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%
111.814718147320472604724447251472510.11
211.874779047754477720.06
单位质量响应值RSD%判断
4000.934024.600.42数据可信
供试品溶液-24042901批-左氨氯地平-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%
5min151022-51022102.759101.471.77102.76101.471.77
250826-50826102.364102.36
350269-50269101.242101.24
450196-50196101.095101.10
551212-51212103.141103.14
648767-4876798.21798.22
10min153617-53617107.985104.252.33108.56104.822.32
251912-51912104.551105.12
351015-51015102.744103.31
451268-51268103.254103.82
552531-52531105.798106.37
650228-50228101.159101.71
15min152794-52794106.327103.681.89107.50104.821.89
251398-51398103.516104.67
350793-50793102.297103.43
451097-51097102.910104.04
552475-52475105.685106.85
650314-50314101.333102.44
20min151938-51938104.603103.151.36106.36104.871.37
251431-51431103.582105.31
350763-50763102.237103.94
451174-51174103.065104.77
551874-51874104.475106.22
650118-50118100.938102.61
30min150620-50620101.949102.231.35104.29104.521.34
250875-50875102.463104.76
350282-50282101.268103.54
451269-51269103.256105.54
551701-51701104.126106.45
649799-49799100.295102.53
45min151826-51826104.378101.781.66107.29104.641.65
250501-50501101.709104.58
350058-50058100.817103.65
450848-50848102.408105.26
550669-50669102.048104.95
649314-4931499.319102.11
60min151938-51938104.603101.552.11108.09104.972.08
250929-50929102.571106.01
349701-49701100.098103.49
449162-4916299.013102.43
551093-51093102.902106.38
649701-49701100.098103.44
极限151026-51026102.767102.091.47106.84106.081.46
250839-50839102.390106.39
349940-49940100.579104.53
451090-51090102.896106.87
551600-51600103.923107.97
649659-49659100.013103.91
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%
110.963777363782063776973776263781413778810.08
210.983821833815523818680.12
单位质量响应值RSD%判断
34478.1934778.510.62数据可信
供试品溶液-24042901批-阿齐沙坦-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%
5min15058-50581.3111.3411.441.311.3411.50
25186-51861.3441.34
35488-54881.4221.42
45676-56761.4711.47
55575-55751.4451.44
64066-40661.0541.05
10min116072-160724.1654.214.064.174.224.06
216941-169414.3904.40
316835-168354.3624.37
416067-160674.1634.17
516465-164654.2674.27
615135-151353.9223.93
15min123928-239286.2006.172.686.236.202.70
224473-244736.3426.37
324504-245046.3506.38
423270-232706.0306.06
523814-238146.1716.20
622912-229125.9375.96
20min129062-290627.5317.572.077.607.632.10
229958-299587.7637.83
329941-299417.7597.83
428519-285197.3907.45
528933-289337.4977.56
628818-288187.4687.53
30min135896-358969.3029.501.359.419.601.34
237108-371089.6169.73
337216-372169.6449.75
436418-364189.4379.54
536465-364659.4499.56
636821-368219.5419.64
45min144341-4434111.49011.411.3611.6511.571.39
244622-4462211.56311.73
344583-4458311.55311.72
443395-4339511.24511.40
543238-4323811.20411.36
644023-4402311.40811.56
60min149143-4914312.73412.671.4912.9612.891.46
249621-4962112.85813.09
349034-4903412.70612.93
447875-4787512.40612.63
548136-4813612.47312.70
649535-4953512.83613.05
极限155040-5504014.26214.631.2914.5614.921.26
256660-5666014.68214.98
356872-5687214.73715.04
456463-5646314.63114.92
556571-5657114.65914.95
657082-5708214.79215.08
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%
111.814737247327474004742047378473790.08
211.874729947337473180.06
单位质量响应值RSD%判断
4011.773986.350.45数据可信
供试品溶液-24042901批-左氨氯地平-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%
5min150099-50099101.246102.841.57101.25102.851.57
250688-50688102.436102.44
352178-52178105.447105.45
450833-50833102.729102.73
550125-50125101.298101.30
651415-51415103.905103.91
10min151414-51414103.903106.181.74104.47106.761.73
252403-52403105.902106.47
353562-53562108.244108.83
452422-52422105.940106.51
551802-51802104.687105.25
653656-53656108.434109.01
15min152539-52539106.177106.531.94107.32107.691.94
251851-51851104.786105.94
354036-54036109.202110.39
451985-51985105.057106.22
551912-51912104.909106.05
653948-53948109.024110.20
20min151479-51479104.034106.062.10105.76107.812.09
252505-52505106.108107.85
353444-53444108.006109.80
452024-52024105.136106.88
551332-51332103.737105.46
654090-54090109.311111.10
30min150953-50953102.971105.201.64105.28107.541.64
251601-51601104.281106.61
352991-52991107.090109.48
451999-51999105.085107.41
551650-51650104.380106.68
653136-53136107.383109.78
45min151442-51442103.960104.431.91106.84107.351.90
250964-50964102.994105.90
352735-52735106.573109.56
451257-51257103.586106.50
550609-50609102.276105.16
653027-53027107.163110.15
60min150956-50956102.977103.982.28106.43107.482.26
250720-50720102.501105.98
352744-52744106.591110.17
450597-50597102.252105.74
550540-50540102.137105.59
653144-53144107.399110.98
极限151305-51305103.683104.302.04107.71108.382.02
251483-51483104.043108.09
353239-53239107.591111.76
451031-51031103.129107.18
550249-50249101.549105.57
652357-52357105.809109.99
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%
110.963777743778993784163783363779343780720.08
210.983777233776533776880.02
单位质量响应值RSD%判断
34495.6234397.810.21数据可信
供试品溶液-24042901批-阿齐沙坦-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%
5min15547-55471.4451.449.931.441.449.99
25189-51891.3521.35
35886-58861.5331.53
46431-64311.6751.68
54989-49891.3001.30
65128-51281.3361.34
10min116155-161554.2084.304.474.224.324.46
216202-162024.2204.23
316770-167704.3684.38
417658-176584.6004.61
516855-168554.3914.40
615515-155154.0414.05
15min123595-235956.1466.282.936.186.312.92
223626-236266.1546.19
324454-244546.3706.40
424724-247246.4406.48
525000-250006.5126.54
623272-232726.0626.09
20min129000-290007.5547.701.687.627.771.68
229433-294337.6677.73
329671-296717.7297.80
430001-300017.8157.89
530201-302017.8677.93
629031-290317.5627.63
30min136082-360829.3999.592.059.519.702.05
236715-367159.5649.67
336880-368809.6079.72
437254-372549.7049.82
538013-380139.90210.01
636000-360009.3789.48
45min143874-4387411.42911.461.1211.5911.621.10
243706-4370611.38511.55
344158-4415811.50311.67
443792-4379211.40711.58
544899-4489911.69611.86
643536-4353611.34111.50
60min148411-4841112.61112.681.0212.8312.911.01
248482-4848212.62912.85
348885-4888512.73412.96
448054-4805412.51812.75
549479-4947912.88913.12
648865-4886512.72912.95
极限156376-5637614.68514.670.9414.9814.970.92
256652-5665214.75715.05
357184-5718414.89615.19
455882-5588214.55714.86
556071-5607114.60614.91
655787-5578714.53214.82
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%
111.814741047525475444758147528475180.14
211.874761847636476270.03
单位质量响应值RSD%判断
4023.544012.380.20数据可信
供试品溶液-24042902批-左氨氯地平-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%
5min150027-50027100.624102.311.64100.62102.301.64
251215-51215103.013103.01
350420-50420101.414101.41
451045-51045102.671102.67
552266-52266105.127105.13
650205-50205100.982100.98
10min151752-51752104.093104.721.57104.65105.291.57
252710-52710106.020106.59
351675-51675103.938104.50
451379-51379103.343103.91
553416-53416107.440108.02
651456-51456103.498104.06
15min151313-51313103.210104.401.88104.35105.551.88
252836-52836106.274107.43
351568-51568103.723104.86
451746-51746104.081105.23
553279-53279107.165108.35
650684-50684101.945103.08
20min150959-50959102.498103.561.82104.21105.291.82
252501-52501105.600107.35
351212-51212103.007104.72
451270-51270103.124104.85
552708-52708106.016107.79
650279-50279101.131102.83
30min150181-50181100.933103.021.84103.21105.321.83
252330-52330105.256107.59
350848-50848102.275104.56
450704-50704101.985104.28
552449-52449105.495107.86
650799-50799102.176104.44
45min150635-50635101.847104.192.40104.69107.072.38
253549-53549107.708110.63
351261-51261103.106105.96
451906-51906104.403107.27
552941-52941106.485109.44
650512-50512101.599104.43
60min151581-51581103.749103.561.98107.16107.021.96
252615-52615105.829109.35
351821-51821104.232107.66
450540-50540101.655105.10
552353-52353105.302108.85
650026-50026100.622104.02
极限151627-51627103.842103.881.97107.82107.911.96
252480-52480105.558109.67
351829-51829104.248108.26
451548-51548103.683107.69
552613-52613105.825109.95
649776-49776100.119104.07
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%
110.963796163796483799223800093792733796940.08
210.983809393810713810050.03
单位质量响应值RSD%判断
34643.6134699.910.12数据可信
供试品溶液-24042902批-阿齐沙坦-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%
5min18373-83732.1671.996.892.171.996.89
27938-79382.0542.05
37296-72961.8881.89
47778-77782.0132.01
57919-79192.0492.05
66878-68781.7801.78
10min118491-184914.7854.784.584.804.804.59
219964-199645.1675.18
318088-180884.6814.69
418238-182384.7204.73
518707-187074.8414.85
617429-174294.5114.52
15min125233-252336.5306.685.466.576.725.43
228485-284857.3727.41
325252-252526.5356.57
425586-255866.6226.66
526014-260146.7326.77
624384-243846.3116.35
20min129885-298857.7348.016.377.818.086.36
234770-347708.9989.08
330331-303317.8507.92
430550-305507.9067.98
530993-309938.0218.10
629173-291737.5507.62
30min136266-362669.3869.896.129.5010.016.11
242815-4281511.08011.21
337710-377109.7599.88
437279-372799.6489.77
538117-381179.8659.98
637106-371069.6039.71
45min143784-4378411.33111.966.7711.5012.136.73
252400-5240013.56113.75
345437-4543711.75911.93
445697-4569711.82612.00
545502-4550211.77611.95
644404-4440411.49211.66
60min149533-4953312.81913.195.4513.0513.445.46
256404-5640414.59714.87
351174-5117413.24413.48
449397-4939712.78413.02
550445-5044513.05513.30
648942-4894212.66612.90
极限157134-5713414.78615.073.1515.0915.383.19
261530-6153015.92416.27
358549-5854915.15215.46
458338-5833815.09815.41
557508-5750814.88315.20
656230-5623014.55214.85
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%
111.814743547447474374740647400474250.05
211.874769247577476340.18
单位质量响应值RSD%判断
4015.664012.970.05数据可信
供试品溶液-24042902批-左氨氯地平-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%
5min151929-51929104.544104.341.28104.54104.341.28
252131-52131104.951104.95
352904-52904106.507106.51
451690-51690104.063104.06
551112-51112102.899102.90
651207-51207103.090103.09
10min154819-54819110.362108.442.33110.94109.022.32
255307-55307111.345111.93
354817-54817110.358110.95
452991-52991106.682107.26
552399-52399105.490106.06
652856-52856106.410106.98
15min153698-53698108.105107.332.02109.30108.512.01
254457-54457109.633110.83
354300-54300109.317110.52
451615-51615103.912105.08
552679-52679106.054107.21
653132-53132106.966108.13
20min154370-54370109.458107.272.50111.25109.052.49
254555-54555109.831111.64
354564-54564109.849111.66
452110-52110104.908106.66
551984-51984104.655106.40
652124-52124104.936106.69
30min153557-53557107.821107.042.03110.22109.422.02
253566-53566107.840110.26
354851-54851110.426112.85
453001-53001106.702109.03
551968-51968104.622106.95
652082-52082104.852107.19
45min152385-52385105.462104.101.88108.46107.071.88
252768-52768106.233109.25
352590-52590105.875108.91
450635-50635101.939104.86
551067-51067102.809105.72
650819-50819102.309105.23
60min153043-53043106.787106.822.40110.37110.372.38
254332-54332109.382112.99
354862-54862110.449114.07
451967-51967104.620108.11
551840-51840104.365107.85
652315-52315105.321108.81
极限153682-53682108.073107.791.31112.25111.931.32
253782-53782108.274112.49
354625-54625109.972114.21
453049-53049106.799110.87
553538-53538107.783111.84
652574-52574105.842109.92
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%
110.963789553791263792983787613791533790590.06
210.983800593804563802580.08
单位质量响应值RSD%判断
34585.6834631.880.10数据可信
供试品溶液-24042902批-阿齐沙坦-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%
5min17830-78302.0302.037.682.032.027.74
27790-77902.0202.02
37093-70931.8391.84
47193-71931.8651.86
58469-84692.1962.20
68494-84942.2022.20
10min118593-185934.8214.813.674.834.833.68
218840-188404.8854.90
318170-181704.7114.72
417582-175824.5584.57
518615-186154.8264.84
619617-196175.0865.10
15min125254-252546.5486.623.866.596.663.87
225796-257966.6886.73
325516-255166.6166.65
424085-240856.2456.28
525467-254676.6036.64
627148-271487.0397.08
20min130792-307927.9837.952.878.068.022.89
230903-309038.0128.09
331160-311608.0798.15
429519-295197.6537.72
529729-297297.7087.78
631833-318338.2538.33
30min137921-379219.8329.912.689.9510.032.65
238094-380949.87710.00
339347-3934710.20110.32
437594-375949.7479.86
536860-368609.5579.68
639487-3948710.23810.36
45min144390-4439011.50911.472.3211.6811.652.34
244793-4479311.61311.79
345169-4516911.71111.89
443173-4317311.19311.36
542819-4281911.10211.27
645199-4519911.71911.90
60min149867-4986712.92913.103.0613.1713.343.04
251527-5152713.35913.60
352456-5245613.60013.84
449735-4973512.89513.12
548223-4822312.50312.74
651444-5144413.33813.59
极限157994-5799415.03615.221.1215.3515.531.12
258910-5891015.27415.59
359632-5963215.46115.78
458717-5871715.22415.52
557920-5792015.01715.32
659025-5902515.30315.62
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