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%
116.167893879090790647926379351791410.21
216.237985879654797560.19
单位质量响应值RSD%判断
4897.344914.110.25数据可信
供试品溶液-3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%
5min158788-5878877.61773.943.7877.6273.943.78
257245-5724575.58075.58
353025-5302570.00870.01
456883-5688375.10275.10
555917-5591773.82673.83
654149-5414971.49271.49
10min172258-7225895.40193.531.7995.5393.651.79
271414-7141494.28794.41
370321-7032192.84492.96
470632-7063293.25493.38
568703-6870390.70790.83
671710-7171094.67794.80
15min174624-7462498.52596.541.5398.8196.811.53
272568-7256895.81096.09
373046-7304696.44196.71
472563-7256395.80496.08
571674-7167494.63094.90
674232-7423298.00798.28
20min175094-7509499.14597.351.3599.6097.791.35
273088-7308896.49796.94
373814-7381497.45597.89
473144-7314496.57197.01
572576-7257695.82196.25
674696-7469698.62099.06
30min175442-7544299.60597.941.62100.2298.551.61
273527-7352797.07697.68
374646-7464698.55499.15
472946-7294696.30996.91
572977-7297796.35096.94
675570-7557099.774100.38
45min175359-7535999.49597.521.67100.2898.281.67
273520-7352097.06797.83
374914-7491498.90899.67
472759-7275996.06296.82
572239-7223995.37696.13
674381-7438198.20498.97
60min175633-7563399.85795.028.81100.8195.958.73
273026-7302696.41597.34
374773-7477398.72199.65
459274-5927478.25879.18
573186-7318696.62697.54
675916-75916100.231101.17
极限176173-76173100.57099.371.52101.69100.461.52
275034-7503499.066100.15
375379-7537999.522100.61
473804-7380497.44298.49
574323-7432398.12799.20
676870-76870101.490102.59
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(%)99.9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%
111.324490594489984496134493394501434494300.11
211.294542274528474535370.22
单位质量响应值RSD%判断
39702.3040171.570.84数据可信
供试品溶液-3批-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%
5min1203455-20345545.80541.087.6945.8141.087.69
2190579-19057942.90742.91
3169575-16957538.17838.18
4188865-18886542.52142.52
5173531-17353139.06839.07
6168691-16869137.97937.98
10min1300503-30050367.65563.973.4067.7364.043.40
2287141-28714164.64664.72
3280337-28033763.11463.18
4284495-28449564.05164.12
5271378-27137861.09761.16
6280931-28093163.24863.31
15min1342598-34259877.13273.652.8077.3273.822.81
2325498-32549873.28273.46
3328869-32886974.04174.21
4325618-32561873.30973.49
5314061-31406170.70770.87
6326050-32605073.40673.57
20min1364976-36497682.17079.192.2882.4979.492.28
2349794-34979478.75279.05
3355788-35578880.10180.39
4348859-34885978.54178.84
5341157-34115776.80777.09
6349863-34986378.76779.06
30min1384121-38412186.48083.742.1686.9384.172.16
2370285-37028583.36583.80
3377265-37726584.93785.36
4365926-36592682.38482.81
5361617-36161781.41481.83
6372541-37254183.87384.30
45min1391646-39164688.17485.492.3188.7786.062.31
2378331-37833185.17785.75
3386953-38695387.11887.69
4375060-37506084.44085.01
5366865-36686582.59583.14
6379469-37946985.43385.99
60min1390666-39066687.95485.352.4388.7086.062.43
2376631-37663184.79485.51
3386845-38684587.09387.81
4368870-36887083.04783.76
5368793-36879383.02983.72
6382768-38276886.17686.88
极限1398545-39854589.72888.281.5090.6289.131.51
2393391-39339188.56789.42
3392073-39207388.27089.13
4386869-38686987.09987.95
5383830-38383086.41587.24
6397894-39789489.58190.43
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%
116.163970939963398914000939918398980.29
216.233998039759398700.40
单位质量响应值RSD%判断
2468.942456.560.36数据可信
供试品溶液-24112201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%
5min127170-2717071.45672.332.5471.4672.332.54
227699-2769972.84872.85
328260-2826074.32374.32
428220-2822074.21874.22
527206-2720671.55171.55
626452-2645269.56869.57
10min135285-3528592.79993.101.0192.9293.221.01
235844-3584494.26994.39
335632-3563293.71193.84
435535-3553593.45693.58
534823-3482391.58491.70
635279-3527992.78392.90
15min136925-3692597.11296.201.0297.3996.481.02
236844-3684496.89997.18
336725-3672596.58696.87
436645-3664596.37596.65
536422-3642295.78996.06
635908-3590894.43794.71
20min137011-3701197.33896.750.6597.7797.180.65
236939-3693997.14997.59
336769-3676996.70197.14
436995-3699597.29697.74
536457-3645795.88196.31
636549-3654996.12396.55
30min137040-3704097.41497.171.3898.0197.761.38
237468-3746898.54099.14
337142-3714297.68298.28
437304-3730498.10898.71
536649-3664996.38696.98
636077-3607794.88295.47
45min135733-3573393.97796.111.3294.7496.871.32
236814-3681496.82097.59
336684-3668496.47897.24
437164-3716497.74098.51
536399-3639995.72896.48
636466-3646695.90596.65
60min137053-3705397.44896.910.8098.3797.840.80
237217-3721797.88098.81
337048-3704897.43598.36
436692-3669296.49997.43
536591-3659196.23397.14
636500-3650095.99496.90
极限138465-38465101.16299.771.06102.24100.861.05
237658-3765899.039100.13
338019-3801999.989101.08
438336-38336100.823101.91
537656-3765699.034100.11
637488-3748898.59299.66
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(%)99.9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%
111.322263502273802266662274352273142270290.22
211.292279552264042271800.49
单位质量响应值RSD%判断
20055.5720122.230.24数据可信
供试品溶液-24112201批-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%
5min1212083-21208394.92091.544.8794.9291.544.87
2203776-20377691.20291.20
3216003-21600396.67596.67
4209715-20971593.86093.86
5194269-19426986.94786.95
6191327-19132785.63185.63
10min1304380-304380136.229133.391.93136.39133.541.93
2297253-297253133.039133.19
3302554-302554135.412135.57
4300862-300862134.654134.81
5293886-293886131.532131.68
6289245-289245129.455129.60
15min1342706-342706153.382150.051.67153.77150.421.67
2331304-331304148.279148.65
3338595-338595151.542151.93
4338761-338761151.617152.00
5332027-332027148.603148.97
6328164-328164146.874147.23
20min1356215-356215159.428157.371.27160.07157.991.27
2351572-351572157.350157.97
3353247-353247158.100158.74
4355818-355818159.251159.88
5347517-347517155.535156.15
6345299-345299154.543155.15
30min1366027-366027163.820162.321.45164.73163.211.45
2363763-363763162.806163.69
3365819-365819163.727164.63
4367638-367638164.541165.44
5358801-358801160.586161.46
6354023-354023158.447159.31
45min1368666-368666165.001164.041.17166.18165.201.18
2365226-365226163.461164.62
3369314-369314165.291166.47
4371897-371897166.447167.62
5363984-363984162.905164.04
6360046-360046161.143162.27
60min1370088-370088165.637162.821.23167.09164.251.23
2361733-361733161.898163.32
3365657-365657163.654165.11
4366821-366821164.175165.63
5358817-358817160.593162.00
6359619-359619160.952162.35
极限1387245-387245173.316171.491.23175.05173.191.23
2378366-378366169.342171.04
3387782-387782173.556175.28
4386810-386810173.121174.85
5381157-381157170.591172.27
6377570-377570168.986170.65
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