苯磺酸左氨氯地平奥美沙坦酯片项目信息
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%
115.691828718190182331832418160182390.37
215.761813118143181370.05
单位质量响应值RSD%判断
1162.461150.820.72数据可信
加速6月-供试品溶液-2024080121批-苯磺酸左氨氯地平-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%
5min116670-1667090.99991.191.6391.0091.191.64
216576-1657690.48690.49
316747-1674791.42091.42
417080-1708093.23793.24
516279-1627988.86588.86
616873-1687392.10792.11
10min117236-1723694.08993.811.3794.2493.961.37
217268-1726894.26494.41
317029-1702992.95993.11
417570-1757095.91296.07
516884-1688492.16792.32
617121-1712193.46193.61
15min117126-1712693.48993.811.2793.8094.121.27
217252-1725294.17694.48
317020-1702092.91093.22
417579-1757995.96196.28
516974-1697492.65992.96
617154-1715493.64193.95
20min117210-1721093.94793.431.9394.4193.901.92
217135-1713593.53894.00
317239-1723994.10594.57
417614-1761496.15296.63
516768-1676891.53491.99
616731-1673191.33291.80
30min117294-1729494.40693.631.9395.0394.251.93
217038-1703893.00893.63
317358-1735894.75595.37
417619-1761996.18096.82
516850-1685091.98292.59
616749-1674991.43192.05
45min117108-1710893.39093.201.0794.1793.981.08
217086-1708693.27094.05
317092-1709293.30394.08
417365-1736594.79395.59
516807-1680791.74792.51
616981-1698192.69793.47
60min116975-1697592.66492.180.7893.6093.110.78
217040-1704093.01993.95
316945-1694592.50093.43
416880-1688092.14693.10
516798-1679891.69892.61
616677-1667791.03891.96
极限116960-1696092.58292.661.6393.6793.741.63
217187-1718793.82294.91
316928-1692892.40893.49
417380-1738094.87595.98
516775-1677591.57292.64
616613-1661390.68891.76
苯磺酸左氨氯地平奥美沙坦酯片项目信息
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%
110.852162562169642157322149402172602162300.44
210.832149562152032150800.09
单位质量响应值RSD%判断
19929.0319859.650.25数据可信
加速6月-供试品溶液-2024080121批-奥美沙坦酯-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%
5min179317-7931735.81135.143.0035.8135.143.00
277931-7793135.18535.18
379612-7961235.94435.94
480171-8017136.19636.20
574672-7467233.71333.71
675328-7532834.01034.01
10min1128215-12821557.88757.032.8657.9557.082.85
2126936-12693657.31057.37
3128472-12847258.00358.06
4130420-13042058.88358.94
5122332-12233255.23155.29
6121470-12147054.84254.90
15min1154291-15429169.66068.412.5269.8268.572.52
2153318-15331869.22169.38
3152267-15226768.74768.90
4155654-15565470.27670.43
5147065-14706566.39866.55
6146589-14658966.18366.33
20min1168009-16800975.85475.112.7676.1375.372.76
2168108-16810875.89976.17
3169303-16930376.43876.71
4171379-17137977.37577.65
5160405-16040572.42172.68
6160902-16090272.64572.90
30min1183575-18357582.88282.352.2383.2882.742.23
2183324-18332482.76883.16
3185304-18530483.66284.06
4187078-18707884.46384.87
5178764-17876480.71081.09
6176362-17636279.62580.00
45min1193170-19317087.21486.952.2587.7587.482.25
2194129-19412987.64788.18
3194385-19438587.76288.30
4198629-19862989.67890.22
5186891-18689184.37984.89
6188294-18829485.01285.52
60min1194428-19442887.78288.122.0088.4688.802.00
2197040-19704088.96189.64
3197045-19704588.96389.65
4200793-20079390.65591.35
5190946-19094686.21086.86
6190860-19086086.17186.82
极限1207513-20751393.68993.282.6294.5294.102.61
2211288-21128895.39496.22
3206729-20672993.33594.17
4213234-21323496.27297.12
5201663-20166391.04891.85
6199217-19921789.94490.74
苯磺酸左氨氯地平奥美沙坦酯片项目信息
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%
115.691826118196181901805018378182150.66
215.761826718164182160.40
单位质量响应值RSD%判断
1160.931155.840.32数据可信
加速6月-供试品溶液-2024080321批-苯磺酸左氨氯地平-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%
5min116082-1608287.65688.212.7687.6688.202.76
215577-1557784.90384.90
316740-1674091.24291.24
416269-1626988.67588.67
516598-1659890.46890.47
615831-1583186.28886.29
10min116706-1670691.05789.352.5891.2089.492.58
216081-1608187.65087.79
315732-1573285.74885.90
416760-1676091.35191.50
516742-1674291.25391.40
616331-1633189.01389.16
15min116692-1669290.98191.182.0891.2891.482.08
216334-1633489.02989.32
317179-1717993.63593.93
416686-1668690.94891.25
517088-1708893.13993.44
616392-1639289.34589.64
20min116847-1684791.82590.123.6592.2790.573.63
216838-1683891.77692.21
315337-1533783.59584.05
416508-1650889.97890.43
516903-1690392.13192.59
616776-1677691.43891.88
30min116829-1682991.72790.790.8092.3391.390.80
216450-1645089.66290.25
316735-1673591.21591.81
416596-1659690.45791.06
516720-1672091.13391.74
616610-1661090.53491.13
45min116625-1662590.61591.110.6691.3791.860.66
216689-1668990.96491.70
316706-1670691.05791.80
416922-1692292.23492.99
516730-1673091.18891.95
616623-1662390.60491.35
60min116524-1652490.06591.110.7190.9792.010.70
216737-1673791.22692.12
316878-1687891.99492.89
416778-1677891.44992.36
516689-1668990.96491.88
616687-1668790.95391.85
极限116586-1658690.40388.954.2291.4690.004.17
216542-1654290.16391.20
316670-1667090.86191.91
414918-1491881.31182.37
516597-1659790.46391.53
616601-1660190.48591.53
苯磺酸左氨氯地平奥美沙坦酯片项目信息
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%
110.852156372161322147862152992149702153650.25
210.832158052158032158040.01
单位质量响应值RSD%判断
19849.3119926.500.28数据可信
加速6月-供试品溶液-2024080321批-奥美沙坦酯-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%
5min176941-7694134.74933.593.7934.7533.593.79
270389-7038931.79031.79
375432-7543234.06834.07
474177-7417733.50133.50
577453-7745334.98034.98
671837-7183732.44432.44
10min1121760-12176054.99153.282.5355.0553.332.53
2118769-11876953.64053.69
3117711-11771153.16253.22
4114511-11451151.71751.77
5120403-12040354.37854.44
6114617-11461751.76551.82
15min1145596-14559665.75664.802.6665.9164.942.67
2145620-14562065.76765.91
3143677-14367764.88965.03
4139052-13905262.80062.94
5148125-14812566.89867.05
6138744-13874462.66162.80
20min1160556-16055672.51272.071.7472.7772.321.74
2163096-16309673.66073.91
3156783-15678370.80871.06
4157120-15712070.96171.21
5162289-16228973.29573.56
6157638-15763871.19571.44
30min1176698-17669879.80379.301.5380.1879.671.54
2178897-17889780.79681.17
3175506-17550679.26479.64
4172175-17217577.76078.12
5177552-17755280.18880.57
6172709-17270978.00178.36
45min1185404-18540483.73584.160.9484.2584.660.94
2188891-18889185.30985.82
3186380-18638084.17584.68
4184580-18458083.36283.86
5187902-18790284.86385.38
6184885-18488583.50083.99
60min1190955-19095586.24286.341.3886.8986.981.38
2193302-19330287.30287.95
3194162-19416287.69088.33
4187563-18756384.71085.34
5192374-19237486.88287.54
6188614-18861485.18485.82
极限1201064-20106490.80791.090.4891.6091.870.48
2201338-20133890.93191.73
3203331-20333191.83192.62
4200904-20090490.73591.51
5202337-20233791.38292.18
6201114-20111490.83091.60
苯磺酸左氨氯地平奥美沙坦酯片项目信息
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%
115.691811918089181211804718209181170.33
215.761807617841179580.93
单位质量响应值RSD%判断
1154.681139.470.94数据可信
加速6月-供试品溶液-2024080421批-苯磺酸左氨氯地平-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%
5min115997-1599788.05589.732.4088.0689.732.40
216505-1650590.85290.85
316665-1666591.73291.73
415667-1566786.23986.24
516378-1637890.15390.15
616596-1659691.35391.35
10min116700-1670091.92593.132.0192.0793.282.01
217179-1717994.56294.71
317134-1713494.31494.47
416505-1650590.85291.00
516659-1665991.69991.85
617334-1733495.41595.57
15min116499-1649990.81993.081.9191.1293.391.91
217042-1704293.80894.12
317267-1726795.04695.36
416585-1658591.29291.59
516843-1684392.71293.02
617222-1722294.79895.11
20min116551-1655191.10592.504.0591.5692.964.04
217301-1730195.23395.70
317224-1722494.80995.28
416704-1670491.94792.39
515613-1561385.94286.40
617433-1743395.96096.43
30min116619-1661991.47992.484.4192.0893.104.39
217169-1716994.50795.13
317159-1715994.45295.08
417158-1715894.44695.05
515374-1537484.62685.23
617330-1733095.39396.02
45min116954-1695493.32392.582.9894.0893.352.97
217061-1706193.91294.69
317115-1711594.20994.99
415862-1586287.31288.07
516705-1670591.95392.69
617222-1722294.79895.59
60min116713-1671391.99792.541.8392.9193.461.83
217087-1708794.05594.99
317112-1711294.19395.13
416368-1636890.09891.00
516573-1657391.22692.12
617017-1701793.67094.62
极限116874-1687492.88393.430.9893.9594.501.00
217084-1708494.03995.13
317143-1714394.36495.46
416828-1682892.63093.68
516773-1677392.32793.37
617135-1713594.32095.42
苯磺酸左氨氯地平奥美沙坦酯片项目信息
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%
110.852155172146982143832144742140752146290.26
210.832145192119062132120.87
单位质量响应值RSD%判断
19781.4719687.170.34数据可信
加速6月-供试品溶液-2024080421批-奥美沙坦酯-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%
5min178215-7821535.59935.662.6935.6035.662.69
278830-7883035.87935.88
381777-8177737.22137.22
475384-7538434.31134.31
577233-7723335.15335.15
678595-7859535.77235.77
10min1121165-12116555.14856.092.7855.2156.152.77
2127337-12733757.95758.02
3126249-12624957.46257.52
4120496-12049654.84454.90
5119079-11907954.19954.26
6125068-12506856.92556.98
15min1145311-14531166.13867.212.5966.2967.362.59
2150644-15064468.56568.72
3152932-15293269.60769.76
4144763-14476365.88966.04
5143187-14318765.17165.32
6149159-14915967.89068.04
20min1160469-16046973.03773.882.4673.3074.152.45
2166282-16628275.68375.95
3166227-16622775.65875.93
4159849-15984972.75573.01
5156537-15653771.24871.51
6164592-16459274.91475.18
30min1174047-17404779.21780.642.8879.6081.032.87
2182474-18247483.05383.45
3180760-18076082.27382.67
4175272-17527279.77580.15
5169449-16944977.12577.50
6181085-18108582.42182.81
45min1185363-18536384.36885.312.6884.8885.832.68
2191043-19104386.95387.49
3190176-19017686.55887.10
4187588-18758885.38085.89
5178444-17844481.21981.72
6191929-19192987.35687.89
60min1189841-18984186.40686.992.5887.0687.662.57
2196320-19632089.35590.03
3193463-19346388.05488.74
4189110-18911086.07386.73
5182941-18294183.26583.91
6195062-19506288.78289.46
极限1204112-20411292.90193.042.1093.7093.842.11
2206373-20637393.93094.76
3207639-20763994.50795.33
4202968-20296892.38193.18
5196779-19677989.56490.34
6208572-20857294.93195.75
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