左氨氯地平贝那普利片项目信息
介质体积(ml)500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2000
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%
113.614228494224844220904208064211254218710.21
213.634210924202234206580.15
单位质量响应值RSD%判断
30997.1330862.660.31数据可信
供试品溶液-2024072121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%
5min1188940-18894042.85440.4415.6842.8540.4415.67
2215753-21575348.93648.94
3177146-17714640.17940.18
4170475-17047538.66638.67
5186561-18656142.31542.31
6130800-13080029.66729.67
10min1318457-31845772.23168.835.1772.3668.955.19
2311428-31142870.63770.78
3303421-30342168.82068.94
4306770-30677069.58069.70
5307355-30735569.71369.84
6273219-27321961.97062.06
15min1328605-32860574.53373.722.3674.8874.052.38
2326663-32666374.09274.45
3325931-32593173.92674.25
4326603-32660374.07874.40
5332267-33226775.36375.70
6310162-31016270.34970.62
20min1342732-34273277.73774.962.8178.3175.512.81
2332217-33221775.35275.93
3317710-31771072.06172.61
4335189-33518976.02676.57
5333612-33361275.66876.23
6321501-32150172.92173.41
30min1344964-34496478.24375.972.2179.0576.742.23
2336500-33650076.32377.13
3332292-33229275.36976.13
4337806-33780676.61977.39
5335555-33555576.10976.90
6322549-32254973.15973.86
45min1350315-35031579.45776.932.3880.4977.922.38
2333615-33361575.66976.70
3337205-33720576.48377.47
4344362-34436278.10679.11
5341711-34171177.50578.52
6327727-32772774.33375.26
60min1354357-35435780.37378.512.2681.6579.752.28
2353444-35344480.16681.43
3341738-34173877.51178.73
4345168-34516878.28979.53
5348673-34867379.08480.33
6333595-33359575.66476.81
极限1366124-36612483.04280.722.0584.5682.192.07
2355223-35522380.57082.07
3351218-35121879.66181.11
4359102-35910281.45082.92
5358810-35881081.38382.87
6344939-34493978.23779.61
左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.068439698444228482098419968425748442340.29
210.078418978411988415480.06
单位质量响应值RSD%判断
83919.8883569.810.30数据可信
供试品溶液-2024072121批-贝那普利-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%
5min1124681-12468114.76936.2083.7914.7736.2083.78
2648266-64826676.79176.79
3535456-53545663.42863.43
4-0.0000.00
5145021-14502117.17917.18
6379971-37997145.01045.01
10min1803692-80369295.20297.171.9795.2597.282.05
2836971-83697199.14499.37
3826971-82697197.95998.15
4799732-79973294.73394.73
5817546-81754696.84396.89
6836770-83677099.12099.26
15min1815741-81574196.62998.091.4596.9698.481.52
2836761-83676199.11999.65
3829563-82956398.26698.75
4811864-81186496.17096.45
5831715-83171598.52198.86
6842581-84258199.808100.24
20min1813347-81334796.34597.731.4096.9798.431.47
2832975-83297598.67199.50
3825757-82575797.81698.59
4809459-80945995.88596.46
5829558-82955898.26698.90
6839189-83918999.407100.14
30min1807493-80749395.65297.271.4496.5698.261.50
2831755-83175598.52699.65
3821090-82109097.26398.34
4807093-80709395.60596.47
5825116-82511697.74098.67
6834546-83454698.85799.89
45min1806561-80656195.54296.981.3596.7498.261.42
2826767-82676797.93599.35
3819339-81933997.05598.42
4804724-80472495.32496.47
5822386-82238697.41698.64
6832335-83233598.59599.92
60min1804633-80463395.31396.691.3696.8098.261.42
2824224-82422497.63499.34
3816728-81672896.74698.40
4801611-80161194.95596.39
5820835-82083597.23298.75
6829615-82961598.27399.89
极限1803304-80330495.15696.421.4696.9298.271.52
2821467-82146797.30799.31
3812109-81210996.19998.14
4798586-79858694.59796.31
5817632-81763296.85398.66
6830582-83058298.387100.30
左氨氯地平贝那普利片项目信息
介质体积(ml)500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2000
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%
113.614224374220884214614206754203694214060.22
213.634233464230244231850.06
单位质量响应值RSD%判断
30962.9731048.060.20数据可信
供试品溶液-2024072121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%
5min1175663-17566339.74641.3913.3139.7541.4013.31
2165733-16573337.49937.50
3188319-18831942.60942.61
4155757-15575735.24235.24
5225739-22573951.07651.08
6186463-18646342.18942.19
10min1300347-30034767.95768.321.6168.0868.441.59
2299582-29958267.78467.90
3305539-30553969.13269.26
4305594-30559469.14469.25
5294053-29405366.53366.69
6306491-30649169.34769.47
15min1323840-32384073.27273.191.9373.6073.521.92
2316690-31669071.65571.97
3329073-32907374.45674.79
4325210-32521073.58273.90
5315500-31550071.38571.74
6330550-33055074.79175.13
20min1329479-32947974.54874.821.9875.0975.371.97
2324405-32440573.40073.93
3339229-33922976.75477.31
4330247-33024774.72275.26
5323336-32333673.15873.73
6337419-33741976.34576.90
30min1330481-33048174.77575.191.4775.5475.961.47
2331448-33144874.99475.74
3340058-34005876.94277.73
4327886-32788674.18874.95
5327853-32785374.18074.97
6336216-33621676.07376.86
45min1337990-33799076.47476.601.1377.4677.601.13
2334822-33482275.75776.73
3341727-34172777.32078.34
4339090-33909076.72377.70
5333967-33396775.56476.57
6343786-34378677.78578.80
60min1320310-32031072.47476.582.9673.6977.812.93
2340342-34034277.00678.21
3348448-34844878.84080.09
4340511-34051177.04478.26
5335373-33537375.88277.12
6345873-34587378.25879.51
极限1349256-34925679.02379.501.0780.4680.961.07
2349425-34942579.06180.50
3356177-35617780.58982.08
4350832-35083279.38080.82
5346911-34691178.49279.96
6355690-35569080.47981.96
左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.068458128451918437088424138420488438340.20
210.078462808466398464600.03
单位质量响应值RSD%判断
83880.1284057.600.15数据可信
供试品溶液-2024072121批-贝那普利-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%
5min1-0.00022.67114.340.0022.67114.34
2321681-32168138.00338.00
386918-8691810.26810.27
4155002-15500218.31218.31
516511-165111.9511.95
6571194-57119467.48067.48
10min1793824-79382493.78296.242.4593.7896.312.50
2809565-80956595.64195.76
3820486-82048696.93296.96
4794422-79442293.85293.91
5823304-82330497.26497.27
6846341-84634199.986100.19
15min1814337-81433796.20597.742.0996.4998.102.12
2818039-81803996.64297.04
3836510-83651098.82599.15
4805014-80501495.10495.44
5841736-84173699.44299.74
6848424-848424100.232100.73
20min1810515-81051595.75497.322.1696.3297.972.19
2814274-81427496.19896.89
3832431-83243198.34398.96
4800722-80072294.59795.22
5839642-83964299.19599.79
6845060-84506099.835100.64
30min1803456-80345694.92096.781.9595.7897.721.97
2811043-81104395.81696.80
3828808-82880897.91598.83
4800929-80092994.62195.53
5835549-83554998.71199.60
6835460-83546098.70199.80
45min1805414-80541495.15196.841.9796.2998.082.00
2810907-81090795.80097.07
3826951-82695197.69598.90
4801122-80112294.64495.83
5834005-83400598.52999.72
6840020-84002099.239100.64
60min1801913-80191394.73796.331.9596.1697.861.99
2807594-80759495.40896.96
3822997-82299797.22898.73
4795864-79586494.02395.50
5828681-82868197.90099.38
6835498-83549898.705100.40
极限1798404-79840494.32395.981.9896.0397.792.01
2804644-80464495.06096.90
3817284-81728496.55398.34
4793828-79382893.78295.54
5826221-82622197.60999.39
6834030-83403098.532100.52
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