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105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数2500
标示量(mg)40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%
111.263815913818443816723818483814953816900.05
211.273811363808103809730.07
单位质量响应值RSD%判断
33897.8733804.170.20数据可信
中间24月-供试品溶液-20220104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%
5min1209014-20901455.57154.983.4855.5754.983.48
2211800-21180056.31256.31
3196975-19697552.37052.37
4216254-21625457.49657.50
5206312-20631254.85254.85
6200288-20028853.25153.25
10min1333803-33380388.74989.782.1289.0690.092.12
2336433-33643389.44889.76
3339028-33902890.13890.43
4350919-35091993.29993.62
5335940-33594089.31789.62
6330056-33005687.75288.05
15min1362402-36240296.35295.572.0797.1596.382.06
2362121-36212196.27897.09
3349683-34968392.97193.76
4365788-36578897.25398.09
5350624-35062493.22194.02
6366201-36620197.36298.15
20min1359792-35979295.65896.281.7197.0097.621.70
2366845-36684597.53498.88
3365596-36559697.20298.51
4369842-36984298.33099.71
5356003-35600394.65195.97
6354802-35480294.33295.66
30min1357604-35760495.07794.291.1596.9596.161.15
2359753-35975395.64897.53
3351676-35167693.50195.35
4357327-35732795.00396.93
5350000-35000093.05594.90
6351586-35158693.47795.32
45min1357832-35783295.13795.192.4297.5397.582.39
2365305-36530597.12499.54
3351800-35180093.53495.90
4371340-37134098.729101.18
5352203-35220393.64196.00
6349689-34968992.97295.34
60min1354844-35484494.34393.853.0597.2796.783.00
2363802-36380296.72599.68
3337604-33760489.75992.65
4365900-36590097.282100.28
5347402-34740292.36495.25
6348421-34842192.63595.52
极限1355290-35529094.46194.321.2897.9197.761.28
2353994-35399494.11797.61
3356545-35654594.79598.18
4361694-36169496.16499.71
5347852-34785292.48495.88
6353146-35314693.89197.29
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105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数2500
标示量(mg)40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%
111.263806393807883806853802953802553805320.07
211.273788563788723788640.01
单位质量响应值RSD%判断
33795.0333617.040.38数据可信
中间24月-供试品溶液-20220105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%
5min1197072-19707252.62159.6411.8852.6259.6411.88
2216228-21622857.73657.74
3223000-22300059.54559.54
4224445-22444559.93059.93
5273165-27316572.94072.94
6206238-20623855.06955.07
10min1323656-32365686.42193.175.1286.7193.505.14
2347591-34759192.81293.13
3342857-34285791.54891.88
4348193-34819392.97393.31
5378952-378952101.186101.59
6352335-35233594.07994.39
15min1352775-35277594.19797.462.0394.9798.312.06
2367743-36774398.19399.03
3372024-37202499.337100.18
4361361-36136196.48997.34
5372286-37228699.406100.37
6363840-36384097.15197.98
20min1362170-36217096.70598.362.4998.0099.752.47
2360827-36082796.34797.73
3369195-36919598.58199.97
4385608-385608102.964104.35
5369115-36911598.560100.08
6363322-36332297.01398.38
30min1348211-34821192.97896.543.1294.8198.473.13
2362184-36218496.70998.63
3364283-36428397.27099.21
4366047-36604797.74199.70
5378650-378650101.106103.17
6349825-34982593.40995.32
45min1345600-34560092.28195.392.7194.6397.862.72
2364130-36413097.22999.68
3349693-34969393.37495.85
4364969-36496997.45399.95
5368423-36842398.375101.00
6350699-35069993.64296.07
60min1342672-34267291.49994.992.7694.3698.002.78
2360671-36067196.30599.30
3350398-35039893.56296.56
4357082-35708295.34798.39
5371373-37137399.163102.34
6352354-35235494.08497.03
极限1344518-34451891.99294.672.2395.3698.202.26
2354605-35460594.68598.21
3355456-35545694.91398.43
4358177-35817795.63999.21
5366786-36678697.938101.66
6347795-34779592.86796.34
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105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数2500
标示量(mg)40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%
111.263800363801133801873802593800673801320.03
211.273781493785943783720.09
单位质量响应值RSD%判断
33759.5033573.380.40数据可信
中间24月-供试品溶液-20220107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%
5min1195236-19523652.19355.615.6852.1955.605.69
2202465-20246554.12554.13
3199206-19920653.25453.25
4216811-21681157.96057.96
5226686-22668660.60060.60
6207609-20760955.50055.50
10min1332731-33273188.94988.034.4189.2488.344.41
2324548-32454886.76287.06
3307550-30755082.21882.51
4346023-34602392.50392.82
5343493-34349391.82692.16
6321376-32137685.91486.22
15min1362925-36292597.02195.322.5297.8196.122.52
2353797-35379794.58195.36
3342395-34239591.53392.29
4365726-36572697.77098.61
5351449-35144993.95394.80
6363177-36317797.08897.87
20min1335055-33505589.57093.792.9990.8995.122.97
2357560-35756095.58796.89
3343318-34331891.77993.04
4359415-35941596.08397.46
5361610-36161096.66998.04
6348099-34809993.05894.38
30min1371395-37139599.28595.272.47101.1197.122.39
2355679-35567995.08496.92
3361432-36143296.62298.39
4349117-34911793.33095.24
5352258-35225894.16996.08
6348306-34830693.11394.95
45min1348095-34809593.05695.241.4995.4397.621.45
2356979-35697995.43197.80
3358495-35849595.83798.14
4362356-36235696.86999.30
5351912-35191294.07796.51
6359720-35972096.16498.52
60min1358398-35839895.81195.351.6198.7098.251.56
2352275-35227594.17497.07
3362027-36202796.78199.62
4364295-36429597.387100.36
5351564-35156493.98496.94
6351402-35140293.94096.83
极限1358362-35836295.80194.961.2499.2298.401.20
2358047-35804795.71799.14
3352834-35283494.32397.70
4359756-35975696.17499.68
5348070-34807093.05096.52
6354222-35422294.69498.11
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