氢溴酸替格列汀片项目信息
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%
114.163226953226763229293225133228743227370.06
214.143226143227423226780.03
单位质量响应值RSD%判断
22792.1622820.230.09数据可信
供试品溶液-1批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1185212-18521247.12544.496.8347.1244.486.83
2162353-16235341.30941.31
3183036-18303646.57146.57
4177919-17791945.26945.27
5183096-18309646.58746.59
6157425-15742540.05540.05
10min1332888-33288884.69982.583.4384.7882.663.43
2316118-31611880.43280.50
3333566-33356684.87284.95
4326823-32682383.15683.23
5331854-33185484.43684.51
6306158-30615877.89877.97
15min1382412-38241297.30095.971.2997.5296.181.29
2369389-36938993.98794.19
3377182-37718295.96996.19
4380715-38071596.86897.08
5373837-37383795.11895.34
6379641-37964196.59596.79
20min1383339-38333997.53696.611.6597.9296.991.64
2371457-37145794.51394.87
3378870-37887096.39996.78
4384309-38430997.78398.16
5373438-37343895.01795.39
6386891-38689198.44098.80
30min1383028-38302897.45796.421.5098.0096.951.49
2371613-37161394.55395.07
3376733-37673395.85596.39
4383707-38370797.63098.17
5373766-37376695.10095.64
6384874-38487497.92798.45
45min1382137-38213797.23096.171.6197.9496.861.60
2369578-36957894.03594.71
3376928-37692895.90596.60
4381641-38164197.10497.81
5372455-37245594.76795.46
6385113-38511397.98798.67
极限1381011-38101196.94495.961.6397.8196.811.63
2369869-36986994.10994.94
3376882-37688295.89396.75
4382118-38211897.22598.09
5369595-36959594.03994.89
6383382-38338297.54798.40
氢溴酸替格列汀片项目信息
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%
114.163222323220493226733225353228033224580.10
214.143217853221753219800.09
单位质量响应值RSD%判断
22772.4622770.860.01数据可信
供试品溶液-1批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1182184-18218446.42547.632.9646.4247.632.96
2180305-18030545.94645.95
3185374-18537447.23847.24
4188796-18879648.11048.11
5195590-19559049.84149.84
6189195-18919548.21148.21
10min1334195-33419585.16184.811.7985.2484.891.79
2323359-32335982.40082.48
3332031-33203184.60984.69
4334194-33419485.16185.24
5341798-34179887.09887.18
6331410-33141084.45184.53
15min1369099-36909994.05595.681.3594.2795.901.35
2371108-37110894.56794.78
3377369-37736996.16396.38
4381866-38186697.30997.53
5379862-37986296.79897.03
6373492-37349295.17595.40
20min1370885-37088594.51095.511.4294.8995.891.42
2367552-36755293.66194.03
3374646-37464695.46995.85
4380965-38096597.07997.46
5380618-38061896.99197.38
6374228-37422895.36295.74
30min1369097-36909794.05595.171.3594.5995.711.35
2367810-36781093.72794.25
3376663-37666395.98396.52
4381477-38147797.20997.76
5372456-37245694.91195.46
6373332-37333295.13495.67
45min1369266-36926694.09895.091.3494.7995.791.33
2370358-37035894.37695.06
3367814-36781493.72894.43
4379692-37969296.75597.46
5378591-37859196.47497.18
6373253-37325395.11495.81
极限1368353-36835393.86595.151.2394.7196.011.23
2368441-36844193.88894.73
3375250-37525095.62396.48
4379140-37914096.61497.48
5377362-37736296.16197.03
6371901-37190194.76995.62
氢溴酸替格列汀片项目信息
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%
114.163218763220543222263217573217853219400.07
214.143218343217653218000.02
单位质量响应值RSD%判断
22735.8822758.130.07数据可信
供试品溶液-1批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1183072-18307246.70249.663.5346.7049.663.54
2197291-19729150.32950.33
3193955-19395549.47849.48
4202789-20278951.73151.73
5191787-19178748.92548.92
6199128-19912850.79850.80
10min1342980-34298087.49488.833.3087.5788.923.30
2343414-34341487.60587.69
3353633-35363390.21290.29
4337432-33743286.07986.17
5342862-34286287.46487.55
6369055-36905594.14694.23
15min1389065-38906599.25198.153.9499.4798.383.93
2376522-37652296.05196.28
3392364-392364100.092100.32
4364644-36464493.02193.25
5377836-37783696.38696.61
6408185-408185104.128104.37
20min1387790-38779098.92598.593.9999.3198.983.99
2378516-37851696.55996.95
3398567-398567101.674102.07
4366854-36685493.58593.97
5377811-37781196.38096.77
6409223-409223104.393104.81
30min1386963-38696398.71498.114.2499.2798.674.23
2376943-37694396.15896.71
3396878-396878101.244101.81
4361721-36172192.27592.82
5377369-37736996.26796.82
6407733-407733104.013104.60
45min1384341-38434198.04598.183.9798.7698.903.96
2376674-37667496.09096.80
3397823-397823101.485102.22
4365399-36539993.21393.91
5377821-37782196.38297.09
6407214-407214103.880104.64
极限1386198-38619898.51997.813.9299.4098.693.92
2372817-37281795.10695.98
3395364-395364100.857101.76
4365325-36532593.19494.04
5375510-37551095.79396.66
6405212-405212103.370104.31
氢溴酸替格列汀片项目信息
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%
114.166445356451446453436453926451176451060.06
214.146439836438556439190.02
单位质量响应值RSD%判断
45558.3345538.830.04数据可信
供试品溶液-2批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1229473-22947329.23428.544.6129.2328.544.62
2218042-21804227.77827.78
3205456-20545626.17526.17
4228923-22892329.16429.16
5231288-23128829.46529.47
6230822-23082229.40629.41
10min1503925-50392564.19964.132.6064.2564.182.60
2498224-49822463.47263.52
3490168-49016862.44662.49
4490439-49043962.48162.53
5520969-52096966.37066.42
6516571-51657165.81065.86
15min1683237-68323787.04287.171.6587.2087.331.65
2681027-68102786.76186.91
3681447-68144786.81486.96
4667021-66702184.97785.13
5699867-69986789.16189.32
6692992-69299288.28588.44
20min1760502-76050296.88695.581.0997.1995.881.09
2736168-73616893.78694.08
3752427-75242795.85796.15
4747038-74703895.17195.46
5752381-75238195.85196.16
6752878-75287895.91596.22
30min1763486-76348697.26696.261.1797.7396.711.17
2738792-73879294.12094.57
3758727-75872796.66097.11
4761229-76122996.97897.43
5756104-75610496.32696.79
6754960-75496096.18096.65
45min1759509-75950996.75996.141.1897.3896.761.18
2737620-73762093.97194.58
3759730-75973096.78797.40
4761617-76161797.02897.64
5752794-75279495.90496.53
6756582-75658296.38697.01
极限1769223-76922397.99796.151.5598.7896.931.54
2734783-73478393.60994.38
3757223-75722396.46897.24
4760829-76082996.92897.70
5749789-74978995.52196.31
6756693-75669396.40197.19
氢溴酸替格列汀片项目信息
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%
114.166440186436176444446442356444816441590.06
214.146455916459136457520.04
单位质量响应值RSD%判断
45491.4545668.460.28数据可信
供试品溶液-2批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1237029-23702930.17630.693.7530.1830.693.75
2246115-24611531.33331.33
3255725-25572532.55632.56
4229740-22974029.24829.25
5241331-24133130.72430.72
6236311-23631130.08530.08
10min1529750-52975067.44268.202.3167.4968.262.31
2547000-54700069.63969.69
3549990-54999070.01970.07
4528131-52813167.23667.29
5541333-54133368.91768.97
6518220-51822065.97566.02
15min1709154-70915490.28291.250.9490.4591.420.94
2721810-72181091.89492.06
3721569-72156991.86392.03
4724057-72405792.18092.34
5715331-71533191.06991.23
6708726-70872690.22890.39
20min1762871-76287197.12197.830.9897.4398.140.98
2775120-77512098.68199.00
3771754-77175498.25298.58
4775327-77532798.70799.02
5769153-76915397.92198.24
6756372-75637296.29496.60
30min1758523-75852396.56897.790.9897.0498.270.98
2774170-77417098.56099.05
3772664-77266498.36898.86
4775674-77567498.75199.23
5767944-76794497.76798.25
6759544-75954496.69897.17
45min1757912-75791296.49097.600.8597.1398.250.85
2774120-77412098.55399.20
3769531-76953197.96998.62
4771450-77145098.21398.86
5767075-76707597.65698.30
6759918-75991896.74597.38
极限1757283-75728396.41097.490.9097.2198.290.90
2772386-77238698.33299.15
3770566-77056698.10198.92
4771178-77117898.17998.99
5765326-76532697.43498.24
6757687-75768796.46197.25
氢溴酸替格列汀片项目信息
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%
114.166438776441956439546441516442836440920.03
214.146470276471816471040.02
单位质量响应值RSD%判断
45486.7245764.070.43数据可信
供试品溶液-2批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1244065-24406531.04133.774.7631.0433.774.76
2280749-28074935.70735.71
3264146-26414633.59533.60
4260546-26054633.13733.14
5271286-27128634.50334.50
6272206-27220634.62034.62
10min1537005-53700568.29871.553.1068.3571.613.10
2563834-56383471.71171.77
3560861-56086171.33271.39
4551234-55123470.10870.16
5577591-57759173.46073.52
6584978-58497874.40074.46
15min1702156-70215689.30392.342.7289.4792.522.72
2718995-71899591.44591.62
3730440-73044092.90093.08
4708270-70827090.08190.25
5748795-74879595.23595.41
6747594-74759495.08295.26
20min1734058-73405893.36096.042.4593.6796.372.45
2749004-74900495.26195.59
3751388-75138895.56495.89
4743535-74353594.56694.89
5767153-76715397.57097.91
6785557-78555799.910100.25
30min1735108-73510893.49496.082.1993.9696.572.20
2747549-74754995.07695.57
3752520-75252095.70896.20
4748692-74869295.22295.70
5766407-76640797.47597.98
6782216-78221699.48599.99
45min1734027-73402793.35695.872.3693.9896.522.36
2745184-74518494.77595.42
3747583-74758395.08195.73
4745919-74591994.86995.51
5767290-76729097.58798.25
6782552-78255299.528100.20
极限1729289-72928992.75495.662.3993.5496.472.39
2746299-74629994.91795.72
3746053-74605394.88695.69
4745310-74531094.79195.59
5765700-76570097.38598.21
6780185-78018599.227100.07
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