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%
111.814741547442474394750547534474670.11
211.874765647700476780.07
单位质量响应值RSD%判断
4019.224016.680.05数据可信
供试品溶液-24042901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%
5min151770-51770104.130102.211.27104.13102.211.27
250948-50948102.476102.48
350157-50157100.885100.89
451255-51255103.094103.09
550126-50126100.823100.82
650640-50640101.857101.86
10min154093-54093108.802105.202.16109.38105.772.16
252252-52252105.099105.67
351032-51032102.645103.21
453012-53012106.628107.20
552139-52139104.872105.43
651297-51297103.178103.74
15min153114-53114106.833103.482.21108.02104.632.20
251081-51081102.744103.90
349855-49855100.278101.41
452301-52301105.198106.36
551385-51385103.355104.50
650943-50943102.466103.61
20min152596-52596105.791102.901.60107.57104.631.60
251083-51083102.748104.47
350276-50276101.125102.81
451458-51458103.502105.25
550961-50961102.502104.22
650584-50584101.744103.45
30min151772-51772104.134101.671.91106.50103.981.90
249917-49917100.402102.70
349800-49800100.167102.42
451722-51722104.033106.36
549662-4966299.890102.18
650423-50423101.420103.69
45min150251-50251101.074100.561.54104.02103.421.53
249445-4944599.453102.31
349359-4935999.280102.09
451307-51307103.198106.10
550234-50234101.040103.88
649363-4936399.288102.13
60min150611-50611101.798100.151.83105.30103.571.82
249800-49800100.167103.57
348176-4817696.901100.26
450639-50639101.855105.33
550028-50028100.626104.03
649495-4949599.554102.94
极限150215-50215101.00299.981.29105.07103.961.30
249465-4946599.493103.45
348926-4892698.409102.31
450700-50700101.977106.02
549532-4953299.628103.59
649404-4940499.371103.31
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%
110.963814283818003814293825163824813819310.15
210.983828513825403826960.06
单位质量响应值RSD%判断
34847.7234853.920.02数据可信
供试品溶液-24042901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%
5min14809-48091.2381.2216.161.241.2216.26
25435-54351.3991.40
35613-56131.4451.45
44502-45021.1591.16
53455-34550.8900.89
64714-47141.2141.21
10min117210-172104.4314.468.124.444.468.14
218877-188774.8604.87
318740-187404.8254.83
415795-157954.0674.07
515592-155924.0144.02
617658-176584.5464.55
15min126446-264466.8096.686.146.846.726.17
227580-275807.1017.14
327316-273167.0337.07
424067-240676.1976.23
523903-239036.1546.18
626386-263866.7946.83
20min133041-330418.5078.246.588.588.316.57
233932-339328.7368.81
333911-339118.7318.80
429236-292367.5277.59
529578-295787.6157.68
632403-324038.3438.41
30min141379-4137910.65410.315.0410.7710.435.06
241618-4161810.71510.84
341943-4194310.79910.92
437358-373589.6199.72
537765-377659.7239.83
640282-4028210.37110.49
45min148963-4896312.60612.384.2312.7812.554.26
249615-4961512.77412.96
350699-5069913.05313.24
445835-4583511.80111.96
545750-4575011.77911.94
647655-4765512.27012.44
60min154983-5498314.15613.683.9314.4013.923.96
255033-5503314.16914.42
354544-5454414.04314.30
450444-5044412.98813.21
550786-5078613.07613.30
652917-5291713.62413.87
极限160645-6064515.61415.353.1415.9415.673.20
261308-6130815.78516.12
361771-6177115.90416.24
457837-5783714.89115.19
557324-5732414.75915.05
658907-5890715.16715.48
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%
111.814778047857478894787047702478200.17
211.874772947889478090.24
单位质量响应值RSD%判断
4049.114027.720.38数据可信
供试品溶液-24042901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%
5min149254-4925498.568100.341.0398.57100.341.03
250116-50116100.293100.29
350053-50053100.167100.17
450510-50510101.081101.08
550772-50772101.605101.61
650124-50124100.309100.31
10min152603-52603105.270103.660.99105.82104.220.98
251834-51834103.731104.29
351993-51993104.049104.61
451806-51806103.675104.24
551462-51462102.986103.55
651099-51099102.260102.82
15min151581-51581103.224102.811.28104.36103.951.28
252290-52290104.643105.78
350718-50718101.497102.63
451262-51262102.586103.72
551825-51825103.713104.85
650578-50578101.217102.34
20min151745-51745103.553102.811.43105.26104.521.41
251896-51896103.855105.57
350601-50601101.263102.96
452147-52147104.357106.06
551505-51505103.072104.79
650352-50352100.765102.45
30min151673-51673103.409102.731.49105.69105.001.47
252238-52238104.539106.83
350393-50393100.847103.11
451883-51883103.829106.12
551360-51360102.782105.07
650444-50444100.949103.20
45min151163-51163102.388101.741.33105.24104.581.31
251663-51663103.389106.26
351009-51009102.080104.90
450209-50209100.479103.34
551141-51141102.344105.20
649850-4985099.760102.57
60min150303-50303100.667100.551.48104.09103.961.46
251377-51377102.816106.26
349452-4945298.964102.35
450576-50576101.213104.64
550371-50371100.803104.23
649401-4940198.862102.22
极限150637-50637101.335100.091.75105.32104.061.72
251369-51369102.800106.82
349813-4981399.686103.62
449722-4972299.504103.49
549714-4971499.488103.47
648835-4883597.729101.64
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%
110.963849713839233837663836743838623840390.14
210.983819673825403822540.11
单位质量响应值RSD%判断
35040.0534813.660.46数据可信
供试品溶液-24042901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%
5min15991-59911.5391.7511.071.541.7511.03
26264-62641.6091.61
37700-77001.9781.98
46625-66251.7021.70
56537-65371.6791.68
67796-77962.0032.00
10min117939-179394.6095.077.254.625.087.24
219623-196235.0415.05
321743-217435.5865.60
419349-193494.9714.98
518674-186744.7984.81
621027-210275.4025.41
15min125741-257416.6137.346.586.657.386.59
230163-301637.7497.79
330647-306477.8747.92
427641-276417.1017.14
527645-276457.1027.14
629610-296107.6077.65
20min131881-318818.1918.935.858.269.005.86
236843-368439.4659.55
337090-370909.5299.61
434224-342248.7938.87
533282-332828.5518.63
635138-351389.0279.11
30min139965-3996510.26711.095.6410.3811.215.65
246062-4606211.83411.97
345795-4579511.76511.90
442176-4217610.83510.96
541451-4145110.64910.77
643443-4344311.16111.29
45min147296-4729612.15113.035.6812.3213.225.70
253903-5390313.84814.05
354351-5435113.96314.17
448625-4862512.49212.68
549314-4931412.66912.85
650737-5073713.03513.23
60min152004-5200413.36014.254.7913.6014.514.82
258875-5887515.12615.40
358324-5832414.98415.27
454391-5439113.97414.23
553944-5394413.85914.11
655292-5529214.20514.47
极限160205-6020515.46715.883.5915.7816.233.62
264922-6492216.67917.04
364315-6431516.52316.89
460344-6034415.50315.84
559930-5993015.39715.73
661231-6123115.73116.08
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%
111.814773247849478194775147836477970.11
211.874763347659476460.04
单位质量响应值RSD%判断
4047.164013.980.59数据可信
供试品溶液-24042902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%
5min149583-4958399.42099.921.5499.4299.921.54
248999-4899998.24998.25
350883-50883102.027102.03
449056-4905698.36398.36
550005-50005100.266100.27
650476-50476101.211101.21
10min152785-52785105.840103.641.96106.39104.201.95
251604-51604103.472104.02
352434-52434105.137105.70
449923-49923100.102100.65
552038-52038104.343104.90
651348-51348102.959103.52
15min150974-50974102.209101.931.50103.35103.061.50
250476-50476101.211102.33
351529-51529103.322104.47
449479-4947999.211100.31
551145-51145102.552103.69
651397-51397103.057104.19
20min151311-51311102.885101.871.80104.59103.571.79
250008-50008100.272101.96
351776-51776103.817105.54
449469-4946999.191100.85
550745-50745101.750103.46
651531-51531103.326105.03
30min150157-50157100.57199.701.63102.85101.961.62
249269-4926998.790101.03
351105-51105102.472104.77
448831-4883197.912100.12
549360-4936098.973101.24
649602-4960299.458101.74
45min150684-50684101.62899.282.15104.47102.092.13
249294-4929498.841101.63
350519-50519101.297104.17
447784-4778495.81398.56
549688-4968899.631102.45
649094-4909498.440101.27
60min149854-4985499.96398.211.70103.37101.581.69
248651-4865197.551100.89
349510-4951099.274102.71
447497-4749795.23798.52
549197-4919798.646102.02
649154-4915498.560101.94
极限149454-4945499.16198.431.85103.12102.341.84
249376-4937699.005102.88
350042-50042100.340104.33
447370-4737094.98398.79
549054-4905498.359102.28
649231-4923198.714102.64
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%
110.963823663827193826283821353824443824580.06
210.983822863823383823120.01
单位质量响应值RSD%判断
34895.8034818.940.16数据可信
供试品溶液-24042902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%
5min18329-83292.1442.075.182.142.075.06
27367-73671.8961.90
38386-83862.1592.16
48065-80652.0762.08
57768-77682.0002.00
68409-84092.1652.16
10min120024-200245.1555.062.745.175.072.76
219064-190644.9074.92
320307-203075.2275.24
418964-189644.8824.89
519889-198895.1205.13
619642-196425.0565.07
15min127938-279387.1927.082.817.237.122.78
226486-264866.8186.86
328312-283127.2887.33
426601-266016.8486.89
527627-276277.1127.15
628019-280197.2137.25
20min133591-335918.6478.563.258.738.643.22
231782-317828.1818.26
334581-345818.9028.98
432246-322468.3018.38
533167-331678.5388.62
634118-341188.7838.86
30min141404-4140410.65810.612.3410.7910.742.33
240050-4005010.31010.43
342890-4289011.04111.17
440604-4060410.45210.58
541018-4101810.55910.69
641323-4132310.63710.77
45min149495-4949512.74112.492.3712.9312.682.36
247759-4775912.29412.47
350232-5023212.93113.12
447150-4715012.13712.32
548025-4802512.36312.55
648558-4855812.50012.69
60min154136-5413613.93613.702.1314.1913.962.12
252146-5214613.42313.67
354731-5473114.08914.35
452028-5202813.39313.64
552594-5259413.53913.79
653751-5375113.83714.09
极限160740-6074015.63615.481.6515.9715.811.65
260400-6040015.54815.87
361415-6141515.80916.15
458770-5877015.12915.45
559153-5915315.22715.56
660222-6022215.50215.84
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%
111.814757547561475664759347542475670.04
211.874762947572476000.09
单位质量响应值RSD%判断
4027.694010.110.31数据可信
供试品溶液-24042902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%
5min149938-49938100.422102.102.14100.42102.102.14
250452-50452101.455101.46
351328-51328103.217103.22
451291-51291103.142103.14
552320-52320105.212105.21
649319-4931999.17799.18
10min151402-51402103.365104.942.54103.92105.512.53
252679-52679105.933106.50
351807-51807104.180104.75
452458-52458105.489106.06
554331-54331109.255109.84
650438-50438101.427101.98
15min151069-51069102.696103.481.96103.83104.631.96
252017-52017104.602105.75
351333-51333103.227104.38
451566-51566103.695104.85
552892-52892106.362107.55
649868-49868100.281101.40
20min150171-50171100.890103.012.37102.59104.742.37
251338-51338103.237104.97
350950-50950102.457104.18
451698-51698103.961105.70
553281-53281107.144108.93
649920-49920100.385102.06
30min149789-49789100.122100.512.41102.39102.812.40
250034-50034100.615102.92
348711-4871197.954100.25
450536-50536101.624103.94
551980-51980104.528106.91
648854-4885498.242100.47
45min149284-4928499.106100.822.02101.93103.682.03
250384-50384101.318104.18
350380-50380101.310104.15
450574-50574101.700104.58
551524-51524103.611106.57
648667-4866797.866100.64
60min148969-4896998.47399.491.87101.84102.901.87
249790-49790100.124103.55
349281-4928199.100102.50
450019-50019100.584104.03
550723-50723102.000105.53
648063-4806396.65199.97
极限149619-4961999.780100.612.57103.70104.582.55
250331-50331101.212105.20
349246-4924699.030102.98
450161-50161100.870104.87
552288-52288105.147109.25
648540-4854097.610101.47
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%
110.963816673818183815863815423816663816560.03
210.983826983821633824300.10
单位质量响应值RSD%判断
34822.6334829.690.02数据可信
供试品溶液-24042902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%
5min18422-84222.1701.897.952.171.897.98
27154-71541.8431.84
37572-75721.9511.95
47074-70741.8231.82
56914-69141.7811.78
66905-69051.7791.78
10min119594-195945.0484.773.555.064.783.55
218517-185174.7714.78
318699-186994.8184.83
417835-178354.5954.61
517822-178224.5924.60
618670-186704.8104.82
15min127144-271446.9946.831.677.036.871.67
226481-264816.8236.86
326714-267146.8836.92
425872-258726.6666.70
526202-262026.7516.79
626687-266876.8766.91
20min132115-321158.2748.392.488.358.472.45
233596-335968.6568.73
332416-324168.3528.43
431418-314188.0958.17
532499-324998.3738.45
633363-333638.5968.67
30min139947-3994710.29210.312.0910.4210.432.08
239236-3923610.10910.23
339806-3980610.25610.38
439138-3913810.08410.20
540665-4066510.47710.60
641287-4128710.63810.76
45min146870-4687012.07612.291.6612.2612.471.64
247400-4740012.21312.39
347617-4761712.26912.45
447008-4700812.11212.29
548480-4848012.49112.67
648823-4882312.57912.76
60min151607-5160713.29713.431.4613.5513.681.45
252108-5210813.42613.67
351655-5165513.30913.56
451308-5130813.22013.46
553112-5311213.68413.93
652998-5299813.65513.91
极限159225-5922515.25915.382.1615.5815.702.12
261276-6127615.78816.11
358318-5831815.02615.35
458602-5860215.09915.41
561235-6123515.77716.10
659458-5945815.31915.65
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