氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2000
标示量(mg)10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%
114.181422351410331421431416441407401415590.47
214.241423801429481426640.29
单位质量响应值RSD%判断
9983.0010018.540.26数据可信
供试品溶液-2025011111批-氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156032-5603236.32530.9019.7636.3330.9019.77
250504-5050432.74132.74
341029-4102926.59926.60
453938-5393834.96834.97
531671-3167120.53220.53
652772-5277234.21234.21
10min1102948-10294866.74069.543.5067.1469.893.45
2110564-11056471.67872.04
3106725-10672569.18969.48
4111307-11130772.16072.55
5109296-10929670.85671.08
6102803-10280366.64667.03
15min1125326-12532681.24882.665.1982.3983.785.18
2126975-12697582.31783.48
3124175-12417580.50281.57
4140765-14076591.25792.45
5123428-12342880.01881.03
6124363-12436380.62481.74
20min1134514-13451487.20486.364.0589.2588.394.07
2132103-13210385.64187.72
3131365-13136585.16387.12
4143026-14302692.72394.93
5126978-12697882.31984.22
6131241-13124185.08387.10
30min1141268-14126891.58390.793.4994.6093.783.51
2139586-13958690.49393.52
3134994-13499487.51690.42
4148967-14896796.57499.81
5138554-13855489.82492.64
6136873-13687388.73491.70
45min1150264-15026497.41596.264.89101.45100.264.85
2146843-14684395.19799.23
3145244-14524494.16198.04
4161980-161980105.011109.32
5145561-14556194.36698.18
6140998-14099891.40895.36
60min1147753-14775395.78796.004.18100.90101.074.17
2147259-14725995.467100.56
3141755-14175591.89996.82
4159783-159783103.586109.06
5147358-14735895.531100.40
6144541-14454193.70598.67
极限1146537-14653794.99996.874.30101.18103.014.26
2149755-14975597.085103.24
3146853-14685395.204101.15
4161155-161155104.476111.10
5150078-15007897.295103.22
6142136-14213692.14698.15
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
110.181385701138340413877391385967138283913851300.15
210.191395675139433713950060.07
单位质量响应值RSD%判断
136063.85136899.510.44数据可信
供试品溶液-2025011111批-厄贝沙坦-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min173268-732684.8323.9222.874.833.9222.90
265655-656554.3304.33
341017-410172.7052.70
464755-647554.2704.27
543682-436822.8812.88
668286-682864.5034.50
10min1163801-16380110.80211.424.7210.8611.474.64
2172120-17212011.35011.40
3177459-17745911.70211.73
4181185-18118511.94812.00
5181473-18147311.96712.00
6163466-16346610.78010.83
15min1204832-20483213.50714.645.7913.6814.815.73
2219293-21929314.46114.64
3224958-22495814.83514.99
4243432-24343216.05316.23
5224473-22447314.80314.97
6215109-21510914.18514.35
20min1227587-22758715.00816.445.4715.3316.775.42
2255467-25546716.84617.18
3253495-25349516.71617.04
4265098-26509817.48117.84
5255526-25552616.85017.18
6238678-23867815.73916.07
30min1252847-25284716.67417.964.6017.1618.474.58
2276616-27661618.24118.76
3279003-27900318.39818.91
4288459-28845919.02219.57
5273490-27349018.03518.55
6263429-26342917.37117.87
45min1278291-27829118.35119.364.7819.0320.074.74
2295487-29548719.48520.21
3301496-30149619.88220.60
4315997-31599720.83821.60
5288773-28877319.04319.76
6281152-28115218.54019.24
60min1281372-28137218.55519.733.8619.4320.663.87
2301230-30123019.86420.81
3307230-30723020.26021.20
4314733-31473320.75521.75
5293139-29313919.33120.26
6297717-29771719.63320.53
极限1288843-28884319.04720.194.1020.1321.344.10
2311482-31148220.54021.70
3314357-31435720.73021.89
4323348-32334821.32322.55
5301660-30166019.89321.04
6297447-29744719.61520.73
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2000
标示量(mg)10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%
114.181427521425421428231427061427791427200.08
214.241407111408551407830.08
单位质量响应值RSD%判断
10064.889886.451.27数据可信
供试品溶液-2025011211批-氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min173780-7378047.95544.7510.5647.9644.7510.56
254868-5486835.66335.66
371665-7166546.58046.58
474718-7471848.56548.56
568071-6807144.24444.24
669992-6999245.49345.49
10min1124171-12417180.70878.253.5781.2478.743.60
2113759-11375973.94074.34
3123315-12331580.15280.67
4123292-12329280.13780.68
5121377-12137778.89279.38
6116390-11639075.65176.16
15min1131957-13195785.76984.562.5287.2085.932.52
2129371-12937184.08885.31
3131857-13185785.70487.11
4134500-13450087.42288.85
5126867-12686782.46083.83
6126042-12604281.92483.27
20min1132507-13250786.12686.432.7288.5188.732.70
2132339-13233986.01788.17
3137312-13731289.24991.61
4136006-13600688.40090.80
5132683-13268386.24188.52
6126956-12695682.51884.77
30min1140703-14070391.45391.030.8394.7994.300.83
2140259-14025991.16594.27
3141074-14107491.69595.05
4139982-13998290.98594.37
5137810-13781089.57392.82
6140463-14046391.29794.47
45min1151448-15144898.43796.032.19102.79100.312.14
2147816-14781696.077100.20
3151136-15113698.235102.61
4145079-14507994.29898.69
5147670-14767095.982100.22
6143312-14331293.14997.34
60min1149989-14998997.48996.892.21102.94102.242.05
2154595-154595100.483105.67
3149661-14966197.276102.74
4144865-14486594.15999.60
5148236-14823696.350101.65
6147095-14709595.608100.83
极限1150882-15088298.06997.362.82104.60103.782.66
2152473-15247399.104105.41
3147730-14773096.021102.56
4150098-15009897.560104.05
5154856-154856100.652107.03
6142695-14269592.74899.03
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
110.181387119138868813870021391334138533113878950.17
210.191378859138139813801280.14
单位质量响应值RSD%判断
136335.46135439.450.47数据可信
供试品溶液-2025011211批-厄贝沙坦-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min175973-759735.0324.6113.925.034.6113.91
254243-542433.5933.59
375999-759995.0345.03
479485-794855.2645.26
562210-622104.1204.12
670113-701134.6444.64
10min1161121-16112110.67110.955.5410.7311.005.57
2153127-15312710.14210.18
3177103-17710311.73011.79
4175204-17520411.60411.66
5162327-16232710.75110.80
6162829-16282910.78410.84
15min1193210-19321012.79713.414.2912.9713.584.31
2198830-19883013.16913.32
3207030-20703013.71213.90
4217058-21705814.37614.56
5195818-19581812.96913.13
6203148-20314813.45513.63
20min1211363-21136313.99914.604.0214.3214.924.02
2217783-21778314.42414.72
3228905-22890515.16115.50
4233669-23366915.47615.82
5216169-21616914.31714.63
6214341-21434114.19614.52
30min1235508-23550815.59816.052.4416.0716.542.51
2237652-23765215.74016.20
3246118-24611816.30116.81
4251482-25148216.65617.18
5239876-23987615.88716.36
6243773-24377316.14616.62
45min1251034-25103416.62616.972.7917.2717.632.83
2250822-25082216.61217.25
3267003-26700317.68418.37
4263543-26354317.45518.16
5251986-25198616.69017.33
6253056-25305616.76017.42
60min1256723-25672317.00317.211.9117.8318.061.94
2261866-26186617.34418.16
3262459-26245917.38318.27
4265887-26588717.61018.51
5251798-25179816.67717.51
6260168-26016817.23118.08
极限1258835-25883517.14317.441.4718.1618.481.52
2263176-26317617.43118.44
3263679-26367917.46418.54
4269760-26976017.86718.96
5264416-26441617.51318.53
6259936-25993617.21618.25
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2000
标示量(mg)10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%
114.181391431404131402191403581391201398510.48
214.241396891402561399720.29
单位质量响应值RSD%判断
9862.559829.490.24数据可信
供试品溶液-2025011111批-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%
5min183013-8301354.66350.9926.7854.6650.9926.78
249639-4963932.68632.69
357600-5760037.92937.93
478344-7834451.58851.59
5105283-10528369.32769.33
690709-9070959.73059.73
10min1151090-15109099.49093.947.64100.1094.507.69
2145791-14579196.00196.36
3122281-12228180.52080.94
4139930-13993092.14192.71
5151832-15183299.979100.75
6145028-14502895.49896.16
15min1160536-160536105.710100.322.98107.42101.933.03
2148795-14879597.97999.41
3151237-15123799.587100.90
4148683-14868397.90599.50
5154481-154481101.723103.60
6150368-15036899.015100.74
20min1159439-159439104.988100.832.41107.88103.562.46
2152275-152275100.270102.79
3151910-151910100.030102.45
4149181-14918198.233100.92
5155216-155216102.207105.22
6150712-15071299.241102.07
30min1156456-156456103.02399.122.23107.08102.962.34
2149169-14916998.225101.86
3146771-14677196.646100.18
4149012-14901298.122101.90
5151972-151972100.071104.22
6149767-14976798.619102.55
45min1159998-159998105.356100.003.51110.55104.943.47
2153399-153399101.010105.73
3148993-14899398.109102.72
4148960-14896098.087102.95
5154889-154889101.992107.25
6144957-14495795.452100.47
60min1155884-155884102.64797.343.56109.02103.403.58
2145563-14556395.851101.70
3144730-14473095.302101.00
4142789-14278994.02499.98
5152878-152878100.667107.06
6145094-14509495.542101.63
极限1156851-156851103.28497.213.13110.79104.353.10
2147245-14724596.958103.87
3144439-14443995.110101.87
4145707-14570795.945102.95
5146077-14607796.189103.70
6145465-14546595.786102.93
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
110.181362859136095113669861366701136138313637760.22
210.191368833136934513690890.03
单位质量响应值RSD%判断
133966.21134356.130.21数据可信
供试品溶液-2025011111批-厄贝沙坦-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%
5min126377-263771.7691.8425.421.771.8425.41
218306-183061.2281.23
321823-218231.4641.46
428156-281561.8891.89
537286-372862.5012.50
632966-329662.2112.21
10min159788-597884.0114.1814.314.034.2014.35
259135-591353.9673.98
348913-489133.2813.30
462378-623784.1854.21
575273-752735.0505.08
668027-680274.5634.59
15min187433-874335.8655.838.455.935.908.53
277818-778185.2205.28
379374-793745.3255.38
488437-884375.9336.00
597274-972746.5256.61
691377-913776.1306.21
20min1100809-1008096.7636.905.056.897.035.19
296736-967366.4896.61
398539-985396.6106.72
4104170-1041706.9887.12
5110897-1108977.4397.60
6105627-1056277.0867.23
30min1118493-1184937.9498.054.148.158.264.27
2113023-1130237.5827.77
3116072-1160727.7877.97
4121905-1219058.1788.39
5125299-1252998.4068.64
6124991-1249918.3858.61
45min1132936-1329368.9189.082.549.219.382.64
2133878-1338788.9819.25
3133034-1330348.9249.20
4137825-1378259.2469.55
5141296-1412969.4799.81
6133371-1333718.9479.26
60min1140426-1404269.4209.522.709.819.922.85
2137133-1371339.1999.57
3139290-1392909.3449.72
4142505-1425059.5609.96
5148016-1480169.92910.37
6143808-1438089.64710.06
极限1148765-1487659.9809.911.4510.4810.421.51
2145473-1454739.75910.23
3146177-1461779.80610.28
4150043-15004310.06510.58
5146006-1460069.79510.34
6150169-15016910.07410.60
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2000
标示量(mg)10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%
114.181390101387701379871379271383551384100.35
214.241385311388391386850.16
单位质量响应值RSD%判断
9760.939739.120.16数据可信
供试品溶液-2025011211批-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%
5min1104067-10406769.20159.5318.4569.2059.5318.45
261054-6105440.59940.60
3105922-10592270.43470.43
483246-8324655.35655.36
595021-9502163.18663.19
687802-8780258.38558.39
10min1149813-14981399.620102.553.66100.39103.213.71
2147246-14724697.91398.36
3162259-162259107.896108.68
4155056-155056103.107103.72
5158833-158833105.618106.32
6152135-152135101.164101.81
15min1162367-162367107.968107.291.46109.84109.091.44
2163258-163258108.561110.10
3160917-160917107.004108.99
4157300-157300104.599106.36
5163746-163746108.885110.76
6160494-160494106.723108.50
20min1160369-160369106.640106.242.52109.72109.242.49
2162634-162634108.146110.89
3163386-163386108.646111.82
4156865-156865104.310107.23
5162271-162271107.904110.99
6153100-153100101.806104.76
30min1158981-158981105.717106.691.67109.98110.871.61
2163009-163009108.395112.34
3161619-161619107.471111.85
4155747-155747103.566107.65
5161121-161121107.140111.42
6162229-162229107.877111.97
45min1157666-157666104.842104.861.47110.28110.221.43
2158669-158669105.509110.66
3156939-156939104.359109.93
4157269-157269104.578109.81
5161353-161353107.294112.77
6154304-154304102.607107.90
60min1158100-158100105.131103.801.53111.73110.331.47
2157529-157529104.751111.07
3153706-153706102.209108.94
4153487-153487102.063108.46
5158969-158969105.709112.38
6154826-154826102.954109.38
极限1154070-154070102.451102.603.29110.22110.273.12
2159542-159542106.090113.58
3158411-158411105.338113.20
4148850-14885098.980106.51
5157271-157271104.580112.42
6147586-14758698.139105.71
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
110.181349002135090713485091350213134722113491700.11
210.191353814135182813528210.11
单位质量响应值RSD%判断
132531.43132759.670.13数据可信
供试品溶液-2025011211批-厄贝沙坦-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%
5min138922-389222.6411.8627.222.641.8627.13
217205-172051.1671.17
332500-325002.2052.21
424102-241021.6351.64
526312-263121.7851.79
625530-255301.7321.73
10min166992-669924.5454.5911.004.574.6011.01
255642-556423.7753.79
377480-774805.2575.28
466715-667154.5274.54
573074-730744.9584.98
665584-655844.4504.47
15min194399-943996.4056.374.976.486.445.05
285570-855705.8065.86
398295-982956.6696.75
492185-921856.2556.32
597812-978126.6376.71
695028-950286.4486.52
20min1106948-1069487.2567.5210.347.417.6610.24
2102977-1029776.9877.11
3133759-1337599.0769.23
4106811-1068117.2477.39
5109794-1097947.4507.60
6104839-1048397.1137.25
30min1121862-1218628.2688.503.448.508.733.46
2119558-1195588.1128.31
3128442-1284428.7158.97
4123880-1238808.4058.62
5127326-1273268.6398.87
6130925-1309258.8839.10
45min1145156-1451569.8499.433.6010.179.743.58
2131669-1316698.9349.22
3137932-1379329.3599.71
4140765-1407659.5519.86
5142761-1427619.68610.01
6135175-1351759.1729.49
60min1143935-1439359.7669.781.8910.2010.201.89
2140116-1401169.5079.89
3141600-1416009.60810.07
4146549-1465499.94310.36
5146659-1466599.95110.39
6145642-1456429.88210.30
极限1148035-14803510.04410.112.5210.5910.652.51
2147840-14784010.03110.52
3151678-15167810.29110.86
4147914-14791410.03610.56
5154847-15484710.50611.05
6143930-1439309.76610.30
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