替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00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%
111.194970234965694973084971564969934970100.06
211.204972814972024972420.02
单位质量响应值RSD%判断
44415.5544396.610.04数据可信
供试品溶液-24112801-1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%
5min1151347-15134730.67436.9413.0130.6736.9413.02
2163022-16302233.04033.04
3202937-20293741.13041.13
4174121-17412135.29035.29
5212956-21295643.16143.16
6189302-18930238.36738.37
10min1310414-31041462.91367.618.3263.0867.828.34
2303024-30302461.41561.60
3342849-34284969.48769.72
4321227-32122765.10565.30
5378192-37819276.65076.89
6345843-34584370.09470.31
15min1420312-42031285.18788.445.9785.7189.025.99
2410763-41076383.25183.78
3432056-43205687.56788.18
4419550-41955085.03285.59
5478029-47802996.88597.55
6457389-45738992.70193.30
20min1443680-44368089.92393.944.8990.9295.024.90
2447260-44726090.64891.64
3441496-44149689.48090.58
4468775-46877595.00996.04
5490687-49068799.450100.65
6489198-48919899.148100.27
30min1483108-48310897.91497.063.1699.4198.653.15
2482825-48282597.85799.35
3457315-45731592.68694.28
4463800-46380094.00195.56
5490916-49091699.496101.25
6495266-495266100.378102.05
45min1473134-47313495.89295.511.3397.9397.641.29
2475806-47580696.43498.47
3473956-47395696.05998.17
4461560-46156093.54795.63
5465526-46552694.35096.66
6477416-47741696.76098.99
60min1471018-47101895.46494.842.0798.0397.502.05
2475793-47579396.43199.00
3452372-45237291.68494.33
4459547-45954793.13995.74
5474478-47447896.16599.00
6474314-47431496.13298.90
极限1464349-46434994.11294.771.5897.2197.961.58
2475478-47547896.36799.47
3468191-46819194.89198.05
4457773-45777392.77995.90
5476677-47667796.61099.98
6463035-46303593.84697.14
替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00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%
111.194974464972424972914972154972704972930.02
211.204965894961034963460.07
单位质量响应值RSD%判断
44440.8444316.610.20数据可信
供试品溶液-24112801-2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%
5min1132755-13275526.92327.277.2026.9227.287.21
2123960-12396025.13925.14
3150078-15007830.43630.44
4127547-12754725.86725.87
5130957-13095726.55826.56
6141643-14164328.72528.73
10min1251275-25127550.95949.014.4551.1149.164.45
2233905-23390547.43647.58
3257548-25754852.23152.40
4236576-23657647.97848.12
5229600-22960046.56346.71
6241007-24100748.87649.04
15min1352411-35241171.46966.015.5371.9066.435.52
2317338-31733864.35664.76
3342734-34273469.50769.97
4321460-32146065.19265.60
5309548-30954862.77663.18
6309359-30935962.73863.17
20min1399742-39974281.06877.103.0981.9077.893.08
2379335-37933576.92977.69
3378329-37832976.72577.57
4382860-38286077.64478.42
5363314-36331473.68074.44
6377389-37738976.53577.31
30min1473838-47383896.09493.741.4297.3794.961.42
2457138-45713892.70893.90
3455080-45508092.29093.56
4461213-46121393.53494.74
5463409-46340993.97995.14
6462820-46282093.86095.06
45min1464557-46455794.21295.722.8496.0397.462.76
2470706-47070695.45997.16
3452370-45237091.74193.53
4477372-47737296.81198.53
5474352-47435296.19997.89
6492518-49251899.883101.61
60min1462816-46281693.85995.982.7496.2098.262.68
2481232-48123297.59499.83
3488161-48816198.999101.29
4473875-47387596.10298.36
5453468-45346891.96394.18
6480198-48019897.38499.67
极限1466620-46662094.63195.752.0997.4998.562.05
2470015-47001595.31998.09
3476433-47643396.62199.46
4469569-46956995.22998.02
5460908-46090893.47296.20
6489381-48938199.247102.07
替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00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%
111.194975844972974976484969984971494973350.06
211.204997715006345002020.13
单位质量响应值RSD%判断
44444.5944660.890.35数据可信
供试品溶液-24112801-3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%
5min1108517-10851721.92123.824.9321.9223.824.93
2119447-11944724.12924.13
3115083-11508323.24823.25
4124615-12461525.17325.17
5116888-11688823.61223.61
6122802-12280224.80724.81
10min1180971-18097136.55839.624.1836.6839.754.18
2196807-19680739.75739.89
3194359-19435939.26239.39
4204540-20454041.31941.46
5200225-20022540.44740.58
6199834-19983440.36840.51
15min1234944-23494447.46152.825.2047.7953.175.19
2270546-27054654.65355.01
3265366-26536653.60653.95
4271846-27184654.91555.28
5261041-26104152.73353.09
6265048-26504853.54253.90
20min1321667-32166764.98066.142.1165.5766.792.11
2318429-31842964.32664.98
3336333-33633367.94268.59
4332724-33272467.21367.89
5330413-33041366.74667.40
6324913-32491365.63566.29
30min1426674-42667486.19287.393.2087.1488.403.18
2420476-42047684.94085.96
3428347-42834786.53087.55
4451624-45162491.23292.28
5448248-44824890.55091.57
6420306-42030684.90685.93
45min1466064-46606494.14996.282.1495.5897.782.14
2468615-46861594.66496.15
3474847-47484795.92397.43
4494804-49480499.955101.51
5476204-47620496.19797.72
6479179-47917996.79898.29
60min1472970-47297095.54495.352.1997.5097.392.17
2463950-46395093.72295.74
3459902-45990292.90494.94
4488719-48871998.726100.84
5469149-46914994.77296.83
6477467-47746796.45398.49
极限1469478-46947894.83994.543.1297.3297.113.07
2442417-44241789.37291.91
3469332-46933294.80997.36
4486761-48676198.330100.99
5474678-47467895.88998.47
6465442-46544294.02396.59
替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00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%
111.195001464997485002294996524996424998830.06
211.205023035026515024770.05
单位质量响应值RSD%判断
44672.3044864.020.31数据可信
供试品溶液-24112801-4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%
5min1107793-10779321.67021.703.0621.6721.703.05
2104948-10494821.09821.10
3109295-10929521.97221.97
4103360-10336020.77920.78
5109981-10998122.11022.11
6112232-11223222.56322.56
10min1181435-18143536.47536.283.1336.6036.403.12
2183762-18376236.94337.06
3186618-18661837.51737.64
4174697-17469735.12135.24
5183814-18381436.95337.08
6172417-17241734.66234.79
15min1244070-24407049.06748.612.5449.3948.942.53
2245303-24530349.31549.64
3248349-24834949.92750.26
4231341-23134146.50846.82
5238060-23806047.85948.19
6243681-24368148.98949.31
20min1296732-29673259.65458.762.2760.2559.362.26
2287166-28716657.73158.33
3296341-29634159.57560.18
4281374-28137456.56657.14
5293992-29399259.10359.70
6298136-29813659.93660.53
30min1407650-40765081.95378.523.5682.8879.443.53
2406763-40676381.77482.69
3392012-39201278.80979.75
4377214-37721475.83476.72
5379617-37961776.31777.24
6380051-38005176.40477.33
45min1465328-46532893.54893.811.1894.9395.171.16
2457586-45758691.99293.36
3473727-47372795.23696.61
4467698-46769894.02495.33
5470234-47023494.53495.88
6465282-46528293.53994.89
60min1455373-45537391.54793.461.8993.4595.341.84
2459519-45951992.38094.26
3466681-46668193.82095.73
4471403-47140394.76996.60
5458322-45832292.14094.01
6478158-47815896.12797.99
极限1462846-46284693.04991.802.2895.4694.202.21
2445949-44594989.65292.05
3442336-44233688.92691.35
4464779-46477993.43895.79
5456604-45660491.79494.18
6467377-46737793.96096.36
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