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%
113.872413112413972412132412732409092412210.08
213.942434322433832434080.02
单位质量响应值RSD%判断
17391.5617461.120.29数据可信
长期6月-供试品溶液-BDJL7批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1139842-13984252.02147.526.2152.0247.526.21
2121237-12123745.10045.10
3130115-13011548.40248.40
4118746-11874644.17344.17
5123852-12385246.07346.07
6132608-13260849.33049.33
10min1170011-17001163.24359.953.6063.3360.033.60
2154537-15453757.48757.56
3160585-16058559.73759.82
4156025-15602558.04158.11
5160348-16034859.64959.73
6165393-16539361.52661.61
15min1184094-18409468.48265.513.0968.6765.683.09
2169618-16961863.09763.27
3176231-17623165.55765.74
4170688-17068863.49563.67
5176364-17636465.60765.78
6179570-17957066.79966.98
20min1192698-19269871.68368.852.7171.9969.142.72
2178949-17894966.56866.84
3185110-18511068.86069.15
4180417-18041767.11467.39
5185494-18549469.00369.29
6187865-18786569.88570.18
30min1204422-20442276.04473.422.6476.4773.822.65
2189919-18991970.64971.04
3196854-19685473.22973.63
4193269-19326971.89572.28
5199152-19915274.08474.48
6200538-20053874.59975.01
45min1215289-21528980.08777.802.0680.6478.322.07
2203175-20317575.58076.09
3208918-20891877.71778.24
4205610-20561076.48676.99
5210675-21067578.37078.89
6211154-21115478.54979.09
60min1221354-22135482.34380.531.9083.0381.181.91
2210461-21046178.29178.92
3216178-21617880.41781.07
4212969-21296979.22479.86
5219044-21904481.48482.14
6218849-21884981.41182.08
90min1227796-22779684.73983.481.6385.5684.261.63
2218480-21848081.27482.04
3224277-22427783.43084.22
4221958-22195882.56883.33
5227593-22759384.66485.45
6226296-22629684.18184.98
120min1234224-23422487.13085.511.6688.0986.441.67
2223831-22383183.26484.16
3228926-22892685.16086.09
4227921-22792184.78685.69
5233189-23318986.74587.68
6231122-23112285.97786.92
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1235691-23569187.67685.852.3788.7986.922.37
2220671-22067182.08983.12
3230938-23093885.90886.98
4229609-22960985.41486.46
5235010-23501087.42388.50
6232706-23270686.56687.65
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%
116.014740691474336147418404746477473676647418270.08
216.004768017477089247694540.05
单位质量响应值RSD%判断
296179.08298090.880.46数据可信
长期6月-供试品溶液-BDJL7批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1250927-2509274.7084.424.624.714.424.65
2233122-2331224.3744.37
3243997-2439974.5784.58
4228143-2281434.2804.28
5220744-2207444.1414.14
6237060-2370604.4474.45
10min1534790-53479010.0339.722.4110.049.722.41
2506493-5064939.5029.51
3530807-5308079.9589.97
4513501-5135019.6349.64
5504804-5048049.4709.48
6517128-5171289.7029.71
15min1794638-79463814.90814.541.8114.9314.561.82
2756466-75646614.19214.21
3787709-78770914.77814.80
4770318-77031814.45214.47
5767143-76714314.39214.41
6772389-77238914.49014.51
20min11008755-100875518.92518.721.1918.9718.771.19
2978718-97871818.36118.41
31010842-101084218.96419.01
4991173-99117318.59518.64
5999561-99956118.75218.80
6999275-99927518.74718.79
30min11369151-136915125.68625.441.0625.7725.521.07
21330161-133016124.95525.03
31356470-135647025.44825.53
41352650-135265025.37725.45
51368673-136867325.67725.76
61358887-135888725.49425.57
45min11764306-176430633.09932.891.3833.2233.011.37
21714660-171466032.16832.29
31754081-175408132.90833.03
41739626-173962632.63632.76
51785806-178580633.50333.62
61760659-176065933.03133.15
60min12062503-206250338.69438.511.4938.8738.691.49
22002036-200203637.55937.73
32051819-205181938.49338.67
42039321-203932138.25938.43
52091401-209140139.23639.41
62069896-206989638.83339.01
90min12477017-247701746.47046.622.1346.7146.862.12
22407866-240786645.17345.41
32479468-247946846.51646.76
42477315-247731546.47646.71
52572660-257266048.26548.51
62495553-249555346.81847.06
120min12778455-277845552.12652.211.4152.4552.521.41
22715380-271538050.94251.25
32782022-278202252.19252.51
42784709-278470952.24352.56
52835348-283534853.19353.52
62800357-280035752.53652.86
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12932135-293213555.00955.331.2855.4255.741.28
22897622-289762254.36154.76
32934784-293478455.05855.46
42945163-294516355.25355.66
53001034-300103456.30156.71
62984532-298453255.99256.40
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%
113.872408202408082409442408052407952408340.03
213.942414242417642415940.10
单位质量响应值RSD%判断
17363.6617330.990.14数据可信
长期6月-供试品溶液-BDJL7批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1118920-11892044.43947.115.6144.4447.115.61
2135981-13598150.81550.81
3132151-13215149.38349.38
4123713-12371346.23046.23
5127161-12716147.51947.52
6118540-11854044.29744.30
10min1155998-15599858.29560.092.7058.3760.172.70
2167458-16745862.57762.66
3163483-16348361.09261.17
4161707-16170760.42860.51
5159434-15943459.57959.66
6156700-15670058.55758.63
15min1171282-17128264.00665.312.0864.1865.492.08
2181041-18104167.65367.84
3176533-17653365.96966.15
4174862-17486265.34465.52
5173088-17308864.68164.86
6171885-17188564.23264.40
20min1181364-18136467.77468.911.5668.0569.201.56
2187489-18748970.06370.36
3185827-18582769.44269.74
4187550-18755070.08570.37
5181975-18197568.00268.29
6182268-18226868.11268.39
30min1194117-19411772.54073.581.7172.9373.981.71
2202204-20220475.56275.98
3196290-19629073.35273.76
4199727-19972774.63675.04
5193949-19394972.47772.88
6195144-19514472.92373.32
45min1205300-20530076.71877.791.7777.2378.311.77
2212518-21251879.41679.96
3207262-20726277.45277.98
4212349-21234979.35379.88
5203467-20346776.03476.55
6208117-20811777.77178.28
60min1212382-21238279.36580.481.6780.0081.131.67
2219535-21953582.03882.71
3214652-21465280.21380.87
4219735-21973582.11382.77
5211135-21113578.89979.55
6214698-21469880.23080.87
90min1223303-22330383.44683.761.5184.2284.551.50
2226986-22698684.82285.64
3221883-22188382.91583.71
4228895-22889585.53686.33
5219660-21966082.08582.86
6224118-22411883.75184.53
120min1228756-22875685.48485.551.2986.3986.481.29
2231562-23156286.53287.49
3227462-22746285.00085.93
4232773-23277386.98587.92
5224575-22457583.92184.84
6228422-22842285.35986.28
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1231446-23144686.48986.341.5987.5487.411.58
2232844-23284487.01188.11
3228785-22878585.49586.57
4236117-23611788.23489.32
5225381-22538184.22385.28
6231714-23171486.58987.65
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%
116.014736040473543447329424733788473226347340930.04
216.004737398474200647397020.07
单位质量响应值RSD%判断
295696.00296231.380.13数据可信
长期6月-供试品溶液-BDJL7批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1224866-2248664.2354.476.034.244.476.01
2254810-2548104.7994.80
3250947-2509474.7274.73
4229391-2293914.3214.32
5243304-2433044.5834.58
6220703-2207034.1574.16
10min1500080-5000809.4199.803.159.439.813.13
2536412-53641210.10310.11
3528386-5283869.9529.96
4538600-53860010.14410.15
5513223-5132239.6669.67
6505513-5055139.5219.53
15min1757197-75719714.26214.581.7714.2814.601.77
2795816-79581614.98915.01
3776590-77659014.62714.65
4780860-78086014.70714.73
5764409-76440914.39714.42
6768820-76882014.48014.50
20min1987668-98766818.60218.810.9718.6518.860.96
21010545-101054519.03319.08
3995448-99544818.74918.80
41007787-100778718.98119.03
5988864-98886418.62518.67
61001650-100165018.86618.91
30min11348273-134827325.39425.581.2225.4725.661.22
21374617-137461725.89025.97
31335973-133597325.16325.24
41373187-137318725.86425.94
51346114-134611425.35425.43
61369761-136976125.79925.88
45min11762623-176262333.19833.221.0933.3233.341.09
21767494-176749433.29033.41
31732049-173204932.62332.74
41782896-178289633.58033.70
51754974-175497433.05433.18
61783091-178309133.58433.71
60min12060304-206030438.80538.811.2438.9838.991.24
22072717-207271739.03939.22
32023227-202322738.10738.28
42092110-209211039.40439.58
52039570-203957038.41538.59
62076407-207640739.10839.29
90min12490828-249082846.91446.831.2547.1547.071.25
22487453-248745346.85047.10
32433902-243390245.84246.08
42511752-251175247.30847.55
52472476-247247646.56846.81
62520554-252055447.47447.72
120min12826126-282612653.22952.661.0953.5552.981.09
22793842-279384252.62152.94
32746862-274686251.73652.05
42810955-281095552.94353.27
52775745-277574552.28052.60
62820649-282064953.12653.45
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12996723-299672356.44255.761.3056.8556.171.30
22955885-295588555.67356.08
32909625-290962554.80255.20
42986734-298673456.25456.67
52920497-292049755.00755.41
62993881-299388156.38956.80
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