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%
111.914689846956470534715547132470390.24
211.994716646935470500.35
单位质量响应值RSD%判断
3949.543924.100.46数据可信
中间条件3月-供试品溶液-24051501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%
5min142166-4216686.56186.832.8786.5686.832.87
241971-4197186.16186.16
342630-4263087.51387.51
440269-4026982.66782.67
543956-4395690.23690.24
642790-4279087.84287.84
10min148255-4825599.06197.131.3399.5497.611.33
246991-4699196.46696.94
347710-4771097.94298.43
446451-4645195.35795.82
547389-4738997.28397.78
647077-4707796.64397.13
15min148342-4834299.23997.961.59100.2798.981.60
246954-4695496.39097.40
347785-4778598.09699.13
446620-4662095.70496.69
548301-4830199.155100.20
648310-4831099.174100.20
20min148874-48874100.33297.942.01101.9199.512.00
246119-4611994.67696.23
348078-4807898.697100.27
447166-4716696.82598.35
548223-4822398.995100.59
647802-4780298.13199.71
30min148910-48910100.40597.451.81102.5599.561.81
246510-4651095.47997.55
347744-4774498.012100.14
446717-4671795.90397.96
547627-4762797.77299.91
647312-4731297.12599.25
45min148088-4808898.71897.041.64101.4299.691.63
246122-4612294.68297.29
347789-4778998.104100.77
446567-4656795.59698.19
547738-4773897.999100.69
647319-4731997.13999.80
60min147981-4798198.49896.751.76101.7499.941.75
246206-4620694.85497.99
348232-4823299.014102.23
446365-4636595.18198.30
547082-4708296.65399.88
646924-4692496.32899.53
极限149509-49509101.635101.051.38105.43104.781.33
248463-4846399.488103.15
349225-49225101.052104.82
450341-50341103.343106.99
549225-49225101.052104.82
648595-4859599.759103.49
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%
111.353939473930623933243930983931403933140.10
211.363922523922843922680.01
单位质量响应值RSD%判断
34653.2234530.630.26数据可信
中间条件3月-供试品溶液-24051501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%
5min1108214-10821428.07027.787.1428.0727.787.14
2104036-10403626.98726.99
3113831-11383129.52729.53
4116185-11618530.13830.14
5105417-10541727.34527.34
694843-9484324.60224.60
10min1282616-28261673.31071.903.3973.4772.053.39
2282060-28206073.16573.32
3288704-28870474.88975.05
4277490-27749071.98072.15
5268003-26800369.51969.67
6264180-26418068.52768.66
15min1311515-31151580.80680.732.0881.3781.282.07
2316796-31679682.17682.73
3319636-31963682.91283.49
4301553-30155378.22278.79
5309795-30979580.36080.90
6308011-30801179.89780.41
20min1320831-32083183.22283.531.4884.2384.531.47
2322613-32261383.68584.70
3327810-32781085.03386.07
4313607-31360781.34982.35
5322489-32248983.65384.64
6324634-32463484.20985.17
30min1331971-33197186.11285.211.8387.5986.681.80
2329842-32984285.56087.04
3332109-33210986.14887.66
4317178-31717882.27583.73
5326852-32685284.78486.23
6333117-33311786.40987.84
45min1333814-33381486.59086.711.4988.5488.651.46
2334821-33482186.85188.80
3337537-33753787.55689.55
4325660-32566084.47586.39
5333525-33352586.51588.44
6340350-34035088.28690.19
60min1340238-34023888.25787.781.6090.6990.201.59
2340626-34062688.35790.79
3344669-34466989.40691.88
4329254-32925485.40787.79
5335121-33512186.92989.33
6340402-34040288.29990.70
极限1387371-387371100.48399.321.66103.41102.231.62
2392235-392235101.744104.67
3380727-38072798.759101.73
4383353-38335399.440102.30
5374136-37413697.05099.93
6379540-37954098.451101.34
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%
111.914688347116468634718546945469980.31
211.994728347122472020.25
单位质量响应值RSD%判断
3946.103936.780.17数据可信
中间条件3月-供试品溶液-24051501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%
5min138684-3868479.31984.633.3979.3284.623.39
242118-4211886.36086.36
341496-4149685.08585.08
442358-4235886.85286.85
542202-4220286.53386.53
640777-4077783.61183.61
10min143299-4329988.78294.513.3489.2294.983.34
246079-4607994.48294.96
346331-4633194.99995.47
447713-4771397.83398.32
547232-4723296.84697.33
645901-4590194.11794.58
15min143907-4390790.02996.103.1690.9697.103.16
247757-4775797.92398.93
347280-4728096.94597.95
447661-4766197.72698.75
547625-4762597.65298.67
646979-4697996.32797.31
20min144676-4467691.60596.763.2793.0498.293.26
247029-4702996.43097.98
349067-49067100.609102.15
447538-4753897.47499.04
548351-4835199.141100.70
646478-4647895.30096.82
30min144781-4478191.82196.292.6293.7698.362.63
246625-4662595.60297.69
347600-4760097.60199.70
447498-4749897.39299.50
548367-4836799.173101.29
646892-4689296.14998.20
45min143949-4394990.11595.453.2592.5798.053.23
246520-4652095.38698.00
346345-4634595.02897.67
447886-4788698.187100.84
548213-4821398.858101.52
646379-4637995.09797.68
60min144397-4439791.03396.062.9193.9999.192.91
247433-4743397.258100.40
347941-4794198.300101.47
447298-4729896.982100.18
547871-4787198.156101.37
646149-4614994.62697.74
极限147754-4775497.917101.301.83101.38104.971.87
249737-49737101.983105.67
349902-49902102.321106.04
450047-50047102.618106.35
550031-50031102.585106.34
648961-48961100.391104.03
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%
111.353926653925453923063926293922583924810.05
211.363927093924263925680.06
单位质量响应值RSD%判断
34579.8234557.040.05数据可信
中间条件3月-供试品溶液-24051501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%
5min1111195-11119528.86326.8913.0228.8626.8913.02
2113355-11335529.42429.42
399438-9943825.81125.81
494088-9408824.42324.42
583874-8387421.77121.77
6119682-11968231.06631.07
10min1275111-27511171.41168.863.4171.5769.013.43
2271568-27156870.49170.65
3262026-26202668.01568.16
4255804-25580466.40066.54
5254492-25449266.05966.18
6272715-27271570.78970.96
15min1300458-30045877.99178.761.8978.5579.291.86
2306080-30608079.45080.00
3300766-30076678.07078.59
4299231-29923177.67278.18
5313994-31399481.50481.99
6300034-30003477.88078.45
20min1310066-31006680.48481.473.0281.4782.442.97
2311528-31152880.86481.86
3316183-31618382.07283.03
4306350-30635079.52080.46
5331765-33176586.11787.06
6307203-30720379.74180.74
30min1318797-31879782.75183.263.5284.1984.683.46
2316414-31641482.13283.58
3320195-32019583.11484.52
4310115-31011580.49781.88
5342673-34267388.94890.37
6316384-31638482.12483.57
45min1321974-32197483.57584.273.4785.4786.163.41
2325384-32538484.46186.36
3317418-31741882.39384.27
4317580-31758082.43584.26
5346766-34676690.01191.92
6318850-31885082.76584.66
60min1328327-32832785.22585.853.0787.5988.203.03
2334455-33445586.81589.19
3332222-33222286.23688.57
4317798-31779882.49184.77
5347464-34746490.19292.61
6324041-32404184.11286.47
极限1382858-38285899.37999.101.31102.21101.931.31
2378611-37861198.277101.13
3379677-37967798.554101.36
4379068-37906898.395101.14
5391429-391429101.604104.52
6379026-37902698.385101.21
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%
111.914708747010470354687047031470070.18
211.994689147131470110.37
单位质量响应值RSD%判断
3946.853920.850.47数据可信
中间条件3月-供试品溶液-24051502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%
5min143102-4310288.54989.522.6788.5589.522.66
242662-4266287.64587.65
345093-4509392.64092.64
442108-4210886.50786.51
543849-4384990.08490.08
644637-4463791.70391.70
10min149343-49343101.37198.983.29101.8699.483.28
249269-49269101.219101.71
349497-49497101.687102.20
445697-4569793.88094.36
548504-4850499.647100.15
646761-4676196.06696.58
15min150000-50000102.72199.802.96103.78100.842.96
249594-49594101.886102.94
349444-49444101.578102.66
446107-4610794.72395.72
548325-4832599.279100.33
647986-4798698.58399.63
20min150609-50609103.972100.163.72105.60101.763.70
249607-49607101.913103.53
350358-50358103.456105.10
445973-4597394.44795.98
548599-4859999.842101.45
647374-4737497.32698.92
30min150239-50239103.212100.262.43105.41102.412.42
249751-49751102.209104.39
349425-49425101.539103.76
447804-4780498.209100.26
548351-4835199.333101.49
647233-4723397.03699.17
45min150476-50476103.698100.153.15106.48102.873.13
248836-48836100.329103.08
350035-50035102.792105.58
446634-4663495.80598.40
549299-49299101.280103.99
647220-4722097.00999.68
60min150232-50232103.19799.743.46106.55103.023.44
249467-49467101.626104.93
349738-49738102.182105.54
445706-4570693.89997.03
548564-4856499.770103.05
647593-4759397.776100.99
极限151022-51022104.820102.112.15108.75105.942.17
250141-50141103.010106.88
350377-50377103.495107.42
447986-4798698.583102.24
549593-49593101.884105.71
649106-49106100.884104.64
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%
111.353927003927233925453928183926983926970.03
211.363927643926593927120.02
单位质量响应值RSD%判断
34598.8534569.720.06数据可信
中间条件3月-供试品溶液-24051502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%
5min1106107-10610727.53029.3316.8227.5329.3316.81
295584-9558424.80024.80
3142236-14223636.90436.90
4130121-13012133.76033.76
596203-9620324.96024.96
6107995-10799528.02028.02
10min1273512-27351270.96471.733.0971.1271.893.12
2269878-26987870.02170.16
3289831-28983175.19875.40
4283849-28384973.64673.83
5273514-27351470.96471.10
6268136-26813669.56969.72
15min1309678-30967880.34779.211.8980.8979.771.87
2312238-31223881.01181.54
3301158-30115878.13678.76
4308651-30865180.08080.68
5297402-29740277.16277.69
6302687-30268778.53379.08
20min1318987-31898782.76280.962.0583.7681.962.04
2318370-31837082.60283.58
3308321-30832179.99581.05
4315755-31575581.92482.97
5304867-30486779.09980.06
6305945-30594579.37880.36
30min1345874-34587489.73884.064.3291.1985.514.26
2326952-32695284.82986.26
3308382-30838280.01181.51
4333033-33303386.40687.90
5315229-31522981.78783.19
6314522-31452281.60483.02
45min1372599-37259996.67286.595.8398.6288.515.72
2329301-32930185.43887.35
3320342-32034283.11485.06
4331171-33117185.92387.90
5323151-32315183.84385.70
6325866-32586684.54786.42
60min1373915-37391597.01387.435.5999.5089.835.49
2336688-33668887.35589.74
3323276-32327683.87586.28
4332902-33290286.37288.83
5323826-32382684.01886.34
6331360-33136085.97288.31
极限1392607-392607101.863100.471.92104.89103.361.91
2380762-38076298.790101.66
3379511-37951198.465101.34
4397314-397314103.084106.02
5382035-38203599.120101.91
6391273-391273101.517104.34
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%
111.914698647057470664702547011470290.08
211.994681346838468260.04
单位质量响应值RSD%判断
3948.703905.420.78数据可信
中间条件3月-供试品溶液-24051502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%
5min139944-3994482.20585.927.7482.2085.927.74
243999-4399990.55090.55
344203-4420390.97090.97
442631-4263187.73587.73
535992-3599274.07274.07
643729-4372989.99489.99
10min147256-4725697.25397.902.8297.7198.382.84
248940-48940100.719101.22
348078-4807898.94599.45
448305-4830599.41299.90
545094-4509492.80493.22
647759-4775998.28898.79
15min148046-4804698.879100.271.7399.88101.301.75
250099-50099103.104104.17
348835-48835100.503101.56
448973-48973100.787101.83
547681-4768198.12899.05
648704-48704100.233101.28
20min145926-4592694.51698.912.7296.06100.482.71
249765-49765102.417104.05
348955-48955100.750102.36
448058-4805898.904100.50
547582-4758297.92499.40
648076-4807698.941100.54
30min147627-4762798.017100.452.42100.09102.582.43
250394-50394103.711105.92
348694-48694100.212102.39
449991-49991102.882105.03
547549-4754997.85699.87
648595-48595100.009102.16
45min146953-4695396.62999.472.8299.25102.162.81
250443-50443103.812106.59
348367-4836799.539102.27
449406-49406101.678104.40
547221-4722197.18199.74
647616-4761697.994100.70
60min147210-4721097.158100.082.64100.31103.322.64
250507-50507103.944107.30
348930-48930100.698103.98
449626-49626102.131105.42
547586-4758697.932101.03
647918-4791898.615101.87
极限148278-4827899.356102.721.99103.05106.511.99
250429-50429103.783107.72
349963-49963102.824106.67
451289-51289105.553109.41
549636-49636102.151105.79
649872-49872102.637106.44
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%
111.353923433926223925853922253924403924430.05
211.363907913908753908330.02
单位质量响应值RSD%判断
34576.4834404.310.36数据可信
中间条件3月-供试品溶液-24051502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%
5min1113664-11366429.57126.9014.0629.5726.9014.07
2103937-10393727.04027.04
3112809-11280929.34929.35
485303-8530322.19322.19
5118639-11863930.86530.87
686022-8602222.38022.38
10min1267270-26727069.53369.855.2069.7070.005.22
2277562-27756272.21172.36
3282900-28290073.60073.76
4252226-25222665.61965.74
5279537-27953772.72572.90
6251318-25131865.38365.51
15min1291375-29137575.80479.012.5776.3579.552.56
2312963-31296381.42181.97
3310591-31059180.80481.38
4300630-30063078.21278.70
5301257-30125778.37578.95
6305380-30538079.44879.94
20min1295237-29523776.80980.073.0277.7881.053.00
2317725-31772582.66083.66
3317821-31782182.68583.71
4301958-30195878.55879.48
5302621-30262178.73079.74
6311334-31133480.99781.93
30min1306125-30612579.64283.793.5681.0485.213.51
2337820-33782087.88889.35
3324919-32491984.53186.01
4323989-32398984.28985.65
5311688-31168881.08982.54
6327935-32793585.31686.69
45min1317353-31735382.56386.985.9284.4088.865.84
2365981-36598195.21497.17
3348336-34833690.62392.57
4328514-32851485.46787.29
5313642-31364281.59783.50
6332141-33214186.41088.26
60min1328205-32820585.38689.355.6887.6991.725.60
2371727-37172796.70999.19
3358673-35867393.31395.77
4334459-33445987.01389.32
5320202-32020283.30485.66
6347288-34728890.35192.68
极限1376433-37643397.933101.302.99100.71104.162.97
2391490-391490101.850104.87
3407248-407248105.950108.92
4380291-38029198.937101.72
5383378-38337899.740102.55
6397378-397378103.382106.22
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