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%
116.051726317500172431742017388173630.63
216.131724017317172780.32
单位质量响应值RSD%判断
1081.811071.170.70数据可信
长期12月-供试品溶液-2024080121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%
5min19323-932354.23354.354.6454.2354.344.64
29231-923153.69853.70
38789-878951.12651.13
49495-949555.23355.23
59132-913253.12253.12
610084-1008458.66058.66
10min115591-1559190.69486.073.1190.7886.163.10
215086-1508687.75787.85
314509-1450984.40084.49
414623-1462385.06385.16
514364-1436483.55783.65
614600-1460084.93085.03
15min116103-1610393.67390.032.2093.9190.262.19
215462-1546289.94490.18
315211-1521188.48488.71
415478-1547890.03790.27
515143-1514388.08888.32
615461-1546189.93890.18
20min116410-1641095.45890.203.2095.8690.583.19
215743-1574391.57891.96
315129-1512988.00788.38
415218-1521888.52588.91
515188-1518888.35088.72
615350-1535089.29289.68
30min116111-1611193.71991.241.5994.2891.771.60
215824-1582492.05092.59
315481-1548190.05490.57
415593-1559390.70691.24
515447-1544789.85790.38
615648-1564891.02691.56
45min116227-1622794.39491.032.4295.1191.722.42
215960-1596092.84193.53
315366-1536689.38590.06
415530-1553090.33991.02
515220-1522088.53689.21
615589-1558990.68391.37
60min116105-1610593.68490.622.2994.5591.462.28
215752-1575291.63192.48
315033-1503387.44888.27
415629-1562990.91591.75
515508-1550890.21191.03
615439-1543989.81090.65
极限116862-1686298.08894.743.1599.1195.733.13
216863-1686398.09499.09
315570-1557090.57291.54
416111-1611193.71994.70
516340-1634095.05196.02
615972-1597292.91193.90
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%
111.032203942195672203172200202202552201110.16
211.102197962195432196700.09
单位质量响应值RSD%判断
19955.6719790.090.59数据可信
长期12月-供试品溶液-2024080121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%
5min1108353-10835348.97346.472.7248.9746.462.72
2102398-10239846.28246.28
3101268-10126845.77145.77
4102420-10242046.29246.29
5101692-10169245.96345.96
6100714-10071445.52145.52
10min1160933-16093372.73967.604.0072.8267.684.00
2150817-15081768.16668.24
3145656-14565665.83465.91
4147505-14750566.66966.75
5147903-14790366.84966.93
6144521-14452165.32165.40
15min1181768-18176882.15676.553.8982.3676.743.89
2170523-17052377.07377.26
3164729-16472974.45474.64
4166264-16626475.14875.34
5168937-16893776.35676.54
6163914-16391474.08674.27
20min1189590-18959085.69180.323.6386.0380.643.63
2179525-17952581.14281.46
3173041-17304178.21178.52
4174362-17436278.80879.12
5177586-17758680.26580.58
6172178-17217877.82178.13
30min1193159-19315987.30482.863.1387.7983.313.13
2186283-18628384.19684.65
3178810-17881080.81981.26
4179772-17977281.25381.70
5183619-18361982.99283.44
6178314-17831480.59481.03
45min1193100-19310087.27783.672.6587.9184.262.66
2188463-18846385.18285.78
3180931-18093181.77782.35
4181076-18107681.84382.42
5185297-18529783.75184.34
6181812-18181282.17682.75
60min1191961-19196186.76383.262.5987.5483.992.60
2187619-18761984.80085.54
3179744-17974481.24181.95
4180965-18096581.79382.51
5184204-18420483.25783.98
6180828-18082881.73182.44
极限1205283-20528392.78489.272.6893.7090.142.69
2202019-20201991.30992.19
3192317-19231786.92487.77
4195533-19553388.37789.23
5197710-19771089.36190.23
6192206-19220686.87387.72
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%
116.051740917603172991753317482174650.67
216.131752717695176110.68
单位质量响应值RSD%判断
1088.161091.820.24数据可信
长期12月-供试品溶液-2024080121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%
5min111671-1167167.04969.994.3267.0569.994.32
211629-1162966.80866.81
312523-1252371.94471.94
412895-1289574.08174.08
512498-1249871.80071.80
611878-1187868.23868.24
10min113976-1397680.29183.883.7980.4084.003.79
213874-1387479.70579.82
314899-1489985.59485.71
415253-1525387.62787.75
514886-1488685.51985.64
614715-1471584.53784.65
15min115030-1503086.34687.782.7986.5988.032.79
214659-1465984.21584.46
315565-1556589.42089.68
415866-1586691.14991.42
515402-1540288.48388.75
615152-1515287.04787.30
20min115013-1501386.24986.253.8886.6486.653.88
214091-1409180.95281.34
315336-1533688.10488.52
415746-1574690.46090.88
515257-1525787.65088.06
614635-1463584.07784.48
30min115264-1526487.69088.352.0888.2288.892.09
214949-1494985.88186.40
315280-1528087.78288.34
415865-1586591.14391.72
515617-1561789.71890.27
615296-1529687.87488.41
45min115247-1524787.59388.761.8388.2789.451.83
215105-1510586.77787.44
315760-1576090.54091.24
415811-1581190.83391.56
515414-1541488.55289.26
615362-1536288.25388.94
60min115111-1511186.81287.343.9687.6488.183.93
215221-1522187.44388.25
315504-1550489.06989.92
415926-1592691.49492.37
514121-1412181.12481.98
615332-1533288.08188.91
极限115950-1595091.63192.731.6192.6093.721.62
215961-1596191.69592.65
316254-1625493.37894.38
416619-1661995.47596.50
516007-1600791.95992.95
616058-1605892.25293.23
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%
111.032203442216412201252200742199822204330.32
211.102226862228382227620.05
单位质量响应值RSD%判断
19984.8620068.650.30数据可信
长期12月-供试品溶液-2024080121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%
5min197042-9704243.52444.325.3143.5244.325.31
294215-9421542.25642.26
3101990-10199045.74345.74
4106862-10686247.92847.93
5100008-10000844.85444.85
692764-9276441.60541.60
10min1145002-14500265.03465.602.7865.1165.682.78
2140619-14061963.06863.14
3147407-14740766.11266.19
4153025-15302568.63268.71
5146617-14661765.75865.83
6144949-14494965.01065.08
15min1165200-16520074.09374.462.4574.2774.642.45
2159402-15940271.49271.67
3166335-16633574.60274.79
4172107-17210777.19077.38
5166102-16610274.49774.68
6166992-16699274.89675.07
20min1173546-17354677.83678.422.3078.1478.732.30
2168195-16819575.43675.73
3175354-17535478.64778.96
4180367-18036780.89581.22
5174879-17487978.43478.74
6176814-17681479.30179.60
30min1181185-18118581.26281.522.2081.7081.952.20
2175138-17513878.55078.97
3181675-18167581.48281.92
4187201-18720183.96084.42
5181247-18124781.29081.73
6184056-18405682.54982.98
45min1183050-18305082.09882.182.1682.6782.762.16
2176592-17659279.20279.75
3183284-18328482.20382.78
4188143-18814384.38384.98
5182187-18218781.71182.29
6186161-18616183.49484.07
60min1181580-18158081.43981.612.0582.1582.322.05
2175387-17538778.66179.34
3182384-18238481.80082.51
4185920-18592083.38584.12
5181462-18146281.38682.10
6185042-18504282.99283.70
极限1194539-19453987.25187.021.4788.0987.871.47
2190760-19076085.55686.37
3193949-19394986.98787.84
4199057-19905789.27790.15
5191992-19199286.10986.96
6193881-19388186.95687.81
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%
116.051743817360171721730217376173300.59
216.131726917372173200.43
单位质量响应值RSD%判断
1079.751073.780.40数据可信
中间条件12月-供试品溶液-2024080121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%
5min112740-1274074.09071.854.0474.0971.854.04
211364-1136466.08866.09
312482-1248272.58972.59
412525-1252572.83972.84
512614-1261473.35773.36
612407-1240772.15372.15
10min115538-1553890.36185.184.0890.4885.304.08
213719-1371979.78379.89
314439-1443983.97084.09
414893-1489386.61086.73
514756-1475685.81485.94
614539-1453984.55284.67
15min115555-1555590.46087.651.9590.7387.911.95
214691-1469185.43685.68
315022-1502287.36187.62
415233-1523388.58888.85
514988-1498887.16387.43
614944-1494486.90787.17
20min115144-1514488.07088.351.1988.5088.761.19
214862-1486286.43086.82
315277-1527788.84489.25
415226-1522688.54788.96
515386-1538689.47889.89
615258-1525888.73389.14
30min115680-1568091.18789.361.5291.7689.921.53
214986-1498687.15187.68
315386-1538689.47890.03
415255-1525588.71689.28
515489-1548990.07790.64
615403-1540389.57690.13
45min115909-1590992.51989.382.1793.2490.082.17
214900-1490086.65187.33
315226-1522688.54789.25
415381-1538189.44890.16
515499-1549990.13590.84
615298-1529888.96689.67
60min116081-1608193.51990.022.2694.4090.872.26
215038-1503887.45488.27
315366-1536689.36190.21
415447-1544789.83290.69
515611-1561190.78691.65
615330-1533089.15290.00
极限116054-1605493.36292.921.4794.4093.921.45
215930-1593092.64193.61
316279-1627994.67195.67
416063-1606393.41594.42
515970-1597092.87493.89
615570-1557090.54891.55
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%
111.032190462191512190012192082192992191410.06
211.102191532196332193930.16
单位质量响应值RSD%判断
19867.7219765.140.37数据可信
中间条件12月-供试品溶液-2024080121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%
5min1100235-10023545.43342.814.2345.4342.804.23
288149-8814939.95539.95
394685-9468542.91742.92
494943-9494343.03443.03
596048-9604843.53543.54
692569-9256941.95841.96
10min1146692-14669266.49064.172.5966.5764.242.59
2136035-13603561.66061.73
3140933-14093363.88063.95
4143309-14330964.95765.03
5143000-14300064.81764.89
6139453-13945363.20963.28
15min1167293-16729375.82873.192.6176.0173.372.61
2155685-15568570.56670.74
3160668-16066872.82573.00
4163273-16327374.00674.19
5163837-16383774.26174.44
6158079-15807971.65171.83
20min1175627-17562779.60577.582.2579.9277.882.26
2165620-16562075.06975.36
3170614-17061477.33377.63
4173598-17359878.68678.99
5173618-17361878.69579.00
6167828-16782876.07076.36
30min1183970-18397083.38781.052.2283.8381.482.22
2172867-17286778.35478.77
3178626-17862680.96581.39
4180239-18023981.69682.13
5181266-18126682.16182.60
6175880-17588079.72080.14
45min1185842-18584284.23582.452.0684.8283.012.06
2175998-17599879.77380.32
3181663-18166382.34182.90
4183565-18356583.20383.77
5185044-18504483.87484.45
6179277-17927781.26081.81
60min1183728-18372883.27781.751.8184.0082.451.81
2175720-17572079.64780.32
3180174-18017481.66682.37
4181827-18182782.41683.12
5183364-18336483.11283.82
6177377-17737780.39881.09
极限1194116-19411687.98686.861.2688.8587.701.26
2191224-19122486.67587.48
3191881-19188186.97387.81
4192943-19294387.45488.30
5192452-19245287.23188.08
6187140-18714084.82485.65
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%
116.051750017475175551743217469174860.27
216.131743417262173480.71
单位质量响应值RSD%判断
1089.471075.510.92数据可信
中间条件12月-供试品溶液-2024080121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%
5min111397-1139765.93172.046.6565.9372.046.65
212387-1238771.65871.66
312709-1270973.52173.52
411593-1159367.06567.06
513355-1335577.25877.26
613282-1328276.83676.84
10min114411-1441183.36784.602.3683.4884.722.37
214738-1473885.25885.38
314308-1430882.77182.89
414263-1426382.51182.62
514974-1497486.62486.75
615051-1505187.06987.20
15min114605-1460584.48986.641.9684.7486.901.96
214857-1485785.94786.21
315439-1543989.31489.57
414781-1478185.50785.76
515065-1506587.15087.42
615112-1511287.42287.70
20min114768-1476885.43288.522.1585.8288.932.15
215381-1538188.97889.38
315519-1551989.77690.19
415040-1504087.00687.40
515511-1551189.73090.15
615596-1559690.22290.64
30min114720-1472085.15488.222.2985.6988.772.29
215405-1540589.11789.67
315059-1505987.11587.67
415199-1519987.92588.46
515364-1536488.88089.45
615750-1575091.11391.68
45min114908-1490886.24287.333.3886.9288.033.37
215398-1539889.07789.78
314406-1440683.33884.04
414683-1468384.94085.62
515468-1546889.48190.20
615716-1571690.91691.64
60min115009-1500986.82687.962.0687.6488.812.06
214747-1474785.31186.16
315310-1531088.56789.41
415142-1514287.59688.42
515376-1537688.94989.81
615649-1564990.52991.40
极限115734-1573491.02092.311.8191.9893.301.81
215616-1561690.33891.33
316218-1621893.82094.81
415822-1582291.52992.50
515995-1599592.53093.54
616360-1636094.64295.67
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%
111.032218872215212218322214842218802217210.10
211.102213092213572213330.02
单位质量响应值RSD%判断
20101.6319939.910.58数据可信
中间条件12月-供试品溶液-2024080121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%
5min187500-8750039.25641.206.3839.2641.206.37
290225-9022540.47940.48
392253-9225341.38941.39
484058-8405837.71237.71
597632-9763243.80243.80
699283-9928344.54244.54
10min1134333-13433360.26762.403.2660.3362.473.27
2138448-13844862.11462.18
3142348-14234863.86363.93
4133102-13310259.71559.78
5143394-14339464.33264.41
6142902-14290264.11264.19
15min1155840-15584069.91671.842.3370.0872.012.34
2159725-15972571.65971.83
3163065-16306573.15873.33
4155519-15551969.77269.93
5163868-16386873.51873.70
6162777-16277773.02873.21
20min1165170-16517074.10276.442.2174.3876.732.22
2169794-16979476.17776.47
3173503-17350377.84178.14
4166732-16673274.80375.08
5173860-17386078.00178.30
6173247-17324777.72678.03
30min1172078-17207877.20179.782.1277.6180.202.12
2178352-17835280.01680.43
3182129-18212981.71182.14
4174755-17475578.40278.81
5180611-18061181.03081.46
6179013-17901380.31380.74
45min1175232-17523278.61681.111.9479.1581.661.94
2181194-18119481.29181.84
3184938-18493882.97183.53
4178699-17869980.17280.71
5183705-18370582.41882.99
6180913-18091381.16581.73
60min1174566-17456678.31880.631.7878.9881.321.79
2180007-18000780.75981.44
3183291-18329182.23282.93
4177804-17780479.77080.44
5182493-18249381.87482.58
6180176-18017680.83481.54
极限1187824-18782484.26685.661.6985.0686.481.69
2189109-18910984.84285.66
3195324-19532487.63088.47
4187514-18751484.12784.93
5192809-19280986.50287.34
6192958-19295886.56987.41
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