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4000
标示量(mg)5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%
1 9.852042120400203542038720367203860.13
2 9.962033920299203190.14
单位质量响应值RSD%判断
2069.642040.061.02数据可信
供试品溶液-25092201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%
5min123983-2398399.58694.679.7099.5994.679.70
223714-2371498.46998.47
323107-2310795.94895.95
424321-24321100.989100.99
523293-2329396.72096.72
618380-1838076.32076.32
10min123870-2387099.11699.511.42100.22100.561.34
224014-2401499.714100.81
324291-24291100.864101.93
423659-2365998.24099.36
523549-2354997.78398.86
624400-24400101.317102.17
15min123714-2371498.46998.682.29100.68100.842.29
224746-24746102.754104.96
323823-2382398.921101.11
423784-2378498.759100.97
523310-2331096.79198.95
623219-2321996.41398.39
20min123126-2312696.02797.371.5199.33100.631.40
223610-2361098.037101.38
323564-2356497.846101.13
423348-2334896.949100.26
523050-2305095.71198.95
624005-2400599.677102.72
30min123154-2315496.14396.732.27100.51101.062.15
223478-2347897.489101.92
323015-2301595.56699.94
423743-2374398.589102.98
522469-2246993.29997.60
623908-2390899.274103.43
45min123004-2300495.52096.131.72100.96101.541.64
223256-2325696.567102.08
322936-2293695.238100.67
423568-2356897.862103.35
522559-2255993.67399.01
623582-2358297.920103.18
极限123002-2300295.51294.982.26102.01101.462.08
222070-2207091.64298.23
322723-2272394.354100.85
423345-2334596.936103.51
522633-2263393.980100.36
623475-2347597.476103.82
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4000
标示量(mg)5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%
113.928266282506823488234982526824780.17
213.938231582199822570.10
单位质量响应值RSD%判断
5925.145905.030.25数据可信
供试品溶液-25092201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%
5min188426-8842696.90991.719.1196.9191.719.11
287576-8757695.97795.98
384149-8414992.22292.22
488484-8848496.97296.97
584863-8486393.00493.00
668586-6858675.16675.17
10min187254-8725495.62496.111.6796.7097.131.57
288012-8801296.45597.52
388236-8823696.70197.73
486788-8678895.11496.19
585829-8582994.06395.10
690086-9008698.72899.56
15min187067-8706795.42095.472.3297.5697.552.31
290929-9092999.652101.79
386485-8648594.78296.88
487201-8720195.56697.70
585469-8546993.66895.75
685506-8550693.70995.64
20min184560-8456092.67294.141.7295.8797.281.62
286927-8692795.26698.51
385826-8582694.05997.21
485441-8544193.63896.83
584380-8438092.47595.59
688237-8823796.70299.68
30min184817-8481792.95493.362.6497.1897.552.52
286153-8615394.41898.72
383565-8356591.58295.78
487070-8707095.42399.66
581794-8179489.64193.79
687715-8771596.130100.18
45min183911-8391191.96192.752.0897.2297.981.99
285646-8564693.86299.22
383208-8320891.19096.41
486177-8617794.44499.74
582263-8226390.15595.30
686592-8659294.899100.01
极限183708-8370891.73891.432.4898.0297.692.30
280506-8050688.22994.62
382436-8243690.34496.57
485399-8539993.59199.94
582434-8243490.34296.49
686055-8605594.310100.48
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4000
标示量(mg)5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%
1 9.852042520422204562042920459204380.09
2 9.962034320275203090.24
单位质量响应值RSD%判断
2074.922039.061.24数据可信
供试品溶液-25092201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%
5min118568-1856877.02276.408.8077.0276.408.80
218233-1823375.63375.63
320145-2014583.56483.56
419815-1981582.19582.20
515581-1558164.63264.63
618159-1815975.32675.33
10min123997-2399799.54394.184.65100.4095.034.67
223017-2301795.47796.32
323458-2345897.30798.24
422418-2241892.99393.91
520959-2095986.94187.66
622380-2238092.83593.67
15min124063-2406399.81696.112.99101.7898.003.02
223421-2342197.15399.05
323609-2360997.93399.94
422623-2262393.84395.79
522148-2214891.87393.56
623148-2314896.02197.89
20min124073-2407399.85896.862.58102.9399.822.60
223493-2349397.452100.43
323871-2387199.020102.12
422595-2259593.72796.72
522704-2270494.17996.88
623363-2336396.91399.85
30min123742-2374298.48596.292.00102.67100.321.98
222820-2282094.66098.72
323613-2361397.950102.15
422549-2254993.53697.57
523163-2316396.08399.83
623384-2338497.000101.01
45min123551-2355197.69296.182.85102.97101.292.77
223071-2307195.701100.82
323679-2367998.223103.51
421955-2195591.07296.14
523155-2315596.050100.87
623709-2370998.348103.44
极限123468-2346897.34895.951.95103.71102.131.88
223004-2300495.423101.60
323396-2339697.049103.43
422297-2229792.49198.57
523469-2346997.352103.24
623159-2315996.066102.25
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4000
标示量(mg)5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%
113.928215282048821028220882166821350.08
213.938220182003821020.18
单位质量响应值RSD%判断
5900.505893.900.08数据可信
供试品溶液-25092201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%
5min157913-5791363.66164.537.1063.6664.527.10
259469-5946965.37165.37
362064-6206468.22468.22
463843-6384370.18070.18
552039-5203957.20457.20
656877-5687762.52262.52
10min185368-8536893.84188.035.0494.5588.745.03
282488-8248890.67591.40
381957-8195790.09190.85
479289-7928987.15987.94
574132-7413281.49082.13
677240-7724084.90685.60
15min186748-8674895.35890.673.6797.1192.363.68
284880-8488093.30595.04
383265-8326591.52993.29
480654-8065488.65990.41
578645-7864586.45187.99
680702-8070288.71290.35
20min187055-8705595.69591.513.3098.5094.223.31
285109-8510993.55696.33
384504-8450492.89195.67
480666-8066688.67291.41
580050-8005087.99590.50
682119-8211990.27092.89
30min185829-8582994.34891.202.1698.2294.922.19
282953-8295391.18695.00
384103-8410392.45096.26
480914-8091488.94592.66
581535-8153589.62893.11
682462-8246290.64794.27
45min186237-8623794.79691.812.8799.7296.542.83
284057-8405792.40097.22
385053-8505393.49598.33
479360-7936087.23791.94
582468-8246890.65395.13
683940-8394092.27196.91
极限185420-8542093.89892.721.6999.8798.471.60
283811-8381192.12997.98
384663-8466393.06698.94
481844-8184489.96795.64
585838-8583894.35899.84
684510-8451092.89898.56
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4000
标示量(mg)5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%
1 9.852032820370202412034320328203220.24
2 9.962045920492204760.12
单位质量响应值RSD%判断
2063.152055.820.26数据可信
供试品溶液-25092201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%
5min122785-2278594.39496.612.3394.3996.602.33
223437-2343797.09597.09
323425-2342597.04597.04
423635-2363597.91597.91
522587-2258793.57393.57
624044-2404499.60999.61
10min124380-24380101.001100.431.70102.05101.511.67
223723-2372398.28099.36
323776-2377698.49999.58
424365-24365100.939102.03
524776-24776102.642103.68
624438-24438101.242102.35
15min123997-2399799.41599.161.67101.59101.361.64
224293-24293100.641102.81
323225-2322596.21698.39
423752-2375298.400100.61
524251-24251100.467102.65
624101-2410199.846102.08
20min123902-2390299.02198.421.36102.30101.711.34
223841-2384198.768102.06
323119-2311995.77799.02
423776-2377698.499101.80
523911-2391199.058102.35
623996-2399699.411102.75
30min123436-2343697.09196.921.96101.47101.311.92
223527-2352797.468101.85
322623-2262393.72298.03
423169-2316995.984100.38
523668-2366898.052102.45
623952-2395299.228103.67
45min123446-2344697.13295.871.44102.59101.331.40
223274-2327496.419101.89
322553-2255393.43298.78
423055-2305595.512100.98
523429-2342997.062102.55
623091-2309195.661101.21
极限122934-2293495.01194.182.45101.54100.712.36
222975-2297595.181101.72
321712-2171289.94896.33
422494-2249493.18899.71
523103-2310395.711102.28
623185-2318596.051102.66
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4000
标示量(mg)5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%
113.928201882186819758211782083820760.11
213.938276182707827340.05
单位质量响应值RSD%判断
5896.265939.270.52数据可信
供试品溶液-25092201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%
5min149231-4923153.93059.088.5553.9359.088.55
250863-5086355.71855.72
361270-6127067.11867.12
456939-5693962.37462.37
550602-5060255.43255.43
654716-5471659.93859.94
10min174424-7442481.52882.302.2682.1382.962.27
272007-7200778.88079.50
375601-7560182.81783.56
476375-7637583.66584.36
576417-7641783.71184.33
675959-7595983.20983.88
15min179123-7912386.67586.611.2788.1888.181.19
279674-7967487.27988.77
377156-7715684.52086.19
478899-7889986.43088.05
579689-7968987.29588.84
679824-7982487.44389.03
20min180190-8019087.84487.931.5590.3190.461.49
280274-8027487.93690.40
378069-7806985.52088.13
480691-8069188.39390.98
580505-8050588.18990.70
681874-8187489.68992.25
30min180516-8051688.20188.212.1691.6591.722.08
280734-8073488.44091.88
377918-7791885.35588.91
480216-8021687.87291.44
580371-8037188.04291.54
683376-8337691.33494.89
45min180879-8087988.59988.491.2193.0292.981.16
281243-8124388.99793.42
378876-7887686.40490.91
480804-8080488.51693.06
581235-8123588.98993.46
681617-8161789.40793.98
极限180538-8053888.22587.962.6493.6393.442.50
280926-8092688.65094.06
376663-7666383.98089.44
479393-7939386.97192.50
581387-8138789.15594.62
682890-8289090.80296.37
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