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100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5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%
116.051753717411175691733517494174690.55
216.131768417470175770.87
单位质量响应值RSD%判断
1088.411089.710.09数据可信
长期12月-供试品溶液-2024080421批-苯磺酸左氨氯地平-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%
5min110081-1008157.96454.404.6757.9654.404.66
28998-899851.73751.74
39330-933053.64653.65
49532-953254.80754.81
59827-982756.50356.50
68995-899551.72051.72
10min114847-1484785.36784.902.2185.4684.992.21
214481-1448183.26383.35
315211-1521187.46087.55
414958-1495886.00686.10
514786-1478685.01785.11
614310-1431082.28082.37
15min115759-1575990.61188.432.8590.8588.662.85
215247-1524787.66787.89
315938-1593891.64091.88
415054-1505486.55886.79
515500-1550089.12289.36
614779-1477984.97685.20
20min115442-1544288.78987.623.6889.1888.003.67
214680-1468084.40784.78
316139-1613992.79693.18
414874-1487485.52385.90
515504-1550489.14589.53
614791-1479185.04585.41
30min115311-1531188.03588.572.7388.5789.102.72
215207-1520787.43787.95
316213-1621393.22293.76
415473-1547388.96789.49
515073-1507386.66787.20
615147-1514787.09287.60
45min115586-1558689.61788.952.6890.3089.622.68
214955-1495585.98886.65
315984-1598491.90592.60
415693-1569390.23290.90
515624-1562489.83590.51
614978-1497886.12186.77
60min115486-1548689.04289.033.4089.8889.853.40
215269-1526987.79488.59
316468-1646894.68895.54
415210-1521087.45588.27
515529-1552989.28990.12
614943-1494385.91986.71
极限116516-1651694.96493.441.2195.9594.411.21
216033-1603392.18793.13
316163-1616392.93493.94
416180-1618093.03294.00
516474-1647494.72295.70
616140-1614092.80293.74
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%
111.032214022199042201592197592189652200380.41
211.102216712198012207360.60
单位质量响应值RSD%判断
19949.0519886.130.23数据可信
长期12月-供试品溶液-2024080421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%
5min1105130-10513047.40944.377.7747.4144.377.77
292122-9212241.54341.54
394612-9461242.66642.67
4108795-10879549.06249.06
5100332-10033245.24645.25
689380-8938040.30740.31
10min1150556-15055667.89566.653.7767.9766.723.77
2142309-14230964.17664.24
3149001-14900167.19367.26
4155548-15554870.14670.23
5148900-14890067.14867.22
6140436-14043663.33163.40
15min1168346-16834675.91775.532.9376.1175.712.93
2163415-16341573.69473.87
3174254-17425478.58178.76
4170976-17097677.10377.30
5167087-16708775.34975.54
6160830-16083072.52872.70
20min1177222-17722279.92079.392.7180.2479.702.71
2170811-17081177.02977.33
3182549-18254982.32282.64
4179361-17936180.88581.21
5175851-17585179.30279.61
6170474-17047476.87777.17
30min1182512-18251282.30582.432.9682.7682.882.96
2177493-17749380.04280.47
3191549-19154986.38186.83
4185812-18581283.79484.26
5182208-18220882.16882.61
6177199-17719979.91080.33
45min1185546-18554683.67483.643.2784.2684.223.27
2181001-18100181.62482.18
3196156-19615688.45889.05
4186544-18654484.12484.73
5185037-18503783.44484.03
6178537-17853780.51381.07
60min1182763-18276382.41983.074.0783.1583.794.06
2179769-17976981.06981.77
3198421-19842189.48090.22
4184926-18492683.39484.14
5182434-18243482.27082.99
6176901-17690179.77580.46
极限1196128-19612888.44688.851.0989.3189.711.11
2194576-19457687.74688.58
3199471-19947189.95390.85
4199373-19937389.90990.79
5197644-19764489.12989.99
6194954-19495487.91688.74
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100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5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%
116.051722117379173021723217446173160.56
216.131729817435173660.56
单位质量响应值RSD%判断
1078.881076.630.15数据可信
长期12月-供试品溶液-2024080421批-苯磺酸左氨氯地平-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%
5min17486-748643.49550.117.5843.4950.117.58
29395-939554.58654.59
38543-854349.63649.64
49078-907852.74452.74
58749-874950.83350.83
68498-849849.37549.37
10min114263-1426382.87085.012.2382.9485.092.23
214853-1485386.29886.39
314165-1416582.30182.38
414795-1479585.96186.05
514878-1487886.44386.53
614831-1483186.17086.25
15min115253-1525388.62290.111.7488.8390.331.74
215718-1571891.32491.56
315093-1509387.69287.91
415726-1572691.37091.60
515644-1564490.89491.12
615620-1562090.75490.98
20min114898-1489886.55989.143.7386.9289.523.73
215755-1575591.53991.93
314391-1439183.61483.98
415833-1583391.99292.38
515611-1561190.70291.08
615567-1556790.44690.82
30min115297-1529788.87888.983.8889.3889.503.86
215767-1576791.60892.15
315083-1508387.63488.14
415429-1542989.64590.18
514306-1430683.12083.65
616003-1600392.98093.51
45min115398-1539889.46490.101.6190.1290.771.61
215556-1555690.38291.07
315080-1508087.61788.27
415524-1552490.19790.88
515737-1573791.43492.10
615750-1575091.51092.19
60min114999-1499987.14688.821.7987.9589.641.79
215621-1562190.76091.60
314927-1492786.72887.53
415465-1546589.85490.69
515414-1541489.55790.38
615293-1529388.85489.69
极限115993-1599392.92293.652.2293.8794.622.22
216261-1626194.47995.47
315496-1549690.03490.98
416096-1609693.52094.51
516342-1634294.94995.92
616525-1652596.01397.00
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%
111.032226182196642189992196502192632200390.67
211.102216952189272203110.89
单位质量响应值RSD%判断
19949.1419847.840.36数据可信
长期12月-供试品溶液-2024080421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%
5min196487-9648743.55444.804.0843.5544.804.08
2100979-10097945.58145.58
397506-9750644.01444.01
4102575-10257546.30246.30
593650-9365042.27342.27
6104323-10432347.09147.09
10min1144669-14466965.30366.191.9165.3866.271.91
2148692-14869267.11967.19
3143734-14373464.88164.95
4148478-14847867.02267.10
5144089-14408965.04165.11
6150206-15020667.80267.88
15min1165083-16508374.51774.911.4874.7075.101.48
2170121-17012176.79276.98
3163336-16333673.72973.91
4166804-16680475.29475.48
5163912-16391273.98974.17
6166450-16645075.13575.33
20min1171265-17126577.30878.722.0377.6179.042.03
2178425-17842580.54080.86
3169916-16991676.69977.00
4177169-17716979.97380.29
5172795-17279577.99978.30
6176851-17685179.82980.15
30min1176936-17693679.86881.212.0180.3081.652.01
2185079-18507983.54483.99
3175810-17581079.36079.79
4182603-18260382.42682.87
5177890-17789080.29880.73
6181174-18117481.78182.23
45min1179782-17978281.15382.141.8381.7282.721.83
2185922-18592283.92484.51
3177157-17715779.96880.53
4185107-18510783.55684.14
5180976-18097681.69182.26
6182872-18287282.54783.13
60min1177980-17798080.33981.492.1081.0482.202.10
2185020-18502083.51784.25
3175063-17506379.02279.72
4183331-18333182.75583.48
5178989-17898980.79581.50
6182737-18273782.48683.21
极限1194729-19472987.90087.881.4388.7488.731.43
2197988-19798889.37190.24
3189770-18977085.66186.49
4196502-19650288.70089.56
5194927-19492787.98988.83
6194217-19421787.66888.53
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100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5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%
116.051759617527174771752317527175300.25
216.131722017350172850.54
单位质量响应值RSD%判断
1092.211071.611.35数据可信
中间条件12月-供试品溶液-2024080421批-苯磺酸左氨氯地平-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%
5min112828-1282874.25368.408.8574.2568.408.85
212066-1206669.84269.84
312511-1251172.41872.42
411844-1184468.55768.56
511807-1180768.34368.34
69842-984256.96956.97
10min114089-1408981.55283.652.5181.6883.772.50
214330-1433082.94783.06
314667-1466784.89885.02
414789-1478985.60485.72
514004-1400481.06081.17
614834-1483485.86485.96
15min114812-1481285.73784.972.5786.0085.222.56
214705-1470585.11885.37
314781-1478185.55785.82
414265-1426582.57182.83
514255-1425582.51382.76
615254-1525488.29588.53
20min114724-1472485.22785.372.5485.6385.762.53
214682-1468284.98485.38
314624-1462484.64985.05
415072-1507287.24287.64
514160-1416081.96382.35
615227-1522788.13988.52
30min114970-1497086.65186.701.9887.2087.241.97
215020-1502086.94187.48
314822-1482285.79586.34
415164-1516487.77488.31
514516-1451684.02484.55
615380-1538089.02589.56
45min114539-1453984.15786.832.7584.8587.512.72
215024-1502486.96487.65
314793-1479385.62786.32
415344-1534488.81689.50
514690-1469085.03185.69
615613-1561390.37391.05
60min114979-1497986.70486.702.2587.5387.522.24
215171-1517187.81588.64
314756-1475685.41386.24
414785-1478585.58186.41
514629-1462984.67885.48
615545-1554589.98090.81
极限115749-1574991.16190.841.8992.1391.811.88
216067-1606793.00193.98
315396-1539689.11790.09
415945-1594592.29593.27
515315-1531588.64889.59
615694-1569490.84291.82
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%
111.032225122215382216242210262209042215210.29
211.102176122198092187100.72
单位质量响应值RSD%判断
20083.5019703.601.36数据可信
中间条件12月-供试品溶液-2024080421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%
5min193212-9321242.08941.013.4342.0941.013.43
287916-8791639.69839.70
393958-9395842.42642.43
493752-9375242.33342.33
588258-8825839.85239.85
687787-8778739.64039.64
10min1137973-13797362.30162.762.0062.3762.822.00
2138463-13846362.52262.59
3138288-13828862.44362.51
4143872-14387264.96565.04
5135509-13550961.18861.25
6139774-13977463.11463.18
15min1157920-15792071.30871.412.0671.4871.582.06
2159061-15906171.82371.99
3155715-15571570.31270.49
4162476-16247673.36573.54
5153396-15339669.26569.43
6160335-16033572.39872.57
20min1165965-16596574.94175.912.4175.2376.202.41
2168866-16886676.25076.54
3164846-16484674.43574.73
4173672-17367278.42178.72
5163467-16346773.81374.10
6171800-17180077.57577.87
30min1173833-17383378.49379.652.4578.9180.072.44
2178171-17817180.45280.87
3172774-17277478.01578.43
4183178-18317882.71383.14
5171946-17194677.64178.05
6178486-17848680.59481.02
45min1174844-17484478.95080.952.7679.5081.502.76
2181355-18135581.89082.44
3176206-17620679.56580.11
4185910-18591083.94784.52
5173966-17396678.55379.09
6183375-18337582.80283.36
60min1176630-17663079.75680.612.1680.4481.302.16
2179207-17920780.92081.61
3175936-17593679.44380.12
4184525-18452583.32184.03
5173895-17389578.52179.19
6180957-18095781.71082.40
极限1186647-18664784.27985.802.3285.0986.622.31
2191485-19148586.46487.29
3185713-18571383.85884.67
4197345-19734589.11089.96
5187226-18722684.54185.34
6191725-19172586.57287.40
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100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5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%
116.051748317402172961735617550174170.58
216.131753917372174560.68
单位质量响应值RSD%判断
1085.171082.210.20数据可信
中间条件12月-供试品溶液-2024080421批-苯磺酸左氨氯地平-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%
5min112334-1233471.27071.015.5771.2771.015.57
211038-1103863.78163.78
312800-1280073.96273.96
412049-1204969.62369.62
512820-1282074.07874.08
612698-1269873.37373.37
10min114811-1481185.58385.334.8185.7085.454.81
213447-1344777.70177.81
315471-1547189.39689.52
414748-1474885.21985.33
514841-1484185.75685.88
615290-1529088.35088.47
15min114767-1476785.32887.183.4485.5987.443.44
214302-1430282.64182.88
315287-1528788.33388.61
415326-1532688.55888.82
515027-1502786.83187.10
615811-1581191.36191.63
20min115332-1533288.59388.512.7689.0088.922.77
214709-1470984.99385.37
315805-1580591.32691.75
415066-1506687.05687.46
515219-1521987.94088.35
615777-1577791.16491.59
30min115623-1562390.27589.123.4390.8389.683.42
214761-1476185.29485.81
316028-1602892.61593.19
415014-1501486.75687.31
515142-1514287.49588.05
615972-1597292.29192.86
45min115255-1525588.14889.322.8188.8590.032.82
214914-1491486.17886.84
315994-1599492.41893.14
415170-1517087.65788.35
515476-1547689.42590.13
615943-1594392.12492.85
60min115577-1557790.00988.971.6490.8689.821.66
214933-1493386.28887.09
315573-1557389.98690.87
415402-1540288.99889.84
515323-1532388.54189.39
615579-1557990.02090.90
极限115803-1580391.31592.312.5692.3193.312.56
215706-1570690.75491.70
316636-1663696.12897.16
415566-1556689.94590.94
515837-1583791.51192.51
616305-1630594.21595.25
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%
111.032212562215582223192216912218962217440.18
211.102202262207762205010.18
单位质量响应值RSD%判断
20103.7219864.950.85数据可信
中间条件12月-供试品溶液-2024080421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%
5min192136-9213641.41241.148.1741.4141.148.16
277348-7734834.76534.77
398414-9841444.23444.23
494979-9497942.69042.69
595689-9568943.00943.01
690572-9057240.70940.71
10min1141753-14175363.71363.174.6663.7863.244.66
2127967-12796757.51757.58
3147063-14706366.10066.17
4141824-14182463.74563.82
5143644-14364464.56364.64
6141031-14103163.38963.46
15min1161492-16149272.58572.483.3072.7672.653.31
2151545-15154568.11568.27
3167603-16760375.33275.52
4160834-16083472.29072.47
5163325-16332573.40973.59
6162717-16271773.13673.31
20min1172462-17246277.51676.992.6777.8177.282.67
2163484-16348473.48173.75
3176729-17672979.43479.74
4168954-16895475.93976.24
5173460-17346077.96578.27
6172663-17266377.60777.90
30min1180963-18096381.33780.772.2881.7681.192.29
2173104-17310477.80578.19
3184783-18478383.05483.50
4176966-17696679.54179.97
5180753-18075381.24381.67
6181633-18163381.63882.06
45min1182446-18244682.00481.551.7882.5682.101.79
2176790-17679079.46179.98
3185387-18538783.32683.91
4178397-17839780.18480.74
5183488-18348882.47283.04
6182065-18206581.83282.39
60min1182888-18288882.20281.201.3382.9081.891.34
2178064-17806480.03480.69
3184053-18405382.72683.45
4178478-17847880.22080.91
5180625-18062581.18581.89
6179795-17979580.81281.51
极限1193006-19300686.75086.301.2087.5887.131.21
2190212-19021285.49486.28
3196096-19609688.13989.00
4189782-18978285.30186.13
5191413-19141386.03486.87
6191553-19155386.09786.93
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