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%
19.761977819726194441965219740196680.68
29.691989419953199240.21
单位质量响应值RSD%判断
2015.162056.141.43数据可信
长期24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%
5min123902-23902100.190100.220.59100.19100.220.59
223699-2369999.33999.34
324076-24076100.920100.92
423894-23894100.157100.16
524046-24046100.794100.79
623831-2383199.89399.89
10min123982-23982100.52699.600.93101.64100.720.92
223529-2352998.62799.73
324077-24077100.924102.05
423735-2373599.490100.60
523616-2361698.991100.11
623635-2363599.071100.18
15min123710-2371099.38598.370.92101.62100.590.90
223198-2319897.23999.44
323429-2342998.208100.45
423731-2373199.473101.69
523315-2331597.73099.95
623417-2341798.157100.37
20min123213-2321397.30297.130.84100.64100.440.82
223218-2321897.323100.60
323381-2338198.006101.34
423346-2334697.860101.18
522923-2292396.08799.39
622951-2295196.20499.51
30min122969-2296996.27995.891.42100.69100.281.38
222676-2267695.05199.41
323480-2348098.421102.84
422779-2277995.48399.89
522782-2278295.49699.87
622567-2256794.59498.96
45min122640-2264094.90095.291.15100.39100.751.11
222374-2237493.78599.20
323093-2309396.799102.32
422601-2260194.737100.21
522962-2296296.250101.68
622727-2272795.265100.69
极限122592-2259294.69994.310.83101.24100.820.80
222604-2260494.749101.21
322642-2264294.909101.50
422632-2263294.867101.39
522283-2228393.40499.91
622237-2223793.21199.69
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%
114.048202481732820568202582023819720.17
214.048184581976819100.12
单位质量响应值RSD%判断
5838.465834.050.06数据可信
长期24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%
5min187800-8780097.52297.271.0097.5297.271.00
287433-8743397.11597.11
387509-8750997.19997.20
486860-8686096.47896.48
589126-8912698.99599.00
686688-8668896.28796.29
10min189007-8900798.86399.511.1299.95100.591.12
288962-8896298.81399.89
390807-90807100.862101.94
488565-8856598.37299.44
590882-90882100.946102.05
689324-8932499.215100.28
15min188401-8840198.19098.250.59100.37100.440.59
287736-8773697.45199.63
388903-8890398.747100.95
488003-8800397.74899.91
589048-8904898.908101.13
688658-8865898.475100.65
20min186661-8666196.25796.990.6199.53100.260.61
287109-8710996.755100.01
388034-8803497.782101.08
486924-8692496.54999.80
587828-8782897.553100.87
687352-8735297.025100.29
30min186879-8687996.49995.721.31100.84100.071.28
284914-8491494.31798.65
387528-8752897.220101.60
485087-8508794.50998.83
587083-8708396.726101.13
685548-8554895.02199.37
45min184166-8416693.48694.751.5798.90100.171.52
284703-8470394.08299.47
386362-8636295.925101.39
483603-8360392.86198.23
586937-8693796.564102.04
686068-8606895.598101.00
极限183649-8364992.91293.761.0399.37100.231.01
284283-8428393.616100.04
384762-8476294.148100.68
483412-8341292.64899.05
585819-8581995.322101.87
684541-8454193.902100.36
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%
19.761988319632196281981919620197160.64
29.691982619765197960.22
单位质量响应值RSD%判断
2020.082042.930.80数据可信
长期24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%
5min123468-2346898.56597.521.4598.5697.511.45
222953-2295396.40296.40
322700-2270095.33995.34
423456-2345698.51598.51
523193-2319397.41097.41
623539-2353998.86398.86
10min123694-2369499.51498.031.43100.6199.121.43
223369-2336998.14999.22
322766-2276695.61796.68
423261-2326197.69698.79
523315-2331597.92299.00
623642-2364299.296100.39
15min123305-2330597.88097.371.10100.0899.541.09
223599-2359999.115101.28
322846-2284695.95398.07
423043-2304396.78098.96
523167-2316797.30199.47
623135-2313597.16699.37
20min122941-2294196.35296.220.5199.6499.480.50
223100-2310097.019100.28
322833-2283395.89899.09
422761-2276195.59698.85
522942-2294296.35699.61
622888-2288896.12999.41
30min122719-2271995.41995.260.9299.7899.580.91
222906-2290696.205100.55
322488-2248894.44998.70
422780-2278095.67599.99
522368-2236893.94598.27
622823-2282395.856100.21
45min122485-2248594.43694.400.7499.8699.780.73
222735-2273595.486100.90
322355-2235593.89099.19
422246-2224693.43398.81
522516-2251694.56799.93
622516-2251694.56799.98
极限122401-2240194.08493.490.96100.5599.920.92
222359-2235993.907100.38
322109-2210992.85799.20
421993-2199392.37098.79
522557-2255794.739101.16
622137-2213792.97599.44
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%
114.048198581991822148218082215821170.15
214.048183882065819520.20
单位质量响应值RSD%判断
5848.795837.040.15数据可信
长期24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%
5min185568-8556894.93595.061.9894.9395.061.98
285078-8507894.39194.39
382690-8269091.74291.74
487052-8705296.58196.58
586381-8638195.83795.84
687313-8731396.87196.87
10min187024-8702496.55095.991.0997.6197.041.10
286711-8671196.20397.25
384656-8465693.92394.94
486607-8660796.08897.16
587241-8724196.79197.86
686850-8685096.35797.43
15min185485-8548594.84395.321.3496.9797.441.34
287224-8722496.77298.89
383948-8394893.13895.20
485736-8573695.12197.26
586372-8637295.82797.97
686702-8670296.19398.34
20min184718-8471893.99293.800.8897.1796.980.89
285167-8516794.49097.68
383155-8315592.25895.36
484346-8434693.57996.78
584836-8483694.12397.33
685065-8506594.37797.59
30min183158-8315892.26192.480.9996.4996.710.99
284144-8414493.35597.60
381961-8196190.93395.06
483821-8382192.99797.23
583036-8303692.12696.38
684022-8402293.22097.48
45min182478-8247891.50791.670.7196.7696.920.72
283391-8339192.52097.80
381781-8178190.73395.87
482225-8222591.22696.50
583084-8308492.17997.45
682769-8276991.82997.13
极限182026-8202691.00590.530.9497.2796.800.92
281889-8188990.85397.16
380479-8047989.28995.43
481077-8107789.95296.24
582640-8264091.68697.99
681498-8149890.41996.74
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%
19.761951819556197651975019697196570.58
29.691969219677196840.06
单位质量响应值RSD%判断
2014.042031.370.61数据可信
长期24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%
5min123918-23918100.89199.091.21100.8999.091.21
223237-2323798.01898.02
323419-2341998.78698.79
423148-2314897.64397.64
523599-2359999.54599.55
623626-2362699.65999.66
10min123453-2345398.929100.110.97100.05101.220.95
224149-24149101.865102.95
323645-2364599.739100.84
423682-2368299.895100.98
523767-23767100.254101.36
623708-23708100.005101.11
15min123246-2324698.05698.560.95100.28100.780.93
223605-2360599.570101.79
323580-2358099.465101.67
423177-2317797.76599.96
523096-2309697.42399.64
623495-2349599.106101.32
20min123047-2304797.21797.771.26100.53101.081.22
223438-2343898.866102.19
323401-2340198.710102.02
423428-2342898.824102.10
522724-2272495.85499.16
623037-2303797.174100.49
30min122917-2291796.66896.490.56101.06100.880.55
223055-2305597.250101.68
322790-2279096.133100.54
422861-2286196.432100.81
522686-2268695.694100.06
622937-2293796.753101.15
45min122485-2248594.84695.840.80100.31101.310.77
222939-2293996.761102.27
322842-2284296.352101.83
422651-2265195.546101.00
522566-2256695.188100.62
622841-2284196.348101.82
极限122225-2222593.74994.961.85100.27101.491.76
223098-2309897.432104.01
322523-2252395.006101.55
422230-2223093.770100.28
522074-2207493.11299.60
622920-2292096.681103.23
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%
114.048234182496817188217682085821630.36
214.048192382329821260.35
单位质量响应值RSD%判断
5852.075849.430.04数据可信
长期24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%
5min187394-8739496.83195.551.4796.8395.551.47
285946-8594695.22695.23
386588-8658895.93895.94
483941-8394193.00593.00
586249-8624995.56295.56
687305-8730596.73296.73
10min186298-8629895.61696.671.0696.6997.731.05
288395-8839597.94099.00
386229-8622995.54096.61
487209-8720996.62697.66
587099-8709996.50497.57
688243-8824397.77198.85
15min185669-8566994.92095.410.9197.0697.540.91
287049-8704996.44998.59
386408-8640895.73897.87
485483-8548394.71396.82
585164-8516494.36096.49
686888-8688896.27098.43
20min185217-8521794.41994.900.6797.6198.100.66
286568-8656895.91699.13
385537-8553794.77397.96
485650-8565094.89898.06
584968-8496894.14397.33
685983-8598395.26798.50
30min183446-8344692.45693.030.7196.7097.280.70
284472-8447293.59397.88
383509-8350992.52696.77
484045-8404593.12097.33
583459-8345992.47196.70
684827-8482793.98798.28
45min182452-8245291.35592.320.9996.6297.600.97
284441-8444193.55998.88
382537-8253791.44996.72
483478-8347892.49297.74
582946-8294691.90397.16
684100-8410093.18198.51
极限181336-8133690.11991.672.2796.4097.982.16
285228-8522894.431100.79
381706-8170690.52996.82
482204-8220491.08097.36
580996-8099689.74296.02
684962-8496294.136100.51
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%
19.763959539535395213951439456395240.13
29.693946339494394780.06
单位质量响应值RSD%判断
4049.594074.100.43数据可信
长期24月-供试品溶液-2022081401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%
5min146091-4609196.81694.854.1496.8294.854.14
245199-4519994.94294.94
345904-4590496.42396.42
447153-4715399.04799.05
541705-4170587.60387.60
644878-4487894.26894.27
10min146517-4651797.71197.451.1298.7998.511.15
246259-4625997.16998.22
346273-4627397.19898.27
447082-4708298.898100.00
545538-4553895.65596.63
646700-4670098.09599.14
15min145750-4575096.10096.490.7298.2698.620.75
245844-4584496.29798.43
345874-4587496.36098.51
446412-4641297.49099.69
545505-4550595.58597.62
646227-4622797.10299.24
20min145015-4501594.55695.430.6397.7998.640.64
245450-4545095.47098.67
345489-4548995.55298.77
445863-4586396.33799.62
545260-4526095.07198.17
645504-4550495.58398.80
30min144876-4487694.26494.491.8398.5498.761.75
244504-4450493.48397.75
344601-4460193.68697.97
444567-4456793.61597.97
544703-4470393.90198.06
646637-4663797.963102.24
45min144352-4435293.16393.560.4098.4998.880.34
244446-4444693.36198.66
344478-4447893.42898.75
444518-4451893.51298.91
544861-4486194.23299.43
644595-4459593.67499.04
极限143818-4381892.04292.060.6598.4098.420.63
243664-4366491.71898.06
344095-4409592.62398.99
444219-4421992.88499.32
543698-4369891.79098.03
643469-4346991.30997.72
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%
114.048227482610825058278082356825050.25
214.048251582629825720.10
单位质量响应值RSD%判断
5876.425881.200.06数据可信
长期24月-供试品溶液-2022081401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%
5min184571-8457193.25691.294.3693.2691.294.36
283092-8309291.62591.62
383918-8391892.53692.54
486790-8679095.70395.70
576142-7614283.96183.96
682198-8219890.63990.64
10min186737-8673795.64494.531.5296.6895.551.55
285453-8545394.22895.25
385824-8582494.63795.67
487037-8703795.97597.04
583365-8336591.92692.86
685953-8595394.78095.79
15min185743-8574394.54893.731.2896.6595.801.31
284670-8467093.36595.43
385185-8518593.93396.01
485916-8591694.73996.87
582982-8298291.50493.46
685536-8553694.32096.38
20min184354-8435493.01692.661.0696.1795.771.10
284296-8429692.95296.05
384189-8418992.83495.96
484977-8497793.70396.89
582340-8234090.79693.77
684056-8405692.68895.80
30min183290-8329091.84391.011.2496.0395.151.21
282680-8268091.17195.31
382372-8237290.83194.99
481491-8149189.85994.08
581386-8138689.74493.72
683999-8399992.62596.76
45min182600-8260091.08290.740.5296.2995.890.54
282049-8204990.47595.62
382772-8277291.27296.44
482590-8259091.07196.29
582032-8203290.45695.43
681699-8169990.08995.26
极限181788-8178890.18789.420.9496.4095.580.94
281238-8123889.58095.73
381547-8154789.92196.10
481676-8167690.06396.30
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