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%
110.212117720828210482113521100210580.65
210.162090220982209420.28
单位质量响应值RSD%判断
2062.492061.220.05数据可信
供试品溶液-731530批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123717-2371798.14297.052.0298.1497.052.02
223439-2343996.99196.99
323082-2308295.51495.51
422744-2274494.11594.12
524040-2404099.47899.48
623698-2369898.06398.06
10min124580-24580101.713101.603.30102.80102.683.26
223888-2388898.84999.93
323565-2356597.51398.57
425665-25665106.202107.25
524321-24321100.641101.75
625297-25297104.680105.77
15min124266-24266100.413100.653.78102.63102.863.72
223560-2356097.49299.67
323200-2320096.00298.15
425681-25681106.269108.49
524203-24203100.153102.38
625030-25030103.575105.83
20min124365-24365100.823100.193.51104.16103.523.47
223355-2335596.64499.90
323293-2329396.38799.60
425379-25379105.019108.43
523926-2392699.006102.34
624953-24953103.256106.66
30min123440-2344096.99598.243.58101.45102.683.53
223009-2300995.21299.54
322770-2277094.22398.51
425034-25034103.591108.16
523869-2386998.770103.21
624327-24327100.666105.22
45min123185-2318595.94097.053.55101.47102.583.50
222805-2280594.36899.76
322679-2267993.84699.18
424762-24762102.466108.19
523104-2310495.605101.14
624185-24185100.078105.75
极限123218-2321896.07796.733.87102.68103.343.79
222631-2263193.648100.09
322603-2260393.53299.90
424976-24976103.351110.21
523000-2300095.175101.77
623830-2383098.609105.39
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%
114.128304283661836018318683732834440.38
214.128334983417833830.06
单位质量响应值RSD%判断
5909.635905.310.06数据可信
供试品溶液-731530批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150283-5028355.17858.289.4755.1858.289.47
258334-5833464.01264.01
354086-5408659.35159.35
445745-4574550.19850.20
558843-5884364.57164.57
651372-5137256.37356.37
10min178450-7845086.08686.641.4586.7087.291.48
279836-7983687.60788.32
377188-7718884.70285.36
478551-7855186.19786.76
580389-8038988.21488.93
679316-7931687.03787.66
15min183979-8397992.15491.881.3693.7293.491.32
283931-8393192.10193.79
381637-8163789.58491.18
484953-8495393.22294.74
583529-8352991.66093.36
684353-8435392.56494.16
20min185308-8530893.61293.141.1596.2195.771.07
284120-8412092.30895.02
384061-8406192.24494.84
486583-8658395.01197.56
584252-8425292.45395.17
684933-8493393.20095.82
30min183839-8383992.00093.151.5995.6396.821.52
284124-8412492.31396.05
383556-8355691.68995.31
486795-8679595.24498.85
584762-8476293.01396.76
686271-8627194.66998.33
45min183115-8311591.20692.572.0595.8697.281.94
283277-8327791.38396.14
383236-8323691.33895.98
487588-8758896.114100.78
584033-8403392.21396.99
684928-8492893.19597.90
极限183731-8373191.88191.972.0897.5597.711.97
282137-8213790.13295.91
382498-8249890.52896.18
487068-8706895.543101.28
583642-8364291.78497.59
683821-8382191.98097.73
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%
110.212124921082209382103120943210490.61
210.162092820988209580.21
单位质量响应值RSD%判断
2061.612062.800.05数据可信
供试品溶液-731530批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123757-2375798.29098.001.6198.2998.001.62
224319-24319100.616100.62
323584-2358497.57597.57
423835-2383598.61398.61
523375-2337596.71096.71
623248-2324896.18596.18
10min125243-25243104.439102.041.87105.53103.131.85
224960-24960103.268104.39
323884-2388498.81699.90
424738-24738102.349103.44
524591-24591101.741102.82
624559-24559101.609102.68
15min124821-24821102.693101.322.19104.95103.552.17
225350-25350104.881107.15
323814-2381498.526100.71
424448-24448101.149103.38
524189-24189100.078102.28
624320-24320100.620102.82
20min125588-25588105.866101.202.98109.26104.542.93
225080-25080103.764107.19
323647-2364797.835101.11
424305-24305100.558103.91
524025-2402599.399102.72
624114-2411499.768103.08
30min125271-25271104.55499.423.08109.12103.893.03
224502-24502101.373105.96
323177-2317795.891100.25
423740-2374098.220102.69
523718-2371898.129102.55
623774-2377498.361102.79
45min125083-25083103.77798.523.11109.51104.103.04
224117-2411799.780105.49
323134-2313495.713101.14
423851-2385198.679104.24
523098-2309895.564101.08
623593-2359397.612103.13
极限124824-24824102.70597.943.17109.59104.613.11
224326-24326100.645107.46
322856-2285694.563101.06
423456-2345697.045103.71
523417-2341796.884103.46
623151-2315195.783102.38
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%
114.128349183323833838334583368833820.08
214.128319082963830760.20
单位质量响应值RSD%判断
5905.245883.570.26数据可信
供试品溶液-731530批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150048-5004855.04259.855.3855.0459.855.38
256668-5666862.32262.32
357960-5796063.74363.74
455843-5584361.41561.41
553238-5323858.55058.55
652770-5277058.03558.04
10min179490-7949087.42187.280.9588.0387.940.92
279083-7908386.97487.67
378029-7802985.81586.52
480221-8022188.22588.91
579589-7958987.53088.18
679743-7974387.70088.34
15min185092-8509293.58292.761.1795.1794.391.15
285783-8578394.34296.00
383295-8329591.60693.27
484599-8459993.04094.70
583580-8358091.91993.54
683700-8370092.05193.67
20min189061-8906197.94794.042.39100.5796.702.32
286277-8627794.88597.59
383401-8340191.72394.40
485729-8572994.28396.98
583960-8396092.33794.98
684627-8462793.07195.71
30min189111-8911198.00293.532.75101.7197.242.66
285956-8595694.53298.29
382232-8223290.43794.14
484259-8425992.66696.41
583874-8387492.24395.91
684850-8485093.31696.99
45min188501-8850197.33193.033.07102.1397.782.96
284674-8467493.12397.93
380814-8081488.87793.58
485368-8536893.88698.66
582884-8288491.15495.85
685290-8529093.80098.51
极限188310-8831097.12193.202.56103.0098.992.48
286080-8608094.669100.52
382037-8203790.22295.91
483906-8390692.27898.09
584070-8407092.45898.17
684082-8408292.47198.23
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%
110.212112220849208192085721030209350.64
210.162089820970209340.25
单位质量响应值RSD%判断
2050.442060.430.35数据可信
供试品溶液-696229批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124001-2400199.62799.304.2199.6399.304.21
225081-25081104.110104.11
322981-2298195.39395.39
422579-2257993.72593.72
524933-24933103.496103.50
623962-2396299.46599.47
10min124408-24408101.317101.493.93102.42102.593.94
225712-25712106.730107.89
323481-2348197.46998.53
423343-2334396.89697.94
525372-25372105.318106.47
624379-24379101.196102.30
15min124319-24319100.947100.113.49103.18102.343.50
225121-25121104.276106.62
322982-2298295.39897.54
423275-2327596.61498.73
524806-24806102.969105.29
624197-24197100.441102.67
20min123896-2389699.19299.283.86102.55102.633.86
224793-24793102.915106.42
322619-2261993.89197.09
423118-2311895.96299.15
524981-24981103.695107.16
624101-24101100.042103.39
30min123342-2334296.89297.024.04101.35101.464.03
224543-24543101.877106.52
322360-2236092.81697.06
422299-2229992.56296.82
524319-24319100.947105.56
623370-2337097.008101.47
45min123480-2348097.46596.713.62103.00102.233.63
224298-24298100.860106.64
322496-2249693.38098.66
422122-2212291.82897.11
523991-2399199.586105.32
623401-2340197.137102.67
极限122890-2289095.01695.053.80101.63101.653.81
223965-2396599.478106.38
321983-2198391.25197.57
421849-2184990.69497.00
523737-2373798.531105.38
622967-2296795.335101.95
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%
114.128319183308834418319183202832670.14
214.128345183401834260.05
单位质量响应值RSD%判断
5897.105908.360.14数据可信
供试品溶液-696229批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163162-6316269.36670.492.5569.3770.492.55
265842-6584272.30972.31
362304-6230468.42468.42
463567-6356769.81169.81
566514-6651473.04773.05
663736-6373669.99670.00
10min180608-8060888.52689.412.0289.3090.192.02
283629-8362991.84392.65
379100-7910086.87087.63
481094-8109489.05989.84
582930-8293091.07691.89
681109-8110989.07689.85
15min184131-8413192.39592.631.5394.1594.411.54
286150-8615094.61296.44
382309-8230990.39492.12
484625-8462592.93794.70
585036-8503693.38995.21
683839-8383992.07493.84
20min184159-8415992.42593.111.8195.2195.921.80
286309-8630994.78797.66
382147-8214790.21692.95
485305-8530593.68496.48
586089-8608994.54597.41
684690-8469093.00995.80
30min182370-8237090.46191.732.0394.2795.572.02
285936-8593694.37798.31
381226-8122689.20492.94
483024-8302491.17995.02
584751-8475193.07696.99
683838-8383892.07395.90
45min183158-8315891.32691.611.6996.1496.461.69
285700-8570094.11899.09
381680-8168089.70394.43
482517-8251790.62295.47
584239-8423992.51397.46
683180-8318091.35096.20
极限180317-8031788.20690.341.9694.0396.221.94
284507-8450792.80898.83
380824-8082488.76394.48
481756-8175689.78695.65
583531-8353191.73697.71
682629-8262990.74596.61
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%
110.212140221233211382123721169212360.49
210.162114020901210200.81
单位质量响应值RSD%判断
2079.922068.900.38数据可信
供试品溶液-696229批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122960-2296094.43596.521.6994.4396.521.69
223695-2369597.45897.46
323279-2327995.74795.75
423719-2371997.55697.56
523162-2316295.26595.27
623993-2399398.68398.68
10min123371-2337196.12597.981.9297.1799.061.92
224358-24358100.185101.27
323645-2364597.25298.32
424034-2403498.85299.94
523279-2327995.74796.81
624247-2424799.728100.82
15min123279-2327995.74797.892.3997.86100.052.38
224510-24510100.810103.01
323281-2328195.75597.90
423995-2399598.692100.87
523358-2335896.07298.19
624380-24380100.275102.48
20min123886-2388698.24397.512.68101.42100.762.64
224385-24385100.296103.61
323231-2323195.54998.76
424177-2417799.440102.72
522687-2268793.31296.50
623885-2388598.239101.56
30min123379-2337996.15895.191.65100.4399.521.64
223368-2336896.113100.54
323026-2302694.70698.98
422985-2298594.53798.92
522519-2251992.62196.85
623584-2358497.001101.41
45min123181-2318195.34495.471.84100.68100.861.84
223693-2369397.449102.95
322893-2289394.15999.48
423300-2330095.833101.27
522579-2257992.86898.12
623620-2362097.149102.64
极限123271-2327195.71493.702.38102.11100.152.32
223041-2304194.768101.35
322220-2222091.39197.76
422835-2283593.921100.42
522023-2202390.58196.87
623299-2329995.829102.40
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%
114.128373683317837168375683266835580.30
214.128326183139832000.11
单位质量响应值RSD%判断
5917.715892.350.31数据可信
供试品溶液-696229批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161810-6181067.85569.241.5867.8669.241.58
263904-6390470.15470.15
361920-6192067.97667.98
463122-6312269.29569.30
564120-6412070.39170.39
663549-6354969.76469.76
10min179847-7984787.65687.500.7688.4188.270.76
280735-8073588.63189.41
379053-7905386.78487.54
479660-7966087.45188.22
579147-7914786.88887.67
679801-7980187.60688.38
15min183821-8382192.01992.061.3893.7593.801.37
285836-8583694.23196.00
382272-8227290.31892.04
483684-8368491.86893.61
583506-8350691.67393.42
684043-8404392.26294.01
20min184404-8440492.65992.181.7795.4194.941.74
286136-8613694.56097.37
382808-8280890.90793.63
485123-8512393.44896.21
582462-8246290.52793.29
682876-8287690.98193.75
30min185217-8521793.55190.901.5697.3394.691.50
282731-8273190.82294.68
382608-8260890.68794.42
481305-8130589.25793.06
582568-8256890.64394.42
682394-8239490.45294.24
45min185507-8550793.87091.321.8598.6996.121.78
283994-8399492.20997.08
381741-8174189.73594.48
482142-8214290.17594.97
581789-8178989.78894.57
683924-8392492.13296.92
极限185816-8581694.20990.102.47100.0795.912.36
282491-8249190.55996.45
380292-8029288.14593.88
480712-8071288.60694.40
580986-8098688.90694.68
682125-8212590.15795.97
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