缬沙坦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)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%
114.012434052444852438042436382433832437430.19
214.032421402418902420150.08
单位质量响应值RSD%判断
17397.7917249.820.61数据可信
供试品溶液-1批-氨氯地平-pH3.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160752-6075222.73431.2028.5222.7331.2028.52
264608-6460824.17724.18
359863-5986322.40122.40
4103904-10390438.88138.88
5106415-10641539.82139.82
6104769-10476939.20539.20
10min185500-8550031.99442.7125.7632.0342.7625.76
289029-8902933.31533.36
387509-8750932.74632.78
4138838-13883851.95452.02
5143293-14329353.62153.69
6140572-14057252.60352.67
15min1100950-10095037.77649.0823.8737.8749.2023.87
2104650-10465039.16039.26
3102288-10228838.27738.37
4157591-15759158.97159.12
5161169-16116960.31060.47
6160301-16030159.98560.14
20min1112171-11217141.97554.1422.2842.1354.3522.29
2117960-11796044.14144.30
3115988-11598843.40343.56
4170762-17076263.90064.15
5176910-17691066.20066.46
6174334-17433465.23665.49
30min1130199-13019948.72160.4819.5848.9560.7719.61
2134983-13498350.51150.75
3133149-13314949.82550.05
4188921-18892170.69571.05
5192009-19200971.85072.22
6190431-19043171.26071.62
45min1147330-14733055.13166.8916.9755.4467.2917.00
2153825-15382557.56257.88
3152369-15236957.01757.33
4204009-20400976.34176.81
5208504-20850478.02378.51
6206498-20649877.27277.75
60min1160062-16006259.89670.8814.8260.2971.3914.87
2167419-16741962.64963.06
3164233-16423361.45761.86
4213971-21397180.06980.67
5216308-21630880.94381.56
6214556-21455680.28880.90
90min1176375-17637566.00075.8112.1766.5076.4312.24
2182340-18234068.23268.75
3181861-18186168.05368.56
4222789-22278983.36884.10
5226818-22681884.87685.63
6225297-22529784.30785.05
120min1188231-18823170.43778.7110.2171.0479.4610.29
2193305-19330572.33572.97
3190928-19092871.44672.07
4228535-22853585.51986.39
5231499-23149986.62887.52
6229513-22951385.88586.77
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1193522-19352272.41780.009.0073.1480.899.10
2198147-19814774.14774.90
3197447-19744773.88574.63
4228537-22853785.51986.54
5234362-23436287.69988.74
6230728-23072886.33987.37
缬沙坦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)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%
114.012430002437292435372449542446092439660.33
214.032419032416742417880.07
单位质量响应值RSD%判断
17413.7017233.640.74数据可信
供试品溶液-1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%
5min157706-5770621.59428.2231.8321.5928.2231.83
250008-5000818.71318.71
353179-5317919.90019.90
496060-9606035.94735.95
598909-9890937.01337.01
696557-9655736.13336.13
10min1107044-10704440.05748.6623.3240.0948.7123.33
299268-9926837.14737.18
3101335-10133537.92137.95
4156395-15639558.52558.58
5161758-16175860.53160.59
6154456-15445657.79957.86
15min1140540-14054052.59161.1117.9752.6961.2417.99
2132738-13273849.67249.76
3136824-13682451.20151.30
4188604-18860470.57770.73
5193939-19393972.57472.74
6187219-18721970.05970.22
20min1166460-16646062.29170.1013.7662.4870.3313.79
2161431-16143160.40960.58
3164031-16403161.38261.56
4209850-20985078.52878.80
5215042-21504280.47180.75
6207210-20721077.54077.81
30min1203340-20334076.09280.988.3676.3981.328.41
2197650-19765073.96374.24
3199747-19974774.74775.03
4232230-23223086.90387.31
5237835-23783589.00089.42
6227539-22753985.14785.55
45min1233188-23318887.26189.853.5087.6890.333.56
2232002-23200286.81787.22
3234660-23466087.81288.22
4246711-24671192.32292.87
5252901-25290194.63895.20
6241161-24116190.24590.79
60min1245975-24597592.04693.301.5792.6193.941.59
2249544-24954493.38293.93
3249646-24964693.42093.97
4249200-24920093.25393.96
5256314-25631495.91596.64
6245352-24535291.81392.51
90min1255667-25566795.67395.652.1396.3996.442.06
2260055-26005597.31598.02
3260868-26086897.61998.33
4251231-25123194.01394.87
5258686-25868696.80397.69
6247190-24719092.50193.35
120min1257225-25722596.25695.752.6297.1496.702.54
2260509-26050997.48598.35
3263420-26342098.57499.45
4250265-25026593.65294.67
5258257-25825796.64297.69
6245547-24554791.88692.89
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1255827-25582795.73395.672.4496.7796.772.37
2259730-25973097.19398.22
3263754-26375498.69999.74
4251224-25122494.01095.18
5257206-25720696.24997.45
6246153-24615392.11393.27
缬沙坦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)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%
114.012439422442662451432457092458822449880.36
214.032417202407622412410.29
单位质量响应值RSD%判断
17486.6517194.651.20数据可信
供试品溶液-1批-氨氯地平-pH5.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min175667-7566728.28938.4328.0728.2938.4328.06
278415-7841529.31629.32
375339-7533928.16628.17
4128906-12890648.19348.19
5129386-12938648.37248.37
6129042-12904248.24448.24
10min1141456-14145652.88561.9917.0352.9362.0517.04
2141893-14189353.04853.10
3136947-13694751.19951.25
4192954-19295472.13872.22
5189964-18996471.02071.10
6191618-19161871.63871.72
15min1184306-18430668.90575.6210.1969.0475.7910.21
2185558-18555869.37369.51
3180949-18094967.65067.78
4223897-22389783.70683.91
5220941-22094182.60182.80
6218021-21802181.50981.71
20min1210268-21026878.61183.016.5078.8683.306.53
2208449-20844977.93178.18
3207969-20796977.75178.00
4235157-23515787.91688.26
5236118-23611888.27588.61
6234185-23418587.55287.89
30min1244035-24403591.23590.882.1191.6291.322.15
2236670-23667088.48188.86
3238470-23847089.15489.53
4251109-25110993.88094.37
5243561-24356191.05891.54
6244714-24471491.48991.97
45min1255350-25535095.46593.641.6596.0094.221.60
2250466-25046693.63994.17
3254115-25411595.00395.53
4250671-25067193.71694.36
5248309-24830992.83393.47
6243883-24388391.17891.81
60min1265068-26506899.09895.592.6599.7996.332.58
2259949-25994997.18497.87
3259459-25945997.00197.68
4252047-25204794.23095.03
5249434-24943493.25394.04
6248153-24815392.77493.56
90min1269351-269351100.69996.403.03101.5697.302.96
2264530-26453098.89799.75
3257960-25796096.44197.28
4254996-25499695.33396.29
5250799-25079993.76494.71
6249498-24949893.27794.22
120min1266352-26635299.57896.092.88100.6097.152.81
2261171-26117197.64198.65
3262403-26240398.10299.11
4254087-25408794.99396.11
5250876-25087693.79294.89
6247312-24731292.46093.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1267335-26733599.94695.743.48101.1496.963.39
2262292-26229298.06099.24
3260587-26058797.42398.59
4254419-25441995.11796.39
5245440-24544091.76093.02
6246420-24642092.12693.38
缬沙坦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)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%
114.012452862461652471102460102461092461360.27
214.032372842380272376560.23
单位质量响应值RSD%判断
17568.5916939.132.58数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液批-氨氯地平-pH5.0(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min172909-7290927.40238.8331.6027.4038.8331.60
280669-8066930.31930.32
368417-6841725.71425.71
4125261-12526147.07847.08
5138768-13876852.15452.15
6133890-13389050.32150.32
10min1137610-13761051.71962.3218.6051.7662.3818.62
2148253-14825355.71955.77
3129648-12964848.72748.77
4184679-18467969.41069.49
5197782-19778274.33474.42
6196892-19689274.00074.08
15min1178392-17839267.04774.1011.3067.1874.2711.32
2189206-18920671.11171.25
3167314-16731462.88363.01
4207591-20759178.02178.21
5220209-22020982.76382.97
6220227-22022782.77082.98
20min1201373-20137375.68480.587.1275.9380.887.16
2212558-21255879.88880.15
3192936-19293672.51372.74
4218958-21895882.29382.62
5229414-22941486.22386.57
6231217-23121786.90087.25
30min1221977-22197783.42886.163.6583.8086.593.70
2233464-23346487.74588.14
3217327-21732781.68082.03
4227883-22788385.64786.11
5236480-23648088.87889.37
6238364-23836489.58690.08
45min1231106-23110686.85988.312.3387.3788.882.36
2241277-24127790.68191.22
3228147-22814785.74686.23
4231604-23160487.04687.65
5236967-23696789.06189.70
6240659-24065990.44991.09
60min1235407-23540788.47589.932.4189.1390.652.43
2244931-24493192.05592.75
3233225-23322587.65588.28
4234239-23423988.03688.79
5246451-24645192.62693.41
6241454-24145490.74891.54
90min1241416-24141690.73390.662.0591.5391.532.04
2249284-24928493.69194.54
3236760-23676088.98489.76
4235389-23538988.46889.36
5241736-24173690.85491.80
6242814-24281491.25992.20
120min1239223-23922389.90990.571.8590.8691.591.84
2248675-24867593.46294.46
3237563-23756389.28590.21
4236439-23643988.86389.91
5241079-24107990.60791.70
6242916-24291691.29792.39
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1256513-25651396.40896.131.7097.5197.301.64
2259927-25992797.69198.85
3260342-26034297.84798.92
4248698-24869893.47094.66
5253424-25342495.24796.49
6255765-25576596.12697.37
缬沙坦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)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%
114.012447562454152454872459272459482455070.20
214.032437252434762436000.08
单位质量响应值RSD%判断
17523.7017362.790.66数据可信
供试品溶液批-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%
5min144384-4438416.49524.1936.7416.4924.1936.74
244505-4450516.54016.54
341136-4113615.28815.29
489638-8963833.31333.31
586332-8633232.08532.08
684573-8457331.43131.43
10min183942-8394231.19641.3228.2631.2241.3628.27
282852-8285230.79130.82
380873-8087330.05630.08
4142349-14234952.90352.96
5139079-13907951.68851.74
6138064-13806451.31051.36
15min1110658-11065841.12551.9823.8541.2052.0823.88
2107611-10761139.99340.07
3110265-11026540.97941.05
4174742-17474264.94265.09
5168998-16899862.80762.95
6166847-16684762.00762.15
20min1132446-13244649.22360.1920.1049.3760.3820.13
2131889-13188949.01649.16
3132940-13294049.40649.55
4197546-19754673.41673.67
5190464-19046470.78471.03
6186443-18644369.29069.53
30min1162685-16268560.46170.1215.3860.6970.4115.41
2160634-16063459.69859.93
3163820-16382060.88261.11
4220804-22080482.06082.43
5213238-21323879.24879.61
6210802-21080278.34378.70
45min1195401-19540172.61978.9810.4172.9579.3910.48
2189735-18973570.51470.84
3193151-19315171.78372.11
4239798-23979889.11989.63
5229818-22981885.41085.90
6227215-22721584.44384.93
60min1211155-21115578.47484.067.5078.9384.607.57
2210928-21092878.39078.83
3211952-21195278.77079.22
4249288-24928892.64693.31
5239328-23932888.94489.58
6234393-23439387.11087.74
90min1232270-23227086.32188.534.2686.9089.214.35
2227899-22789984.69785.27
3230789-23078985.77186.35
4255175-25517594.83495.65
5243327-24332790.43191.22
6239753-23975389.10289.88
120min1244195-24419590.75391.452.4391.4892.292.49
2242062-24206289.96090.68
3244025-24402590.69091.41
4257248-25724895.60496.58
5247958-24795892.15293.09
6240999-24099989.56590.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1247052-24705291.81592.512.2492.6993.492.30
2245315-24531591.16992.04
3246131-24613191.47392.35
4259790-25979096.54997.68
5249632-24963292.77493.86
6245582-24558291.26992.34
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