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%
115.977678076778767867686076698767800.08
216.037672876761767440.04
单位质量响应值RSD%判断
4807.764787.520.30数据可信
供试品溶液-1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%
5min158929-5892979.55682.952.3979.5682.952.39
261099-6109982.48582.49
363378-6337885.56285.56
461710-6171083.31083.31
562122-6212283.86683.87
661401-6140182.89382.89
10min166612-6661289.92892.041.4390.0692.181.43
267561-6756191.20991.35
369336-6933693.60593.75
468179-6817992.04392.18
568731-6873192.78992.93
668651-6865192.68192.82
15min166290-6629089.49393.372.5189.7893.662.50
269235-6923593.46993.76
370854-7085495.65595.95
471028-7102895.89096.18
569007-6900793.16193.46
668534-6853492.52392.82
20min168447-6844792.40593.023.4892.8493.473.47
267960-6796091.74892.19
371050-7105095.91996.38
470683-7068395.42495.88
564755-6475587.42187.87
670531-7053195.21995.67
30min168323-6832392.23894.892.2192.8295.492.21
268710-6871092.76093.36
372062-7206297.28697.90
471872-7187297.02997.64
570465-7046595.13095.73
670277-7027794.87695.48
45min168513-6851392.49494.194.3293.2394.954.29
270297-7029794.90395.66
372234-7223497.51898.30
472182-7218297.44898.22
571069-7106995.94596.70
664298-6429886.80487.57
60min169574-6957493.92795.331.6394.8296.251.63
270617-7061795.33596.25
372520-7252097.90498.85
471042-7104295.90996.84
569320-6932093.58494.50
670617-7061795.33596.24
极限171686-7168696.77896.571.7297.8397.651.71
269296-6929693.55194.62
373087-7308798.66999.78
471771-7177196.89397.99
571704-7170496.80297.87
671661-7166196.74497.81
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%
110.514407424409914407484406974404044407160.05
210.574415044418564416800.06
单位质量响应值RSD%判断
41933.0241786.190.25数据可信
供试品溶液-1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%
5min1204397-20439743.90246.373.4243.9046.373.42
2218272-21827246.88346.88
3225276-22527648.38748.39
4217809-21780946.78346.78
5219233-21923347.08947.09
6210282-21028245.16645.17
10min1303309-30330965.14867.171.8165.2267.251.81
2312855-31285567.19867.28
3320395-32039568.81868.90
4311319-31131966.86866.95
5315747-31574767.81967.90
6312682-31268267.16167.24
15min1343501-34350173.78175.991.7673.9676.181.76
2355322-35532276.32076.51
3359513-35951377.22077.42
4360523-36052377.43777.63
5352171-35217175.64375.83
6351789-35178975.56175.75
20min1369137-36913779.28780.261.0579.5980.581.05
2370466-37046679.57279.89
3376618-37661880.89481.22
4379611-37961181.53781.86
5373804-37380480.28980.61
6372485-37248580.00680.32
30min1384062-38406282.49383.871.6582.9384.321.65
2382710-38271082.20282.65
3396072-39607285.07285.53
4398900-39890085.68086.13
5391790-39179084.15384.60
6389434-38943483.64784.09
45min1390903-39090383.96285.591.2684.5486.181.26
2398194-39819485.52886.12
3402026-40202686.35186.95
4405345-40534587.06487.66
5398669-39866985.63086.22
6395851-39585185.02585.61
60min1392805-39280584.37185.490.7985.0886.220.79
2397709-39770985.42486.15
3400968-40096886.12486.87
4401321-40132186.20086.94
5398391-39839185.57086.30
6396802-39680285.22985.96
极限1414663-41466389.06689.210.7689.9290.080.76
2413610-41361088.83989.71
3418847-41884789.96490.85
4419179-41917990.03590.92
5414723-41472389.07889.96
6411027-41102788.28589.15
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%
115.973849838512386493850138313384950.32
216.033845138579385150.24
单位质量响应值RSD%判断
2410.462402.680.23数据可信
供试品溶液-1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%
5min129008-2900878.07175.565.2278.0775.565.22
226932-2693272.48472.48
329154-2915478.46478.46
425665-2566569.07469.07
529274-2927478.78778.79
628414-2841476.47276.47
10min133705-3370590.71289.101.4990.8489.221.50
232456-3245687.35187.47
332970-3297088.73488.86
432680-3268087.95488.07
533557-3355790.31490.45
633268-3326889.53689.66
15min134763-3476393.56092.331.3593.8492.611.35
233875-3387591.17091.44
333802-3380290.97391.25
434945-3494594.04994.31
534256-3425692.19592.48
634198-3419892.03992.32
20min134801-3480193.66292.921.8794.1093.351.86
234479-3447992.79593.21
333664-3366490.60291.03
435586-3558695.77596.19
534454-3445492.72893.16
634173-3417391.97292.40
30min135258-3525894.89295.162.3695.4995.742.34
235162-3516294.63395.21
334238-3423892.14792.73
436807-3680799.06199.64
535502-3550295.54996.14
635175-3517594.66895.25
45min134955-3495594.07695.732.9794.8396.472.95
236912-3691299.343100.07
334534-3453492.94393.68
436777-3677798.98099.72
535594-3559495.79696.55
634638-3463893.22393.96
60min135629-3562995.89095.492.8896.8096.392.86
236652-3665298.64499.54
333675-3367590.63191.52
436200-3620097.42798.34
535428-3542895.34996.26
635295-3529594.99195.89
极限137094-3709499.833100.621.69100.90101.681.68
238227-38227102.882103.94
336563-3656398.40499.44
437734-37734101.556102.63
537797-37797101.725102.79
636900-3690099.311100.37
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%
110.514445954446864447354432074426964439840.22
210.574466254470494468370.07
单位质量响应值RSD%判断
42243.9642274.080.06数据可信
供试品溶液-1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%
5min182655-8265517.58617.675.8117.5917.675.81
279064-7906416.82216.82
390338-9033819.22019.22
476905-7690516.36216.36
586075-8607518.31318.31
683199-8319917.70117.70
10min1126867-12686726.99226.762.0327.0226.792.04
2123645-12364526.30726.33
3129102-12910227.46827.50
4122374-12237426.03626.06
5127661-12766127.16127.19
6124976-12497626.59026.62
15min1147033-14703331.28331.180.6731.3631.260.68
2146078-14607831.07931.15
3146905-14690531.25531.33
4147100-14710031.29731.37
5147474-14747431.37631.45
6144816-14481630.81130.88
20min1156866-15686633.37533.351.5533.5033.481.53
2156734-15673433.34733.47
3155740-15574033.13533.27
4160088-16008834.06034.18
5158285-15828533.67733.80
6152907-15290732.53232.66
30min1166057-16605735.33035.942.9235.5136.122.91
2174832-17483237.19737.38
3164377-16437734.97335.16
4174758-17475837.18137.36
5169325-16932536.02536.21
6164084-16408434.91035.09
45min1170292-17029236.23137.123.9536.4737.363.93
2183787-18378739.10239.34
3168192-16819235.78436.03
4181961-18196138.71438.96
5174321-17432137.08837.33
6168365-16836535.82136.06
60min1172160-17216036.62937.313.5136.9337.613.48
2182304-18230438.78739.09
3169274-16927436.01536.32
4183402-18340239.02039.33
5174854-17485437.20237.51
6170069-17006936.18436.48
极限1189408-18940840.29840.942.4140.6641.302.40
2199189-19918942.37942.75
3189493-18949340.31640.68
4196263-19626341.75742.13
5193067-19306741.07741.44
6187111-18711139.81040.17
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%
115.973806538002380233805138028380340.07
216.033881238804388080.02
单位质量响应值RSD%判断
2381.592420.961.16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%
5min126796-2679672.28175.176.0472.2875.166.04
227284-2728473.59873.60
328904-2890477.96877.97
425684-2568469.28269.28
530466-3046682.18182.18
628057-2805775.68375.68
10min131773-3177385.70787.183.5085.8387.303.50
231412-3141284.73384.86
333290-3329089.79989.93
430912-3091283.38483.50
533787-3378791.13991.28
632734-3273488.29988.42
15min133279-3327989.76991.312.7790.0391.582.77
232660-3266088.09988.36
334581-3458193.28193.56
433208-3320889.57789.83
535067-3506794.59294.88
634303-3430392.53192.80
20min133256-3325689.70792.652.8090.1293.072.81
233314-3331489.86390.27
335141-3514194.79295.23
433916-3391691.48791.89
535170-3517094.87095.32
635277-3527795.15895.59
30min133373-3337390.02292.713.1490.5893.283.15
233073-3307389.21389.77
335075-3507594.61495.21
433949-3394991.57692.13
535852-3585296.70997.31
634890-3489094.11594.70
45min133973-3397391.64193.393.2192.3594.123.19
233127-3312789.35990.07
334001-3400191.71692.47
434952-3495294.28294.99
535926-3592696.90997.67
635756-3575696.45197.19
60min134084-3408491.94091.764.8492.8192.654.82
230819-3081983.13383.99
334316-3431692.56693.47
434403-3440392.80193.67
535429-3542995.56896.50
635051-3505194.54995.45
极限135914-3591496.87797.932.0597.9098.972.06
235334-3533495.31296.31
337054-3705499.952101.01
435725-3572596.36797.39
537095-37095100.062101.15
636694-3669498.981100.04
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%
110.514413254412294414184415974412654413670.04
210.574529844529884529860.01
单位质量响应值RSD%判断
41994.9642855.821.44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%
5min185689-8568918.16218.583.0018.1618.582.99
287959-8795918.64318.64
388368-8836818.72918.73
484674-8467417.94617.95
592215-9221519.54519.54
687090-8709018.45818.46
10min1129641-12964127.47727.881.8527.5127.911.85
2130509-13050927.66127.69
3129154-12915427.37427.40
4131296-13129627.82827.86
5135594-13559428.73928.77
6133120-13312028.21428.25
15min1149218-14921831.62632.422.4331.7032.492.42
2153853-15385332.60932.69
3147941-14794131.35631.43
4153994-15399432.63932.71
5157887-15788733.46433.54
6154763-15476332.80232.88
20min1158414-15841433.57534.782.8033.7034.912.80
2164716-16471634.91135.04
3158401-15840133.57333.70
4166958-16695835.38635.52
5168932-16893235.80535.94
6167043-16704335.40435.54
30min1168276-16827635.66636.932.9135.8537.122.91
2173138-17313836.69636.89
3168338-16833835.67935.86
4179307-17930738.00438.19
5177631-17763137.64837.84
6178673-17867337.86938.06
45min1172371-17237136.53337.822.7836.7838.072.77
2177527-17752737.62637.88
3173382-17338236.74836.99
4184659-18465939.13839.39
5179975-17997538.14538.40
6182693-18269338.72138.98
60min1172847-17284736.63437.852.5636.9438.162.55
2177611-17761137.64437.96
3173688-17368836.81337.12
4182621-18262138.70639.02
5181528-18152838.47438.80
6183153-18315338.81939.14
极限1192258-19225840.74841.531.8141.1141.911.82
2195936-19593641.52841.90
3191910-19191040.67541.04
4199462-19946242.27542.66
5200479-20047942.49142.88
6195762-19576241.49141.87
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