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%
111.984774947743479754801148088479130.33
212.034774347812477780.11
单位质量响应值RSD%判断
3999.423971.570.50数据可信
供试品溶液-24111401批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135024-3502471.02162.1023.8171.0262.1023.81
217901-1790136.30036.30
336341-3634173.69273.69
425788-2578852.29352.29
533777-3377768.49368.49
634910-3491070.79070.79
10min142346-4234685.86987.452.1386.2687.792.14
243367-4336787.93988.14
344149-4414989.52589.93
442024-4202485.21685.51
542695-4269586.57786.96
644164-4416489.55589.95
15min143780-4378088.77789.830.9989.6590.660.98
244745-4474590.73491.42
344504-4450490.24591.15
443731-4373188.67789.44
544427-4442790.08990.95
644609-4460990.45891.35
20min143932-4393289.08589.801.4290.4591.131.34
245392-4539292.04693.24
344028-4402889.28090.69
443727-4372788.66989.93
544645-4464590.53191.89
643973-4397389.16890.56
30min143888-4388888.99689.520.9490.8691.350.90
244645-4464590.53192.24
343838-4383888.89490.80
443765-4376588.74690.50
544058-4405889.34191.21
644680-4468090.60292.49
45min142179-4217985.53087.961.5987.8890.291.53
243867-4386788.95391.16
343894-4389489.00891.41
443652-4365288.51790.76
542927-4292787.04789.41
643749-4374988.71491.11
60min143277-4327787.75788.791.4690.5991.611.40
244746-4474690.73693.44
343716-4371688.64791.54
442949-4294987.09289.83
544127-4412789.48092.33
643914-4391489.04991.93
极限144832-4483290.91091.111.3794.2394.421.31
245969-4596993.21696.42
344782-4478290.80994.19
444080-4408089.38592.60
545135-4513591.52494.87
644799-4479990.84394.22
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%
110.323598713591163612593611233613753605490.28
210.363601913600923601420.02
单位质量响应值RSD%判断
34936.9234762.740.36数据可信
供试品溶液-24111401批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186897-18689748.12223.4964.7948.1223.4964.79
292794-9279423.89223.89
347097-4709712.12612.13
4131612-13161233.88733.89
530843-308437.9417.94
658192-5819214.98314.98
10min1361200-36120093.00190.414.4593.2790.544.52
2357185-35718591.96792.10
3330368-33036885.06285.13
4369784-36978495.21195.40
5334073-33407386.01686.06
6354304-35430491.22591.31
15min1369322-36932295.09295.401.6695.8896.031.71
2372825-37282595.99496.64
3364255-36425593.78894.33
4379536-37953697.72298.44
5363384-36338493.56394.09
6373737-37373796.22996.82
20min1371616-37161695.68395.511.4697.0096.671.52
2375252-37525296.61997.80
3363334-36333493.55094.61
4378040-37804097.33798.60
5366770-36677094.43595.48
6370559-37055995.41196.54
30min1367473-36747394.61694.911.9696.4696.602.01
2370481-37048195.39197.10
3359582-35958292.58494.17
4380194-38019497.89199.69
5362833-36283393.42194.99
6371104-37110495.55197.21
45min1366120-36612094.26894.212.0996.6496.432.13
2369414-36941495.11697.36
3362820-36282093.41895.51
4375965-37596596.80399.15
5353155-35315590.93093.01
6367899-36789994.72696.91
60min1365819-36581994.19095.371.2697.0898.121.28
2375385-37538596.65399.43
3369917-36991795.24597.86
4376830-37683097.02599.91
5366801-36680194.44397.03
6367717-36771794.67997.39
极限1378266-37826697.39599.271.41100.81102.541.41
2386424-38642499.496102.80
3384693-38469399.050102.19
4394738-394738101.636105.06
5382814-38281498.566101.68
6386427-38642799.496102.73
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%
111.984755047343475184754147777475460.33
212.034727247613474420.51
单位质量响应值RSD%判断
3968.783943.640.45数据可信
供试品溶液-24111401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%
5min141902-4190285.59789.914.6885.6089.914.68
244277-4427790.44990.45
346463-4646394.91594.91
446467-4646794.92394.92
542479-4247986.77686.78
642501-4250186.82186.82
10min145540-4554093.02993.392.9793.5093.892.98
244979-4497991.88392.39
347204-4720496.42896.96
446837-4683795.67996.21
546228-4622894.43494.92
643502-4350288.86689.35
15min146005-4600593.97994.063.5394.9795.083.52
245102-4510292.13493.15
347420-4742096.87097.93
447543-4754397.12198.18
546880-4688095.76696.77
643320-4332088.49489.47
20min145927-4592793.82093.403.0795.3394.943.07
245757-4575793.47295.00
347361-4736196.74998.35
446185-4618594.34795.95
545984-4598493.93695.47
643110-4311088.06589.53
30min144952-4495291.82891.603.0693.8693.663.05
244190-4419090.27192.32
345718-4571893.39395.53
446423-4642394.83396.96
545251-4525192.43994.50
642500-4250086.81988.78
45min144125-4412590.13890.793.3292.6893.363.32
244214-4421490.32092.87
346187-4618794.35197.01
445300-4530092.53995.19
544974-4497491.87394.45
641862-4186285.51687.95
60min144171-4417190.23290.043.4393.2893.113.42
243346-4334688.54791.59
345416-4541692.77695.96
445214-4521492.36395.53
544893-4489391.70794.79
641409-4140984.59087.50
极限144134-4413490.15790.033.1893.7093.603.17
243307-4330788.46792.01
345760-4576093.47897.18
444961-4496191.84695.52
544509-4450990.92394.52
641760-4176085.30788.69
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%
110.323591043573303599473581043576803584330.31
210.363566263578533572400.25
单位质量响应值RSD%判断
34731.8834482.630.51数据可信
供试品溶液-24111401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%
5min12476-24760.6420.8045.200.640.8045.04
21304-13040.3380.34
34647-46471.2051.20
44703-47031.2191.22
52041-20410.5290.53
63414-34140.8850.89
10min117832-178324.6244.8010.834.634.8010.87
216279-162794.2214.22
320509-205095.3185.32
420765-207655.3845.39
516314-163144.2304.23
619366-193665.0215.03
15min128422-284227.3697.645.577.407.675.59
227780-277807.2037.23
331403-314038.1428.18
431611-316118.1968.23
528427-284277.3717.40
629191-291917.5697.60
20min135580-355809.2259.433.859.309.513.88
235479-354799.1999.26
338311-383119.93310.01
438024-380249.8599.94
535125-351259.1079.17
635806-358069.2849.36
30min144281-4428111.48111.803.9411.6011.933.97
244994-4499411.66611.78
347326-4732612.27112.41
448169-4816912.48912.63
544622-4462211.57011.69
643753-4375311.34411.47
45min152442-5244213.59713.943.6113.7814.133.63
253570-5357013.89014.07
356250-5625014.58514.79
455903-5590314.49514.70
553132-5313213.77613.96
651353-5135313.31513.50
60min157538-5753814.91915.263.2115.1815.533.22
258783-5878315.24215.50
360908-6090815.79216.08
460724-6072415.74516.03
559236-5923615.35915.62
655988-5598814.51714.78
极限162819-6281916.28816.453.0816.6316.813.09
263545-6354516.47616.82
365851-6585117.07417.45
465133-6513316.88817.26
563090-6309016.35816.70
660312-6031215.63815.98
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%
111.984791247942473854752147489476500.55
212.034721047596474030.58
单位质量响应值RSD%判断
3977.463940.400.67数据可信
供试品溶液-24111401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%
5min143959-4395989.73985.865.7989.7485.865.79
241584-4158484.89084.89
343119-4311988.02488.02
441978-4197885.69585.69
537561-3756176.67876.68
644154-4415490.13790.14
10min145475-4547592.83495.081.5393.3395.561.52
246167-4616794.24694.72
346782-4678295.50295.99
447507-4750796.98297.46
546474-4647494.87395.30
647051-4705196.05196.55
15min145990-4599093.88595.251.5394.9096.261.51
245979-4597993.86294.86
346365-4636594.65095.67
447811-4781197.60298.62
547115-4711596.18197.13
646689-4668995.31296.35
20min145286-4528692.44894.451.6993.9895.981.67
245582-4558293.05294.57
345864-4586493.62895.17
447019-4701995.98597.54
546854-4685495.64997.14
646989-4698995.92497.49
30min144723-4472391.29894.272.3693.3596.332.32
244999-4499991.86293.90
346474-4647494.87396.94
447498-4749896.96399.05
546873-4687395.68797.71
646510-4651094.94697.04
45min145751-4575193.39795.111.5795.9597.701.56
245799-4579993.49596.04
347089-4708996.12898.72
447601-4760197.17499.80
546521-4652194.96997.52
646787-4678795.51298.14
60min145781-4578193.45894.621.9596.5397.721.92
244752-4475291.35894.42
346821-4682195.58198.71
446931-4693195.80698.97
546837-4683795.61498.69
646967-4696795.87999.03
极限145436-4543692.75494.521.7796.3598.151.75
245182-4518292.23595.81
346694-4669495.32298.98
447287-4728796.533100.23
546740-4674095.41699.03
646454-4645494.83298.52
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%
110.323586033606383590773594363592393593990.22
210.363576993591643584320.29
单位质量响应值RSD%判断
34825.4834597.680.47数据可信
供试品溶液-24111401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%
5min12236-22360.5780.4464.580.580.4464.69
2-0.0000.00
33311-33110.8560.86
41361-13610.3520.35
51575-15750.4070.41
61618-16180.4180.42
10min114585-145853.7703.459.663.773.459.66
211700-117003.0253.02
315048-150483.8903.89
412316-123163.1843.19
513057-130573.3753.38
613263-132633.4293.43
15min123356-233566.0385.805.206.065.825.21
220591-205915.3235.34
323436-234366.0586.08
421432-214325.5405.56
523135-231355.9806.00
622613-226135.8465.87
20min129184-291847.5447.304.827.607.354.86
226288-262886.7966.84
328444-284447.3537.41
426823-268236.9346.98
529371-293717.5937.65
629340-293407.5857.64
30min135661-356619.2199.234.189.329.324.19
233374-333748.6278.71
335951-359519.2939.39
434724-347248.9769.07
537328-373289.6499.75
637128-371289.5989.69
45min143167-4316711.15911.052.8911.3111.202.93
241050-4105010.61210.74
342951-4295111.10311.26
441458-4145810.71710.86
543873-4387311.34111.49
644007-4400711.37611.53
60min147784-4778412.35212.163.5912.5712.373.60
244432-4443211.48611.68
347336-4733612.23712.45
445591-4559111.78511.98
548280-4828012.48112.69
648815-4881512.61912.83
极限150731-5073113.11413.032.5213.4013.302.56
248388-4838812.50912.76
350831-5083113.14013.42
449461-4946112.78613.05
551140-5114013.22013.50
651906-5190613.41813.70
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