替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.263851253846013845533849083840893846550.11
211.273851443849863850650.03
单位质量响应值RSD%判断
34161.1934167.260.02数据可信
长期24月-供试品溶液-20220104批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1208656-20865654.96754.203.7154.9754.203.71
2218276-21827657.50157.50
3197624-19762452.06152.06
4208385-20838554.89654.90
5199706-19970652.60952.61
6201739-20173953.14553.14
10min1343581-34358190.51186.694.6990.8286.994.68
2348591-34859191.83192.15
3305963-30596380.60180.89
4324002-32400285.35385.66
5329165-32916586.71387.01
6323138-32313885.12585.42
15min1373805-37380598.47395.693.2199.2896.483.21
2379473-37947399.966100.80
3349889-34988992.17292.91
4357481-35748194.17294.95
5364946-36494696.13996.91
6353921-35392193.23594.00
20min1371337-37133797.82394.693.0999.1896.003.10
2370650-37065097.64299.03
3347835-34783591.63192.88
4355918-35591893.76195.06
5364663-36466396.06497.37
6346210-34621091.20392.49
30min1371469-37146997.85795.981.9899.7697.821.99
2369880-36988097.43999.37
3359748-35974894.77096.53
4356728-35672893.97495.80
5371088-37108897.75799.60
6357147-35714794.08495.88
45min1366663-36666396.59195.702.4699.0398.072.46
2378201-37820199.631102.10
3357376-35737694.14596.43
4356665-35666593.95796.30
5366138-36613896.45398.84
6354548-35454893.40095.72
60min1367805-36780596.89294.372.7699.8797.282.75
2372313-37231398.080101.10
3353215-35321593.04995.86
4346432-34643291.26294.13
5356851-35685194.00696.93
6352773-35277392.93295.77
极限1370190-37019097.52093.302.80101.0496.732.79
2361198-36119895.15298.72
3342383-34238390.19593.52
4349742-34974292.13495.51
5351961-35196192.71896.16
6349548-34954892.08395.43
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.263849743845503847343845783845543846780.05
211.273842163845533843840.07
单位质量响应值RSD%判断
34163.2334106.830.12数据可信
长期24月-供试品溶液-20220105批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1187991-18799149.56655.536.8049.5755.536.80
2217777-21777757.41957.42
3214437-21443756.53856.54
4222765-22276558.73458.73
5198101-19810152.23152.23
6222517-22251758.66958.67
10min1327481-32748186.34390.503.2986.6290.813.29
2362119-36211995.47695.79
3338670-33867089.29389.61
4345132-34513290.99791.32
5345032-34503290.97191.26
6341006-34100689.90990.24
15min1355301-35530193.67896.692.8394.4397.502.83
2365227-36522796.29597.14
3357038-35703894.13694.95
4371647-37164797.98898.82
5367548-36754896.90797.70
6383621-383621101.145101.97
20min1354583-35458393.48995.842.1094.7697.192.10
2362494-36249495.57596.96
3356107-35610793.89195.22
4363550-36355095.85397.23
5370261-37026197.62398.96
6373965-37396598.59999.99
30min1347708-34770891.67695.422.5593.4797.302.55
2363529-36352995.84897.76
3355649-35564993.77095.62
4367236-36723696.82598.73
5363196-36319695.76097.64
6374211-37421198.664100.60
45min1353661-35366193.24695.562.0195.5597.972.02
2368920-36892097.26999.72
3353575-35357593.22395.60
4368959-36895997.27999.73
5362122-36212295.47797.88
6367292-36729296.84099.32
60min1349073-34907392.03694.451.7794.8697.391.78
2358432-35843294.50497.49
3353167-35316793.11696.01
4361512-36151295.31698.30
5360304-36030494.99797.94
6366882-36688296.73299.75
极限1341440-34144090.02493.012.8693.3696.482.83
2354823-35482393.55297.07
3349839-34983992.23895.65
4361596-36159695.33898.85
5342555-34255590.31893.78
6366331-36633196.586100.15
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.263840103840073836703840043845843840550.09
211.273842523839723841120.06
单位质量响应值RSD%判断
34107.9034082.700.06数据可信
长期24月-供试品溶液-20220107批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186516-18651649.23451.997.5949.2351.997.59
2185944-18594449.08349.08
3197465-19746552.12452.12
4221931-22193158.58258.58
5183669-18366948.48248.48
6206218-20621854.43554.43
10min1332958-33295887.89087.861.3388.1688.141.33
2327177-32717786.36486.64
3340378-34037889.84890.14
4332008-33200887.63987.96
5330397-33039787.21487.48
6334049-33404988.17888.48
15min1370815-37081597.88396.172.6598.6496.952.63
2354766-35476693.64694.40
3377765-37776599.717100.51
4355058-35505893.72394.54
5358177-35817794.54795.30
6369427-36942797.51698.31
20min1359589-35958994.91994.561.2396.2295.871.24
2350803-35080392.60093.87
3363377-36337795.91997.26
4358186-35818694.54995.88
5356208-35620894.02795.31
6361123-36112395.32496.66
30min1375979-37597999.24695.602.11101.0897.442.08
2357494-35749494.36696.15
3363909-36390996.06097.94
4360366-36036695.12496.98
5353750-35375093.37895.18
6361506-36150695.42597.29
45min1347656-34765691.76996.512.8194.1598.882.73
2375787-37578799.195101.51
3374640-37464098.892101.30
4363797-36379796.03098.42
5368473-36847397.26499.58
6363359-36335995.91498.31
60min1362115-36211595.58695.051.5098.4897.951.48
2356412-35641294.08196.94
3366857-36685796.83899.80
4365035-36503596.35799.28
5356686-35668694.15397.01
6353345-35334593.27196.20
极限1344308-34430890.88694.693.2694.3198.123.17
2352639-35263993.08596.47
3368404-36840497.246100.74
4376313-37631399.334102.79
5353177-35317793.22796.61
6357526-35752694.37597.82
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