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%
116.051758217531176131770517679176220.41
216.131752117426174740.39
单位质量响应值RSD%判断
1097.941083.320.95数据可信
长期12月-供试品溶液-2024080321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%
5min19784-978456.17752.607.1256.1852.607.12
28477-847748.67348.67
38990-899051.61951.62
49600-960055.12155.12
59774-977456.12056.12
68342-834247.89847.90
10min114905-1490585.58184.571.9585.6784.661.95
214281-1428181.99882.08
314956-1495685.87485.96
415032-1503286.31086.40
514579-1457983.70983.80
614625-1462583.97384.05
15min115649-1564989.85389.421.0590.0989.641.06
215270-1527087.67787.89
315526-1552689.14789.38
415636-1563689.77890.01
515619-1561989.68189.91
615739-1573990.37090.59
20min115719-1571990.25589.601.6390.6489.981.62
215212-1521287.34487.71
315851-1585191.01391.39
415836-1583690.92791.31
515606-1560689.60689.99
615409-1540988.47588.85
30min115695-1569590.11789.921.4590.6590.441.45
215264-1526487.64288.15
315815-1581590.80691.34
415762-1576290.50291.04
515543-1554389.24489.78
615883-1588391.19791.71
45min115570-1557089.39988.752.6190.0989.432.60
214855-1485585.29485.95
315705-1570590.17490.86
415977-1597791.73692.42
515140-1514086.93087.61
615495-1549588.96989.64
60min115596-1559689.54990.090.9590.3890.920.95
215553-1555389.30290.10
315706-1570690.18091.01
415634-1563489.76790.61
515685-1568590.06090.89
615972-1597291.70892.53
极限116270-1627093.41993.491.2894.4094.461.26
216187-1618792.94293.89
316251-1625193.31094.29
415981-1598191.75992.75
516594-1659495.27996.25
616408-1640894.21195.18
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%
111.032206942204422205112208152205202205960.07
211.102194322204282199300.33
单位质量响应值RSD%判断
19999.6419813.510.67数据可信
长期12月-供试品溶液-2024080321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%
5min1104011-10401146.93245.195.0046.9345.185.00
291507-9150741.29041.29
396736-9673643.64943.65
4101847-10184745.95545.96
5103659-10365946.77346.77
6103083-10308346.51346.51
10min1146839-14683966.25666.461.7266.3366.541.73
2142468-14246864.28464.35
3149624-14962467.51367.59
4148095-14809566.82366.90
5148559-14855967.03267.11
6148170-14817066.85766.93
15min1164053-16405374.02475.061.5974.2175.251.59
2162475-16247573.31273.49
3169751-16975176.59576.78
4167678-16767875.65975.85
5167045-16704575.37475.56
6167151-16715175.42175.61
20min1173007-17300778.06479.091.3878.3879.401.38
2172274-17227477.73378.03
3178975-17897580.75781.07
4176352-17635279.57379.89
5175690-17569079.27479.59
6175375-17537579.13279.45
30min1179055-17905580.79381.851.3981.2382.291.39
2178206-17820680.41080.84
3185015-18501583.48283.93
4182942-18294282.54782.99
5182028-18202882.13482.58
6181138-18113881.73382.18
45min1181632-18163281.95683.221.5982.5383.801.59
2180592-18059281.48682.05
3187160-18716084.45085.04
4185037-18503783.49284.08
5187942-18794284.80385.39
6184234-18423483.13083.71
60min1180298-18029881.35482.411.2782.0783.121.27
2179331-17933180.91781.61
3185153-18515383.54484.27
4184230-18423083.12883.85
5183213-18321382.66983.39
6183591-18359182.83983.56
极限1193321-19332187.23088.741.0088.0889.600.99
2196234-19623488.54489.38
3199188-19918889.87790.74
4196654-19665488.73489.60
5197745-19774589.22690.09
6196925-19692588.85689.72
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%
116.051750317406174601737817421174340.28
216.131746117226173440.96
单位质量响应值RSD%判断
1086.231075.260.72数据可信
长期12月-供试品溶液-2024080321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%
5min112340-1234071.50071.293.5171.5071.283.51
212779-1277974.04474.04
311955-1195569.26969.27
412356-1235671.59371.59
512720-1272073.70273.70
611668-1166867.60767.61
10min114227-1422782.43486.072.7182.5586.192.71
215093-1509387.45287.58
314976-1497686.77486.89
414659-1465984.93785.06
515401-1540189.23689.36
614768-1476885.56885.68
15min115180-1518087.95688.251.6188.2188.511.61
215481-1548189.70089.97
314981-1498186.80387.06
415229-1522988.24088.50
515546-1554690.07690.35
614965-1496586.71086.97
20min115474-1547489.65989.201.8590.0689.611.85
215801-1580191.55491.97
314917-1491786.43286.84
415429-1542989.39889.81
515409-1540989.28389.70
615341-1534188.88989.29
30min115212-1521288.14189.561.0988.6990.121.09
215572-1557290.22790.80
315629-1562990.55791.11
415378-1537889.10389.66
515599-1559990.38390.95
615354-1535488.96489.51
45min114895-1489586.30489.222.4987.0089.932.47
215714-1571491.05091.77
315811-1581191.61292.31
415274-1527488.50089.21
515043-1504387.16287.88
615657-1565790.72091.42
60min115521-1552189.93290.890.8990.7791.750.89
215812-1581291.61892.49
315826-1582691.69992.55
415611-1561190.45391.31
515796-1579691.52592.39
615557-1555790.14090.99
极限116050-1605092.99793.270.4793.9994.280.47
216211-1621193.93094.96
316166-1616693.66994.67
416017-1601792.80593.81
516078-1607893.15994.18
616064-1606493.07894.08
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%
111.032183752183712186432185282185492184930.06
211.102183432181122182280.08
单位质量响应值RSD%判断
19808.9819660.180.54数据可信
长期12月-供试品溶液-2024080321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%
5min194413-9441342.97244.535.2342.9744.535.23
2105610-10561048.06848.07
394797-9479743.14743.15
4100827-10082745.89145.89
599608-9960845.33645.34
691746-9174641.75841.76
10min1143414-14341465.27466.832.1965.3566.912.19
2151685-15168569.03969.12
3144736-14473665.87665.95
4146393-14639366.63066.71
5149720-14972068.14568.22
6145062-14506266.02466.09
15min1163578-16357874.45276.071.5374.6376.251.54
2170504-17050477.60477.80
3166368-16636875.72275.90
4165958-16595875.53575.72
5169679-16967977.22977.42
6166655-16665575.85276.03
20min1172992-17299278.73780.161.3079.0480.471.30
2178912-17891281.43181.76
3176045-17604580.12680.43
4174487-17448779.41779.73
5178468-17846881.22981.55
6175789-17578980.01080.32
30min1180934-18093482.35283.431.0682.7983.881.06
2184707-18470784.06984.53
3183616-18361683.57284.01
4181041-18104182.40082.85
5185626-18562684.48784.94
6183952-18395283.72584.16
45min1182523-18252383.07584.441.2883.6585.031.28
2186103-18610384.70485.30
3185129-18512984.26184.84
4183222-18322283.39383.98
5188024-18802485.57886.17
6188185-18818585.65286.23
60min1180842-18084282.31083.871.3083.0284.601.30
2184824-18482484.12284.86
3184594-18459484.01784.74
4182102-18210282.88383.61
5186202-18620284.74985.49
6187099-18709985.15785.88
极限1195141-19514188.81888.970.7689.6789.840.76
2196075-19607589.24390.12
3194212-19421288.39589.26
4193508-19350888.07588.93
5197404-19740489.84890.73
6196570-19657089.46890.33
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%
116.051746817395174761757517290174410.61
216.131744117541174910.41
单位质量响应值RSD%判断
1086.671084.380.15数据可信
中间条件12月-供试品溶液-2024080321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%
5min112582-1258272.58070.483.1872.5870.493.17
212110-1211069.85769.86
311874-1187468.49668.50
412491-1249172.05572.06
512573-1257372.52872.53
611682-1168267.38867.39
10min114209-1420981.96585.643.1582.0985.763.15
215036-1503686.73686.85
315016-1501686.62186.73
415022-1502286.65586.78
515438-1543889.05589.18
614357-1435782.81982.93
15min115145-1514587.36587.580.8987.6287.840.89
215432-1543289.02089.28
315157-1515787.43487.69
415172-1517287.52187.79
515170-1517087.50987.78
615021-1502186.64986.90
20min115315-1531588.34588.962.5388.7589.362.52
215809-1580991.19591.60
315676-1567690.42890.83
415561-1556189.76490.17
515462-1546289.19389.61
614706-1470684.83285.23
30min115532-1553289.59788.961.4690.1589.511.46
215626-1562690.13990.70
315638-1563890.20990.76
415373-1537388.68089.24
515305-1530588.28888.85
615054-1505486.84087.38
45min115709-1570990.61889.461.6591.3290.161.64
215755-1575590.88491.60
315746-1574690.83291.54
415259-1525988.02288.73
515357-1535788.58889.30
615224-1522487.82088.50
60min115706-1570690.60189.732.9791.4590.582.94
216059-1605992.63793.50
315672-1567290.40591.26
415756-1575690.88991.74
514709-1470984.85085.71
615432-1543289.02089.85
极限116345-1634594.28794.053.5595.2995.063.51
216625-1662595.90296.92
316757-1675796.66497.67
416372-1637294.44395.45
515169-1516987.50388.50
616560-1656095.52796.50
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%
111.032184732191862187042190562193372189510.17
211.102187392186942187160.02
单位质量响应值RSD%判断
19850.5019704.140.53数据可信
中间条件12月-供试品溶液-2024080321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%
5min194086-9408642.73041.466.2442.7341.466.23
286228-8622839.16239.16
391565-9156541.58541.59
495240-9524043.25443.25
597724-9772444.38344.38
682848-8284837.62637.63
10min1140342-14034263.73863.772.8063.8163.842.80
2139559-13955963.38363.45
3143896-14389665.35265.42
4141946-14194664.46764.54
5143526-14352665.18465.26
6133208-13320860.49860.56
15min1159707-15970772.53373.572.2572.7173.752.25
2163023-16302374.03974.21
3166398-16639875.57275.75
4163239-16323974.13774.32
5163643-16364374.32174.50
6155961-15596170.83271.00
20min1170078-17007877.24378.062.3077.5478.362.30
2174902-17490279.43479.73
3176500-17650080.16080.46
4172174-17217478.19578.50
5172312-17231278.25878.56
6165271-16527175.06075.34
30min1177543-17754380.63381.891.9281.0682.321.92
2183845-18384583.49683.92
3184306-18430683.70584.14
4180600-18060082.02282.46
5180145-18014581.81582.25
6175464-17546479.68980.10
45min1181420-18142082.39483.442.2382.9684.012.23
2189566-18956686.09486.66
3187583-18758385.19385.77
4182771-18277183.00883.58
5182498-18249882.88483.46
6178519-17851981.07781.62
60min1180799-18079982.11283.222.0582.8183.932.05
2187801-18780185.29286.00
3185363-18536384.18584.90
4181694-18169482.51983.23
5185982-18598284.46685.18
6177825-17782580.76181.44
极限1193643-19364387.94588.801.3788.7889.641.37
2198767-19876790.27391.12
3198087-19808789.96490.82
4194013-19401388.11388.96
5196531-19653189.25790.11
6192087-19208787.23988.05
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%
116.051762017567174521748317448175140.44
216.131754417667176060.50
单位质量响应值RSD%判断
1091.211091.510.02数据可信
中间条件12月-供试品溶液-2024080321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%
5min112379-1237971.02772.892.1971.0372.892.19
212525-1252571.86571.86
312724-1272473.00673.01
413178-1317875.61175.61
512815-1281573.52873.53
612599-1259972.28972.29
10min114710-1471084.40185.921.3084.5286.041.30
215256-1525687.53487.65
315094-1509486.60586.73
414930-1493085.66485.79
514832-1483285.10185.22
615023-1502386.19786.32
15min115077-1507786.50787.991.7286.7788.261.72
215632-1563289.69289.96
315344-1534488.03988.31
415256-1525687.53487.80
515048-1504886.34186.61
615658-1565889.84190.10
20min115001-1500186.07188.162.2086.4788.572.20
215220-1522087.32887.74
315458-1545888.69389.11
415539-1553989.15889.57
515069-1506986.46186.87
615903-1590391.24691.66
30min115000-1500086.06588.001.7386.6188.551.73
215715-1571590.16890.73
315221-1522187.33387.89
415337-1533787.99988.56
515174-1517487.06487.62
615571-1557189.34289.91
45min115029-1502986.23288.451.8986.9289.151.89
215527-1552789.08989.80
315361-1536188.13788.84
415511-1551188.99789.71
515199-1519987.20787.90
615866-1586691.03491.75
60min115099-1509986.63388.572.2387.4789.422.22
215937-1593791.44292.30
315419-1541988.46989.32
415361-1536188.13788.99
515072-1507286.47887.32
615730-1573090.25491.12
极限115648-1564889.78391.261.6990.7692.261.68
215839-1583990.87991.89
316040-1604092.03293.03
415932-1593291.41392.42
515631-1563189.68690.67
616344-1634493.77794.79
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%
111.032198502200412200782198552196282198900.09
211.102216352214532215440.06
单位质量响应值RSD%判断
19935.6319958.920.09数据可信
中间条件12月-供试品溶液-2024080321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%
5min192211-9221141.52141.972.5541.5241.972.55
291035-9103540.99240.99
392913-9291341.83841.84
497598-9759843.94743.95
593888-9388842.27742.28
691612-9161241.25241.25
10min1137493-13749361.91163.281.8161.9863.351.81
2142723-14272364.26664.33
3139314-13931462.73162.80
4141671-14167163.79363.87
5138236-13823662.24662.32
6143711-14371164.71164.78
15min1157813-15781371.06172.762.1571.2372.942.15
2164501-16450174.07374.25
3160336-16033672.19772.37
4161191-16119172.58272.76
5158819-15881971.51471.69
6166896-16689675.15175.33
20min1166307-16630774.88677.162.4575.1877.452.44
2176199-17619979.34079.64
3169880-16988076.49576.79
4170839-17083976.92777.23
5168303-16830375.78576.08
6176551-17655179.49979.80
30min1173932-17393278.31980.442.4778.7380.862.47
2183804-18380482.76583.20
3176553-17655379.50079.92
4178343-17834380.30680.73
5175042-17504278.81979.24
6184153-18415382.92283.36
45min1176336-17633679.40281.862.9979.9582.422.99
2187832-18783284.57885.15
3179235-17923580.70781.26
4181766-18176681.84782.41
5176779-17677979.60180.15
6188826-18882685.02685.60
60min1174514-17451478.58181.313.1679.2682.013.16
2186678-18667884.05984.77
3178303-17830380.28880.98
4180375-18037581.22181.92
5175436-17543678.99779.68
6188136-18813684.71585.43
极限1186309-18630983.89386.352.1684.7087.182.16
2195918-19591888.21989.07
3192554-19255486.70587.53
4191722-19172286.33087.16
5187712-18771284.52485.34
6196375-19637588.42589.28
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