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%
19.741994419914199651985219995199340.28
29.781994820033199900.31
单位质量响应值RSD%判断
2046.612043.970.10数据可信
长期18月-供试品溶液-2022081901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%
5min122767-2276794.97396.521.9994.9796.521.99
223906-2390699.72599.72
323122-2312296.45496.45
423241-2324196.95196.95
522577-2257794.18194.18
623216-2321696.84696.85
10min123424-2342497.71497.640.8298.7798.710.82
223449-2344997.81898.93
323480-2348097.94899.02
423268-2326897.06398.14
523129-2312996.48497.53
623684-2368498.79999.87
15min123022-2302296.03796.601.2298.1898.761.20
222912-2291295.57897.77
323313-2331397.25199.41
423024-2302496.04598.20
523008-2300895.97998.10
623660-2366098.699100.87
20min122764-2276494.96195.761.5598.1798.991.53
223065-2306596.21799.47
322933-2293395.66698.91
423309-2330997.234100.46
522370-2237093.31796.50
623292-2329297.163100.43
30min122247-2224792.80494.111.1397.0798.401.11
222717-2271794.76599.09
322880-2288095.44599.75
422433-2243393.58097.88
522342-2234293.20197.42
622737-2273794.84899.20
45min122305-2230593.04692.830.6398.3498.160.62
222356-2235693.25998.64
322421-2242193.53098.89
422040-2204091.94197.28
522153-2215392.41297.67
622239-2223992.77198.17
极限121668-2166890.38991.871.1596.7298.251.13
222235-2223592.75499.17
322041-2204191.94598.35
422025-2202591.87898.24
521823-2182391.03597.32
622352-2235293.24299.68
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%
114.178228682092824448242482633823760.25
214.188198481039815120.82
单位质量响应值RSD%判断
5813.415748.380.80数据可信
长期18月-供试品溶液-2022081901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%
5min181412-8141291.29695.192.3991.3095.182.38
285418-8541895.78895.79
385592-8559295.98395.98
486556-8655697.06497.06
583629-8362993.78293.78
686676-8667697.19997.20
10min186253-8625396.72498.391.3697.7499.441.37
287893-8789398.56499.63
386987-8698797.54898.61
488294-8829499.013100.09
587302-8730297.90198.94
689683-89683100.571101.65
15min184862-8486295.16597.081.9097.2599.231.88
285172-8517295.51297.67
385604-8560495.99798.15
487438-8743898.053100.23
587273-8727397.868100.00
689087-8908799.903102.10
20min184280-8428094.51296.441.9897.6699.671.97
285716-8571696.12299.34
384974-8497495.29098.51
488521-8852199.268102.54
584856-8485695.15898.38
687647-8764798.288101.60
30min182193-8219392.17294.041.1596.3798.341.16
284542-8454294.80699.09
383368-8336893.48997.76
484384-8438494.62999.00
583905-8390594.09198.37
684782-8478295.07599.47
45min180287-8028790.03492.411.3195.2597.751.31
282529-8252992.54897.89
382503-8250392.51997.83
482933-8293393.00198.42
583310-8331093.42498.74
682853-8285392.91298.37
极限180687-8068790.48392.131.0796.7098.501.10
282119-8211992.08998.46
381873-8187391.81398.16
482777-8277792.82699.28
582198-8219892.17798.54
683262-8326293.37099.86
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%
19.741989920017198551991420094199560.49
29.782014220088201150.19
单位质量响应值RSD%判断
2048.872056.750.28数据可信
长期18月-供试品溶液-2022082001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%
5min122492-2249293.48393.911.7593.4893.911.75
222416-2241693.16793.17
322936-2293695.32895.33
422105-2210591.87491.87
522435-2243593.24693.25
623189-2318996.38096.38
10min122796-2279694.74695.442.2295.7996.482.20
222421-2242193.18894.22
323776-2377698.81999.88
422502-2250293.52494.55
523265-2326596.69697.73
623012-2301295.64496.71
15min122868-2286895.04694.671.1597.1496.771.16
222665-2266594.20296.27
323095-2309595.98998.15
422328-2232892.80194.86
522804-2280494.78096.89
622904-2290495.19597.33
20min121903-2190391.03592.201.6494.1895.361.62
222364-2236492.95196.07
322451-2245193.31296.54
421612-2161289.82592.92
522572-2257293.81596.98
622204-2220492.28695.48
30min122101-2210191.85891.411.9696.0295.591.92
222194-2219492.24496.39
321951-2195191.23495.49
421160-2116087.94792.04
522374-2237492.99297.20
622180-2218092.18696.40
45min121680-2168090.10889.861.0995.2995.061.07
221897-2189791.01096.18
321761-2176190.44595.72
421284-2128488.46293.53
521392-2139288.91194.15
621713-2171390.24595.49
极限121594-2159489.75188.761.8095.9394.951.76
221220-2122088.19694.38
321739-2173990.35396.63
420666-2066685.89391.94
521541-2154189.53095.76
621374-2137488.83695.08
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%
114.178225582473820128237482553823330.26
214.188266382201824320.40
单位质量响应值RSD%判断
5810.375813.260.04数据可信
长期18月-供试品溶液-2022082001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%
5min181176-8117690.54492.771.8990.5492.771.89
282593-8259392.12492.12
385057-8505794.87394.87
482119-8211991.59691.60
583129-8312992.72292.72
684983-8498394.79094.79
10min183598-8359893.24594.741.7194.2595.771.71
284038-8403893.73694.76
386637-8663796.63597.69
483393-8339393.01794.03
586473-8647396.45297.48
685489-8548995.35596.41
15min183617-8361793.26793.921.7095.3196.011.69
284828-8482894.61796.68
385664-8566495.55097.68
481646-8164691.06893.12
584408-8440894.14996.25
685076-8507694.89497.01
20min182129-8212991.60792.021.7894.6995.141.76
283197-8319792.79895.91
383129-8312992.72295.91
479711-7971188.91091.97
583757-8375793.42396.57
683071-8307192.65895.82
30min180653-8065389.96190.721.6094.0694.871.59
281837-8183791.28195.43
381528-8152890.93695.16
479074-7907488.19992.25
582636-8263692.17296.36
682277-8227791.77295.97
45min178729-7872987.81489.111.6192.9194.271.59
281416-8141690.81295.97
380975-8097590.32095.55
478118-7811887.13392.16
579782-7978288.98994.20
680344-8034489.61694.83
极限178872-7887287.97488.202.0494.0594.351.99
279040-7904088.16194.33
380375-8037589.65095.88
476082-7608284.86290.86
580454-8045489.73995.94
679623-7962388.81295.02
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%
19.741991820073201021995419994200080.39
29.782041220318203650.33
单位质量响应值RSD%判断
2054.212082.310.97数据可信
长期18月-供试品溶液-2022082001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%
5min122961-2296194.72391.892.5594.7291.892.55
222433-2243392.54592.55
322607-2260793.26393.26
421891-2189190.30990.31
522388-2238892.35992.36
621361-2136188.12388.12
10min122840-2284094.22493.640.7795.2894.660.78
222566-2256693.09494.12
322939-2293994.63295.67
422678-2267893.55694.56
522460-2246092.65693.68
622703-2270393.65994.64
15min122379-2237992.32292.880.9894.4294.940.94
222380-2238092.32694.39
322525-2252592.92595.01
422815-2281594.12196.16
522253-2225391.80293.86
622730-2273093.77095.79
20min122385-2238592.34791.541.1095.4794.631.08
221887-2188790.29393.38
322355-2235592.22395.34
422444-2244492.59095.68
521917-2191790.41693.49
622148-2214891.36994.43
30min121984-2198490.69390.720.9294.8494.830.90
221815-2181589.99694.09
322326-2232692.10496.25
421949-2194990.54894.67
521777-2177789.83993.92
622095-2209591.15195.23
45min121386-2138688.22689.230.7593.3894.350.69
221612-2161289.15894.25
321549-2154988.89894.07
421733-2173389.65794.78
521640-2164089.27494.35
621862-2186290.18995.28
极限121610-2161089.15089.080.7695.2995.190.72
221680-2168089.43995.52
321631-2163189.23695.39
421673-2167389.41095.53
521267-2126787.73593.81
621695-2169589.50095.59
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%
114.178231282924821858229682182823800.38
214.188240182547824740.13
单位质量响应值RSD%判断
5813.695816.220.04数据可信
长期18月-供试品溶液-2022082001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%
5min183880-8388093.50991.122.4293.5191.122.43
282484-8248491.95391.95
383418-8341892.99492.99
480913-8091390.20290.20
581283-8128390.61490.61
678466-7846687.47487.47
10min185545-8554595.36693.971.1096.4094.981.10
283521-8352193.10994.13
384845-8484594.58595.62
484694-8469494.41795.42
583016-8301692.54693.55
684139-8413993.79894.77
15min184039-8403993.68793.231.0395.7995.291.01
283485-8348593.06995.13
383563-8356393.15695.24
484825-8482594.56396.61
582205-8220591.64293.68
683660-8366093.26495.28
20min182547-8254792.02391.631.1395.1694.721.11
281090-8109090.39993.49
382519-8251991.99295.11
483460-8346093.04196.14
581121-8112190.43493.49
682444-8244491.90994.96
30min181543-8154390.90490.071.2395.0794.181.20
280170-8017089.37493.47
380431-8043189.66493.81
481885-8188591.28595.42
579299-7929988.40392.46
681429-8142990.77794.85
45min180507-8050789.74989.220.7794.9294.340.77
279359-7935988.46993.56
380022-8002289.20994.35
480883-8088390.16895.32
579355-7935588.46593.51
680075-8007589.26894.35
极限180925-8092590.21588.741.4696.3894.841.41
278809-7880987.85693.93
379654-7965488.79894.93
480204-8020489.41195.56
577738-7773886.66292.69
680283-8028389.49995.57
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%
19.742034020256201582022020174202300.36
29.782016720172201700.02
单位质量响应值RSD%判断
2077.002062.370.50数据可信
长期18月-供试品溶液-2022082101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%
5min123047-2304795.00995.772.0295.0195.772.02
222635-2263593.31193.31
323332-2333296.18496.18
423934-2393498.66698.67
523541-2354197.04697.05
622902-2290294.41294.41
10min123518-2351896.95196.801.5398.0197.861.52
223600-2360097.28998.33
323856-2385698.34499.41
423733-2373397.83798.93
523331-2333196.18097.26
622852-2285294.20595.25
15min123062-2306295.07195.511.2397.2097.651.23
223116-2311695.29497.41
323206-2320695.66597.83
423675-2367597.59899.78
523138-2313895.38497.53
622811-2281194.03696.13
20min122684-2268493.51393.561.2196.7096.761.19
222938-2293894.56097.74
322336-2233692.07895.30
422944-2294494.58597.85
522878-2287894.31397.52
622395-2239592.32195.46
30min122671-2267193.45992.771.1297.6997.011.11
222613-2261393.22097.45
322467-2246792.61896.87
422736-2273693.72798.05
522501-2250192.75897.01
622036-2203690.84295.01
45min122149-2214991.30792.561.5496.5797.841.49
222149-2214991.30796.57
322320-2232092.01297.29
422829-2282994.11199.47
522941-2294194.57299.86
622335-2233592.07497.25
极限122160-2216091.35391.542.4297.6397.842.32
222034-2203490.83397.11
321918-2191890.35596.65
423252-2325295.854102.26
522133-2213391.24197.58
621734-2173489.59795.80
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%
114.178341983071831568327383211832260.16
214.188311882623828700.43
单位质量响应值RSD%判断
5873.395844.150.36数据可信
长期18月-供试品溶液-2022082101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%
5min183119-8311991.96994.002.4491.9794.002.44
283212-8321292.07292.07
385894-8589495.03995.04
488048-8804897.42297.42
586218-8621895.39895.40
683245-8324592.10892.11
10min187105-8710596.37995.491.3997.4096.531.39
286326-8632695.51796.54
386367-8636795.56296.62
487961-8796197.32698.41
585490-8549094.59295.65
684537-8453793.53894.56
15min185680-8568094.80294.581.5596.9096.691.55
285562-8556294.67296.76
385402-8540294.49596.61
487778-8777897.12499.29
584593-8459393.60095.71
683868-8386892.79794.86
20min183951-8395192.88992.781.1396.0495.931.12
284498-8449893.49496.63
382898-8289891.72494.89
485065-8506594.12297.36
584084-8408493.03696.19
682599-8259991.39394.49
30min182692-8269291.49691.451.1195.6795.641.11
283558-8355892.45496.63
382886-8288691.71195.90
483495-8349592.38596.67
582134-8213490.87995.06
681130-8113089.76893.88
45min180355-8035588.91090.911.7694.1196.121.68
281105-8110589.74094.94
381316-8131689.97495.18
483716-8371692.62997.94
583776-8377692.69697.89
682719-8271991.52696.63
极限180951-8095189.57090.042.3895.7596.252.30
280443-8044389.00895.21
381088-8108889.72195.93
485129-8512994.193100.54
581100-8110089.73595.96
679522-7952287.98994.11
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%
19.742026519988202022010220104201320.53
29.782009720053200750.16
单位质量响应值RSD%判断
2066.942052.660.50数据可信
长期18月-供试品溶液-2022082101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%
5min123397-2339796.91594.952.2996.9294.952.29
222358-2235892.61192.61
323506-2350697.36797.37
423273-2327396.40196.40
522431-2243192.91492.91
622572-2257293.49893.50
10min123126-2312695.79396.732.0796.8797.792.07
223127-2312795.79796.83
323943-2394399.177100.26
423975-2397599.309100.38
523119-2311995.76496.80
622829-2282994.56295.60
15min123284-2328496.44796.612.9198.5998.742.88
223258-2325896.33998.43
324394-24394101.045103.23
423716-2371698.236100.41
522815-2281594.50496.60
622472-2247293.08495.17
20min122627-2262793.72694.061.8396.9497.271.84
222672-2267293.91297.08
323090-2309095.64398.95
423290-2329096.47299.74
522344-2234492.55395.70
622226-2222692.06595.19
30min122651-2265193.82593.231.7998.0897.481.75
222993-2299395.24299.45
322736-2273694.17798.55
422410-2241092.82797.16
522447-2244792.98097.15
621811-2181190.34694.49
45min122394-2239492.76092.021.3498.0697.311.36
222066-2206691.40296.67
322579-2257993.52798.94
422402-2240292.79498.16
522087-2208791.48996.70
621767-2176790.16395.31
极限122244-2224492.13991.142.6298.4797.442.56
222209-2220991.99498.28
322760-2276094.276100.73
422144-2214491.72598.13
521483-2148388.98795.21
621172-2117287.69993.85
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%
114.178125281281812778144081237812970.11
214.188238082495824380.10
单位质量响应值RSD%判断
5737.265813.680.94数据可信
长期18月-供试品溶液-2022082101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%
5min183786-8378694.04793.832.0894.0593.832.08
282203-8220392.27092.27
385066-8506695.48495.48
486005-8600596.53896.54
581396-8139691.36591.36
683109-8310993.28793.29
10min184788-8478895.17296.392.0196.2297.432.01
285384-8538495.84196.87
388408-8840899.235100.30
487634-8763498.36799.44
584783-8478395.16696.18
684226-8422694.54195.58
15min184531-8453194.88495.812.7096.9997.922.67
285211-8521195.64797.74
388255-8825599.064101.23
487625-8762598.356100.52
584521-8452194.87296.94
681976-8197692.01694.10
20min182408-8240892.50193.712.4095.6696.882.39
283159-8315993.34496.50
385620-8562096.10699.37
486187-8618796.742100.00
582458-8245892.55795.68
681060-8106090.98794.10
30min181177-8117791.11991.561.9395.3095.781.93
280571-8057190.43994.63
383472-8347293.69598.03
482841-8284192.98797.32
582157-8215792.21996.37
679192-7919288.89193.01
45min181512-8151291.49591.661.3396.6996.891.36
281440-8144091.41496.61
383217-8321793.40998.78
482483-8248392.58597.95
581186-8118691.12996.31
680104-8010489.91495.02
极限181407-8140791.37790.732.3897.5996.982.32
280921-8092190.83197.04
383999-8399994.286100.70
480987-8098790.90597.30
578934-7893488.60194.79
678736-7873688.37994.49
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