奥美沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.661848418539184471850718511184980.19
215.661867318655186640.07
单位质量响应值RSD%判断
1181.231191.830.64数据可信
长期12月-供试品溶液-2023060521批-左氨氯地平-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%
5min113148-1314869.96570.573.4269.9770.573.42
212571-1257166.89566.89
313260-1326070.56170.56
413780-1378073.32873.33
513068-1306869.53969.54
613740-1374073.11573.12
10min115693-1569383.50884.932.0683.6285.052.06
215563-1556382.81682.93
316443-1644387.49987.62
415839-1583984.28584.41
516028-1602885.29185.41
616193-1619386.16986.29
15min116225-1622586.33986.281.4386.5986.531.43
215883-1588384.51984.77
316601-1660188.34088.60
416123-1612385.79686.06
516232-1623286.37686.63
616215-1621586.28686.55
20min116324-1632486.86686.562.0287.2786.962.02
215754-1575483.83384.22
316685-1668588.78789.20
416031-1603185.30785.71
516362-1636287.06887.47
616441-1644187.48887.90
30min116255-1625586.49986.291.3587.0486.841.35
215974-1597485.00385.53
316459-1645987.58488.14
416232-1623286.37686.92
516433-1643387.44687.99
615946-1594684.85485.41
45min116400-1640087.27086.931.9487.9687.621.93
215830-1583084.23784.91
316625-1662588.46789.17
416135-1613585.86086.55
516676-1667688.73989.43
616354-1635487.02587.72
60min116331-1633186.90386.612.7887.7487.442.77
215457-1545782.25283.06
316835-1683589.58590.44
416289-1628986.67987.51
516451-1645187.54288.38
616293-1629386.70187.54
极限117047-1704790.71390.281.8991.6991.261.88
216910-1691089.98490.93
317460-1746092.91193.91
416490-1649087.74988.73
516818-1681889.49490.48
617072-1707290.84691.83
奥美沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.922191132199602192282197362200312196140.20
211.012221962220762221360.04
单位质量响应值RSD%判断
20111.1720175.840.23数据可信
长期12月-供试品溶液-2023060521批-奥美沙坦酯-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%
5min1104419-10441946.56148.356.2046.5648.356.20
298323-9832343.84243.84
3115947-11594751.70151.70
4109579-10957948.86148.86
5107013-10701347.71747.72
6115311-11531151.41751.42
10min1148173-14817366.07167.273.1866.1567.353.18
2144326-14432664.35564.43
3157696-15769670.31770.40
4149090-14909066.47966.56
5151114-15111467.38267.46
6154743-15474369.00069.09
15min1167556-16755674.71475.372.5374.9075.562.54
2163132-16313272.74172.92
3175596-17559678.29978.50
4166574-16657474.27674.47
5170344-17034475.95776.15
6170913-17091376.21076.41
20min1176554-17655478.72679.172.2079.0479.492.21
2172363-17236376.85777.16
3183417-18341781.78682.12
4174665-17466577.88378.20
5178858-17885879.75380.07
6179479-17947980.03080.36
30min1183756-18375681.93782.271.9582.3882.721.96
2179893-17989380.21580.64
3189706-18970684.59085.06
4181408-18140880.89081.34
5186806-18680683.29783.75
6185406-18540682.67383.13
45min1186199-18619983.02683.141.9583.6183.731.96
2181634-18163480.99181.55
3191027-19102785.17985.79
4183123-18312381.65582.24
5189665-18966584.57285.16
6187114-18711483.43484.03
60min1184133-18413382.10582.361.7782.8283.081.77
2180455-18045580.46581.16
3188999-18899984.27585.03
4181816-18181681.07281.79
5187424-18742483.57384.30
6185353-18535382.64983.39
极限1198918-19891888.69888.951.4689.5589.821.46
2197611-19761188.11588.95
3204883-20488391.35892.25
4196502-19650287.62188.47
5199757-19975789.07289.94
6199267-19926788.85389.73
奥美沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.661852018510184931852418493185080.08
215.661861818661186400.17
单位质量响应值RSD%判断
1181.861190.290.51数据可信
中间条件12月-供试品溶液-2023060521批-左氨氯地平-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%
5min114685-1468578.17375.293.6278.1775.303.61
213735-1373573.11673.12
314375-1437576.52376.52
413448-1344871.58871.59
513958-1395874.30374.30
614665-1466578.06678.07
10min115756-1575683.87483.592.8584.0083.712.84
215095-1509580.35580.48
315584-1558482.95983.09
415427-1542782.12382.24
515966-1596684.99285.12
616383-1638387.21287.34
15min116213-1621386.30785.833.3186.5886.093.30
215327-1532781.59081.85
316231-1623186.40386.67
415854-1585484.39684.65
516158-1615886.01486.28
616953-1695390.24690.52
20min116315-1631586.85085.222.7887.2685.622.78
215515-1551582.59182.98
316046-1604685.41885.83
415853-1585384.39184.79
515624-1562483.17283.58
616698-1669888.88989.31
30min116356-1635687.06884.914.4887.6385.464.47
214833-1483378.96179.49
316169-1616986.07386.62
415834-1583484.28984.83
515585-1558582.96483.51
616921-1692190.07690.65
45min116097-1609785.68986.182.6886.3986.872.68
215540-1554082.72483.39
316218-1621886.33487.03
415998-1599885.16285.84
516463-1646387.63888.32
616819-1681989.53390.26
60min116340-1634086.98386.213.7687.8387.053.74
215221-1522181.02681.83
316368-1636887.13287.97
415815-1581584.18885.01
516427-1642787.44688.28
616999-1699990.49191.36
极限117367-1736792.45091.182.4393.4492.162.43
216510-1651087.88888.82
317303-1730392.10993.09
416699-1669988.89489.85
517408-1740892.66893.65
617486-1748693.08494.11
奥美沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.922194482194932192692195482194012194320.05
211.012212552211152211850.05
单位质量响应值RSD%判断
20094.5120089.460.02数据可信
中间条件12月-供试品溶液-2023060521批-奥美沙坦酯-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%
5min1104996-10499646.93844.784.3346.9444.784.33
295120-9512042.52342.52
3103874-10387446.43646.44
495051-9505142.49242.49
599627-9962744.53844.54
6102326-10232645.74445.74
10min1151233-15123367.60864.953.3167.6965.033.32
2140037-14003762.60362.67
3148104-14810466.20966.29
4139640-13964062.42562.50
5144077-14407764.40964.48
6148664-14866466.45966.54
15min1170706-17070676.31374.142.7676.5074.322.76
2160647-16064771.81671.99
3168864-16886475.49075.68
4160674-16067471.82872.00
5164343-16434373.46973.65
6169778-16977875.89876.09
20min1179443-17944380.21978.602.4880.5478.912.48
2170682-17068276.30276.60
3178487-17848779.79280.11
4170952-17095276.42376.72
5174729-17472978.11278.42
6180652-18065280.75981.07
30min1185500-18550082.92782.092.2383.3882.522.23
2178704-17870479.88980.31
3185954-18595483.13083.58
4179278-17927880.14580.57
5183115-18311581.86082.29
6189173-18917384.56985.02
45min1184930-18493082.67282.502.5883.2683.082.58
2179114-17911480.07280.63
3186849-18684983.53084.11
4179720-17972080.34380.90
5184754-18475482.59383.16
6191965-19196585.81786.41
60min1184028-18402882.26982.252.5683.0082.962.55
2178917-17891779.98480.67
3185625-18562582.98383.71
4178884-17888479.96980.66
5185056-18505682.72883.44
6191368-19136885.55086.28
极限1199121-19912189.01688.822.7589.8889.672.75
2191487-19148785.60386.43
3199549-19954989.20790.07
4194198-19419886.81587.64
5200497-20049789.63190.48
6207223-20722392.63893.51
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