奥美沙坦酯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070220417对照品来源原料药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1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.167736477352775837730077247773690.17
216.137693077026769780.09
单位质量响应值RSD%判断
4787.694772.350.23数据可信
供试品溶液-1批-氨氯地平-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147167-4716763.91173.1810.7363.9173.1810.73
256554-5655476.63176.63
360673-6067382.21282.21
459342-5934280.40980.41
552550-5255071.20571.21
647737-4773764.68464.68
10min161272-6127283.02485.114.5683.1385.244.56
264186-6418686.97287.10
366289-6628989.82289.96
465406-6540688.62588.76
559391-5939180.47580.59
660345-6034581.76881.88
15min164339-6433987.18087.993.5587.4288.263.56
266109-6610989.57889.85
367274-6727491.15691.44
467057-6705790.86291.14
561371-6137183.15883.41
663493-6349386.03386.28
20min165401-6540188.61989.583.5289.0189.993.52
267180-6718091.02991.45
368897-6889793.35693.79
467473-6747391.42691.86
562192-6219284.27084.66
665515-6551588.77389.16
30min166723-6672390.41090.632.7190.9591.192.72
268091-6809192.26392.84
368208-6820892.42293.02
468027-6802792.17792.76
563438-6343885.95986.49
666823-6682390.54591.08
45min167335-6733591.23991.352.6591.9392.062.65
268436-6843692.73193.46
368625-6862592.98793.74
468753-6875393.16193.90
564017-6401786.74387.42
667338-6733891.24391.93
60min167813-6781391.88791.872.3192.7392.732.32
268817-6881793.24794.13
369009-6900993.50794.41
468681-6868193.06393.96
564820-6482087.83188.65
667645-6764591.65992.50
极限175091-75091101.749100.891.11102.74101.911.10
274554-74554101.021102.06
374771-74771101.315102.37
474129-74129100.445101.49
575226-75226101.931102.90
672981-7298198.88999.88
奥美沙坦酯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OM230503W对照品来源原料药对照品使用方法直接使用
对照品含量(%)10099.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.09 4700404697334691114685084694894693760.13
211.174679954679724679840.01
单位质量响应值RSD%判断
42324.2641896.510.72数据可信
供试品溶液-1批-奥美沙坦酯-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1137623-1376232970.7953199.519.402970.793199.519.40
2155931-1559313366.0003366.00
3158020-1580203411.0943411.09
4158191-1581913414.7853414.79
5154916-1549163344.0893344.09
6124629-1246292690.3002690.30
10min1242380-2423805232.1285364.904.275237.085370.234.28
2256727-2567275541.8295547.44
3257916-2579165567.4965573.18
4256135-2561355529.0505534.74
5247087-2470875333.7365339.31
6230939-2309394985.1574989.64
15min1292132-2921326306.0986398.832.656319.776413.102.65
2303896-3038966560.0416574.89
3304578-3045786574.7636589.73
4301052-3010526498.6506513.56
5291433-2914336291.0096305.47
6285475-2854756162.3976175.19
20min1319310-3193106892.7756984.422.056916.967009.362.06
2329262-3292627107.6047133.38
3333072-3330727189.8487215.77
4324924-3249247013.9627039.70
5317021-3170216843.3646868.31
6317744-3177446858.9716882.03
30min1349647-3496477547.6447551.591.137583.317588.171.13
2354349-3543497649.1447686.77
3353231-3532317625.0107662.92
4349139-3491397536.6787574.11
5343187-3431877408.1957444.55
6349426-3494267542.8737577.37
45min1366276-3662767906.6057896.931.087954.857946.091.07
2369778-3697787982.2018032.58
3367949-3679497942.7207993.33
4365475-3654757889.3157939.30
5358427-3584277737.1737785.87
6367061-3670617923.5517970.62
60min1371687-3716878023.4108056.721.178084.848119.051.17
2378734-3787348175.5308239.21
3376910-3769108136.1568200.01
4370959-3709598007.6958070.83
5366784-3667847917.5717979.17
6374307-3743078079.9668140.24
极限1429384-4293849268.8849221.391.109343.689297.141.10
2427438-4274389226.8779304.18
3428869-4288699257.7679335.18
4423349-4233499138.6109215.09
5433654-4336549361.0589435.85
6420409-4204099075.1469148.88
奥美沙坦酯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070220417对照品来源原料药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1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.163878738828391433892538945389260.36
216.133855038556385530.02
单位质量响应值RSD%判断
2408.792390.140.55数据可信
供试品溶液-2批-氨氯地平-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130079-3007981.19483.777.3981.1983.777.39
231527-3152785.10385.10
328575-2857577.13477.13
430888-3088883.37883.38
535247-3524795.14495.14
629887-2988780.67680.68
10min137085-37085100.10695.684.55100.2495.824.55
236093-3609397.42897.57
333192-3319289.59789.73
434959-3495994.36794.51
537165-37165100.322100.48
634184-3418492.27592.41
15min137755-37755101.91498.263.28102.2298.563.29
236785-3678599.29699.60
334475-3447593.06093.34
435790-3579096.61096.91
537407-37407100.975101.30
636199-3619997.71498.00
20min138187-38187103.08099.023.65103.5599.493.65
237046-37046100.000100.47
334517-3451793.17493.61
435858-3585896.79497.25
537766-37766101.944102.44
636730-3673099.14799.60
30min138503-38503103.93399.583.45104.58100.213.45
237039-3703999.982100.62
334935-3493594.30294.89
435999-3599997.17497.79
537767-37767101.947102.61
637108-37108100.168100.78
45min138549-38549104.05899.513.39104.87100.303.39
237113-37113100.181100.98
334918-3491894.25695.00
436037-3603797.27798.06
537478-37478101.167102.00
637082-37082100.098100.88
60min138702-38702104.47199.893.33105.46100.853.33
237001-3700199.879100.85
335089-3508994.71895.62
436391-3639198.23299.18
537809-37809102.060103.06
637033-3703399.965100.92
极限138484-38484103.882101.611.93105.05102.741.93
236813-3681399.372100.51
337420-37420101.010102.07
437749-37749101.898103.00
538454-38454103.801104.97
636937-3693799.706100.82
奥美沙坦酯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OM230503W对照品来源原料药对照品使用方法直接使用
对照品含量(%)10099.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.09 2362472367802363762363292362842364030.10
211.172351352344122347740.22
单位质量响应值RSD%判断
21316.7721018.261.00数据可信
供试品溶液-2批-奥美沙坦酯-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min184671-846713636.1854026.598.903636.184026.598.90
297187-971874173.6834173.68
386936-869363733.4553733.45
495132-951324085.4314085.43
5107786-1077864628.8554628.86
690859-908593901.9283901.93
10min1145918-1459186266.4296243.184.526272.496249.904.53
2149413-1494136416.5216423.48
3135824-1358245832.9435839.17
4143883-1438836179.0366185.85
5155118-1551186661.5226669.24
6142104-1421046102.6376109.14
15min1173348-1733487444.4077245.323.857460.917262.443.85
2172552-1725527410.2227427.87
3158681-1586816814.5346830.48
4165008-1650087086.2467103.35
5176156-1761567564.9967583.81
6166528-1665287151.5237168.20
20min1188409-1884098091.1997793.333.888120.117822.523.88
2185608-1856087970.9118000.91
3170570-1705707325.1067352.41
4176010-1760107558.7267587.64
5187238-1872388040.9118072.34
6181003-1810037773.1507801.74
30min1202540-2025408698.0538310.874.258740.458353.054.24
2198139-1981398509.0538552.34
3180826-1808267765.5487805.06
4186297-1862978000.5008042.02
5197516-1975168482.2988527.13
6195827-1958278409.7648451.31
45min1214558-2145589214.1648650.035.089271.068706.075.07
2207365-2073658905.2628962.73
3186852-1868528024.3348076.79
4191897-1918978240.9918295.84
5203881-2038818755.6428814.61
6203978-2039788759.8088815.37
60min1220104-2201049452.3378823.975.399524.598894.425.37
2210996-2109969061.1959133.50
3190230-1902308169.4028235.23
4194648-1946488359.1328427.72
5207950-2079508930.3859003.94
6208905-2089058971.3979041.56
极限1226645-2266459733.2399400.472.219821.249485.622.22
2216970-2169709317.7479405.16
3214341-2143419204.8459284.29
4216819-2168199311.2639393.78
5223029-2230299577.9509666.39
6215573-2155739257.7549342.87
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