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%
110.502860922863942863342859262861402861770.07
210.532858792860172859480.04
单位质量响应值RSD%判断
27254.9527155.560.26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%
5min181056-8105626.73420.9319.8626.7320.9319.84
246109-4610915.20815.21
355296-5529618.23818.24
466134-6613421.81321.81
572978-7297824.07024.07
659176-5917619.51819.52
10min1273845-27384590.32283.996.3190.4784.106.32
2239780-23978079.08679.17
3262854-26285486.69686.80
4261409-26140986.22086.34
5259125-25912585.46685.60
6230856-23085676.14376.25
15min1305684-305684100.823101.000.83101.47101.580.83
2307979-307979101.580102.10
3309906-309906102.215102.80
4304236-304236100.345100.95
5306609-306609101.128101.74
6302881-30288199.898100.43
20min1307449-307449101.405101.570.95102.62102.710.94
2309942-309942102.227103.32
3311468-311468102.731103.88
4303043-30304399.952101.11
5308829-308829101.860103.03
6306909-306909101.227102.31
30min1300790-30079099.209100.631.18100.98102.341.15
2307365-307365101.377103.03
3309029-309029101.926103.65
4300853-30085399.229100.94
5307820-307820101.527103.26
6304700-304700100.498102.15
45min1301164-30116499.332100.601.26101.66102.861.21
2309117-309117101.955104.17
3308028-308028101.596103.88
4299525-29952598.791101.06
5305710-305710100.831103.13
6306462-306462101.079103.29
60min1301781-30178199.536100.450.96102.41103.270.93
2308088-308088101.616104.40
3308254-308254101.671104.52
4302033-30203399.619102.43
5303788-303788100.198103.06
6303288-303288100.033102.80
极限1303408-303408100.072100.570.79103.50103.950.78
2305679-305679100.821104.17
3307872-307872101.545104.96
4301655-30165599.494102.86
5307099-307099101.290104.71
6303722-303722100.176103.50
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%
114.937230372011721577219172132721590.15
214.987197571844719100.13
单位质量响应值RSD%判断
4833.154800.400.49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%
5min141821-4182156.29254.8113.8256.2954.8113.82
239407-3940753.04353.04
345304-4530460.98060.98
442117-4211756.69056.69
545456-4545661.18561.18
630236-3023640.69840.70
10min160008-6000880.77281.912.2181.0882.212.21
261452-6145282.71683.01
362876-6287684.63284.97
458901-5890179.28279.60
561076-6107682.21082.55
660804-6080481.84382.07
15min164146-6414686.34288.552.4887.1089.312.45
267662-6766291.07491.83
366385-6638589.35690.16
463514-6351485.49186.25
566004-6600488.84389.64
667006-6700690.19190.87
20min164574-6457486.91889.222.6788.1690.472.62
267971-6797191.49092.75
365715-6571588.45489.76
464104-6410486.28587.52
566997-6699790.17991.47
668333-6833391.97893.16
30min165715-6571588.45490.362.7390.1892.112.69
269303-6930393.28395.05
367236-6723690.50192.30
464504-6450486.82488.53
567141-6714190.37392.16
668906-6890692.74994.44
45min166854-6685489.98791.483.5592.2093.733.48
270336-7033694.67496.96
365809-6580988.58090.88
465043-6504387.54989.74
568946-6894692.80395.10
670794-7079495.29097.50
60min167296-6729690.58292.952.3793.3095.712.35
271019-7101995.59398.41
369660-6966093.76496.56
466907-6690790.05892.74
569218-6921893.16995.98
670238-7023894.54297.28
极限167950-6795091.46293.161.9994.6896.431.97
269625-6962593.71797.06
369469-6946993.50796.82
467238-6723890.50493.68
570046-7004694.28397.61
670936-7093695.48198.74
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%
110.502860712862672856502851502852072856690.18
210.532852552853312852930.02
单位质量响应值RSD%判断
27206.5727093.350.30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%
5min161198-6119820.22622.568.9120.2322.568.91
277672-7767225.67125.67
362632-6263220.70020.70
466867-6686722.09922.10
569705-6970523.03723.04
671534-7153423.64223.64
10min1251493-25149383.11885.052.4983.2385.182.49
2259460-25946085.75185.89
3253314-25331483.72083.84
4252395-25239583.41683.54
5258986-25898685.59585.72
6268371-26837188.69688.83
15min1307199-307199101.529102.571.64102.10103.171.65
2314882-314882104.068104.69
3301930-30193099.788100.37
4311408-311408102.920103.51
5311345-311345102.899103.50
6315408-315408104.242104.87
20min1308930-308930102.101103.251.72103.24104.421.73
2318125-318125105.140106.34
3304605-304605100.672101.81
4313173-313173103.503104.66
5311170-311170102.841104.02
6318380-318380105.224106.43
30min1309687-309687102.351103.201.36104.06104.941.37
2317542-317542104.947106.73
3305331-305331100.912102.61
4313957-313957103.763105.50
5312604-312604103.315105.06
6314402-314402103.910105.70
45min1306351-306351101.249102.381.61103.52104.701.60
2317511-317511104.937107.30
3303333-303333100.251102.51
4312736-312736103.359105.67
5309923-309923102.429104.75
6308776-308776102.050104.42
60min1308102-308102101.827101.931.45104.66104.821.45
2314120-314120103.816106.76
3301222-30122299.554102.36
4306706-306706101.366104.25
5308618-308618101.998104.89
6311789-311789103.046105.98
极限1306330-306330101.242101.511.57104.64104.961.56
2309351-309351102.240105.76
3297825-29782598.431101.80
4309726-309726102.364105.81
5308832-308832102.069105.52
6310756-310756102.705106.21
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%
114.937166771917720087174071450717560.31
214.987181271963718880.15
单位质量响应值RSD%判断
4806.164798.930.11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%
5min144833-4483360.52459.383.8460.5259.383.83
246223-4622362.40162.40
344626-4462660.24560.24
441234-4123455.66655.67
543525-4352558.75958.76
643460-4346058.67158.67
10min158648-5864879.17482.392.3779.5182.722.36
260858-6085882.15882.50
362863-6286384.86585.20
461430-6143082.93083.24
560426-6042681.57581.90
661945-6194583.62583.95
15min162684-6268484.62388.382.3785.4089.162.36
265199-6519988.01888.82
366303-6630389.50990.31
466356-6635689.58090.35
565166-6516687.97488.75
667080-6708090.55891.35
20min158539-5853979.02788.855.6080.2790.135.55
267108-6710890.59591.89
367698-6769891.39292.70
466079-6607989.20690.47
566679-6667990.01691.28
668806-6880692.88894.18
30min164660-6466087.29190.693.3588.9892.463.32
268247-6824792.13393.93
368629-6862992.64994.46
468822-6882292.90994.67
563937-6393786.31588.08
668762-6876292.82894.64
45min163606-6360685.86891.583.4988.0493.863.46
269150-6915093.35295.66
369474-6947493.79096.12
470116-7011694.65696.94
567358-6735890.93393.18
667304-6730490.86093.19
60min166858-6685890.25891.651.7292.9194.431.71
269163-6916393.37096.20
369519-6951993.85096.70
466940-6694090.36993.17
567577-6757791.22993.98
667256-6725690.79593.63
极限164748-6474887.40990.452.3290.5693.742.27
266946-6694690.37793.72
367181-6718190.69494.06
468802-6880292.88296.19
568497-6849792.47195.73
665810-6581088.84392.18
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%
110.502854272858062854552857302857442856320.07
210.532851922850112851020.05
单位质量响应值RSD%判断
27203.0527075.210.34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%
5min158013-5801319.18124.3018.5519.1824.3018.55
272255-7225523.89023.89
379414-7941426.25726.26
457910-5791019.14719.15
592208-9220830.48730.49
681223-8122326.85526.85
10min1252423-25242383.45985.612.0583.5785.752.05
2257764-25776485.22585.36
3261934-26193486.60486.75
4260994-26099486.29386.40
5253922-25392283.95584.12
6266564-26656488.13488.28
15min1305274-305274100.933100.631.35101.50101.241.35
2308452-308452101.984102.59
3306276-306276101.264101.89
4296502-29650298.03398.62
5304581-304581100.704101.34
6305075-305075100.867101.51
20min1307404-307404101.637101.271.20102.77102.451.21
2305424-305424100.983102.16
3306100-306100101.206102.40
4299804-29980499.125100.26
5310554-310554102.679103.87
6308550-308550102.016103.22
30min1311010-311010102.830101.401.11104.53103.131.10
2307925-307925101.810103.54
3306875-306875101.463103.21
4300674-30067499.412101.09
5306142-306142101.220102.99
6307480-307480101.663103.43
45min1308086-308086101.863100.530.94104.13102.820.91
2305754-305754101.092103.39
3304090-304090100.542102.86
4301496-30149699.684101.92
5304542-304542100.691103.02
6300295-30029599.287101.62
60min1309278-309278102.257100.401.11105.09103.251.09
2304029-304029100.522103.38
3302911-302911100.152103.03
4298753-29875398.777101.56
5303742-303742100.427103.31
6303164-303164100.236103.12
极限1303385-303385100.30999.481.29103.71102.891.27
2305181-305181100.902104.32
3300885-30088599.482102.91
4295134-29513497.581100.92
5303157-303157100.233103.68
6297446-29744698.345101.78
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%
114.937206671709718717213972099719770.26
214.987194572220720820.27
单位质量响应值RSD%判断
4820.964811.880.14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%
5min145082-4508260.68563.438.9760.6963.438.97
245001-4500160.57660.58
346047-4604761.98461.98
444768-4476860.26260.26
555660-5566074.92474.92
646159-4615962.13562.13
10min160050-6005080.83481.373.3381.1781.723.33
257771-5777177.76678.10
361587-6158782.90383.25
458867-5886779.24179.58
560988-6098882.09682.51
663421-6342185.37185.72
15min163981-6398186.12588.162.7386.9188.962.72
265792-6579288.56389.33
366666-6666689.73990.54
462906-6290684.67885.45
565783-6578388.55189.42
667809-6780991.27892.10
20min165232-6523287.80989.792.6089.0791.082.61
266119-6611989.00390.26
367267-6726790.54991.85
464555-6455586.89888.14
567879-6787991.37292.74
669180-6918093.12494.45
30min167082-6708290.29992.262.5992.0594.052.58
268317-6831791.96293.72
369464-6946493.50695.31
466579-6657989.62291.35
568273-6827391.90393.77
671494-7149496.23898.08
45min166868-6686890.01192.002.5792.2794.312.56
268107-6810791.67993.95
370188-7018894.48096.81
465841-6584188.62990.86
569019-6901992.90795.29
670067-7006794.31896.70
60min168446-6844692.13692.942.4794.8995.762.47
267955-6795591.47594.25
369716-6971693.84596.70
466762-6676289.86992.59
569733-6973393.86896.77
671652-7165296.45199.35
极限166742-6674289.84291.992.4493.1195.322.44
268306-6830691.94795.23
369255-6925593.22596.60
466058-6605888.92192.14
569192-6919293.14096.56
670461-7046194.84898.29
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%
110.502863132862962860422861582863142862250.05
210.532850892850862850880.01
单位质量响应值RSD%判断
27259.5227073.880.49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%
5min148826-4882616.12721.0320.2516.1321.0220.25
270359-7035923.23923.24
348899-4889916.15116.15
463836-6383621.08521.08
581715-8171526.99026.99
668300-6830022.55922.56
10min1223451-22345173.80581.865.9073.8981.975.92
2263864-26386487.15487.28
3244549-24454980.77480.86
4241924-24192479.90780.02
5259429-25942985.68985.84
6253779-25377983.82383.95
15min1293929-29392997.08499.642.5497.58100.212.53
2309594-309594102.258102.87
3306971-306971101.392101.93
4303901-303901100.378100.94
5290472-29047295.94296.57
6305159-305159100.793101.38
20min1296176-29617697.82699.603.2398.87100.723.20
2313294-313294103.480104.66
3308486-308486101.892102.99
4308601-308601101.930103.05
5290764-29076496.03997.20
6291897-29189796.41397.56
30min1296771-29677198.023100.123.3999.61101.803.35
2305593-305593100.937102.69
3314816-314816103.983105.65
4307104-307104101.436103.12
5285854-28585494.41796.11
6308597-308597101.929103.62
45min1296250-29625097.85199.893.0099.98102.122.97
2308268-308268101.820104.14
3312155-312155103.104105.35
4306697-306697101.301103.55
5287512-28751294.96597.18
6303636-303636100.290102.54
60min1293145-29314596.82598.772.7499.50101.562.72
2303659-303659100.298103.18
3308451-308451101.881104.70
4300847-30084799.369102.18
5285765-28576594.38897.13
6302303-30230399.850102.66
极限1296092-29609297.79998.572.88101.01101.912.84
2304048-304048100.426103.87
3304405-304405100.544103.93
4304772-304772100.666104.03
5282466-28246693.29896.57
6298785-29878598.688102.05
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%
114.937202872055720047193671965719980.07
214.987174471791717680.05
单位质量响应值RSD%判断
4822.374790.920.47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%
5min140408-4040854.50560.328.9854.5060.318.98
249336-4933666.54766.55
347575-4757564.17264.17
439444-3944453.20453.20
546873-4687363.22563.22
644658-4465860.23760.24
10min159027-5902779.61982.643.3979.9282.983.37
261102-6110282.41882.79
362241-6224183.95484.31
464533-6453387.04687.34
561615-6161583.11083.46
659097-5909779.71380.05
15min164351-6435186.80089.163.1187.5589.953.08
265681-6568188.59489.42
365593-6559388.47689.30
470036-7003694.46995.25
566255-6625589.36990.18
664672-6467287.23388.01
20min164997-6499787.67291.383.4088.9092.673.38
267066-6706690.46291.78
366972-6697290.33691.65
471976-7197697.08598.39
567731-6773191.35992.67
667720-6772091.34592.61
30min166452-6645289.63492.333.9691.3594.123.92
266583-6658389.81191.63
368838-6883892.85394.67
473662-7366299.360101.20
568001-6800191.72493.54
667149-6714990.57492.34
45min166902-6690290.24192.794.1692.4595.104.11
267262-6726290.72793.05
369232-6923293.38495.72
473968-7396899.772102.17
569349-6934993.54295.87
666033-6603389.06991.34
60min166679-6667989.94092.213.2692.6595.043.24
267258-6725890.72193.55
368748-6874892.73195.58
472297-7229797.518100.47
568992-6899293.06095.91
666212-6621289.31192.08
极限167713-6771391.33592.344.0094.5595.683.95
267451-6745190.98294.31
367634-6763491.22994.59
473934-7393499.726103.22
567747-6774791.38194.74
666284-6628489.40892.67
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