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%
111.073827633804993823623823533822113820380.24
210.933844413841703843060.05
单位质量响应值RSD%判断
34511.1135160.661.32数据可信
供试品溶液-24041901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%
5min1142637-14263736.85439.875.6736.8539.875.67
2146533-14653337.86137.86
3157524-15752440.70140.70
4163335-16333542.20242.20
5163723-16372342.30242.30
6152058-15205839.28839.29
10min1241780-24178062.47065.836.6662.6866.056.65
2237025-23702561.24261.45
3243104-24310462.81263.04
4272544-27254470.41970.65
5277029-27702971.57871.81
6257139-25713966.43966.66
15min1304489-30448978.67381.084.7679.2281.664.75
2321820-32182083.15183.70
3290559-29055975.07475.65
4331630-33163085.68586.31
5323606-32360683.61284.24
6310684-31068480.27480.86
20min1336844-33684487.03391.253.9288.0292.293.92
2353953-35395391.45392.47
3336104-33610486.84187.83
4369087-36908795.36396.47
5362512-36251293.66594.76
6360605-36060593.17294.21
30min1347701-34770189.83893.952.2091.3195.502.21
2367374-36737494.92196.44
3364219-36421994.10695.58
4368799-36879995.28996.92
5365391-36539194.40996.03
6368242-36824295.14596.70
45min1354217-35421791.52193.701.8393.4995.771.85
2369103-36910395.36897.42
3358947-35894792.74494.74
4370812-37081295.80997.97
5364736-36473694.23996.38
6358080-35808092.52094.60
60min1349872-34987290.39991.911.8492.8894.501.85
2358584-35858492.65095.23
3354205-35420591.51894.03
4364793-36479394.25496.95
5359600-35960092.91295.58
6347323-34732389.74092.33
极限1345369-34536989.23592.072.0192.2295.172.03
2357497-35749792.36995.46
3355963-35596391.97394.99
4365705-36570594.49097.71
5361504-36150493.40496.59
6352099-35209990.97494.07
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%
111.073810773804753808173807143808593807880.06
210.933835183818453826820.31
单位质量响应值RSD%判断
34398.1935012.081.26数据可信
供试品溶液-24042201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%
5min1142660-14266036.99938.294.2937.0038.294.28
2137992-13799235.78835.79
3148717-14871738.56938.57
4151097-15109739.18739.19
5149553-14955338.78638.79
6155704-15570440.38240.38
10min1252339-25233965.44465.513.1365.6565.733.13
2240536-24053662.38362.58
3250985-25098565.09265.31
4264867-26486768.69368.91
5251065-25106565.11365.33
6255846-25584666.35366.58
15min1315200-31520081.74682.581.1882.3283.161.19
2314672-31467281.61082.15
3322531-32253183.64884.22
4322095-32209583.53584.13
5315272-31527281.76582.34
6320811-32081183.20283.79
20min1350747-35074790.96591.481.3391.9992.511.32
2353844-35384491.76992.77
3358000-35800092.84793.89
4355710-35571092.25393.32
5344585-34458589.36790.40
6353401-35340191.65492.71
30min1346390-34639089.83693.423.8491.3694.963.79
2362579-36257994.03495.54
3340491-34049188.30689.86
4373507-37350796.86898.44
5365051-36505194.67596.20
6373193-37319396.78798.35
45min1355478-35547892.19293.662.5894.2295.722.56
2356283-35628392.40194.43
3350522-35052290.90792.95
4368731-36873195.63097.74
5360339-36033993.45395.51
6375528-37552897.39299.49
60min1348836-34883690.47092.522.7793.0195.102.74
2350672-35067290.94693.49
3346161-34616189.77692.33
4369681-36968195.87698.52
5358078-35807892.86795.44
6367077-36707795.20197.84
极限1347550-34755090.13691.721.9293.1894.821.92
2347189-34718990.04393.09
3347694-34769490.17493.22
4359732-35973293.29696.47
5359318-35931893.18896.28
6360489-36048993.49296.66
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%
111.073844103811923845903846103846223838850.40
210.933842943840733841840.05
单位质量响应值RSD%判断
34677.9635149.500.96数据可信
供试品溶液-2404050921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%
5min1140682-14068236.26639.917.0336.2739.927.03
2146949-14694937.88237.88
3161026-16102641.51141.51
4165193-16519342.58542.59
5166757-16675742.98842.99
6148375-14837538.25038.25
10min1245636-24563663.32366.875.0363.5267.095.03
2251002-25100264.70664.92
3264837-26483768.27268.50
4275320-27532070.97571.21
5272134-27213470.15370.39
6247443-24744363.78864.00
15min1322553-32255383.15183.433.3083.7084.023.31
2308678-30867879.57480.14
3329825-32982585.02685.64
4334064-33406486.11886.75
5333241-33324185.90686.53
6313376-31337680.78581.35
20min1330737-33073785.26189.833.5486.2890.883.54
2337341-33734186.96387.98
3354027-35402791.26592.35
4356820-35682091.98593.09
5363343-36334393.66694.77
6348425-34842589.82090.84
30min1374577-37457796.56294.451.9898.0596.011.91
2368134-36813494.90196.40
3355148-35514891.55493.14
4360302-36030292.88294.50
5370205-37020595.43597.06
6369956-36995695.37196.89
45min1351192-35119290.53493.312.1392.5695.402.07
2367936-36793694.85096.87
3359624-35962492.70794.81
4358608-35860892.44694.58
5361292-36129293.13795.29
6373219-37321996.21298.26
60min1364225-36422593.89493.010.9296.4295.610.86
2361719-36171993.24895.80
3364062-36406293.85296.46
4360851-36085193.02495.67
5356102-35610291.80094.47
6357833-35783392.24694.82
极限1354400-35440091.36191.592.1894.4194.702.14
2358998-35899892.54695.61
3353582-35358291.15094.28
4356277-35627791.84595.01
5366042-36604294.36297.55
6342421-34242188.27391.36
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