培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.024289142999429914307243018429940.16
210.024297843043430100.11
单位质量响应值RSD%判断
4290.824292.420.03数据可信
供试品溶液-2022081001批-培哚普利-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%
5min148935-4893597.28696.850.5397.2996.850.53
248437-4843796.29696.30
349038-4903897.49197.49
448414-4841496.25096.25
548658-4865896.73596.74
648798-4879897.01397.01
10min149815-4981599.03597.770.99100.1298.840.98
248513-4851396.44797.52
349428-4942898.26699.35
448719-4871996.85697.93
549204-4920497.82198.90
649380-4938098.17199.25
15min149572-4957298.55297.390.76100.7399.550.76
248460-4846096.34198.48
349010-4901097.43599.61
448774-4877496.96699.11
549119-4911997.65299.81
648995-4899597.40599.57
20min149228-4922897.86896.190.97101.1499.440.95
248028-4802895.48398.69
347897-4789795.22298.48
448489-4848996.39999.62
548347-4834796.11799.36
648326-4832696.07599.33
30min147965-4796595.35794.601.0999.7298.911.07
246609-4660992.66296.93
347830-4783095.08999.40
448011-4801195.44999.74
547534-4753494.50198.82
647554-4755494.54098.86
45min147803-4780395.03594.070.69100.4699.430.69
246845-4684593.13198.43
347408-4740894.25099.62
447175-4717593.78799.14
547206-4720693.84899.21
647468-4746894.36999.74
极限147258-4725893.95292.951.10100.4399.361.07
245931-4593191.31497.65
346396-4639692.23898.66
446760-4676092.96299.36
547221-4722193.878100.29
646944-4694493.32899.75
培哚普利氨氯地平片项目信息
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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.871656471656091656201655331655091655840.04
213.901657601656511657060.05
单位质量响应值RSD%判断
11938.2811921.290.11数据可信
供试品溶液-2022081001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%
5min196187-9618752.26753.393.5352.2753.393.53
2104844-10484456.97156.97
397082-9708252.75352.75
498041-9804153.27453.27
598415-9841553.47853.48
694986-9498651.61451.61
10min1136820-13682074.34672.761.8574.9373.351.86
2136144-13614473.97974.61
3132346-13234671.91572.50
4132817-13281772.17172.76
5134898-13489873.30273.90
6130365-13036570.83971.41
15min1147793-14779380.30978.431.7181.7279.841.71
2145995-14599579.33280.79
3143307-14330777.87179.26
4142281-14228177.31478.71
5145376-14537678.99680.40
6141287-14128776.77478.13
20min1150511-15051181.78680.151.5084.0982.421.51
2148855-14885580.88683.22
3146425-14642579.56681.82
4147099-14709979.93282.18
5148056-14805680.45282.74
6144045-14404578.27280.49
30min1148670-14867080.78680.781.1583.9983.941.12
2148412-14841280.64583.88
3151431-15143182.28685.42
4147646-14764680.22983.37
5149402-14940281.18384.36
6146401-14640179.55382.64
45min1153607-15360783.46882.471.5887.5786.531.53
2150873-15087381.98386.11
3155551-15555184.52588.57
4149111-14911181.02585.06
5151490-15149082.31886.40
6150005-15000581.51185.48
极限1163226-16322688.69587.501.1993.7392.481.12
2159519-15951986.68191.72
3160099-16009986.99691.98
4158558-15855886.15991.09
5161970-16197088.01393.01
6162799-16279988.46393.34
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.024308242978431924303443169430910.21
210.024314343066431040.13
单位质量响应值RSD%判断
4300.504301.800.03数据可信
供试品溶液-2022081001批-培哚普利-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%
5min148639-4863996.48396.062.1296.4896.062.12
248636-4863696.47796.48
348727-4872796.65896.66
449498-4949898.18798.19
546451-4645192.14392.14
648591-4859196.38896.39
10min149187-4918797.57098.201.2998.6499.261.28
249577-4957798.34499.42
348766-4876696.73597.81
450451-50451100.077101.17
550011-5001199.205100.23
649020-4902097.23998.31
15min148560-4856096.32697.241.3998.4899.391.36
248605-4860596.41698.58
348464-4846496.13698.28
449876-4987698.937101.14
549897-4989798.979101.10
648711-4871196.62698.78
20min148943-4894397.08696.750.44100.3199.990.45
248647-4864796.49999.73
348561-4856196.32899.55
449039-4903997.277100.58
548907-4890797.015100.24
648551-4855196.30999.53
30min147698-4769894.61695.050.7398.9299.360.72
247434-4743494.09398.40
347816-4781694.85199.14
448330-4833095.870100.25
548301-4830195.813100.12
647916-4791695.04999.34
45min147229-4722993.68693.910.9099.0499.280.87
246868-4686892.97098.32
347023-4702393.27798.62
447753-4775394.726100.17
547953-4795395.122100.49
647231-4723193.69099.04
极限146829-4682992.89393.340.9099.2999.750.88
246857-4685792.94899.33
346988-4698893.20899.59
447741-4774194.702101.20
547332-4733293.890100.32
646565-4656592.36998.76
培哚普利氨氯地平片项目信息
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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.871655731655841655871655231655161655570.03
213.901654871656771655820.09
单位质量响应值RSD%判断
11936.3411912.370.15数据可信
供试品溶液-2022081001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%
5min191809-9180949.91149.815.4949.9149.815.49
288783-8878348.26648.27
396425-9642552.42052.42
494492-9449251.36951.37
583022-8302245.13445.13
695227-9522751.76951.77
10min1132032-13203271.77774.642.5672.3375.192.55
2133856-13385672.76973.31
3139727-13972775.96176.54
4137977-13797775.00975.58
5140423-14042376.33976.84
6139757-13975775.97776.55
15min1144625-14462578.62381.033.5179.9882.423.46
2142268-14226877.34278.69
3150471-15047181.80283.23
4148707-14870780.84382.25
5157045-15704585.37586.73
6151191-15119182.19383.61
20min1148523-14852380.74382.943.3982.9785.233.35
2145765-14576579.24381.45
3154964-15496484.24486.58
4151423-15142382.31984.62
5160348-16034887.17189.47
6154414-15441483.94586.28
30min1149518-14951881.28383.603.8684.4186.813.80
2146252-14625279.50882.59
3156306-15630684.97488.25
4152731-15273183.03086.25
5163402-16340288.83192.10
6154462-15446283.97187.24
45min1150452-15045281.79184.593.9185.8288.723.84
2148874-14887480.93384.90
3156791-15679185.23789.45
4155207-15520784.37688.52
5166119-16611990.30894.56
6156109-15610984.86789.06
极限1162296-16229688.23088.711.5193.1693.781.53
2160322-16032287.15792.02
3163289-16328988.77093.93
4165787-16578790.12895.21
5166296-16629690.40595.66
6161052-16105287.55492.70
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