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%
111.044577145765457364573245758457520.04
211.084581945819458190.00
单位质量响应值RSD%判断
4144.204135.290.16数据可信
加速1月-供试品溶液-24051501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%
5min142807-4280783.56882.272.4683.5782.272.45
241974-4197481.94281.94
342672-4267283.30583.30
441850-4185081.70081.70
540317-4031778.70778.71
643221-4322184.37784.38
10min149049-4904995.75493.172.5996.2293.622.59
247931-4793193.57294.03
348465-4846594.61495.08
448088-4808893.87894.33
545501-4550188.82889.26
647304-4730492.34892.82
15min148815-4881595.29794.152.2496.2995.122.24
248843-4884395.35296.33
348784-4878495.23796.23
448444-4844494.57395.55
546064-4606489.92790.86
648406-4840694.49995.48
20min150462-5046298.51394.363.48100.0495.863.46
248116-4811693.93395.44
349259-4925996.16497.68
448132-4813293.96495.46
545410-4541088.65090.08
648629-4862994.93496.44
30min149167-4916795.98595.381.9198.0697.401.91
248315-4831594.32196.35
349360-4936096.36198.41
448994-4899495.64797.67
547318-4731892.37594.30
649996-4999697.60399.64
45min150711-5071198.99996.502.54101.6099.052.52
250657-5065798.893101.44
349948-4994897.509100.10
448838-4883895.34297.90
547462-4746292.65695.09
648978-4897895.61698.19
60min150814-5081499.20095.782.82102.3698.862.80
249031-4903195.71998.82
350162-5016297.927101.06
449318-4931896.27999.36
547046-4704691.84494.79
647990-4799093.68796.79
极限151048-5104899.65796.682.80103.36100.302.78
249863-4986397.343100.98
350372-5037298.337102.01
450006-5000697.622101.24
547197-4719792.13995.60
648645-4864594.96598.59
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%
111.253984543982173982073981483981293982310.04
211.163984693985543985120.02
单位质量响应值RSD%判断
35398.3135708.960.62数据可信
加速1月-供试品溶液-24051501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%
5min1118886-11888630.00528.615.4830.0028.605.49
2109334-10933427.59427.59
3119368-11936830.12730.13
4107865-10786527.22327.22
5118526-11852629.91429.91
6106086-10608626.77426.77
10min1293366-29336674.04172.963.8474.2173.123.84
2272331-27233168.73268.89
3290147-29014773.22873.40
4279402-27940270.51770.67
5299794-29979475.66375.83
6299386-29938675.56075.71
15min1318203-31820380.30981.465.1080.8982.035.08
2304109-30410976.75277.29
3331758-33175883.73084.30
4307413-30741377.58678.13
5326912-32691282.50783.09
6348271-34827187.89888.47
20min1335182-33518284.59583.115.5685.6284.135.53
2305198-30519877.02777.99
3334197-33419784.34685.39
4313379-31337979.09280.07
5330767-33076783.48084.53
6357186-35718690.14891.20
30min1340891-34089186.03585.686.4287.5387.156.38
2315588-31558879.64981.04
3335420-33542084.65586.16
4321682-32168281.18782.60
5345976-34597687.31988.83
6377228-37722895.20696.76
45min1354737-35473789.53090.865.7591.5092.825.68
2365126-36512692.15293.98
3344107-34410786.84788.83
4331338-33133883.62485.49
5384319-38431996.99698.99
6380417-38041796.01198.10
60min1359652-35965290.77092.864.3493.2495.324.32
2365449-36544992.23494.58
3374290-37429094.46596.93
4342060-34206086.33088.66
5386843-38684397.633100.17
6379273-37927395.72298.34
极限1398142-398142100.485100.351.94103.46103.332.00
2386705-38670597.598100.45
3395574-39557499.837102.82
4392771-39277199.129101.94
5405973-405973102.461105.54
6406531-406531102.602105.75
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%
111.044581545785458004578645800457970.03
211.084569045718457040.05
单位质量响应值RSD%判断
4148.284124.910.40数据可信
加速1月-供试品溶液-24051502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%
5min141717-4171781.50383.472.9481.5083.472.94
241348-4134880.78280.78
341807-4180781.67981.68
444033-4403386.02886.03
543269-4326984.53584.54
644175-4417586.30586.31
10min146533-4653390.91294.152.4991.3694.622.49
246883-4688391.59692.04
348476-4847694.70895.16
449273-4927396.26596.74
549267-4926796.25496.72
648722-4872295.18995.67
15min147614-4761493.02495.472.7393.9896.452.72
247062-4706291.94692.90
348603-4860394.95695.94
450386-5038698.44099.45
549607-4960796.91897.92
649912-4991297.51498.52
20min145922-4592289.71893.993.6491.1995.503.62
246140-4614090.14491.61
348036-4803693.84995.36
450158-5015897.99499.55
549402-4940296.51798.06
648980-4898095.69397.24
30min147511-4751192.82393.682.1594.8095.722.14
246643-4664391.12793.10
347888-4788893.55995.59
449242-4924296.20598.31
549093-4909395.91497.99
647328-4732892.46594.55
45min145824-4582489.52793.043.9792.0295.603.93
244949-4494987.81890.29
347472-4747292.74795.30
449328-4932896.37399.01
549456-4945696.62399.23
648694-4869495.13497.73
60min146872-4687291.57594.043.0694.5697.123.05
245853-4585389.58492.55
348449-4844994.65697.72
449578-4957896.861100.04
549360-4936096.43599.58
648695-4869595.13698.26
极限147953-4795393.68695.272.7397.1898.872.73
246572-4657290.98894.45
348804-4880495.34998.94
449758-4975897.213100.92
550199-5019998.075101.76
649310-4931096.33899.99
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%
111.253983213983693983543982273982883983120.02
211.163975533975783975660.01
单位质量响应值RSD%判断
35405.5135624.190.44数据可信
加速1月-供试品溶液-24051502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%
5min194320-9432023.83126.498.4123.8326.498.42
2118523-11852329.94629.95
3105694-10569426.70426.70
496010-9601024.25824.26
5107558-10755827.17527.18
6107031-10703127.04227.04
10min1242901-24290161.37168.825.9261.5068.975.92
2288845-28884572.97973.15
3267079-26707967.47967.63
4281128-28112871.02971.16
5275725-27572569.66469.81
6278729-27872970.42370.57
15min1313146-31314679.11978.582.9879.5979.122.96
2316685-31668580.01380.58
3299744-29974475.73276.26
4323747-32374781.79782.33
5300937-30093776.03476.57
6311945-31194578.81579.36
20min1319113-31911380.62679.612.9681.5480.572.95
2320634-32063481.01182.03
3302274-30227476.37277.32
4327964-32796482.86283.85
5307901-30790177.79378.75
6312576-31257678.97579.95
30min1333461-33346184.25181.362.8885.6182.772.84
2326919-32691982.59884.06
3310383-31038378.42179.79
4329530-32953083.25884.70
5314091-31409179.35780.75
6317749-31774980.28281.70
45min1345295-34529587.24183.863.7589.0785.723.69
2334087-33408784.41086.33
3318785-31878580.54382.35
4347681-34768187.84489.75
5321910-32191081.33383.17
6323654-32365481.77483.64
60min1347429-34742987.78086.132.8390.0988.462.80
2338824-33882485.60688.00
3334513-33451384.51786.77
4357348-35734890.28792.68
5333150-33315084.17386.46
6334173-33417384.43186.75
极限1397396-397396100.40597.841.37103.21100.641.35
2385791-38579197.473100.34
3385440-38544097.384100.11
4387017-38701797.783100.68
5381710-38171096.44299.19
6386097-38609797.550100.34
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%
111.044582945800458144579545715457910.10
211.084567645660456680.03
单位质量响应值RSD%判断
4147.744121.660.45数据可信
加速1月-供试品溶液-24051503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%
5min142080-4208082.25083.482.4182.2583.482.41
241696-4169681.50081.50
342059-4205982.20982.21
442417-4241782.90982.91
543908-4390885.82385.82
644096-4409686.19186.19
10min148663-4866395.11795.190.8695.5795.650.86
248577-4857794.94995.40
348572-4857294.94095.40
448525-4852594.84895.31
549522-4952296.79697.27
648340-4834094.48694.96
15min148291-4829194.39095.011.4495.3896.001.43
247569-4756992.97993.96
348618-4861895.02996.01
448439-4843994.68095.67
549198-4919896.16397.18
649536-4953696.82497.83
20min149145-4914596.06095.230.9597.5796.760.95
248073-4807393.96495.46
348840-4884095.46396.98
448478-4847894.75696.27
549308-4930896.37897.93
648491-4849194.78196.32
30min147709-4770993.25394.682.1295.3096.732.09
247803-4780393.43695.46
349055-4905595.88497.93
447414-4741492.67694.72
550137-5013797.999100.08
648503-4850394.80596.87
45min150544-5054498.79496.901.60101.3699.471.57
248857-4885795.49798.03
350300-5030098.317100.89
448513-4851394.82497.38
549571-4957196.89299.52
649653-4965397.05299.65
60min149052-4905295.87895.512.2898.9998.622.24
247702-4770293.23996.31
349870-4987097.477100.60
447381-4738192.61295.69
550107-5010797.940101.11
649060-4906095.89399.03
极限149835-4983597.40897.381.28101.05101.021.27
249494-4949496.742100.33
349798-4979897.336101.00
448860-4886095.50299.10
550728-5072899.154102.86
650205-5020598.131101.80
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%
111.253987793986483987183983843979263984910.09
211.163977673977933977800.01
单位质量响应值RSD%判断
35421.4235643.370.45数据可信
加速1月-供试品溶液-24051503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%
5min1121858-12185830.77328.096.7030.7728.096.70
2109909-10990927.75627.76
3107152-10715227.05927.06
4105565-10556526.65926.66
5119017-11901730.05630.06
6103911-10391126.24126.24
10min1286513-28651372.35471.142.4272.5271.302.42
2281928-28192871.19671.35
3275699-27569969.62369.77
4289029-28902972.98973.14
5285521-28552172.10372.27
6271555-27155568.57668.72
15min1306123-30612377.30678.342.9777.8878.902.96
2303721-30372176.69977.25
3297581-29758175.14975.69
4321528-32152881.19681.75
5317955-31795580.29480.86
6314455-31445579.41079.94
20min1317206-31720680.10580.042.4881.1181.032.48
2312089-31208978.81379.79
3304813-30481376.97577.93
4326887-32688782.55083.55
5323140-32314081.60382.62
6317659-31765980.21981.19
30min1332240-33224083.90183.671.7985.3585.101.76
2322363-32236381.40782.82
3339323-33932385.69087.07
4334022-33402284.35185.81
5333078-33307884.11385.58
6326979-32697982.57383.99
45min1359280-35928090.73088.054.0692.6489.943.97
2332772-33277284.03685.90
3371056-37105693.70495.56
4347760-34776087.82189.75
5341770-34177086.30888.24
6339395-33939585.70887.58
60min1353818-35381889.35188.653.5191.7791.033.45
2336238-33623884.91187.24
3370557-37055793.57895.96
4355409-35540989.75292.17
5350527-35052788.51990.93
6339602-33960285.76188.11
极限1383983-38398396.96899.011.7799.88101.891.70
2400130-400130101.046103.85
3385972-38597297.471100.37
4400095-400095101.037103.96
5392709-39270999.172102.08
6389593-38959398.385101.21
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%
111.044569545684456914569645648456830.05
211.084566445664456640.00
单位质量响应值RSD%判断
4137.954121.300.29数据可信
加速1月-供试品溶液-2024052421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%
5min142044-4204482.28082.782.6282.2882.782.62
240795-4079579.83679.84
341628-4162881.46681.47
442149-4214982.48682.49
543455-4345585.04285.04
643710-4371085.54185.54
10min148808-4880895.51793.261.8595.9793.721.84
247181-4718192.33392.78
347582-4758293.11893.57
446255-4625590.52190.98
547947-4794793.83294.30
648147-4814794.22494.70
15min148722-4872295.34995.372.3496.3496.352.34
247904-4790493.74894.70
348068-4806894.06995.04
447482-4748292.92293.88
550091-5009198.02899.02
650133-5013398.11099.11
20min149400-4940096.67695.132.1998.1996.642.19
247372-4737292.70794.18
348114-4811494.15995.65
447598-4759893.14994.63
549198-4919896.28197.82
649980-4998097.81199.35
30min149581-4958197.03094.983.1399.0897.013.11
246618-4661891.23293.22
347903-4790393.74695.76
447106-4710692.18794.18
549818-4981897.49499.57
650163-5016398.169100.26
45min148254-4825494.43395.523.0297.0398.082.99
247957-4795793.85296.35
347833-4783393.60996.15
447751-4775193.44995.96
549573-4957397.01599.63
651479-51479100.745103.38
60min149259-4925996.40096.032.9299.5299.132.90
248327-4832794.57697.60
348368-4836894.65697.71
447160-4716092.29295.32
550190-5019098.222101.38
651126-51126100.054103.25
极限150027-5002797.90396.612.31101.56100.242.30
249258-4925896.39899.94
348937-4893795.77099.35
447662-4766293.27596.81
549235-4923596.353100.05
651082-5108299.968103.72
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%
111.253978003978763979313978393975653978020.04
211.163980123978413979260.04
单位质量响应值RSD%判断
35360.1835656.450.59数据可信
加速1月-供试品溶液-2024052421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%
5min1101014-10101425.52728.2917.0825.5328.2917.08
292608-9260823.40323.40
3132803-13280333.56033.56
4125788-12578831.78731.79
5128421-12842132.45332.45
691068-9106823.01323.01
10min1254266-25426664.25469.076.2664.4069.236.28
2258211-25821165.25165.38
3282845-28284571.47771.66
4294769-29476974.49074.67
5287483-28748372.64972.83
6262350-26235066.29766.43
15min1302141-30214176.35378.704.0976.8579.244.08
2299402-29940275.66176.15
3299380-29938075.65576.24
4323171-32317181.66782.26
5316637-31663780.01680.60
6327815-32781582.84183.34
20min1316278-31627879.92580.423.8180.8581.403.78
2305280-30528077.14678.06
3305310-30531077.15478.16
4327530-32753082.76983.81
5319170-31917080.65681.68
6335769-33576984.85185.81
30min1329962-32996283.38383.403.2684.7584.823.23
2318153-31815380.39981.74
3319893-31989380.83982.27
4333339-33333984.23785.74
5330763-33076383.58685.06
6347969-34796987.93489.36
45min1344057-34405786.94586.482.8088.7888.372.77
2335595-33559584.80786.59
3332340-33234083.98485.87
4346781-34678187.63489.61
5336315-33631584.98986.93
6358242-35824290.53092.45
60min1346770-34677087.63188.132.9389.9490.492.91
2337956-33795685.40387.66
3340115-34011585.94988.30
4349986-34998688.44390.90
5350963-35096388.69091.10
6366581-36658192.63795.06
极限1392129-39212999.09398.741.17101.89101.601.17
2389817-38981798.509101.24
3382026-38202696.54099.37
4392592-39259299.210102.16
5394753-39475399.756102.66
6393022-39302299.319102.25
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