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%
115.951854818556185051853618480185250.18
215.861847018523184960.21
单位质量响应值RSD%判断
1161.441166.200.29数据可信
供试品溶液-2024080121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%
5min113763-1376374.66575.952.2074.6775.962.20
213574-1357473.64073.64
314472-1447278.51278.51
414047-1404776.20676.21
514071-1407176.33676.34
614077-1407776.36976.37
10min115674-1567485.03384.291.4785.1684.411.47
215534-1553484.27384.40
315759-1575985.49485.62
415105-1510581.94682.07
515540-1554084.30684.43
615608-1560884.67584.80
15min115824-1582485.84685.841.4886.1186.111.48
215712-1571285.23985.50
316026-1602686.94287.22
416141-1614187.56687.83
515487-1548784.01884.29
615745-1574585.41885.69
20min116076-1607687.21387.111.0787.6287.521.07
215951-1595186.53586.94
316190-1619087.83288.25
416296-1629688.40788.82
516015-1601586.88387.29
615818-1581885.81486.22
30min116080-1608087.23586.762.3687.7987.312.35
216000-1600086.80187.35
316061-1606187.13287.70
416569-1656989.88890.44
515836-1583685.91186.46
615407-1540783.58484.14
45min116028-1602886.95386.840.9487.6587.540.93
216078-1607887.22487.92
315898-1589886.24886.96
416264-1626488.23388.94
515894-1589486.22686.92
615883-1588386.16686.86
60min116207-1620787.92487.091.9288.7787.931.91
215918-1591886.35687.20
316136-1613687.53988.39
416490-1649089.45990.31
515994-1599486.76987.61
615572-1557284.47985.32
极限116971-1697192.06991.302.2693.0692.302.24
216746-1674690.84891.83
316952-1695291.96692.97
417366-1736694.21295.21
516730-1673090.76191.75
616215-1621587.96888.95
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%
110.972247142251772252122249952249162250030.10
211.122235042238052236540.10
单位质量响应值RSD%判断
20510.7620112.771.39数据可信
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%
5min1113137-11313750.03549.342.7650.0349.342.76
2106587-10658747.13847.14
3114680-11468050.71750.72
4114292-11429250.54650.55
5110524-11052448.87948.88
6110196-11019648.73448.73
10min1158798-15879870.22869.861.5670.3169.941.56
2155054-15505468.57368.65
3159763-15976370.65570.74
4161489-16148971.41871.50
5156289-15628969.11969.20
6156331-15633169.13769.22
15min1176163-17616377.90877.811.3278.1178.011.32
2173933-17393376.92277.11
3177033-17703378.29378.49
4179900-17990079.56179.76
5174883-17488377.34277.54
6173801-17380176.86377.06
20min1183494-18349481.15081.261.2381.4881.591.24
2182564-18256480.73981.06
3184565-18456581.62481.96
4187879-18787983.08983.43
5182113-18211380.53980.86
6181859-18185980.42780.75
30min1187791-18779183.05083.321.3783.5283.781.37
2187930-18793083.11283.57
3188979-18897983.57684.04
4193192-19319285.43985.91
5186374-18637482.42482.88
6186116-18611682.31082.77
45min1188923-18892383.55183.771.3584.1684.381.35
2189403-18940383.76384.36
3190145-19014584.09184.70
4193954-19395485.77686.39
5186915-18691582.66383.26
6187218-18721882.79783.39
60min1186724-18672482.57982.781.2083.3283.521.20
2187356-18735682.85883.59
3187633-18763382.98183.73
4191168-19116884.54485.30
5185208-18520881.90882.64
6184948-18494881.79382.53
极限1202548-20254889.57789.061.3190.4689.941.31
2199348-19934888.16289.03
3201958-20195889.31690.20
4205824-20582491.02691.93
5199510-19951088.23389.10
6199091-19909188.04888.92
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%
115.951852218552185441852018452185180.22
215.861838718449184180.24
单位质量响应值RSD%判断
1161.001161.290.02数据可信
供试品溶液-2024080321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%
5min114459-1445978.62278.391.4778.6278.391.47
214241-1424177.43677.44
314136-1413676.86576.87
414678-1467879.81379.81
514620-1462079.49779.50
614364-1436478.10578.11
10min115879-1587986.34385.841.2086.4785.971.20
215892-1589286.41486.54
315880-1588086.34886.48
415405-1540583.76683.90
515839-1583986.12686.26
615823-1582386.03986.17
15min116094-1609487.51287.230.7587.7987.500.75
216000-1600087.00187.27
316140-1614087.76288.03
416109-1610987.59487.87
516093-1609387.50787.78
615816-1581686.00086.27
20min116084-1608487.45887.081.8287.8887.501.82
216384-1638489.08989.51
316079-1607987.43187.85
416022-1602287.12187.54
515487-1548784.21284.63
616030-1603087.16487.58
30min115596-1559684.80486.132.1885.3786.702.17
216126-1612687.68688.25
316130-1613087.70888.27
415520-1552084.39184.95
516200-1620088.08988.65
615470-1547084.11984.68
45min116173-1617387.94287.601.4488.6588.311.43
216006-1600687.03487.75
316191-1619188.04088.75
416348-1634888.89389.60
516244-1624488.32889.04
615696-1569685.34886.05
60min115359-1535983.51685.561.9784.3786.411.95
215548-1554884.54385.40
316135-1613587.73588.59
415655-1565585.12585.98
516084-1608487.45888.31
615627-1562784.97385.82
极限116817-1681791.44390.412.3492.4491.412.32
216088-1608887.48088.48
317158-1715893.29894.30
416774-1677491.21092.20
516656-1665690.56891.57
616273-1627388.48589.47
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%
110.972251052249702247842251812249472249970.07
211.122234172234702234440.02
单位质量响应值RSD%判断
20510.2120093.881.46数据可信
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%
5min1114558-11455850.68849.312.2850.6949.312.28
2113736-11373650.32450.32
3109219-10921948.32648.33
4111502-11150249.33649.34
5107941-10794147.76047.76
6111739-11173949.44149.44
10min1160236-16023670.89970.191.0370.9870.271.03
2160554-16055471.04071.12
3157841-15784169.83969.92
4159161-15916170.42370.51
5156464-15646469.23069.31
6157488-15748869.68369.77
15min1177535-17753578.55378.280.9578.7678.480.95
2179177-17917779.28079.48
3176622-17662278.14978.35
4178100-17810078.80379.00
5174886-17488677.38177.58
6175221-17522177.52977.73
20min1184614-18461481.68582.011.0682.0282.341.06
2186548-18654882.54182.88
3184433-18443381.60581.93
4188781-18878183.52983.86
5183989-18398981.40981.73
6183734-18373481.29681.62
30min1188864-18886483.56683.900.7684.0484.370.75
2190842-19084284.44184.91
3189930-18993084.03784.50
4191606-19160684.77985.25
5188604-18860483.45183.91
6187885-18788583.13383.60
45min1190141-19014184.13184.160.8384.7484.770.83
2190980-19098084.50285.11
3191215-19121584.60685.21
4192193-19219385.03985.65
5188698-18869883.49284.09
6188072-18807283.21583.82
60min1187158-18715882.81182.921.0283.5683.671.02
2188713-18871383.49984.25
3189149-18914983.69284.44
4188979-18897983.61784.37
5186115-18611582.34983.09
6184370-18437081.57782.32
极限1200307-20030788.62989.021.1689.5289.911.16
2202531-20253189.61390.51
3204586-20458690.52291.41
4202123-20212389.43290.32
5199438-19943888.24489.12
6198175-19817587.68588.56
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%
115.951844018456184171842418397184270.13
215.861856718546185560.09
单位质量响应值RSD%判断
1155.301169.990.90数据可信
供试品溶液-2024080321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%
5min113750-1375074.67378.093.5574.6778.093.55
214401-1440178.20978.21
314480-1448078.63878.64
414942-1494281.14781.15
513815-1381575.02675.03
614885-1488580.83780.84
10min115728-1572885.41587.601.7485.5487.731.74
215950-1595086.62186.75
316428-1642889.21789.35
416344-1634488.76188.90
515989-1598986.83386.96
616339-1633988.73388.87
15min115813-1581385.87788.401.9986.1488.681.99
216031-1603187.06187.34
316274-1627488.38088.66
416736-1673690.88991.17
516378-1637888.94589.21
616436-1643689.26089.54
20min116009-1600986.94188.751.7087.3589.181.71
216028-1602887.04487.46
316659-1665990.47190.90
416600-1660090.15190.59
516327-1632788.66889.09
616433-1643389.24489.68
30min116268-1626888.34888.281.9788.9088.851.96
215744-1574485.50286.07
316666-1666690.50991.09
416490-1649089.55390.14
516257-1625788.28888.85
616106-1610687.46888.05
45min116299-1629988.51689.581.7889.2290.301.78
216155-1615587.73488.44
316860-1686091.56392.29
416788-1678891.17291.91
516280-1628088.41389.13
616583-1658390.05990.78
60min116261-1626188.31088.551.4189.1689.421.41
216014-1601486.96887.82
316646-1664690.40191.28
416460-1646089.39190.28
516123-1612387.56088.42
616332-1633288.69589.57
极限116672-1667290.54290.951.3491.5491.971.34
216586-1658690.07591.07
317106-1710692.89993.93
416912-1691291.84592.88
516714-1671490.77091.78
616497-1649789.59190.62
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%
110.972235312234932237312238632240402237320.11
211.122294162295682294920.05
单位质量响应值RSD%判断
20394.9020637.770.84数据可信
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%
5min1103528-10352845.32647.564.6145.3347.564.61
2113475-11347549.68149.68
3107949-10794947.26147.26
4114597-11459750.17250.17
5102435-10243544.84744.85
6109740-10974048.04648.05
10min1154918-15491867.82569.882.0267.9069.962.02
2158442-15844269.36869.45
3161616-16161670.75870.84
4163960-16396071.78471.87
5157770-15777069.07469.15
6160990-16099070.48370.56
15min1174861-17486176.55678.471.9476.7478.661.94
2175316-17531676.75676.95
3181285-18128579.36979.57
4183347-18334780.27280.47
5179183-17918378.44978.64
6181368-18136879.40579.60
20min1184205-18420580.64782.131.9280.9682.461.92
2182329-18232979.82680.15
3190180-19018083.26383.59
4191281-19128183.74584.08
5187807-18780782.22482.54
6189786-18978683.09183.42
30min1189701-18970183.05484.542.0583.5085.002.05
2187156-18715681.93982.40
3195866-19586685.75386.22
4197042-19704286.26886.74
5192905-19290584.45684.91
6195949-19594985.78986.26
45min1190448-19044883.38184.822.0683.9785.422.06
2187415-18741582.05382.65
3196513-19651386.03686.65
4196759-19675986.14486.76
5194148-19414885.00085.60
6197143-19714386.31286.92
60min1187991-18799182.30583.471.9483.0384.221.94
2184615-18461580.82781.56
3193541-19354184.73585.49
4193745-19374584.82485.59
5190821-19082183.54484.28
6193237-19323784.60285.36
极限1199269-19926987.24389.012.0688.1189.892.06
2198205-19820586.77787.64
3209622-20962291.77592.67
4204749-20474989.64290.55
5202909-20290988.83689.72
6205053-20505389.77590.67
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