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%
115.691862318582185781863818611186060.14
215.761902419001190120.09
单位质量响应值RSD%判断
1185.851206.351.22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%
5min117337-1733791.52389.381.6291.5289.381.62
216662-1666287.96087.96
317028-1702889.89289.89
416879-1687989.10589.11
516606-1660687.66487.66
617073-1707390.12990.13
10min117769-1776993.80391.581.6193.9691.731.61
217033-1703389.91890.06
317494-1749492.35292.50
417240-1724091.01191.16
517095-1709590.24590.39
617458-1745892.16292.31
15min117879-1787994.38491.621.8994.6991.921.89
216974-1697489.60789.90
317523-1752392.50592.81
417177-1717790.67890.98
517133-1713390.44690.74
617445-1744592.09392.40
20min117756-1775693.73591.571.5594.2092.021.55
217073-1707390.12990.58
317506-1750692.41592.87
417176-1717690.67391.12
517115-1711590.35190.80
617447-1744792.10492.56
30min117575-1757592.77991.402.3293.4092.012.31
216594-1659487.60188.20
317452-1745292.13092.74
417111-1711190.33090.93
517672-1767293.29193.89
617482-1748292.28892.90
45min117578-1757892.79591.221.3993.5791.971.39
216936-1693689.40690.15
317535-1753592.56893.33
417216-1721690.88491.64
517189-1718990.74291.49
617218-1721890.89591.66
60min117502-1750292.39490.651.6493.3391.561.64
216675-1667588.02888.92
317318-1731891.42392.34
417077-1707790.15091.05
517217-1721790.88991.79
617244-1724491.03291.95
极限117422-1742291.97290.311.7893.0691.371.77
216796-1679688.66789.70
316699-1669988.15589.23
417099-1709990.26691.32
517221-1722190.91191.97
617401-1740191.86192.93
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%
110.852176392173512170642176812176622174790.13
210.832212102213072212580.04
单位质量响应值RSD%判断
20044.1520430.101.35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%
5min183115-8311536.89334.883.5536.8934.883.55
277068-7706834.20934.21
380375-8037535.67735.68
478341-7834134.77434.77
575274-7527433.41233.41
677277-7727734.30234.30
10min1130258-13025857.81955.642.1157.8855.702.11
2122994-12299454.59454.65
3125263-12526355.60255.66
4124357-12435755.19955.26
5125847-12584755.86155.92
6123363-12336354.75854.82
15min1154936-15493668.77366.692.0868.9366.842.08
2147359-14735965.40965.56
3148970-14897066.12566.28
4148317-14831765.83565.98
5153406-15340668.09468.24
6148486-14848665.91066.06
20min1169595-16959575.28073.261.9375.5573.521.92
2161505-16150571.68971.95
3163871-16387172.73973.00
4163308-16330872.48972.75
5168340-16834074.72274.98
6163670-16367072.65072.91
30min1184828-18482882.04179.992.3882.4480.382.38
2174980-17498077.67078.05
3178361-17836179.17179.55
4178307-17830779.14779.53
5186037-18603782.57882.96
6178764-17876479.34979.73
45min1192934-19293485.63984.061.8386.1784.581.83
2184921-18492182.08282.59
3187940-18794083.42283.94
4187624-18762483.28283.79
5194039-19403986.13086.65
6188830-18883083.81884.33
60min1196226-19622687.10085.601.9087.7886.261.90
2187624-18762483.28283.92
3191415-19141584.96585.62
4190841-19084184.71085.36
5197462-19746287.64988.32
6193502-19350285.89186.54
极限1208630-20863092.60691.391.6593.4392.191.65
2200302-20030288.91089.69
3205472-20547291.20592.00
4204377-20437790.71891.51
5209773-20977393.11493.93
6206811-20681191.79992.59
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%
115.691890518858188551894618836188800.24
215.761879018800187950.04
单位质量响应值RSD%判断
1203.311192.580.64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%
5min116618-1661887.58786.782.2287.5986.782.22
216223-1622385.50585.51
316509-1650987.01387.01
416264-1626485.72185.72
516079-1607984.74684.75
617092-1709290.08690.09
10min117263-1726390.98790.111.3091.1390.251.31
217066-1706689.94990.09
317200-1720090.65590.80
416897-1689789.05889.20
516786-1678688.47388.61
617363-1736391.51491.66
15min117304-1730491.20389.401.6991.5089.691.68
217106-1710690.15990.45
317183-1718390.56590.86
416599-1659987.48787.78
516904-1690489.09589.38
616671-1667187.86788.17
20min117176-1717690.52890.401.5590.9890.851.55
217351-1735191.45191.89
317236-1723690.84591.29
416907-1690789.11189.55
516773-1677388.40488.84
617472-1747292.08892.54
30min116997-1699789.58589.333.5890.1989.933.57
217357-1735791.48292.08
317180-1718090.54991.15
416860-1686088.86389.45
515805-1580583.30283.89
617498-1749892.22592.83
45min117049-1704989.85989.791.5490.6190.531.54
217303-1730391.19891.95
317091-1709190.08090.83
416762-1676288.34689.08
516695-1669587.99388.72
617311-1731191.24092.00
60min117021-1702189.71189.750.9890.6190.640.98
216988-1698889.53790.44
317088-1708890.06490.96
416856-1685688.84289.72
516897-1689789.05889.93
617319-1731991.28292.19
极限116906-1690689.10589.801.1690.1590.841.16
217175-1717590.52391.57
317219-1721990.75591.80
416951-1695189.34290.37
516749-1674988.27889.30
617223-1722390.77691.84
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%
110.852199772200802201942200232212552203060.25
210.832203992197972200980.20
单位质量响应值RSD%判断
20304.7020322.990.07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%
5min174562-7456232.96832.893.4232.9732.883.42
277306-7730634.18234.18
374298-7429832.85232.85
470831-7083131.31931.32
572282-7228231.96031.96
676967-7696734.03234.03
10min1118169-11816952.25052.281.8952.3052.331.89
2121029-12102953.51453.57
3120036-12003653.07553.13
4115518-11551851.07851.13
5115756-11575651.18351.24
6118850-11885052.55152.61
15min1144879-14487964.06063.131.9364.2063.271.93
2145979-14597964.54664.69
3144884-14488464.06264.21
4140040-14004061.92062.06
5140822-14082262.26662.40
6140047-14004761.92362.07
20min1160774-16077471.08870.271.4371.3470.521.43
2159532-15953270.53970.79
3161141-16114171.25071.50
4155797-15579768.88769.13
5156430-15643069.16769.41
6159858-15985870.68370.93
30min1178327-17832778.84977.641.5279.2278.011.52
2176533-17653378.05678.43
3177930-17793078.67479.04
4173065-17306576.52376.88
5171732-17173275.93376.29
6175988-17598877.81578.18
45min1188637-18863783.40882.391.4083.9182.881.40
2187117-18711782.73683.24
3188531-18853183.36183.86
4183718-18371881.23381.72
5182501-18250180.69581.18
6187507-18750782.90883.40
60min1193458-19345885.54084.481.3186.1885.121.31
2191492-19149284.67085.31
3192846-19284685.26985.91
4188309-18830983.26383.88
5187637-18763782.96683.58
6192694-19269485.20285.84
极限1205452-20545290.84390.320.8691.6291.090.87
2206107-20610791.13391.91
3205282-20528290.76891.55
4202133-20213389.37590.13
5202064-20206489.34590.10
6204554-20455490.44691.22
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%
115.691864318617186111858218651186210.15
215.761883818845188420.03
单位质量响应值RSD%判断
1186.811195.560.52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%
5min116632-1663288.15887.183.4688.1687.183.46
216894-1689489.54789.55
315934-1593484.45884.46
416860-1686089.36789.37
516816-1681689.13389.13
615548-1554882.41282.41
10min116963-1696389.91390.931.2790.0691.081.27
217453-1745392.51092.66
316874-1687489.44189.58
417302-1730291.71091.86
517233-1723391.34491.49
617105-1710590.66590.80
15min117075-1707590.50691.081.5590.8091.381.55
217502-1750292.77093.07
316757-1675788.82189.11
417384-1738492.14492.45
517100-1710090.63990.94
617285-1728591.61991.91
20min117025-1702590.24190.890.9790.6991.340.97
217356-1735691.99692.45
316891-1689189.53189.97
417247-1724791.41891.87
517167-1716790.99491.45
617198-1719891.15891.60
30min116934-1693489.75991.151.4690.3691.751.46
217614-1761493.36393.97
316996-1699690.08890.67
417353-1735391.98092.59
517131-1713190.80391.41
617151-1715190.90991.50
45min116992-1699290.06690.880.9690.8191.630.97
217415-1741592.30893.08
316960-1696089.89790.63
417212-1721291.23291.99
517161-1716190.96291.72
617131-1713190.80391.55
60min116896-1689689.55889.553.2090.4690.463.18
217508-1750892.80193.72
316682-1668288.42389.31
417369-1736992.06592.98
516919-1691989.67990.59
615996-1599684.78785.68
极限116910-1691089.63290.281.3890.6891.341.38
217504-1750492.78093.86
316966-1696689.92990.96
416987-1698790.04091.11
516949-1694989.83890.89
616883-1688389.48990.53
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%
110.852189792186492183132178052173742182240.30
210.832194922192922193920.07
单位质量响应值RSD%判断
20112.8120257.800.51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%
5min180283-8028335.72534.662.4435.7234.662.43
277532-7753234.50034.50
374827-7482733.29733.30
479271-7927135.27435.27
578324-7832434.85334.85
677085-7708534.30234.30
10min1124634-12463455.46054.822.5455.5254.882.54
2126655-12665556.35956.42
3118990-11899052.94953.00
4126312-12631256.20756.27
5121538-12153854.08254.14
6121058-12105853.86953.93
15min1148780-14878066.20565.652.3766.3665.802.37
2152333-15233367.78667.94
3143551-14355163.87864.02
4150426-15042666.93767.09
5145015-14501564.52964.68
6145119-14511964.57564.72
20min1163290-16329072.66172.122.2572.9272.372.25
2167047-16704774.33374.60
3158330-15833070.45470.70
4165195-16519573.50973.77
5159662-15966271.04771.30
6158880-15888070.69970.95
30min1179175-17917579.73079.222.5780.1179.602.57
2184168-18416881.95282.34
3173755-17375577.31877.69
4182118-18211881.03981.43
5176130-17613078.37578.75
6172855-17285576.91877.29
45min1188685-18868583.96283.952.3984.4884.462.39
2195430-19543086.96387.49
3186875-18687583.15683.65
4191917-19191785.40085.92
5186367-18636782.93083.43
6182655-18265581.27881.78
60min1194634-19463486.60986.312.9387.2786.962.92
2200171-20017189.07389.74
3189094-18909484.14484.78
4200688-20068889.30389.97
5192343-19234385.58986.23
6186897-18689783.16683.80
极限1203931-20393190.74690.712.0091.5591.512.01
2210148-21014893.51294.33
3199368-19936888.71589.49
4206862-20686292.05092.86
5202498-20249890.10890.89
6200336-20033689.14689.92
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