氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.999052891012903159067390235905530.35
2 14.999138590777910810.48
单位质量响应值RSD%判断
6040.896076.120.42数据可信
长期6月-供试品溶液-2025021021批-氨氯地平-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%
5min148705-4870552.11447.5415.3852.1147.5415.38
240242-4024243.05943.06
344537-4453747.65447.65
434129-3412936.51836.52
553979-5397957.75757.76
644975-4497548.12348.12
10min169426-6942674.28571.3511.4974.3771.4211.49
264385-6438568.89268.96
362798-6279867.19367.27
456995-5699560.98461.05
579773-7977385.35785.45
666704-6670471.37371.45
15min176561-7656181.92080.6210.0582.1380.8210.05
272072-7207277.11777.30
369401-6940174.25974.45
469717-6971774.59774.76
589721-8972196.00196.24
674607-7460779.82980.03
20min177872-7787283.32384.429.0983.6784.769.10
276976-7697682.36482.68
372942-7294278.04878.36
475137-7513780.39680.68
593059-9305999.57399.97
677419-7741982.83883.17
30min179637-7963785.21186.638.6685.7087.108.67
278792-7879284.30784.76
374468-7446879.68080.13
478767-7876784.28084.70
594735-94735101.366101.93
679355-7935584.90985.38
45min181426-8142687.12588.808.6687.7589.428.67
280508-8050886.14386.74
375783-7578381.08781.67
480264-8026485.88286.44
596783-96783103.557104.29
683203-8320389.02789.64
极限185520-8552091.50690.478.5792.2891.238.58
281348-8134887.04287.78
375673-7567380.97081.68
481634-8163487.34888.05
597293-97293104.103105.01
685822-8582291.82992.59
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.613608233634693605233629393607893617090.39
211.653694603614683654641.55
单位质量响应值RSD%判断
31154.9531370.300.49数据可信
长期6月-供试品溶液-2025021021批-阿托伐他汀钙-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%
5min1225968-22596859.83054.1211.4559.8354.1211.46
2195588-19558851.78651.79
3201623-20162353.38453.38
4164574-16457443.57543.57
5228123-22812360.40160.40
6210613-21061355.76555.76
10min1285272-28527275.53271.767.7975.6371.857.80
2269596-26959671.38271.47
3258298-25829868.39068.48
4242190-24219064.12564.20
5302956-30295680.21580.32
6267811-26781170.90971.00
15min1302196-30219680.01378.736.5780.2478.946.57
2294494-29449477.97478.18
3279802-27980274.08474.29
4283132-28313274.96675.15
5333703-33370388.35688.59
6290797-29079776.99577.21
20min1307462-30746281.40881.476.2781.7781.816.27
2307024-30702481.29281.63
3287645-28764576.16176.49
4301251-30125179.76380.07
5344219-34421991.14091.52
6298595-29859579.06079.40
30min1311430-31143082.45883.066.2782.9583.536.27
2312809-31280982.82383.29
3290171-29017176.83077.28
4312364-31236482.70683.14
5349834-34983492.62793.16
6305544-30554480.90081.37
45min1315215-31521583.46084.265.8784.0984.885.87
2316308-31630883.75084.36
3293724-29372477.77078.35
4317648-31764884.10584.68
5351666-35166693.11293.80
6314896-31489683.37683.98
极限1335653-33565388.87286.275.9989.6487.035.99
2318421-31842184.30985.06
3294786-29478678.05178.76
4320715-32071584.91785.63
5352510-35251093.33594.18
6332954-33295488.15788.90
氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.999018590821902899092890072904590.43
2 14.998988989237895630.52
单位质量响应值RSD%判断
6034.625974.850.71数据可信
长期6月-供试品溶液-2025021121批-氨氯地平-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%
5min146892-4689250.62449.984.2450.6249.984.23
248758-4875852.63952.64
343109-4310946.54046.54
447102-4710250.85150.85
546901-4690150.63450.63
645032-4503248.61648.62
10min167990-6799073.40273.563.4273.4973.653.42
265526-6552670.74170.83
366233-6623371.50571.58
470548-7054876.16376.25
571305-7130576.98077.06
667235-6723572.58672.67
15min175802-7580281.83582.784.3282.0482.994.31
272069-7206977.80578.01
374566-7456680.50180.70
479798-7979886.14986.36
580975-8097587.42087.63
676860-7686082.97883.18
20min176296-7629682.36986.125.4182.7186.465.39
273699-7369979.56579.90
379344-7934485.65985.99
485255-8525592.04192.40
583348-8334889.98290.34
680664-8066487.08487.42
30min178501-7850184.74988.635.3185.2389.125.30
276195-7619582.26082.73
381666-8166688.16688.64
487569-8756994.53995.05
586208-8620893.07093.58
682460-8246089.02389.51
45min179453-7945385.77788.884.3686.4089.524.36
276945-7694583.06983.67
382463-8246389.02689.65
484526-8452691.25491.92
586823-8682393.73494.40
683757-8375790.42391.06
极限182094-8209488.62890.575.1589.3991.365.14
277652-7765283.83384.58
382672-8267289.25290.02
487630-8763094.60595.42
589846-8984696.99797.82
683482-8348290.12790.91
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.613613633635513620423643553615543625730.37
211.653612363586853599600.51
单位质量响应值RSD%判断
31229.3730897.850.76数据可信
长期6月-供试品溶液-2025021121批-阿托伐他汀钙-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%
5min1228965-22896561.01359.024.4961.0159.024.49
2224698-22469859.87659.88
3204983-20498354.62354.62
4229258-22925861.09161.09
5227291-22729160.56760.57
6213721-21372156.95156.95
10min1288689-28868976.92876.244.6377.0376.344.63
2273696-27369672.93373.03
3270026-27002671.95572.05
4302401-30240180.58280.68
5299456-29945679.79779.90
6282333-28233375.23475.33
15min1310106-31010682.63582.734.9982.8782.964.99
2291541-29154177.68877.91
3295753-29575378.81079.02
4329420-32942087.78288.02
5326642-32664287.04287.28
6309319-30931982.42582.65
20min1315656-31565684.11485.335.3484.4885.705.33
2298761-29876179.61279.96
3306369-30636981.63981.98
4342910-34291091.37791.76
5336601-33660189.69590.07
6321084-32108485.56185.92
30min1319197-31919785.05886.755.3985.5787.265.38
2305182-30518281.32381.81
3310689-31068982.79183.27
4350483-35048393.39593.93
5340869-34086990.83391.36
6326924-32692487.11787.62
45min1320127-32012785.30686.985.3585.9687.645.35
2304229-30422981.06981.69
3313492-31349283.53784.15
4349374-34937493.09993.79
5343590-34359091.55892.24
6327747-32774787.33687.98
极限1331444-33144488.32188.065.9589.1188.865.94
2304088-30408881.03281.79
3315732-31573284.13484.89
4350049-35004993.27994.12
5355243-35524394.66395.50
6326209-32620986.92687.72
氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.999148691638917499172391844916880.15
2 14.999172091948918340.18
单位质量响应值RSD%判断
6116.616126.350.12数据可信
长期6月-供试品溶液-2025021221批-氨氯地平-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%
5min145950-4595048.66045.7816.0048.6645.7816.00
251046-5104654.05754.06
332586-3258634.50834.51
447352-4735250.14550.14
545243-4524347.91147.91
637214-3721439.40939.41
10min172856-7285677.15373.937.6277.2374.007.62
276030-7603080.51480.60
365134-6513468.97569.03
471748-7174875.98076.06
571384-7138475.59475.67
661736-6173665.37765.44
15min180301-8030185.03783.305.3485.2583.505.35
283853-8385388.79989.02
375751-7575180.21980.39
480265-8026584.99985.21
579908-7990884.62184.83
671893-7189376.13376.31
20min186028-8602891.10289.215.5091.4589.555.51
289440-8944094.71595.09
382050-8205086.88987.20
484220-8422089.18789.54
587368-8736892.52192.87
676338-7633880.84081.14
30min187515-8751592.67691.496.2293.1891.986.23
291582-9158296.98397.51
384669-8466989.66390.11
487211-8721192.35592.86
590702-9070296.05196.55
676701-7670181.22581.66
45min187860-8786093.04292.105.5893.7092.745.58
292681-9268198.14798.84
385683-8568390.73691.34
486769-8676991.88692.54
590315-9031595.64296.30
678534-7853483.16683.74
极限188621-8862193.84892.414.8894.6693.204.90
291145-9114596.52197.38
386519-8651991.62292.37
487601-8760192.76893.58
590380-9038095.71096.53
679304-7930483.98184.69
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.613720023723513725193719243717013720990.09
211.653727193733033730110.12
单位质量响应值RSD%判断
32049.8732018.110.08数据可信
长期6月-供试品溶液-2025021221批-阿托伐他汀钙-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%
5min1221859-22185957.32754.8912.8357.3354.8912.83
2232736-23273660.13860.14
3163903-16390342.35242.35
4235535-23553560.86160.86
5222767-22276757.56257.56
6197760-19776051.10051.10
10min1302502-30250278.16576.275.4478.2676.365.45
2308585-30858579.73779.84
3275060-27506071.07471.14
4309902-30990280.07780.18
5299957-29995777.50777.60
6274982-27498271.05471.14
15min1327699-32769984.67683.644.4384.9083.864.44
2333514-33351486.17886.41
3309807-30980780.05280.24
4336662-33666286.99287.23
5332455-33245585.90586.13
6301912-30191278.01278.22
20min1340191-34019187.90486.844.2088.2787.204.21
2346368-34636889.50089.88
3325048-32504883.99184.31
4345595-34559589.30089.68
5346550-34655089.54789.91
6312661-31266180.79081.12
30min1345551-34555189.28988.534.0789.8089.044.07
2351921-35192190.93491.46
3333000-33300086.04586.51
4350155-35015590.47891.01
5355902-35590291.96392.48
6319221-31922182.48582.95
45min1347920-34792089.90188.764.0890.5689.414.08
2352019-35201990.96091.64
3336650-33665086.98987.59
4350406-35040690.54391.22
5355778-35577891.93192.60
6318203-31820382.22282.83
极限1348814-34881490.13289.193.5990.9489.993.60
2352973-35297391.20692.04
3337401-33740187.18387.93
4352724-35272491.14291.97
5355521-35552191.86592.69
6323587-32358783.61384.36
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