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%
111.421873881873151870351871761869881871800.10
211.451889961887301888630.10
单位质量响应值RSD%判断
16390.5416494.590.45数据可信
供试品溶液-24011001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%
5min15252-52522.8652.9810.702.872.9810.75
25271-52712.8762.88
35102-51022.7832.78
44875-48752.6602.66
55736-57363.1293.13
66498-64983.5453.55
10min19657-96575.2684.6840.235.284.7040.08
29653-96535.2665.28
39277-92775.0615.08
41653-16530.9020.92
511071-110716.0406.06
610213-102135.5725.59
15min112061-120616.5806.567.296.636.607.15
211335-113356.1846.23
310866-108665.9285.97
413149-131497.1747.19
511848-118486.4646.51
612872-128727.0227.07
20min112959-129597.0706.793.207.156.873.15
212868-128687.0207.10
312424-124246.7786.85
412148-121486.6276.69
512354-123546.7406.83
611944-119446.5166.61
30min113907-139077.5877.471.697.717.591.58
213776-137767.5167.63
313567-135677.4027.52
413971-139717.6227.72
513614-136147.4277.55
613355-133557.2867.41
45min115034-150348.2028.404.058.378.563.89
215818-158188.6308.79
316227-162278.8539.01
415653-156538.5408.68
515219-152198.3038.47
614479-144797.8998.07
60min115555-155558.4868.394.028.698.593.89
216052-160528.7578.97
315801-158018.6208.82
415403-154038.4038.59
515130-151308.2548.47
614292-142927.7978.01
极限114940-149408.1518.572.658.418.822.53
215874-158748.6608.92
316131-161318.8009.05
415955-159558.7048.94
515607-156078.5158.77
615712-157128.5728.83
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%
111.274320214320164318694317184315364318320.05
211.204349314347004348160.04
单位质量响应值RSD%判断
38316.9538822.860.93数据可信
供试品溶液-24011001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%
5min18829-88292.0502.0016.802.052.0016.80
27800-78001.8111.81
38035-80351.8661.87
46595-65951.5311.53
510147-101472.3562.36
610354-103542.4042.40
10min128348-283486.5826.1233.216.596.1333.17
228877-288776.7056.71
328491-284916.6156.63
48791-87912.0412.05
531867-318677.3997.41
631762-317627.3757.39
15min140294-402949.3568.847.719.408.887.61
236180-361808.4008.45
334734-347348.0658.11
441159-411599.5579.58
540598-405989.4269.48
635346-353468.2078.26
20min147547-4754711.04010.246.8711.1410.346.86
245883-4588310.65310.75
343345-4334510.06410.16
441154-411549.5559.63
546577-4657710.81510.92
640172-401729.3279.43
30min149472-4947211.48711.514.7211.6511.664.61
247808-4780811.10011.25
347057-4705710.92611.07
453762-5376212.48312.61
550064-5006411.62411.79
649272-4927211.44011.59
45min153919-5391912.51912.723.9512.7412.933.94
255101-5510112.79413.01
355963-5596312.99413.20
453397-5339712.39812.59
558172-5817213.50713.74
652018-5201812.07812.29
60min158502-5850213.58313.085.9713.8813.375.88
260684-6068414.09014.38
354663-5466312.69212.97
456734-5673413.17313.44
556572-5657213.13513.44
650871-5087111.81212.09
极限152955-5295512.29513.254.2912.6713.614.15
257509-5750913.35313.72
360326-6032614.00714.36
457181-5718113.27713.61
558226-5822613.51913.90
656151-5615113.03713.39
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%
111.421872531872891871311873701868501871790.11
211.451892851894781893820.08
单位质量响应值RSD%判断
16390.4616539.910.65数据可信
供试品溶液-24011001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%
5min15865-58653.1953.5610.723.203.5610.67
26787-67873.6983.70
35443-54432.9652.97
46943-69433.7833.78
57097-70973.8673.87
67041-70413.8363.84
10min19346-93465.0925.214.105.115.234.12
29060-90604.9364.96
39244-92445.0365.05
49997-99975.4475.47
59940-99405.4155.44
69748-97485.3115.33
15min111316-113166.1656.353.806.216.403.81
211335-113356.1756.22
311115-111156.0566.10
412065-120656.5736.62
512096-120966.5906.64
611983-119836.5296.58
20min112354-123546.7316.832.456.816.912.48
212171-121716.6316.71
312598-125986.8646.94
412374-123746.7426.83
513045-130457.1077.20
612654-126546.8946.98
30min113970-139707.6117.592.617.737.722.66
213445-134457.3257.44
313629-136297.4257.54
414226-142267.7517.88
514424-144247.8587.99
613927-139277.5887.71
45min115073-150738.2128.003.218.378.173.19
214418-144187.8558.01
313976-139767.6147.77
414573-145737.9408.11
514836-148368.0838.25
615277-152778.3238.49
60min114824-148248.0768.282.238.288.492.25
215126-151268.2418.44
314771-147718.0478.25
415516-155168.4538.67
515484-154848.4368.65
615448-154488.4168.63
极限114940-149408.1408.613.068.398.862.99
216059-160598.7499.00
316141-161418.7949.04
415940-159408.6848.94
516176-161768.8139.08
615513-155138.4528.71
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%
111.274317714308684317494313094301924311780.16
211.204362814363744363280.02
单位质量响应值RSD%判断
38258.9238957.861.29数据可信
供试品溶液-24011001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%
5min121853-218535.0695.4814.885.075.4814.86
222042-220425.1135.11
318356-183564.2584.26
425886-258866.0056.00
525483-254835.9115.91
628065-280656.5106.51
10min134234-342347.9417.924.797.977.954.80
231785-317857.3737.40
332836-328367.6177.64
435688-356888.2788.31
536049-360498.3628.39
634382-343827.9758.01
15min140276-402769.3439.615.199.419.685.22
238485-384858.9279.00
340256-402569.3389.40
441851-418519.7089.79
543869-4386910.17610.26
643792-4379210.15810.24
20min145120-4512010.46610.626.1610.5910.746.15
241108-411089.5369.65
345768-4576810.61710.73
445283-4528310.50410.64
548235-4823511.18911.32
649130-4913011.39611.53
30min149634-4963411.51311.725.1511.7011.915.15
246096-4609610.69310.86
350254-5025411.65711.83
453338-5333812.37212.56
552774-5277412.24212.44
651092-5109211.85112.05
45min157042-5704213.23212.567.6613.4812.817.56
252981-5298112.29012.52
348011-4801111.13711.38
452466-5246612.17012.43
554305-5430512.59712.86
660112-6011213.94414.21
60min156324-5632413.06513.053.0313.3813.363.07
254033-5403312.53412.83
354570-5457012.65812.96
458385-5838513.54313.87
556406-5640613.08413.42
657716-5771613.38813.73
极限154316-5431612.59913.805.0112.9914.194.86
260267-6026713.98014.35
361392-6139214.24114.61
461418-6141814.24714.65
561973-6197314.37514.78
657614-5761413.36413.78
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%
111.421868841870371875421869521872411871310.15
211.451858411862051860230.14
单位质量响应值RSD%判断
16386.2516246.550.61数据可信
供试品溶液-24011003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%
5min15916-59163.2533.2513.893.253.2613.95
25311-53112.9202.92
35173-51732.8442.84
46994-69943.8453.85
55267-52672.8962.90
66852-68523.7673.77
10min19155-91555.0334.906.915.054.926.95
28359-83594.5964.61
38195-81954.5054.52
49733-97335.3515.37
58619-86194.7394.75
69419-94195.1785.20
15min110913-109136.0005.963.366.056.013.35
210666-106665.8645.91
310249-102495.6355.68
411315-113156.2216.27
510847-108475.9636.01
611065-110656.0836.13
20min112142-121426.6756.600.726.756.680.74
211877-118776.5306.60
312007-120076.6016.67
411978-119786.5856.67
511992-119926.5936.67
612041-120416.6206.70
30min11864-18641.0256.2340.961.146.3540.22
213339-133397.3347.44
312966-129667.1287.24
413338-133387.3337.46
513339-133397.3347.45
613187-131877.2507.37
45min114467-144677.9548.061.658.088.221.71
214524-145247.9858.14
314695-146958.0798.23
414974-149748.2328.40
514938-149388.2138.37
614414-144147.9258.09
60min115407-154078.4708.331.478.648.531.35
214957-149578.2238.42
314992-149928.2428.44
415209-152098.3628.57
515417-154178.4768.67
614940-149408.2148.42
极限115262-152628.3918.471.538.608.711.57
215649-156498.6048.84
315234-152348.3758.61
415625-156258.5908.85
515554-155548.5518.80
615093-150938.2988.55
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%
111.274301554299314294974291564290704295620.12
211.204285804283724284760.04
单位质量响应值RSD%判断
38115.5338256.790.27数据可信
供试品溶液-24011003批-辛伐他汀-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%
5min110069-100692.3612.4321.252.362.4321.21
28730-87302.0472.05
37689-76891.8031.80
413155-131553.0853.08
59715-97152.2782.28
612837-128373.0103.01
10min118748-187484.3974.1110.984.414.1211.03
215762-157623.6963.71
315797-157973.7053.71
419400-194004.5494.57
515761-157613.6963.71
619586-195864.5934.61
15min123324-233245.4705.378.325.515.418.36
221005-210054.9264.96
321557-215575.0555.09
425985-259856.0946.14
521583-215835.0615.09
624045-240455.6395.68
20min129144-291446.8356.554.966.906.624.97
227012-270126.3356.39
328177-281776.6086.67
426965-269656.3246.40
526390-263906.1896.25
629907-299077.0137.09
30min113030-130303.0567.4429.673.167.5429.28
232816-328167.6967.79
334459-344598.0818.18
435626-356268.3558.47
534940-349408.1948.29
639402-394029.2409.35
45min143915-4391510.29910.303.7410.4210.443.78
242066-420669.86510.00
342373-423739.93710.08
446387-4638710.87811.04
543636-4363610.23310.37
645119-4511910.58110.74
60min149983-4998311.72211.542.6311.9011.742.63
247943-4794311.24311.44
348015-4801511.26011.46
451254-5125412.02012.24
548563-4856311.38911.59
649535-4953511.61611.84
极限152654-5265412.34812.431.8912.5912.691.94
253088-5308812.45012.70
351586-5158612.09712.36
454490-5449012.77813.06
552518-5251812.31612.58
653649-5364912.58112.87
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%
111.421904341900511899731903431901521901910.11
211.451876331884251880290.30
单位质量响应值RSD%判断
16654.2016421.751.00数据可信
供试品溶液-24011003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%
5min15728-57283.1073.028.463.113.028.50
26007-60073.2583.26
35937-59373.2203.22
45323-53232.8872.89
55699-56993.0913.09
64744-47442.5732.57
10min18691-86914.7144.735.004.734.745.02
28850-88504.8014.82
39136-91364.9564.97
48782-87824.7644.78
58965-89654.8634.88
67888-78884.2794.29
15min110675-106755.7905.663.635.835.703.66
210660-106605.7825.83
310786-107865.8515.90
410571-105715.7345.78
59996-99965.4225.47
69912-99125.3775.41
20min111659-116596.3246.282.236.406.352.26
211621-116216.3046.38
311910-119106.4606.54
411536-115366.2586.33
511598-115986.2916.37
611116-111166.0306.10
30min112813-128136.9507.082.387.067.192.39
213443-134437.2927.40
313412-134127.2757.39
412821-128216.9557.06
513115-131157.1147.22
612759-127596.9217.02
45min114184-141847.6947.742.787.847.892.77
214887-148878.0758.23
314599-145997.9198.07
413810-138107.4917.64
514108-141087.6537.80
614041-140417.6167.76
60min114932-149328.1008.191.798.298.381.82
215558-155588.4398.64
315281-152818.2898.49
414918-149188.0928.28
514938-149388.1038.29
614920-149208.0938.28
极限115279-152798.2887.0144.308.527.2542.80
215843-158438.5948.84
31264-12640.6860.93
414660-146607.9528.19
515172-151728.2308.47
615326-153268.3138.54
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%
111.274364814374614383104385514373484376300.19
211.204334934333704334320.03
单位质量响应值RSD%判断
38831.4138699.290.25数据可信
供试品溶液-24011003批-辛伐他汀-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%
5min110669-106692.4652.635.522.462.635.62
211985-119852.7692.77
311450-114502.6452.65
411211-112112.5902.59
512197-121972.8182.82
610753-107532.4842.48
10min117552-175524.0554.225.194.074.245.19
218078-180784.1764.19
319053-190534.4014.42
418570-185704.2904.30
519496-194964.5044.52
616954-169543.9163.93
15min124134-241345.5755.524.035.615.554.03
223900-239005.5215.56
323995-239955.5435.58
425335-253355.8535.89
523517-235175.4335.47
622369-223695.1675.20
20min128310-283106.5406.388.476.616.448.40
227593-275936.3746.44
327578-275786.3716.44
428644-286446.6176.69
530228-302286.9837.05
623269-232695.3755.44
30min136473-364738.4258.593.248.538.693.26
237905-379058.7568.86
338483-384838.8909.00
437043-370438.5578.66
537960-379608.7698.88
635205-352058.1338.23
45min144938-4493810.38110.421.8510.5310.571.83
245069-4506910.41110.56
344583-4458310.29910.45
444232-4423210.21810.37
546647-4664710.77610.93
645242-4524210.45110.59
60min149954-4995411.54011.701.7611.7511.911.69
249599-4959911.45811.67
351513-5151311.90012.11
451048-5104811.79212.00
550120-5012011.57811.80
651743-5174311.95312.15
极限155235-5523512.76011.1233.0813.0311.3932.26
255212-5521212.75413.03
315723-157233.6323.91
452347-5234712.09212.37
554678-5467812.63112.91
655540-5554012.83013.09
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原始图谱下载图谱(王丹 于 2024-01-18 14:30:57 完成)
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