阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.284897548970489294885748929489320.10
212.294896448900489320.10
单位质量响应值RSD%判断
3984.693981.450.06数据可信
供试品溶液-24050701批-左氨氯地平-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%
5min122013-2201344.66485.2824.3444.6685.2824.34
246018-4601893.37193.37
346941-4694195.24395.24
440603-4060382.38482.38
549179-4917999.78499.78
647430-4743096.23696.24
10min148552-4855298.51297.882.4798.7698.352.48
248695-4869598.80299.32
347444-4744496.26496.79
446554-4655494.45894.92
550056-50056101.564102.12
648142-4814297.68098.21
15min149479-49479100.39397.453.24101.1998.463.20
248192-4819297.78298.85
347062-4706295.48996.55
445771-4577192.87093.85
549978-49978101.406102.52
647678-4767896.73997.82
20min148073-4807397.54096.162.6398.8997.722.62
247728-4772896.84098.45
346995-4699595.35396.95
445513-4551392.34693.84
549182-4918299.790101.47
646879-4687995.11896.73
30min148373-4837398.14995.643.44100.0497.733.39
247130-4713095.62797.78
345017-4501791.34093.46
445569-4556992.46094.47
549272-4927299.973102.21
647457-4745796.29098.43
45min146392-4639294.13093.782.3696.5796.412.38
246109-4610993.55596.24
345417-4541792.15194.78
444947-4494791.19893.72
548121-4812197.638100.43
646339-4633994.02296.70
60min146960-4696095.28292.793.9498.2595.943.84
246048-4604893.43296.63
345632-4563292.58795.73
444410-4441090.10893.14
548206-4820697.810101.14
643148-4314887.54790.75
极限145964-4596493.26193.502.6296.7597.162.64
246339-4633994.02297.74
345756-4575692.83996.50
444365-4436590.01793.55
548105-4810597.605101.48
645953-4595393.23996.93
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.843787943769873768453780963768403775120.24
210.963771713781223776460.18
单位质量响应值RSD%判断
34825.8334456.750.76数据可信
供试品溶液-24050701批-阿齐沙坦-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%
5min12289-22890.5930.3081.670.590.3081.62
21425-14250.3690.37
31590-15900.4120.41
4-0.0000.00
51597-15970.4140.41
6-0.0000.00
10min111774-117743.0502.4316.073.052.4415.98
29446-94462.4472.45
38004-80042.0732.08
48633-86332.2362.24
510503-105032.7212.72
67993-79932.0702.07
15min123258-232586.0255.1211.676.045.1311.67
219612-196125.0805.10
317497-174974.5324.55
419646-196465.0895.10
521352-213525.5315.55
617186-171864.4524.46
20min131439-314398.1447.357.268.207.397.33
228185-281857.3017.34
326885-268856.9647.00
428389-283897.3547.39
529768-297687.7117.76
625616-256166.6356.67
30min142481-4248111.00410.314.7311.1010.404.77
239330-3933010.18810.27
337736-377369.7759.85
440171-4017110.40610.49
541313-4131310.70110.79
637891-378919.8159.89
45min150592-5059213.10512.942.6913.2713.082.75
249681-4968112.86913.01
349549-4954912.83512.97
451073-5107313.23013.37
551184-5118413.25813.41
647583-4758312.32612.45
60min157463-5746314.88514.533.4915.1214.743.51
256059-5605914.52114.73
356357-5635714.59814.80
456766-5676614.70414.92
557540-5754014.90515.13
652278-5227813.54213.74
极限159968-5996815.53415.692.0515.8515.992.05
260531-6053115.68015.97
361102-6110215.82716.11
461723-6172315.98816.28
561710-6171015.98516.29
658480-5848015.14815.42
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.284910448947491054898548942490170.17
212.294890848897489020.02
单位质量响应值RSD%判断
3991.613979.010.23数据可信
供试品溶液-24050701批-左氨氯地平-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%
5min116028-1602832.50368.5039.2132.5068.5039.21
248751-4875198.86198.86
329770-2977060.37060.37
421759-2175944.12444.12
542971-4297187.13987.14
643390-4339087.98987.99
10min144450-4445090.13995.484.6890.3295.864.78
249068-4906899.503100.05
349190-4919099.751100.09
444280-4428089.79490.04
548001-4800197.34097.82
647523-4752396.37096.86
15min145570-4557092.41096.813.4293.0997.723.52
248824-4882499.009100.11
349831-49831101.051101.94
446186-4618693.65994.40
548504-4850498.36099.38
647519-4751996.36297.39
20min145655-4565592.58296.862.6393.7898.302.73
248438-4843898.22699.88
349366-49366100.108101.56
447191-4719195.69796.96
547929-4792997.19498.76
647997-4799797.33298.89
30min145824-4582492.92596.382.5894.6398.362.61
248352-4835298.051100.25
349209-4920999.789101.80
448002-4800297.34299.14
546850-4685095.00697.12
646917-4691795.14197.24
45min145811-4581192.89994.892.0895.1297.412.06
246949-4694995.20697.95
348348-4834898.043100.60
447378-4737896.07698.41
546351-4635193.99496.63
645927-4592793.13495.76
60min145550-4555092.36994.531.4795.1197.581.52
246767-4676794.83798.11
347468-4746896.25999.36
447185-4718595.68598.56
546409-4640994.11197.27
646320-4632093.93197.08
极限146281-4628193.85294.711.9097.1198.291.86
246742-4674294.78798.58
348338-4833898.023101.66
446849-4684995.00498.41
546194-4619493.67597.36
645825-4582592.92796.60
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.843782083783503782123784893783703783260.04
210.963765153770623767880.11
单位质量响应值RSD%判断
34900.9234378.471.07数据可信
供试品溶液-24050701批-阿齐沙坦-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%
5min13497-34970.9060.33117.250.910.34117.34
21809-18090.4690.47
3-0.0000.00
4-0.0000.00
52436-24360.6310.63
6-0.0000.00
10min110373-103732.6872.2646.062.692.2646.12
212470-124703.2303.23
37893-78932.0452.04
44736-47361.2271.23
513274-132743.4393.44
63565-35650.9240.92
15min120585-205855.3334.6834.995.354.6935.04
224358-243586.3106.33
317667-176674.5774.59
411554-115542.9933.00
524499-244996.3476.37
69714-97142.5162.52
20min129384-293847.6126.9624.327.667.0024.37
234810-348109.0189.07
326039-260396.7456.78
420041-200415.1925.22
532312-323128.3718.43
618675-186754.8384.86
30min140514-4051410.49510.1711.8310.5910.2511.99
244206-4420611.45211.56
337569-375699.7329.81
435097-350979.0929.14
544655-4465511.56811.67
633560-335608.6948.74
45min149933-4993312.93512.865.0213.0913.005.22
253063-5306313.74613.92
348487-4848712.56112.69
448245-4824512.49812.60
551858-5185813.43413.60
646325-4632512.00112.09
60min154885-5488514.21814.563.2314.4414.773.37
258845-5884515.24415.49
354977-5497714.24214.44
455882-5588214.47614.65
558085-5808515.04715.29
654608-5460814.14614.31
极限158929-5892915.26615.702.2615.5715.992.36
262662-6266216.23316.56
360357-6035715.63615.91
460542-6054215.68415.94
561669-6166915.97616.30
659549-5954915.42615.67
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.284915549305493644923849347492820.18
212.294885948890488740.05
单位质量响应值RSD%判断
4013.193976.730.65数据可信
供试品溶液-24050702批-左氨氯地平-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%
5min144108-4410889.23169.1435.3989.2369.1435.39
216983-1698334.35734.36
337841-3784176.55376.55
436667-3666774.17874.18
522150-2215044.81044.81
647325-4732595.73995.74
10min147160-4716095.40595.341.5095.9095.721.56
247219-4721995.52495.72
346756-4675694.58895.01
446556-4655694.18394.60
546624-4662494.32194.57
648448-4844898.01198.54
15min147240-4724095.56795.481.5196.5996.391.53
247563-4756396.22096.94
346159-4615993.38094.33
446966-4696695.01295.95
546956-4695694.99295.77
648291-4829197.69398.77
20min147073-4707395.22995.211.2396.7996.661.25
247240-4724095.56796.82
346074-4607493.20894.68
447144-4714495.37396.84
546988-4698895.05796.36
647863-4786396.82798.45
30min146517-4651794.10494.351.4896.1996.331.55
246145-4614593.35295.14
345954-4595492.96594.95
446825-4682594.72796.72
546499-4649994.06895.90
647901-4790196.90499.06
45min145528-4552892.10392.502.0294.7195.002.00
246110-4611093.28195.59
344075-4407589.16491.67
445882-4588292.82095.34
545905-4590592.86695.22
646859-4685994.79697.49
60min145433-4543391.91191.381.3895.0394.391.42
245169-4516991.37794.20
344083-4408389.18092.18
445116-4511691.27094.30
545223-4522391.48694.35
645996-4599693.05096.27
极限145714-4571492.48091.761.4596.1195.281.51
245215-4521591.47094.80
344390-4439089.80193.30
445741-4574192.53496.08
544906-4490690.84594.22
646196-4619693.45597.19
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.843790153791123796833811253787823795430.25
210.963772353763913768130.16
单位质量响应值RSD%判断
35013.1934380.751.29数据可信
供试品溶液-24050702批-阿齐沙坦-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%
5min16669-66691.7251.1823.061.721.1822.81
24516-45161.1681.17
33954-39541.0231.02
44118-41181.0651.07
54201-42011.0871.09
63928-39281.0161.02
10min115254-152543.9452.9520.673.952.9620.56
212570-125703.2513.26
311095-110952.8702.88
48631-86312.2322.24
511328-113282.9302.94
69472-94722.4502.46
15min121335-213355.5185.0813.365.555.1013.33
221834-218345.6475.67
320682-206825.3495.37
415532-155324.0174.04
521265-212655.5005.52
617176-171764.4424.46
20min129484-294847.6267.416.377.697.466.41
230322-303227.8427.90
329110-291107.5297.58
427635-276357.1477.19
529870-298707.7257.78
625428-254286.5766.62
30min140241-4024110.40810.314.8710.5110.404.88
241145-4114510.64110.74
340842-4084210.56310.66
436635-366359.4759.56
541785-4178510.80710.90
638472-384729.95010.03
45min150119-5011912.96213.062.7913.1213.212.82
252219-5221913.50613.66
350631-5063113.09513.25
448211-4821112.46912.60
551677-5167713.36513.52
650160-5016012.97313.11
60min156098-5609814.50914.642.0614.7414.862.09
257457-5745714.86015.09
357441-5744114.85615.08
454614-5461414.12514.33
557632-5763214.90515.14
656338-5633814.57114.78
极限160743-6074315.71015.761.1516.0316.071.20
261422-6142215.88616.20
361804-6180415.98416.29
459788-5978815.46315.74
561199-6119915.82816.14
660735-6073515.70816.00
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.284900249079490244900149138490490.13
212.294935149124492380.33
单位质量响应值RSD%判断
3994.224006.350.22数据可信
供试品溶液-24050702批-左氨氯地平-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%
5min146699-4669994.34592.992.2194.3492.992.21
246344-4634493.62893.63
346492-4649293.92793.93
445280-4528091.47891.48
544338-4433889.57589.58
647011-4701194.97594.98
10min147407-4740795.77594.662.4296.3095.182.42
246707-4670794.36194.88
346219-4621993.37593.90
445050-4505091.01391.52
547439-4743995.84096.34
648303-4830397.58598.11
15min147755-4775596.47895.182.3497.5396.222.32
245081-4508191.07692.12
346642-4664294.23095.27
447957-4795796.88697.90
547406-4740695.77396.80
647824-4782496.61897.69
20min147353-4735395.66694.662.0097.2696.231.98
245539-4553992.00193.55
345875-4587592.68094.24
446981-4698194.91596.47
547788-4778896.54598.11
647582-4758296.12997.74
30min147773-4777396.51594.762.3098.6496.862.28
245363-4536391.64693.71
345789-4578992.50694.59
447242-4724295.44297.52
547261-4726195.48097.58
647991-4799196.95599.10
45min145826-4582692.58191.271.8995.2493.891.87
244368-4436889.63692.21
344352-4435289.60392.20
445515-4551591.95394.56
544624-4462490.15392.78
646376-4637693.69296.37
60min145570-4557092.06490.612.7495.2493.742.71
243445-4344587.77190.84
343921-4392188.73391.82
445015-4501590.94394.06
544331-4433189.56192.69
646824-4682494.59797.80
极限145246-4524691.40991.172.3695.1094.812.32
244602-4460290.10893.66
343601-4360188.08691.67
445076-4507691.06694.69
545416-4541691.75395.38
646837-4683794.62498.35
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.843779993777443778703783953778733779760.07
210.963802053784943793500.32
单位质量响应值RSD%判断
34868.6334612.230.53数据可信
供试品溶液-24050702批-阿齐沙坦-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%
5min14671-46711.2061.175.071.211.175.19
24910-49101.2681.27
34516-45161.1661.17
44378-43781.1311.13
54454-44541.1501.15
64263-42631.1011.10
10min112461-124613.2193.115.523.233.125.55
212000-120003.0993.11
312760-127603.2963.30
410832-108322.7982.80
512265-122653.1683.17
612022-120223.1053.11
15min121312-213125.5055.606.085.535.636.06
221980-219805.6775.70
323381-233816.0396.06
419546-195465.0495.07
522628-226285.8455.87
621322-213225.5075.53
20min130434-304347.8617.814.277.927.864.28
229480-294807.6147.67
331543-315438.1478.21
428193-281937.2827.33
531572-315728.1558.21
630131-301317.7837.84
30min143975-4397511.35810.922.8611.4611.022.86
241396-4139610.69210.79
342613-4261311.00711.11
440518-4051810.46510.56
542940-4294011.09111.19
642272-4227210.91811.02
45min151375-5137513.27013.221.5613.4313.381.57
250181-5018112.96113.12
351427-5142713.28313.45
450366-5036613.00913.16
552319-5231913.51313.68
651518-5151813.30713.46
60min157474-5747414.84514.751.3915.0814.981.39
255825-5582514.41914.65
357188-5718814.77115.01
456774-5677414.66414.88
557132-5713214.75715.00
658226-5822615.03915.27
极限160500-6050015.62715.751.0515.9416.061.06
260710-6071015.68115.99
360687-6068715.67516.00
460364-6036415.59115.89
561589-6158915.90816.23
661919-6191915.99316.31
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