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%
112.455096350927509345087150967509320.08
212.435090950875508920.05
单位质量响应值RSD%判断
4090.924094.290.06数据可信
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%
5min139843-3984378.67884.664.4178.6884.664.41
241645-4164582.23682.24
343782-4378286.45686.46
442716-4271684.35184.35
544398-4439887.67387.67
644863-4486388.59188.59
10min145284-4528489.42292.112.5589.8692.582.56
245932-4593290.70291.16
347433-4743393.66694.15
445538-4553889.92490.39
547709-4770994.21194.70
647961-4796194.70995.20
15min146015-4601590.86693.422.5691.8094.402.56
246713-4671392.24493.20
347386-4738693.57394.57
446263-4626391.35592.32
548572-4857295.91596.93
648912-4891296.58697.60
20min145223-4522389.30293.753.5990.7495.263.58
247068-4706892.94594.42
348476-4847695.72597.25
445958-4595890.75392.23
548404-4840495.58397.13
649733-4973398.20899.76
30min145692-4569290.22893.593.6592.1695.613.63
246624-4662492.06894.06
348734-4873496.23598.29
445310-4531089.47491.45
548762-4876296.29098.36
649238-4923897.23099.33
45min143644-4364486.18492.934.6288.6295.474.58
245979-4597990.79593.30
348877-4887796.51799.10
446172-4617291.17693.65
548439-4843995.65298.26
649246-4924697.24699.89
60min145697-4569790.23893.013.2793.1596.073.27
245842-4584290.52493.53
348546-4854695.86498.99
445618-4561890.08293.07
548042-4804294.86898.01
648855-4885596.47499.65
极限149143-4914397.04397.001.52100.46100.571.55
247996-4799694.77898.29
349557-4955797.860101.52
448650-4865096.06999.55
549198-4919897.151100.82
650169-5016999.069102.79
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%
111.053893353893523894753894073894833894100.02
211.153893043893753893400.02
单位质量响应值RSD%判断
35240.7234918.390.65数据可信
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%
5min1126057-12605732.24534.108.7132.2434.108.71
2127923-12792332.72232.72
3129865-12986533.21933.22
4149603-14960338.26838.27
5145768-14576837.28737.29
6120715-12071530.87830.88
10min1287284-28728473.48678.706.8173.6778.906.80
2288941-28894173.91074.09
3316310-31631080.91181.10
4302182-30218277.29777.51
5343977-34397787.98888.19
6307410-30741078.63478.81
15min1314671-31467180.49185.636.5381.0886.266.52
2312554-31255479.95080.54
3345370-34537088.34488.98
4323477-32347782.74483.39
5369037-36903794.39895.09
6343411-34341187.84388.45
20min1319200-31920081.65087.006.5082.6888.106.49
2318286-31828681.41682.45
3347861-34786188.98190.11
4328264-32826483.96885.07
5374183-37418395.71496.93
6352905-35290590.27191.37
30min1330391-33039184.51388.165.9286.0089.745.93
2322269-32226982.43583.92
3352237-35223790.10191.72
4331944-33194484.91086.48
5377507-37750796.56598.32
6353479-35347990.41892.02
45min1336664-33666486.11789.275.1788.0791.355.19
2329346-32934684.24586.19
3355089-35508990.83092.95
4336697-33669786.12688.17
5377328-37732896.51998.81
6358852-35885291.79393.89
60min1339874-33987486.93889.655.0789.3792.225.09
2327087-32708783.66786.08
3357094-35709491.34393.97
4342280-34228087.55490.07
5377588-37758896.58599.41
6358894-35889491.80394.41
极限1383459-38345998.08799.192.39101.01102.262.48
2376126-37612696.21199.09
3386395-38639598.838101.97
4385882-38588298.707101.71
5403792-403792103.288106.65
6390948-390948100.003103.12
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%
112.455075850700507375073050776507400.06
212.435088550906508960.03
单位质量响应值RSD%判断
4075.504094.610.34数据可信
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%
5min141170-4117081.44984.021.8681.4584.021.86
242059-4205983.20883.21
343428-4342885.91685.92
442478-4247884.03784.04
542698-4269884.47284.47
642992-4299285.05485.05
10min145652-4565290.31690.740.8990.7791.210.88
246608-4660892.20792.67
345757-4575790.52491.00
445835-4583590.67891.14
545415-4541589.84790.32
645939-4593990.88491.36
15min145703-4570390.41791.080.6991.3792.050.69
246314-4631491.62692.60
346267-4626791.53392.51
445820-4582090.64891.62
545737-4573790.48491.45
646377-4637791.75092.73
20min145618-4561890.24991.080.5691.7192.560.57
246334-4633491.66593.15
346153-4615391.30792.80
446125-4612591.25292.73
545855-4585590.71892.19
646149-4614991.29992.79
30min145458-4545889.93290.750.8691.8992.740.86
246048-4604891.09993.09
346008-4600891.02093.02
445837-4583790.68292.66
545425-4542589.86791.84
646460-4646091.91593.91
45min145925-4592590.85690.590.8593.3193.080.83
245781-4578190.57193.07
346110-4611091.22293.72
446128-4612891.25893.74
545074-4507489.17391.65
645721-4572190.45392.96
60min145351-4535189.72190.190.6592.6893.180.65
245872-4587290.75193.75
345787-4578790.58393.59
445663-4566390.33893.33
545110-4511089.24492.21
645740-4574090.49093.50
极限146910-4691092.80593.822.1296.2797.312.05
247108-4710893.19796.70
349060-4906097.058100.57
446415-4641591.82695.32
548220-4822095.39698.86
646834-4683492.65496.16
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%
111.053885783885433885543888833890203887160.06
211.153895863899233897540.07
单位质量响应值RSD%判断
35177.9234955.520.45数据可信
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%
5min1126331-12633132.32631.602.9532.3331.602.95
2119980-11998030.70130.70
3120476-12047630.82830.83
4124424-12442431.83831.84
5128897-12889732.98332.98
6120935-12093530.94630.95
10min1301221-30122177.07877.132.9677.2677.302.95
2304797-30479777.99378.16
3297402-29740276.10176.27
4314404-31440480.45280.63
5287399-28739973.54173.72
6303298-30329877.61077.78
15min1329325-32932584.27083.624.4084.8884.224.38
2329175-32917584.23184.84
3320956-32095682.12882.72
4346219-34621988.59389.22
5302745-30274577.46878.06
6332233-33223385.01485.62
20min1335732-33573285.90984.954.0786.9986.014.05
2334221-33422185.52386.59
3326331-32633183.50484.55
4351167-35116789.85990.97
5309987-30998779.32180.34
6334371-33437185.56186.64
30min1341739-34173987.44686.393.8289.0087.933.80
2338018-33801886.49488.04
3332695-33269585.13286.65
4355410-35541090.94592.56
5316290-31629080.93482.40
6341454-34145487.37388.92
45min1357089-35708991.37488.104.1893.4190.124.16
2343058-34305887.78489.81
3339355-33935586.83688.82
4361608-36160892.53194.65
5320934-32093482.12384.04
6343729-34372987.95689.99
60min1351599-35159989.96988.523.3692.5291.033.36
2347112-34711288.82191.34
3342625-34262587.67390.14
4361363-36136392.46895.10
5326153-32615383.45885.83
6346820-34682088.74691.27
极限1389342-38934299.62799.861.92102.67102.861.96
2393566-393566100.708103.72
3394382-394382100.917103.87
4397249-397249101.651104.80
5376036-37603696.22299.05
6390989-390989100.049103.07
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%
112.455124051205512805124351170512280.09
212.435071850749507340.05
单位质量响应值RSD%判断
4114.704081.580.58数据可信
供试品溶液-24051503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%
5min140656-4065680.17682.941.9880.1882.941.98
241711-4171182.25782.26
342429-4242983.67383.67
442418-4241883.65183.65
543109-4310985.01485.01
642032-4203282.89082.89
10min145468-4546889.66689.081.3390.1189.541.33
244850-4485088.44788.90
345262-4526289.26089.72
445648-4564890.02190.49
545681-4568190.08690.56
644118-4411887.00487.46
15min145921-4592190.55989.681.1591.5090.641.15
245065-4506588.87189.82
345533-4553389.79490.75
445845-4584590.40991.37
545861-4586190.44191.41
644633-4463388.01988.96
20min145976-4597690.66889.231.8792.1190.691.85
243970-4397086.71288.15
345445-4544589.62091.08
445574-4557489.87591.34
546050-4605090.81492.29
644478-4447887.71389.15
30min145451-4545189.63289.460.6791.5891.410.68
245101-4510188.94290.87
345440-4544089.61191.57
445787-4578790.29592.26
545459-4545989.64891.63
644933-4493388.61190.53
45min146252-4625291.21289.941.5393.6692.381.51
244717-4471788.18590.60
345660-4566090.04492.50
446368-4636891.44193.91
545803-4580390.32692.80
644838-4483888.42390.84
60min145790-4579090.30189.601.2693.2692.551.25
244528-4452887.81290.72
345771-4577190.26393.22
445988-4598890.69193.67
545592-4559289.91092.89
644953-4495388.65091.55
极限148535-4853595.71494.501.0899.1797.941.07
247073-4707392.83196.23
348082-4808294.82198.28
448294-4829495.23998.72
547844-4784494.35197.83
647690-4769094.04897.44
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%
111.053922063916183919923915553917703918280.07
211.153881543883043882290.03
单位质量响应值RSD%判断
35459.5534818.741.29数据可信
供试品溶液-24051503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%
5min1161928-16192841.35336.9110.0341.3536.9110.03
2147340-14734037.62737.63
3156227-15622739.89739.90
4123445-12344531.52531.53
5132082-13208233.73133.73
6146149-14614937.32337.32
10min1306112-30611278.17478.092.5378.4078.292.54
2311557-31155779.56579.77
3314989-31498980.44180.66
4292637-29263774.73374.91
5303113-30311377.40877.60
6306225-30622578.20378.41
15min1318301-31830181.28782.302.4081.9582.942.41
2327995-32799583.76384.41
3329999-32999984.27484.94
4309165-30916578.95479.54
5321757-32175782.16982.79
6326393-32639383.35384.00
20min1325683-32568383.17283.682.3584.2984.782.36
2333609-33360985.19686.31
3333273-33327385.11086.25
4314331-31433180.27381.30
5325062-32506283.01484.09
6334037-33403785.30686.41
30min1333009-33300985.04385.202.4486.6286.762.45
2339656-33965686.74088.33
3337314-33731486.14287.75
4320779-32077981.92083.39
5328139-32813983.79985.33
6342864-34286487.56089.14
45min1354411-35441190.50988.162.8092.5690.202.79
2347999-34799988.87190.94
3345453-34545388.22190.31
4330976-33097684.52486.45
5337080-33708086.08388.08
6355468-35546890.77992.84
60min1356039-35603990.92488.992.9993.4891.522.98
2351484-35148489.76192.33
3349136-34913689.16191.74
4332985-33298585.03787.44
5339953-33995386.81689.30
6361192-36119292.24094.81
极限1385615-38561598.47799.081.76101.54102.101.75
2391498-39149899.980103.04
3386838-38683898.790101.86
4376304-37630496.10098.97
5395869-395869101.096104.06
6391730-391730100.039103.12
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