替米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(%)100.0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%
111.868216038187588233258182488171898198250.32
211.658234728181938208320.46
单位质量响应值RSD%判断
69125.2170457.681.36数据可信
供试品溶液-2024070321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%
5min1296436-29643638.23135.897.4938.2335.897.49
2255050-25505032.89332.89
3267354-26735434.48034.48
4306075-30607539.47439.47
5285471-28547136.81636.82
6259355-25935533.44833.45
10min1539622-53962269.59465.456.0569.8165.656.05
2471321-47132160.78560.97
3478793-47879361.74961.94
4546507-54650770.48270.70
5504283-50428365.03665.24
6504604-50460465.07765.26
15min1697287-69728789.92785.593.9490.5386.153.95
2643497-64349782.99083.51
3632745-63274581.60382.14
4684577-68457788.28888.90
5646346-64634683.35883.92
6677261-67726187.34587.89
20min1751187-75118796.87996.331.8097.9897.371.81
2742525-74252595.76296.74
3727265-72726593.79394.78
4750673-75067396.81297.91
5742053-74205395.70196.73
6767813-76781399.023100.06
30min1785391-785391101.29099.631.29102.93101.211.26
2776415-776415100.132101.65
3774496-77449699.885101.39
4758372-75837297.80599.44
5763451-76345198.460100.02
6777226-777226100.237101.82
45min1720271-72027192.89196.302.5795.0998.432.48
2773930-77393099.812101.88
3731723-73172394.36896.43
4743283-74328395.85998.04
5756066-75606697.50899.62
6754910-75491097.35999.50
60min1740594-74059495.51297.192.0098.2399.861.93
2773262-77326299.726102.35
3739871-73987195.41998.01
4740475-74047595.49798.21
5762681-76268198.361101.01
6764865-76486598.643101.32
极限1715295-71529592.25095.142.5195.5098.342.41
2769836-76983699.284102.46
3737400-73740095.10198.22
4724973-72497393.49896.74
5736946-73694695.04298.24
6741630-74163095.64698.87
替米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(%)100.0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%
111.868344438311218358738405118355708355040.41
211.658358668291808325230.57
单位质量响应值RSD%判断
70447.2271461.201.02数据可信
供试品溶液-2024070421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%
5min1307251-30725138.97439.714.6638.9739.714.66
2327371-32737141.52741.53
3314790-31479039.93139.93
4318420-31842040.39140.39
5286952-28695236.40036.40
6323621-32362141.05141.05
10min1538610-53861068.32268.686.7968.5468.906.78
2559189-55918970.93271.16
3556791-55679170.62870.85
4554901-55490170.38970.61
5469362-46936259.53859.74
6569791-56979172.27772.51
15min1668891-66889184.84884.976.5085.4485.586.50
2711996-71199690.31690.94
3684855-68485586.87387.49
4695663-69566388.24488.86
5587407-58740774.51275.04
6670516-67051685.05485.68
20min1733290-73329093.01792.673.6394.0893.743.65
2731929-73192992.84493.97
3756238-75623895.92897.02
4743649-74364994.33195.44
5679579-67957986.20487.15
6738521-73852193.68194.78
30min1762941-76294196.77896.411.0198.3698.001.00
2763482-76348296.84798.49
3770925-77092597.79199.42
4755049-75504995.77797.41
5759028-75902896.28297.71
6748863-74886394.99296.61
45min1705272-70527289.46393.442.6391.5895.562.55
2745403-74540394.55496.73
3752944-75294495.51097.68
4734648-73464893.18995.35
5756768-75676895.99597.96
6724796-72479691.94094.09
60min1739187-73918793.76593.111.7196.3895.751.63
2740117-74011793.88396.59
3741444-74144494.05196.75
4717882-71788291.06393.74
5746852-74685294.73797.23
6718643-71864391.15993.82
极限1738908-73890893.73093.471.0196.8796.630.97
2735163-73516393.25596.48
3726608-72660892.16995.40
4749358-74935895.05598.24
5737040-73704093.49396.51
6733990-73399093.10696.27
替米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(%)100.0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%
111.868242478317798366528239868341738301670.70
211.658131908023938077920.95
单位质量响应值RSD%判断
69997.2269338.370.67数据可信
供试品溶液-2024070521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%
5min1283119-28311936.57540.015.0536.5840.015.04
2318798-31879841.18541.18
3311916-31191640.29640.30
4300273-30027338.79138.79
5325942-32594242.10842.11
6318185-31818541.10541.11
10min1505308-50530865.27968.993.5665.4869.213.56
2550290-55029071.09171.32
3535993-53599369.24469.47
4516440-51644066.71866.93
5549649-54964971.00871.24
6546362-54636270.58370.81
15min1654743-65474384.58587.422.6685.1588.022.66
2689620-68962089.09089.71
3693487-69348789.59090.20
4656180-65618084.77085.36
5692531-69253189.46690.09
6673543-67354387.01387.63
20min1726824-72682493.89794.442.0294.9395.532.00
2740704-74070495.69096.81
3718659-71865992.84293.95
4746001-74600196.37497.43
5743852-74385296.09697.22
6710202-71020291.74992.85
30min1728817-72881794.15495.821.6495.7197.441.63
2737966-73796695.33696.99
3753426-75342697.33398.96
4754737-75473797.50399.10
5747985-74798596.63098.29
6727240-72724093.95095.56
45min1732463-73246394.62594.931.1596.7197.081.14
2728560-72856094.12196.30
3737803-73780395.31597.48
4740573-74057395.67397.81
5746445-74644596.43198.63
6723210-72321093.43095.57
60min1741241-74124195.75994.411.7098.3797.081.64
2731430-73143094.49297.19
3744437-74443796.17298.86
4733951-73395194.81797.48
5722556-72255693.34596.08
6711011-71101191.85494.51
极限1723687-72368793.49192.671.2896.6395.871.23
2714038-71403892.24595.47
3729936-72993694.29997.53
4721091-72109193.15696.35
5707146-70714691.35494.60
6707923-70792391.45594.62
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