依折麦布辛伐他汀片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1101821531819731816651816971817201818420.12
2101809401807221808310.09
单位质量响应值RSD%判断
18184.2018083.100.40数据可信
供试品溶液-W033649批-依折麦布-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%
5min14674-46742.5782.3314.962.582.3314.96
24222-42222.3282.33
33789-37892.0902.09
45201-52012.8682.87
53937-39372.1712.17
63476-34761.9171.92
10min18832-88324.8714.936.454.884.936.50
29105-91055.0215.03
39120-91205.0295.03
49687-96875.3425.35
58929-89294.9244.93
67926-79264.3714.37
15min111256-112566.2075.983.556.225.993.54
210661-106615.8795.89
310876-108765.9986.01
411307-113076.2356.25
510613-106135.8535.87
610326-103265.6945.71
20min112301-123016.7846.503.806.816.533.82
212085-120856.6646.69
311562-115626.3766.40
412088-120886.6666.70
511632-116326.4156.44
611093-110936.1176.14
30min112931-129317.1316.962.187.177.002.16
212625-126256.9627.00
312722-127227.0167.05
412430-124306.8556.90
512840-128407.0817.12
612189-121896.7226.76
45min113375-133757.3767.392.367.437.452.37
213751-137517.5837.64
313607-136077.5047.56
413151-131517.2527.31
513624-136247.5137.57
612931-129317.1317.18
60min113963-139637.7007.743.057.777.813.04
214121-141217.7877.86
314698-146988.1058.17
413820-138207.6217.69
514218-142187.8417.91
613416-134167.3987.46
极限114611-146118.0577.922.878.148.002.87
214665-146658.0878.17
314463-144637.9768.06
414138-141387.7977.88
514671-146718.0918.17
613627-136277.5157.59
依折麦布辛伐他汀片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1104329334320654314774315104314784318930.15
2104296484298154297320.03
单位质量响应值RSD%判断
43189.3042973.200.36数据可信
供试品溶液-W033649批-辛伐他汀-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%
5min17145-71451.6591.5719.971.661.5719.93
27194-71941.6701.67
36053-60531.4051.41
49033-90332.0972.10
55640-56401.3091.31
65417-54171.2571.26
10min126837-268376.2296.279.966.236.289.99
226668-266686.1906.19
326836-268366.2296.23
431735-317357.3667.37
526774-267746.2156.22
623310-233105.4115.41
15min138643-386438.9708.336.968.998.356.97
233992-339927.8907.91
336258-362588.4168.43
439113-391139.0799.10
533581-335817.7957.81
633850-338507.8577.87
20min142133-421339.7809.334.429.819.364.39
240570-405709.4179.45
338337-383378.8998.93
440429-404299.3849.42
541892-418929.7249.75
637855-378558.7878.82
30min145633-4563310.59210.222.6210.6510.272.62
243062-430629.99610.05
343229-4322910.03410.08
442774-427749.9299.98
544714-4471410.37910.43
644684-4468410.37210.42
45min148478-4847811.25311.166.5611.3311.236.51
249943-4994311.59311.66
348745-4874511.31511.38
444859-4485910.41310.49
552381-5238112.15912.23
643997-4399710.21310.28
60min151082-5108211.85712.064.1411.9512.164.11
252709-5270912.23512.33
355708-5570812.93113.02
451503-5150311.95512.05
551565-5156511.96912.06
649240-4924011.43011.52
极限152324-5232412.14512.403.3312.2712.513.28
255106-5510612.79112.91
351495-5149511.95312.07
451866-5186612.03912.16
555729-5572912.93613.05
653890-5389012.50912.62
依折麦布辛伐他汀片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1101814481813851815671819401819131816510.15
2101825361831951828660.26
单位质量响应值RSD%判断
18165.1018286.600.48数据可信
供试品溶液-W033649批-依折麦布-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%
5min17014-70143.8483.785.563.853.785.56
27553-75534.1444.14
36564-65643.6023.60
46511-65113.5723.57
56950-69503.8133.81
66734-67343.6953.69
10min110035-100355.5065.262.935.515.272.91
29769-97695.3605.37
39567-95675.2495.26
49514-95145.2205.23
59431-94315.1755.18
69226-92265.0625.07
15min111369-113696.2386.134.146.266.154.11
211946-119466.5546.57
311045-110456.0606.08
410641-106415.8385.86
511213-112136.1526.17
610810-108105.9315.95
20min111975-119756.5706.492.416.606.522.39
211765-117656.4556.49
312225-122256.7086.74
411438-114386.2766.31
511976-119766.5716.60
611608-116086.3696.40
30min112944-129447.1027.251.377.157.291.37
213294-132947.2947.34
313016-130167.1427.18
413323-133237.3107.35
513368-133687.3357.38
613310-133107.3037.35
45min113303-133037.2997.552.517.367.602.47
214105-141057.7397.80
313991-139917.6777.73
413639-136397.4837.54
514063-140637.7167.77
613434-134347.3717.43
60min114705-147058.0687.863.058.147.933.04
214439-144397.9228.00
314844-148448.1458.22
414340-143407.8687.94
513806-138067.5757.65
613821-138217.5837.65
极限113910-139107.6327.891.637.727.981.62
214519-145197.9668.06
314514-145147.9648.05
414422-144227.9138.00
514385-143857.8937.98
614496-144967.9548.04
依折麦布辛伐他汀片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1104308584305204310064316144317924311580.13
2104327424339774333600.21
单位质量响应值RSD%判断
43115.8043336.000.37数据可信
供试品溶液-W033649批-辛伐他汀-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%
5min126355-263556.0975.988.956.105.988.95
225773-257735.9625.96
323798-237985.5065.51
423309-233095.3925.39
529820-298206.8996.90
625932-259325.9996.00
10min134104-341047.8907.543.717.907.553.69
233371-333717.7207.73
331827-318277.3637.37
433419-334197.7317.74
531972-319727.3977.41
630929-309297.1557.17
15min138158-381588.8288.744.438.868.764.43
240208-402089.3029.33
338107-381078.8168.84
435068-350688.1138.14
537110-371108.5858.61
637960-379608.7828.81
20min139903-399039.2319.444.339.289.484.29
240409-404099.3489.39
344178-4417810.22010.26
439092-390929.0449.09
540923-409239.4679.51
640291-402919.3219.36
30min145899-4589910.61810.772.5610.6810.842.54
245489-4548910.52410.59
345451-4545110.51510.58
447587-4758711.00911.07
546602-4660210.78110.85
648350-4835011.18511.25
45min146139-4613910.67411.025.2310.7611.105.19
251033-5103311.80611.89
346659-4665910.79410.88
444258-4425810.23910.32
549828-4982811.52711.61
647790-4779011.05611.14
60min155411-5541112.81911.985.6212.9312.095.58
251705-5170511.96212.07
351932-5193212.01412.12
454178-5417812.53412.64
550459-5045911.67311.78
647137-4713710.90511.01
极限147648-4764811.02311.494.1411.1611.624.08
251261-5126111.85911.99
352435-5243512.13112.26
448991-4899111.33411.46
547248-4724810.93111.06
650353-5035311.64911.78
依折麦布辛伐他汀片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1101837491840091837181836921828631836060.24
2101864661871071867860.25
单位质量响应值RSD%判断
18360.6018678.601.22数据可信
供试品溶液-X024017批-依折麦布-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%
5min17085-70853.8263.744.243.833.744.30
26520-65203.5213.52
37164-71643.8693.87
46997-69973.7783.78
57219-72193.8983.90
66619-66193.5743.57
10min19908-99085.3505.292.665.365.292.63
29484-94845.1215.13
310101-101015.4555.46
410031-100315.4175.42
59674-96745.2245.23
69545-95455.1545.16
15min111739-117396.3396.132.836.366.152.87
210937-109375.9065.92
311363-113636.1366.15
411481-114816.2006.22
511597-115976.2626.28
611012-110125.9475.96
20min112464-124646.7316.592.866.766.622.83
212381-123816.6866.71
312463-124636.7306.76
412240-122406.6106.64
512064-120646.5156.55
611557-115576.2416.27
30min112882-128826.9567.182.947.007.222.94
212936-129366.9867.03
313271-132717.1667.21
413769-137697.4357.48
513764-137647.4337.48
613165-131657.1097.15
45min114514-145147.8387.891.397.907.951.38
214893-148938.0428.10
314399-143997.7767.83
414786-147867.9858.04
514412-144127.7837.84
614662-146627.9187.97
60min114800-148007.9928.032.618.078.102.58
215316-153168.2718.34
314388-143887.7707.84
415254-152548.2378.31
514963-149638.0808.15
614470-144707.8147.89
极限114716-147167.9478.132.408.048.222.36
214752-147527.9668.06
314973-149738.0868.18
415705-157058.4818.57
515157-151578.1858.28
615008-150088.1048.19
依折麦布辛伐他汀片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1104356544361734358254358964341094355310.19
2104406554420774413660.23
单位质量响应值RSD%判断
43553.1044136.600.95数据可信
供试品溶液-X024017批-辛伐他汀-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%
5min126570-265706.0605.655.506.065.655.48
222824-228245.2065.21
325244-252445.7585.76
423529-235295.3675.37
525417-254175.7975.80
625017-250175.7065.71
10min133168-331687.5657.423.257.587.433.28
231186-311867.1137.12
334260-342607.8147.83
432157-321577.3357.35
532243-322437.3547.37
632132-321327.3297.34
15min141721-417219.5168.785.789.548.805.76
236202-362028.2578.28
336118-361188.2388.27
437800-378008.6228.65
540155-401559.1599.19
638877-388778.8678.89
20min143777-437779.9859.166.6910.039.206.67
240125-401259.1529.19
338442-384428.7688.81
442532-425329.7019.74
539734-397349.0639.11
636393-363938.3018.34
30min144899-4489910.24110.405.6110.3110.465.60
241403-414039.4439.50
345871-4587110.46310.52
448816-4881611.13411.20
547527-4752710.84010.90
644942-4494210.25110.31
45min151337-5133711.70911.731.4611.8011.811.44
252030-5203011.86711.95
350638-5063811.55011.63
450404-5040411.49711.58
551992-5199211.85911.94
652093-5209311.88211.96
60min150771-5077111.58011.575.8011.6911.675.77
247879-4787910.92111.02
348775-4877511.12511.23
455776-5577612.72212.83
552243-5224311.91612.02
648864-4886411.14511.25
极限151402-5140211.72412.085.3711.8612.215.32
247933-4793310.93311.06
353443-5344312.19012.32
454602-5460212.45412.59
555360-5536012.62712.76
654949-5494912.53312.66
依折麦布辛伐他汀片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1101844181850991850231850241846981848520.16
2101850911851731851320.04
单位质量响应值RSD%判断
18485.2018513.200.11数据可信
供试品溶液-X024017批-依折麦布-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%
5min14420-44202.3892.289.592.392.289.55
23457-34571.8691.87
34406-44062.3822.38
44152-41522.2442.24
54614-46142.4942.49
64281-42812.3142.31
10min19723-97235.2565.142.365.265.142.38
29256-92565.0035.01
39718-97185.2535.26
49478-94785.1235.13
59644-96445.2135.22
69229-92294.9894.99
15min111078-110785.9886.194.026.006.204.01
210911-109115.8985.91
311411-114116.1686.18
411943-119436.4566.47
512041-120416.5096.52
611270-112706.0926.11
20min112709-127096.8706.632.676.906.662.66
212089-120896.5356.56
312585-125856.8036.83
412333-123336.6676.69
511877-118776.4206.45
612041-120416.5096.54
30min113834-138347.4787.214.547.527.254.50
213398-133987.2427.28
312958-129587.0057.05
412728-127286.8806.92
514250-142507.7037.74
612858-128586.9516.99
45min115006-150068.1127.952.018.178.001.98
214268-142687.7137.77
314666-146667.9287.98
415019-150198.1198.17
514791-147917.9958.05
614490-144907.8337.89
60min115305-153058.2738.033.588.358.103.55
214892-148928.0508.12
315295-152958.2688.34
413848-138487.4867.56
514858-148588.0328.10
614902-149028.0558.12
极限114668-146687.9297.962.018.028.052.00
214334-143347.7487.83
315234-152348.2358.32
414618-146187.9027.99
514693-146937.9438.03
614820-148208.0118.10
依折麦布辛伐他汀片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1104376164384074380734383184375714379970.09
2104365494372604369040.12
单位质量响应值RSD%判断
43799.7043690.400.18数据可信
供试品溶液-X024017批-辛伐他汀-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%
5min16320-63201.4451.2923.641.441.2923.64
22976-29760.6800.68
35610-56101.2821.28
46243-62431.4271.43
56303-63031.4411.44
66337-63371.4491.45
10min131507-315077.2026.636.517.216.636.52
227366-273666.2566.26
330435-304356.9576.96
426401-264016.0356.04
529069-290696.6456.65
629117-291176.6566.66
15min135294-352948.0688.445.488.098.455.46
233744-337447.7147.73
337018-370188.4628.48
439086-390868.9358.95
538152-381528.7218.74
638127-381278.7168.73
20min142132-421329.6319.163.739.669.193.70
239560-395609.0439.07
340851-408519.3389.37
437807-378078.6438.68
539359-393598.9979.03
640691-406919.3029.34
30min148702-4870211.13310.218.1611.1910.268.12
244707-4470710.22010.27
341573-415739.5039.56
440942-409429.3599.41
549437-4943711.30111.35
642686-426869.7589.81
45min154001-5400112.34512.013.7012.4212.083.69
248789-4878911.15311.22
352952-5295212.10512.18
453312-5331212.18712.26
553852-5385212.31012.38
652239-5223911.94212.01
60min154427-5442712.44212.033.7912.5412.133.76
252687-5268712.04412.13
353352-5335212.19612.29
448965-4896511.19311.29
552221-5222111.93812.04
654224-5422412.39512.49
极限150333-5033311.50611.935.0911.6312.055.05
248089-4808910.99311.11
355560-5556012.70112.82
452226-5222611.93912.05
552963-5296312.10712.23
653919-5391912.32612.45
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