阿齐沙坦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%
110.712830352833222828842827022827572829400.09
210.742805092806712805900.05
单位质量响应值RSD%判断
26418.3026125.700.79数据可信
供试品溶液-2023101221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%
5min15213-52131.7811.2829.241.781.2829.09
24600-46001.5711.57
32125-21250.7260.73
43407-34071.1641.16
53180-31801.0861.09
63888-38881.3281.33
10min117714-177146.0505.2112.926.065.2212.95
216635-166355.6825.69
313047-130474.4564.46
416399-163995.6015.61
513018-130184.4464.45
614730-147305.0315.04
15min120912-209127.1437.335.237.197.365.19
222471-224717.6757.72
323050-230507.8737.90
420746-207467.0867.12
520074-200746.8566.89
621453-214537.3277.36
20min127350-273509.3418.739.159.428.809.08
224171-241718.2568.34
323539-235398.0408.11
424240-242408.2798.36
524519-245198.3758.44
629463-2946310.06310.14
30min129254-292549.99210.081.5110.1310.211.46
229147-291479.95510.08
329067-290679.92810.05
429632-2963210.12110.24
530220-3022010.32210.44
629784-2978410.17310.30
45min135889-3588912.25812.646.3912.4512.826.30
238256-3825613.06613.25
337577-3757712.83513.01
440845-4084513.95114.13
535015-3501511.95912.13
634531-3453111.79411.98
60min136326-3632612.40712.853.3612.6713.103.28
236966-3696612.62612.88
336857-3685712.58912.83
439592-3959213.52313.78
538727-3872713.22713.47
637217-3721712.71212.97
极限140454-4045413.81714.352.5914.1414.682.53
242071-4207114.36914.70
341759-4175914.26314.58
441443-4144314.15514.49
542817-4281714.62414.94
643574-4357414.88315.21
阿齐沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.726795767868676996765367653677660.21
214.836760967497675530.12
单位质量响应值RSD%判断
4603.674555.160.75数据可信
供试品溶液-2023101221批-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%
5min158844-5884483.31285.545.5883.3185.545.58
265264-6526492.40292.40
355879-5587979.11479.11
459028-5902883.57383.57
560231-6023185.27685.28
663274-6327489.58489.58
10min168091-6809196.40497.942.4096.8798.422.40
270729-70729100.139100.65
369026-6902697.72898.17
466713-6671394.45394.92
571177-71177100.773101.25
669333-6933398.16398.66
15min167607-6760795.71997.062.5496.7298.082.53
269772-6977298.78499.85
368771-6877197.36798.35
465748-6574893.08794.08
570728-70728100.138101.17
668692-6869297.25598.30
20min166916-6691694.74196.432.9196.2797.992.90
270044-7004499.169100.79
367585-6758595.68897.21
465456-6545692.67394.18
570758-70758100.180101.77
667897-6789796.12997.71
30min167103-6710395.00595.822.5897.0697.912.57
268465-6846596.93499.10
368230-6823096.60198.66
464930-6493091.92993.95
570145-7014599.312101.46
667188-6718895.12697.24
45min166032-6603293.48995.022.9696.0797.652.95
269154-6915497.909100.62
366891-6689194.70597.30
464184-6418490.87393.40
569504-6950498.405101.10
666924-6692494.75297.40
60min165618-6561892.90394.352.9096.0197.512.89
268454-6845496.918100.17
366610-6661094.30797.43
463967-6396790.56593.60
569219-6921998.001101.25
665992-6599293.43296.60
极限165045-6504592.09293.632.8095.7197.312.79
267642-6764295.76899.56
365907-6590793.31296.95
463227-6322789.51893.06
568333-6833396.747100.54
666631-6663194.33798.03
阿齐沙坦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%
110.712742752736862739092737652738642739000.09
210.742720642720382720510.01
单位质量响应值RSD%判断
25574.2325330.630.68数据可信
供试品溶液-2023101221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%
5min14966-49661.7512.3249.631.752.3249.64
25532-55321.9501.95
33512-35121.2381.24
49855-98553.4743.47
54197-41971.4801.48
611474-114744.0454.05
10min114831-148315.2295.628.665.245.648.70
215310-153105.3985.41
314141-141414.9854.99
417469-174696.1596.18
517291-172916.0966.10
616654-166545.8715.89
15min121479-214797.5727.873.687.617.923.75
222113-221137.7967.84
322534-225347.9447.98
423434-234348.2628.32
521390-213907.5417.58
623002-230028.1098.16
20min126695-266959.4119.408.089.499.488.11
225580-255809.0189.10
324686-246868.7038.78
430653-3065310.80710.91
525243-252438.8998.98
627056-270569.5399.64
30min131599-3159911.14011.424.6611.2711.564.66
232648-3264811.51011.64
329836-2983610.51910.65
432711-3271111.53211.69
533992-3399211.98412.12
633621-3362111.85312.01
45min135970-3597012.68113.024.3312.8813.224.28
234885-3488512.29912.50
336928-3692813.01913.20
436158-3615812.74712.97
538854-3885413.69813.90
638760-3876013.66513.88
60min140535-4053514.29113.822.3214.5614.102.22
240037-4003714.11514.38
338415-3841513.54313.80
438863-3886313.70114.00
539028-3902813.75914.04
638273-3827313.49313.79
极限143171-4317115.22014.2119.3815.5614.5718.92
240651-4065114.33114.68
342392-4239214.94515.28
449356-4935617.40017.77
525801-258019.0969.45
640530-4053014.28914.66
阿齐沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.726679666978671556670467021669310.27
214.836637266711665420.37
单位质量响应值RSD%判断
4546.944486.990.94数据可信
供试品溶液-2023101221批-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%
5min162809-6280990.15790.156.3190.1690.156.31
262528-6252889.75389.75
358216-5821683.56483.56
458732-5873284.30484.30
566755-6675595.82195.82
667806-6780697.32997.33
10min168938-6893898.95498.762.5699.4699.262.54
267201-6720196.46196.96
370739-70739101.539102.00
468137-6813797.80598.27
570995-70995101.907102.44
666824-6682495.92096.46
15min166988-6698896.15598.892.4197.2199.942.38
268860-6886098.84299.88
371489-71489102.616103.64
467761-6776197.26598.28
570108-70108100.634101.73
668140-6814097.80998.88
20min168155-6815597.83098.381.1599.4299.981.14
267629-6762997.07598.66
369835-69835100.242101.84
468516-6851698.34999.90
568992-6899299.032100.69
668095-6809597.74499.36
30min167866-6786697.41697.581.5899.5499.721.56
267441-6744196.80598.93
369361-6936199.561101.72
467639-6763997.09099.19
569075-6907599.151101.36
666496-6649695.44997.61
45min167687-6768797.15996.622.0499.8399.302.01
265582-6558294.13796.80
369381-6938199.590102.30
466540-6654095.51298.15
568165-6816597.845100.60
666495-6649595.44898.14
60min167602-6760297.03796.512.13100.2599.732.10
265398-6539893.87397.06
369326-6932699.511102.77
466039-6603994.79397.96
568141-6814197.810101.11
666902-6690296.03299.25
极限167024-6702496.20795.121.9299.9698.881.84
264456-6445692.52196.23
365841-6584194.50998.32
468240-6824097.952101.65
566122-6612294.91298.76
665901-6590194.59598.35
阿齐沙坦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%
110.712782522783642779112783092781882782050.07
210.742767752767152767450.02
单位质量响应值RSD%判断
25976.1925767.690.57数据可信
供试品溶液-2024010621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%
5min18761-87613.0392.2921.363.042.2921.31
26478-64782.2472.25
37016-70162.4332.43
44484-44841.5551.56
57007-70072.4302.43
65922-59222.0542.05
10min118396-183966.3805.976.306.405.986.30
215923-159235.5235.54
317994-179946.2416.25
415851-158515.4985.51
517800-178006.1746.19
617228-172285.9755.99
15min124221-242218.4018.173.308.458.223.30
222208-222087.7027.75
323767-237678.2438.29
423241-232418.0618.10
524339-243398.4418.49
623621-236218.1928.24
20min127745-277459.6239.805.039.729.894.95
230958-3095810.73710.82
328048-280489.7289.82
427000-270009.3649.45
528375-283759.8419.94
627328-273289.4789.57
30min132357-3235711.22211.544.9011.3711.684.83
231357-3135710.87611.02
332920-3292011.41811.57
435411-3541112.28212.42
535112-3511212.17812.33
632451-3245111.25511.40
45min136774-3677412.75412.851.8812.9713.061.86
235968-3596812.47512.68
337576-3757613.03213.24
437510-3751013.01013.21
537784-3778413.10513.32
636673-3667312.71912.92
60min139704-3970413.77113.852.4414.0614.132.40
238433-3843313.33013.61
339881-3988113.83214.12
440467-4046714.03514.31
541377-4137714.35114.64
639735-3973513.78114.06
极限141713-4171314.46714.752.0814.8315.112.06
241555-4155514.41214.76
343796-4379615.19015.55
442718-4271814.81615.17
543229-4322914.99315.36
642155-4215514.62114.97
阿齐沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.726718567341670836763566929672350.41
214.836700967120670640.12
单位质量响应值RSD%判断
4567.604522.180.71数据可信
供试品溶液-2024010621批-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%
5min168107-6810797.15986.6310.5597.1686.6310.55
255676-5567679.42579.43
368663-6866397.95297.95
454371-5437177.56477.56
561432-6143287.63787.64
656122-5612280.06280.06
10min168514-6851497.74099.612.3398.28100.092.33
268440-6844097.63498.08
370486-70486100.553101.10
469424-6942499.03899.47
572777-72777103.821104.31
669297-6929798.85799.30
15min167915-6791596.88599.232.8597.97100.262.83
267788-6778896.70497.69
369272-6927298.82199.92
470365-70365100.380101.36
573104-73104104.287105.35
668906-6890698.29999.29
20min167411-6741196.16698.712.7497.79100.292.73
267945-6794596.92898.45
369624-6962499.323100.97
468754-6875498.08299.62
572734-72734103.760105.40
668693-6869397.99599.53
30min165882-6588293.98598.524.6496.14100.664.58
266836-6683695.34697.41
368528-6852897.76099.96
469695-6969599.424101.51
574992-74992106.981109.20
668439-6843997.63399.72
45min166085-6608594.27497.082.6696.9599.762.65
267087-6708795.70498.29
368302-6830297.437100.18
468382-6838297.551100.19
571290-71290101.700104.51
667147-6714795.78998.42
60min166348-6634894.65096.743.2297.8599.963.19
265950-6595094.08297.20
367196-6719695.85999.15
468266-6826697.386100.56
571944-71944102.633106.01
667160-6716095.80898.97
极限165517-6551793.46496.112.4897.1999.872.48
266254-6625494.51698.16
367701-6770196.580100.40
467797-6779796.717100.44
570282-70282100.262104.21
666689-6668995.13698.83
阿齐沙坦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%
110.712769222764332764072767522765462766120.08
210.742744172746372745270.06
单位质量响应值RSD%判断
25827.4525561.170.74数据可信
供试品溶液-2024010621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%
5min17455-74552.6042.707.902.602.707.97
28270-82702.8882.89
38214-82142.8692.87
48181-81812.8572.86
56702-67022.3412.34
67626-76262.6632.66
10min117115-171155.9776.254.535.996.264.55
218054-180546.3056.32
318785-187856.5606.58
418906-189066.6036.62
517228-172286.0176.03
617273-172736.0326.05
15min123511-235118.2118.313.078.268.363.10
223653-236538.2608.31
325065-250658.7538.81
424161-241618.4388.49
523537-235378.2208.27
622926-229268.0068.05
20min127137-271379.4779.642.239.579.742.25
227356-273569.5549.65
328028-280289.7889.89
428610-286109.99110.09
527602-276029.6399.73
626950-269509.4129.50
30min132269-3226911.26911.402.5111.4211.552.53
232536-3253611.36311.51
333387-3338711.66011.82
433679-3367911.76211.92
532529-3252911.36011.51
631401-3140110.96611.11
45min136085-3608512.60212.932.6812.8113.142.69
236836-3683612.86413.08
338094-3809413.30413.52
438165-3816513.32813.55
537168-3716812.98013.19
635786-3578612.49812.70
60min139617-3961713.83513.901.9314.1114.191.94
239241-3924113.70413.99
340858-4085814.26914.56
440476-4047614.13514.43
539904-3990413.93614.22
638798-3879813.54913.82
极限142098-4209814.70214.782.0315.0615.152.04
241982-4198214.66115.02
343191-4319115.08415.46
443528-4352815.20115.57
541976-4197614.65915.02
641236-4123614.40114.75
阿齐沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.726711767069669266691567339670730.26
214.836667066723666960.06
单位质量响应值RSD%判断
4556.594497.370.93数据可信
供试品溶液-2024010621批-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%
5min158740-5874084.12994.816.1784.1394.816.16
266742-6674295.59095.59
369597-6959799.67999.68
468400-6840097.96597.96
564628-6462892.56292.56
669091-6909198.95498.95
10min168099-6809997.534100.681.9298.00101.201.93
270638-70638101.170101.70
370736-70736101.310101.86
469589-6958999.668100.21
572120-72120103.293103.81
670583-70583101.091101.64
15min167356-6735696.46999.482.2397.48100.572.22
269623-6962399.716100.81
369869-69869100.069101.19
468650-6865098.32399.42
572024-72024103.155104.24
669233-6923399.158100.27
20min167134-6713496.15198.882.1097.70100.522.09
268634-6863498.30099.95
369579-6957999.653101.33
468188-6818897.66199.31
571393-71393102.251103.91
669313-6931399.272100.93
30min167172-6717296.20698.482.1598.29100.672.14
269381-6938199.370101.56
369099-6909998.966101.19
467225-6722596.28298.47
571104-71104101.837104.07
668573-6857398.212100.43
45min165256-6525693.46297.172.3596.0899.902.35
268798-6879898.535101.28
368595-6859598.244101.02
466779-6677995.64398.36
569684-6968499.804102.60
667942-6794297.309100.07
60min166451-6645195.17397.182.2898.31100.462.26
267856-6785697.186100.48
367733-6773397.009100.33
466032-6603294.57397.83
570241-70241100.601103.95
668794-6879498.529101.83
极限165652-6565294.02996.201.4997.69100.021.50
267238-6723896.300100.13
366866-6686695.76899.63
467353-6735396.465100.24
568755-6875598.473102.38
667159-6715996.187100.03
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