替米沙坦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100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.897197887192197198367201577184967194990.10
210.957214897212137213510.03
单位质量响应值RSD%判断
66069.7065876.800.21数据可信
供试品溶液-2026031621批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1275646-27564637.60347.9711.7237.6047.9711.73
2345161-34516147.08747.09
3387634-38763452.88152.88
4367235-36723550.09850.10
5348885-34888547.59547.59
6385178-38517852.54652.55
10min1477350-47735065.12078.449.2065.3378.719.21
2568658-56865877.57677.84
3618636-61863684.39484.69
4604155-60415582.41882.70
5566597-56659777.29577.56
6614691-61469183.85684.15
15min1639743-63974387.27395.014.7687.8495.714.80
2683690-68369093.26893.96
3727355-72735599.22599.99
4717987-71798797.94798.68
5688463-68846393.92094.61
6721421-72142198.41699.17
20min1710503-71050396.92699.772.1897.98101.002.23
2730550-73055099.661100.87
3743575-743575101.438102.75
4753304-753304102.765104.05
5717385-71738597.86599.08
6732926-73292699.985101.29
30min1727885-72788599.298100.621.47100.89102.401.53
2737889-737889100.662102.43
3741774-741774101.192103.07
4745527-745527101.704103.56
5721845-72184598.474100.23
6750447-750447102.375104.24
45min1702837-70283795.88099.032.0598.03101.372.10
2729333-72933399.495101.82
3735585-735585100.348102.79
4743986-743986101.494103.91
5714619-71461997.48899.79
6729087-72908799.461101.89
60min1714057-71405797.41199.321.46100.09102.221.49
2741894-741894101.209104.08
3727030-72703099.181102.18
4737140-737140100.560103.54
5718703-71870398.045100.89
6729567-72956799.527102.51
极限1713743-71374397.36898.991.00100.59102.441.06
2730001-73000199.586103.02
3728736-72873699.414102.96
4733834-733834100.109103.65
5726669-72666999.132102.52
6720991-72099198.357101.89
替米沙坦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100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.897178507182617165707170857171457173820.10
210.957154217151287152740.03
单位质量响应值RSD%判断
65875.3065321.830.60数据可信
供试品溶液-2026031621批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1345231-34523147.36647.124.6947.3747.124.69
2368032-36803250.49450.49
3320700-32070044.00044.00
4345003-34500347.33547.33
5332050-33205045.55745.56
6349555-34955547.95947.96
10min1569434-56943478.12779.293.8278.3979.563.82
2617424-61742484.71184.99
3560639-56063976.92077.16
4579842-57984279.55579.82
5556430-55643076.34376.60
6583853-58385380.10580.37
15min1684608-68460893.92994.741.9594.6395.451.96
2700913-70091396.16696.92
3683630-68363093.79494.47
4697148-69714895.64996.35
5670313-67031391.96792.64
6706707-70670796.96197.67
20min1729096-729096100.03299.892.33101.25101.122.27
2704225-70422596.62097.91
3747134-747134102.507103.70
4744368-744368102.128103.36
5730375-730375100.208101.40
6713126-71312697.84199.09
30min1731113-731113100.309100.441.54102.08102.221.52
2726221-72622199.638101.46
3746204-746204102.380104.14
4745493-745493102.282104.09
5722856-72285699.176100.92
6720536-72053698.858100.65
45min1724130-72413099.35199.261.59101.68101.601.57
2715144-71514498.118100.49
3732691-732691100.526102.86
4741178-741178101.690104.06
5714907-71490798.086100.38
6712552-71255297.763100.11
60min1724241-72424199.36698.602.23102.25101.492.16
2699165-69916595.92698.85
3736439-736439101.040103.93
4720902-72090298.908101.85
5731842-731842100.409103.25
6699236-69923695.93698.82
极限1719973-71997398.78198.792.17102.22102.232.11
2702397-70239796.36999.82
3745707-745707102.311105.76
4728272-72827299.919103.41
5707378-70737897.053100.45
6716544-71654498.310101.73
替米沙坦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100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.897163477167827167137158167160667163450.06
210.957163667158017160840.06
单位质量响应值RSD%判断
65780.0765395.800.42数据可信
供试品溶液-2026031721批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1319870-31987043.89344.3712.8343.8944.3712.83
2331854-33185445.53845.54
3400349-40034954.93754.94
4310725-31072542.63842.64
5286377-28637739.29739.30
6290790-29079039.90339.90
10min1583238-58323880.03377.082.4080.2877.332.41
2567150-56715077.82578.08
3561677-56167777.07477.38
4552680-55268075.84076.08
5562008-56200877.12077.34
6543497-54349774.57974.80
15min1698249-69824995.81595.581.6996.5096.261.67
2686425-68642594.19294.88
3692400-69240095.01295.75
4713078-71307897.85098.51
5706614-70661496.96397.61
6682625-68262593.67194.31
20min1715533-71553398.18798.851.9399.41100.051.89
2708068-70806897.16298.37
3708550-70855097.22898.49
4743416-743416102.013103.21
5730229-730229100.203101.39
6716203-71620398.27899.43
30min1706487-70648796.94598.471.7398.71100.231.70
2707823-70782397.12998.88
3712467-71246797.76699.57
4732952-732952100.577102.35
5733512-733512100.654102.40
6712348-71234897.74999.45
45min1708938-70893897.28298.442.0599.59100.742.02
2708304-70830497.19599.48
3712097-71209797.715100.06
4736240-736240101.028103.36
5735626-735626100.944103.25
6703113-70311396.48298.73
60min1702566-70256696.40797.732.0999.25100.582.06
2711476-71147697.630100.46
3702818-70281896.44299.33
4735772-735772100.964103.85
5723650-72365099.300102.16
6696784-69678495.61498.40
极限1702849-70284996.44697.201.6899.83100.591.65
2707256-70725697.051100.42
3699346-69934695.96599.39
4716994-71699498.387101.84
5727496-72749699.828103.24
6696168-69616895.52998.84
替米沙坦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100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.897214347212017210457209977187727206900.16
210.957098247131567114900.34
单位质量响应值RSD%判断
66179.0664976.261.30数据可信
供试品溶液-2026031721批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1349078-34907847.91245.157.6347.9145.147.63
2303240-30324041.62141.62
3291202-29120239.96839.97
4345563-34556347.43047.43
5345895-34589547.47547.48
6338533-33853346.46546.46
10min1565440-56544077.60976.424.5577.8776.674.56
2541380-54138074.30674.54
3513768-51376870.51670.74
4585357-58535780.34280.61
5567781-56778177.93078.19
6566901-56690177.80978.07
15min1679835-67983593.31093.093.0894.0193.773.10
2649593-64959389.15989.80
3655939-65593990.03090.64
4700286-70028696.11796.83
5691844-69184494.95895.65
6691980-69198094.97795.67
20min1699393-69939395.99496.701.4497.2197.901.38
2714562-71456298.07699.22
3715896-71589698.25999.37
4708282-70828297.21498.46
5699391-69939195.99497.22
6689898-68989894.69195.91
30min1702077-70207796.36296.761.4498.1198.491.41
2720815-72081598.934100.62
3701045-70104596.22197.88
4705189-70518996.79098.57
5710446-71044697.51199.27
6690473-69047394.77096.51
45min1714059-71405998.00797.091.43100.2999.361.38
2715325-71532598.181100.41
3715154-71515498.157100.35
4707019-70701997.04199.36
5703311-70331196.53298.83
6689442-68944294.62896.90
60min1700435-70043596.13796.551.3498.9799.361.26
2716785-71678598.381101.16
3711842-71184297.703100.44
4697909-69790995.79098.65
5691238-69123894.87597.71
6702648-70264896.44199.24
极限1683756-68375693.84895.661.9397.2199.001.85
2719800-71980098.795102.12
3689479-68947994.63397.92
4697982-69798295.80099.19
5687039-68703994.29897.66
6703660-70366096.58099.91
替米沙坦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100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.897205627207687207297197817195877202850.08
210.957142017150847146420.09
单位质量响应值RSD%判断
66141.8765264.110.95数据可信
供试品溶液-2026031821批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1310584-31058442.54643.742.5242.5543.752.52
2308170-30817042.21542.22
3328174-32817444.95544.96
4323647-32364744.33544.34
5321616-32161644.05744.06
6323773-32377344.35244.35
10min1543872-54387274.50375.021.4074.7475.261.39
2558274-55827476.47676.71
3542875-54287574.36674.62
4552596-55259675.69875.94
5537318-53731873.60573.85
6550994-55099475.47975.72
15min1667227-66722791.40193.102.0192.0593.762.00
2692206-69220694.82395.48
3670184-67018491.80692.47
4687317-68731794.15394.82
5665170-66517091.11991.77
6695598-69559895.28795.95
20min1694450-69445095.13097.982.0696.2999.162.05
2719212-71921298.52299.71
3709171-70917197.14798.32
4739655-739655101.323102.51
5714459-71445997.87199.03
6714676-71467697.90199.10
30min1708424-70842497.04497.521.0398.7399.241.00
2716918-71691898.20899.94
3721773-72177398.873100.59
4705686-70568696.66998.42
5715627-71562798.03199.73
6703145-70314596.32198.06
45min1702966-70296696.29797.311.5698.5299.571.55
2726354-72635499.500101.78
3707316-70731696.89399.15
4721221-72122198.797101.09
5697782-69778295.58697.83
6706409-70640996.76899.04
60min1708455-70845597.04997.090.9899.8199.890.97
2716760-71676098.186101.02
3711799-71179997.507100.31
4713598-71359897.753100.59
5697882-69788295.60098.38
6703879-70387996.42299.23
极限1697766-69776695.58496.000.9798.8899.340.95
2711851-71185197.514100.89
3702105-70210596.17999.52
4692690-69269094.88998.27
5696288-69628895.38298.69
6704158-70415896.46099.81
替米沙坦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100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.897062787055367054987047587046047053350.10
210.957161897168757165320.07
单位质量响应值RSD%判断
64769.0565436.710.73数据可信
供试品溶液-2026031821批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1296818-29681841.03443.444.6541.0343.444.66
2305185-30518542.19142.19
3339878-33987846.98746.99
4311539-31153943.06943.07
5318197-31819743.99043.99
6313690-31369043.36743.37
10min1522178-52217872.18975.052.5772.4275.292.57
2549313-54931375.94176.17
3562110-56211077.71077.97
4548740-54874075.86176.10
5541508-54150874.86275.11
6533371-53337173.73773.98
15min1672892-67289293.02593.681.2893.6594.341.26
2681105-68110594.16094.82
3667786-66778692.31993.01
4690171-69017195.41496.07
5670570-67057092.70493.36
6683280-68328094.46195.11
20min1721024-72102499.67998.721.35100.8299.901.33
2726357-726357100.416101.60
3705710-70571097.56298.77
4717908-71790899.248100.44
5700763-70076396.87898.05
6712590-71259098.51399.69
30min1723950-723950100.08398.921.23101.78100.641.20
2713649-71364998.659100.40
3700894-70089496.89698.64
4723760-723760100.057101.80
5719214-71921499.429101.14
6711536-71153698.367100.09
45min1728156-728156100.66598.511.81102.92100.791.76
2712580-71258098.512100.80
3717950-71795099.254101.54
4694672-69467296.03698.33
5721801-72180199.786102.05
6700463-70046396.83699.11
60min1732571-732571101.27598.941.43104.09101.761.39
2710073-71007398.165101.00
3718332-71833299.307102.14
4720084-72008499.549102.38
5708358-70835897.928100.75
6704694-70469497.421100.23
极限1714166-71416698.73197.442.20102.11100.812.14
2695611-69561196.16699.54
3697190-69719096.38499.77
4732262-732262101.233104.62
5697616-69761696.44399.81
6691963-69196395.66199.01
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