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%
112.455138651427513705131351363513720.09
212.435142451398514110.04
单位质量响应值RSD%判断
4126.274136.040.17数据可信
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%
5min151742-51742101.222101.514.27101.22101.514.27
252800-52800103.291103.29
352717-52717103.129103.13
453474-53474104.610104.61
547523-4752392.96892.97
653073-53073103.825103.83
10min154206-54206106.042105.091.53106.60105.651.52
254619-54619106.850107.42
352280-52280102.274102.85
454088-54088105.811106.39
553744-53744105.138105.65
653376-53376104.418104.99
15min154152-54152105.936104.291.62107.09105.441.59
251885-51885101.501102.67
352813-52813103.317104.46
453751-53751105.152106.32
554024-54024105.686106.79
653245-53245104.162105.32
20min153997-53997105.633103.742.91107.37105.462.87
254093-54093105.821107.55
349983-4998397.78099.50
453708-53708105.068106.82
553180-53180104.035105.72
653213-53213104.099105.83
30min153606-53606104.868103.801.24107.19106.111.23
253979-53979105.598107.92
352279-52279102.272104.53
453199-53199104.072106.41
552791-52791103.274105.54
652518-52518102.740105.05
45min153391-53391104.447102.771.82107.36105.661.78
253183-53183104.041106.95
352054-52054101.832104.66
452949-52949103.583106.50
552806-52806103.303106.14
650831-5083199.439102.32
60min152892-52892103.471102.491.01106.96105.941.01
252983-52983103.649107.13
351875-51875101.482104.87
452710-52710103.115106.61
551871-51871101.474104.89
652016-52016101.758105.19
极限153346-53346104.359103.011.36108.42107.031.35
253405-53405104.475108.53
352077-52077101.877105.83
453068-53068103.816107.88
552351-52351102.413106.39
651698-51698101.135105.14
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%
111.053884193886343885333884903886273885410.03
211.153888413887153887780.03
单位质量响应值RSD%判断
35162.0834867.980.60数据可信
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%
5min14853-48531.2441.5813.541.241.5813.69
25975-59751.5311.53
36523-65231.6721.67
47438-74381.9061.91
56119-61191.5681.57
66201-62011.5891.59
10min112856-128563.2953.637.303.303.647.32
215948-159484.0874.10
314035-140353.5973.61
413878-138783.5563.57
513733-137333.5193.53
614572-145723.7343.74
15min119015-190154.8735.083.904.905.113.91
220426-204265.2345.27
319583-195835.0185.05
419169-191694.9124.94
519714-197145.0525.08
621035-210355.3915.42
20min123153-231535.9336.155.925.996.205.93
225857-258576.6266.69
322307-223075.7175.77
423433-234336.0056.06
523587-235876.0456.10
625600-256006.5606.62
30min128800-288007.3807.675.617.477.765.58
232649-326498.3678.46
328743-287437.3667.45
428972-289727.4257.52
528966-289667.4237.51
631398-313988.0468.14
45min134021-340218.7188.913.758.849.043.75
237102-371029.5089.65
333829-338298.6698.80
433886-338868.6848.82
534220-342208.7698.90
635472-354729.0909.23
60min137624-376249.6429.823.689.8210.003.71
240154-4015410.29010.49
337224-372249.5399.72
437312-373129.5629.74
537470-374709.6029.78
640093-4009310.27410.47
极限142350-4235010.85310.962.4011.0811.202.44
244315-4431511.35611.61
341624-4162410.66710.90
442182-4218210.81011.04
542395-4239510.86411.10
643706-4370611.20011.45
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%
112.455150351492515175142851531514940.08
212.435174651783517640.06
单位质量响应值RSD%判断
4136.064164.440.49数据可信
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%
5min153264-53264103.721104.721.84103.72104.721.84
254655-54655106.429106.43
354641-54641106.402106.40
453160-53160103.518103.52
554590-54590106.303106.30
652342-52342101.925101.93
10min155679-55679108.423106.062.76109.00106.642.74
252492-52492102.217102.81
356282-56282109.598110.19
453256-53256103.705104.28
555276-55276107.639108.23
653809-53809104.782105.35
15min155574-55574108.219106.962.16109.40108.132.15
255807-55807108.673109.83
355940-55940108.932110.13
453365-53365103.917105.07
555402-55402107.884109.07
653471-53471104.124105.27
20min155112-55112107.319105.133.42109.10106.903.39
256173-56173109.385111.15
355293-55293107.672109.48
452863-52863102.940104.67
553225-53225103.645105.43
651260-5126099.818101.55
30min152515-52515102.262101.852.44104.64104.202.42
254225-54225105.592107.96
352749-52749102.718105.12
450757-5075798.839101.14
552564-52564102.357104.72
650999-5099999.310101.59
45min152270-52270101.785100.842.29104.73103.762.28
253038-53038103.280106.24
352943-52943103.095106.07
450243-5024397.838100.69
551642-51642100.562103.49
650574-5057498.482101.32
60min151904-51904101.072100.372.37104.58103.842.36
252465-52465102.165105.70
352871-52871102.955106.50
449741-4974196.860100.25
551884-51884101.033104.52
650391-5039198.126101.51
极限152177-52177101.604100.512.62105.67104.542.60
252993-52993103.193107.29
352932-52932103.074107.19
449761-4976196.899100.83
551538-51538100.360104.41
650299-5029997.947101.87
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%
111.053888153888443889783891703889753889560.04
211.153912543913423912980.02
单位质量响应值RSD%判断
35199.6435093.990.22数据可信
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%
5min16633-66331.6931.3812.821.691.3812.74
24776-47761.2191.22
35597-55971.4291.43
45170-51701.3201.32
55380-53801.3741.37
64777-47771.2201.22
10min114867-148673.7963.417.833.803.427.78
211727-117272.9943.00
313968-139683.5663.57
413316-133163.4003.41
513324-133243.4023.41
612974-129743.3123.32
15min121212-212125.4155.113.475.455.143.52
219688-196885.0265.05
320420-204205.2135.24
419469-194694.9705.00
519988-199885.1035.13
619376-193764.9474.97
20min125157-251576.4236.103.966.486.163.94
224323-243236.2106.26
324583-245836.2766.33
423583-235836.0216.07
523041-230415.8825.94
622723-227235.8015.85
30min129461-294617.5217.361.587.627.451.61
228603-286037.3027.39
328977-289777.3987.49
428330-283307.2337.32
529166-291667.4467.53
628388-283887.2477.33
45min135495-354959.0628.722.189.208.852.19
234144-341448.7178.84
334282-342828.7528.88
433381-333818.5228.65
534046-340468.6928.82
633583-335838.5748.70
60min137865-378659.6679.560.989.869.731.04
237392-373929.5469.72
337682-376829.6209.80
436892-368929.4199.59
537600-376009.5999.78
637127-371279.4799.65
极限142243-4224310.78510.700.8911.0310.930.89
242250-4225010.78611.01
342137-4213710.75810.99
441402-4140210.57010.80
541848-4184810.68410.91
641532-4153210.60310.83
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%
112.455155251537516265150451540515520.09
212.435202852053520400.04
单位质量响应值RSD%判断
4140.724186.650.79数据可信
供试品溶液-24051503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%
5min148133-4813393.42896.211.7593.4396.221.75
250416-5041697.86097.86
349725-4972596.51996.52
449714-4971496.49796.50
549047-4904795.20395.20
650374-5037497.77897.78
10min150398-5039897.82599.121.6498.3499.651.64
252033-52033100.998101.54
350930-5093098.85899.39
451389-5138999.748100.28
549853-4985396.76797.30
651792-51792100.531101.07
15min150582-5058298.18298.581.4899.2499.661.48
251925-51925100.789101.89
350286-5028697.60798.69
450786-5078698.57899.67
549817-4981796.69797.76
651320-5132099.615100.72
20min150046-5004697.14297.761.4498.7599.391.44
251245-5124599.469101.13
350255-5025597.54799.17
450402-5040297.83399.47
549219-4921995.53697.14
651014-5101499.021100.68
30min149394-4939495.87697.161.3198.0299.341.31
250916-5091698.830101.05
349451-4945195.98798.16
450335-5033597.70399.88
549622-4962296.31998.45
650626-5062698.267100.47
45min149462-4946296.00896.672.1998.6999.382.16
250504-5050498.031100.80
349544-4954496.16798.87
449806-4980696.67699.40
548134-4813493.43096.10
651365-5136599.702102.45
60min148875-4887594.86995.601.4798.0898.851.46
250349-5034997.730101.04
348747-4874794.62097.86
449903-4990396.864100.13
548512-4851294.16497.35
649117-4911795.33898.64
极限147398-4739892.00293.513.6895.7497.293.57
249621-4962196.317100.17
345031-4503187.40791.17
449270-4927095.63599.43
548191-4819193.54197.25
649544-4954496.167100.00
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%
111.053893953895173892893894603891953893710.04
211.153931713931903931800.01
单位质量响应值RSD%判断
35237.1935262.780.06数据可信
供试品溶液-24051503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%
5min18607-86072.1912.336.832.192.336.88
29487-94872.4152.41
39405-94052.3942.39
48226-82262.0942.09
59264-92642.3582.36
69933-99332.5282.53
10min120453-204535.2065.313.795.225.323.79
220643-206435.2555.27
320714-207145.2735.29
419800-198005.0405.05
521983-219835.5965.61
621564-215645.4895.50
15min128392-283927.2277.403.527.277.443.52
229038-290387.3927.43
328596-285967.2797.32
427875-278757.0967.14
530654-306547.8037.85
629842-298427.5967.64
20min134436-344368.7668.892.878.858.982.88
234781-347818.8548.94
334566-345668.7998.88
433705-337058.5808.66
536570-365709.3099.40
635574-355749.0559.14
30min142456-4245610.80710.983.1410.9411.123.14
243110-4311010.97411.11
342388-4238810.79010.92
441712-4171210.61810.74
545553-4555311.59611.73
643655-4365511.11311.25
45min150253-5025312.79212.902.2712.9813.092.28
250429-5042912.83713.03
350192-5019212.77712.97
449083-4908312.49412.68
551921-5192113.21713.42
652103-5210313.26313.46
60min154903-5490313.97614.082.0414.2414.342.04
255566-5556614.14514.41
354601-5460113.89914.16
454392-5439213.84614.10
557446-5744614.62314.90
654893-5489313.97314.25
极限159218-5921815.07415.393.1515.4115.743.12
261548-6154815.66716.01
357545-5754514.64814.99
460412-6041215.37815.71
563018-6301816.04116.40
661033-6103315.53615.89
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%
112.455178851696517595177051739517500.07
212.435167851673516760.01
单位质量响应值RSD%判断
4156.634157.360.02数据可信
供试品溶液-2024052421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%
5min140841-4084179.39984.084.3779.4084.084.37
241416-4141680.51780.52
342743-4274383.09783.10
444030-4403085.59985.60
545172-4517287.81987.82
645281-4528188.03188.03
10min147774-4777492.87894.151.2393.3294.611.24
248930-4893095.12595.57
347805-4780592.93893.40
448251-4825193.80594.28
549234-4923495.71696.20
648568-4856894.42294.91
15min147145-4714591.65594.172.2392.6195.162.23
248693-4869394.66595.64
347499-4749992.34393.32
447976-4797693.27194.27
549691-4969196.60597.62
649623-4962396.47397.49
20min146849-4684991.08094.262.6092.5595.772.59
249051-4905195.36196.86
347277-4727791.91293.40
448361-4836194.01995.53
549151-4915195.55597.11
650211-5021197.61699.17
30min147222-4722291.80594.102.2293.7896.142.22
248526-4852694.34096.37
347462-4746292.27194.27
447942-4794293.20595.24
549301-4930195.84797.93
649969-4996997.14599.24
45min146673-4667390.73893.802.7293.2296.362.71
248409-4840994.11396.67
347350-4735092.05494.57
447576-4757692.49395.05
549324-4932495.89198.51
650162-5016297.521100.15
60min146984-4698491.34293.642.5094.3396.722.48
248112-4811293.53596.61
347183-4718391.72994.75
447958-4795893.23696.30
548419-4841994.13297.28
650342-5034297.870101.04
极限149404-4940496.04798.812.9499.54102.412.91
249863-4986396.939100.54
349681-4968196.585100.12
450843-5084398.844102.43
551997-51997101.088104.76
653169-53169103.366107.08
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%
111.053906783908263909123912733908863909150.06
211.153894573896043895300.03
单位质量响应值RSD%判断
35376.9234935.430.89数据可信
供试品溶液-2024052421批-阿齐沙坦-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%
5min1129673-12967333.09830.329.2733.1030.329.27
2108004-10800427.56727.57
3131207-13120733.49033.49
4123054-12305431.40931.41
5105036-10503626.81026.81
6115742-11574229.54229.54
10min1299417-29941776.42476.913.6976.6177.083.68
2320186-32018681.72581.88
3306884-30688478.33078.52
4288488-28848873.63473.81
5299317-29931776.39876.55
6293725-29372574.97175.14
15min1323889-32388982.67084.424.5883.2885.024.56
2359489-35948991.75792.36
3330494-33049484.35684.98
4315338-31533880.48881.07
5330546-33054684.36984.94
6324801-32480182.90383.48
20min1329742-32974284.16486.164.6885.2387.224.66
2369041-36904194.19595.31
3334897-33489785.48086.57
4325353-32535383.04484.07
5333348-33334885.08586.13
6332978-33297884.99086.03
30min1337967-33796786.26487.694.1587.8089.244.13
2371573-37157394.84196.48
3342933-34293387.53189.10
4331700-33170084.66486.16
5340342-34034286.87088.38
6336891-33689185.98987.50
45min1338798-33879886.47688.993.9188.4991.023.90
2375526-37552695.85098.02
3347581-34758188.71790.77
4340062-34006286.79888.76
5346556-34655688.45690.45
6343310-34331087.62789.62
60min1347467-34746788.68889.853.4691.1892.383.46
2376415-37641596.07798.78
3349136-34913689.11491.66
4342846-34284687.50989.95
5348774-34877489.02291.51
6347570-34757088.71591.19
极限1397428-397428101.441101.021.54104.43104.041.55
2402136-402136102.642105.88
3389152-38915299.328102.37
4388331-38833199.119102.05
5402206-402206102.660105.64
6395417-395417100.927103.90
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