依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
111.421856921855141852831854731856251855170.09
211.451870831878001874420.28
单位质量响应值RSD%判断
16244.9216370.480.55数据可信
供试品溶液-24011002批-依折麦布-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%
5min15464-54643.0063.209.883.013.209.83
26167-61673.3923.39
35435-54352.9902.99
45195-51952.8582.86
56747-67473.7113.71
65925-59253.2593.26
10min19405-94055.1735.333.875.195.353.88
210017-100175.5105.53
39561-95615.2595.28
49727-97275.3515.37
510205-102055.6135.63
69211-92115.0675.08
15min111247-112476.1876.354.276.236.404.27
211532-115326.3436.39
311004-110046.0536.10
411337-113376.2366.28
512414-124146.8296.88
611723-117236.4496.49
20min112929-129297.1127.233.827.197.313.81
212836-128367.0617.15
312949-129497.1237.20
412825-128257.0557.13
514130-141307.7737.86
613157-131577.2377.32
30min113643-136437.5057.451.687.627.581.64
213738-137387.5577.68
313771-137717.5757.69
413369-133697.3547.47
513585-135857.4737.61
613189-131897.2557.38
45min113913-139137.6538.165.157.818.325.06
214734-147348.1058.27
314592-145928.0278.19
414649-146498.0588.22
514878-148788.1848.36
616235-162358.9309.09
60min114825-148258.1558.623.098.368.823.01
215879-158798.7358.95
316121-161218.8689.07
416066-160668.8379.04
515634-156348.6008.82
615448-154488.4988.71
极限115257-152578.3928.854.498.649.114.39
217354-173549.5469.81
316061-160618.8359.09
416282-162828.9569.21
515582-155828.5718.84
615973-159738.7869.05
依折麦布辛伐他汀片项目信息
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(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.274305644300794300124303204301724302290.06
211.204343444363064353250.32
单位质量响应值RSD%判断
38174.7138868.301.28数据可信
供试品溶液-24011002批-辛伐他汀-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%
5min19657-96572.2452.5818.632.252.5818.58
212470-124702.8992.90
310068-100682.3412.34
48477-84771.9711.97
514082-140823.2743.27
611871-118712.7602.76
10min130956-309567.1977.318.517.217.328.51
234358-343587.9888.00
330114-301147.0017.01
429372-293726.8296.84
535151-351518.1728.19
628755-287556.6856.70
15min135301-353018.2078.936.728.268.996.72
238102-381028.8588.92
337211-372118.6518.70
437884-378848.8088.86
543053-4305310.00910.07
638945-389459.0549.11
20min147664-4766411.08110.833.3511.1810.933.31
244276-4427610.29410.40
346854-4685410.89310.99
448386-4838611.24911.35
547150-4715010.96211.08
645165-4516510.50010.60
30min149683-4968311.55111.432.5811.7111.592.55
250922-5092211.83912.01
350081-5008111.64311.80
447647-4764711.07711.24
548470-4847011.26911.45
648140-4814011.19211.35
45min150071-5007111.64112.515.4711.8612.745.37
250975-5097511.85112.08
353371-5337112.40812.63
457717-5771713.41813.64
554654-5465412.70612.95
656051-5605113.03113.25
60min154261-5426112.61513.705.6612.9014.005.56
261179-6117914.22314.52
362365-6236514.49914.79
461699-6169914.34414.64
558156-5815613.52013.83
655992-5599213.01713.31
极限157047-5704713.26313.722.4013.6214.092.36
257993-5799313.48313.86
359460-5946013.82414.20
460856-6085614.14814.52
558514-5851413.60413.99
660146-6014613.98314.35
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
111.421851661851081850011848291850251850260.07
211.451887761898721893240.41
单位质量响应值RSD%判断
16201.9316534.851.44数据可信
供试品溶液-24011002批-依折麦布-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%
5min17516-75164.1193.587.914.123.587.91
26235-62353.4173.42
36249-62493.4253.42
46523-65233.5753.58
56092-60923.3393.34
66591-65913.6123.61
10min19425-94255.1665.154.165.195.174.15
29780-97805.3605.38
39469-94695.1905.21
49818-98185.3815.40
58800-88004.8234.84
69119-91194.9985.02
15min111537-115376.3236.202.216.376.252.23
211269-112696.1766.23
311475-114756.2896.34
411462-114626.2826.33
510854-108545.9495.99
611309-113096.1986.25
20min112622-126226.9186.974.197.007.064.12
213117-131177.1897.27
312437-124376.8176.90
412137-121376.6526.74
513590-135907.4487.53
612440-124406.8186.90
30min113542-135427.4227.480.747.557.600.71
213809-138097.5687.69
313621-136217.4657.59
413612-136127.4617.58
513586-135867.4467.57
613737-137377.5297.65
45min115986-159868.7628.243.438.938.403.38
214936-149368.1868.35
315048-150488.2488.41
414988-149888.2158.38
514720-147208.0688.23
614482-144827.9378.10
60min114948-149488.1938.261.268.418.471.23
215017-150178.2318.44
315293-152938.3828.59
415012-150128.2288.44
514841-148418.1348.34
615306-153068.3898.60
极限114695-146958.0548.393.448.318.653.36
216200-162008.8799.14
315337-153378.4068.66
415010-150108.2278.48
515555-155558.5258.78
615060-150608.2548.51
依折麦布辛伐他汀片项目信息
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(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.274312854310624309364306394310184309880.06
211.204398284422634410460.40
单位质量响应值RSD%判断
38242.0639379.112.08数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-24011002批-辛伐他汀-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%
5min121252-212524.9055.507.884.905.507.94
222293-222935.1455.14
324074-240745.5565.56
425473-254735.8795.88
523678-236785.4655.46
626246-262466.0576.06
10min132982-329827.6127.633.587.647.663.59
233096-330967.6387.67
333688-336887.7757.81
434775-347758.0268.06
531206-312067.2027.23
632601-326017.5247.56
15min144554-4455410.2829.524.3510.359.604.29
240373-403739.3189.39
341267-412679.5249.60
441337-413379.5409.62
539195-391959.0469.12
640825-408259.4229.50
20min147748-4774811.02010.762.0411.1510.892.01
247375-4737510.93311.06
345635-4563510.53210.66
445755-4575510.56010.69
547341-4734110.92611.05
645971-4597110.60910.74
30min147973-4797311.07111.473.5411.2611.653.48
250852-5085211.73611.92
350402-5040211.63211.82
447713-4771311.01111.20
548978-4897811.30311.48
652180-5218012.04212.23
45min154709-5470912.62612.912.7712.8813.162.71
255659-5565912.84513.09
354565-5456512.59312.84
455246-5524612.75013.00
556841-5684113.11813.36
658614-5861413.52713.78
60min158218-5821813.43613.084.5213.7613.404.44
253623-5362312.37512.70
357732-5773213.32413.64
456920-5692013.13613.46
553668-5366812.38612.70
659956-5995613.83714.17
极限152082-5208212.02013.265.8912.4113.655.72
258097-5809713.40813.80
360561-6056113.97714.37
454576-5457612.59512.99
559790-5979013.79914.18
659575-5957513.74914.15
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
111.421858561864551865291864471865061863590.16
211.451851321850321850820.04
单位质量响应值RSD%判断
16318.6516164.370.68数据可信
供试品溶液-24011003批-依折麦布-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%
5min15886-58863.2513.779.223.253.779.23
27178-71783.9653.96
36155-61553.4003.40
47290-72904.0264.03
57292-72924.0284.03
67116-71163.9303.93
10min19193-91935.0775.666.005.105.685.99
210440-104405.7665.79
39995-99955.5205.54
411033-110336.0946.12
510430-104305.7615.78
610382-103825.7345.76
15min112005-120056.6316.700.666.686.760.70
212118-121186.6936.75
312138-121386.7046.75
412108-121086.6876.74
512229-122296.7546.81
612209-122096.7436.80
20min112914-129147.1337.191.507.227.281.49
213377-133777.3887.48
313027-130277.1957.28
413014-130147.1887.28
512923-129237.1387.23
612817-128177.0797.17
30min113523-135237.4697.542.447.597.672.42
213451-134517.4297.56
314091-140917.7837.91
413661-136617.5457.68
513968-139687.7157.85
613204-132047.2937.42
45min114300-143007.8988.072.868.068.242.82
215084-150848.3318.50
314038-140387.7537.92
414471-144717.9938.17
515021-150218.2968.47
614796-147968.1728.34
60min115504-155048.5638.472.708.778.682.64
215512-155128.5688.79
315234-152348.4148.63
415000-150008.2858.50
514795-147958.1728.39
615955-159558.8129.03
极限114925-149258.2438.464.188.508.724.10
215069-150698.3238.59
315229-152298.4118.67
415271-152718.4348.70
514806-148068.1788.44
616567-165679.1509.42
依折麦布辛伐他汀片项目信息
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(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.274312844317684319764311214315094315320.09
211.204299654302104300880.05
单位质量响应值RSD%判断
38290.3338400.710.21数据可信
供试品溶液-24011003批-辛伐他汀-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%
5min120549-205494.7995.7211.604.805.7211.60
227220-272206.3576.36
321365-213654.9894.99
426545-265456.1996.20
526246-262466.1296.13
624952-249525.8275.83
10min129698-296986.9368.348.636.968.378.66
237598-375988.7808.82
335121-351218.2028.23
437447-374478.7458.78
536883-368838.6138.65
637452-374528.7468.78
15min144272-4427210.33910.071.4710.4010.151.39
242672-426729.96510.05
342639-426399.95810.03
442766-427669.98710.07
542988-4298810.03910.12
643419-4341910.14010.22
20min146631-4663110.89010.924.2611.0111.064.22
250434-5043411.77811.92
347229-4722911.03011.16
446290-4629010.81010.95
544932-4493210.49310.63
645166-4516610.54810.69
30min149138-4913811.47511.674.0411.6611.863.95
247324-4732411.05211.26
351532-5153212.03512.22
450315-5031511.75011.95
552854-5285412.34312.54
648639-4863911.35911.55
45min151449-5144912.01512.417.3412.2612.677.22
257361-5736113.39613.66
346696-4669610.90511.16
452312-5231212.21712.48
556426-5642613.17713.44
654645-5464512.76213.02
60min160342-6034214.09213.485.0914.4113.804.99
259787-5978713.96214.30
354410-5441012.70713.02
454866-5486612.81313.14
555970-5597013.07113.41
660830-6083014.20614.54
极限153774-5377412.55813.409.8312.9513.819.55
254053-5405312.62313.04
357435-5743513.41313.80
458574-5857413.67914.08
552617-5261712.28812.70
667898-6789815.85716.27
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
111.421864741877651881251880531879831876800.37
211.451877851880161879000.09
单位质量响应值RSD%判断
16434.3316410.480.11数据可信
供试品溶液-24011003批-依折麦布-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%
5min16312-63123.4483.6310.123.453.6310.06
26763-67633.6943.69
36336-63363.4613.46
47785-77854.2524.25
55815-58153.1763.18
66872-68723.7543.75
10min19915-99155.4165.244.375.435.264.32
210061-100615.4965.52
39413-94135.1425.16
49808-98085.3575.38
59371-93715.1195.14
68942-89424.8844.91
15min111651-116516.3646.282.556.416.332.52
211814-118146.4536.50
311427-114276.2426.29
411705-117056.3946.45
511418-114186.2376.28
610998-109986.0076.06
20min112868-128687.0297.164.107.117.244.08
212713-127136.9447.03
312800-128006.9927.07
414156-141567.7327.82
513183-131837.2017.28
612933-129337.0647.15
30min113701-137017.4847.532.137.617.652.11
214192-141927.7527.88
313700-137007.4837.60
413710-137107.4897.62
513366-133667.3017.42
614046-140467.6727.79
45min114145-141457.7268.375.127.898.545.04
215266-152668.3398.51
314772-147728.0698.23
416090-160908.7898.96
516197-161978.8479.01
615499-154998.4668.63
60min115089-150898.2428.353.498.458.563.39
215090-150908.2438.46
314404-144047.8688.08
415560-155608.4998.72
515878-158788.6738.88
615660-156608.5548.76
极限115981-159818.7298.872.418.989.132.32
216047-160478.7659.03
316127-161278.8099.06
416197-161978.8479.12
516059-160598.7729.03
617020-170209.2979.55
依折麦布辛伐他汀片项目信息
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(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.274328164333824333774339154342914335560.14
211.204350014349184349600.02
单位质量响应值RSD%判断
38469.9238835.710.67数据可信
供试品溶液-24011003批-辛伐他汀-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%
5min124330-243305.6375.649.245.645.659.24
226401-264016.1176.12
323608-236085.4705.47
427268-272686.3186.32
520966-209664.8574.86
623602-236025.4685.47
10min137042-370428.5828.097.448.618.127.42
238225-382258.8568.89
332700-327007.5767.61
436348-363488.4218.46
532894-328947.6217.65
632241-322417.4707.50
15min143848-4384810.1599.613.2710.249.683.26
240898-408989.4759.56
342165-421659.7699.84
441204-412049.5469.63
540458-404589.3739.44
640210-402109.3169.39
20min148323-4832311.19611.024.5911.3311.154.49
243851-4385110.16010.30
347443-4744310.99211.12
447744-4774411.06111.20
550626-5062611.72911.85
647342-4734210.96811.09
30min149303-4930311.42311.826.1511.6212.026.07
254314-5431412.58412.78
348023-4802311.12611.31
451454-5145411.92112.12
547984-4798411.11711.30
655135-5513512.77412.96
45min152163-5216312.08513.004.8812.3513.254.75
257855-5785513.40413.67
356772-5677213.15313.40
455013-5501312.74613.01
560019-6001913.90514.15
654727-5472712.67912.93
60min158104-5810413.46213.233.3713.7913.563.32
258906-5890613.64813.98
353514-5351412.39812.72
457910-5791013.41713.75
557665-5766513.36013.69
656502-5650213.09113.42
极限161466-6146614.24113.822.3014.6414.222.22
258529-5852913.56013.97
360684-6068414.05914.45
458338-5833813.51613.92
560506-6050614.01814.42
658497-5849713.55313.95
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