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%
1 14.112513072510652510992517232513662513120.11
2 14.042533702535102534400.04
单位质量响应值RSD%判断
17810.9118051.280.95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%
5min127726-2772610.02410.377.0510.0210.367.07
230942-3094211.18711.19
329277-2927710.58510.58
425127-251279.0849.08
529251-2925110.57510.58
629705-2970510.74010.74
10min164173-6417323.20123.984.3223.2224.004.31
269673-6967325.19025.21
367416-6741624.37424.39
461796-6179622.34222.36
568077-6807724.61324.63
666842-6684224.16624.18
15min194195-9419534.05535.265.0434.1135.325.04
2100918-10091836.48636.55
399290-9929035.89735.96
489035-8903532.19032.24
5101408-10140836.66336.72
6100265-10026536.25036.31
20min1113132-11313240.90244.326.4141.0144.446.41
2130678-13067847.24547.37
3122857-12285744.41844.54
4112908-11290840.82140.93
5127231-12723145.99946.12
6128786-12878646.56146.68
30min1151877-15187754.91058.855.3455.0959.045.33
2169012-16901261.10561.30
3161960-16196058.55558.75
4153240-15324055.40255.58
5167540-16754060.57260.77
6173002-17300262.54762.74
45min1190997-19099769.05372.954.9069.3273.234.91
2208892-20889275.52375.82
3201230-20123072.75373.04
4189044-18904468.34768.61
5207386-20738674.97875.28
6213072-21307277.03477.33
60min1215409-21540977.87982.263.7978.2782.673.80
2230719-23071983.41483.84
3228376-22837682.56782.98
4219705-21970579.43279.81
5231837-23183783.81884.24
6239087-23908786.43986.87
90min1245413-24541388.72791.042.6889.2491.592.70
2253500-25350091.65092.22
3253285-25328591.57392.12
4242313-24231387.60688.12
5255917-25591792.52493.09
6260423-26042394.15394.73
120min1259322-25932293.75594.231.9294.4294.931.93
2262636-26263694.95395.67
3261802-26180294.65295.35
4251612-25161290.96891.63
5262050-26205094.74195.46
6266463-26646396.33797.07
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1262833-26283395.02595.811.6595.8596.671.67
2266208-26620896.24597.12
3267364-26736496.66397.52
4257435-25743593.07393.88
5266248-26624896.25997.13
6270005-27000597.61898.51
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100
标示量(mg)160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%
115.509230494922413092180509234760922655392267970.07
215.619309998931694893134730.06
单位质量响应值RSD%判断
595277.23596635.040.17数据可信
供试品溶液-1批-缬沙坦-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%
5min13132548-313254829.30129.052.1429.3029.052.14
23108800-310880029.07929.08
33176434-317643429.71129.71
43152602-315260229.48829.49
53070827-307082728.72428.72
62992326-299232627.98927.99
10min14812333-481233345.01345.451.4145.0645.501.40
24966486-496648646.45546.50
34886150-488615045.70345.75
44775236-477523644.66644.72
54887263-488726345.71445.76
64826518-482651845.14645.19
15min15834740-583474054.57656.292.1954.7056.412.19
26157024-615702457.59157.72
36012378-601237856.23856.36
45886520-588652055.06155.18
56095457-609545757.01557.14
66119263-611926357.23857.36
20min16712909-671290962.79064.872.6963.0165.092.68
27013698-701369865.60465.83
36999007-699900765.46665.69
46716088-671608862.82063.04
56984803-698480365.33465.55
67186570-718657067.22167.44
30min17656463-765646371.61675.063.2371.9475.383.22
28300209-830020977.63777.97
37960574-796057474.46174.79
47812583-781258373.07673.40
58146264-814626476.19876.53
68268833-826883377.34477.67
45min18647437-864743780.88583.852.3981.3284.302.38
29039427-903942784.55285.01
38952050-895205083.73584.19
48802542-880254282.33682.78
59111336-911133685.22585.68
69236162-923616286.39286.85
60min19231075-923107586.34588.892.0286.9289.482.02
29553081-955308189.35689.96
39498865-949886588.84989.44
49348657-934865787.44488.02
59630163-963016390.07790.67
69760332-976033291.29591.90
90min19791035-979103591.58293.221.4392.3093.961.44
29966320-996632093.22293.97
39982116-998211693.37094.11
49822932-982293291.88192.61
510076098-1007609894.24995.00
610161025-1016102595.04395.80
120min110019754-1001975493.72294.611.2694.5995.511.26
210104591-1010459194.51595.42
310117361-1011736194.63595.53
49946589-994658993.03793.92
510198531-1019853195.39496.30
610303383-1030338396.37597.29
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110071045-1007104594.20195.191.1595.2396.241.16
210162694-1016269495.05996.12
310207745-1020774595.48096.53
410023464-1002346493.75694.79
510253039-1025303995.90496.97
610339862-1033986296.71697.79
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%
1 14.112527692526592529142528822529442528340.05
2 14.042547072546542546800.02
单位质量响应值RSD%判断
17918.7818139.600.87数据可信
供试品溶液-3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%
5min121452-214527.7139.8117.077.719.8117.08
231181-3118111.21211.21
331751-3175111.41711.42
429951-2995110.76910.77
521641-216417.7817.78
627659-276599.9459.95
10min166931-6693124.06625.855.7424.0825.865.75
276902-7690227.65227.67
375787-7578727.25127.27
472953-7295326.23226.25
567599-6759924.30724.32
671123-7112325.57425.59
15min197661-9766135.11637.965.3035.1738.025.30
2110123-11012339.59739.66
3111843-11184340.21540.28
4107671-10767138.71538.78
5100191-10019136.02636.08
6105932-10593238.09038.15
20min1123038-12303844.24147.965.0044.3548.085.01
2140069-14006950.36550.50
3140362-14036250.47050.60
4131686-13168647.35047.48
5129597-12959746.59946.71
6135458-13545848.70748.83
30min1160600-16060057.74761.564.0857.9361.764.09
2179112-17911264.40364.62
3176919-17691963.61563.83
4168434-16843460.56460.77
5167319-16731960.16360.35
6174855-17485562.87363.08
45min1196724-19672470.73674.562.8971.0274.872.90
2210544-21054475.70576.03
3211859-21185976.17876.50
4209500-20950075.33075.64
5203813-20381373.28573.58
6211695-21169576.11976.43
60min1223425-22342580.33783.222.6580.7483.652.66
2240649-24064986.53086.98
3233604-23360483.99784.45
4228376-22837682.11782.55
5227767-22776781.89882.31
6234762-23476284.41384.85
90min1249969-24996989.88190.982.2890.4191.552.29
2262132-26213294.25594.85
3250103-25010389.93090.52
4251058-25105890.27390.84
5246918-24691888.78489.33
6257965-25796592.75693.33
120min1256892-25689292.37193.912.1593.0594.622.16
2269421-26942196.87697.63
3264156-26415694.98395.72
4256654-25665492.28593.00
5255597-25559791.90592.60
6264262-26426295.02195.75
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1263067-26306794.59195.241.6595.4396.121.65
2270777-27077797.36398.27
3263695-26369594.81795.71
4261532-26153294.03994.91
5260392-26039293.62994.48
6269776-26977697.00397.89
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100
标示量(mg)160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%
115.509294736929263293036859289209930759692975720.09
215.619375200939209593836480.13
单位质量响应值RSD%判断
599843.35601130.560.16数据可信
供试品溶液-3批-缬沙坦-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%
5min13132961-313296129.08428.892.4429.0828.892.44
23187455-318745529.58929.59
33203921-320392129.74229.74
43073935-307393528.53628.54
53070355-307035528.50228.50
63006812-300681227.91327.91
10min15115342-511534247.48647.451.4947.5347.491.49
25218404-521840448.44348.49
35182207-518220748.10748.16
45054733-505473346.92446.97
55026002-502600246.65746.70
65069761-506976147.06347.11
15min16234873-623487357.87958.531.6958.0158.661.69
26450178-645017859.87860.01
36418930-641893059.58859.72
46244011-624401157.96458.09
56187131-618713157.43657.56
66295348-629534858.44058.57
20min17058938-705893865.52966.882.0165.7567.112.01
27319525-731952567.94868.18
37431284-743128468.98569.21
47083605-708360565.75865.98
57143513-714351366.31466.53
67191889-719188966.76366.99
30min18178451-817845175.92176.661.4576.2576.991.45
28429134-842913478.24978.59
38343351-834335177.45277.80
48158829-815882975.73976.07
58131521-813152175.48675.82
68304066-830406677.08777.42
45min19116036-911603684.62585.061.2985.0885.531.30
29337200-933720086.67887.15
39221332-922133285.60386.08
49039481-903948183.91484.37
59041432-904143283.93384.39
69224006-922400685.62786.09
60min19668940-966894089.75889.541.2890.3690.151.28
29800659-980065990.98191.60
39683749-968374989.89590.51
49469972-946997287.91188.51
59531250-953125088.48089.08
69721153-972115390.24290.85
90min110122856-1012285693.97293.371.2894.7294.131.28
210220585-1022058594.87995.65
310060159-1006015993.38994.16
49865673-986567391.58492.33
59957417-995741792.43693.18
610123621-1012362193.97994.73
120min110528480-1052848097.73794.971.9598.6495.881.94
210351267-1035126796.09297.02
310221626-1022162694.88895.81
49988345-998834592.72393.62
510040079-1004007993.20394.10
610251880-1025188095.16996.08
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110349186-1034918696.07395.101.3697.1496.181.36
210385680-1038568096.41197.50
310255000-1025500095.19896.28
410048726-1004872693.28394.34
510101822-1010182293.77694.83
610329384-1032938495.88996.96
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%
1 14.112513532513142516502510932509762512770.11
2 14.042493832492912493370.03
单位质量响应值RSD%判断
17808.4317759.050.20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%
5min135108-3510812.79813.534.3612.8013.534.35
239318-3931814.33214.33
337385-3738513.62813.63
437969-3796913.84013.84
537571-3757113.69513.70
635340-3534012.88212.88
10min176736-7673627.97228.652.8827.9928.682.88
281590-8159029.74129.77
380641-8064129.39529.42
476438-7643827.86327.89
579497-7949728.97829.00
676745-7674527.97528.00
15min1107013-10701339.00840.652.5839.0840.722.58
2113948-11394841.53641.61
3113694-11369441.44441.52
4111106-11110640.50040.57
5113949-11394941.53741.61
6109434-10943439.89139.96
20min1134604-13460449.06649.591.7549.2049.731.75
2136897-13689749.90250.04
3137507-13750750.12450.26
4135199-13519949.28349.42
5139402-13940250.81550.96
6132696-13269648.37048.50
30min1168501-16850161.42262.471.6361.6462.691.63
2173225-17322563.14463.37
3173013-17301363.06763.29
4169220-16922061.68461.90
5175166-17516663.85164.08
6169073-16907361.63061.85
45min1204698-20469874.61675.051.9574.9375.371.95
2207937-20793775.79776.13
3205854-20585475.03875.37
4205439-20543974.88775.21
5211745-21174577.18577.52
6199572-19957272.74873.07
60min1225791-22579182.30583.101.4882.7583.551.49
2230115-23011583.88184.34
3226637-22663782.61483.07
4227190-22719082.81583.26
5233638-23363885.16685.63
6224384-22438481.79282.23
90min1248831-24883190.70490.401.3791.2890.981.37
2249010-24901090.76991.37
3246134-24613489.72190.31
4244425-24442589.09889.68
5253823-25382392.52393.13
6245684-24568489.55790.13
120min1253557-25355792.42793.121.1893.1693.861.18
2255494-25549493.13393.88
3254863-25486392.90393.64
4253590-25359092.43993.17
5261389-26138995.28196.04
6253886-25388692.54693.27
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1262370-26237095.63996.440.9696.5297.340.96
2266827-26682797.26498.17
3264923-26492396.57097.47
4265382-26538296.73797.62
5267184-26718497.39498.31
6260779-26077995.05995.94
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100
标示量(mg)160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%
115.509258074925897792589789259495926509592601240.04
215.619215442921939592174180.04
单位质量响应值RSD%判断
597427.35590481.610.83数据可信
供试品溶液-1批-缬沙坦-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%
5min13224338-322433830.26231.072.8030.2631.072.81
23427971-342797132.17332.17
33385725-338572531.77731.78
43236415-323641530.37530.38
53365358-336535831.58631.59
63223571-322357130.25530.25
10min15163866-516386648.46649.142.0548.5249.192.05
25347612-534761250.19050.24
35297627-529762749.72149.77
45141824-514182448.25948.31
55347065-534706550.18550.24
65115508-511550848.01248.06
15min16317686-631768659.29559.921.6859.4360.051.68
26510823-651082361.10761.24
36418726-641872660.24360.38
46314256-631425659.26359.39
56494597-649459760.95561.09
66247914-624791458.64058.77
20min17056329-705632966.22766.931.4566.4667.161.45
27219971-721997167.76368.00
37157569-715756967.17767.41
47070691-707069166.36266.59
57271991-727199168.25168.49
67007699-700769965.77166.00
30min18011486-801148675.19275.971.3975.5376.311.39
28184095-818409576.81277.16
38106138-810613876.08076.43
48027214-802721475.33975.68
58263243-826324377.55577.91
67973623-797362374.83775.17
45min18868869-886886983.23983.781.1883.7084.241.18
29007875-900787584.54385.02
38895428-889542883.48883.96
48860839-886083983.16383.63
59098276-909827685.39285.87
68825027-882502782.82783.29
60min19312575-931257587.40387.891.1888.0188.501.18
29436791-943679188.56989.19
39329359-932935987.56188.17
49299788-929978887.28387.89
59551963-955196389.65090.27
69253090-925309086.84587.45
90min19761720-976172091.61991.781.1892.3792.541.18
29854664-985466492.49193.26
39704276-970427691.08091.84
49655759-965575990.62491.37
59970371-997037193.57794.35
69727411-972741191.29792.04
120min19872382-987238292.65793.001.1193.5693.911.11
29964694-996469493.52494.45
39871231-987123192.64793.56
49819481-981948192.16193.06
510104985-1010498594.84095.77
69821487-982148792.18093.08
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110046296-1004629694.29094.720.8695.3595.790.86
210138632-1013863295.15696.23
310069204-1006920494.50595.57
410096627-1009662794.76295.82
510228975-1022897596.00497.09
69976346-997634693.63394.68
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%
1 14.112492802492782496702495112487402492960.15
2 14.042518882519202519040.01
单位质量响应值RSD%判断
17668.0417941.881.09数据可信
供试品溶液-3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%
5min140965-4096514.91612.3812.6614.9212.3812.67
229801-2980110.85110.85
332819-3281911.95011.95
432404-3240411.79811.80
537379-3737913.61013.61
630667-3066711.16611.17
10min178297-7829728.50827.802.6828.5327.822.68
274787-7478727.23027.25
375728-7572827.57327.59
475815-7581527.60527.62
579341-7934128.88928.91
674123-7412326.98927.01
15min1111175-11117540.47940.192.1240.5540.262.12
2111119-11111940.45940.52
3111013-11101340.42140.49
4107408-10740839.10839.17
5113652-11365241.38141.45
6107912-10791239.29139.36
20min1136694-13669449.77149.402.2149.9149.532.21
2138349-13834950.37450.50
3133861-13386148.74048.87
4133423-13342348.58048.71
5139605-13960550.83150.97
6132101-13210148.09948.23
30min1173363-17336363.12362.722.4263.3562.942.42
2176684-17668464.33264.55
3171023-17102362.27162.48
4166724-16672460.70560.92
5176925-17692564.41964.64
6168797-16879761.46061.67
45min1209596-20959676.31576.112.5176.6476.432.51
2214244-21424478.00878.33
3208587-20858775.94876.27
4202516-20251673.73774.05
5215415-21541578.43478.77
6203870-20387074.23074.54
60min1235303-23530385.67583.983.2986.1384.433.29
2236178-23617885.99486.45
3227901-22790182.98083.42
4220972-22097280.45780.89
5239864-23986487.33687.80
6223691-22369181.44781.88
90min1259259-25925994.39891.842.8895.0092.422.87
2257001-25700193.57694.17
3252156-25215691.81292.39
4241766-24176688.02888.60
5257890-25789093.89994.51
6245270-24527089.30489.88
120min1266426-26642697.00794.873.4897.7695.623.47
2270007-27000798.31199.06
3255337-25533792.97093.71
4247783-24778390.21990.94
5268678-26867897.82798.59
6255176-25517692.91193.63
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1269982-26998298.30298.061.6099.2298.961.61
2274214-27421499.843100.76
3266980-26698097.20998.10
4267505-26750597.40098.27
5273983-27398399.759100.69
6263164-26316495.82096.69
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100
标示量(mg)160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%
115.509225042921951892403449241657921381792280760.14
215.619304001931435393091770.08
单位质量响应值RSD%判断
595359.74596359.830.12数据可信
供试品溶液-3批-缬沙坦-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%
5min13070493-307049328.72527.773.3028.7327.763.30
22894031-289403127.07427.07
33020773-302077328.26028.26
42993149-299314928.00128.00
53021196-302119628.26428.26
62807917-280791726.26926.27
10min15222189-522218948.85547.662.3448.9047.712.34
25107234-510723447.77947.82
35108788-510878847.79447.84
45029621-502962147.05347.10
55201979-520197948.66548.71
64898032-489803245.82245.87
15min16376186-637618659.65059.091.8759.7859.221.88
26419802-641980260.05860.18
36314896-631489659.07759.20
46217019-621701958.16158.29
56433532-643353260.18760.32
66138013-613801357.42257.54
20min17134296-713429666.74366.531.9566.9766.761.95
27267763-726776367.99168.22
37102543-710254366.44666.67
47011311-701131165.59265.81
57248823-724882367.81468.04
66906307-690630764.61064.83
30min18169588-816958876.42876.132.1376.7776.462.13
28318382-831838277.82078.16
38107734-810773475.84976.19
47985018-798501874.70175.03
58336063-833606377.98578.33
67908088-790808873.98274.31
45min19041363-904136384.58484.212.1985.0584.672.19
29220365-922036586.25886.73
38967584-896758483.89384.36
48809820-880982082.41882.87
59213739-921373986.19686.67
68756168-875616881.91682.36
60min19569183-956918389.52188.732.1290.1389.342.12
29684221-968422190.59891.21
39424490-942449088.16888.77
49300563-930056387.00887.60
59707454-970745490.81591.43
69224374-922437486.29686.88
90min110013147-1001314793.67592.622.6594.4393.372.65
210200587-1020058795.42896.19
39824787-982478791.91392.66
49574782-957478289.57490.31
510149376-1014937694.94995.72
69640840-964084090.19290.92
120min110124545-1012454594.71793.922.2395.6394.822.23
210284367-1028436796.21297.13
39917600-991760092.78193.68
49858837-985883792.23193.12
510284837-1028483796.21797.14
69767570-976757091.37792.25
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110163698-1016369895.08395.201.4796.1596.261.48
210353114-1035311496.85597.94
310139863-1013986394.86095.92
410090041-1009004194.39495.44
510343002-1034300296.76197.85
69967904-996790493.25294.28
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