缬沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.071151101150011150061152461151121150950.09
214.091156731156981156860.02
单位质量响应值RSD%判断
8180.178210.500.27数据可信
供试品溶液-2024081921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%
5min174116-7411657.10057.953.3357.1057.953.33
275010-7501057.78957.79
370970-7097054.67654.68
477857-7785759.98259.98
577287-7728759.54359.54
676061-7606158.59958.60
10min1109410-10941084.29183.771.1884.3983.871.19
2108099-10809983.28183.38
3107018-10701882.44882.54
4109441-10944184.31584.42
5107927-10792783.14983.25
6110540-11054085.16285.26
15min1122318-12231894.23693.570.9194.4793.800.91
2121114-12111493.30893.54
3121129-12112993.32093.55
4121942-12194293.94694.19
5119587-11958792.13292.37
6122595-12259594.44994.69
20min1125468-12546896.66397.802.1697.0698.192.16
2126854-12685497.73098.12
3125003-12500396.30496.69
4129064-12906499.43399.83
5124028-12402895.55395.94
6131252-131252101.119101.52
30min1130021-130021100.170100.741.44100.72101.291.44
2129310-12931099.622100.18
3129987-129987100.144100.69
4133036-133036102.493103.06
5128985-12898599.37299.92
6133205-133205102.623103.19
45min1131783-131783101.528101.901.34102.25102.621.34
2132182-132182101.835102.55
3131908-131908101.624102.34
4131486-131486101.299102.03
5130564-130564100.589101.30
6135688-135688104.536105.27
60min1131293-131293101.150101.221.10102.04102.121.10
2128834-12883499.256100.15
3130865-130865100.820101.70
4132686-132686102.223103.13
5132013-132013101.705102.59
6132623-132623102.175103.09
极限1129289-12928999.606102.371.45100.66103.431.44
2133661-133661102.975104.03
3132702-132702102.236103.28
4134677-134677103.757104.83
5132749-132749102.272103.33
6134161-134161103.360104.44
缬沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.944631397462812146296854627863462788446289900.04
215.954663667466759046656280.06
单位质量响应值RSD%判断
290400.88292515.860.52数据可信
供试品溶液-2024081921批-缬沙坦-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%
5min14572697-457269787.45886.721.5687.4686.721.56
24580121-458012187.60087.60
34437443-443744384.87184.87
44618952-461895288.34288.34
54466235-446623585.42185.42
64528792-452879286.61886.62
10min15183219-518321999.13598.661.2699.2898.801.26
25148608-514860898.47398.62
35100361-510036197.55097.69
45233320-5233320100.093100.24
55069073-506907396.95197.09
65215894-521589499.75999.90
15min15278875-5278875100.964100.561.19101.28100.881.19
25232473-5232473100.077100.39
35225455-522545599.942100.25
45316149-5316149101.677101.99
55164835-516483598.78399.09
65329730-5329730101.937102.25
20min15282104-5282104101.026100.651.25101.51101.121.25
25235529-5235529100.135100.61
35233648-5233648100.099100.57
45322249-5322249101.794102.28
55162073-516207398.73099.20
65338282-5338282102.100102.58
30min15282250-5282250101.029100.691.22101.68101.331.22
25240580-5240580100.232100.88
35237303-5237303100.169100.81
45315596-5315596101.666102.32
55165685-516568598.79999.43
65345208-5345208102.233102.88
45min15278538-5278538100.958100.551.16101.77101.361.16
25233493-5233493100.096100.91
35231183-5231183100.052100.86
45305173-5305173101.467102.29
55163228-516322898.75299.55
65331428-5331428101.969102.79
60min15264965-5264965100.698100.331.19101.68101.311.19
25217248-521724899.785100.76
35218933-521893399.818100.79
45298307-5298307101.336102.33
55152757-515275798.55299.51
65323514-5323514101.818102.81
极限15251276-5251276100.436100.161.20101.59101.301.20
25215700-521570099.756100.90
35212582-521258299.696100.83
45285346-5285346101.088102.25
55138200-513820098.27399.40
65316529-5316529101.684102.84
缬沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.071149361148441146551148211148191148150.09
214.091152691152551152620.01
单位质量响应值RSD%判断
8160.278180.410.18数据可信
供试品溶液-2024082021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%
5min172143-7214355.75055.611.8855.7555.611.87
273086-7308656.47956.48
370910-7091054.79754.80
473828-7382857.05257.05
570219-7021954.26354.26
671593-7159355.32555.33
10min1107766-10776683.27881.571.5783.3781.661.57
2104906-10490681.06881.16
3107367-10736782.97083.06
4105221-10522181.31281.41
5103609-10360980.06680.16
6104445-10444580.71280.80
15min1121348-12134893.77492.591.2594.0192.821.25
2118393-11839391.49191.72
3121574-12157493.94994.18
4118155-11815591.30791.54
5120425-12042593.06193.28
6119032-11903291.98592.21
20min1127487-12748798.51896.911.2398.9197.301.22
2123218-12321895.21995.60
3125853-12585397.25697.64
4125062-12506296.64497.03
5126477-12647797.73898.12
6124346-12434696.09196.47
30min1131324-131324101.48399.432.91102.0499.982.90
2128037-12803798.94399.48
3133335-133335103.037103.59
4127845-12784598.79599.34
5129093-12909399.759100.30
6122363-12236394.55995.10
45min1131121-131121101.32799.432.18102.05100.142.17
2130413-130413100.779101.48
3130224-130224100.633101.35
4125973-12597397.34898.06
5129926-129926100.403101.11
6124313-12431396.06696.76
60min1132129-132129102.10699.302.32103.00100.182.31
2131829-131829101.874102.75
3125227-12522796.77297.66
4126383-12638397.66598.54
5129083-12908399.752100.63
6126366-12636697.65298.51
极限1131771-131771101.829100.932.28102.89101.972.27
2131777-131777101.834102.88
3135342-135342104.588105.64
4129495-129495100.070101.10
5127312-12731298.38399.42
6127968-12796898.89099.91
缬沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.944625685463012246281984631310462889246288410.05
215.954659899466313746615180.05
单位质量响应值RSD%判断
290391.53292258.180.46数据可信
供试品溶液-2024082021批-缬沙坦-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%
5min14487640-448764085.87083.271.9485.8783.271.94
24372120-437212083.65983.66
34357346-435734683.37783.38
44343032-434303283.10383.10
54225987-422598780.86380.86
64325047-432504782.75982.76
10min15133033-513303398.21997.591.2898.3697.731.28
25116042-511604297.89498.03
35207713-520771399.64899.79
45041241-504124196.46396.60
55052274-505227496.67496.81
65051217-505121796.65496.79
15min15247316-5247316100.406100.241.58100.71100.541.58
25263084-5263084100.708101.01
35386697-5386697103.073103.38
45165160-516516098.83499.13
55189799-518979999.30699.60
65179385-517938599.10699.41
20min15247530-5247530100.410100.311.43100.88100.781.43
25253847-5253847100.531101.00
35380700-5380700102.958103.44
45172391-517239198.97299.44
55213155-521315599.752100.21
65187407-518740799.26099.72
30min15244719-5244719100.356100.251.41101.00100.881.41
25254399-5254399100.542101.18
35373502-5373502102.821103.47
45169915-516991598.92599.55
55208474-520847499.663100.29
65182482-518248299.16699.80
45min15236972-5236972100.208100.281.38101.02101.091.38
25268997-5268997100.821101.63
35369894-5369894102.752103.57
45170743-517074398.94199.73
55212219-521221999.735100.53
65186939-518693999.251100.05
60min15234963-5234963100.170100.221.83101.15101.191.82
25244923-5244923100.360101.33
35419519-5419519103.701104.69
45155417-515541798.64899.61
55194357-519435799.393100.35
65176714-517671499.055100.02
极限15230548-5230548100.08599.851.59101.23100.981.59
25239015-5239015100.247101.39
35358012-5358012102.524103.69
45148099-514809998.50899.63
55210840-521084099.708100.83
65122115-512211598.01099.14
缬沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.071153391154061148091146971148331150170.29
214.091148531150951149740.15
单位质量响应值RSD%判断
8174.638159.970.13数据可信
供试品溶液-2024082121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%
5min173880-7388057.11457.974.2357.1157.974.23
269236-6923653.52353.52
377371-7737159.81259.81
475937-7593758.70458.70
577993-7799360.29360.29
675505-7550558.37058.37
10min1111166-11116685.93883.881.3886.0383.971.38
2106950-10695082.67982.77
3108878-10887884.16984.27
4108487-10848783.86783.96
5108240-10824083.67683.78
6107283-10728382.93683.03
15min1121191-12119193.68892.821.7993.9393.061.79
2119702-11970292.53792.76
3121488-12148893.91794.16
4122279-12227994.52994.77
5119472-11947292.35992.60
6116271-11627189.88490.12
20min1129258-12925899.92496.622.17100.3297.022.16
2125222-12522296.80497.19
3123964-12396495.83196.23
4126153-12615397.52497.92
5121069-12106993.59393.99
6124274-12427496.07196.46
30min1132888-132888102.73099.691.62103.29100.251.61
2128237-12823799.13599.68
3129283-12928399.943100.50
4128581-12858199.40199.96
5126897-12689798.09998.65
6127881-12788198.86099.40
45min1132220-132220102.21498.633.47102.9599.353.45
2127726-12772698.74099.45
3119950-11995092.72893.45
4130398-130398100.805101.53
5129828-129828100.365101.08
6125383-12538396.92897.64
60min1133235-133235102.998100.472.85103.90101.352.83
2131029-131029101.293102.17
3129042-12904299.757100.63
4133041-133041102.849103.74
5130248-130248100.689101.57
6123177-12317795.22396.09
极限1132049-132049102.082102.212.94103.16103.262.91
2134021-134021103.606104.65
3125745-12574597.20898.25
4137235-137235106.091107.15
5130562-130562100.932101.98
6133691-133691103.351104.38
缬沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.944657890466124246527424639951464301546509680.20
215.954658098466248446602910.07
单位质量响应值RSD%判断
291779.67292181.250.10数据可信
供试品溶液-2024082121批-缬沙坦-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%
5min14618397-461839788.17388.141.6988.1788.141.69
24473585-447358585.40885.41
34671159-467115989.18089.18
44685287-468528789.45089.45
54655972-465597288.89088.89
64596106-459610687.74787.75
10min15220301-522030199.66498.930.9199.8199.080.91
25137265-513726598.07998.22
35140780-514078098.14698.29
45249082-5249082100.213100.36
55196314-519631499.20699.35
65148626-514862698.29698.44
15min15367404-5367404102.472100.411.33102.79100.721.33
25242563-5242563100.089100.39
35188443-518844399.05699.37
45313184-5313184101.437101.75
55251689-5251689100.263100.58
65193858-519385899.15999.47
20min15309964-5309964101.376100.381.09101.86100.861.08
25253257-5253257100.293100.77
35188945-518894599.06599.54
45335311-5335311101.860102.34
55252320-5252320100.275100.76
65206824-520682499.40799.88
30min15302222-5302222101.228100.371.04101.88101.011.04
25285298-5285298100.905101.54
35186532-518653299.01999.66
45318313-5318313101.535102.19
55250542-5250542100.241100.89
65199908-519990899.27599.92
45min15292085-5292085101.034100.630.60101.86101.440.60
25252513-5252513100.279101.09
35277220-5277220100.751101.56
45319023-5319023101.549102.37
55245579-5245579100.147100.96
65238350-5238350100.009100.82
60min15343549-5343549102.017100.241.26103.01101.221.25
25244045-5244045100.117101.09
35178077-517807798.85899.83
45307123-5307123101.322102.31
55244132-5244132100.119101.10
65184352-518435298.97899.95
极限15295808-5295808101.106100.441.09102.27101.591.09
25259887-5259887100.420101.56
35186993-518699399.028100.17
45333666-5333666101.828102.99
55288316-5288316100.962102.11
65201169-520116999.299100.44
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