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%
110.502883672885202882062879822879452882040.09
210.532893802885462889630.21
单位质量响应值RSD%判断
27448.0027441.880.02数据可信
供试品溶液-20220124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%
5min155338-5533818.09312.3536.8518.0912.3436.86
245085-4508514.74014.74
329255-292559.5659.56
426867-268678.7848.78
520889-208896.8306.83
649143-4914316.06716.07
10min1228751-22875174.78967.9810.0674.8968.0410.08
2195535-19553563.92964.01
3195985-19598564.07664.13
4190317-19031762.22362.27
5196944-19694464.39064.43
6239948-23994878.45078.54
15min1294355-29435596.23895.101.9196.7595.551.90
2294477-29447796.27896.71
3297885-29788597.39297.80
4289179-28917994.54694.94
5285055-28505593.19793.59
6284359-28435992.97093.49
20min1302294-30229498.83497.491.9899.8898.471.96
2297338-29733897.21398.19
3307444-307444100.517101.47
4297310-29731097.20498.12
5293085-29308595.82396.74
6291659-29165995.35796.40
30min1306541-306541100.22299.231.70101.82100.741.68
2300090-30009098.11399.63
3312464-312464102.159103.67
4300588-30058898.27699.74
5302467-30246798.890100.34
6298834-29883497.70299.27
45min1307903-307903100.668100.101.86102.82102.171.84
2301286-30128698.504100.56
3314808-314808102.925105.00
4299730-29973097.995100.00
5309699-309699101.255103.25
6303636-30363699.272101.39
60min1304093-30409399.422100.431.66102.14103.061.60
2303717-30371799.299101.90
3313457-313457102.483105.13
4314013-314013102.665105.22
5304360-30436099.509102.07
6303414-30341499.200101.87
极限1308285-308285100.792100.081.58104.06103.271.56
2308283-308283100.792103.95
3313084-313084102.361105.58
4300102-30010298.117101.24
5305459-30545999.868102.98
6301503-30150398.575101.79
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%
114.937261672958729587286172948728680.21
214.987299572643728190.35
单位质量响应值RSD%判断
4880.644861.080.29数据可信
供试品溶液-20220124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%
5min137175-3717549.48241.9924.3149.4841.9924.31
220645-2064527.48027.48
323222-2322230.91030.91
433199-3319944.19044.19
537639-3763950.10050.10
637405-3740549.78949.79
10min159741-5974179.51977.372.8079.7977.602.86
256660-5666075.41875.57
356399-5639975.07175.24
457329-5732976.30976.55
560323-6032380.29480.57
658305-5830577.60877.88
15min165344-6534486.97786.911.2187.6987.571.18
265540-6554087.23887.81
365927-6592787.75388.34
464791-6479186.24186.91
566150-6615088.05088.77
664002-6400285.19185.90
20min167248-6724889.51190.031.5090.7191.181.43
268576-6857691.27992.34
369132-6913292.01993.10
467062-6706289.26490.41
567381-6738189.68990.90
666429-6642988.42189.60
30min170069-7006993.26692.871.7994.9694.521.72
271431-7143195.07996.64
370909-7090994.38595.97
468529-6852991.21792.86
569288-6928892.22793.94
668405-6840591.05292.72
45min170608-7060893.98493.692.4196.2095.862.31
272061-7206195.91898.01
372331-7233196.27798.39
470199-7019993.43995.59
569269-6926992.20294.43
667863-6786390.33092.51
60min170124-7012493.34095.042.0296.0897.721.92
272833-7283396.94599.57
373003-7300397.17299.82
472213-7221396.12098.79
569872-6987293.00495.74
670343-7034393.63196.31
极限171074-7107494.60494.851.6497.8698.061.57
272487-7248796.48599.65
372834-7283496.947100.13
470560-7056093.92097.12
570763-7076394.19097.44
669821-6982192.93696.14
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%
110.502885872859402867972883382884452876210.42
210.532890362857302873830.82
单位质量响应值RSD%判断
27392.4827291.830.27数据可信
供试品溶液-20220124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%
5min121173-211736.94811.9536.676.9511.9536.67
253778-5377817.64917.65
321137-211376.9376.94
434158-3415811.21011.21
543501-4350114.27614.28
644694-4469414.66714.67
10min1201743-20174366.20767.944.3266.2568.004.34
2219553-21955372.05272.15
3202950-20295066.60366.64
4194736-19473663.90863.97
5209952-20995268.90168.98
6213113-21311369.93970.02
15min1288084-28808494.54295.891.4294.9596.331.41
2287847-28784794.46494.96
3289943-28994395.15295.56
4295927-29592797.11697.53
5297429-29742997.60998.07
6293943-29394396.46596.93
20min1299101-29910198.15898.450.8099.0999.430.77
2296664-29666497.35898.38
3301263-30126398.86799.80
4303097-30309799.469100.43
5298295-29829597.89398.90
6301555-30155598.96399.97
30min1304950-304950100.07799.121.36101.55100.641.32
2297669-29766997.68899.25
3301872-30187299.067100.55
4308125-308125101.119102.63
5297602-29760297.66699.21
6301918-30191899.082100.64
45min1301863-30186399.06498.370.79101.10100.440.78
2302423-30242399.248101.35
3297935-29793597.77599.81
4300406-30040698.586100.66
5296194-29619497.20499.29
6299630-29963098.331100.44
60min1299843-29984398.40197.861.26100.98100.481.22
2300726-30072698.691101.35
3296269-29626997.22899.81
4303460-30346099.588102.21
5294042-29404296.49799.13
6294771-29477196.73799.39
极限1301722-30172299.01898.711.49102.15101.881.44
2297263-29726397.554100.76
3298625-29862598.001101.12
4309381-309381101.531104.70
5298451-29845197.944101.11
6299340-29934098.236101.43
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%
114.937256272443727667282272524726230.23
214.987285672971729140.12
单位质量响应值RSD%判断
4864.234867.420.05数据可信
供试品溶液-20220124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%
5min124381-2438132.48636.0127.7132.4936.0127.71
216409-1640921.86421.86
335324-3532447.06747.07
422594-2259430.10530.11
535461-3546147.25047.25
627996-2799637.30337.30
10min155380-5538073.79075.494.9473.9775.695.00
252461-5246169.90170.02
359925-5992579.84680.11
455442-5544273.87374.04
559337-5933779.06379.33
657373-5737376.44676.65
15min163154-6315484.14986.122.9384.7486.742.99
262105-6210582.75183.26
366581-6658188.71589.42
464663-6466386.15986.74
566961-6696189.22189.92
664351-6435185.74486.38
20min165469-6546987.23389.732.4888.2990.832.54
265352-6535287.07788.05
369143-6914392.12993.33
467325-6732589.70690.76
569100-6910092.07193.27
667675-6767590.17391.28
30min166724-6672488.90691.632.2590.4593.232.31
266997-6699789.26990.72
370470-7047093.89795.61
469250-6925092.27193.83
569845-6984593.06494.77
669329-6932992.37793.99
45min166870-6687089.10091.631.9791.1493.742.02
267801-6780190.34192.29
369555-6955592.67894.91
468231-6823190.91492.98
570415-7041593.82496.05
669733-6973392.91595.04
60min167446-6744689.86891.711.4892.4094.331.54
268485-6848591.25293.70
370283-7028393.64896.39
468759-6875991.61794.19
569691-6969192.85995.61
668324-6832491.03793.68
极限168144-6814490.79892.121.8393.8395.251.87
268317-6831791.02893.99
371139-7113994.78898.05
469042-6904291.99495.08
570153-7015393.47496.74
668032-6803290.64893.79
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%
110.502903772891102885992896962884472892460.28
210.532884762891652888200.17
单位质量响应值RSD%判断
27547.2427428.300.31数据可信
供试品溶液-20220126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%
5min130194-301949.85613.6259.339.8613.6259.31
29516-95163.1063.11
354792-5479217.88617.89
466068-6606821.56721.57
568472-6847222.35222.35
621340-213406.9666.97
10min1214092-21409269.88870.9610.8769.9471.0310.92
2182939-18293959.71859.74
3230204-23020475.14775.25
4238324-23832477.79877.92
5241450-24145078.81878.94
6197207-19720764.37664.41
15min1297136-29713696.99696.251.3597.4496.721.37
2295374-29537496.42196.77
3295423-29542396.43796.95
4300347-30034798.04598.60
5291679-29167995.21595.78
6289194-28919494.40494.80
20min1295962-29596296.61396.922.5497.6097.922.50
2305991-30599199.887100.77
3290143-29014394.71495.77
4306541-306541100.067101.16
5291972-29197295.31196.40
6290795-29079594.92695.85
30min1296971-29697196.94397.522.0898.4699.062.01
2311146-311146101.570103.01
3297193-29719397.01598.59
4297387-29738797.07898.73
5295752-29575296.54598.17
6293998-29399895.97297.42
45min1300340-30034098.04297.202.05100.1099.282.05
2300923-30092398.233100.24
3298827-29882797.54899.67
4304485-30448599.395101.59
5294819-29481996.24098.40
6287135-28713593.73295.71
60min1304011-30401199.24197.271.82101.8499.891.78
2303571-30357199.097101.65
3296879-29687996.91299.57
4299550-29955097.784100.53
5292420-29242095.45798.15
6291359-29135995.11197.61
极限1305756-30575699.81099.640.75102.96102.800.78
2306585-306585100.081103.18
3306913-306913100.188103.39
4304483-30448399.395102.68
5306670-306670100.109103.33
6300931-30093198.235101.27
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%
114.937247172204729447268372990726580.46
214.987252072976727480.45
单位质量响应值RSD%判断
4866.584856.340.15数据可信
供试品溶液-20220126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%
5min140954-4095454.61842.3734.5654.6242.3734.56
211740-1174015.65715.66
334404-3440445.88245.88
428070-2807037.43537.44
541303-4130355.08355.08
634152-3415245.54645.55
10min156882-5688275.86074.552.6376.1674.782.70
254428-5442872.58772.67
356542-5654275.40675.66
455233-5523373.66173.87
557974-5797477.31677.62
654339-5433972.46872.72
15min163973-6397385.31784.772.9486.0485.422.89
266090-6609088.14088.63
363638-6363884.87085.54
462013-6201382.70383.32
564748-6474886.35087.09
660913-6091381.23681.89
20min164241-6424185.67487.863.6186.8788.983.50
270448-7044893.95294.93
364262-6426285.70286.85
465017-6501786.70987.79
566444-6644488.61289.83
664858-6485886.49787.60
30min166799-6679989.08690.603.9590.7692.213.84
272929-7292997.26198.76
368437-6843791.27092.89
465171-6517186.91488.47
567655-6765590.22791.93
666628-6662888.85790.44
45min167174-6717489.58690.953.1391.7693.073.05
271714-7171495.64097.68
368751-6875191.68993.82
467323-6732389.78491.83
568828-6882891.79194.00
665405-6540587.22689.31
60min169219-6921992.31391.413.3294.9894.033.24
272475-7247596.65599.23
368649-6864991.55394.19
465744-6574487.67990.22
567978-6797890.65893.38
667204-6720489.62692.19
极限167329-6732989.79291.463.0192.9794.592.94
272238-7223896.33999.45
368583-6858391.46594.61
467026-6702689.38892.42
569489-6948992.67395.90
666816-6681689.10892.17
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%
110.502892812873272894572875212888352884840.35
210.532878752883442881100.12
单位质量响应值RSD%判断
27474.6727360.870.30数据可信
供试品溶液-20220126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%
5min150684-5068416.5879.1259.6916.599.1259.70
29761-97613.1943.19
312831-128314.1994.20
418055-180555.9095.91
535775-3577511.70811.71
640132-4013213.13413.13
10min1213897-21389770.00266.526.3570.0966.576.37
2202254-20225466.19266.21
3179597-17959758.77758.80
4209171-20917168.45668.49
5200573-20057365.64265.71
6213976-21397670.02870.10
15min1294318-29431896.32297.661.6196.8098.081.57
2301122-30112298.54898.93
3302592-30259299.03099.38
4292732-29273295.80396.22
5304090-30409099.52099.95
6295573-29557396.73297.19
20min1300652-30065298.39599.142.8399.41100.102.79
2317497-317497103.908104.84
3302350-30235098.95099.85
4291750-29175095.48196.43
5306064-306064100.166101.15
6299274-29927497.94498.94
30min1302080-30208098.862100.403.10100.42101.913.05
2322713-322713105.615107.12
3310648-310648101.666103.12
4298883-29888397.81699.29
5309126-309126101.168102.71
6297137-29713797.24498.79
45min1300897-30089798.47599.792.08100.59101.862.05
2314665-314665102.981105.08
3306241-306241100.224102.24
4297903-29790397.49599.51
5309274-309274101.216103.32
6300522-30052298.352100.44
60min1295034-29503496.55699.502.4799.22102.122.43
2315671-315671103.310105.98
3304667-30466799.709102.28
4297968-29796897.516100.08
5308882-308882101.088103.75
6301897-30189798.802101.43
极限1304598-30459899.686101.302.27102.88104.482.23
2321101-321101105.087108.33
3314850-314850103.041106.17
4302968-30296899.153102.26
5308042-308042100.813104.04
6305666-305666100.036103.21
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%
114.937233873136730037276172808728090.42
214.987257672790726830.21
单位质量响应值RSD%判断
4876.694852.000.36数据可信
供试品溶液-20220126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%
5min135503-3550347.32030.4131.0147.3230.4231.01
219346-1934625.78525.79
324430-2443032.56232.56
422696-2269630.25030.25
514509-1450919.33819.34
620428-2042827.22727.23
10min159686-5968679.55372.855.5279.8273.025.58
251216-5121668.26368.41
356169-5616974.86575.05
454843-5484373.09873.27
552450-5245069.90870.02
653571-5357171.40271.55
15min166025-6602588.00285.434.3188.7186.004.33
260775-6077581.00481.53
368357-6835791.11091.71
461876-6187682.47283.05
563800-6380085.03685.53
663722-6372284.93285.48
20min169227-6922792.26989.893.4193.4690.943.42
267364-6736489.78690.76
370342-7034293.75594.86
463657-6365784.84585.88
566824-6682489.06690.03
667256-6725689.64290.66
30min171400-7140095.16693.193.9496.8794.743.94
270548-7054894.03095.50
374008-7400898.642100.27
466633-6663388.81290.32
569792-6979293.02294.49
667132-6713289.47790.99
45min172142-7214296.15593.723.3798.3995.783.39
269609-6960992.77894.77
373708-7370898.242100.41
466889-6688989.15391.15
570181-7018193.54195.52
669364-6936492.45294.47
60min171009-7100994.64493.632.4697.4196.212.50
270174-7017493.53296.04
372952-7295297.23499.95
467721-6772190.26292.75
570175-7017593.53396.03
669445-6944592.56095.09
极限172819-7281997.05793.803.18100.3596.913.21
269258-6925892.31195.34
373398-7339897.829101.09
467772-6777290.33093.32
569888-6988893.15096.17
669122-6912292.12995.17
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