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%
111.163799033801773803843799013797943800320.07
211.083794953798593796770.07
单位质量响应值RSD%判断
34053.0534266.880.45数据可信
加速3月-供试品溶液-2024050921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%
5min1176848-17684846.59443.694.0646.5943.694.06
2164457-16445743.32943.33
3167904-16790444.23744.24
4167779-16777944.20544.20
5158956-15895641.88041.88
6158956-15895641.88041.88
10min1301265-30126579.37475.563.9979.6375.803.99
2284375-28437574.92475.16
3277904-27790473.21973.46
4300050-30005079.05479.30
5283554-28355474.70874.94
6273650-27365072.09872.33
15min1356758-35675893.99591.952.0394.6992.612.04
2344747-34474790.83091.49
3345453-34545391.01691.67
4359143-35914394.62395.31
5345159-34515990.93991.59
6342613-34261390.26890.90
20min1347553-34755391.56994.831.8992.7996.011.86
2362032-36203295.38496.55
3362542-36254295.51996.68
4367994-36799496.95598.17
5359875-35987594.81695.97
6359635-35963594.75395.89
30min1345642-34564291.06695.152.5892.8096.852.52
2357988-35798894.31996.01
3359064-35906494.60296.29
4369455-36945597.34099.09
5363348-36334895.73197.41
6371299-37129997.82699.49
45min1349840-34984092.17294.522.5894.4196.752.53
2348168-34816891.73193.95
3354101-35410193.29595.51
4369202-36920297.27399.56
5363299-36329995.71897.93
6367927-36792796.93799.14
60min1353158-35315893.04693.981.3295.7996.731.29
2356461-35646193.91696.64
3349398-34939892.05694.79
4360211-36021194.90497.73
5359508-35950894.71997.46
6361508-36150895.24697.99
极限1353690-35369093.18693.111.7796.4596.381.75
2349756-34975692.15095.40
3348213-34821391.74394.99
4364917-36491796.14499.50
5349006-34900691.95295.22
6354783-35478393.47496.75
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%
111.163826643825703810853811843806833816370.24
211.083824183819073821620.10
单位质量响应值RSD%判断
34196.8634491.160.61数据可信
长期3月-供试品溶液-2024050921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%
5min1138087-13808736.18738.424.5536.1938.424.55
2140039-14003936.69936.70
3147328-14732838.60938.61
4153806-15380640.30640.31
5153960-15396040.34740.35
6146331-14633138.34738.35
10min1273151-27315171.58268.672.5671.7868.882.55
2256622-25662267.25067.45
3254577-25457766.71466.93
4260084-26008468.15768.38
5265508-26550869.57969.80
6262373-26237368.75768.97
15min1336822-33682288.26786.391.5088.8786.991.50
2327527-32752785.83186.41
3333517-33351787.40187.99
4327419-32741985.80386.41
5329890-32989086.45187.06
6322864-32286484.60985.20
20min1364893-36489395.62493.691.4496.7194.761.43
2348855-34885591.42192.48
3357470-35747093.67894.75
4358597-35859793.97495.05
5358191-35819193.86794.96
6356994-35699493.55494.62
30min1346315-34631590.75593.332.2292.3894.922.16
2363835-36383595.34696.91
3350516-35051691.85693.45
4358554-35855493.96295.56
5351559-35155992.12993.74
6365959-36595995.90397.49
45min1355175-35517593.07794.871.3195.2096.981.27
2369084-36908496.72298.81
3360599-36059994.49896.60
4361743-36174394.79896.92
5365134-36513495.68797.81
6360434-36043494.45596.57
60min1353245-35324592.57192.281.2595.2194.921.23
2353922-35392292.74995.38
3346066-34606690.69093.32
4349902-34990291.69594.35
5359053-35905394.09396.75
6350509-35050991.85494.50
极限1333868-33386887.49390.083.5190.6593.233.40
2337553-33755388.45991.60
3329517-32951786.35389.48
4346854-34685490.89694.06
5355023-35502393.03796.22
6359551-35955194.22497.38
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%
111.163808483805373806453805473803743805900.05
211.083799563802603801080.06
单位质量响应值RSD%判断
34103.0534305.780.42数据可信
中间条件3月-供试品溶液-2024050921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%
5min1144945-14494538.13939.554.5538.1439.564.54
2155180-15518040.83240.83
3159775-15977542.04142.04
4149152-14915239.24639.25
5151906-15190639.97039.97
6140982-14098237.09637.10
10min1264787-26478769.67270.131.8169.8870.351.80
2272860-27286071.79772.02
3265980-26598069.98670.22
4268252-26825270.58470.80
5258556-25855668.03368.25
6268803-26880370.72970.94
15min1330759-33075987.03187.071.9987.6387.681.97
2336841-33684188.63289.26
3323575-32357585.14185.76
4335695-33569588.33088.94
5322330-32233084.81385.41
6336311-33631188.49289.09
20min1361149-36114995.02895.101.2896.1196.201.28
2369167-36916797.13898.26
3359538-35953894.60495.70
4364230-36423095.83896.94
5356959-35695993.92595.00
6357490-35749094.06595.16
30min1357324-35732494.02195.321.5895.6396.941.58
2369867-36986797.32298.98
3364609-36460995.93897.56
4365769-36576996.24397.88
5354342-35434293.23794.83
6361579-36157995.14196.75
45min1361010-36101094.99195.861.8897.1298.011.86
2371414-37141497.72999.93
3369032-36903297.10299.26
4369057-36905797.10999.28
5362067-36206795.26997.38
6353261-35326192.95295.09
60min1359157-35915794.50494.221.7697.1696.901.74
2367523-36752396.70599.45
3351790-35179092.56595.26
4363027-36302795.52298.23
5353802-35380293.09595.73
6353143-35314392.92195.58
极限1346263-34626391.11192.981.8794.3096.191.83
2358774-35877494.40397.68
3346359-34635991.13694.34
4359891-35989194.69797.93
5349785-34978592.03895.20
6359184-35918494.51197.69
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