沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.065550015530605553475538585539445542420.17
228.025567865564775566320.04
单位质量响应值RSD%判断
19752.0319865.520.41数据可信
供试品溶液-2024032421批-沙库巴曲-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%
5min17329-73290.6461.5656.500.651.5656.50
213221-132211.1651.17
316904-169041.4901.49
49107-91070.8030.80
528543-285432.5162.52
631148-311482.7452.75
10min1136654-13665412.04513.077.9912.0513.087.99
2160330-16033014.13214.13
3136352-13635212.01812.02
4140190-14019012.35612.36
5160940-16094014.18514.19
6155573-15557313.71213.72
15min1271379-27137923.92023.326.5923.9423.346.58
2289170-28917025.48825.51
3241395-24139521.27721.30
4271590-27159023.93823.96
5265849-26584923.43223.46
6247927-24792721.85221.88
20min1362354-36235431.93830.089.4032.0030.149.38
2357560-35756031.51631.58
3303489-30348926.75026.81
4384157-38415733.86033.92
5331515-33151529.22029.29
6308596-30859627.20027.26
30min1448707-44870739.54936.5910.7039.6636.7010.69
2446639-44663939.36739.49
3367163-36716332.36232.46
4465114-46511440.99541.11
5399884-39988435.24635.36
6363113-36311332.00532.11
45min1485780-48578042.81740.329.5743.0040.509.56
2496366-49636643.75043.94
3407697-40769735.93536.09
4505788-50578844.58144.77
5436841-43684138.50338.68
6412556-41255636.36336.53
60min1506971-50697144.68542.728.7744.9442.968.76
2520657-52065745.89146.15
3451110-45111039.76139.98
4537059-53705947.33747.60
5459754-45975440.52340.76
6432436-43243638.11538.34
90min1533903-53390347.05944.808.1147.3845.128.11
2545775-54577548.10548.44
3466520-46652041.11941.40
4553110-55311048.75149.09
5491104-49110443.28643.59
6459492-45949240.50040.79
120min1548001-54800148.30146.577.3848.7146.967.39
2560079-56007949.36649.78
3483165-48316542.58642.94
4570618-57061850.29550.72
5528418-52841846.57546.95
6479676-47967642.27942.63
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1562412-56241249.57148.286.7150.0648.746.72
2572752-57275250.48350.98
3500354-50035444.10244.52
4588797-58879751.89752.40
5557828-55782849.16749.62
6504492-50449244.46644.89
极限1585812-58581251.63451.074.3552.2051.624.38
2596566-59656652.58253.16
3548576-54857648.35248.85
4611601-61160153.90754.50
5583458-58345851.42651.96
6550580-55058048.52949.03
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.069673949666779685739696479672659679110.13
228.029705809698529702160.06
单位质量响应值RSD%判断
34494.3334625.840.27数据可信
供试品溶液-2024032421批-缬沙坦钠-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%
5min17588-75880.3621.0261.480.361.0261.46
215871-158710.7580.76
319516-195160.9310.93
410611-106110.5060.51
536100-361001.7231.72
639080-390801.8651.87
10min1181022-1810228.6409.238.228.649.238.24
2212367-21236710.13610.14
3173933-1739338.3028.30
4184475-1844758.8058.81
5209484-2094849.99810.00
6199193-1991939.5079.51
15min1375431-37543117.91917.178.6717.9317.198.68
2400975-40097519.13819.16
3319468-31946815.24815.26
4376943-37694317.99118.01
5357714-35771417.07317.09
6328187-32818715.66415.68
20min1510657-51065724.37322.5911.2024.4222.6411.18
2505332-50533224.11924.17
3410985-41098519.61619.66
4539531-53953125.75125.80
5454463-45446321.69121.74
6418723-41872319.98520.03
30min1659508-65950831.47828.5712.4531.5628.6512.44
2650557-65055731.05031.14
3517689-51768924.70924.78
4679658-67965832.43932.53
5571899-57189927.29627.38
6511912-51191224.43324.51
45min1745476-74547635.58132.7911.3735.7232.9211.36
2754439-75443936.00936.15
3601123-60112328.69128.81
4768469-76846936.67836.82
5648983-64898330.97531.10
6603091-60309128.78528.90
60min1800450-80045038.20535.8110.5338.4035.9910.52
2814838-81483838.89139.09
3692628-69262833.05833.22
4842332-84233240.20440.41
5702864-70286433.54733.73
6648175-64817530.93731.10
90min1868809-86880941.46738.909.5141.7339.149.51
2888699-88869942.41742.68
3746330-74633035.62235.84
4888515-88851542.40842.68
5785973-78597337.51437.75
6711505-71150533.95934.18
120min1908219-90821943.34841.248.6743.6841.558.68
2929887-92988744.38344.72
3787729-78772937.59837.87
4939004-93900444.81845.16
5857026-85702640.90541.20
6762802-76280236.40836.68
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1941817-94181744.95243.447.8845.3543.827.90
2963041-96304145.96546.38
3821111-82111139.19139.53
4987874-98787447.15047.57
5924601-92460144.13044.50
6822227-82222739.24439.58
极限1990481-99048147.27546.415.8347.7546.865.86
21014833-101483348.43748.93
3903820-90382043.13843.54
41042456-104245649.75550.25
5975854-97585446.57747.02
6906993-90699343.29043.69
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.065541815533315537235538575537365537660.06
228.025541485544265542870.04
单位质量响应值RSD%判断
19735.0719781.830.17数据可信
供试品溶液-2024032521批-沙库巴曲-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%
5min16118-61180.5412.1396.300.542.1396.30
210503-105030.9280.93
38957-89570.7910.79
465134-651345.7565.76
515700-157001.3871.39
638004-380043.3583.36
10min1131166-13116611.59011.8031.4511.5911.8031.47
2118945-11894510.51110.51
3109556-1095569.6819.68
4217715-21771519.23819.25
5109821-1098219.7049.71
6114158-11415810.08810.09
15min1223541-22354119.75320.9414.8119.7720.9614.85
2226952-22695220.05520.07
3219046-21904619.35619.37
4306609-30660927.09327.14
5234947-23494720.76120.78
6210538-21053818.60418.63
20min1278802-27880224.63626.239.9724.6926.289.99
2288985-28898525.53625.59
3281637-28163724.88724.94
4349043-34904330.84330.93
5313155-31315527.67227.72
6269158-26915823.78423.84
30min1334439-33443929.55331.798.6429.6531.898.66
2349751-34975130.90631.00
3353525-35352531.23931.33
4398445-39844535.20835.35
5396836-39683635.06635.17
6325478-32547828.76128.85
45min1380566-38056633.62935.408.2433.7735.558.24
2392554-39255434.68834.83
3386248-38624834.13134.27
4433427-43342738.30038.50
5448074-44807439.59439.75
6362748-36274832.05432.20
60min1408673-40867336.11237.767.7436.3137.987.75
2420950-42095037.19737.40
3410363-41036336.26236.46
4458723-45872340.53540.80
5475931-47593142.05542.28
6389474-38947434.41634.61
90min1439000-43900038.79240.837.2139.0541.107.21
2470115-47011541.54241.81
3445946-44594639.40639.67
4489034-48903443.21343.54
5508406-50840644.92545.22
6419558-41955837.07437.33
120min1456626-45662640.35042.536.7340.6742.876.75
2489932-48993243.29343.63
3467983-46798341.35341.68
4506104-50610444.72245.12
5526773-52677346.54846.92
6440084-44008438.88839.20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1474140-47414041.89744.555.8642.2944.975.87
2507881-50788144.87945.29
3512230-51223045.26345.66
4518933-51893345.85546.33
5545711-54571148.22248.67
6466241-46624141.19941.58
极限1541494-54149447.84948.693.5548.3149.183.59
2547016-54701648.33748.82
3544602-54460248.12448.59
4566458-56645850.05550.61
5580795-58079551.32251.85
6525854-52585446.46746.91
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.069665979655099656029651879665629658910.07
228.029673769675229674490.02
单位质量响应值RSD%判断
34422.3434527.090.22数据可信
供试品溶液-2024032521批-缬沙坦钠-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%
5min110603-106030.5071.4397.380.511.4397.21
210400-104000.4980.50
314164-141640.6780.68
483797-837974.0094.01
517504-175040.8380.84
642400-424002.0292.03
10min1167750-1677508.0268.1535.038.038.1535.06
2147864-1478647.0757.08
3140301-1403016.7136.71
4289948-28994813.87313.88
5135474-1354746.4826.48
6140826-1408266.7386.74
15min1292305-29230513.98614.9617.2214.0014.9717.25
2295029-29502914.11614.13
3290245-29024513.88713.90
4419827-41982720.08820.12
5306825-30682514.68114.69
6271116-27111612.97212.99
20min1372878-37287817.84119.1211.7617.8819.1611.77
2384375-38437518.39118.43
3380485-38048518.20518.24
4485723-48572323.24023.30
5418576-41857620.02820.06
6355599-35559917.01417.05
30min1464218-46421822.21223.9810.0522.2824.0610.08
2483411-48341123.13023.20
3493483-49348323.61223.68
4573388-57338827.43527.54
5549660-54966026.30026.37
6443069-44306921.20021.26
45min1547627-54762726.20227.799.6626.3127.919.67
2568911-56891127.22127.33
3558738-55873826.73426.84
4646727-64672730.94431.09
5651096-65109631.15331.27
6512073-51207324.50124.60
60min1606982-60698229.04230.639.2329.1930.799.23
2631463-63146330.21430.36
3611782-61178229.27229.42
4704441-70444133.70633.90
5718298-71829834.36934.53
6567977-56797727.17627.32
90min1676923-67692332.38934.599.0732.5934.809.08
2740771-74077135.44435.64
3696815-69681533.34133.54
4785124-78512437.56637.82
5804076-80407638.47338.70
6634050-63405030.33830.52
120min1718401-71840134.37336.908.5034.6237.178.50
2787453-78745337.67737.94
3754015-75401536.07736.33
4830690-83069039.74640.06
5853919-85391940.85841.14
6683201-68320132.68932.93
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1751551-75155135.96039.177.4536.2739.507.45
2826835-82683539.56239.88
3831195-83119539.77040.08
4859307-85930741.11541.50
5899748-89974843.05043.41
6743807-74380735.58935.88
极限1867987-86798741.53143.154.9041.9043.554.94
2898422-89842242.98743.38
3893847-89384742.76843.15
4939231-93923144.94045.39
5965424-96542446.19346.62
6846258-84625840.49140.84
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.065561025548675548635556285554135553750.10
228.025567075569185568120.03
单位质量响应值RSD%判断
19792.4119871.950.29数据可信
供试品溶液-2024032621批-沙库巴曲-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%
5min13063-30630.2702.15112.550.272.14112.54
24623-46230.4070.41
355291-552914.8684.87
463552-635525.5955.59
58288-82880.7300.73
611409-114091.0041.00
10min169061-690616.08010.8262.066.0810.8362.05
245066-450663.9673.97
3257554-25755422.67422.68
4132996-13299611.70811.72
586282-862827.5967.60
6146612-14661212.90712.91
15min1163431-16343114.38820.0828.3514.4020.1028.37
2195016-19501617.16817.18
3332159-33215929.24229.29
4188421-18842116.58816.62
5208102-20810218.32118.33
6281097-28109724.74724.77
20min1217568-21756819.15426.0819.5619.1926.1419.60
2270959-27095923.85423.89
3375920-37592033.09533.19
4267561-26756123.55523.61
5296495-29649526.10226.15
6348959-34895930.72130.79
30min1303517-30351726.72132.1512.5626.7932.2512.60
2349241-34924130.74630.82
3415273-41527336.55936.71
4332607-33260729.28129.38
5372271-37227132.77332.86
6418363-41836336.83136.95
45min1349373-34937330.75835.8511.4530.8736.0011.48
2398221-39822135.05835.18
3448602-44860239.49339.70
4360049-36004931.69731.84
5422618-42261837.20637.35
6464303-46430340.87641.05
60min1375065-37506533.01938.1010.8333.1838.3110.86
2420509-42050937.02037.21
3470541-47054141.42541.70
4385715-38571533.95734.15
5453726-45372639.94440.15
6491199-49119943.24343.49
90min1412736-41273636.33641.228.6536.5541.508.70
2457811-45781140.30440.55
3498265-49826543.86544.21
4435261-43526138.31938.57
5484770-48477042.67742.95
6520574-52057445.82946.15
120min1437600-43760038.52543.257.6038.8043.597.65
2483794-48379442.59142.91
3515073-51507345.34545.76
4463683-46368340.82141.14
5506260-50626044.56944.91
6540931-54093147.62248.02
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1458695-45869540.38245.396.6640.7245.806.71
2518676-51867645.66246.05
3532111-53211146.84547.34
4494586-49458643.54243.93
5533525-53352546.97047.39
6555670-55567048.91949.39
极限1539424-53942447.48949.662.9447.9050.153.02
2565512-56551249.78650.25
3571825-57182550.34150.91
4549972-54997248.41848.88
5572955-57295550.44150.94
6584710-58471051.47652.03
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.069707049674659672799700029692599689420.16
228.029706349709179707760.03
单位质量响应值RSD%判断
34531.0834645.820.24数据可信
供试品溶液-2024032621批-缬沙坦钠-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%
5min11340-13400.0641.35123.600.061.35123.74
24031-40310.1920.19
365826-658263.1393.14
479962-799623.8133.81
57642-76420.3640.36
611032-110320.5260.53
10min183633-836333.9887.5165.743.997.5265.73
253821-538212.5672.57
3340339-34033916.23116.24
4171594-1715948.1838.19
5105578-1055785.0355.04
6190040-1900409.0639.06
15min1209308-2093089.98214.4430.829.9914.4630.85
2258230-25823012.31512.32
3454525-45452521.67621.71
4248507-24850711.85111.87
5268425-26842512.80112.81
6378137-37813718.03318.05
20min1286358-28635813.65619.2221.5413.6819.2621.58
2366505-36650517.47917.50
3524215-52421525.00025.07
4363378-36337817.32917.37
5395085-39508518.84218.87
6483141-48314123.04123.09
30min1411385-41138519.61924.4314.3319.6724.5014.36
2486622-48662223.20723.26
3595252-59525228.38728.50
4469519-46951922.39122.46
5512515-51251524.44224.50
6598038-59803828.52028.60
45min1494779-49477923.59628.2013.0023.6728.3113.03
2574179-57417927.38327.48
3663122-66312231.62431.78
4521198-52119824.85624.96
5605467-60546728.87528.98
6689439-68943932.87933.01
60min1546890-54689026.08130.7912.6526.2030.9512.68
2618831-61883129.51229.65
3717370-71737034.21134.42
4568713-56871327.12227.27
5671254-67125432.01232.16
6751097-75109735.82036.01
90min1627932-62793229.94634.5210.8830.1134.7410.92
2691285-69128532.96733.16
3789456-78945637.64937.92
4655846-65584631.27731.47
5749639-74963935.75035.95
6829497-82949739.55939.81
120min1686019-68601932.71637.109.7432.9337.379.79
2743956-74395635.47935.72
3832837-83283739.71840.05
4716240-71624034.15734.40
5803162-80316238.30338.57
6885806-88580642.24442.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1736959-73695935.14539.778.1635.4140.108.21
2824371-82437139.31439.62
3875074-87507441.73242.13
4779667-77966737.18237.48
5863170-86317041.16441.49
6924110-92411044.07144.45
极限1870211-87021141.50044.034.3741.8244.424.45
2919852-91985243.86844.23
3947048-94704845.16545.63
4886082-88608242.25742.62
5936038-93603844.64045.04
6979691-97969146.72147.18
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