替米沙坦氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
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10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.162769727693277462784527560277080.38
214.192781627903278600.23
单位质量响应值RSD%判断
1956.781963.350.24数据可信
供试品溶液-2026031621批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114296-1429652.54273.7316.2352.5473.7316.24
223761-2376187.32887.33
319584-1958471.97771.98
422153-2215381.41981.42
521111-2111177.58977.59
619457-1945771.51071.51
10min118230-1823067.00082.809.9167.5383.549.96
224703-2470390.79191.66
322493-2249382.66883.39
423491-2349186.33687.15
522978-2297884.45185.23
623286-2328685.58386.30
15min119121-1912170.27585.409.1271.4786.979.18
225024-2502491.97093.75
324347-2434789.48291.03
424232-2423289.06090.74
523178-2317885.18686.81
623524-2352486.45788.03
20min119938-1993873.27886.737.9675.1889.158.04
225287-2528792.93795.64
324255-2425589.14491.59
424098-2409888.56791.14
523583-2358386.67489.15
624430-2443089.78792.22
30min119832-1983272.88884.777.8875.5288.067.95
225086-2508692.19895.83
323902-2390287.84791.18
423909-2390987.87291.33
522372-2237282.22485.56
623285-2328585.57988.91
45min120314-2031474.66084.946.6678.0289.086.76
224410-2441089.71494.27
324619-2461990.48294.69
423069-2306984.78589.12
523246-2324685.43689.60
623012-2301284.57688.76
60min121486-2148678.96785.354.7283.0790.334.93
224668-2466890.66296.11
323866-2386687.71492.83
423604-2360486.75191.93
523020-2302084.60589.62
622689-2268983.38988.42
极限122787-2278783.74987.402.6788.6493.232.95
224558-2455890.25896.61
323952-2395288.03094.02
423437-2343786.13892.19
524279-2427989.23295.09
623662-2366286.96592.83
替米沙坦氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
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10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.162766527825278552788227921278300.36
214.192825228207282300.12
单位质量响应值RSD%判断
1965.401989.430.86数据可信
供试品溶液-2026031721批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124600-2460089.62274.6415.0089.6274.6415.00
215665-1566557.07057.07
319663-1966371.63671.64
419249-1924970.12770.13
522578-2257882.25682.26
621165-2116577.10877.11
10min125411-2541192.57784.738.9793.4785.489.02
219361-1936170.53571.11
323815-2381586.76287.48
422897-2289783.41884.12
524415-2441588.94889.77
623648-2364886.15486.92
15min126084-2608495.02986.628.2596.8588.228.30
220236-2023673.72375.00
324663-2466389.85291.44
423475-2347585.52387.06
524465-2446589.13090.84
623733-2373386.46388.10
20min125737-2573793.76488.066.6296.5490.526.71
221189-2118977.19579.21
325166-2516691.68494.17
423894-2389487.05089.44
524755-2475590.18792.79
624293-2429388.50491.00
30min125192-2519291.77988.614.2695.4991.954.42
222364-2236481.47684.26
325190-2519091.77295.17
424408-2440888.92392.18
524386-2438688.84292.35
624399-2439988.89092.27
45min124758-2475890.19888.433.9294.8392.664.06
222487-2248781.92485.52
325259-2525992.02396.34
424563-2456389.48793.64
524403-2440388.90493.30
624174-2417488.07092.34
60min124886-2488690.66487.763.7596.1992.873.86
222734-2273482.82487.24
325145-2514591.60896.84
424242-2424288.31893.36
523412-2341285.29490.58
624119-2411987.87093.02
极限125020-2502091.15290.163.4797.5996.143.31
224809-2480990.38395.63
326086-2608695.036101.19
424911-2491190.75596.68
524028-2402887.53893.67
623628-2362886.08192.11
替米沙坦氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
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10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.162793728012277902770427689278260.52
214.192791527910279120.02
单位质量响应值RSD%判断
1965.111967.020.07数据可信
供试品溶液-2026031821批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124423-2442389.48775.3920.8489.4975.3820.85
223679-2367986.76186.76
321357-2135778.25378.25
416048-1604858.80158.80
523510-2351086.14286.14
614430-1443052.87252.87
10min124711-2471190.54386.896.3991.4487.646.49
224286-2428688.98589.85
324871-2487191.12991.91
421299-2129978.04178.63
524767-2476790.74891.61
622351-2235181.89582.42
15min125685-2568594.11189.016.4695.9190.646.55
225718-2571894.23295.99
325173-2517392.23593.93
421881-2188180.17381.54
524324-2432489.12590.89
622981-2298184.20485.55
20min125579-2557993.72387.625.8896.4690.145.98
224195-2419588.65291.35
325100-2510091.96894.58
422346-2234681.87784.05
524120-2412088.37791.04
622148-2214881.15283.34
30min124415-2441589.45887.543.5393.1490.933.65
224326-2432689.13292.72
324787-2478790.82194.36
422419-2241982.14585.13
523549-2354986.28589.83
623858-2385887.41790.42
45min124069-2406988.19088.352.7192.7692.622.80
224397-2439789.39293.87
324888-2488891.19195.64
422945-2294584.07287.88
524000-2400087.93892.34
624382-2438289.33793.21
60min124174-2417488.57587.152.2894.0392.302.42
224095-2409588.28693.66
324313-2431389.08494.44
422929-2292984.01388.66
523345-2334585.53890.82
623861-2386187.42892.20
极限124247-2424788.84389.262.6195.1895.282.27
224007-2400787.96394.22
324375-2437589.31295.56
424260-2426088.89094.38
523716-2371686.89793.04
625565-2556593.67299.31
替米沙坦氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
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10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.162804128057280212803227837279980.33
214.192789527957279260.16
单位质量响应值RSD%判断
1977.261968.010.34数据可信
供试品溶液-2026031621批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122068-2206880.59070.5912.6380.5970.5912.63
216186-1618659.10959.11
319230-1923070.22670.23
417206-1720662.83462.83
522133-2213380.82780.83
619158-1915869.96369.96
10min124972-2497291.19580.009.8292.0080.709.84
219130-1913069.86170.45
322461-2246182.02582.73
420171-2017173.66274.29
523417-2341785.51686.32
621285-2128577.73078.43
15min125557-2555793.33184.207.7595.0585.717.80
220294-2029474.11175.40
324004-2400487.66089.18
422290-2229081.40182.77
523641-2364186.33488.00
622555-2255582.36883.85
20min125389-2538992.71885.166.4295.3787.516.45
221717-2171779.30881.34
322921-2292183.70586.10
423757-2375786.75888.94
524456-2445689.31191.84
621681-2168179.17781.48
30min125522-2552293.20386.765.0896.7889.965.16
222122-2212280.78783.61
323798-2379886.90890.14
424219-2421988.44591.49
524166-2416688.25191.67
622715-2271582.95386.04
45min124246-2424688.54486.424.1493.0590.494.21
222261-2226181.29584.93
323627-2362786.28390.39
424438-2443889.24593.18
524675-2467590.11094.41
622741-2274183.04886.97
60min124813-2481390.61486.084.1496.0191.014.23
222612-2261282.57687.02
322958-2295883.84088.81
424089-2408987.97092.79
524383-2438389.04494.25
622577-2257782.44987.20
极限124420-2442089.17987.712.4995.4893.502.65
223154-2315484.55689.83
323462-2346285.68191.49
424215-2421588.43094.13
524741-2474190.35196.45
624115-2411588.06593.64
替米沙坦氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
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10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.162832328042279502804228361281440.66
214.192819928309282540.28
单位质量响应值RSD%判断
1987.571991.120.13数据可信
供试品溶液-2026031721批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115691-1569156.82072.7419.6756.8272.7419.67
225094-2509490.87090.87
318517-1851767.05467.05
423351-2335184.55884.56
521930-2193079.41379.41
615947-1594757.74757.75
10min119461-1946170.47280.5310.9371.0481.2511.00
225379-2537991.90292.81
320254-2025473.34474.01
423889-2388986.50787.35
523843-2384386.34087.13
620603-2060374.60775.18
15min121353-2135377.32383.108.7678.6084.648.86
225933-2593393.90895.74
321119-2111976.47677.88
423834-2383486.30788.02
524228-2422887.73489.39
621230-2123076.87878.20
20min122668-2266882.08585.377.4884.1387.747.60
226076-2607694.42697.19
321831-2183179.05481.22
424385-2438588.30390.88
524750-2475089.62492.16
621743-2174378.73580.83
30min122007-2200779.69184.748.4382.5687.968.51
226382-2638295.53499.25
320962-2096275.90778.87
424310-2431088.03191.49
524332-2433288.11191.54
622410-2241081.15184.03
45min122206-2220680.41284.106.5484.0888.166.70
225760-2576093.28297.95
321496-2149677.84181.56
423639-2363985.60189.94
523784-2378486.12690.44
622460-2246081.33285.02
60min123056-2305683.49083.764.5787.9688.674.77
224975-2497590.43996.04
321723-2172378.66383.16
423118-2311883.71588.91
523200-2320084.01289.19
622718-2271882.26686.77
极限124698-2469889.43686.942.9094.7492.693.03
224956-2495690.37096.87
323236-2323684.14289.43
424071-2407187.16693.20
523619-2361985.52991.54
623476-2347685.01190.34
替米沙坦氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
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10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.162757227371276472728927573274900.56
214.192726127066271640.51
单位质量响应值RSD%判断
1941.381914.311.00数据可信
供试品溶液-2026031821批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116236-1623660.67266.5614.8460.6766.5614.84
220672-2067277.24977.25
318733-1873370.00370.00
414241-1424153.21753.22
520694-2069477.33177.33
616287-1628760.86360.86
10min119650-1965073.43078.637.1674.0479.297.21
222334-2233483.46084.23
321693-2169381.06481.76
420111-2011175.15375.68
523013-2301385.99786.77
619444-1944472.66073.27
15min120346-2034676.03184.045.8577.3785.495.82
222644-2264484.61886.23
322865-2286585.44486.95
423798-2379888.93190.21
523674-2367488.46790.10
621610-2161080.75482.09
20min121526-2152680.44084.065.3182.5486.355.37
224021-2402189.76492.22
322720-2272084.90287.27
421812-2181281.50983.68
523733-2373388.68891.21
621151-2115179.03981.18
30min121040-2104078.62484.614.2181.5387.744.25
223076-2307686.23289.58
323648-2364888.37091.58
422760-2276085.05288.04
523273-2327386.96990.37
622055-2205582.41785.35
45min121408-2140879.99985.774.2583.6989.754.27
223364-2336487.30991.52
324211-2421190.47494.57
423194-2319486.67390.51
523256-2325686.90591.18
622282-2228283.26587.02
60min121589-2158980.67684.823.3885.1789.663.48
223079-2307986.24491.33
323721-2372188.64393.65
422354-2235483.53488.24
523166-2316686.56991.71
622279-2227983.25487.84
极限123096-2309686.30790.124.1491.6195.813.90
223948-2394889.49195.44
324889-2488993.00798.90
425623-2562395.750101.29
523099-2309986.31892.33
624050-2405089.87295.29
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