沙库巴曲缬沙坦片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
127.945729235733945719285718175719635724050.13
228.145831985829735830860.03
单位质量响应值RSD%判断
20486.9420720.900.81数据可信
供试品溶液-TAWW4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%
5min184691-846916.78012.9948.266.7812.9948.25
271537-715375.7275.73
3114261-1142619.1489.15
475095-750956.0126.01
5102936-1029368.2418.24
6115247-1152479.2279.23
7224697-22469717.98917.99
8197436-19743615.80715.81
9260966-26096620.89320.89
10194144-19414415.54315.54
11202721-20272116.23016.23
12303844-30384424.32624.33
10min1368354-36835429.49131.0017.1029.5131.0317.12
2306905-30690524.57124.58
3370873-37087329.69229.71
4314665-31466525.19225.21
5290078-29007823.22423.24
6433854-43385434.73534.76
7444063-44406335.55235.59
8381771-38177130.56530.60
9480634-48063438.48038.53
10391756-39175631.36431.40
11367377-36737729.41329.45
12496011-49601139.71139.77
15min1531899-53189942.58442.198.5742.6642.298.60
2471174-47117437.72337.79
3551425-55142544.14844.23
4483680-48368038.72438.79
5444062-44406235.55235.62
6533884-53388442.74342.84
7570887-57088745.70645.82
8523162-52316241.88541.99
9594625-59462547.60647.74
10551892-55189244.18544.29
11497294-49729439.81439.92
12570285-57028545.65845.80
20min1592347-59234747.42447.045.3347.6047.235.37
2548903-54890343.94644.10
3613595-61359549.12549.31
4552035-55203544.19644.35
5521303-52130341.73641.88
6594279-59427947.57847.77
7603289-60328948.30048.52
8608272-60827248.69948.89
9626907-62690750.19150.43
10603583-60358348.32348.53
11580033-58003346.43846.63
12606087-60608748.52448.77
30min1140951-14095111.28513.1351.4111.5713.4350.48
235791-357912.8653.11
388211-882117.0627.36
497685-976857.8218.07
583024-830246.6476.89
690898-908987.2777.58
7249725-24972519.99320.32
8180289-18028914.43414.74
9215016-21501617.21417.56
10259025-25902520.73821.05
11266874-26687421.36621.66
12260798-26079820.88021.23
45min1391828-39182831.37031.6115.3731.6831.9415.33
2300689-30068924.07324.33
3310323-31032324.84525.15
4368822-36882229.52829.80
5365209-36520929.23929.50
6364646-36464629.19429.51
7481569-48156938.55538.93
8371190-37119029.71830.05
9397974-39797431.86232.25
10475785-47578538.09238.45
11448635-44863535.91836.26
12461744-46174436.96837.37
60min1531483-53148342.55142.517.1142.9342.917.14
2456750-45675036.56836.88
3476191-47619138.12438.49
4538763-53876343.13443.47
5520670-52067041.68542.01
6530669-53066942.48642.87
7569088-56908845.56246.02
8511435-51143540.94641.35
9520916-52091641.70542.16
10576754-57675446.17546.62
11568809-56880945.53945.96
12570000-57000045.63546.11
极限1592167-59216747.40947.414.2147.8847.904.26
2543759-54375943.53443.92
3541819-54181943.37843.83
4598781-59878147.93948.37
5590979-59097947.31447.73
6591905-59190547.38847.86
7609489-60948948.79649.36
8597366-59736647.82648.32
9595544-59554447.68048.23
10613472-61347249.11549.66
11618228-61822849.49650.02
12613014-61301449.07849.66
沙库巴曲缬沙坦片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
127.949838729847629830949830389830469835620.08
228.149968779972399970580.03
单位质量响应值RSD%判断
35202.6535432.050.46数据可信
供试品溶液-TAWW4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%
5min1107113-1071135.29510.6050.395.3010.6050.38
290752-907524.4864.49
3145217-1452177.1797.18
496094-960944.7514.75
5133140-1331406.5826.58
6147788-1477887.3067.31
7299825-29982514.82214.82
8264924-26492413.09713.10
9353359-35335917.46917.47
10257523-25752312.73112.73
11267273-26727313.21313.21
12408990-40899020.21920.22
10min1512363-51236325.32926.9218.4225.3426.9418.44
2427578-42757821.13821.15
3518721-51872125.64425.66
4433929-43392921.45221.46
5393242-39324219.44019.46
6600814-60081429.70229.72
7636711-63671131.47731.51
8545832-54583226.98427.01
9689109-68910934.06734.11
10556256-55625627.49927.53
11512306-51230625.32725.36
12706898-70689834.94734.99
15min1792470-79247039.17739.6810.7439.2439.7610.77
2702668-70266834.73734.79
3829195-82919540.99241.07
4714775-71477535.33635.39
5647287-64728732.00032.06
6791695-79169539.13939.22
7894140-89414044.20344.31
8817124-81712440.39640.48
9937491-93749146.34646.46
10857098-85709842.37242.46
11759283-75928337.53637.62
12888382-88838243.91844.04
20min1974967-97496748.19947.506.5448.3547.676.57
2889777-88977743.98744.12
31000722-100072249.47249.64
4885833-88583343.79243.93
5827266-82726640.89741.03
6963217-96321747.61847.79
7998507-99850749.36349.56
8998360-99836049.35549.53
91040964-104096451.46251.68
10993235-99323549.10249.29
11945517-94551746.74346.91
121011459-101145950.00350.22
30min1176214-1762148.71110.6953.328.9710.9652.25
243900-439002.1702.40
3113070-1130705.5905.86
4126589-1265896.2586.49
5105811-1058115.2315.45
6116699-1166995.7696.04
7331715-33171516.39916.71
8238845-23884511.80812.10
9285257-28525714.10214.43
10348787-34878717.24317.54
11359567-35956717.77618.05
12348032-34803217.20517.54
45min1540708-54070826.73127.4316.6527.0127.7316.60
2416252-41625220.57820.81
3424941-42494121.00821.29
4510393-51039325.23225.48
5510873-51087325.25625.49
6502941-50294124.86425.15
7683421-68342133.78634.13
8528197-52819726.11226.43
9559962-55996227.68328.05
10677675-67767533.50233.83
11645010-64501031.88732.20
12657207-65720732.49032.86
60min1784399-78439938.77839.958.8239.1240.328.84
2676519-67651933.44533.73
3707547-70754734.97935.31
4800928-80092839.59539.90
5776527-77652738.38938.68
6785665-78566538.84039.18
7880204-88020443.51443.94
8793215-79321539.21439.59
9820599-82059940.56740.99
10899887-89988744.48744.89
11887374-88737443.86944.25
12885431-88543143.77344.21
极限1948025-94802546.86747.694.9747.2948.145.03
2870456-87045643.03243.39
3885083-88508343.75544.17
4966754-96675447.79348.18
5955466-95546647.23547.61
6944383-94438346.68747.12
71002806-100280649.57550.09
8976288-97628848.26448.72
9988679-98867948.87749.39
101017326-101732650.29350.80
111016632-101663250.25950.74
121005247-100524749.69650.23
沙库巴曲缬沙坦片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
127.941165916116653111677471166958116658511667470.06
228.141176539117624211763900.02
单位质量响应值RSD%判断
41759.0241804.900.08数据可信
供试品溶液-TYN28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%
5min1183561-1835617.24711.0151.387.2511.0151.39
2158768-1587686.2686.27
3184497-1844977.2847.28
4125237-1252374.9444.94
5148425-1484255.8605.86
6102832-1028324.0604.06
7405106-40510615.99315.99
8473064-47306418.67618.68
9491605-49160519.40819.41
10337145-33714513.31013.31
11409869-40986916.18116.18
12325176-32517612.83812.84
10min1562525-56252522.20825.2014.2122.2225.2314.24
2685999-68599927.08327.10
3629112-62911224.83724.85
4500185-50018519.74719.76
5586462-58646223.15323.17
6487560-48756019.24819.26
7685542-68554227.06527.10
8782417-78241730.88930.93
9742050-74205029.29529.34
10640483-64048325.28625.32
11699426-69942627.61327.65
12658457-65845725.99526.02
15min1842329-84232933.25436.637.1833.3236.717.21
2908742-90874235.87635.95
3877893-87789334.65834.73
4858527-85852733.89433.95
5851694-85169433.62433.69
6867943-86794334.26634.32
7954480-95448037.68237.78
81000957-100095739.51739.63
9981105-98110538.73338.84
101018093-101809340.19340.28
11969771-96977138.28638.38
121002655-100265539.58439.67
20min11009316-100931639.84744.307.3139.9944.467.33
21051338-105133841.50641.66
31030165-103016540.67040.82
41079984-107998442.63742.77
51036230-103623040.90941.05
61075395-107539542.45642.58
71151650-115165045.46645.65
81196108-119610847.22147.42
91205578-120557847.59547.79
101212169-121216947.85548.03
111206116-120611647.61647.80
121211351-121135147.82348.00
30min1102151-1021514.0339.4958.544.269.7557.27
2100189-1001893.9554.20
3128787-1287875.0845.32
484422-844223.3333.56
5125893-1258934.9705.20
6147262-1472625.8146.04
7315184-31518412.44312.72
8380872-38087215.03615.34
9445848-44584817.60217.90
10276178-27617810.90311.18
11450171-45017117.77218.06
12326823-32682312.90313.18
45min1522404-52240420.62426.9215.4220.8627.2015.41
2613626-61362624.22524.48
3673922-67392226.60626.86
4593664-59366423.43723.67
5591969-59196923.37023.61
6582140-58214022.98223.22
7670569-67056926.47326.78
8807532-80753231.88132.22
9853522-85352233.69634.04
10763861-76386130.15730.46
11792814-79281431.30031.63
12715080-71508028.23128.54
60min1920787-92078736.35241.407.2936.6341.747.34
21014448-101444840.05040.36
31026839-102683940.53940.85
4918797-91879736.27336.56
51036332-103633240.91341.21
61026906-102690640.54140.83
71076263-107626342.49042.86
81101833-110183343.49943.91
91125136-112513644.41944.83
101043832-104383241.21041.58
111139266-113926644.97745.37
121154049-115404945.56145.93
极限11156011-115601145.63847.253.5546.0047.683.60
21154275-115427545.57045.97
31176675-117667546.45446.85
41103611-110361143.57043.93
51207839-120783947.68448.07
61212120-121212047.85348.23
71251952-125195249.42649.89
81207055-120705547.65348.16
91202450-120245047.47247.98
101217512-121751248.06648.53
111227928-122792848.47848.97
121244947-124494749.14949.62
沙库巴曲缬沙坦片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
127.942003155200376920061592004668200333320042170.07
228.142020574201941920199960.05
单位质量响应值RSD%判断
71732.8971783.800.06数据可信
供试品溶液-TYN28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%
5min1234662-2346625.7108.9751.705.718.9751.70
2206290-2062905.0195.02
3243417-2434175.9235.92
4165021-1650214.0154.02
5196133-1961334.7724.77
6134494-1344943.2723.27
7530117-53011712.89812.90
8620363-62036315.09415.09
9648625-64862515.78215.78
10455014-45501411.07111.07
11551152-55115213.41013.41
12439076-43907610.68310.68
10min1759631-75963118.48321.4714.4718.5021.4914.49
2915823-91582322.28322.29
3854278-85427820.78520.80
4690050-69005016.79016.80
5810409-81040919.71819.73
6677897-67789716.49416.50
7950953-95095323.13823.17
81072340-107234026.09126.12
91035166-103516625.18725.22
10901248-90124821.92821.95
11987424-98742424.02524.05
12933981-93398122.72522.75
15min11214271-121427129.54433.789.8029.6033.859.83
21312979-131297931.94632.01
31277606-127760631.08531.14
41253666-125366630.50330.55
51242598-124259830.23430.29
61277229-127722931.07631.12
71450991-145099135.30435.38
81531029-153102937.25137.34
91498282-149828236.45536.55
101567859-156785938.14738.22
111488906-148890636.22636.31
121546322-154632237.62337.70
20min11597725-159772538.87444.078.5938.9944.218.61
21677448-167744840.81440.95
31628623-162862339.62639.75
41734773-173477342.20942.32
51658261-165826140.34740.47
61718286-171828641.80741.92
71869355-186935545.48345.64
81943209-194320947.28047.45
91958366-195836647.64947.82
101994131-199413148.51948.68
111975316-197531648.06148.22
121980145-198014548.17948.34
30min1129125-1291253.1427.7058.653.357.9457.25
2131923-1319233.2103.43
3165257-1652574.0214.24
4115152-1151522.8023.01
5166171-1661714.0434.25
6191941-1919414.6704.88
7414802-41480210.09310.35
8501193-50119312.19412.47
9584322-58432214.21714.50
10370655-3706559.0189.28
11591338-59133814.38814.66
12435087-43508710.58610.85
45min1712851-71285117.34422.7215.8017.5622.9715.80
2828199-82819920.15120.38
3897258-89725821.83122.06
4810407-81040719.71819.93
5799947-79994719.46319.68
6798081-79808119.41819.63
7935031-93503122.75023.03
81106397-110639726.92027.23
91157461-115746128.16228.47
101059536-105953625.77926.07
111095043-109504326.64326.95
121003127-100312724.40724.70
60min11341502-134150232.64037.589.5132.8937.889.55
21435121-143512134.91835.19
31450707-145070735.29735.57
41321056-132105632.14232.40
51473939-147393935.86236.13
61477731-147773135.95536.21
71658573-165857340.35540.69
81647666-164766640.08940.46
91683638-168363840.96441.34
101575934-157593438.34438.69
111717806-171780641.79642.16
121748359-174835942.53942.88
极限11853367-185336745.09446.704.9945.4247.095.04
21797309-179730943.73044.08
31857668-185766845.19945.55
41737315-173731542.27042.60
51891372-189137246.01946.36
61917077-191707746.64446.98
72059441-205944150.10850.53
81961376-196137647.72248.18
91958730-195873047.65848.12
101972534-197253447.99448.42
111998115-199811548.61649.07
122027819-202781949.33949.78
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