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%
115.239286392926924559268592696927250.20
215.149161591707916610.08
单位质量响应值RSD%判断
6088.316054.230.40数据可信
供试品溶液-2025021521批-氨氯地平-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%
5min181448-8144886.96686.800.7686.9786.800.76
280286-8028685.72585.72
381209-8120986.71086.71
482081-8208187.64187.64
581041-8104186.53186.53
681701-8170187.23687.24
10min190530-9053096.66396.391.3296.8196.541.32
288938-8893894.96395.11
392170-9217098.41498.56
490975-9097597.13897.28
589569-8956995.63795.78
689479-8947995.54195.69
15min192786-9278699.07299.371.3899.3899.671.37
291641-9164197.84998.15
394888-94888101.316101.62
494228-94228100.611100.92
592927-9292799.22299.53
691905-9190598.13198.44
20min194337-94337100.728101.101.14101.20101.581.14
293316-9331699.638100.10
396458-96458102.992103.47
495316-95316101.773102.25
594407-94407100.803101.27
694306-94306100.695101.16
30min194477-94477100.877101.691.44101.52102.331.43
294029-94029100.399101.03
397379-97379103.976104.62
496236-96236102.755103.40
595387-95387101.849102.49
693941-93941100.305100.94
45min195124-95124101.568102.201.23102.38103.011.22
294384-94384100.778101.58
397715-97715104.335105.16
496287-96287102.810103.63
595669-95669102.150102.96
695103-95103101.546102.35
极限195367-95367101.828102.461.20102.80103.441.20
294723-94723101.140102.11
398114-98114104.761105.76
495912-95912102.409103.40
595696-95696102.179103.16
695926-95926102.424103.40
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%
1 11.431730111735011727001735351733231732140.21
2 11.391731951734421733180.11
单位质量响应值RSD%判断
15154.3315216.680.30数据可信
供试品溶液-2025021521批-阿托伐他汀钙-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%
5min180738-8073844.00941.844.2544.0141.854.25
274315-7431540.50840.51
372866-7286639.71839.72
480199-8019943.71643.72
574881-7488140.81740.82
677596-7759642.29742.30
10min1124591-12459167.91365.233.2367.9965.303.23
2117099-11709963.82963.90
3116995-11699563.77363.84
4124463-12446367.84367.92
5118704-11870464.70464.77
6116121-11612163.29663.37
15min1148389-14838980.88578.742.7481.0778.922.74
2141784-14178477.28577.46
3141706-14170677.24277.41
4150243-15024381.89682.08
5143921-14392178.45078.63
6140695-14069576.69176.87
20min1162697-16269788.68487.221.8289.0187.531.83
2158061-15806186.15786.46
3157032-15703285.59685.90
4164413-16441389.62089.94
5159570-15957086.98087.29
6158303-15830386.28986.59
30min1175095-17509595.44294.801.1995.9195.261.19
2172201-17220193.86594.31
3171445-17144593.45393.90
4177168-17716896.57297.04
5173547-17354794.59895.05
6174101-17410194.90095.35
45min1182001-18200199.20799.000.6099.8399.610.61
2180938-18093898.62799.23
3180161-18016198.20498.80
4183195-18319599.857100.49
5181179-18117998.75999.37
6182234-18223499.33499.94
极限1185736-185736101.243101.000.39102.04101.780.39
2184457-184457100.545101.31
3186211-186211101.501102.26
4185149-185149100.923101.72
5184521-184521100.580101.35
6185710-185710101.228102.00
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%
115.239157491654915979185791722916810.13
215.149125091333912920.07
单位质量响应值RSD%判断
6019.766029.850.12数据可信
供试品溶液-2025021521批-氨氯地平-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%
5min184444-8444490.85986.903.5790.8686.903.57
284425-8442590.83990.84
379488-7948885.52785.53
478773-7877384.75784.76
578189-7818984.12984.13
679241-7924185.26185.26
10min192467-9246799.49295.663.0599.6495.813.05
291819-9181998.79598.95
388713-8871395.45395.60
488079-8807994.77094.91
586201-8620192.75092.89
686159-8615992.70592.85
15min194866-94866102.07399.152.48102.3999.462.48
294876-94876102.084102.40
392159-9215999.16099.46
491234-9123498.16598.46
589706-8970696.52196.82
690061-9006196.90397.20
20min195708-95708102.97999.651.82103.47100.121.82
292449-9244999.47299.96
393100-93100100.173100.64
491743-9174398.71399.18
591734-9173498.70399.16
690959-9095997.86998.33
30min196814-96814104.169101.572.23104.83102.212.24
296994-96994104.363105.01
394609-94609101.796102.43
493237-93237100.320100.95
592315-9231599.32899.95
692437-9243799.459100.08
45min196895-96895104.256102.051.94105.09102.861.94
297082-97082104.457105.28
395264-95264102.501103.30
493517-93517100.622101.42
593187-93187100.266101.05
693133-93133100.208101.00
极限196466-96466103.795101.931.91104.80102.911.92
297194-97194104.578105.58
395058-95058102.280103.25
493697-93697100.815101.78
593191-93191100.271101.22
692806-9280699.856100.81
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%
1 11.431738421737401734461738461735351736820.11
2 11.391725791726441726120.03
单位质量响应值RSD%判断
15195.2815154.700.19数据可信
供试品溶液-2025021521批-阿托伐他汀钙-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%
5min184395-8439546.03542.694.7846.0342.684.78
280071-8007143.67643.68
375789-7578941.34041.34
475071-7507140.94940.95
574873-7487340.84140.84
679334-7933443.27443.27
10min1129949-12994970.88365.865.0870.9665.925.07
2124757-12475768.05168.12
3117852-11785264.28464.35
4122251-12225166.68466.75
5113198-11319861.74661.81
6116390-11639063.48763.56
15min1154266-15426684.14779.883.6584.3480.063.65
2149122-14912281.34181.53
3144639-14463978.89679.07
4147749-14774980.59280.77
5138367-13836775.47475.65
6144529-14452978.83679.01
20min1168200-16820091.74788.052.7392.0888.362.74
2163705-16370589.29589.62
3160294-16029487.43587.74
4161960-16196088.34488.66
5155129-15512984.61784.91
6159267-15926786.87587.18
30min1181268-18126898.87595.981.9599.3696.441.96
2176728-17672896.39996.87
3175717-17571795.84796.30
4176420-17642096.23196.69
5170571-17057193.04193.48
6175072-17507295.49695.95
45min1187370-187370102.204100.261.20102.86100.881.21
2183485-183485100.085100.72
3184432-184432100.601101.21
4183871-183871100.295100.92
5180553-18055398.48599.08
6183115-18311599.883100.50
极限1187990-187990102.542101.870.87103.37102.660.87
2187053-187053102.031102.83
3188654-188654102.904103.68
4187014-187014102.010102.80
5184239-184239100.496101.25
6185613-185613101.245102.03
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%
115.238955289598895878956589486895580.05
215.148914989152891500.01
单位质量响应值RSD%判断
5880.375888.380.10数据可信
供试品溶液-2025021221批-氨氯地平-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%
5min175058-7505882.68882.192.6482.6982.192.64
277526-7752685.40685.41
374546-7454682.12482.12
474866-7486682.47682.48
574254-7425481.80281.80
671382-7138278.63878.64
10min187041-8704195.88995.241.2096.0395.371.20
288214-8821497.18197.32
385683-8568394.39394.53
486195-8619594.95795.09
586166-8616694.92595.06
685388-8538894.06894.20
15min190524-9052499.72698.991.07100.0299.291.07
291315-91315100.597100.90
388523-8852397.52197.82
489542-8954298.64498.94
589724-8972498.84499.14
689536-8953698.63798.93
20min191948-91948101.294100.441.07101.76100.901.07
292115-92115101.478101.95
389381-8938198.46798.92
491249-91249100.524100.98
591062-91062100.318100.78
691294-91294100.574101.03
30min192795-92795102.228101.420.79102.86102.040.80
293113-93113102.578103.22
391564-91564100.871101.49
491333-91333100.617101.24
591915-91915101.258101.88
691624-91624100.938101.56
45min192905-92905102.349102.260.60103.15103.060.60
293370-93370102.861103.67
391866-91866101.204101.99
492521-92521101.926102.72
593068-93068102.528103.32
693232-93232102.709103.50
极限193758-93758103.288102.340.86104.26103.310.85
292447-92447101.844102.83
391734-91734101.059102.02
492730-92730102.156103.12
592926-92926102.372103.34
693802-93802103.337104.30
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%
1 11.433516663513593514453507263511703512730.11
2 11.393510893512423511660.04
单位质量响应值RSD%判断
30732.5530831.080.23数据可信
供试品溶液-2025021221批-阿托伐他汀钙-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%
5min1149952-14995240.32341.435.6540.3241.435.65
2161307-16130743.37743.38
3155705-15570541.87041.87
4162267-16226743.63543.63
5156384-15638442.05342.05
6138783-13878337.32037.32
10min1245264-24526465.95365.522.9166.0265.592.91
2251276-25127667.57067.64
3242623-24262365.24365.31
4249640-24964067.13067.20
5241629-24162964.97665.05
6231481-23148162.24762.31
15min1294990-29499079.32577.992.5279.5078.172.52
2296436-29643679.71479.90
3284037-28403776.37976.56
4297645-29764580.03980.22
5286763-28676377.11277.29
6280277-28027775.36875.53
20min1322073-32207386.60884.572.7286.9284.882.72
2316974-31697485.23685.55
3304627-30462781.91682.22
4325333-32533387.48487.80
5312523-31252384.03984.35
6305446-30544682.13682.43
30min1344652-34465292.67990.652.5693.1391.102.56
2337290-33729090.69991.16
3332156-33215689.31989.76
4347775-34777593.51993.98
5336969-33696990.61391.06
6323846-32384687.08487.51
45min1358769-35876996.47594.702.1997.0895.302.19
2350655-35065594.29394.90
3347217-34721793.36993.96
4361875-36187597.31197.93
5353732-35373295.12195.72
6340852-34085291.65792.23
极限1370496-37049699.62997.961.51100.4098.721.51
2363579-36357997.76998.54
3357198-35719896.05396.80
4371029-37102999.772100.55
5362776-36277697.55398.31
6360611-36061196.97197.70
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%
115.239053790683907479066390755906770.10
215.148925889273892660.02
单位质量响应值RSD%判断
5953.845896.040.69数据可信
供试品溶液-2025021221批-氨氯地平-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%
5min176679-7667983.89783.712.2983.9083.702.29
276709-7670983.93083.93
376930-7693084.17284.17
476300-7630083.48283.48
573485-7348580.40280.40
678919-7891986.34886.35
10min186409-8640994.54394.921.8994.6895.061.89
287367-8736795.59195.73
385225-8522593.24793.39
487053-8705395.24795.39
584988-8498892.98893.12
689472-8947297.89498.04
15min190266-9026698.76398.292.4599.0698.592.44
289914-8991498.37898.68
386753-8675394.91995.21
490209-9020998.70199.00
588516-8851696.84897.14
693366-93366102.155102.46
20min191162-9116299.74399.882.00100.21100.352.00
290954-9095499.51699.98
389094-8909497.48197.93
491638-91638100.264100.73
590343-9034398.84799.30
694548-94548103.448103.93
30min192763-92763101.495101.082.64102.12101.712.64
292227-92227100.909101.54
388665-8866597.01197.63
492889-92889101.633102.26
591544-91544100.161100.78
696223-96223105.281105.93
45min193136-93136101.903101.362.12102.70102.152.12
292252-92252100.936101.73
389760-8976098.20998.99
492744-92744101.474102.27
592095-92095100.764101.55
695826-95826104.846105.67
极限193584-93584102.393101.741.96103.36102.701.96
291921-91921100.574101.54
390875-9087599.429100.37
493286-93286102.067103.04
592118-92118100.789101.74
696111-96111105.158106.16
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%
1 11.433520413519793524783522993523093522210.06
2 11.393519003521943520470.06
单位质量响应值RSD%判断
30815.4930908.430.22数据可信
供试品溶液-2025021221批-阿托伐他汀钙-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%
5min1154038-15403841.31441.461.9641.3141.461.95
2154801-15480141.51941.52
3150985-15098540.49540.50
4160066-16006642.93142.93
5153136-15313641.07241.07
6154428-15442841.41941.42
10min1239712-23971264.29364.312.3764.3664.382.37
2245136-24513665.74765.82
3231250-23125062.02362.09
4246627-24662766.14766.22
5236278-23627863.37263.44
6239649-23964964.27664.34
15min1283792-28379276.11575.903.3976.2976.073.39
2290322-29032277.86778.05
3265648-26564871.24971.42
4291818-29181878.26878.45
5279599-27959974.99175.16
6286651-28665176.88277.06
20min1305131-30513181.83982.612.6182.1482.922.61
2315902-31590284.72785.04
3295175-29517579.16879.46
4315849-31584984.71385.03
5304475-30447581.66381.96
6311554-31155483.56183.87
30min1328851-32885188.20188.503.5788.6488.943.57
2342166-34216691.77292.22
3309039-30903982.88783.31
4337238-33723890.45090.90
5326337-32633787.52687.96
6336189-33618990.16990.61
45min1341329-34132991.54791.973.0692.1392.553.06
2355196-35519695.26695.87
3325119-32511987.20087.76
4348910-34891093.58094.18
5338788-33878890.86691.45
6348011-34801193.33993.93
极限1356203-35620395.53795.502.1396.2896.242.13
2360326-36032696.64297.40
3341645-34164591.63292.34
4362775-36277597.29998.06
5355533-35553395.35796.09
6359843-35984396.51397.26
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