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%
1 10.982947982942432940252938042946532943050.15
2 10.962934962936502935730.04
单位质量响应值RSD%判断
26803.7326785.860.05数据可信
长期18月-供试品溶液-2023101221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%
5min181990-8199027.45745.2223.6927.4645.2223.69
2176457-17645759.09259.09
3152634-15263451.11451.11
4120970-12097040.51040.51
5143856-14385648.17448.17
6134232-13423244.95144.95
10min1278875-27887593.38996.362.8893.5496.612.92
2291686-29168697.67998.01
3294965-29496598.77799.06
4276155-27615592.47892.70
5295372-29537298.91499.18
6289461-28946196.93497.18
15min1304419-304419101.943101.501.23102.61102.281.18
2300317-300317100.570101.44
3302720-302720101.374102.21
4306636-306636102.686103.42
5297455-29745599.611100.43
6307005-307005102.809103.60
20min1307845-307845103.091102.021.17104.33103.371.11
2298053-29805399.812101.24
3303786-303786101.731103.13
4304908-304908102.107103.42
5305914-305914102.444103.81
6307303-307303102.909104.27
30min1305951-305951102.456101.951.21104.27103.861.15
2297441-29744199.607101.59
3304889-304889102.101104.06
4305796-305796102.405104.28
5304388-304388101.933103.87
6308152-308152103.193105.12
45min1308490-308490103.307102.361.72105.69104.851.65
2297899-29789999.760102.30
3303088-303088101.498104.03
4309964-309964103.800106.25
5302889-302889101.431103.94
6311674-311674104.373106.88
60min1302662-302662101.355101.691.57104.31104.741.52
2296292-29629299.222102.31
3301542-301542100.980104.07
4305103-305103102.172105.19
5306025-306025102.481105.55
6310362-310362103.934107.02
极限1302138-302138101.180101.261.90104.70104.881.84
2296095-29609599.156102.80
3298802-298802100.062103.72
4301843-301843101.081104.67
5302478-302478101.293104.93
6312906-312906104.785108.45
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%
115.127170171883717917128571851717020.34
215.117161571930717720.32
单位质量响应值RSD%判断
4742.204749.970.12数据可信
长期18月-供试品溶液-2023101221批-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%
5min145154-4515461.68365.5810.7461.6865.5810.73
249016-4901666.95966.96
340310-4031055.06655.07
447564-4756464.97564.98
550336-5033668.76268.76
655667-5566776.04476.04
10min163691-6369187.00584.604.6887.3584.974.70
260044-6004482.02382.40
358274-5827479.60679.91
461052-6105283.40083.76
562009-6200984.70885.09
666529-6652990.88291.30
15min167426-6742692.10888.584.9592.9389.424.96
262185-6218584.94885.78
361333-6133383.78484.53
464236-6423687.75088.57
564108-6410887.57588.43
669791-6979195.33896.27
20min167671-6767192.44288.974.9893.7890.304.99
262782-6278285.76487.06
362032-6203284.73985.95
463547-6354786.80988.12
564354-6435487.91189.25
670401-7040196.17297.63
30min168559-6855993.65590.814.5495.5192.634.56
263807-6380787.16488.94
363180-6318086.30787.99
465829-6582989.92691.72
566231-6623190.47592.30
671232-7123297.30799.30
45min167244-6724491.85989.945.1494.2392.275.14
264138-6413887.61689.88
362238-6223885.02187.18
466561-6656190.92693.22
563318-6331886.49688.83
671545-7154597.734100.27
60min168406-6840693.44690.905.2696.3393.725.26
263703-6370387.02289.77
362613-6261385.53388.17
465779-6577989.85892.66
566399-6639990.70593.52
672334-7233498.812101.89
极限168243-6824393.22490.395.7996.6293.725.76
263779-6377987.12690.36
361812-6181284.43987.55
464560-6456088.19391.49
565995-6599590.15393.47
672613-7261399.193102.82
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%
1 10.982943362941142945682943602940322942820.08
2 10.962950522946432948480.10
单位质量响应值RSD%判断
26801.6426902.190.27数据可信
长期18月-供试品溶液-2024010621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%
5min1173204-17320457.87951.9814.5057.8851.9814.50
2118487-11848739.59439.59
3154999-15499951.79651.80
4184035-18403561.49861.50
5153446-15344651.27751.28
6149136-14913649.83649.84
10min1297094-29709499.27998.321.7299.6098.611.75
2285590-28559095.43595.65
3293796-29379698.17798.46
4297066-29706699.27099.61
5291993-29199397.57597.86
6299863-299863100.204100.48
15min1302799-302799101.186100.681.45102.06101.511.47
2297076-29707699.273100.02
3299859-299859100.203101.04
4305264-305264102.009102.90
5296010-29601098.91799.74
6306688-306688102.485103.32
20min1299379-299379100.043100.261.92101.48101.651.93
2292762-29276297.83199.13
3298825-29882599.858101.25
4303006-303006101.255102.71
5296630-29663099.124100.50
6309518-309518103.431104.83
30min1300852-300852100.535100.462.30102.53102.412.30
2292944-29294497.89299.74
3298711-29871199.819101.76
4301145-301145100.633102.66
5296813-29681399.185101.11
6313320-313320104.701106.68
45min1300346-300346100.366100.152.19102.92102.662.19
2290471-29047197.06699.45
3298212-29821299.653102.15
4302688-302688101.148103.73
5296408-29640899.050101.53
6310006-310006103.594106.15
60min1299436-299436100.06299.972.57103.17103.042.57
2288774-28877496.49999.43
3296928-29692899.224102.28
4304822-304822101.862105.00
5294500-29450098.412101.44
6310481-310481103.753106.89
极限1299732-299732100.161100.092.88103.82103.712.84
2289844-28984496.856100.32
3295379-29537998.706102.31
4299384-299384100.044103.75
5297318-29731899.354102.93
6315452-315452105.414109.12
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%
115.127155871856715527139771424715570.26
215.117205071831719400.22
单位质量响应值RSD%判断
4732.614761.090.43数据可信
长期18月-供试品溶液-2024010621批-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%
5min151283-5128370.04569.967.2870.0469.967.28
243843-4384359.88359.88
352342-5234271.49171.49
452580-5258071.81671.82
553299-5329972.79872.80
653984-5398473.73473.73
10min166266-6626690.50989.512.8990.9089.902.91
261968-6196884.63984.97
365512-6551289.47989.88
465465-6546589.41589.81
566600-6660090.96591.37
667404-6740492.06492.47
15min168833-6883394.01592.901.2994.9193.781.30
266702-6670291.10591.91
368512-6851293.57794.47
468670-6867093.79394.69
568186-6818693.13294.04
667176-6717691.75292.67
20min168620-6862093.72493.771.5095.1495.171.52
266661-6666191.04992.36
368982-6898294.21995.63
469186-6918694.49895.91
568937-6893794.15795.58
669545-6954594.98896.42
30min170320-7032096.04695.451.6397.9897.371.64
268391-6839193.41295.23
369280-6928094.62696.56
469313-6931394.67196.61
570342-7034296.07698.03
671656-7165697.87199.83
45min170413-7041396.17396.021.9098.6498.471.91
268504-6850493.56695.90
369667-6966795.15597.62
470498-7049896.29098.76
570127-7012795.78398.27
672583-7258399.137101.64
60min170345-7034596.08196.511.9499.0899.501.94
268977-6897794.21297.07
370250-7025095.95198.94
471241-7124197.304100.31
570121-7012195.77598.79
673027-7302799.744102.80
极限171230-7123097.28996.272.66100.8399.792.63
268092-6809293.00396.38
369341-6934194.70998.23
469678-6967895.17098.71
571103-7110397.116100.66
673458-73458100.332103.94
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%
1 10.982955192956382954882962512950582955910.15
2 10.962937422942112939760.12
单位质量响应值RSD%判断
26920.8626822.630.26数据可信
长期18月-供试品溶液-2024010721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%
5min1150292-15029250.18647.8411.0650.1947.8411.06
2164502-16450254.93154.93
3152800-15280051.02351.02
4120354-12035440.18940.19
5132138-13213844.12444.12
6139495-13949546.58046.58
10min1294682-29468298.40098.551.8798.6898.821.89
2297364-29736499.29699.60
3301518-301518100.683100.97
4285532-28553295.34595.57
5298398-29839899.64199.89
6293355-29335597.95798.22
15min1304515-304515101.684101.471.48102.51102.281.49
2305318-305318101.952102.81
3308872-308872103.139103.98
4295977-29597798.83399.59
5306476-306476102.339103.14
6302023-302023100.852101.65
20min1301595-301595100.709100.201.56102.10101.571.57
2297469-29746999.331100.75
3306469-306469102.336103.75
4292812-29281297.77699.08
5302532-302532101.022102.39
6299495-299495100.008101.37
30min1301390-301390100.640100.161.77102.59102.101.78
2298698-29869899.741101.72
3307393-307393102.645104.63
4291636-29163697.38399.23
5302788-302788101.107103.04
6297871-29787199.465101.38
45min1305510-305510102.016102.091.28104.53104.581.28
2303782-303782101.439103.97
3313029-313029104.527107.08
4304670-304670101.736104.12
5305939-305939102.159104.65
6301456-301456100.662103.13
60min1300903-300903100.478100.221.40103.55103.281.41
2298491-29849199.672102.77
3306027-306027102.189105.32
4293713-29371398.077101.03
5302768-302768101.100104.16
6298972-29897299.833102.86
极限1299530-299530100.01998.871.72103.65102.481.71
2294262-29426298.260101.91
3299493-299493100.007103.71
4286527-28652795.67799.17
5298792-29879299.773103.39
6297912-29791299.479103.06
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%
115.127193872246717227231671891720230.35
215.117156771567715670.00
单位质量响应值RSD%判断
4763.434736.400.41数据可信
长期18月-供试品溶液-2024010721批-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%
5min153147-5314772.54470.905.8472.5470.905.84
251307-5130770.03270.03
349517-4951767.58967.59
447621-4762165.00165.00
554669-5466974.62174.62
655415-5541575.64075.64
10min165594-6559489.53390.463.0089.9490.853.00
263849-6384987.15287.54
368100-6810092.95493.33
464181-6418187.60587.97
567927-6792792.71893.13
667980-6798092.79093.21
15min168552-6855293.57194.132.2494.4795.032.24
267295-6729591.85592.73
370830-7083096.68097.57
467145-6714591.65192.50
569877-6987795.38096.31
670081-7008195.65896.59
20min168232-6823293.13493.953.0794.5595.373.06
265796-6579689.80991.19
371052-7105296.98398.41
467339-6733991.91593.27
569474-6947494.83096.29
671084-7108497.02798.49
30min168911-6891194.06194.922.9796.0096.862.97
266559-6655990.85192.73
372122-7212298.444100.41
468064-6806492.90594.77
570681-7068196.47798.46
670919-7091996.80298.81
45min170310-7031095.97197.452.6398.4399.922.62
268531-6853193.54295.93
374017-74017101.031103.55
471362-7136297.40799.79
571606-7160697.740100.26
672543-7254399.019101.56
60min170166-7016695.77497.242.8998.77100.252.88
267903-6790392.68595.59
373625-73625100.496103.57
471048-7104896.97899.90
571760-7176097.950101.02
672935-7293599.554102.65
极限168921-6892194.07596.062.7597.6099.622.75
267716-6771692.43095.85
372084-7208498.392102.03
469637-6963795.05298.52
571228-7122897.224100.83
672683-7268399.210102.86
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%
1 10.982945612946572948312939022947792945460.13
2 10.962935962934662935310.04
单位质量响应值RSD%判断
26825.6826782.030.12数据可信
长期18月-供试品溶液-2024010921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%
5min1135693-13569345.42551.877.5945.4351.877.59
2150299-15029950.31550.31
3160235-16023553.64153.64
4160731-16073153.80753.81
5152615-15261551.09051.09
6170154-17015456.96256.96
10min1302691-302691101.331102.161.21101.58102.451.22
2307835-307835103.053103.33
3302037-302037101.112101.41
4307534-307534102.952103.25
5301086-301086100.793101.08
6309882-309882103.738104.05
15min1307412-307412102.911103.270.30103.73104.120.30
2308603-308603103.310104.16
3308343-308343103.223104.08
4308131-308131103.152104.02
5310142-310142103.825104.67
6308244-308244103.189104.08
20min1310151-310151103.828103.971.01105.21105.401.00
2311202-311202104.180105.61
3311046-311046104.127105.56
4315959-315959105.772107.22
5307041-307041102.787104.21
6308055-308055103.126104.59
30min1308747-308747103.358103.001.10105.32105.011.08
2303502-303502101.602103.61
3311724-311724104.354106.37
4311119-311119104.152106.18
5305712-305712102.342104.33
6305287-305287102.200104.24
45min1308077-308077103.134102.971.30105.67105.541.27
2306726-306726102.681105.25
3314170-314170105.173107.76
4309303-309303103.544106.15
5303998-303998101.768104.33
6303215-303215101.506104.11
60min1316858-316858106.073103.051.68109.18106.201.61
2307700-307700103.007106.15
3302857-302857101.386104.56
4310234-310234103.856107.04
5305125-305125102.145105.27
6304229-304229101.845105.02
极限1306768-306768102.695100.961.94106.40104.681.88
2305646-305646102.320106.03
3303460-303460101.588105.33
4302426-302426101.242105.00
5290518-29051897.255100.95
6300655-300655100.649104.39
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%
115.127200672031720207178371630718940.25
215.117172771549716380.18
单位质量响应值RSD%判断
4754.894741.100.21数据可信
长期18月-供试品溶液-2024010921批-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%
5min154926-5492675.00275.242.5875.0075.242.58
255082-5508275.21575.21
353453-5345372.99072.99
453868-5386873.55773.56
555886-5588676.31376.31
657385-5738578.36078.36
10min167784-6778492.56091.002.0092.9891.421.99
267287-6728791.88192.30
364143-6414387.58887.99
467557-6755792.25092.66
566568-6656890.89991.32
666511-6651190.82191.26
15min169211-6921194.50893.062.0595.4493.982.05
269330-6933094.67195.60
365717-6571789.73790.63
468976-6897694.18795.11
568301-6830193.26694.19
667368-6736891.99192.93
20min169926-6992695.48494.292.0596.9495.732.04
269696-6969695.17096.62
366807-6680791.22592.62
470263-7026395.94597.39
569843-6984395.37196.82
667771-6777192.54293.99
30min171189-7118997.20995.112.3099.2097.082.28
268918-6891894.10896.09
367220-6722091.78993.69
471229-7122997.26499.24
570549-7054996.33598.31
668824-6882493.98095.94
45min171806-7180698.05295.921.47100.5898.421.47
269781-6978195.28697.79
369411-6941194.78197.19
470506-7050696.27698.79
570934-7093496.86199.37
669046-6904694.28396.77
60min171943-7194398.23996.622.50101.3199.652.47
271177-7117797.193100.23
367690-6769092.43195.37
472343-7234398.785101.84
571722-7172297.937100.99
669665-6966595.12898.14
极限170239-7023995.91295.561.9899.5399.131.97
271016-7101696.973100.55
367353-6735391.97195.42
470893-7089396.805100.41
570747-7074796.606100.20
669659-6965995.12098.66
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