762237122413223962245222357223980.17
210.832236122397223790.12
单位质量响应值RSD%判断
2081.602066.390.52数据可信
供试品溶液-2022081701批-培哚普利-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119945-1994582.05185.952.5882.0585.952.58
220618-2061884.81984.82
321418-2141888.11188.11
421104-2110486.81986.82
521008-2100886.42486.42
621260-2126087.46187.46
10min121428-2142888.15292.092.7889.0693.042.77
222724-2272493.48394.43
322705-2270593.40594.38
422810-2281093.83794.80
522873-2287394.09695.06
621771-2177189.56390.53
15min121658-2165889.09892.962.3790.9994.942.36
222883-2288394.13796.12
322944-2294494.38896.41
422815-2281593.85895.86
522254-2225491.55093.56
623023-2302394.71396.68
20min122376-2237692.05293.971.3594.9396.981.37
223072-2307294.91597.94
323052-2305294.83397.90
422967-2296794.48397.53
522528-2252892.67795.70
623058-2305894.85797.88
30min121381-2138187.95890.711.7091.8694.771.70
222375-2237592.04896.13
322060-2206090.75294.87
422261-2226191.57995.68
521894-2189490.06994.12
622332-2233291.87195.94
45min121676-2167689.17290.870.9994.0595.931.03
222294-2229491.71496.82
322217-2221791.39896.53
422147-2214791.11096.23
522065-2206590.77295.83
622131-2213191.04496.14
极限122016-2201690.57192.231.1996.4498.301.19
222778-2277893.70599.83
322388-2238892.10198.24
422255-2225591.55497.68
522483-2248392.49298.55
622591-2259192.93699.04
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%
113.981639961640961640731639001639271639980.06
213.981636111639091637600.13
单位质量响应值RSD%判断
11730.9011713.880.11数据可信
供试品溶液-2022081701批-氨氯地平-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1127430-12743070.46972.532.7370.4772.532.73
2128740-12874071.19471.19
3137680-13768076.13776.14
4131568-13156872.75772.76
5130021-13002171.90271.90
6131518-13151872.73072.73
10min1149500-14950082.67485.522.6083.4686.332.59
2155043-15504385.73986.53
3158875-15887587.85888.70
4157795-15779587.26188.07
5156725-15672586.66987.47
6149950-14995082.92383.73
15min1151871-15187183.98587.713.2685.6989.463.23
2157912-15791287.32689.07
3165816-16581691.69793.52
4160846-16084688.94890.73
5153816-15381685.06186.82
6161362-16136289.23490.96
20min1156454-15645486.52088.732.5989.1591.462.58
2159531-15953188.22190.94
3166805-16680592.24495.08
4162327-16232789.76792.53
5155654-15565486.07788.78
6161968-16196889.56992.29
30min1148087-14808781.89385.722.8985.4989.442.86
2155488-15548885.98589.68
3159985-15998588.47292.34
4157856-15785687.29591.06
5151332-15133283.68787.35
6157307-15730786.99190.71
45min1151163-15116383.59486.021.9388.1090.691.96
2156293-15629386.43091.08
3159529-15952988.22093.07
4156232-15623286.39791.13
5152998-15299884.60889.20
6157089-15708986.87191.55
极限1165719-16571991.64393.061.3897.0898.691.36
2172199-17219995.227100.84
3169365-16936593.65999.49
4166830-16683092.25797.95
5167117-16711792.41697.95
6168463-16846393.16198.81
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%
110.762233722368223412232022332223400.08
210.832227122390223300.38
单位质量响应值RSD%判断
2076.212061.870.50数据可信
供试品溶液-2022081701批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121036-2103686.74688.482.0486.7588.482.04
221612-2161289.12289.12
321084-2108486.94486.94
421869-2186990.18190.18
521118-2111887.08487.08
622027-2202790.83390.83
10min122858-2285894.26095.571.1995.2296.551.20
223182-2318295.59696.59
323242-2324295.84396.81
423262-2326295.92696.93
522897-2289794.42195.39
623610-2361097.36198.37
15min122848-2284894.21894.850.8496.2396.890.83
222970-2297094.72296.77
322801-2280194.02596.06
423335-2333596.22798.29
523090-2309095.21697.23
622958-2295894.67296.76
20min122682-2268293.53494.130.8996.5997.230.88
222672-2267293.49396.60
323058-2305895.08498.16
423071-2307195.13898.28
522617-2261793.26696.34
622861-2286194.27297.42
30min122250-2225091.75292.653.1895.8596.793.03
222349-2234992.16196.30
322857-2285794.25698.39
423061-2306195.09799.29
523082-2308295.18399.29
621204-2120487.43991.63
45min122460-2246092.61893.281.3497.7498.461.28
222454-2245492.59497.76
322562-2256293.03998.22
422716-2271693.67498.92
522346-2234692.14897.32
623184-2318495.604100.77
极限122570-2257093.07292.830.8899.2299.040.83
222162-2216291.39097.59
322399-2239992.36798.58
422604-2260493.21299.50
522690-2269093.56799.76
622637-2263793.34899.57
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%
113.981640771642331637961637181635421638730.18
213.981630091639781634940.42
单位质量响应值RSD%判断
11721.9611694.850.17数据可信
供试品溶液-2022081701批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1142658-14265878.98579.983.0078.9879.983.00
2149510-14951082.77882.78
3140852-14085277.98577.98
4147049-14704981.41681.42
5138744-13874476.81876.82
6147975-14797581.92881.93
10min1167158-16715892.54993.521.6893.4394.421.69
2171415-17141594.90695.83
3170498-17049894.39995.27
4169447-16944793.81794.72
5164037-16403790.82191.67
6170962-17096294.65595.57
15min1167485-16748592.73093.300.9394.6495.230.94
2170613-17061394.46296.44
3167860-16786092.93894.85
4170414-17041494.35296.30
5167265-16726592.60994.47
6167443-16744392.70794.67
20min1166698-16669892.29592.791.2795.2395.761.27
2168961-16896193.54896.57
3170216-17021694.24297.19
4168399-16839993.23696.23
5164086-16408690.84893.74
6167221-16722192.58495.58
30min1163421-16342190.48091.303.0494.4495.292.90
2166246-16624692.04496.11
3168830-16883093.47597.47
4168030-16803093.03297.06
5167407-16740792.68796.59
6155442-15544286.06390.08
45min1165464-16546491.61192.131.5396.5897.141.48
2168457-16845793.26998.35
3166114-16611491.97197.01
4165950-16595091.88196.95
5162544-16254489.99594.93
6169880-16988094.05699.03
极限1169817-16981794.02293.260.62100.0199.300.52
2167235-16723592.59298.71
3168487-16848793.28599.34
4167414-16741492.69198.78
5169411-16941193.79799.73
6168317-16831793.19199.21
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%
110.762238922314223452235322341223480.13
210.832240622391223980.05
单位质量响应值RSD%判断
2076.952068.140.31数据可信
供试品溶液-2022081801批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121996-2199690.55188.632.9890.5588.642.98
222199-2219991.38691.39
321546-2154688.69888.70
420976-2097686.35286.35
521903-2190390.16890.17
620563-2056384.65284.65
10min123652-2365297.36895.591.5798.3796.571.58
223605-2360597.17498.19
323188-2318895.45896.44
422730-2273093.57294.53
523212-2321295.55796.56
622933-2293394.40895.35
15min123814-2381498.03595.301.52100.1297.351.51
223156-2315695.32697.42
323009-2300994.72196.77
422782-2278293.78695.79
523112-2311295.14597.21
623029-2302994.80396.79
20min123393-2339396.30294.412.0899.4897.522.06
222944-2294494.45397.61
323239-2323995.66898.77
422816-2281693.92696.97
523151-2315195.30698.43
622055-2205590.79493.84
30min123297-2329795.90794.912.02100.1599.061.99
223842-2384298.150102.35
323004-2300494.70098.86
422539-2253992.78696.87
522918-2291894.34698.53
622723-2272393.54497.60
45min123160-2316095.34393.571.15100.6698.781.17
222656-2265693.26898.56
322691-2269193.41298.63
422451-2245192.42497.54
522898-2289894.26499.49
622522-2252292.71697.81
极限122816-2281693.92693.101.05100.3099.351.03
222402-2240292.22298.55
322852-2285294.075100.33
422267-2226791.66697.81
522733-2273393.58599.86
622628-2262893.15299.27
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%
113.981638771642411639151639901640131640070.09
213.981638121638991638560.04
单位质量响应值RSD%判断
11731.5511720.740.07数据可信
供试品溶液-2022081801批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1149944-14994482.89379.404.7382.8979.404.73
2151802-15180283.92083.92
3142867-14286778.98178.98
4140977-14097777.93677.94
5143244-14324479.18979.19
6132889-13288973.46473.46
10min1171337-17133794.71993.232.2295.6494.112.24
2174816-17481696.64397.58
3166636-16663692.12193.00
4164663-16466391.03091.90
5167650-16765092.68193.56
6166714-16671492.16492.98
15min1173382-17338295.85093.521.9697.8295.441.98
2172989-17298995.63397.64
3166590-16659092.09594.00
4165443-16544391.46193.34
5167774-16777492.75094.66
6168806-16880693.32095.16
20min1170766-17076694.40492.781.9397.4495.741.94
2171174-17117494.62997.70
3168422-16842293.10896.03
4165878-16587891.70294.60
5168206-16820692.98995.93
6162545-16254589.85992.74
30min1168825-16882593.33193.112.6997.4297.102.66
2177126-17712697.920102.04
3166469-16646992.02895.99
4164149-16414990.74694.66
5166556-16655692.07696.05
6167434-16743492.56296.44
45min1169978-16997893.96892.341.5299.0997.361.55
2170030-17003093.99799.21
3165015-16501591.22596.21
4163936-16393690.62895.55
5167011-16701192.32897.32
6166211-16621191.88696.79
极限1169510-16951093.70993.230.8099.8899.280.80
2168717-16871793.27199.52
3168768-16876893.29999.29
4166061-16606191.80397.73
5168914-16891493.38099.40
6169869-16986993.90899.83
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%
110.762243222445223852241622392224140.12
210.832239322376223840.06
单位质量响应值RSD%判断
2083.092066.850.56数据可信
供试品溶液-2022081801批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122355-2235591.92286.933.5791.9286.933.57
220156-2015682.88082.88
321069-2106986.63486.63
420626-2062684.81384.81
521143-2114386.93986.94
621495-2149588.38688.39
10min123042-2304294.74793.881.5395.7794.851.54
222191-2219191.24892.17
323078-2307894.89595.86
422881-2288194.08595.03
522698-2269893.33394.30
623103-2310394.99895.98
15min123135-2313595.13093.851.0097.2095.861.02
222461-2246192.35894.29
322707-2270793.37095.39
422845-2284593.93795.92
522850-2285093.95895.96
622947-2294794.35796.39
20min122662-2266293.18592.261.0496.3295.311.03
222235-2223591.42994.39
322400-2240092.10795.16
422777-2277793.65796.69
522323-2232391.79194.84
622219-2221991.36394.45
30min122590-2259092.88992.530.9897.0696.610.98
222199-2219991.28195.26
322349-2234991.89895.98
422840-2284093.91797.99
522473-2247392.40796.47
622570-2257092.80696.91
45min122434-2243492.24792.120.8397.4597.220.83
222153-2215391.09296.08
322286-2228691.63996.74
422560-2256092.76597.88
522331-2233191.82496.92
622654-2265493.15298.28
极限122253-2225391.50391.271.8397.7397.401.74
222081-2208190.79696.80
322527-2252792.63098.75
422507-2250792.54798.69
521442-2144288.16894.28
622365-2236591.96398.13
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%
113.981630181632291629451629991629431630270.08
213.981635741635221635480.03
单位质量响应值RSD%判断
11661.4411698.710.23数据可信
供试品溶液-2022081801批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1152093-15209384.41377.375.7484.4177.365.75
2129303-12930371.76471.76
3138131-13813176.66476.66
4133890-13389074.31074.31
5138615-13861576.93276.93
6144336-14433680.10880.11
10min1167866-16786693.16790.723.0294.1091.583.04
2155169-15516986.12086.92
3165045-16504591.60192.45
4163488-16348890.73791.56
5160833-16083389.26390.12
6168375-16837593.44994.34
15min1168535-16853593.53891.092.2995.5192.962.32
2158598-15859888.02389.78
3163179-16317990.56692.44
4163424-16342490.70192.54
5162755-16275590.33092.18
6168244-16824493.37795.31
20min1166242-16624292.26689.991.8995.2892.871.93
2157855-15785587.61190.34
3162046-16204689.93792.81
4163830-16383090.92793.77
5159467-15946788.50591.36
6163423-16342390.70193.67
30min1166012-16601292.13890.441.9096.1894.321.93
2158072-15807287.73191.44
3161706-16170689.74893.62
4164566-16456691.33595.19
5161572-16157289.67493.51
6165819-16581992.03196.00
45min1165109-16510991.63790.471.8096.7095.351.84
2158669-15866988.06292.74
3162418-16241890.14395.02
4163422-16342290.70095.57
5161347-16134789.54994.38
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