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%
111.237673317679717665577658867654117666310.14
211.327681187678987680080.03
单位质量响应值RSD%判断
68266.3467845.230.44数据可信
供试品溶液-F49232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%
5min191070-9107012.04412.3211.2312.0412.3211.24
2101927-10192713.47913.48
388564-8856411.71211.71
498868-9886813.07513.07
575478-754789.9829.98
6103160-10316013.64213.64
10min1168934-16893422.34123.096.6922.4123.166.71
2183463-18346324.26224.34
3170511-17051122.54922.61
4180363-18036323.85223.92
5156214-15621420.65920.71
6188097-18809724.87524.95
15min1222484-22248429.42331.787.7029.6131.987.70
2265164-26516435.06735.28
3235358-23535831.12531.32
4250116-25011633.07733.28
5217319-21731928.74028.91
6251445-25144533.25333.47
20min1261487-26148734.58138.697.3034.9439.077.29
2322925-32292542.70543.11
3289693-28969338.31138.67
4303112-30311240.08540.47
5277968-27796836.76037.09
6300400-30040039.72740.13
30min1377289-37728949.89552.373.7850.4452.963.79
2418144-41814455.29855.94
3394578-39457852.18152.76
4407589-40758953.90254.51
5394187-39418752.13052.66
6384193-38419350.80851.43
45min1475812-47581262.92464.314.3063.7565.194.27
2492521-49252165.13466.08
3502185-50218566.41267.28
4512687-51268767.80168.71
5480700-48070063.57164.39
6453787-45378760.01160.91
60min1533019-53301970.48973.553.3071.6674.783.28
2554450-55445073.32474.63
3571974-57197475.64176.88
4582221-58222176.99678.28
5553261-55326173.16674.34
6542066-54206671.68672.92
极限1657737-65773786.98387.002.3388.5588.642.25
2651212-65121286.12087.84
3676075-67607589.40891.06
4643046-64304685.04086.76
5676365-67636589.44691.03
6642651-64265184.98886.62
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%
111.237686167690737682157670477669667679830.13
211.327614277615467614860.02
单位质量响应值RSD%判断
68386.7367269.081.17数据可信
供试品溶液-F49232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%
5min1137909-13790918.30018.833.4318.3018.833.42
2141305-14130518.75118.75
3142601-14260118.92318.92
4149905-14990519.89219.89
5143709-14370919.07019.07
6136064-13606418.05518.06
10min1253498-25349833.63934.882.8133.7434.982.81
2267239-26723935.46235.57
3268482-26848235.62735.73
4269911-26991135.81735.93
5264142-26414235.05135.16
6253800-25380033.67933.78
15min1361315-36131547.94649.482.3848.2349.782.38
2366307-36630748.60848.91
3378884-37888450.27750.58
4383297-38329750.86351.17
5379555-37955550.36650.67
6367898-36789848.81949.11
20min1458222-45822260.80562.761.6461.3663.331.64
2470900-47090062.48763.06
3476834-47683463.27563.86
4477053-47705363.30463.90
5479323-47932363.60564.19
6475307-47530763.07263.63
30min1603254-60325480.05082.812.7780.9483.732.76
2613338-61333881.38982.31
3646009-64600985.72486.66
4639947-63994784.92085.86
5630516-63051683.66884.60
6611315-61131581.12082.03
45min1741850-74185098.44297.422.2499.7898.812.22
2726845-72684596.45197.82
3740392-74039298.24899.66
4759627-759627100.801102.22
5713852-71385294.72796.13
6722488-72248895.87397.23
60min1737806-73780697.90597.212.3399.7999.142.29
2730372-73037296.91998.83
3743671-74367198.683100.64
4749056-74905699.398101.37
5700652-70065292.97594.90
6734052-73405297.40799.30
极限1735113-73511397.54897.191.7999.9899.661.78
2722784-72278495.91298.36
3733757-73375797.36899.87
4751993-75199399.788102.32
5713724-71372494.71097.15
6737150-73715097.818100.25
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%
111.237683817682917680557675837670587678740.08
211.327616297641367628820.24
单位质量响应值RSD%判断
68377.0367392.401.03数据可信
供试品溶液-F49232批-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%
5min1159341-15934121.12619.285.3521.1319.285.35
2146732-14673219.45419.45
3146255-14625519.39119.39
4143784-14378419.06419.06
5138029-13802918.30118.30
6138474-13847418.36018.36
10min1296447-29644739.30435.855.8139.4235.965.81
2270240-27024035.83035.94
3275123-27512336.47736.58
4272320-27232036.10536.21
5253775-25377533.64733.75
6254511-25451133.74433.85
15min1405526-40552653.76749.945.5754.1050.245.57
2387299-38729951.35051.66
3385854-38585451.15851.47
4375898-37589849.83850.14
5350100-35010046.41846.71
6355210-35521047.09547.38
20min1492881-49288165.34861.415.3765.9861.995.37
2475947-47594763.10363.70
3479400-47940063.56164.16
4463610-46361061.46862.05
5430584-43058457.08957.64
6436504-43650457.87458.42
30min1634876-63487684.17581.003.5085.1781.933.52
2618792-61879282.04282.99
3616569-61656981.74882.70
4626059-62605983.00683.93
5585066-58506677.57178.43
6584309-58430977.47078.34
45min1712094-71209494.41396.101.3095.8897.481.27
2739429-73942998.03799.44
3720829-72082995.57196.97
4727386-72738696.44097.83
5729230-72923096.68597.98
6719950-71995095.45496.76
60min1739075-73907597.99097.171.5499.9899.081.54
2745114-74511498.791100.73
3726695-72669596.34998.28
4732527-73252797.12299.04
5739960-73996098.10799.94
6713934-71393494.65796.49
极限1728629-72862996.60596.031.5299.1498.481.51
2734665-73466597.40599.90
3715373-71537394.84897.32
4728560-72856096.59699.06
5732018-73201897.05499.43
6706524-70652493.67496.03
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%
111.237612577613477611807620197627257617060.09
211.327566977563977565470.03
单位质量响应值RSD%判断
67827.7866832.771.05数据可信
供试品溶液-F49232批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min132872-328724.3944.1014.334.394.1014.31
226830-268303.5873.59
328544-285443.8163.82
438591-385915.1595.16
529217-292173.9063.91
627928-279283.7333.73
10min184115-8411511.24410.394.9311.2710.424.94
273173-731739.7829.80
378580-7858010.50410.53
474453-744539.9539.98
578411-7841110.48210.50
677803-7780310.40010.42
15min1120419-12041916.09715.476.0316.1815.556.02
2107203-10720314.33114.40
3120382-12038216.09216.17
4109497-10949714.63714.72
5124554-12455416.65016.73
6112506-11250615.03915.12
20min1147015-14701519.65219.437.5319.8319.597.50
2137557-13755718.38818.54
3156405-15640520.90821.08
4134145-13414517.93218.10
5159966-15996621.38421.56
6136838-13683818.29218.45
30min1183048-18304824.46924.002.9924.7524.282.99
2183203-18320324.49024.75
3184737-18473724.69524.98
4173476-17347623.19023.45
5180672-18067224.15224.44
6172283-17228323.03023.29
45min1192560-19256025.74125.845.1426.1626.255.03
2213107-21310728.48728.88
3190352-19035225.44625.87
4189150-18915025.28525.68
5186823-18682324.97425.40
6187731-18773125.09525.49
60min1192001-19200125.66626.355.9826.2326.905.86
2221118-22111829.55830.11
3192893-19289325.78526.35
4192542-19254225.73826.27
5190896-19089625.51826.08
6193300-19330025.84026.37
极限1184334-18433424.64125.947.0025.3526.636.85
2221324-22132429.58630.30
3188315-18831525.17325.88
4189509-18950925.33326.01
5191416-19141625.58826.29
6189231-18923125.29625.97
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