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%
112.455135151325511355144751291513100.23
212.435165051705516780.08
单位质量响应值RSD%判断
4121.294157.520.62数据可信
供试品溶液-24051501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%
5min149021-4902195.70997.543.1595.7197.543.15
250498-5049898.59398.59
349838-4983897.30497.30
450599-5059998.79098.79
552210-52210101.935101.94
647579-4757992.89492.89
10min148999-4899995.66699.342.7496.2099.882.74
250785-5078599.15399.70
351502-51502100.553101.09
451399-51399100.352100.90
552900-52900103.283103.85
649698-4969897.03197.55
15min150855-5085599.29098.762.62100.3599.852.62
249659-4965996.95598.05
350765-5076599.114100.21
449712-4971297.05898.16
553010-53010103.497104.64
649503-4950396.65097.71
20min151024-5102499.62097.982.99101.2399.622.97
248397-4839794.49196.13
349720-4972097.07498.72
450954-5095499.483101.13
552274-52274102.060103.78
648725-4872595.13196.72
30min150582-5058298.75798.011.67100.93100.201.63
251452-51452100.455102.62
350568-5056898.729100.92
449113-4911395.88998.09
549925-4992597.47499.76
649562-4956296.76598.89
45min149088-4908895.84097.242.7198.5699.982.68
251138-5113899.842102.56
349554-4955496.75099.49
449844-4984497.316100.05
551428-51428100.409103.23
647786-4778693.29895.96
60min148552-4855294.79394.312.9898.0497.582.93
246254-4625490.30793.58
348794-4879495.26698.54
449239-4923996.13599.41
550053-5005397.724101.11
646930-4693091.62794.80
极限149439-4943996.52596.683.18100.30100.483.12
251131-5113199.829103.61
349149-4914995.95999.76
449764-4976497.160100.97
550890-5089099.358103.28
646745-4674591.26594.95
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%
111.053889093887943891523882083892013888530.11
211.153908663911273909960.05
单位质量响应值RSD%判断
35190.3235066.910.25数据可信
供试品溶液-24051501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%
5min14877-48771.2461.1119.441.251.1119.64
23501-35010.8940.89
33422-34220.8740.87
44381-43811.1191.12
55640-56401.4411.44
64199-41991.0731.07
10min119817-198175.0624.5211.845.074.5211.85
216007-160074.0894.09
315648-156483.9974.00
416753-167534.2794.29
520727-207275.2945.30
617165-171654.3854.39
15min129452-294527.5236.8011.997.566.8312.00
222604-226045.7745.80
324245-242456.1936.22
425795-257956.5896.62
531139-311397.9547.99
626464-264646.7606.79
20min135949-359499.1838.459.499.268.529.53
229122-291227.4397.50
330689-306897.8397.90
432287-322878.2478.31
537443-374439.5649.65
633082-330828.4508.52
30min145131-4513111.52810.757.0211.6610.867.10
239345-3934510.05010.15
339025-390259.96810.07
440331-4033110.30210.41
545809-4580911.70111.84
642797-4279710.93211.05
45min152367-5236713.37612.606.1813.5712.786.23
247840-4784012.22012.38
345689-4568911.67111.83
447715-4771512.18812.36
553659-5365913.70613.91
648740-4874012.45012.63
60min158759-5875915.00913.697.7915.2813.947.80
249094-4909412.54012.77
350502-5050212.90013.13
451088-5108813.05013.29
558526-5852614.95015.23
653548-5354813.67813.92
极限163092-6309216.11615.592.9016.4715.913.01
259861-5986115.29115.58
358760-5876015.00915.31
460792-6079215.52815.84
563145-6314516.12916.49
660467-6046715.44515.77
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%
112.455152951428514175124351292513820.23
212.435162851464515460.23
单位质量响应值RSD%判断
4127.074146.900.34数据可信
供试品溶液-24051502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%
5min145986-4598689.83592.042.4589.8392.042.45
246770-4677091.36691.37
348664-4866495.06695.07
448112-4811293.98893.99
547359-4735992.51792.52
645785-4578589.44289.44
10min149484-4948496.66895.813.0797.1796.323.06
248785-4878595.30395.81
350067-5006797.80798.34
450670-5067098.98599.51
548926-4892695.57896.09
646337-4633790.52191.02
15min148932-4893295.59093.374.2096.6394.414.16
249364-4936496.43497.47
346445-4644590.73191.80
449264-4926496.23897.31
548418-4841894.58695.63
644341-4434186.62187.62
20min148993-4899395.70993.972.6097.2895.542.60
247578-4757892.94594.52
348886-4888695.50097.08
449563-4956396.82398.43
547358-4735892.51594.09
646248-4624890.34791.83
30min148948-4894895.62193.513.8197.7295.603.79
247828-4782893.43395.52
349286-4928696.28198.39
449012-4901295.74697.89
547757-4775793.29595.38
644387-4438786.71188.69
45min147587-4758792.96292.762.8595.5995.372.85
247364-4736492.52795.14
348702-4870295.14197.78
448611-4861194.96397.64
547674-4767493.13295.74
644968-4496887.84690.31
60min148284-4828494.32492.523.2397.4795.643.21
247509-4750992.81095.93
348098-4809893.96197.13
448681-4868195.10098.30
547151-4715192.11195.23
644450-4445086.83489.79
极限147778-4777893.33692.552.9497.0196.182.94
247389-4738992.57696.21
348770-4877095.27398.97
448219-4821994.19797.93
547345-4734592.49096.12
644760-4476087.44090.87
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%
111.053876303879813884463879213878183879590.08
211.153897813894453896130.07
单位质量响应值RSD%判断
35109.4134942.870.34数据可信
供试品溶液-24051502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%
5min17460-74601.9111.9223.481.911.9223.49
27497-74971.9211.92
36950-69501.7801.78
45096-50961.3061.31
510560-105602.7052.71
67363-73631.8861.89
10min119607-196075.0234.647.485.034.647.48
218423-184234.7204.73
318284-182844.6844.69
415545-155453.9823.99
518551-185514.7524.77
618151-181514.6504.66
15min127208-272086.9706.674.837.016.704.86
225158-251586.4456.48
326531-265316.7976.83
423883-238836.1186.15
526764-267646.8566.90
626621-266216.8206.86
20min132648-326488.3648.163.148.448.233.17
231632-316328.1048.18
332408-324088.3028.38
429967-299677.6777.74
531852-318528.1608.24
632514-325148.3298.40
30min139916-3991610.22610.141.6710.3510.261.72
239825-3982510.20210.32
339933-3993310.23010.35
438235-382359.7959.90
539643-3964310.15610.28
639844-3984410.20710.33
45min146950-4695012.02812.011.8012.2112.181.82
246012-4601211.78711.96
347494-4749412.16712.34
445707-4570711.70911.87
547849-4784912.25812.44
647174-4717412.08512.26
60min151849-5184913.28313.220.9913.5313.461.02
251279-5127913.13713.38
351655-5165513.23313.48
450826-5082613.02113.25
551667-5166713.23613.49
652328-5232813.40513.65
极限158796-5879615.06214.950.7515.3815.260.76
257609-5760914.75815.07
358765-5876515.05515.37
458224-5822414.91615.21
558387-5838714.95815.28
658264-5826414.92615.24
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%
112.455177151428516805172351907517020.34
212.435172251903518120.25
单位质量响应值RSD%判断
4152.774168.300.27数据可信
供试品溶液-24051502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%
5min146888-4688891.07893.541.7791.0893.551.77
247655-4765592.56892.57
348190-4819093.60793.61
448946-4894695.07695.08
548048-4804893.33193.33
649221-4922195.61095.61
10min149781-4978196.69896.590.7797.2097.110.77
249521-4952196.19396.71
349183-4918395.53696.06
450054-5005497.22897.76
549584-4958496.31596.83
650226-5022697.56298.09
15min150068-5006897.25596.621.2198.3097.681.20
249230-4923095.62796.68
349347-4934795.85596.91
450485-5048598.06599.13
549063-4906395.30396.36
650246-5024697.60198.67
20min148945-4894595.07496.121.2196.6697.721.21
249317-4931795.79697.38
349599-4959996.34497.93
450156-5015697.42699.04
548741-4874194.67896.26
650154-5015497.42299.04
30min148849-4884994.88795.411.4097.0097.541.39
248842-4884294.87496.99
349266-4926695.69797.82
450082-5008297.28299.44
548096-4809693.42595.53
649567-4956796.28298.44
45min148450-4845094.11293.693.3296.7596.353.25
245149-4514987.70090.34
349105-4910595.38598.03
449387-4938795.93298.63
548018-4801893.27395.90
649292-4929295.74898.44
60min148052-4805293.33994.651.6896.5097.821.66
247727-4772792.70895.83
349151-4915195.47498.65
449549-4954996.24799.47
548257-4825793.73796.88
649618-4961896.38199.60
极限148023-4802393.28393.581.2396.9697.281.22
248218-4821893.66297.30
348027-4802793.29197.00
448834-4883494.85898.62
547212-4721291.70895.37
648749-4874994.69398.45
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%
111.053906623913363907763911713912363910360.08
211.153931873931073931470.02
单位质量响应值RSD%判断
35387.8735259.820.26数据可信
供试品溶液-24051502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%
5min17341-73411.8651.699.851.861.699.86
27307-73071.8561.86
35557-55571.4121.41
46497-64971.6501.65
56725-67251.7081.71
66520-65201.6561.66
10min119727-197275.0114.638.325.024.648.29
218113-181134.6014.61
316734-167344.2514.26
417636-176364.4804.49
520317-203175.1615.17
616724-167244.2484.26
15min128967-289677.3586.728.227.406.768.20
225869-258696.5716.61
324237-242376.1576.19
424808-248086.3026.34
529338-293387.4527.49
625447-254476.4646.50
20min134910-349108.8688.148.068.958.228.04
232142-321428.1658.24
329748-297487.5577.62
430140-301407.6567.73
535488-354889.0159.09
629954-299547.6097.68
30min143134-4313410.95710.057.4811.0910.177.49
237970-379709.6459.76
336550-365509.2849.39
438473-384739.7739.88
543478-4347811.04411.17
637857-378579.6179.73
45min151041-5104112.96611.916.8313.1512.086.84
245079-4507911.45111.62
344262-4426211.24411.40
444978-4497811.42511.59
550929-5092912.93713.13
644953-4495311.41911.58
60min155664-5566414.14013.135.8314.4013.375.83
249530-4953012.58212.82
349268-4926812.51512.74
449367-4936712.54012.77
555310-5531014.05014.31
651011-5101112.95813.19
极限160534-6053415.37714.693.7215.7215.003.79
256666-5666614.39414.70
356167-5616714.26814.56
456516-5651614.35614.66
560636-6063615.40315.74
656386-5638614.32314.62
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