厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.663272432795328183288332747327930.20
213.723291232898329050.04
单位质量响应值RSD%判断
2400.662398.320.07数据可信
供试品溶液-24032502批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136579-3657996.25197.532.6096.2597.532.60
236265-3626595.42495.42
336449-3644995.90995.91
438574-38574101.500101.50
537977-3797799.92999.93
636544-3654496.15896.16
10min137611-3761198.96699.502.0699.50100.042.06
237292-3729298.12798.66
336714-3671496.60697.14
438797-38797102.087102.65
538537-38537101.403101.96
637926-3792699.795100.33
15min139086-39086102.84798.643.00103.9399.732.98
237650-3765099.069100.14
335672-3567293.86494.93
437445-3744598.52999.66
538004-38004100.000101.12
637066-3706697.53298.62
20min136086-3608694.95396.953.0896.6198.593.05
236567-3656796.21997.84
335355-3535593.03094.62
437567-3756798.850100.53
538577-38577101.508103.18
636913-3691397.12998.76
30min137593-3759398.91998.462.59101.10100.642.58
237386-3738698.374100.53
335578-3557893.61795.72
438135-38135100.345102.57
538279-38279100.724102.96
637545-3754598.792100.96
45min138655-38655101.71397.563.35104.45100.293.30
237239-3723997.987100.69
335388-3538893.11795.74
437291-3729198.124100.91
537996-3799699.979102.78
635886-3588694.42797.15
60min137881-3788199.67799.812.86102.97103.072.83
238391-38391101.019104.27
336455-3645595.92499.07
438742-38742101.942105.27
539236-39236103.242106.59
636874-3687497.027100.27
90min138949-38949102.48799.892.60106.34103.722.55
237649-3764999.066102.88
336373-3637395.70999.39
438578-38578101.511105.41
537470-3747098.595102.52
638761-38761101.992105.77
120min1-0.0000.00-4.424.382.20
2-0.0004.36
3-0.0004.21
4-0.0004.46
5-0.0004.47
6-0.0004.35
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-4.424.382.20
2-0.0004.36
3-0.0004.21
4-0.0004.46
5-0.0004.47
6-0.0004.35
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.952062915206639220654172064490206328020644990.08
215.092060798205627320585360.16
单位质量响应值RSD%判断
138093.58136417.230.87数据可信
供试品溶液-24032502批-厄贝沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1302501-30250113.22413.425.2713.2213.425.28
2285929-28592912.50012.50
3299222-29922213.08113.08
4320002-32000213.98913.99
5331366-33136614.48614.49
6302724-30272413.23413.23
10min1579877-57987725.35025.712.5125.4225.782.53
2566038-56603824.74524.81
3582346-58234625.45825.53
4606818-60681826.52826.61
5595797-59579726.04626.13
6597673-59767326.12826.20
15min1782490-78249034.20733.141.8134.4233.361.80
2744856-74485632.56232.77
3745570-74557032.59332.81
4760127-76012733.23033.45
5756712-75671233.08033.31
6759298-75929833.19333.41
20min1844125-84412536.90238.132.5037.3138.522.48
2848746-84874637.10437.49
3868307-86830737.95938.35
4888578-88857838.84539.25
5891798-89179838.98639.39
6891174-89117438.95839.36
30min11051683-105168345.97546.671.8246.5847.281.82
21045435-104543545.70246.30
31058642-105864246.27946.89
41085801-108580147.46748.09
51069612-106961246.75947.38
61094505-109450547.84748.47
45min11303507-130350756.98455.801.2757.8556.681.25
21253310-125331054.78955.64
31278576-127857655.89456.76
41273380-127338055.66756.56
51277689-127768955.85556.74
61272423-127242355.62556.51
60min11411767-141176761.71662.791.1662.9063.971.15
21419881-141988162.07163.22
31448200-144820063.30964.48
41451282-145128263.44464.64
51447775-144777563.29164.49
61438939-143893962.90464.10
90min11533020-153302067.01767.113.1268.5468.643.07
21481763-148176364.77666.27
31548770-154877067.70669.23
41541463-154146367.38668.94
51490912-149091265.17666.72
61615194-161519470.60972.15
120min1-0.0000.00-1.901.911.48
2-0.0001.86
3-0.0001.90
4-0.0001.93
5-0.0001.91
6-0.0001.94
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.901.911.48
2-0.0001.86
3-0.0001.90
4-0.0001.93
5-0.0001.91
6-0.0001.94
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.663284032859327553271132795327920.19
213.723254832745326460.43
单位质量响应值RSD%判断
2400.592379.450.63数据可信
供试品溶液-24032502批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133683-3368388.98387.421.5588.9887.421.55
232423-3242385.65585.65
333534-3353488.59088.59
432694-3269486.37186.37
533383-3338388.19188.19
632821-3282186.70686.71
10min135106-3510692.74392.062.2593.2492.542.24
235046-3504692.58493.06
336048-3604895.23195.72
433992-3399289.80090.28
533961-3396189.71890.21
634932-3493292.28392.76
15min134667-3466791.58392.352.6892.5993.352.67
235260-3526093.15094.14
336161-3616195.53096.55
433941-3394189.66590.64
533936-3393689.65290.64
635783-3578394.53195.53
20min134777-3477791.87492.441.7793.3993.951.77
235085-3508592.68794.19
335693-3569394.29395.85
434530-3453091.22192.70
534176-3417690.28691.77
635684-3568494.27095.79
30min134866-3486692.10992.551.9094.1494.571.89
235193-3519392.97395.00
335935-3593594.93397.01
434366-3436690.78892.77
534260-3426090.50892.50
635567-3556793.96196.00
45min133576-3357688.70190.812.2491.2493.352.22
234555-3455591.28793.83
335468-3546893.69996.30
433736-3373689.12391.61
533878-3387889.49991.99
635041-3504192.57195.14
60min134066-3406689.99591.482.6893.0394.522.64
235514-3551493.82196.87
335002-3500292.46895.59
433718-3371889.07692.06
533679-3367988.97391.96
635778-3577894.51897.60
90min134135-3413590.17892.362.3693.7195.922.32
235118-3511892.77496.34
335398-3539893.51497.15
435055-3505592.60896.09
533922-3392289.61593.10
636149-3614995.49899.10
120min1-0.0000.00-4.034.061.88
2-0.0004.08
3-0.0004.16
4-0.0003.99
5-0.0003.98
6-0.0004.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-4.034.061.88
2-0.0004.08
3-0.0004.16
4-0.0003.99
5-0.0003.98
6-0.0004.14
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.952108886207727820883082081760207453620861540.66
215.092063662208319820734300.67
单位质量响应值RSD%判断
139542.07137404.241.10数据可信
供试品溶液-24032502批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133924-339241.4701.376.181.471.376.16
230372-303721.3161.32
330461-304611.3201.32
431134-311341.3491.35
533923-339231.4701.47
629329-293291.2711.27
10min162157-621572.6932.632.562.702.642.60
260149-601492.6062.61
361456-614562.6632.67
459727-597272.5882.60
562569-625692.7112.72
658537-585372.5372.54
15min178580-785803.4053.401.603.433.421.65
278245-782453.3913.41
379696-796963.4533.48
476568-765683.3183.34
579944-799443.4643.49
677744-777443.3693.39
20min190891-908913.9393.931.083.983.971.14
290360-903603.9163.96
391070-910703.9463.99
489855-898553.8943.93
592470-924704.0074.05
689853-898533.8943.93
30min1107401-1074014.6544.631.224.724.691.28
2106287-1062874.6064.67
3107781-1077814.6704.73
4105257-1052574.5614.62
5108504-1085044.7024.77
6105533-1055334.5734.63
45min1117798-1177985.1045.191.335.195.271.33
2118871-1188715.1515.24
3121492-1214925.2655.35
4118486-1184865.1345.22
5121575-1215755.2685.36
6119882-1198825.1955.28
60min1128430-1284305.5655.591.425.685.711.42
2130845-1308455.6705.79
3128696-1286965.5775.70
4125960-1259605.4585.57
5129701-1297015.6205.74
6130723-1307235.6655.78
90min1133262-1332625.7755.830.535.925.980.56
2134619-1346195.8335.98
3134783-1347835.8405.99
4134371-1343715.8235.97
5135105-1351055.8546.01
6135254-1352545.8616.01
120min1-0.0000.00-0.180.180.00
2-0.0000.18
3-0.0000.18
4-0.0000.18
5-0.0000.18
6-0.0000.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-0.180.180.00
2-0.0000.18
3-0.0000.18
4-0.0000.18
5-0.0000.18
6-0.0000.18
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.663317132977329613291832873329800.35
213.723297333011329920.09
单位质量响应值RSD%判断
2414.352404.660.29数据可信
供试品溶液-24032502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%
5min120647-2064754.10354.089.2954.1054.089.30
216995-1699544.53344.53
320751-2075154.37654.38
422154-2215458.05258.05
522264-2226458.34058.34
621023-2102355.08855.09
10min131719-3171983.11681.002.0083.4281.302.02
229945-2994578.46778.71
331060-3106081.38981.69
431174-3117481.68882.01
531099-3109981.49181.82
630472-3047279.84880.15
15min133900-3390088.83187.052.2689.5987.802.27
231990-3199083.82684.51
333630-3363088.12388.88
432629-3262985.50086.28
533758-3375888.45989.24
633405-3340587.53488.28
20min135217-3521792.28289.282.2193.5490.512.20
233775-3377588.50389.65
334194-3419489.60190.85
433797-3379788.56189.81
534457-3445790.29091.56
632983-3298386.42887.66
30min134531-3453190.48490.571.2492.2592.301.22
234621-3462190.72092.36
333973-3397389.02290.76
434539-3453990.50592.25
535294-3529492.48494.25
634426-3442690.20991.93
45min136700-3670096.16895.861.8398.4498.091.81
236694-3669496.15298.30
336039-3603994.43696.67
436558-3655895.79698.04
537713-3771398.822101.11
635783-3578393.76595.98
60min1-0.0000.00-2.812.771.94
2-0.0002.68
3-0.0002.76
4-0.0002.78
5-0.0002.83
6-0.0002.74
90min1-0.0000.00-2.812.771.94
2-0.0002.68
3-0.0002.76
4-0.0002.78
5-0.0002.83
6-0.0002.74
120min1-0.0000.00-2.812.771.94
2-0.0002.68
3-0.0002.76
4-0.0002.78
5-0.0002.83
6-0.0002.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-2.812.771.94
2-0.0002.68
3-0.0002.76
4-0.0002.78
5-0.0002.83
6-0.0002.74
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.952068744206751920681542065712206733320674920.06
215.092058860205603520574480.10
单位质量响应值RSD%判断
138293.78136345.131.01数据可信
供试品溶液-24032502批-厄贝沙坦-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%
5min1612928-61292826.78227.058.6326.7827.058.63
2528058-52805823.07423.07
3623132-62313227.22827.23
4634210-63421027.71227.71
5694376-69437630.34130.34
6622133-62213327.18527.18
10min11153469-115346950.40250.442.1650.5550.592.18
21112310-111231048.60348.73
31176143-117614351.39351.54
41147890-114789050.15850.31
51182670-118267051.67851.85
61153396-115339650.39950.55
15min11452460-145246063.46763.021.2163.9063.461.22
21418051-141805161.96362.36
31452381-145238163.46363.90
41422048-142204862.13862.57
51452561-145256163.47163.93
61456376-145637663.63864.07
20min11631544-163154471.29270.850.8772.0771.630.86
21619770-161977070.77771.52
31643379-164337971.80972.60
41607541-160754170.24371.02
51619034-161903470.74571.55
61607625-160762570.24771.03
30min11869099-186909981.67281.520.8882.8582.690.86
21893291-189329182.72983.86
31856389-185638981.11782.30
41847736-184773680.73981.91
51872155-187215581.80683.01
61854624-185462481.04082.21
45min12071142-207114290.50090.170.7192.1391.800.71
22068205-206820590.37291.97
32056448-205644889.85891.50
42052457-205245789.68491.30
52086762-208676291.18392.84
62047036-204703689.44791.07
60min134880-348801.5241.541.833.663.671.33
234916-349161.5263.62
335314-353141.5433.68
434992-349921.5293.64
536595-365951.5993.76
635306-353061.5433.66
90min136622-366221.6001.581.453.743.721.10
236282-362821.5853.69
336268-362681.5853.73
435497-354971.5513.67
536756-367561.6063.78
635578-355781.5553.69
120min136377-363771.5901.571.413.743.721.15
235509-355091.5523.67
336485-364851.5943.75
435306-353061.5433.67
536414-364141.5913.77
635824-358241.5653.70
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限136941-369411.6141.601.523.773.750.67
237353-373531.6323.76
335836-358361.5663.73
436133-361331.5793.72
536486-364861.5943.78
636299-362991.5863.73
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