阿齐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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.132900312905532902282898512895722900470.13
211.192895072895022895040.01
单位质量响应值RSD%判断
26059.9325871.670.52数据可信
供试品溶液-2023101221批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112481-124814.3135.2726.164.315.2626.15
222575-225757.8017.80
312142-121424.1964.20
412735-127354.4014.40
514846-148465.1305.13
616649-166495.7535.75
10min186148-8614829.77132.017.6329.7932.047.63
297632-9763233.73933.78
396725-9672533.42633.45
498892-9889234.17534.20
594783-9478332.75532.78
681608-8160828.20228.23
15min1160498-16049855.46455.773.5955.6555.983.59
2161313-16131355.74655.98
3165669-16566957.25157.46
4164271-16427156.76856.98
5165998-16599857.36557.58
6150498-15049852.00852.20
20min1195194-19519467.45467.553.1567.9568.073.15
2193784-19378466.96767.51
3199736-19973669.02469.55
4198406-19840668.56469.09
5201377-20137769.59170.12
6184327-18432763.69964.18
30min1214132-21413273.99974.482.7174.8775.372.72
2213522-21352273.78874.70
3223084-22308477.09278.00
4217208-21720875.06275.97
5219240-21924075.76476.68
6205993-20599371.18672.02
45min1240007-24000782.94083.232.7084.2284.542.70
2235294-23529481.31282.63
3247646-24764685.58086.92
4243148-24314884.02685.35
5247374-24737485.48686.82
6231620-23162080.04281.27
60min1258669-25866989.38990.402.0791.1392.172.08
2256506-25650688.64290.42
3263091-26309190.91892.73
4268512-26851292.79194.59
5266941-26694192.24894.06
6255814-25581488.40390.07
阿齐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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.957033670087699527018870045701220.21
214.886994370152700480.22
单位质量响应值RSD%判断
4690.434707.530.26数据可信
供试品溶液-2023101221批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122696-2269631.31542.8518.2531.3142.8518.25
237521-3752151.77051.77
326171-2617136.11036.11
431191-3119143.03643.04
535572-3557249.08149.08
633192-3319245.79745.80
10min150909-5090970.24274.824.6270.4275.064.62
254192-5419274.77275.06
356790-5679078.35678.56
456968-5696878.60278.84
554723-5472375.50475.78
651782-5178271.44671.70
15min165909-6590990.93893.332.9091.5093.982.90
267274-6727492.82193.52
370274-7027496.96197.60
468382-6838294.35095.03
568977-6897795.17195.86
665047-6504789.74990.40
20min168206-6820694.10796.262.1395.1897.442.14
269012-6901295.21996.44
371733-7173398.974100.15
470496-7049697.26798.47
570914-7091497.84499.06
668249-6824994.16795.32
30min168442-6844294.43396.222.1496.0397.922.13
268951-6895195.13596.88
372323-7232399.788101.51
470020-7002096.61098.35
570259-7025996.94098.70
668426-6842694.41196.08
45min169132-6913295.38597.812.6697.50100.052.65
269425-6942595.78998.07
374047-74047102.167104.45
471297-7129798.372100.65
571795-7179599.059101.36
669647-6964796.09698.29
60min169175-6917595.44496.293.1798.0999.073.09
270166-7016696.81299.62
372228-7222899.657102.50
465764-6576490.73893.56
570904-7090497.830100.68
670483-7048397.24999.98
阿齐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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.132920162925502903502898532907572911050.40
211.192907142906142906640.03
单位质量响应值RSD%判断
26154.9925975.340.49数据可信
供试品溶液-2023101221批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110900-109003.7524.5118.583.754.5118.61
212371-123714.2594.26
310549-105493.6323.63
412766-127664.3954.39
515401-154015.3025.30
616611-166115.7185.72
10min187777-8777730.21831.208.1930.2431.238.17
296800-9680033.32433.35
396799-9679933.32433.34
489974-8997430.97431.00
594922-9492232.67832.71
677518-7751826.68626.72
15min1153756-15375652.93254.644.1353.1254.844.11
2158182-15818254.45554.66
3168754-16875458.09558.30
4152923-15292352.64552.84
5154162-15416253.07153.28
6164543-16454356.64556.83
20min1188303-18830364.82565.472.7765.3165.982.75
2186540-18654064.21864.73
3193989-19398966.78267.31
4184980-18498063.68164.17
5188370-18837064.84865.35
6198938-19893868.48668.98
30min1206403-20640371.05672.653.2071.9073.523.18
2204387-20438770.36271.23
3218288-21828875.14776.05
4206285-20628571.01571.86
5210481-21048172.45973.33
6220314-22031475.84576.72
45min1229958-22995879.16581.393.0380.4082.653.01
2230507-23050779.35480.61
3241878-24187883.26884.58
4232734-23273480.12081.36
5235385-23538581.03382.30
6247999-24799985.37586.67
60min1253303-25330387.20188.572.2388.8890.292.23
2257102-25710288.50990.21
3261196-26119689.91891.70
4251565-25156586.60388.29
5253804-25380487.37489.09
6266638-26663891.79293.56
阿齐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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.957077670333705247044070314704770.27
214.887038570129702570.26
单位质量响应值RSD%判断
4714.184721.570.12数据可信
供试品溶液-2023101221批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130474-3047441.87847.498.6941.8847.498.69
235008-3500848.10948.11
332339-3233944.44144.44
433758-3375846.39146.39
537443-3744351.45551.46
638334-3833452.67952.68
10min152115-5211571.61875.557.6471.8575.827.63
256142-5614277.15277.42
357917-5791779.59179.84
448938-4893867.25267.51
554080-5408074.31874.60
660687-6068783.39783.69
15min169424-6942495.40494.535.2596.0395.215.24
270652-7065297.09297.79
370624-7062497.05397.74
464844-6484489.11089.74
564004-6400487.95688.65
673189-73189100.578101.33
20min173033-73033100.36496.683.67101.5297.893.65
271785-7178598.64999.88
368997-6899794.81796.05
467704-6770493.04094.17
567560-6756092.84294.03
673052-73052100.390101.70
30min172998-72998100.31697.263.58102.0399.003.57
270680-7068097.13098.91
370771-7077197.25599.01
467674-6767492.99994.64
568346-6834693.92395.63
674160-74160101.912103.78
45min173139-73139100.50999.062.71102.78101.352.73
272371-7237199.454101.78
371774-7177498.633100.93
471062-7106297.65599.81
569201-6920195.09897.32
674978-74978103.036105.48
60min174118-74118101.85598.583.90104.69101.423.88
273811-73811101.433104.31
369704-6970495.78998.63
468824-6882494.58097.28
569117-6911794.98297.74
674837-74837102.843105.85
阿齐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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.132901992900812901432896822896682899550.09
211.192921412925862923640.11
单位质量响应值RSD%判断
26051.6626127.260.21数据可信
供试品溶液-2024010621批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118786-187866.4615.9925.926.466.0025.92
218361-183616.3156.31
324210-242108.3278.33
418218-182186.2666.27
513919-139194.7874.79
611075-110753.8093.81
10min193963-9396332.31733.817.4432.3533.857.45
299264-9926434.14034.18
3100587-10058734.59534.64
4107171-10717136.86036.89
5102636-10263635.30035.33
686258-8625829.66729.69
15min1185527-18552763.80966.834.6464.0267.054.65
2201312-20131269.23869.46
3204070-20407070.18670.42
4194014-19401466.72866.97
5199295-19929568.54468.77
6181704-18170462.49462.68
20min1203744-20374470.07473.374.3470.6473.974.35
2220081-22008175.69376.30
3223329-22332976.81077.44
4209451-20945172.03772.65
5220953-22095375.99376.60
6202473-20247369.63770.17
30min1229341-22934178.87882.524.8879.8483.524.88
2247137-24713784.99986.03
3248597-24859785.50186.56
4233807-23380780.41481.42
5254629-25462987.57588.60
6226071-22607177.75378.67
45min1248312-24831285.40388.733.6486.8090.183.65
2262946-26294690.43691.94
3269538-26953892.70394.23
4253880-25388087.31888.77
5265700-26570091.38392.90
6247467-24746785.11286.46
60min1258015-25801588.74092.763.7690.6194.713.76
2279154-27915496.01098.01
3277866-27786695.56797.61
4262936-26293690.43292.37
5279403-27940396.09698.12
6260791-26079189.69591.52
阿齐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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.957009270405701217017370343702270.20
214.887058170127703540.46
单位质量响应值RSD%判断
4697.464728.090.46数据可信
供试品溶液-2024010621批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136845-3684550.68950.0016.3050.6950.0016.30
235879-3587949.36049.36
325667-2566735.31135.31
442771-4277158.84158.84
540777-4077756.09856.10
636131-3613149.70649.71
10min154638-5463875.16776.424.5375.4576.704.54
254536-5453675.02675.30
355310-5531076.09176.29
458715-5871580.77681.10
558143-5814379.98980.30
651961-5196171.48471.76
15min169631-6963195.79396.252.5396.4996.952.56
270581-7058197.10097.79
368047-6804793.61494.23
472132-7213299.234100.01
571510-7151098.37899.13
667888-6788893.39594.07
20min169248-6924895.26696.752.5996.5097.982.62
270542-7054297.04698.28
368594-6859494.36695.51
471932-7193298.959100.29
572965-72965100.380101.68
668664-6866494.46395.65
30min170831-7083197.44498.103.2499.2099.873.25
271664-7166498.590100.36
369317-6931795.36197.02
472619-7261999.904101.78
574875-74875103.007104.87
668521-6852194.26695.98
45min170823-7082397.43398.062.4499.73100.382.47
270791-7079197.38999.71
370246-7024696.63998.83
473280-73280100.813103.24
573465-73465101.068103.50
669088-6908895.04697.29
60min170726-7072697.29998.052.23100.14100.922.26
272514-7251499.759102.62
369590-6959095.73798.47
472948-72948100.356103.35
572483-7248399.717102.71
669378-6937895.44598.21
阿齐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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.132876412874822881122882402877792878510.12
211.192888282891312889800.08
单位质量响应值RSD%判断
25862.6225824.840.11数据可信
供试品溶液-2024010621批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119693-196936.8375.2131.876.845.2231.85
212789-127894.4404.44
316156-161565.6095.61
420049-200496.9616.96
57251-72512.5182.52
614162-141624.9174.92
10min1100037-10003734.73333.628.4134.7733.648.40
2106728-10672837.05637.08
389458-8945831.06031.09
4100148-10014834.77234.81
599900-9990034.68634.70
684664-8466429.39629.42
15min1204566-20456671.02668.574.4371.2668.794.43
2204159-20415970.88471.12
3197971-19797168.73668.94
4188556-18855665.46765.70
5204663-20466371.05971.27
6185024-18502464.24164.43
20min1223001-22300177.42675.263.0278.0575.863.02
2221751-22175176.99277.62
3216012-21601275.00075.59
4209909-20990972.88173.48
5221839-22183977.02377.62
6208043-20804372.23372.78
30min1253233-25323387.92383.833.8288.9884.843.82
2245801-24580185.34386.39
3239745-23974583.24084.24
4233060-23306080.91981.92
5247743-24774386.01787.05
6229032-22903279.52080.47
45min1268508-26850893.22790.393.1894.7791.873.18
2266671-26667192.58994.11
3256320-25632088.99590.46
4252329-25232987.60989.06
5267794-26779492.97994.49
6250415-25041586.94588.34
60min1283278-28327898.35594.283.34100.4296.263.34
2275566-27556695.67797.72
3269069-26906993.42195.38
4261434-26143490.77092.71
5278378-27837896.65398.68
6261478-26147890.78692.66
阿齐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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.956949769872696046981469687696950.22
214.886989069788698390.11
单位质量响应值RSD%判断
4661.874693.480.48数据可信
供试品溶液-2024010621批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138537-3853753.41450.188.0753.4150.188.07
237722-3772252.28452.28
338001-3800152.67152.67
437495-3749551.97051.97
531017-3101742.99142.99
634439-3443947.73447.73
10min152609-5260972.91976.096.5673.2276.376.54
256821-5682178.75779.05
357263-5726379.36979.66
455717-5571777.22677.52
558261-5826180.75380.99
648712-4871267.51767.78
15min168815-6881595.38195.623.6696.0896.323.65
269769-6976996.70397.43
371631-7163199.284100.02
467451-6745193.49094.21
571310-7131098.83999.53
664945-6494590.01790.66
20min168287-6828794.64995.642.7795.8896.872.78
269563-6956396.41897.68
371471-7147199.062100.35
467512-6751293.57594.81
570680-7068097.96699.20
666495-6649592.16593.31
30min170562-7056297.80296.752.5099.5698.522.51
270454-7045497.65399.45
371348-7134898.892100.73
468288-6828894.65096.41
571148-7114898.615100.40
667027-6702792.90394.56
45min169540-6954096.38696.561.8598.6998.861.87
270521-7052197.745100.09
370004-7000497.02999.41
469506-6950696.33998.62
571085-7108598.527100.86
667351-6735193.35295.52
60min170888-7088898.25497.022.10101.0999.862.11
269757-6975796.68799.57
371150-7115098.617101.54
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