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%
19.672076320724209252097020814208390.51
29.702060520738206720.46
单位质量响应值RSD%判断
2155.022131.130.79数据可信
长期18月-供试品溶液-2022081901批-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%
5min124093-2409395.92296.441.4895.9296.441.48
224239-2423996.50396.50
324449-2444997.33997.34
424457-2445797.37197.37
524525-2452597.64297.64
623570-2357093.84093.84
10min123780-2378094.67697.202.1995.7498.272.18
224501-2450197.54698.62
325016-2501699.597100.68
424705-2470598.35899.44
524741-2474198.50299.59
623740-2374094.51795.56
15min124136-2413696.09395.911.6598.2198.061.64
224294-2429496.72298.88
324599-2459997.936100.12
424118-2411896.02198.20
523989-2398995.50897.69
623406-2340693.18795.28
20min123672-2367294.24695.521.8297.4398.741.81
223937-2393795.30198.53
324425-2442597.244100.52
424290-2429096.70699.95
524317-2431796.814100.05
623314-2331492.82095.95
30min123336-2333692.90893.762.6597.1498.042.60
223701-2370194.36198.65
324088-2408895.902100.26
424041-2404195.715100.03
523730-2373094.47798.79
622406-2240689.20593.37
45min123319-2331992.84093.072.3198.1198.392.26
224060-2406095.791101.13
323774-2377494.652100.07
423566-2356693.82499.20
522934-2293491.30896.67
622605-2260589.99895.15
极限123027-2302791.67892.081.9697.9798.431.94
223500-2350093.56199.96
323534-2353493.696100.17
422980-2298091.49197.91
523387-2338793.11199.49
622341-2234188.94795.10
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%
114.018398684212846448392784081841700.34
214.068321883813835160.51
单位质量响应值RSD%判断
6007.855939.970.81数据可信
长期18月-供试品溶液-2022081901批-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%
5min181826-8182688.79590.892.3988.8090.892.39
282715-8271589.76089.76
386198-8619893.54093.54
486273-8627393.62193.62
583448-8344890.55590.56
682079-8207989.07089.07
10min186205-8620593.54795.821.9494.5396.831.94
289913-8991397.57198.57
389931-8993197.59198.63
489117-8911796.70797.75
588429-8842995.96196.97
686220-8622093.56494.55
15min188030-8803095.52894.641.3097.5596.711.29
287727-8772795.19997.28
387799-8779995.27797.40
487477-8747794.92897.04
587246-8724694.67796.75
684979-8497992.21794.25
20min186072-8607293.40394.461.5796.4997.591.56
288007-8800795.50398.64
388389-8838995.91799.10
487941-8794195.43198.60
587004-8700494.41497.54
684868-8486892.09695.15
30min184687-8468791.90092.782.7596.0396.962.70
286352-8635293.70797.91
387453-8745394.90299.15
487447-8744794.89599.12
585858-8585893.17197.34
681202-8120288.11892.20
45min184701-8470191.91591.732.6397.0696.942.56
287701-8770195.171100.41
385557-8555792.84498.15
484841-8484192.06797.35
583311-8331190.40795.62
681075-8107587.98093.04
极限182837-8283789.89291.401.9096.0697.631.88
286334-8633493.68799.99
385333-8533392.60198.94
484583-8458391.78798.09
584267-8426791.44497.66
681998-8199888.98295.02
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%
19.672090320974208642086520828208870.27
29.702071620802207590.30
单位质量响应值RSD%判断
2159.982140.100.66数据可信
长期18月-供试品溶液-2022082001批-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%
5min123503-2350393.26995.271.7393.2795.271.73
223616-2361693.71793.72
324112-2411295.68695.69
424640-2464097.78197.78
523970-2397095.12295.12
624207-2420796.06396.06
10min123739-2373994.20596.291.7395.2497.351.71
224846-2484698.59899.64
324529-2452997.34098.40
424085-2408595.57896.66
523921-2392194.92895.98
624472-2447297.11498.18
15min123739-2373994.20595.141.8196.2997.261.78
224719-2471998.094100.23
323540-2354093.41695.56
424069-2406995.51597.66
523646-2364693.83695.95
624127-2412795.74597.89
20min123302-2330292.47194.441.8795.6097.631.84
223966-2396695.10698.33
323317-2331792.53195.71
424326-2432696.53599.74
523656-2365693.87697.03
624228-2422896.14699.36
30min122909-2290990.91292.952.2195.0797.182.16
224306-2430696.455100.74
323117-2311791.73795.95
423708-2370894.08298.36
523084-2308491.60695.80
623413-2341392.91297.19
45min122412-2241288.93991.562.2194.1196.832.16
223872-2387294.733100.09
323054-2305491.48796.72
423365-2336592.72198.05
522713-2271390.13495.35
623017-2301791.34096.65
极限122610-2261089.72590.411.5495.8896.701.52
223324-2332492.55998.97
322711-2271190.12696.37
422814-2281490.53596.89
522281-2228188.41994.64
622962-2296291.12297.45
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%
114.018307483951829878312183991834250.61
214.068350383567835350.06
单位质量响应值RSD%判断
5954.685941.320.16数据可信
长期18月-供试品溶液-2022082001批-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%
5min182615-8261590.03992.271.9990.0492.271.99
283566-8356691.07691.08
385180-8518092.83592.83
487550-8755095.41895.42
584381-8438191.96491.96
684671-8467192.28092.28
10min186176-8617693.92095.061.4494.9296.091.42
289477-8947797.51898.53
387745-8774595.63096.66
486694-8669494.48595.55
586171-8617193.91594.94
687067-8706794.89195.92
15min186614-8661494.39894.461.9096.4496.541.87
289518-8951897.56399.66
384909-8490992.53994.63
487214-8721495.05297.16
585251-8525192.91294.98
686517-8651794.29296.37
20min184530-8453092.12693.471.5795.2296.601.55
286677-8667794.46697.65
384060-8406091.61494.74
487567-8756795.43698.60
585360-8536093.03196.13
686368-8636894.13097.26
30min182970-8297090.42691.742.1694.5495.912.10
287779-8777995.66799.90
383057-8305790.52194.66
483937-8393791.48095.71
583953-8395391.49795.63
683368-8336890.86095.03
45min181219-8121988.51890.492.2493.6495.682.18
286075-8607593.81099.10
382737-8273790.17295.32
484386-8438691.96997.21
581796-8179689.14794.29
681955-8195589.32094.50
极限181361-8136188.67389.081.6994.7895.281.67
284136-8413691.69798.03
381150-8115088.44394.59
482384-8238489.78796.05
580103-8010387.30193.44
681288-8128888.59394.77
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%
19.672073720796209032073920826208000.34
29.702108621025210560.21
单位质量响应值RSD%判断
2150.982170.720.65数据可信
长期18月-供试品溶液-2022082001批-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%
5min123173-2317391.49993.222.4191.5093.222.42
222965-2296590.67890.68
323313-2331392.05292.05
423679-2367993.49793.50
524060-2406095.00295.00
624456-2445696.56596.57
10min125493-25493100.66096.202.63101.6897.242.60
223780-2378093.89694.90
323994-2399494.74195.76
424447-2444796.53097.57
524591-2459197.09898.15
623882-2388294.29995.37
15min124377-2437796.25393.651.6398.3995.761.61
223294-2329491.97794.03
323822-2382294.06296.14
423655-2365593.40295.51
523779-2377993.89296.03
623385-2338592.33694.46
20min124276-2427695.85493.981.8699.0697.121.84
223240-2324091.76494.84
323747-2374793.76696.89
423315-2331592.06095.21
524055-2405594.98298.16
624169-2416995.43298.58
30min123929-2392994.48491.771.9298.7595.961.89
222643-2264389.40693.50
323376-2337692.30196.46
422906-2290690.44594.62
523181-2318191.53195.76
623413-2341392.44796.65
45min123535-2353592.92990.791.8598.2596.001.83
222613-2261389.28894.37
322607-2260789.26494.45
422664-2266489.48994.67
523436-2343692.53897.79
623104-2310491.22796.46
极限122999-2299990.81289.591.6897.1695.811.64
222383-2238388.38094.46
322899-2289990.41796.60
422361-2236188.29394.46
523180-2318091.52797.81
622312-2231288.09994.35
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%
114.018325783468835678383783510835280.25
214.068369983721837100.02
单位质量响应值RSD%判断
5962.035953.770.10数据可信
长期18月-供试品溶液-2022082001批-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%
5min180587-8058787.68390.502.8687.6890.502.86
280169-8016987.22887.23
383323-8332390.66090.66
483703-8370391.07391.07
585589-8558993.12593.13
685691-8569193.23693.24
10min189715-8971597.61594.941.9598.5995.951.93
285599-8559993.13694.11
386264-8626493.86094.87
487297-8729794.98496.00
588860-8886096.68497.72
685805-8580593.36094.40
15min186956-8695694.61392.811.2896.6794.871.27
283811-8381191.19193.19
385837-8583793.39595.45
485241-8524192.74794.81
585434-8543492.95795.07
684493-8449391.93394.01
20min187333-8733395.02393.281.7198.1396.371.69
283549-8354990.90693.92
386010-8601093.58496.67
484388-8438891.81994.92
586250-8625093.84596.99
686831-8683194.47797.57
30min185090-8509092.58391.081.8296.7595.211.80
280952-8095288.08092.11
385032-8503292.51996.65
483299-8329990.63494.75
584122-8412291.52995.71
683785-8378591.16395.31
45min183496-8349690.84889.771.2396.0494.911.22
281275-8127588.43293.44
381556-8155688.73793.89
481992-8199289.21294.34
583428-8342890.77495.98
683265-8326590.59795.75
极限182365-8236589.61888.711.3295.8294.841.30
280104-8010487.15793.15
381928-8192889.14295.28
481661-8166188.85294.97
582745-8274590.03196.24
680371-8037187.44893.61
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%
19.672083920916208972084821030209060.37
29.702077320926208500.52
单位质量响应值RSD%判断
2161.942149.480.41数据可信
长期18月-供试品溶液-2022082101批-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%
5min124088-2408895.33895.052.5095.3495.052.50
224989-2498998.90498.90
323410-2341092.65492.65
423585-2358593.34793.35
523628-2362893.51793.52
624387-2438796.52196.52
10min124814-2481498.21197.051.5299.2798.111.50
224084-2408495.32296.42
324506-2450696.99298.02
424768-2476898.02999.07
524061-2406195.23196.27
624893-2489398.52499.60
15min124638-2463897.51496.151.3499.6698.291.33
224198-2419895.77397.93
323768-2376894.07196.18
424160-2416095.62397.75
524398-2439896.56498.66
624602-2460297.37299.54
20min124095-2409595.36594.901.5798.6098.111.55
224087-2408795.33498.56
323458-2345892.84496.00
424078-2407895.29898.49
523641-2364193.56896.74
624512-2451297.016100.26
30min123842-2384294.36494.011.2798.6698.271.26
224152-2415295.59199.87
323476-2347692.91597.10
423787-2378794.14698.39
523335-2333592.35796.57
623929-2392994.70899.04
45min123288-2328892.17192.251.4197.5197.561.39
223483-2348392.94398.29
322743-2274390.01495.23
423566-2356693.27298.57
523154-2315491.64196.88
623617-2361793.47398.85
极限123443-2344392.78590.722.2099.1597.052.09
223387-2338792.56398.94
322785-2278590.18096.40
423172-2317291.71298.04
522159-2215987.70393.96
622583-2258389.38195.80
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%
114.018290983534841308393583822836660.57
214.068380783221835140.50
单位质量响应值RSD%判断
5971.885939.830.39数据可信
长期18月-供试品溶液-2022082101批-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%
5min183619-8361991.01491.482.1091.0191.482.10
286683-8668394.34994.35
381851-8185189.08989.09
483689-8368991.09091.09
582927-8292790.26190.26
685500-8550093.06193.06
10min188312-8831296.12295.401.3697.1396.421.35
286709-8670994.37795.43
387343-8734395.06796.06
487824-8782495.59196.60
586182-8618293.80394.81
689511-8951197.42798.46
15min188999-8899996.87095.321.5598.9597.401.53
287058-8705894.75796.85
385464-8546493.02295.07
487177-8717794.88696.96
587693-8769395.44897.49
689059-8905996.93599.05
20min186274-8627493.90494.231.1397.0697.371.13
287101-8710194.80497.95
385083-8508392.60795.69
486736-8673694.40697.54
586257-8625793.88596.99
688009-8800995.79298.99
30min185547-8554793.11293.171.3397.3197.351.31
287292-8729295.01299.21
384288-8428891.74295.85
485755-8575593.33997.52
584435-8443591.90296.05
686266-8626693.89598.15
45min182918-8291890.25191.231.5395.4896.441.49
284792-8479292.29197.55
381964-8196489.21294.34
485064-8506492.58797.80
583289-8328990.65595.82
684862-8486292.36797.67
极限183493-8349390.87789.691.7997.1195.921.70
284077-8407791.51297.80
381988-8198889.23995.36
483255-8325590.61896.86
580175-8017587.26593.44
681430-8143088.63194.96
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%
19.672091120805208892085521012208940.37
29.702078421005208940.75
单位质量响应值RSD%判断
2160.702154.020.22数据可信
长期18月-供试品溶液-2022082101批-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%
5min124564-2456497.14796.691.7497.1596.691.74
223953-2395394.73094.73
324699-2469997.68197.68
424717-2471797.75297.75
523879-2387994.43894.44
624873-2487398.36998.37
10min124517-2451796.96196.682.3198.0497.762.30
223983-2398394.84995.90
324690-2469097.64598.73
424602-2460297.29798.38
523643-2364393.50494.55
625243-2524399.832100.93
15min123976-2397694.82195.842.0996.9897.992.09
223876-2387694.42696.53
324390-2439096.45998.63
424399-2439996.49498.66
523679-2367993.64795.73
625085-2508599.207101.41
20min124110-2411095.35195.111.9198.5698.321.90
223700-2370093.73096.89
323915-2391594.58097.82
423972-2397294.80598.04
523678-2367893.64396.77
624921-2492198.559101.86
30min124059-2405995.14994.313.0599.4298.582.99
223670-2367093.61197.81
323509-2350992.97497.27
423854-2385494.33998.63
522902-2290290.57494.74
625092-2509299.235103.63
45min123769-2376994.00391.742.1599.3397.062.04
222648-2264889.56994.81
323383-2338392.47697.80
423732-2373293.85699.20
522899-2289990.56295.74
622756-2275689.99695.50
极限123770-2377094.00792.671.38100.3899.011.37
223332-2333292.27498.51
323534-2353493.07399.43
423079-2307991.27497.66
523079-2307991.27497.46
623797-2379794.113100.62
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%
114.018361083737835738364083662836440.08
214.068356483181833720.33
单位质量响应值RSD%判断
5970.315929.730.49数据可信
长期18月-供试品溶液-2022082101批-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%
5min184740-8474092.32592.411.8792.3292.411.87
282111-8211189.46189.46
386600-8660094.35194.35
485795-8579593.47493.47
584099-8409991.62691.63
685588-8558893.24993.25
10min187513-8751395.34694.652.0096.3795.682.00
284952-8495292.55693.55
388285-8828596.18797.24
486840-8684094.61395.65
584711-8471192.29393.31
688948-8894896.90997.95
15min185271-8527192.90394.021.8294.9996.101.82
284973-8497392.57994.60
387646-8764695.49197.61
487246-8724695.05597.14
584490-8449092.05294.10
688176-8817696.06898.18
20min186294-8629494.01893.531.3697.1496.651.35
284528-8452892.09495.14
385224-8522492.85296.03
485823-8582393.50596.65
585311-8531192.94796.01
687876-8787695.74298.92
30min185841-8584193.52492.882.2297.6997.042.17
284432-8443291.98996.06
384692-8469292.27396.48
485900-8590093.58997.77
582484-8248489.86793.97
688140-8814096.029100.27
45min184986-8498692.59390.572.5997.7995.762.45
281684-8168488.99594.09
383878-8387891.38696.62
485825-8582593.50798.73
582290-8229089.65694.75
680130-8013087.30292.61
极限185662-8566293.32990.981.4499.5697.181.38
283280-8328090.73496.82
383478-8347890.95097.20
482412-8241289.78896.05
582412-8241289.78895.88
683769-8376991.26797.55
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