XXYYYY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%
19.942132221265211512120321196212270.32
29.962119121181211860.04
单位质量响应值RSD%判断
2135.512127.110.28数据可信
加速6月-供试品溶液-2022081601批-尚未录入-培哚普利-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%
5min123860-2386095.51697.031.7795.5297.041.77
223745-2374595.05695.06
324216-2421696.94196.94
424927-2492799.78799.79
524470-2447097.95897.96
624218-2421896.94996.95
10min123708-2370894.90896.781.1395.9797.861.13
224014-2401496.13397.19
324351-2435197.48298.56
424344-2434497.45498.56
524217-2421796.94598.03
624423-2442397.77098.85
15min123533-2353394.20795.991.5596.3298.141.54
223490-2349094.03596.16
324327-2432797.38699.55
424123-2412396.56998.76
524258-2425897.10999.27
624143-2414396.64998.81
20min123273-2327393.16695.371.6596.3398.601.63
223528-2352894.18797.36
324347-2434797.466100.71
424054-2405496.29399.56
524022-2402296.16599.41
623723-2372394.96898.21
30min123237-2323793.02294.861.5097.2299.141.48
223289-2328993.23097.45
323938-2393895.828100.15
423700-2370094.87699.21
523982-2398296.004100.32
624024-2402496.173100.47
45min123303-2330393.28694.090.7898.5299.420.80
223278-2327893.18698.44
323580-2358094.39599.79
423600-2360094.47599.86
523516-2351694.13999.52
623745-2374595.056100.42
极限122594-2259490.44892.721.5196.7299.101.49
222870-2287091.55397.84
323404-2340493.691100.13
423290-2329093.23499.67
523375-2337593.574100.00
623443-2344393.847100.26
XXYYYY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%
114.061682071681471682271682551680381681750.06
214.201681411682251681830.04
单位质量响应值RSD%判断
11961.2411843.870.70数据可信
加速6月-供试品溶液-2022081601批-尚未录入-氨氯地平-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%
5min1171346-17134693.32394.691.8493.3294.691.84
2171345-17134593.32293.32
3173093-17309394.27494.27
4178287-17828797.10397.10
5177466-17746696.65696.66
6171654-17165493.49193.49
10min1175440-17544095.55396.890.8496.5997.940.84
2177534-17753496.69397.73
3179191-17919197.59698.64
4177756-17775696.81497.89
5179668-17966897.85598.93
6177784-17778496.82997.87
15min1174657-17465795.12696.461.0797.2298.591.07
2175561-17556195.61897.73
3179009-17900997.49699.63
4177156-17715696.48798.64
5179477-17947797.75199.91
6176771-17677196.27798.39
20min1172378-17237893.88595.811.4697.0499.011.45
2174541-17454195.06398.24
3178867-17886797.419100.63
4177099-17709996.45699.68
5178280-17828097.099100.35
6174265-17426594.91398.10
30min1172092-17209293.72995.021.3097.9399.291.28
2172754-17275494.09098.32
3176569-17656996.167100.47
4172880-17288094.15898.46
5177581-17758196.719101.04
6174907-17490795.26299.50
45min1171791-17179193.56594.270.6098.8199.590.62
2172993-17299394.22099.50
3173616-17361694.55999.93
4172861-17286194.14899.49
5174772-17477295.189100.59
6172435-17243593.91699.21
极限1167624-16762491.29692.991.0797.5899.361.07
2170401-17040192.80899.13
3171998-17199893.678100.09
4170693-17069392.96799.36
5173031-17303194.240100.70
6170634-17063492.93599.28
XXYYYY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%
19.942123021181212172122321158212020.15
29.962125421141211980.38
单位质量响应值RSD%判断
2133.002128.310.16数据可信
加速6月-供试品溶液-2022081701批-尚未录入-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%
5min124387-2438797.65596.921.6897.6696.921.68
224105-2410596.52696.53
324668-2466898.78198.78
424305-2430597.32797.33
523465-2346593.96393.96
624284-2428497.24397.24
10min124183-2418396.83996.710.4997.9297.790.49
223983-2398396.03897.11
324150-2415096.70697.80
424147-2414796.69497.78
524104-2410496.52297.57
624344-2434497.48398.56
15min124075-2407596.40696.691.5098.5798.841.47
223569-2356994.38096.52
324134-2413496.64298.81
424358-2435897.53999.70
524080-2408096.42698.54
624658-2465898.741100.90
20min124005-2400596.12695.781.3599.3699.011.34
223507-2350794.13297.32
324299-2429997.303100.55
423978-2397896.01899.26
523558-2355894.33697.52
624170-2417096.786100.05
30min123514-2351494.16094.340.9598.4698.630.94
223240-2324093.06297.30
323443-2344393.87598.20
423735-2373595.04599.35
523550-2355094.30498.54
623874-2387495.60199.94
45min123099-2309992.49892.181.7097.8497.521.64
222250-2225089.09894.37
323328-2332893.41598.78
423165-2316592.76298.12
523051-2305192.30697.59
623224-2322492.99898.40
极限122797-2279791.28891.621.3897.6697.981.34
222485-2248590.03996.30
322807-2280791.32897.74
423426-2342693.807100.20
522761-2276191.14497.45
623001-2300192.10598.54
XXYYYY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%
114.061687121689661688251687871687161688010.07
214.201685111686031685570.04
单位质量响应值RSD%判断
12005.7611870.210.81数据可信
加速6月-供试品溶液-2022081701批-尚未录入-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%
5min1174272-17427294.63593.971.9494.6493.971.94
2176124-17612495.64195.64
3176578-17657895.88895.89
4171279-17127993.01093.01
5167671-16767191.05191.05
6172390-17239093.61393.61
10min1177662-17766296.47696.160.5497.5397.200.55
2178725-17872597.05498.12
3176604-17660495.90296.97
4176174-17617495.66896.70
5176798-17679896.00797.02
6176490-17649095.84096.88
15min1176595-17659595.89795.970.8498.0298.090.81
2174348-17434894.67796.82
3177440-17744096.35698.49
4176909-17690996.06798.16
5176302-17630295.73897.82
6178835-17883597.11399.22
20min1176679-17667995.94395.231.2999.1398.411.27
2173540-17354094.23897.43
3178930-17893097.165100.37
4174262-17426294.63097.79
5172901-17290193.89197.03
6175931-17593195.53698.72
30min1172330-17233093.58193.840.5397.8498.080.50
2171764-17176493.27497.51
3172376-17237693.60697.89
4172813-17281393.84398.06
5173249-17324994.08098.27
6174352-17435294.67998.92
45min1169774-16977492.19391.781.5397.4997.061.45
2163783-16378388.94094.22
3170410-17041092.53897.86
4170065-17006592.35197.61
5169600-16960092.09897.33
6170427-17042792.54797.85
极限1167499-16749990.95791.280.8797.2897.580.82
2167605-16760591.01597.28
3167642-16764291.03597.38
4170749-17074992.72299.01
5166527-16652790.43096.68
6168492-16849291.49797.82
XXYYYY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%
19.942120921186211342117921165211750.14
29.962116621203211840.13
单位质量响应值RSD%判断
2130.282126.910.12数据可信
加速6月-供试品溶液-2022081801批-尚未录入-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%
5min123160-2316092.83293.071.7192.8393.071.70
223114-2311492.64792.65
323050-2305092.39192.39
422657-2265790.81690.82
523773-2377395.28995.29
623556-2355694.41994.42
10min122841-2284191.55392.401.3192.5893.431.31
222722-2272291.07692.11
322969-2296992.06693.09
422956-2295692.01493.02
523526-2352694.29995.36
623297-2329793.38194.43
15min122834-2283491.52592.211.3793.5794.271.36
222565-2256590.44792.49
323037-2303792.33994.39
422899-2289991.78693.82
523247-2324793.18195.29
623449-2344993.99096.08
20min123409-2340993.83093.871.3796.9096.951.36
223536-2353694.33997.39
323041-2304192.35595.43
423039-2303992.34795.40
523780-2378095.31798.46
623703-2370395.00898.14
30min122935-2293591.93092.701.4796.0496.831.46
222920-2292091.87095.96
323259-2325993.22997.33
422682-2268290.91694.99
523369-2336993.67097.87
623598-2359894.58798.77
45min122187-2218788.93291.621.7994.0696.781.73
222674-2267490.88496.00
323315-2331593.45398.59
422753-2275391.20096.29
523147-2314792.78098.02
623076-2307692.49597.73
极限122567-2256790.45590.591.8696.5796.771.79
222289-2228989.34195.47
322953-2295392.00298.18
422048-2204888.37594.48
522561-2256190.43196.70
623189-2318992.94899.21
XXYYYY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%
114.061680861680431680111680221679281680180.04
214.201681091682631681860.07
单位质量响应值RSD%判断
11950.0711844.080.63数据可信
加速6月-供试品溶液-2022081801批-尚未录入-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%
5min1168803-16880391.98091.682.4191.9891.682.41
2170928-17092893.13893.14
3165221-16522190.02890.03
4162175-16217588.36888.37
5173526-17352694.55394.55
6168894-16889492.02992.03
10min1170091-17009192.68192.941.2293.7093.961.23
2169151-16915192.16993.20
3168600-16860091.86992.87
4169669-16966992.45293.43
5174246-17424694.94696.00
6171646-17164693.52994.55
15min1170379-17037992.83892.751.2694.8994.801.27
2168569-16856991.85293.91
3168231-16823191.66893.69
4168496-16849691.81293.82
5172800-17280094.15896.26
6172798-17279894.15696.22
20min1174015-17401594.82094.461.3597.9097.551.34
2174504-17450495.08698.17
3170011-17001192.63895.68
4170946-17094693.14796.18
5175740-17574095.76098.91
6174953-17495395.33198.44
30min1171277-17127793.32893.531.0797.4697.661.07
2171754-17175493.58897.72
3171288-17128893.33497.40
4168566-16856691.85195.91
5173586-17358694.58698.80
6173390-17339094.47998.65
45min1165983-16598390.44392.331.2995.6297.511.25
2168451-16845191.78896.96
3170758-17075893.04598.15
4168678-16867891.91297.00
5171945-17194593.69298.96
6170913-17091393.12998.35
极限1168022-16802291.55491.311.2597.7397.511.21
2166828-16682890.90397.10
3168606-16860691.87298.01
4164099-16409989.41695.52
5167522-16752291.28297.59
6170378-17037892.83899.09
XXYYYY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%
19.942111521139209682101321147210760.39
29.962126221224212430.13
单位质量响应值RSD%判断
2120.322132.830.42数据可信
长期6月-供试品溶液-2022081601批-尚未录入-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%
5min124359-2435997.73197.910.8197.7397.910.81
224478-2447898.20998.21
324484-2448498.23398.23
424604-2460498.71498.71
524038-2403896.44396.44
624464-2446498.15298.15
10min124714-2471499.15598.571.44100.2499.661.41
224363-2436397.74798.84
324438-2443898.04899.14
424360-2436097.73598.83
525225-25225101.206102.28
624314-2431497.55198.64
15min124306-2430697.51996.780.7399.7198.960.72
223943-2394396.06298.24
324030-2403096.41198.59
424120-2412096.77298.96
524358-2435897.72799.92
623972-2397296.17898.35
20min123894-2389495.86695.151.6299.1498.411.58
223165-2316592.94196.19
323797-2379795.47698.73
423815-2381595.54998.81
524240-2424097.254100.54
623385-2338593.82397.07
30min123264-2326493.33893.401.9397.6797.721.85
223268-2326893.35497.63
322457-2245790.10094.41
423790-2379095.44899.77
523510-2351094.32598.69
623394-2339493.85998.15
45min123525-2352594.38593.651.1699.7699.011.13
223225-2322593.18198.50
322884-2288491.81397.13
423437-2343794.03299.41
523651-2365194.891100.30
623335-2333593.62398.95
极限123101-2310192.68492.931.1599.1199.321.11
223275-2327593.38299.73
322681-2268190.99997.33
423251-2325193.28699.71
523470-2347094.164100.63
623193-2319393.05399.42
XXYYYY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%
114.061669111673041674381673881674531672990.14
214.201678301678621678460.02
单位质量响应值RSD%判断
11898.9311820.140.47数据可信
长期6月-供试品溶液-2022081601批-尚未录入-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%
5min1175093-17509395.70895.990.9895.7195.990.98
2177226-17722696.87496.87
3176639-17663996.55396.55
4177233-17723396.87896.88
5173077-17307794.60694.61
6174351-17435195.30395.30
10min1181406-18140699.15998.661.89100.2299.721.87
2178642-17864297.64898.72
3180405-18040598.61299.68
4178193-17819397.40398.48
5186789-186789102.101103.15
6177499-17749997.02398.08
15min1179016-17901697.85396.991.03100.0299.151.01
2175346-17534695.84698.01
3177003-17700396.75298.92
4176964-17696496.73198.89
5180151-18015198.473100.66
6176118-17611896.26898.41
20min1176277-17627796.35595.522.1199.6198.762.06
2170907-17090793.42096.65
3176735-17673596.60699.85
4174386-17438695.32298.56
5179914-17991498.343101.62
6170283-17028393.07996.29
30min1172029-17202994.03393.621.7598.3697.921.69
2171623-17162393.81198.08
3165962-16596290.71795.03
4172993-17299394.56098.85
5174731-17473195.51099.88
6170336-17033693.10897.35
45min1173142-17314294.64293.741.51100.0199.081.48
2170505-17050593.20098.51
3168229-16822991.95697.28
4171454-17145493.71999.06
5175594-17559495.982101.42
6170037-17003792.94598.22
极限1169821-16982192.82693.121.3999.2599.501.35
2171006-17100693.47499.82
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