培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.524386894384084380994387094385834384980.06
210.384390614385104387860.09
单位质量响应值RSD%判断
41682.3242272.251.00数据可信
供试品溶液-2025072412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%
5min1202347-20234754.12446.1845.0354.1246.1845.04
2108370-10837028.98728.99
3108323-10832328.97428.97
4286482-28648276.62876.63
5101965-10196527.27427.27
6228471-22847161.11161.11
10min1317251-31725184.85892.054.9584.9592.134.92
2358463-35846395.88195.93
3347241-34724192.88092.93
4329438-32943888.11888.25
5355205-35520595.01095.06
6357194-35719495.54295.64
15min1338969-33896990.66794.002.7190.9094.232.69
2360580-36058096.44896.66
3352560-35256094.30294.51
4340483-34048391.07291.35
5356486-35648695.35395.56
6359489-35948996.15696.42
20min1346289-34628992.62594.631.8193.0195.021.79
2362110-36211096.85797.23
3352858-35285894.38294.74
4346571-34657192.70193.13
5357332-35733295.57995.94
6357471-35747195.61696.04
30min1354746-35474694.88795.561.0095.4296.100.98
2363473-36347397.22197.75
3355277-35527795.02995.55
4353763-35376394.62495.21
5358025-35802595.76496.29
6358250-35825095.82496.41
极限1367390-36739098.26997.050.9498.9697.750.93
2366691-36669198.08298.77
3359505-35950596.16096.84
4361601-36160196.72197.46
5359872-35987296.25896.94
6361837-36183796.78497.52
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.524364164366934373714368044375734369710.12
210.384389394384924387160.08
单位质量响应值RSD%判断
41537.1742265.511.23数据可信
供试品溶液-2025072412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%
5min1169584-16958445.44444.4250.4845.4444.4250.48
2292964-29296478.50678.51
3102668-10266827.51227.51
4237278-23727863.58463.58
594884-9488425.42625.43
697271-9727126.06626.07
10min1357293-35729395.74494.611.7495.8294.691.74
2360424-36042496.58396.71
3351396-35139694.16494.21
4343754-34375492.11692.22
5349257-34925793.59193.63
6356327-35632795.48595.53
15min1358787-35878796.14595.911.4696.3896.141.48
2365065-36506597.82798.12
3356659-35665995.57495.78
4355134-35513495.16695.43
5350139-35013993.82794.03
6361669-36166996.91797.12
20min1360361-36036196.56696.561.5796.9696.951.59
2366246-36624698.14398.60
3359042-35904296.21396.57
4358844-35884496.16096.58
5351135-35113594.09494.45
6366368-36636898.17698.54
30min1362692-36269297.19197.051.6997.7597.601.70
2367857-36785798.57599.19
3360899-36089996.71197.23
4362223-36222397.06597.64
5351311-35131194.14194.65
6367962-36796298.60399.13
极限1371440-37144099.53598.162.07100.2598.872.07
2370564-37056499.300100.08
3364852-36485297.77098.45
4366554-36655498.22698.97
5352103-35210394.35395.02
6372331-37233199.774100.47
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.524382704385294386094375384370874380070.16
210.384390034387254388640.05
单位质量响应值RSD%判断
41635.6542279.771.09数据可信
供试品溶液-2025072512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%
5min1108195-10819528.95436.0737.7728.9536.0637.77
2227624-22762460.91460.91
3160374-16037442.91742.92
497993-9799326.22426.22
5114178-11417830.55530.55
6100259-10025926.83026.83
10min1337159-33715990.22689.835.9290.2789.885.93
2347431-34743192.97593.08
3340563-34056391.13791.21
4344645-34464592.22992.27
5348148-34814893.16793.22
6296024-29602479.21879.26
15min1360283-36028396.41495.623.3096.6195.833.31
2358904-35890496.04596.30
3359193-35919396.12296.35
4363193-36319397.19397.39
5368001-36800198.48098.69
6334314-33431489.46589.64
20min1364273-36427397.48297.131.5897.8497.501.58
2360745-36074596.53896.95
3362460-36246096.99797.38
4364604-36460497.57097.93
5371551-37155199.43099.80
6354045-35404594.74595.07
30min1365946-36594697.93098.001.0698.4598.521.06
2363185-36318597.19197.77
3365604-36560497.83898.38
4364963-36496397.66798.19
5373784-373784100.027100.56
6363656-36365697.31797.80
极限1368673-36867398.65999.151.3699.3499.841.34
2367937-36793798.46299.20
3369898-36989898.98799.70
4363995-36399597.40798.09
5378087-378087101.179101.88
6374412-374412100.195100.84
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.524394744391434392694390564393784392640.04
210.384389054386684387860.04
单位质量响应值RSD%判断
41755.1342272.250.88数据可信
供试品溶液-2025072512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%
5min1233836-23383662.49142.1153.4262.4942.1153.41
2292515-29251578.17378.17
394561-9456125.27125.27
4102027-10202727.26627.27
5107262-10726228.66528.67
6115137-11513730.77030.77
10min1331764-33176488.66290.133.8288.7790.203.83
2356057-35605795.15495.28
3340871-34087191.09691.14
4346480-34648092.59592.64
5325255-32525586.92386.97
6323116-32311686.35186.40
15min1347096-34709692.75994.781.9793.0195.001.97
2360361-36036196.30496.59
3358296-35829695.75395.95
4362245-36224596.80897.01
5354336-35433694.69494.89
6345570-34557092.35292.55
20min1352066-35206694.08895.781.4094.4996.161.41
2362952-36295296.99797.45
3361440-36144096.59396.95
4363468-36346897.13597.50
5357525-35752595.54795.90
6353011-35301194.34094.69
30min1357692-35769295.59196.520.7196.1597.050.70
2362311-36231196.82697.44
3362890-36289096.98097.49
4364314-36431497.36197.88
5360966-36096696.46696.98
6358749-35874995.87496.38
极限1364331-36433197.36597.420.4198.0998.120.41
2364668-36466897.45598.23
3364523-36452397.41798.09
4366650-36665097.98598.67
5364891-36489197.51598.19
6362088-36208896.76697.43
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.524389164391954389544387174387814389130.05
210.384395314396284395800.02
单位质量响应值RSD%判断
41721.7742348.751.06数据可信
供试品溶液-2025072612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%
5min1159970-15997042.73049.6634.4042.7349.6634.40
2169736-16973645.33945.34
3237176-23717663.35363.35
4165673-16567344.25344.25
5100884-10088426.94726.95
6282075-28207575.34675.35
10min1332323-33232388.76788.416.6888.8488.506.69
2354698-35469894.74494.82
3327425-32742587.45987.56
4339858-33985890.78090.85
5290067-29006777.48077.53
6341641-34164191.25691.38
15min1349548-34954893.36894.112.4593.5994.342.46
2361755-36175596.62996.86
3349303-34930393.30393.55
4361762-36176296.63196.86
5339091-33909190.57590.75
6352570-35257094.17694.45
20min1360919-36091996.40696.331.6896.7896.721.68
2364638-36463897.39997.79
3362271-36227196.76797.17
4368450-36845098.41798.80
5351815-35181593.97494.30
6355738-35573895.02295.46
30min1367352-36735298.12497.881.4198.6698.431.41
2369046-36904698.57799.13
3370229-37022998.89399.46
4371849-37184999.32599.88
5359938-35993896.14496.63
6360248-36024896.22796.82
极限1369265-36926598.63599.321.4799.33100.031.46
2376534-376534100.577101.30
3374882-374882100.136100.87
4377620-377620100.867101.58
5369101-36910198.59199.23
6363523-36352397.10197.85
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.524355884361744354924358934360844358460.07
210.384387364383084385220.07
单位质量响应值RSD%判断
41430.2342246.821.39数据可信
供试品溶液-2025072612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%
5min1116254-11625431.20031.6926.9931.2031.6926.99
2104125-10412527.94527.94
3107990-10799028.98228.98
4101658-10165827.28327.28
5181734-18173448.77448.77
696738-9673825.96225.96
10min1300810-30081080.73174.7314.2280.7874.7814.22
2281818-28181875.63475.68
3295721-29572179.36579.41
4259630-25963069.67969.72
5322860-32286086.64986.73
6209906-20990656.33456.38
15min1349121-34912193.69788.628.3293.8888.808.33
2322402-32240286.52686.70
3347253-34725393.19593.38
4334214-33421489.69689.86
5349658-34965893.84194.07
6278613-27861374.77474.91
20min1364072-36407297.70993.126.9598.0593.446.96
2338485-33848590.84291.16
3359521-35952196.48896.82
4360941-36094196.86997.18
5357376-35737695.91296.29
6301384-30138480.88581.15
30min1372097-37209799.86396.304.16100.3796.784.19
2356268-35626895.61596.08
3366627-36662798.39598.89
4364235-36423597.75398.23
5363444-36344497.54198.08
6330212-33021288.62289.02
极限1377431-377431101.29499.691.03101.97100.331.02
2369319-36931999.11799.74
3370675-37067599.481100.14
4366526-36652698.36899.00
5370724-37072499.494100.20
6374085-374085100.396100.94
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