氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.163214683207633209613206063204213208440.13
214.143206553201593204070.11
单位质量响应值RSD%判断
22658.4722659.620.01数据可信
供试品溶液-1批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1167162-16716242.80942.085.9642.8142.085.95
2163005-16300541.74441.74
3157100-15710040.23240.23
4150085-15008538.43538.44
5176937-17693745.31245.31
6171692-17169243.96943.97
10min1313659-31365980.32579.792.2680.4079.862.26
2304159-30415977.89277.96
3304951-30495178.09578.16
4307740-30774078.80978.87
5320519-32051982.08282.16
6318505-31850581.56681.64
15min1375544-37554496.17394.211.8996.3894.411.89
2358483-35848391.80492.00
3361386-36138692.54792.74
4366725-36672593.91594.11
5370858-37085894.97395.19
6374202-37420295.83096.04
20min1374973-37497396.02795.521.3696.3995.881.36
2364884-36488493.44393.80
3369561-36956194.64194.99
4379375-37937597.15497.51
5373774-37377495.72096.09
6375366-37536696.12896.50
30min1374438-37443895.89095.331.3796.4295.841.37
2364045-36404593.22893.74
3369142-36914294.53495.04
4378884-37888497.02997.54
5372737-37273795.45495.98
6374180-37418095.82496.35
45min1374316-37431695.85995.231.4896.5495.911.48
2363141-36314192.99793.66
3368382-36838294.33995.01
4379011-37901197.06197.74
5372363-37236395.35996.05
6374047-37404795.79096.48
极限1373150-37315095.56094.961.4196.4195.801.41
2362737-36273792.89393.71
3367408-36740894.09094.91
4377854-37785496.76597.60
5370862-37086294.97495.82
6372901-37290195.49696.34
氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.163204033207553205453210633207173206970.08
214.143208463209853209160.04
单位质量响应值RSD%判断
22648.0922695.620.15数据可信
供试品溶液-1批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1176653-17665345.21445.002.3845.2145.002.38
2181895-18189546.55546.56
3169361-16936143.34743.35
4178023-17802345.56445.56
5174745-17474544.72544.73
6174351-17435144.62444.62
10min1313367-31336780.20580.952.9480.2881.022.94
2322735-32273582.60382.68
3302596-30259677.44877.52
4328343-32834384.03884.11
5310449-31044979.45879.53
6320086-32008681.92582.00
15min1368746-36874694.37994.382.4994.5994.592.48
2367539-36753994.07094.29
3373010-37301095.47095.67
4381116-38111697.54597.76
5353046-35304690.36190.57
6369103-36910394.47094.68
20min1372473-37247395.33395.662.4495.7096.022.44
2372575-37257595.35995.73
3381047-38104797.52797.89
4382644-38264497.93698.31
5357282-35728291.44591.80
6376469-37646996.35696.72
30min1371227-37122795.01495.512.4195.5496.042.40
2372488-37248895.33795.87
3380256-38025697.32597.85
4381957-38195797.76098.30
5357001-35700191.37391.88
6376133-37613396.27096.80
45min1370216-37021694.75594.821.9895.4495.501.97
2371568-37156895.10195.79
3379055-37905597.01897.70
4368487-36848794.31395.02
5357783-35778391.57392.24
6375632-37563296.14196.83
极限1370665-37066594.87095.142.3595.7195.992.35
2370994-37099494.95495.80
3378084-37808496.76997.62
4380725-38072597.44598.31
5355847-35584791.07891.89
6374115-37411595.75396.60
氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.163217533221603215173215993211683216390.12
214.143205273206333205800.03
单位质量响应值RSD%判断
22714.6222671.850.14数据可信
供试品溶液-1批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1184407-18440747.15448.643.2547.1548.643.25
2189952-18995248.57248.57
3194288-19428849.68049.68
4185654-18565447.47347.47
5200504-20050451.27051.27
6186533-18653347.69747.70
10min1348227-34822789.04387.821.6789.1287.901.68
2346916-34691688.70888.79
3338990-33899086.68186.76
4334612-33461285.56285.64
5349051-34905189.25489.34
6342982-34298287.70287.78
15min1396585-396585101.40998.501.73101.6498.731.73
2387803-38780399.16399.39
3380959-38095997.41397.64
4377334-37733496.48696.71
5385396-38539698.54898.78
6383214-38321497.99098.22
20min1397492-397492101.64198.651.82102.0499.051.82
2389139-38913999.50599.90
3381316-38131697.50497.89
4377290-37729096.47596.86
5385908-38590898.67899.08
6383735-38373598.12398.51
30min1396150-396150101.29798.451.81101.8699.011.80
2387909-38790999.19099.75
3380353-38035397.25897.81
4375872-37587296.11296.66
5386191-38619198.75199.31
6383625-38362598.09598.65
45min1395484-395484101.12798.301.75101.8699.011.75
2386857-38685798.92199.65
3380285-38028597.24197.95
4375702-37570296.06996.77
5385157-38515798.48699.21
6382965-38296597.92698.64
极限1395125-395125101.03598.231.81101.9499.121.81
2386792-38679298.90599.79
3378780-37878096.85697.73
4375026-37502695.89696.76
5384895-38489598.41999.31
6384335-38433598.27699.16
氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.166435996428556433976431086431636432240.05
214.146432536432056432290.01
单位质量响应值RSD%判断
45425.4245490.030.11数据可信
供试品溶液-2批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1221346-22134628.25527.774.5728.2627.774.57
2209324-20932426.72126.72
3206655-20665526.38026.38
4210865-21086526.91726.92
5230535-23053529.42829.43
6226485-22648528.91128.91
10min1482964-48296461.65161.143.7361.7061.193.73
2473244-47324460.41060.46
3456752-45675258.30558.35
4468416-46841659.79459.84
5509291-50929165.01265.06
6483176-48317661.67861.73
15min1664124-66412484.77784.952.2884.9385.102.28
2658089-65808984.00684.15
3649127-64912782.86283.00
4655591-65559183.68783.83
5690376-69037688.12888.29
6675533-67553386.23386.38
20min1754473-75447396.31096.572.1496.6096.862.14
2738273-73827394.24294.53
3751459-75145995.92596.20
4743669-74366994.93195.21
5780103-78010399.58299.89
6771283-77128398.45698.75
30min1770619-77061998.37198.361.6798.8298.811.67
2750949-75094995.86096.30
3770007-77000798.29398.73
4763397-76339797.44997.89
5787526-787526100.529101.00
6780598-78059899.645100.10
45min1771128-77112898.43698.301.7199.0598.921.71
2750666-75066695.82496.43
3768004-76800498.03798.64
4762547-76254797.34197.95
5787862-787862100.572101.21
6780325-78032599.610100.23
极限1767987-76798798.03598.101.6998.8198.881.69
2750073-75007395.74896.51
3767083-76708397.92098.69
4760583-76058397.09097.86
5786522-786522100.401101.21
6778896-77889699.428100.22
氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.166472496467496462736465076454126464380.11
214.146454226461396457800.08
单位质量响应值RSD%判断
45652.4045670.440.03数据可信
供试品溶液-2批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1232747-23274729.57828.426.8329.5828.426.84
2201139-20113925.56125.56
3232743-23274329.57829.58
4207529-20752926.37326.37
5237538-23753830.18730.19
6229896-22989629.21629.22
10min1509768-50976864.78363.466.7464.8363.516.74
2478521-47852160.81260.85
3521457-52145766.26866.32
4440289-44028955.95356.00
5523208-52320866.49166.54
6523065-52306566.47266.52
15min1693620-69362088.14786.855.7388.3087.015.73
2666255-66625584.66984.81
3719117-71911791.38791.55
4612579-61257977.84877.99
5698858-69885888.81388.97
6710240-71024090.25990.42
20min1752829-75282995.67195.843.1395.9896.143.14
2744051-74405194.55694.84
3783668-78366899.59099.90
4717150-71715091.13791.40
5752205-75220595.59295.90
6775052-77505298.49598.81
30min1756654-75665496.15797.611.9296.6298.071.91
2752259-75225995.59996.04
3785453-78545399.817100.30
4781395-78139599.30299.72
5756197-75619796.09996.57
6776781-77678198.71599.19
45min1755262-75526295.98197.541.9596.6098.161.94
2751894-75189495.55296.15
3785783-78578399.859100.50
4780320-78032099.16599.75
5755566-75556696.01996.65
6776541-77654198.68599.32
极限1752393-75239395.61697.191.8696.4097.971.85
2750441-75044195.36896.13
3780268-78026899.15899.97
4777883-77788398.85599.60
5752939-75293995.68596.47
6774572-77457298.43499.24
氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.166440116436896442206437006434356438110.05
214.146457306464676460980.09
单位质量响应值RSD%判断
45466.8845692.930.36数据可信
供试品溶液-2批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1251001-25100131.95532.003.4331.9632.003.44
2237683-23768330.26030.26
3260995-26099533.22733.23
4259805-25980533.07633.08
5246947-24694731.43931.44
6251822-25182232.06032.06
10min1552242-55224270.30668.422.5470.3668.472.54
2516789-51678965.79365.84
3526847-52684767.07367.13
4539071-53907168.62968.68
5550169-55016970.04270.09
6539265-53926568.65468.71
15min1739478-73947894.14391.052.6794.3191.212.66
2704853-70485389.73589.90
3689535-68953587.78587.95
4704741-70474189.72189.89
5733572-73357293.39193.56
6718707-71870791.49991.67
20min1786392-786392100.11697.452.93100.4497.772.92
2788941-788941100.440100.75
3728826-72882692.78793.10
4753693-75369395.95396.27
5771367-77136798.20398.53
6763434-76343497.19397.51
30min1785008-78500899.94097.533.15100.4398.013.14
2795972-795972101.336101.81
3728103-72810392.69593.16
4753463-75346395.92496.40
5771404-77140498.20898.70
6762585-76258597.08597.57
45min1784533-78453399.87997.303.24100.5497.943.23
2794948-794948101.205101.85
3725381-72538192.34992.97
4751280-75128095.64696.28
5768608-76860897.85298.50
6760688-76068896.84497.49
极限1782064-78206499.56597.033.35100.3997.843.34
2795242-795242101.243102.06
3724800-72480092.27593.05
4743947-74394794.71295.51
5766986-76698697.64598.46
6759975-75997596.75397.56
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