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%
1 13.971259481261171263281259561259201260540.14
2 13.941263041262391262720.04
单位质量响应值RSD%判断
9023.199058.250.28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%
15min1413572-413572288.829307.535.44288.83307.535.44
2418404-418404292.203292.20
3458266-458266320.042320.04
4469574-469574327.939327.94
5425411-425411297.097297.10
6456847-456847319.051319.05
5min1113921-11392179.56077.804.3980.0478.324.36
2115333-11533380.54681.03
3117156-11715681.81982.35
4107444-10744475.03675.58
5104536-10453673.00573.50
6110059-11005976.86377.39
10min1121551-12155184.88888.023.1785.5088.673.16
2131111-13111191.56592.19
3128579-12857989.79690.47
4128809-12880989.95790.63
5122012-12201285.21085.83
6124186-12418686.72887.39
20min1125168-12516887.41487.652.7588.1788.442.72
2128662-12866289.85490.63
3125772-12577287.83688.66
4127576-12757689.09689.92
5126919-12691988.63789.40
6118954-11895483.07583.88
30min1127032-12703288.71686.914.2789.6287.844.23
2130175-13017590.91191.83
3125268-12526887.48488.45
4125072-12507287.34788.32
5114444-11444479.92580.83
6124662-12466287.06188.00
45min1125810-12581087.86388.103.3888.9189.183.34
2132956-13295692.85393.93
3123268-12326886.08787.20
4129014-12901490.10091.22
5124747-12474787.12088.16
6121089-12108984.56685.65
60min1121541-12154184.88186.971.3986.0888.201.39
2124878-12487887.21288.44
3126485-12648588.33489.59
4124749-12474987.12288.39
5123847-12384786.49287.68
6125727-12572787.80589.03
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%
116.324871933487143748621474864226486393948667360.10
216.384881890488504348834660.05
单位质量响应值RSD%判断
298206.86298135.900.02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%
15min12927368-292736854.72855.8812.0654.7355.8812.06
22700067-270006750.47850.48
33184034-318403459.52659.53
43559431-355943166.54466.54
52544221-254422147.56547.56
63018719-301871956.43656.44
5min15017440-501744093.80290.564.2593.8990.654.25
24978406-497840693.07293.16
34915978-491597891.90592.00
44948175-494817592.50792.62
54723896-472389688.31488.39
64479383-447938383.74383.84
10min15201777-520177797.24895.283.0397.5095.533.03
25257100-525710098.28398.52
35069373-506937394.77395.03
45206736-520673697.34197.61
54988349-498834993.25893.48
64856929-485692990.80191.03
20min15228484-522848497.74895.962.6598.1696.372.65
25296796-529679699.02599.43
35074255-507425594.86495.27
45225156-522515697.68598.11
55014874-501487493.75494.14
64959202-495920292.71393.10
30min15227632-522763297.73296.102.5198.3096.662.51
25301370-530137099.11099.68
35071364-507136494.81095.38
45229642-522964297.76998.36
55014715-501471593.75194.29
64996661-499666193.41493.95
45min15215418-521541897.50396.082.4498.2496.812.44
25308924-530892499.25199.98
35068878-506887894.76495.49
45218413-521841397.55998.31
55025840-502584093.95994.65
64999718-499971893.47194.17
60min15231490-523149097.80496.352.4998.7097.232.49
25330377-533037799.652100.55
35072439-507243994.83095.71
45231012-523101297.79598.71
55043086-504308694.28295.13
65012479-501247993.70994.56
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%
1 13.971258851261231257951256731255361258020.18
2 13.941254121256571255340.14
单位质量响应值RSD%判断
9005.159005.310.01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%
15min1454124-454124318.398308.684.82318.40308.684.82
2453613-453613318.040318.04
3456095-456095319.780319.78
4402779-402779282.399282.40
5447558-447558313.794313.79
6427408-427408299.667299.67
5min1113818-11381879.80177.373.8180.3377.883.78
2106370-10637074.57975.11
3114293-11429380.13480.67
4110529-11052977.49577.97
5104164-10416473.03273.56
6112914-11291479.16779.67
10min1131776-13177692.39289.361.8693.0690.001.86
2125103-12510387.71388.37
3127546-12754689.42690.09
4126604-12660488.76589.37
5127880-12788089.66090.30
6125779-12577988.18788.82
20min1127800-12780089.60487.253.0290.4288.042.98
2125095-12509587.70788.51
3119999-11999984.13484.95
4127012-12701289.05189.80
5119501-11950183.78584.58
6127245-12724589.21589.99
30min1127436-12743689.34988.503.3090.3289.443.28
2126200-12620088.48289.43
3124011-12401186.94787.90
4122829-12282986.11987.01
5133862-13386293.85494.79
6122986-12298686.22987.16
45min1138556-13855697.14589.034.7798.2690.124.73
2124091-12409187.00388.10
3125082-12508287.69888.80
4126473-12647388.67389.71
5126799-12679988.90289.99
6120908-12090884.77285.84
60min1123518-12351886.60288.303.2987.8889.533.24
2131922-13192292.49493.73
3127997-12799789.74290.99
4124494-12449487.28688.47
5120053-12005384.17285.41
6127639-12763989.49190.70
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%
116.324862897486502048621564858715485969348616960.06
216.384856811485059648537040.10
单位质量响应值RSD%判断
297898.04296318.930.38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%
15min12979415-297941555.90053.1510.8555.9053.1510.85
22974178-297417855.80255.80
33127698-312769858.68358.68
42371637-237163744.49744.50
53021068-302106856.68256.68
62523693-252369347.35047.35
5min15018333-501833394.15593.661.3694.2593.751.35
24975339-497533993.34893.44
35064692-506469295.02595.12
45062029-506202994.97595.05
54917047-491704792.25592.35
64914526-491452692.20792.29
10min15243038-524303898.37197.800.8798.6298.050.87
25172956-517295697.05697.30
35259960-525996098.68998.94
45251435-525143598.52998.76
55151979-515197996.66396.91
65197760-519776097.52297.75
20min15256922-525692298.63298.040.8699.0598.450.85
25187988-518798897.33897.75
35266255-526625598.80799.23
45257685-525768598.64699.04
55156187-515618796.74297.15
65227899-522789998.08798.48
30min15267178-526717898.82498.230.8699.4098.800.86
25205954-520595497.67598.25
35271238-527123898.90099.49
45272081-527208198.91699.48
55161324-516132496.83897.41
65235772-523577298.23598.79
45min15269903-526990398.87598.220.8199.6298.960.81
25211421-521142197.77898.51
35271517-527151798.90599.66
45263058-526305898.74799.47
55164238-516423896.89397.62
65230230-523023098.13198.85
60min15274824-527482498.96798.260.9199.8899.160.90
25211231-521123197.77498.67
35278139-527813999.03099.94
45268926-526892698.85799.75
55157432-515743296.76597.66
65231206-523120698.14999.03
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%
1 13.971255241250371253441254331251311252940.17
2 13.941273681271371272520.13
单位质量响应值RSD%判断
8968.799128.551.25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%
15min1436095-436095304.313298.064.12304.31298.064.12
2449387-449387313.589313.59
3427024-427024297.983297.98
4430411-430411300.347300.35
5396367-396367276.590276.59
6423562-423562295.567295.57
5min1129213-12921390.16784.024.5490.6784.524.52
2114530-11453079.92180.44
3124274-12427486.72087.22
4120204-12020483.88084.38
5116856-11685681.54482.00
6117367-11736781.90082.39
10min1125549-12554987.61088.712.8488.2789.352.80
2124743-12474387.04787.70
3129461-12946190.34090.98
4127507-12750788.97689.62
5132756-13275692.63993.24
6122729-12272985.64286.27
20min1132062-13206292.15588.063.4692.9688.843.43
2122885-12288585.75186.55
3123792-12379286.38487.18
4128309-12830989.53690.32
5129341-12934190.25691.01
6120748-12074884.26085.03
30min1123021-12302185.84687.382.8186.8088.322.77
2122571-12257185.53286.48
3128964-12896489.99390.93
4124031-12403186.55187.49
5130370-13037090.97491.88
6122401-12240185.41386.33
45min1127419-12741988.91588.671.9390.0189.751.92
2126268-12626888.11289.20
3128919-12891989.96191.05
4130672-13067291.18592.27
5124895-12489587.15388.21
6124227-12422786.68787.74
60min1128516-12851689.68088.171.6790.9389.391.65
2124728-12472887.03788.27
3124518-12451886.89088.13
4127314-12731488.84190.08
5128790-12879089.87191.07
6124210-12421086.67587.87
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%
116.324850906484893848478544850305484566848487340.05
216.384914689491251249136000.04
单位质量响应值RSD%判断
297103.80299975.580.69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%
15min13501816-350181665.38855.1415.9465.3955.1415.94
23411797-341179763.70763.71
32995035-299503555.92555.93
42960647-296064755.28355.28
52294853-229485342.85142.85
62552692-255269247.66547.67
5min15106988-510698895.36190.964.9095.4791.054.90
24845071-484507190.47090.58
34990487-499048793.18593.28
44677580-467758087.34287.43
55092702-509270295.09495.17
64513883-451388384.28684.37
10min15321230-532123099.36195.534.6299.6395.774.62
25089679-508967995.03795.29
35212404-521240497.32997.58
44972966-497296692.85893.10
55363938-5363938100.159100.39
64734996-473499688.41588.63
20min15329866-532986699.52295.874.5799.9696.274.57
25111783-511178395.45095.87
35239169-523916997.82998.24
44997420-499742093.31593.71
55376409-5376409100.391100.79
64749687-474968788.68989.06
30min15319053-531905399.32095.714.4699.9296.274.46
25104105-510410595.30795.88
35224474-522447497.55498.13
44991025-499102593.19593.74
55362215-5362215100.126100.69
64753062-475306288.75289.27
45min15320175-532017599.34195.764.43100.1196.484.43
25108286-510828695.38596.12
35216774-521677497.41198.15
44993617-499361793.24493.95
55370286-5370286100.277101.01
64759725-475972588.87689.54
60min15309613-530961399.14495.734.35100.0796.624.35
25099025-509902595.21296.10
35227286-522728697.60798.51
44999574-499957493.35594.21
55363216-5363216100.145101.04
64763374-476337488.94489.76
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