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%
115.661828818275183081830318260182870.11
215.661852918536185320.03
单位质量响应值RSD%判断
1167.751183.400.95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%
5min112790-1279068.69671.462.6368.7071.462.63
213791-1379174.07274.07
313171-1317170.74270.74
413138-1313870.56570.56
513536-1353672.70372.70
613405-1340571.99972.00
10min115668-1566884.15485.112.3784.2785.222.37
216303-1630387.56487.69
315795-1579584.83684.95
415256-1525681.94182.06
516180-1618086.90487.02
615869-1586985.23385.35
15min116211-1621187.07087.051.9187.3287.311.91
215681-1568184.22484.49
316120-1612086.58186.84
416481-1648188.52088.77
516552-1655288.90289.17
616198-1619887.00087.26
20min116340-1634087.76387.062.2888.1687.462.27
216563-1656388.96189.37
315512-1551283.31683.72
416352-1635287.82788.23
516121-1612186.58787.00
616364-1636487.89288.30
30min116457-1645788.39189.011.6688.9489.561.66
216751-1675189.97190.53
316061-1606186.26586.81
416727-1672789.84290.39
516762-1676290.03090.59
616678-1667889.57890.13
45min116477-1647788.49988.191.5689.1988.881.55
216465-1646588.43489.14
315929-1592985.55686.24
416557-1655788.92989.63
516663-1666389.49890.21
616421-1642188.19888.90
60min115138-1513881.30786.893.6082.1587.733.57
216278-1627887.43088.29
316027-1602786.08286.91
416707-1670789.73490.58
516726-1672689.83690.69
616184-1618486.92587.77
极限116889-1688990.71290.560.7491.6991.560.75
216950-1695091.03992.04
316616-1661689.24590.22
416935-1693590.95991.95
516920-1692090.87891.89
616860-1686090.55691.55
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%
110.922192322191692192112191972190052191630.05
211.012222232224832223530.09
单位质量响应值RSD%判断
20069.8720195.550.45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%
5min1112831-11283150.33949.442.4950.3449.442.49
2112096-11209650.01150.01
3105905-10590547.24947.25
4111495-11149549.74349.74
5109416-10941648.81548.82
6113190-11319050.49950.50
10min1155499-15549969.37568.971.4869.4669.051.48
2155345-15534569.30669.39
3150709-15070967.23867.32
4157318-15731870.18670.27
5153316-15331668.40168.48
6155350-15535069.30869.39
15min1173628-17362877.46377.391.2077.6677.591.20
2173910-17391077.58977.79
3170039-17003975.86276.05
4176509-17650978.74878.95
5173164-17316477.25677.45
6173567-17356777.43677.64
20min1181805-18180581.11181.291.2581.4481.611.25
2182590-18259081.46181.79
3178314-17831479.55479.87
4185322-18532282.68083.01
5182298-18229881.33181.66
6182866-18286681.58581.91
30min1188866-18886684.26184.421.2484.7384.881.24
2189380-18938084.49184.95
3185155-18515582.60683.06
4192413-19241385.84486.31
5189896-18989684.72185.18
6189577-18957784.57985.04
45min1190111-19011184.81785.061.2285.4285.671.22
2190951-19095185.19285.80
3186528-18652883.21883.81
4193552-19355286.35286.96
5191536-19153685.45386.05
6191325-19132585.35885.96
60min1187350-18735083.58584.121.1684.3384.861.16
2188894-18889484.27485.02
3184977-18497782.52683.25
4191400-19140085.39286.15
5189533-18953384.55985.30
6189169-18916984.39785.14
极限1197904-19790488.29489.621.2689.1890.501.25
2201599-20159989.94290.83
3198352-19835288.49489.36
4201354-20135489.83390.73
5204845-20484591.39092.27
6201188-20118889.75990.65
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%
115.661830718315183101832018329183160.05
215.661870118695186980.03
单位质量响应值RSD%判断
1169.601194.001.46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%
5min114806-1480679.11077.102.0479.1177.102.05
214054-1405475.09275.09
314098-1409875.32775.33
414566-1456677.82777.83
514500-1450077.47577.47
614560-1456077.79577.80
10min116169-1616986.39284.883.1686.5285.013.15
215181-1518181.11381.24
315344-1534481.98482.11
416271-1627186.93787.07
516358-1635887.40287.53
615992-1599285.44785.58
15min116484-1648488.07686.981.9688.3587.251.96
216175-1617586.42586.68
315701-1570183.89284.15
416536-1653688.35388.63
516509-1650988.20988.48
616267-1626786.91687.19
20min116530-1653088.32186.633.3588.7487.043.35
216129-1612986.17986.58
315172-1517281.06581.47
416632-1663288.86689.29
516535-1653588.34888.77
616278-1627886.97587.39
30min116505-1650588.18887.862.1088.7688.422.10
216356-1635687.39287.94
315808-1580884.46485.00
416797-1679789.74890.32
516641-1664188.91489.48
616552-1655288.43989.00
45min116669-1666989.06487.732.0589.7888.432.05
216285-1628587.01287.71
315947-1594785.20685.88
416816-1681689.84990.57
516623-1662388.81889.54
616171-1617186.40387.11
60min116657-1665789.00087.602.2589.8788.452.25
216190-1619086.50587.34
315793-1579384.38385.20
416744-1674489.46590.33
516673-1667389.08589.95
616315-1631587.17388.03
极限116502-1650288.17289.913.2289.1990.913.20
216586-1658688.62189.60
316034-1603485.67186.63
417170-1717091.74192.76
517460-1746093.29094.30
617217-1721791.99292.99
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%
110.922195732195142195342193482194682194870.04
211.012236732235512236120.04
单位质量响应值RSD%判断
20099.5420309.900.74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%
5min1107815-10781547.93046.442.2947.9346.442.30
2103160-10316045.86145.86
3102822-10282245.71145.71
4107264-10726447.68547.69
5102956-10295645.77045.77
6102786-10278645.69545.69
10min1155716-15571669.22566.992.9569.3167.062.95
2149670-14967066.53866.61
3146320-14632065.04865.12
4156332-15633269.49969.58
5149939-14993966.65766.73
6146134-14613464.96665.04
15min1175949-17594978.22075.862.7478.4276.052.75
2169878-16987875.52175.71
3164901-16490173.30973.49
4176206-17620678.33478.53
5170321-17032175.71875.91
6166577-16657774.05474.24
20min1184122-18412281.85480.002.5582.1880.322.54
2179287-17928779.70480.02
3172694-17269476.77377.08
4185214-18521482.33982.66
5180832-18083280.39180.70
6177586-17758678.94879.26
30min1190468-19046884.67583.102.3285.1483.542.32
2185750-18575082.57783.02
3179659-17965979.86980.30
4191891-19189185.30785.77
5187941-18794183.55184.00
6185795-18579582.59783.04
45min1189955-18995584.44782.982.2085.0583.572.20
2185264-18526482.36182.94
3179703-17970379.88980.46
4191269-19126985.03185.64
5187707-18770783.44784.03
6186052-18605282.71283.29
60min1188962-18896284.00582.691.9384.7583.421.93
2184415-18441581.98482.70
3179838-17983879.94980.65
4189787-18978784.37285.12
5186618-18661882.96383.69
6186450-18645082.88983.60
极限1198128-19812888.08087.901.7688.9688.761.77
2195596-19559686.95487.81
3192078-19207885.39186.22
4202109-20210989.85090.74
5199608-19960888.73889.60
6198795-19879588.37789.23
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