依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.911717021715761714951719081717541716870.10
29.991718241719261718750.05
单位质量响应值RSD%判断
17324.6217204.700.50数据可信
供试品溶液-B25010111批-依折麦布-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%
5min18546-85464.4444.3510.514.444.3410.53
29131-91314.7484.75
38033-80334.1774.18
46777-67773.5243.52
58541-85414.4414.44
69120-91204.7424.74
10min114769-147697.6807.792.137.707.812.15
215241-152417.9257.95
315079-150797.8417.86
414443-144437.5107.53
515280-152807.9467.97
615046-150467.8247.85
15min114559-145597.5717.872.257.647.942.24
215597-155978.1108.18
315305-153057.9598.03
415087-150877.8457.91
515104-151047.8547.92
615197-151977.9027.97
20min115596-155968.1108.221.728.228.331.73
215777-157778.2048.32
315874-158748.2548.37
415655-156558.1418.25
515615-156158.1208.23
616316-163168.4848.60
30min115218-152187.9138.111.988.078.261.97
216146-161468.3968.56
315467-154678.0438.20
415656-156568.1418.29
515554-155548.0888.25
615503-155038.0628.22
45min115131-151317.8688.082.108.078.282.08
215820-158208.2268.43
315712-157128.1708.37
415170-151707.8888.08
515510-155108.0658.27
615881-158818.2588.46
60min115119-151197.8628.132.038.108.382.01
216058-160588.3508.60
315859-158598.2478.49
415629-156298.1278.37
515555-155558.0898.34
615588-155888.1068.36
极限114688-146887.6387.952.897.928.242.85
215426-154268.0228.32
315917-159178.2778.57
414889-148897.7428.03
515380-153807.9988.29
615462-154628.0408.34
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.961512771506771509221506391507921508610.18
210.971510501512761511630.11
单位质量响应值RSD%判断
13764.6913779.670.08数据可信
供试品溶液-B25010111批-阿托伐他汀钙-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%
5min134907-3490720.93620.824.5320.9420.824.53
235991-3599121.58621.59
333347-3334720.00020.00
434242-3424220.53720.54
532823-3282319.68619.69
636948-3694822.16022.16
10min160910-6091036.53137.953.9336.6538.063.93
265891-6589139.51939.64
361012-6101236.59336.70
466169-6616939.68639.80
561313-6131336.77336.88
664328-6432838.58138.70
15min169121-6912141.45644.734.3541.7845.064.33
274223-7422344.51644.86
374507-7450744.68645.00
477822-7782246.67547.01
573813-7381344.27044.58
677972-7797246.76447.10
20min175820-7582045.47447.883.8146.0248.463.80
280535-8053548.30248.89
377528-7752846.49847.06
483761-8376150.23650.83
578762-7876247.23847.80
682593-8259349.53650.13
30min176880-7688046.11049.774.1146.9150.624.09
283367-8336750.00050.86
385612-8561251.34752.17
486076-8607651.62552.50
581553-8155348.91249.73
684452-8445250.65151.52
45min179701-7970147.80151.474.4448.8652.594.40
285337-8533751.18252.31
390085-9008554.02955.14
487217-8721752.30953.47
583650-8365050.17051.26
688948-8894853.34754.50
60min180561-8056148.31752.625.0049.6454.024.94
288757-8875753.23354.65
392956-9295655.75157.16
489789-8978953.85255.30
584792-8479250.85552.23
689566-8956653.71855.17
极限184911-8491150.92655.235.0952.5256.935.00
289779-8977953.84655.56
398882-9888259.30561.02
491847-9184755.08656.84
592521-9252155.49057.15
694575-9457556.72258.47
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.911717931718061715311715291716811716680.08
29.991720481720781720630.02
单位质量响应值RSD%判断
17322.7017223.520.41数据可信
供试品溶液-B25010111批-依折麦布-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%
5min18943-89434.6484.405.504.654.405.56
28852-88524.6014.60
37648-76483.9753.97
48427-84274.3804.38
58318-83184.3234.32
68580-85804.4594.46
10min115213-152137.9077.692.687.937.722.68
215207-152077.9047.93
314250-142507.4067.43
414428-144287.4997.52
514811-148117.6987.72
614876-148767.7327.76
15min115159-151597.8797.702.137.957.772.14
215219-152197.9107.98
314482-144827.5277.59
414583-145837.5797.65
514833-148337.7097.78
614598-145987.5877.65
20min115964-159648.2978.091.848.418.201.86
215838-158388.2328.35
315299-152997.9528.06
415287-152877.9458.05
515409-154098.0098.12
615583-155838.0998.21
30min115715-157158.1688.102.498.338.252.48
216296-162968.4708.63
315327-153277.9668.12
415275-152757.9398.09
515479-154798.0458.20
615357-153577.9828.14
45min115654-156548.1368.110.948.348.310.96
215653-156538.1368.34
315353-153537.9808.17
415559-155598.0878.28
515785-157858.2048.40
615667-156678.1438.34
60min115568-155688.0918.111.928.348.361.92
215813-158138.2198.47
315088-150887.8428.08
415788-157888.2068.45
515895-158958.2618.51
615467-154678.0398.28
极限115412-154128.0108.103.828.318.393.69
215491-154918.0518.35
315259-152597.9318.21
415435-154358.0228.31
515129-151297.8638.15
616766-167668.7149.00
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.961507991507211509011505781504051506810.13
210.971509111511251510180.11
单位质量响应值RSD%判断
13748.2713766.450.10数据可信
供试品溶液-B25010111批-阿托伐他汀钙-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%
5min136660-3666022.01120.394.4822.0120.394.47
234012-3401220.42120.42
332753-3275319.66519.67
433751-3375120.26420.26
532321-3232119.40619.41
634227-3422720.55020.55
10min162609-6260937.59136.613.2037.7136.723.20
263694-6369438.24238.36
359988-5998836.01736.13
461193-6119336.74136.85
558333-5833335.02335.13
660013-6001336.03236.15
15min173565-7356544.16943.192.2944.5043.502.29
274378-7437844.65744.98
370428-7042842.28542.59
471337-7133742.83143.15
570590-7059042.38342.69
671263-7126342.78743.10
20min179954-7995448.00546.123.1748.5846.683.17
279388-7938847.66548.24
373913-7391344.37844.92
476614-7661446.00046.55
574703-7470344.85245.39
676325-7632545.82646.38
30min181177-8117748.73948.941.7849.5849.751.77
282992-8299249.82950.67
380152-8015248.12448.91
479509-7950947.73848.55
582660-8266049.63050.42
682530-8253049.55250.36
45min184691-8469150.84951.232.2651.9652.312.23
287265-8726552.39453.51
382605-8260549.59750.65
483888-8388850.36751.44
587417-8741752.48653.55
686042-8604251.66052.74
60min184943-8494351.00051.902.6952.4053.272.63
286489-8648951.92953.34
383404-8340450.07651.41
486569-8656951.97753.33
590357-9035754.25155.61
686845-8684552.14253.51
极限191825-9182555.13255.292.1856.8156.952.14
292165-9216555.33657.03
389556-8955653.77055.38
490512-9051254.34455.99
593272-9327256.00157.66
695203-9520357.16058.82
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.911716201716641716231714811715441715860.05
29.991718311717951718130.02
单位质量响应值RSD%判断
17314.4317198.500.48数据可信
供试品溶液-B25010311批-依折麦布-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%
5min19772-97725.0845.015.405.085.015.41
29784-97845.0905.09
310326-103265.3725.37
48868-88684.6144.61
59833-98335.1165.12
69183-91834.7774.78
10min115874-158748.2588.171.648.298.201.63
215599-155998.1158.14
315338-153387.9808.01
415732-157328.1858.21
515642-156428.1388.17
616094-160948.3738.40
15min115625-156258.1298.194.738.208.264.67
215654-156548.1448.22
314862-148627.7327.81
415534-155348.0818.15
515608-156088.1208.19
617122-171228.9088.98
20min116227-162278.4428.461.298.568.581.26
216314-163148.4878.61
316200-162008.4288.55
416232-162328.4458.56
515986-159868.3178.44
616627-166278.6508.77
30min116126-161268.3898.292.678.568.462.65
216453-164538.5608.73
315314-153147.9678.13
415908-159088.2768.44
515587-155878.1098.27
616230-162308.4448.61
45min116110-161108.3818.243.118.598.453.04
216177-161778.4168.63
315276-152767.9478.16
415934-159348.2908.50
515164-151647.8898.10
616325-163258.4938.71
60min115991-159918.3198.263.198.588.523.15
215879-158798.2618.52
315246-152467.9328.18
415874-158748.2588.51
515563-155638.0978.35
616757-167578.7188.98
极限115445-154458.0357.943.158.348.243.08
215200-152007.9088.21
314547-145477.5687.86
415747-157478.1928.49
514896-148967.7508.05
615745-157458.1918.50
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.961508731508241507581507121506211507580.07
210.971509861507391508620.12
单位质量响应值RSD%判断
13755.2913752.230.02数据可信
供试品溶液-B25010311批-阿托伐他汀钙-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%
5min129740-2974017.86118.233.2517.8618.233.26
229029-2902917.43417.43
329848-2984817.92617.93
430956-3095618.59118.59
530823-3082318.51118.51
631730-3173019.05619.06
10min153764-5376432.28933.364.4532.3933.464.45
252800-5280031.71031.81
353972-5397232.41432.51
455844-5584433.53833.64
558823-5882335.32735.43
658102-5810234.89435.00
15min163678-6367838.24339.856.4138.5240.146.39
262369-6236937.45737.73
363445-6344538.10338.38
466569-6656939.97940.27
573770-7377044.30444.60
668283-6828341.00841.31
20min166145-6614539.72441.906.1640.2242.416.14
265801-6580139.51840.00
367011-6701140.24440.74
470785-7078542.51143.02
576798-7679846.12246.67
672061-7206143.27743.80
30min172246-7224643.38844.904.6444.1045.644.64
273594-7359444.19844.90
371804-7180443.12343.84
474313-7431344.63045.38
581318-8131848.83749.64
675338-7533845.24546.01
45min176040-7604045.66746.724.7346.6247.714.74
276746-7674646.09147.04
373896-7389644.37945.33
477336-7733646.44547.44
584725-8472550.88351.96
678050-7805046.87447.89
60min178472-7847247.12747.735.1048.3348.985.08
278527-7852747.16048.36
375943-7594345.60946.81
477473-7747346.52747.78
587438-8743852.51253.87
678971-7897147.42748.71
极限184753-8475350.90050.803.8152.3752.313.83
283253-8325349.99951.46
380449-8044948.31549.77
483413-8341350.09551.61
590131-9013154.12955.78
685505-8550551.35152.89
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.911726551730081730461731861732071730200.13
29.991721461717641719550.16
单位质量响应值RSD%判断
17459.1317212.711.01数据可信
供试品溶液-B25010311批-依折麦布-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%
5min110084-100845.2224.907.295.224.907.23
29203-92034.7664.77
38701-87014.5064.51
410454-104545.4145.41
59514-95144.9274.93
68861-88614.5894.59
10min115733-157338.1487.843.618.187.863.57
215791-157918.1788.20
315180-151807.8617.89
414436-144367.4767.51
514729-147297.6287.66
614919-149197.7267.75
15min115454-154548.0037.932.028.088.002.05
215543-155438.0498.12
314970-149707.7537.82
415693-156938.1278.20
514934-149347.7347.80
615284-152847.9157.98
20min116374-163748.4808.132.858.608.252.83
216046-160468.3108.43
315145-151457.8437.96
415381-153817.9668.08
515593-155938.0758.19
615688-156888.1258.24
30min115674-156748.1178.051.588.288.211.58
215755-157558.1598.32
315580-155808.0698.22
415709-157098.1358.30
515484-154848.0198.18
615090-150907.8157.97
45min115647-156478.1037.992.108.318.202.05
215640-156408.1008.31
315798-157988.1818.38
415354-153547.9528.16
515174-151747.8588.06
614958-149587.7467.95
60min115813-158138.1897.982.748.458.232.71
215843-158438.2058.46
315406-154067.9788.22
415363-153637.9568.21
515357-153577.9538.20
614680-146807.6037.85
极限114936-149367.7357.851.608.048.141.54
215186-151867.8658.16
315041-150417.7898.08
415614-156148.0868.38
515169-151697.8568.15
615016-150167.7778.06
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.961517311515781514711518061518541516880.11
210.971504891503421504160.07
单位质量响应值RSD%判断
13840.1513711.580.66数据可信
供试品溶液-B25010311批-阿托伐他汀钙-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%
5min129453-2945317.66017.373.5517.6617.373.57
230562-3056218.32518.33
327556-2755616.52316.52
428301-2830116.97016.97
529137-2913717.47117.47
628775-2877517.25417.25
10min153699-5369932.19931.286.4732.3031.386.47
257536-5753634.49934.60
349862-4986229.89829.99
447647-4764728.57028.66
552084-5208431.23031.33
652155-5215531.27331.37
15min163060-6306037.81239.296.5138.0939.566.49
269729-6972941.81042.10
359995-5999535.97436.23
464556-6455638.70938.96
571406-7140642.81643.09
664454-6445438.64738.92
20min166753-6675340.02639.745.8640.5140.235.85
273095-7309543.82944.35
362861-6286137.69238.15
463143-6314337.86138.33
567765-6776540.63341.14
664049-6404938.40538.89
30min172297-7229743.35044.145.5444.0644.855.54
279267-7926747.52948.30
370504-7050442.27542.94
471758-7175843.02743.71
578186-7818646.88147.62
669690-6969041.78742.48
45min175397-7539745.20946.115.8246.1647.065.80
282610-8261049.53450.57
374639-7463944.75445.66
474089-7408944.42545.34
582410-8241049.41450.41
672247-7224743.32044.25
60min177746-7774646.61746.545.8247.8247.765.79
281787-8178749.04150.35
374292-7429244.54645.70
474631-7463144.75045.91
584223-8422350.50151.77
673064-7306443.81044.98
极限181417-8141748.81950.594.2650.2852.064.27
288216-8821652.89554.48
381701-8170148.98950.39
483839-8383950.27151.68
589433-8943353.62555.17
681580-8158048.91650.33
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.911721971721221722791720741722591721860.06
29.991727411726891727150.03
单位质量响应值RSD%判断
17374.9717288.790.36数据可信
供试品溶液-B25010511批-依折麦布-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%
5min110703-107035.5445.528.975.545.528.96
212141-121416.2896.29
311051-110515.7245.72
410808-108085.5985.60
59744-97445.0475.05
69495-94954.9184.92
10min115882-158828.2278.081.648.268.111.63
215282-152827.9167.95
315537-155378.0488.08
415787-157878.1778.21
515746-157468.1568.18
615312-153127.9317.96
15min116376-163768.4828.301.268.568.381.27
215900-159008.2368.31
315900-159008.2368.31
415937-159378.2558.33
516185-161858.3838.46
615901-159018.2368.31
20min116439-164398.5158.282.348.648.412.30
215739-157398.1528.28
315558-155588.0598.18
415803-158038.1868.31
516448-164488.5208.64
615967-159678.2718.39
30min114888-148887.7127.912.187.888.082.13
215398-153987.9768.15
314963-149637.7517.92
415096-150967.8197.99
515655-156558.1098.28
615610-156108.0868.25
45min115410-154107.9827.971.058.208.180.98
215160-151607.8538.07
315550-155508.0558.26
415318-153187.9348.15
515276-152767.9138.12
615569-155698.0648.27
60min115391-153917.9727.932.358.238.182.28
214895-148957.7157.97
315229-152297.8888.14
414996-149967.7688.02
515901-159018.2368.49
615410-154107.9828.23
极限115249-152497.8997.743.428.208.043.28
214280-142807.3977.70
314514-145147.5187.82
414693-146937.6117.91
515335-153357.9438.25
615550-155508.0558.35
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.961518441520541519811517611520541519390.09
210.971517791519991518890.11
单位质量响应值RSD%判断
13863.0513845.850.09数据可信
供试品溶液-B25010511批-阿托伐他汀钙-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%
5min133213-3321319.80218.116.8119.8018.116.81
228943-2894317.25617.26
330439-3043918.14818.15
428153-2815316.78516.78
529005-2900517.29317.29
632478-3247819.36319.36
10min160113-6011335.83932.118.1035.9532.218.10
247943-4794328.58428.68
353045-5304531.62531.73
451705-5170530.82630.92
552708-5270831.42431.52
657659-5765934.37634.48
15min175290-7529044.88841.446.0245.2041.726.03
263698-6369837.97738.23
367009-6700939.95140.23
467956-6795640.51540.78
570225-7022541.86842.14
672841-7284143.42843.73
20min182675-8267549.29147.216.4149.8547.726.40
272034-7203442.94743.41
374517-7451744.42744.93
478295-7829546.67947.17
583758-8375849.93650.44
683860-8386049.99750.54
30min176243-7624345.45646.817.6446.2947.587.58
271313-7131342.51743.22
374300-7430044.29845.04
477842-7784246.40947.16
586608-8660851.63652.42
684740-8474050.52251.34
45min183544-8354449.80948.956.6350.8949.986.58
275852-7585245.22346.16
378908-7890847.04548.04
481719-8171948.72149.73
591846-9184654.75855.83
680783-8078348.16349.26
60min184491-8449150.37351.2511.3651.7452.5511.19
274516-7451644.42645.62
380216-8021647.82549.08
482951-8295149.45550.73
5102555-10255561.14362.51
691016-9101654.26455.63
极限188788-8878852.93552.657.5854.5854.247.54
278413-7841346.75048.19
383605-8360549.84551.36
488226-8822652.60054.15
596394-9639457.47059.18
694468-9446856.32257.99
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.911714491712701708131709871709931711020.15
29.991737921738651738280.03
单位质量响应值RSD%判断
17265.5917400.200.55数据可信
供试品溶液-B25010511批-依折麦布-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%
5min18748-87484.5315.238.514.535.228.49
210646-106465.5145.51
310518-105185.4485.45
411130-111305.7655.76
59937-99375.1475.15
69558-95584.9514.95
10min115755-157558.1607.941.768.197.971.75
215274-152747.9117.94
315235-152357.8917.92
414948-149487.7427.77
515475-154758.0158.04
615300-153007.9257.95
15min116068-160688.3228.182.098.398.252.07
216145-161458.3628.44
315657-156578.1108.18
415296-152967.9238.00
515600-156008.0808.15
615997-159978.2868.36
20min116005-160058.2908.190.968.418.310.95
215843-158438.2068.33
315541-155418.0508.17
415857-158578.2138.33
515831-158318.2008.32
615779-157798.1738.29
30min115164-151647.8547.732.818.027.902.77
215485-154858.0218.19
314982-149827.7607.92
414614-146147.5697.73
514297-142977.4057.57
615010-150107.7747.94
45min115527-155278.0427.831.618.258.041.58
215101-151017.8228.03
315047-150477.7948.00
414848-148487.6917.90
515274-152747.9118.12
614955-149557.7467.95
60min115559-155598.0597.941.268.318.191.21
215300-153007.9258.18
315231-152317.8898.14
415552-155528.0558.30
515285-152857.9178.17
615064-150647.8028.05
极限115089-150897.8157.840.888.118.140.85
215064-150647.8028.10
315049-150497.7958.09
415186-151867.8668.16
515076-150767.8098.10
615395-153957.9748.27
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.961512141527711525651513941513601518610.49
210.971535291530811533050.21
单位质量响应值RSD%判断
13855.9313974.930.61数据可信
供试品溶液-B25010511批-阿托伐他汀钙-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%
5min142137-4213725.01218.6316.8425.0118.6316.83
229272-2927217.37617.38
329893-2989317.74417.74
428967-2896717.19517.19
528549-2854916.94716.95
629525-2952517.52617.53
10min158653-5865334.81631.375.6034.9631.485.64
251301-5130130.45230.55
352735-5273531.30331.40
450901-5090130.21530.31
550903-5090330.21630.31
652627-5262731.23931.34
15min174059-7405943.96140.684.5844.2940.964.61
266595-6659539.53139.80
369079-6907941.00541.28
465854-6585439.09139.35
566011-6601139.18439.45
669553-6955341.28641.56
20min183387-8338749.49846.344.0650.0746.854.07
278679-7867946.70447.19
376652-7665245.50046.00
473812-7381243.81544.30
577180-7718045.81446.29
678720-7872046.72847.23
30min180439-8043947.74846.144.6548.6046.904.63
279728-7972847.32648.07
377877-7787746.22846.98
471964-7196442.71843.44
574998-7499844.51945.25
681336-8133648.28149.04
45min187364-8736451.85949.714.2552.9850.724.25
284311-8431150.04751.05
381194-8119448.19649.21
477869-7786946.22347.18
585829-8582950.94851.93
685864-8586450.96952.00
60min188742-8874252.67750.604.4354.0851.894.34
282171-8217148.77650.06
388399-8839952.47353.75
488765-8876552.69153.91
580740-8074047.92749.19
682643-8264349.05750.37
极限187579-8757951.98752.613.6553.6854.183.55
284908-8490850.40151.96
387938-8793852.20053.77
486420-8642051.29952.81
591255-9125554.16955.70
693633-9363355.58057.16
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