阿齐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直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
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%
112.029638096142966359648696638964560.22
212.089665196659966550.01
单位质量响应值RSD%判断
8024.638001.240.21数据可信
供试品溶液-2024030121批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193069-9306993.86796.721.4893.8796.721.48
296820-9682097.65197.65
396721-9672197.55197.55
496532-9653297.36097.36
596132-9613296.95796.96
696114-9611496.93996.94
10min193519-9351994.32196.981.6394.8497.521.63
297793-9779398.63299.17
397273-9727398.10898.65
496907-9690797.73898.28
595315-9531596.13396.67
696135-9613596.96097.50
15min191699-9169992.48696.472.2193.5397.542.20
295267-9526796.08497.17
396239-9623997.06598.15
497352-9735298.18799.27
597438-9743898.27499.35
695896-9589696.71997.80
20min191235-9123592.01894.961.8593.5896.571.84
293952-9395294.75896.38
396385-9638597.21298.84
494718-9471895.53197.16
593529-9352994.33195.95
695080-9508095.89697.51
30min189561-8956190.32993.091.7192.4095.231.71
292917-9291793.71495.86
393743-9374394.54796.71
493755-9375594.55996.72
592055-9205592.84594.99
691768-9176892.55594.70
45min189277-8927790.04392.661.8792.6295.311.84
291787-9178792.57495.25
392011-9201192.80095.49
492472-9247293.26595.95
591152-9115291.93494.59
694511-9451195.32297.98
60min188481-8848189.24090.971.5892.3194.141.55
290744-9074491.52394.71
391062-9106291.84395.05
488284-8828489.04192.24
591339-9133992.12395.29
691241-9124192.02495.21
极限187298-8729888.04790.312.0391.6293.991.98
289632-8963290.40194.10
387723-8772388.47692.19
492165-9216592.95696.65
589893-8989390.66494.35
690552-9055291.32995.03
阿齐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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.073777773765003770933763653776893770850.18
210.033782383783303782840.02
单位质量响应值RSD%判断
37446.3837715.250.51数据可信
供试品溶液-2024030121批-阿齐沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111051-110512.6392.379.462.642.379.48
29482-94822.2642.26
39367-93672.2372.24
48581-85812.0492.05
510629-106292.5382.54
610508-105082.5092.51
10min135357-353578.4427.926.428.467.936.45
234704-347048.2868.30
332393-323937.7347.75
429405-294057.0217.03
534014-340148.1218.14
633053-330537.8927.91
15min151544-5154412.30712.003.4612.3712.063.49
251339-5133912.25812.32
350425-5042512.04012.10
446906-4690611.20011.25
551256-5125612.23812.30
650053-5005311.95112.01
20min159599-5959914.23014.022.1614.3614.142.15
258993-5899314.08614.21
360528-6052814.45214.57
457200-5720013.65813.77
557467-5746713.72113.85
658493-5849313.96614.09
30min165953-6595315.74715.682.2615.9615.882.25
266476-6647615.87216.08
368107-6810716.26216.46
464241-6424115.33915.53
564539-6453915.41015.61
664670-6467015.44115.64
45min171169-7116916.99316.812.0317.2917.102.02
270520-7052016.83817.13
372000-7200017.19117.48
468588-6858816.37716.65
568723-6872316.40916.70
671354-7135417.03717.32
60min173360-7336017.51617.321.5617.9117.701.58
273039-7303917.43917.83
373955-7395517.65818.05
470953-7095316.94117.31
572279-7227917.25817.64
671620-7162017.10117.48
极限174833-7483317.86817.541.0818.3618.021.07
273404-7340417.52718.01
372845-7284517.39317.88
473472-7347217.54318.00
572593-7259317.33317.81
673736-7373617.60618.08
阿齐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直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
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%
112.029647896562964899653896536965210.04
212.089642796333963800.07
单位质量响应值RSD%判断
8030.037978.480.46数据可信
供试品溶液-2024030221批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193613-9361394.51996.461.8494.5296.461.84
295108-9510896.02996.03
398467-9846799.42099.42
494655-9465595.57195.57
596698-9669897.63497.63
694652-9465295.56895.57
10min195320-9532096.24396.611.4996.7797.141.49
295064-9506495.98496.52
398066-9806699.01599.57
494286-9428695.19995.73
596663-9666397.59998.14
694697-9469795.61496.14
15min193226-9322694.12995.741.6895.1996.811.68
293921-9392194.83095.90
396587-9658797.52298.62
493499-9349994.40495.46
596929-9692997.86798.95
694741-9474195.65896.72
20min192854-9285493.75395.171.5495.3496.781.54
293072-9307293.97395.57
396648-9664897.58499.23
493400-9340094.30495.89
595057-9505795.97797.61
694499-9449995.41497.01
30min189182-8918290.04592.832.4092.1594.972.38
290878-9087891.75893.87
394220-9422095.13297.32
491265-9126592.14994.26
594980-9498095.89998.06
691135-9113592.01794.14
45min189280-8928090.14491.881.6492.7594.531.63
290872-9087291.75294.38
392196-9219693.08995.80
489840-8984090.71093.33
593251-9325194.15496.85
690540-9054091.41794.05
60min187302-8730288.14791.092.0691.2594.252.04
289108-8910889.97193.11
392135-9213593.02796.26
490568-9056891.44594.57
592110-9211093.00296.22
690095-9009590.96794.11
极限188116-8811688.96991.621.8192.5695.281.80
291237-9123792.12095.76
392498-9249893.39397.14
489592-8959290.45994.09
592128-9212893.02096.75
690857-9085791.73795.38
阿齐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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.073780593776643774473779043772123776570.10
210.033770453770283770360.01
单位质量响应值RSD%判断
37503.1837590.830.17数据可信
供试品溶液-2024030221批-阿齐沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19069-90692.1672.4713.402.172.4713.35
210131-101312.4212.42
310777-107772.5752.58
412471-124712.9802.98
510935-109352.6132.61
68655-86552.0682.07
10min132833-328337.8467.926.057.867.946.05
233705-337058.0558.07
333421-334217.9878.00
435510-355108.4868.50
533969-339698.1188.13
629496-294967.0497.06
15min149765-4976511.89311.912.9111.9511.962.94
250398-5039812.04412.10
349432-4943211.81311.87
450667-5066712.10812.17
551453-5145312.29612.36
647244-4724411.29011.34
20min158505-5850513.98214.010.9114.1014.130.94
258800-5880014.05214.18
358879-5887914.07114.20
458962-5896214.09114.22
558981-5898114.09514.22
657596-5759613.76413.88
30min164685-6468515.45815.701.5615.6615.901.56
266206-6620615.82216.03
366015-6601515.77615.98
465810-6581015.72715.94
567106-6710616.03716.24
664350-6435015.37815.57
45min170068-7006816.74516.761.1617.0317.041.17
271332-7133217.04717.34
369543-6954316.61916.91
469801-6980116.68116.98
570776-7077616.91417.21
669150-6915016.52616.80
60min171463-7146317.07817.300.8817.4617.680.89
272502-7250217.32717.71
372287-7228717.27517.66
473187-7318717.49017.88
572880-7288017.41717.81
671904-7190417.18417.55
极限173907-7390717.66217.811.2218.1418.291.20
276263-7626318.22518.71
374430-7443017.78718.27
473779-7377917.63218.12
574636-7463617.83718.32
674159-7415917.72318.19
阿齐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直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
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%
112.029646396481965389647496394964700.06
212.089634196435963880.07
单位质量响应值RSD%判断
8025.797979.140.42数据可信
供试品溶液-2024030321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%
5min196983-9698397.94496.851.1597.9496.851.15
296380-9638097.33597.33
395510-9551096.45696.46
496450-9645097.40597.41
596184-9618497.13797.14
693873-9387394.80394.80
10min1101352-101352102.35698.802.29102.9099.342.29
298539-9853999.515100.06
397356-9735698.32098.86
497559-9755998.52599.07
597791-9779198.76099.30
694388-9438895.32395.85
15min198847-9884799.82698.721.04100.9499.801.05
298420-9842099.395100.49
396875-9687597.83598.92
498232-9823299.205100.29
597936-9793698.90699.99
696182-9618297.13598.19
20min199882-99882100.87199.221.55102.54100.861.55
299607-99607100.594102.24
397493-9749398.459100.08
498617-9861799.594101.23
598149-9814999.121100.76
695744-9574496.69298.29
30min195251-9525196.19496.761.2698.4298.941.25
295817-9581796.76698.97
395854-9585496.80398.98
497423-9742398.388100.58
596610-9661097.56799.76
693886-9388694.81696.95
45min196870-9687097.82997.421.32100.59100.141.32
297557-9755798.523101.27
396251-9625197.20499.91
497518-9751898.484101.22
596484-9648497.440100.17
694105-9410595.03797.70
60min196568-9656897.52597.081.68100.83100.341.67
297189-9718998.152101.44
395897-9589796.847100.10
497699-9769998.667101.95
596299-9629997.253100.52
693104-9310494.02697.21
极限196730-9673097.68897.321.39101.54101.121.39
297620-9762098.587102.42
395408-9540896.353100.14
497394-9739498.359102.19
596892-9689297.852101.66
694138-9413895.07098.78
阿齐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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.073772433775613771413774803774963773840.05
210.033758833767983763400.18
单位质量响应值RSD%判断
37476.0737521.440.09数据可信
供试品溶液-2024030321批-阿齐沙坦-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%
5min17533-75331.8031.6017.621.801.6017.52
25392-53921.2901.29
35586-55861.3371.34
45950-59501.4241.42
57953-79531.9031.90
67788-77881.8641.86
10min125668-256686.1425.839.376.155.849.34
223715-237155.6755.68
324070-240705.7605.77
420302-203024.8584.87
526587-265876.3626.37
625910-259106.2006.21
15min138539-385399.2229.056.139.279.096.13
237916-379169.0739.11
337748-377489.0339.07
433404-334047.9938.03
539975-399759.5669.61
639262-392629.3959.44
20min146937-4693711.23111.003.4511.3311.093.48
246434-4643411.11111.20
346031-4603111.01511.10
442841-4284110.25110.33
547109-4710911.27311.37
646493-4649311.12511.22
30min150749-5074912.14412.411.4812.3012.561.49
251387-5138712.29612.45
352164-5216412.48212.63
451629-5162912.35412.49
552882-5288212.65412.82
652379-5237912.53412.69
45min156130-5613013.43113.590.6913.6613.810.66
257287-5728713.70813.93
356994-5699413.63813.86
456899-5689913.61513.82
556636-5663613.55213.78
656806-5680613.59313.82
60min158510-5851014.00114.120.6914.3014.420.65
259406-5940614.21514.51
359053-5905314.13114.43
459381-5938114.20914.49
559227-5922714.17214.48
658546-5854614.00914.31
极限159993-5999314.35614.540.8514.7314.920.83
261052-6105214.60914.98
360314-6031414.43214.81
461147-6114714.63214.99
561277-6127714.66315.05
660903-6090314.57314.96
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