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%
111.087573437588807577517581507575967579440.08
211.057555387550667553020.05
单位质量响应值RSD%判断
68406.5068353.120.06数据可信
供试品溶液-2024070321批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min180153-8015310.55011.7610.6310.5511.7610.63
299303-9930313.07013.07
391389-9138912.02812.03
477477-7747710.19710.20
5100267-10026713.19713.20
687652-8765211.53711.54
10min1172819-17281922.74625.5212.4022.8025.5812.41
2218781-21878128.79528.87
3187800-18780024.71824.78
4171391-17139122.55822.61
5228327-22832730.05230.13
6184119-18411924.23324.30
15min1252240-25224033.19938.1011.3533.3838.3011.35
2306225-30622540.30540.54
3276915-27691536.44736.65
4271951-27195135.79435.98
5346198-34619845.56645.81
6283120-28312037.26437.46
20min1323069-32306942.52248.8411.9942.8949.2611.99
2397373-39737352.30152.76
3336992-33699244.35444.76
4350911-35091146.18646.57
5444037-44403758.44358.94
6373906-37390649.21349.62
30min1443005-44300558.30762.227.1758.9162.917.19
2456260-45626060.05260.80
3458255-45825560.31560.97
4462231-46223160.83861.48
5537730-53773070.77571.59
6479007-47900763.04663.73
45min1530994-53099469.88874.115.1570.8275.155.21
2568598-56859874.83875.92
3541567-54156771.28072.27
4563489-56348974.16575.14
5614696-61469680.90582.12
6559154-55915473.59574.62
60min1573964-57396475.54479.053.2676.8680.503.34
2599397-59939778.89180.39
3602057-60205779.24180.63
4601901-60190179.22180.61
5634254-63425483.47985.14
6592255-59225577.95179.39
90min1612233-61223380.58182.073.9982.3283.954.01
2658430-65843086.66188.60
3592450-59245077.97779.80
4617006-61700681.20983.04
5648230-64823085.31987.44
6612757-61275780.65082.52
120min1694074-69407491.35390.102.1193.5492.442.14
2690113-69011390.83193.25
3683446-68344689.95492.21
4665900-66590087.64489.92
5703469-70346992.58995.19
6670196-67019688.21090.53
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1667607-66760787.86990.052.9590.5692.892.99
2706245-70624592.95495.88
3693480-69348091.27494.03
4664189-66418987.41990.18
5706306-70630692.96296.08
6667101-66710187.80290.61
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%
111.087526117520467518997516877517407519970.05
211.057493877483927488900.10
单位质量响应值RSD%判断
67869.7767772.850.11数据可信
供试品溶液-2024070421批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1107586-10758614.27713.274.3714.2813.274.38
297181-9718112.89612.90
395158-9515812.62812.63
4101771-10177113.50513.51
5100070-10007013.27913.28
698198-9819813.03113.03
10min1237720-23772031.54628.068.4631.6328.138.44
2198528-19852826.34526.42
3230474-23047430.58430.65
4204883-20488327.18827.26
5199128-19912826.42526.50
6197917-19791726.26426.34
15min1337201-33720144.74743.176.3145.0043.406.30
2327091-32709143.40643.62
3355540-35554047.18147.42
4314023-31402341.67141.90
5323023-32302342.86643.09
6295101-29510139.16039.38
20min1412631-41263154.75753.893.1455.2654.363.16
2408072-40807254.15254.61
3423854-42385456.24656.75
4405010-40501053.74654.20
5401362-40136253.26153.72
6385502-38550251.15751.59
30min1496321-49632165.86367.783.0266.6768.552.98
2515126-51512668.35869.12
3521665-52166569.22670.04
4486900-48690064.61265.37
5520218-52021869.03469.79
6524328-52432869.57970.30
45min1574716-57471676.26677.504.5577.4478.654.48
2569037-56903775.51276.65
3590981-59098178.42479.62
4547368-54736872.63773.75
5597792-59779279.32880.47
6624414-62441482.86183.97
60min1586017-58601777.76582.343.3379.3683.923.26
2609256-60925680.84982.41
3626007-62600783.07284.71
4621252-62125282.44183.96
5640247-64024784.96286.54
6640150-64015084.94986.52
90min1596707-59670779.18487.207.1481.2189.246.99
2606918-60691880.53982.55
3687916-68791691.28893.38
4686187-68618791.05893.03
5712081-71208194.49496.55
6653050-65305086.66188.70
120min1681958-68195890.49793.533.2792.9796.053.24
2676457-67645789.76792.22
3721317-72131795.72098.32
4715086-71508694.89397.38
5734972-73497297.532100.11
6699117-69911792.77495.29
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1679824-67982490.21491.274.3493.1994.314.26
2631193-63119383.76086.71
3711325-71132594.39497.53
4696507-69650792.42895.44
5707044-70704493.82696.94
6700994-70099493.02396.06
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%
111.087556557552507553017548317541357550340.08
211.057610117605777607940.05
单位质量响应值RSD%判断
68143.8668850.140.73数据可信
供试品溶液-2024070521批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min197957-9795712.87112.454.3512.8712.454.37
295510-9551012.55012.55
390731-9073111.92211.92
491727-9172712.05312.05
5100957-10095713.26513.27
691559-9155912.03012.03
10min1224441-22444129.49127.106.3929.5627.176.38
2196939-19693925.87725.95
3188631-18863124.78524.85
4202708-20270826.63526.70
5217397-21739728.56528.64
6207288-20728827.23727.30
15min1332850-33285043.73541.064.6443.9741.284.64
2302155-30215539.70239.92
3305508-30550840.14340.35
4293735-29373538.59638.81
5321688-32168842.26942.50
6319113-31911341.93042.15
20min1398207-39820752.32350.982.2052.8051.422.20
2385643-38564350.67251.11
3391526-39152651.44551.87
4375429-37542949.33049.76
5382089-38208950.20550.67
6394850-39485051.88252.33
30min1476195-47619562.57060.775.2463.3461.505.19
2416711-41671154.75455.47
3486990-48699063.98964.70
4469638-46963861.70962.41
5462947-46294760.82961.58
6462266-46226660.74061.48
45min1525146-52514669.00273.093.8570.1274.163.75
2578746-57874676.04577.06
3567849-56784974.61375.68
4564427-56442774.16475.21
5567178-56717874.52575.61
6534119-53411970.18171.26
60min1516649-51664967.88675.925.9769.3977.405.84
2574335-57433575.46576.91
3615173-61517380.83182.31
4605116-60511679.51080.97
5573285-57328575.32776.83
6582421-58242176.52877.99
90min1649858-64985885.38990.013.1587.2791.903.09
2701349-70134992.15594.02
3705797-70579792.73994.67
4687472-68747290.33192.23
5696333-69633391.49593.41
6669228-66922887.93489.83
120min1671412-67141288.22190.562.8690.5792.952.81
2701736-70173692.20594.58
3716846-71684694.19196.64
4700422-70042292.03394.43
5671471-67147188.22990.65
6673241-67324188.46190.84
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1687077-68707790.27992.261.7293.1295.161.71
2707318-70731892.93995.82
3710052-71005293.29896.27
4714237-71423793.84896.76
5707380-70738092.94795.86
6686706-68670690.23093.10
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