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%
112.195074750767507675070850758507490.05
212.235070650674506900.05
单位质量响应值RSD%判断
4163.174144.730.32数据可信
中间条件3月-供试品溶液-24051501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%
5min147625-4762592.65794.032.2892.6694.042.28
249065-4906595.45895.46
349161-4916195.64595.65
448162-4816293.70193.70
549414-4941496.13796.14
646566-4656690.59690.60
10min150527-5052798.30398.581.7198.8299.101.72
251316-5131699.838100.37
351525-51525100.244100.78
450345-5034597.94998.47
551129-5112999.474100.01
649164-4916495.65196.15
15min149669-4966996.63397.903.2597.6998.973.23
250676-5067698.59399.68
351657-51657100.501101.59
450590-5059098.42599.49
551905-51905100.984102.07
647424-4742492.26693.30
20min150748-5074898.73397.523.13100.3399.133.12
250724-5072498.686100.32
350966-5096699.157100.80
449824-4982496.93598.55
551387-5138799.976101.62
647100-4710091.63593.18
30min150091-5009197.45496.733.0599.6098.883.03
250486-5048698.223100.40
350762-5076298.760100.96
449590-4959096.48098.63
550626-5062698.495100.70
646757-4675790.96893.02
45min148718-4871894.78395.793.1197.4798.483.10
249940-4994097.16199.89
350594-5059498.433101.18
449215-4921595.75098.44
550452-5045298.157100.91
646480-4648090.42992.99
60min149760-4976096.81095.002.31100.0298.232.30
249466-4946696.23899.50
348924-4892495.18498.48
448532-4853294.42197.64
549571-4957196.44399.74
646734-4673490.92393.99
极限149268-4926895.85395.772.7599.6199.522.75
249936-4993697.153100.95
350089-5008997.451101.27
449310-4931095.93599.68
550171-5017197.610101.44
646578-4657890.62094.19
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%
111.293914793916253915113913663920003915960.07
211.343910913914233912570.07
单位质量响应值RSD%判断
34685.2134502.380.38数据可信
中间条件3月-供试品溶液-24051501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%
5min13232-32320.8380.834.460.840.834.42
23042-30420.7890.79
32991-29910.7760.78
43350-33500.8690.87
53187-31870.8270.83
63302-33020.8560.86
10min111379-113792.9523.013.082.963.023.06
211208-112082.9072.91
311869-118693.0793.08
412168-121683.1563.16
511401-114012.9572.96
611617-116173.0133.02
15min117077-170774.4294.572.914.454.592.88
217074-170744.4294.45
318202-182024.7214.74
418116-181164.6994.72
517332-173324.4964.52
617839-178394.6274.65
20min121588-215885.6005.692.285.655.742.27
221387-213875.5475.59
322452-224525.8245.87
422291-222915.7825.83
521503-215035.5785.62
622425-224255.8175.86
30min127474-274747.1267.262.417.207.342.42
227499-274997.1337.21
328503-285037.3937.47
428532-285327.4017.48
527238-272387.0657.14
628792-287927.4687.55
45min133301-333018.6388.842.258.758.962.27
233342-333428.6488.76
334635-346358.9849.10
434639-346398.9859.11
533579-335798.7108.83
635026-350269.0859.21
60min140461-4046110.49510.052.8810.6610.222.84
237725-377259.7859.95
338687-3868710.03510.21
438876-3887610.08410.26
537379-373799.6959.86
639327-3932710.20110.37
极限143517-4351711.28811.211.3611.5111.431.36
242581-4258111.04511.26
343465-4346511.27411.50
443784-4378411.35711.58
542370-4237010.99011.21
643546-4354611.29511.52
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%
112.195091950978509965092551011509660.09
212.235085850862508600.01
单位质量响应值RSD%判断
4180.974158.630.38数据可信
中间条件3月-供试品溶液-24051501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%
5min148211-4821193.44096.222.5293.4496.222.52
248747-4874794.47994.48
348644-4864494.28094.28
451087-5108799.01599.01
550398-5039897.67997.68
650785-5078598.42998.43
10min151636-51636100.079100.871.40100.60101.401.40
251480-5148099.776100.30
351121-5112199.08099.60
452875-52875102.480103.03
552714-52714102.168102.71
652440-52440101.637102.18
15min150439-5043997.75999.701.6798.83100.791.67
250588-5058898.04799.13
351279-5127999.387100.46
452677-52677102.096103.22
552033-52033100.848101.96
651622-51622100.051101.16
20min150279-5027997.44999.662.3499.07101.302.33
250756-5075698.373100.00
350373-5037397.63199.26
453350-53350103.401105.09
552219-52219101.209102.88
651527-5152799.867101.53
30min150445-5044597.77099.312.1399.93101.512.13
250403-5040397.68999.86
350398-5039897.67999.85
453048-53048102.815105.08
552023-52023100.829103.06
651120-5112099.079101.30
45min148180-4818093.38097.722.4896.08100.472.45
250644-5064498.156100.87
350050-5005097.00599.72
451555-5155599.922102.75
551539-5153999.891102.68
650546-5054697.966100.74
60min148647-4864794.28596.172.2797.5199.472.25
248435-4843593.87597.13
348766-4876694.51697.77
450936-5093698.722102.11
550618-5061898.106101.45
650324-5032497.536100.85
极限148701-4870194.39095.831.8998.1499.661.89
248461-4846193.92597.70
348629-4862994.25198.03
450270-5027097.431101.37
550188-5018897.272101.17
650402-5040297.687101.55
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%
111.293920713915633925313925863924003922300.11
211.343917333916393916860.02
单位质量响应值RSD%判断
34741.3634540.210.42数据可信
中间条件3月-供试品溶液-24051501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%
5min15075-50751.3151.3113.131.311.3013.03
24445-44451.1511.15
34857-48571.2581.26
46196-61961.6051.60
54401-44011.1401.14
65273-52731.3661.37
10min112506-125063.2393.235.813.253.245.83
212465-124653.2293.24
312009-120093.1113.12
413591-135913.5213.53
511444-114442.9642.97
612776-127763.3093.32
15min117950-179504.6504.704.184.674.724.19
218032-180324.6714.70
318219-182194.7194.74
419461-194615.0415.07
517116-171164.4344.46
617985-179854.6594.68
20min122053-220535.7125.794.145.765.844.15
222469-224695.8205.87
322064-220645.7155.77
424114-241146.2466.30
521411-214115.5465.59
622025-220255.7055.76
30min128301-283017.3317.363.597.417.443.58
228301-283017.3317.41
328457-284577.3717.45
430309-303097.8517.94
527450-274507.1107.19
627611-276117.1527.24
45min133143-331438.5858.893.028.719.013.01
234606-346068.9649.09
334906-349069.0429.16
435932-359329.3089.44
533732-337328.7388.86
633551-335518.6918.81
60min137635-376359.7499.832.339.9210.012.36
237458-374589.7039.88
338391-383919.94510.12
439578-3957810.25210.44
537247-372479.6489.81
637470-374709.7069.88
极限142044-4204410.89111.021.8111.1211.251.82
241835-4183510.83711.06
343014-4301411.14211.37
443733-4373311.32811.57
541872-4187210.84611.07
642876-4287611.10611.33
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%
112.195082450827508115083250882508350.06
212.235082950835508320.01
单位质量响应值RSD%判断
4170.224156.340.24数据可信
中间条件3月-供试品溶液-24051502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%
5min146931-4693191.10293.261.3491.1093.261.35
247831-4783192.84992.85
348076-4807693.32493.32
448156-4815693.48093.48
548406-4840693.96593.96
648846-4884694.81994.82
10min151306-5130699.594100.290.37100.10100.800.37
251781-51781100.516101.03
351645-51645100.252100.77
451664-51664100.289100.81
551807-51807100.567101.09
651770-51770100.495101.02
15min150563-5056398.15299.801.9299.21100.881.91
251282-5128299.548100.62
351480-5148099.932101.01
450826-5082698.66399.74
551017-5101799.033100.11
653315-53315103.494104.58
20min150555-5055598.13699.241.1099.74100.871.10
251671-51671100.303101.93
351557-51557100.082101.71
450528-5052898.08499.71
550767-5076798.548100.18
651660-51660100.281101.94
30min150750-5075098.51599.081.39100.66101.261.38
250472-5047297.975100.16
351388-5138899.753101.94
450713-5071398.443100.61
550601-5060198.226100.40
652334-52334101.590103.81
45min148399-4839993.95196.321.6296.6599.051.60
249638-4963896.35699.09
350023-5002397.10499.84
449740-4974096.55499.27
549146-4914695.40198.13
650774-5077498.562101.34
60min149549-4954996.18496.321.5399.4099.581.51
249657-4965796.39399.66
350047-5004797.150100.43
449088-4908895.28998.54
548594-4859494.33097.58
650781-5078198.575101.90
极限149529-4952996.14596.151.1099.9099.951.10
249135-4913595.38099.18
349374-4937495.84499.66
449108-4910895.32899.11
549444-4944495.98099.76
650587-5058798.199102.08
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%
111.293915083917173916403917193916543916480.03
211.343924003921663922830.05
单位质量响应值RSD%判断
34689.8134592.860.20数据可信
中间条件3月-供试品溶液-24051502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%
5min16223-62231.6121.4816.001.611.4815.97
27140-71401.8491.85
34662-46621.2081.21
44862-48621.2591.26
55816-58161.5061.51
65529-55291.4321.43
10min114336-143363.7133.569.053.723.579.04
215231-152313.9453.96
312358-123583.2013.21
412309-123093.1883.20
514792-147923.8323.84
613449-134493.4843.49
15min119345-193455.0115.055.215.045.085.26
220485-204855.3065.34
318724-187244.8504.87
417943-179434.6484.67
520118-201185.2115.24
620371-203715.2775.30
20min123194-231946.0086.104.636.076.164.63
224743-247436.4096.47
322788-227885.9035.95
421951-219515.6865.74
524379-243796.3156.37
624294-242946.2936.35
30min128756-287567.4497.653.957.547.743.97
229997-299977.7707.87
329069-290697.5307.61
427879-278797.2217.30
530456-304567.8897.98
631001-310018.0308.12
45min133584-335848.6999.163.688.839.293.68
235700-357009.2479.39
334585-345858.9589.08
434874-348749.0339.16
535981-359819.3209.46
637349-373499.6749.81
60min138765-3876510.04110.374.4910.2210.554.47
240190-4019010.41010.60
338852-3885210.06410.24
438914-3891410.08010.25
539996-3999610.36010.55
643478-4347811.26211.45
极限142394-4239410.98111.324.1711.2211.564.14
243476-4347611.26111.51
342281-4228110.95211.18
442382-4238210.97811.21
544794-4479411.60311.85
646832-4683212.13112.38
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%
112.195077250849507035069950698507440.14
212.235109251060510760.05
单位质量响应值RSD%判断
4162.764176.290.23数据可信
中间条件3月-供试品溶液-24051502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%
5min148272-4827293.56493.501.1293.5693.501.12
248319-4831993.65693.66
348597-4859794.19494.19
447710-4771092.47592.48
547542-4754292.14992.15
648979-4897994.93594.93
10min150218-5021897.33698.481.4797.8699.001.46
250560-5056097.99998.52
351336-5133699.503100.03
450568-5056898.01598.53
550121-5012197.14897.66
652049-52049100.885101.41
15min150635-5063598.14598.980.9899.21100.040.98
251100-5110099.046100.11
351575-5157599.967101.04
451048-5104898.945100.00
550381-5038197.65298.70
651642-51642100.096101.18
20min150224-5022497.34898.750.8798.95100.360.87
250791-5079198.447100.06
351200-5120099.240100.87
450893-5089398.645100.25
551025-5102598.900100.49
651544-5154499.906101.55
30min150330-5033097.55397.710.7999.7099.880.79
250366-5036697.62399.79
350805-5080598.474100.66
449689-4968996.31198.47
550619-5061998.114100.26
650660-5066098.193100.39
45min149553-4955396.04795.750.9998.7498.450.97
249545-4954596.03298.74
349820-4982096.56599.29
448499-4849994.00496.70
549231-4923195.42398.11
649735-4973596.40099.14
60min149468-4946895.88396.331.2899.1099.571.25
249826-4982696.57799.81
349184-4918495.33298.60
448966-4896694.91098.12
550058-5005897.026100.24
650699-5069998.269101.55
极限148383-4838393.78095.481.3497.5399.251.31
248607-4860794.21497.99
349815-4981596.555100.35
449750-4975096.429100.17
549102-4910295.17398.93
649899-4989996.718100.54
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%
111.293910343910533913043913123908363911080.06
211.343938043936273937160.04
单位质量响应值RSD%判断
34641.9834719.220.16数据可信
中间条件3月-供试品溶液-24051502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%
5min16352-63521.6431.448.681.641.448.53
25963-59631.5431.54
35276-52761.3651.37
45328-53281.3791.38
55068-50681.3111.31
65471-54711.4161.42
10min114884-148843.8513.436.913.863.446.90
213397-133973.4663.47
312863-128633.3283.34
413025-130253.3703.38
512110-121103.1333.14
613349-133493.4543.46
15min120906-209065.4094.905.155.444.935.14
218667-186674.8304.86
318560-185604.8024.83
418603-186034.8134.84
518289-182894.7324.76
618593-185934.8114.84
20min125040-250406.4795.964.356.546.014.34
222509-225095.8245.88
322428-224285.8035.86
422677-226775.8675.92
522747-227475.8855.94
622698-226985.8735.93
30min131718-317188.2067.504.898.307.584.87
228225-282257.3037.39
327995-279957.2437.33
428940-289407.4887.57
528941-289417.4887.57
627998-279987.2447.33
45min137894-378949.8048.975.019.959.105.02
235179-351799.1029.23
334182-341828.8448.97
432952-329528.5268.65
534061-340618.8138.94
633757-337578.7348.86
60min142098-4209810.89210.203.7411.0910.383.76
239649-3964910.25810.44
339265-3926510.15910.33
437623-376239.7349.91
538923-3892310.07110.24
639059-3905910.10610.28
极限144960-4496011.63311.192.2111.8911.422.24
242597-4259711.02111.26
343679-4367911.30111.53
442680-4268011.04311.27
542439-4243910.98011.21
643099-4309911.15111.38
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