沙库巴曲缬沙坦钠片项目信息
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%
128.531179496117749611768281174797117874211774720.16
228.431193982119362111938020.03
单位质量响应值RSD%判断
41271.3641990.931.23数据可信
供试品溶液-2024032121批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1340698-34069813.50017.2219.9413.5017.2219.94
2542889-54288921.51221.51
3440579-44057917.45817.46
4402991-40299115.96915.97
5351270-35127013.91913.92
6529592-52959220.98520.99
10min1649139-64913925.72233.3017.1125.7533.3417.12
21039245-103924541.18041.23
3785275-78527531.11731.16
4825653-82565332.71732.75
5766729-76672930.38230.41
6976590-97659038.69738.74
15min1895617-89561735.48943.9912.4135.5844.1012.41
21318083-131808352.22952.37
31060246-106024642.01242.12
41149310-114931045.54145.65
51092966-109296643.30943.41
61144284-114428445.34245.47
20min11048166-104816641.53449.238.6441.7049.448.65
21347522-134752253.39653.65
31198423-119842347.48847.69
41310590-131059051.93252.14
51269331-126933150.29750.49
61279884-127988450.71650.95
30min11177194-117719446.64652.245.3246.9052.565.35
21366726-136672654.15754.53
31338418-133841853.03553.34
41343468-134346853.23553.56
51335665-133566552.92653.23
61348943-134894353.45253.80
45min11233596-123359648.88152.343.2649.2452.773.31
21342532-134253253.19853.69
31331590-133159052.76453.19
41335413-133541352.91653.36
51338012-133801253.01953.44
61343913-134391353.25353.72
60min11259742-125974249.91752.412.3550.3952.972.40
21335639-133563952.92553.54
31330608-133060852.72553.27
41332411-133241152.79753.36
51340187-134018753.10553.65
61337830-133783053.01253.59
极限11337635-133763553.00452.810.5053.5953.480.50
21336252-133625252.94953.68
31331471-133147152.76053.42
41331311-133131152.75353.43
51321136-132113652.35053.01
61339129-133912953.06353.76
沙库巴曲缬沙坦钠片项目信息
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%
128.532015454201336120124452012070201089620128450.09
228.432027785203073620292600.11
单位质量响应值RSD%判断
70551.8871377.420.83数据可信
供试品溶液-2024032121批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1574153-57415314.12618.1320.3714.1318.1320.37
2924523-92452322.74722.75
3747154-74715418.38318.38
4682018-68201816.78016.78
5592284-59228414.57214.57
6900861-90086122.16522.16
10min11094559-109455926.93035.0917.2526.9635.1317.25
21761488-176148843.33943.39
31337523-133752332.90832.95
41403543-140354334.53334.57
51299097-129909731.96332.00
61661577-166157740.88140.93
15min11521285-152128537.42946.4412.4737.5246.5612.48
22241545-224154555.15155.30
31797076-179707644.21544.33
41951290-195129048.00948.12
51860792-186079245.78345.89
61952206-195220648.03248.17
20min11771025-177102543.57451.968.9243.7552.188.93
22295204-229520456.47156.74
32035686-203568650.08650.30
42234678-223467854.98255.20
52157683-215768353.08753.29
62177745-217774553.58153.83
30min12002193-200219349.26255.125.2649.5355.455.30
22315002-231500256.95857.35
32263678-226367855.69556.02
42285885-228588556.24256.58
52277529-227752956.03656.36
62296275-229627556.49756.86
45min12092952-209295251.49555.363.4551.8855.823.49
22283187-228318756.17556.70
32271266-227126655.88256.33
42276182-227618256.00356.47
52282032-228203256.14756.59
62295133-229513356.46956.96
60min12147855-214785552.84655.512.3753.3456.092.42
22278424-227842456.05856.70
32269201-226920155.83156.40
42273393-227339355.93456.53
52284635-228463556.21156.78
62283646-228364656.18756.80
极限12282363-228236356.15555.980.3656.7756.680.37
22277330-227733056.03156.80
32270177-227017755.85556.55
42266987-226698755.77756.49
52267729-226772955.79556.49
62286510-228651056.25757.00
沙库巴曲缬沙坦钠片项目信息
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%
128.531198462120276311988741196049119603511984370.23
228.431217364121813412177490.05
单位质量响应值RSD%判断
42006.2042833.241.38数据可信
供试品溶液-2024032121批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1277392-27739210.78813.0918.7810.7913.1018.78
2353519-35351913.74813.75
3402669-40266915.65915.66
4290382-29038211.29311.29
5416797-41679716.20916.21
6279551-27955110.87210.87
10min1615821-61582123.94926.838.7223.9726.868.74
2716678-71667827.87127.90
3773827-77382730.09430.13
4687016-68701626.71826.74
5719089-71908927.96528.00
6626881-62688124.37924.40
15min1896824-89682434.87737.918.7134.9538.008.71
21001000-100100038.92839.02
31124213-112421343.72043.82
4977600-97760038.01838.10
5955918-95591837.17537.27
6894032-89403234.76834.85
20min11028376-102837639.99343.806.1940.1543.986.19
21175069-117506945.69845.88
31217954-121795447.36547.56
41150853-115085344.75644.92
51115703-111570343.38943.57
61070177-107017741.61841.77
30min11164614-116461445.29149.344.6045.5349.614.60
21318629-131862951.28051.56
31304754-130475450.74151.04
41298408-129840850.49450.76
51236632-123663248.09248.37
61289585-128958550.15150.40
45min11231800-123180047.90450.563.1048.2550.943.11
21333542-133354251.86052.25
31325509-132550951.54851.96
41327335-132733551.61952.00
51271921-127192149.46449.85
61311138-131113850.98951.35
60min11279542-127954249.76051.031.7350.2151.521.76
21339416-133941652.08952.60
31328861-132886151.67852.21
41318114-131811451.26051.76
51291251-129125150.21650.71
61315814-131581451.17151.64
极限11337832-133783252.02751.740.4652.5952.340.46
21333054-133305451.84152.47
31334250-133425051.88852.53
41321998-132199851.41252.02
51330544-133054451.74452.35
61324316-132431651.50252.09
沙库巴曲缬沙坦钠片项目信息
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%
128.532035658203353020329142036275203569220348140.08
228.432058238206164420599410.12
单位质量响应值RSD%判断
71321.9172456.601.12数据可信
供试品溶液-2024032121批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1462184-46218411.22613.8119.5311.2313.8119.55
2598402-59840214.53414.53
3683704-68370416.60616.61
4487181-48718111.83311.83
5709204-70920417.22517.23
6469906-46990611.41311.41
10min11045584-104558425.39528.488.8025.4228.518.80
21216178-121617829.53929.57
31318041-131804132.01332.05
41169349-116934928.40128.43
51220619-122061929.64729.68
61064880-106488025.86425.89
15min11522654-152265436.98240.248.6037.0640.348.61
21703862-170386241.38441.48
31904521-190452146.25746.37
41662192-166219240.37140.46
51628889-162888939.56339.67
61518905-151890536.89136.97
20min11743028-174302842.33546.566.3742.5046.746.38
21999041-199904148.55348.74
32079021-207902150.49550.71
41959704-195970447.59847.78
51899001-189900146.12346.32
61821943-182194344.25244.42
30min11976980-197698048.01752.414.7348.2752.704.73
22245627-224562754.54254.84
32217109-221710953.84954.17
42213726-221372653.76754.05
52099074-209907450.98351.28
62195154-219515453.31653.58
45min12091273-209127350.79353.733.1551.1654.143.17
22271155-227115555.16255.58
32255692-225569254.78655.23
42253055-225305554.72255.13
52167012-216701252.63353.04
62235934-223593454.30754.69
60min12175791-217579152.84654.211.7053.3254.731.73
22274504-227450455.24355.78
32260569-226056954.90555.47
42240939-224093954.42854.95
52197041-219704153.36253.89
62242488-224248854.46654.97
极限12284802-228480255.49455.150.6356.0955.790.63
22282358-228235855.43456.10
32277107-227710755.30755.99
42253891-225389154.74355.39
52274001-227400155.23155.87
62252181-225218154.70155.32
沙库巴曲缬沙坦钠片项目信息
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%
128.531194569119472111948871195148119424311947140.03
228.431209011121076512098880.11
单位质量响应值RSD%判断
41875.7142556.741.15数据可信
供试品溶液-2024032221批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1352584-35258413.77713.7820.0713.7813.7820.07
2267190-26719010.44110.44
3285308-28530811.14911.15
4439059-43905917.15617.16
5343492-34349213.42213.42
6427702-42770216.71316.71
10min1837048-83704832.70827.3712.6832.7427.4012.68
2585571-58557122.88122.90
3637574-63757424.91424.94
4728619-72861928.47128.51
5670297-67029726.19226.22
6743870-74387029.06729.10
15min11120746-112074643.79437.219.6843.9037.309.69
2852160-85216033.29933.37
3899108-89910835.13335.21
4969112-96911237.86937.97
5921712-92171236.01636.10
6951201-95120137.16937.27
20min11254411-125441149.01743.157.0049.2243.327.01
21073276-107327641.93942.09
31035882-103588240.47840.64
41107597-110759743.28043.47
51085204-108520442.40542.57
61068623-106862341.75741.94
30min11303087-130308750.91948.665.1451.2348.935.14
21276933-127693349.89750.14
31140247-114024744.55644.80
41264635-126463549.41649.70
51291748-129174850.47650.74
61194573-119457346.67946.96
45min11320012-132001251.58050.283.9852.0050.663.98
21301387-130138750.85251.20
31188795-118879546.45346.80
41309886-130988651.18451.58
51325539-132553951.79652.17
61275212-127521249.83050.21
60min11324089-132408951.73950.702.8752.2851.192.88
21321238-132123851.62852.09
31226272-122627247.91748.37
41310761-131076151.21951.72
51314940-131494051.38251.87
61287497-128749750.31050.80
极限11318164-131816451.50851.440.5352.1652.040.57
21312966-131296651.30551.88
31305891-130589151.02851.59
41323878-132387851.73152.35
51323658-132365851.72352.33
61313734-131373451.33551.94
沙库巴曲缬沙坦钠片项目信息
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%
128.532036778203671420379322038280203774320374890.04
228.432059345206154520604450.08
单位质量响应值RSD%判断
71415.6772474.321.05数据可信
供试品溶液-2024032221批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1596221-59622114.47014.4420.7114.4714.4420.71
2445871-44587110.82110.82
3476711-47671111.56911.57
4741772-74177218.00218.00
5579811-57981114.07114.07
6728618-72861817.68317.68
10min11426651-142665134.62428.8812.9834.6628.9212.99
2987681-98768123.97023.99
31083822-108382226.30326.33
41237455-123745530.03230.07
51137697-113769727.61127.64
61267453-126745330.76030.80
15min11910763-191076346.37239.2810.1046.4839.3810.10
21431564-143156434.74334.82
31524735-152473537.00437.09
41659428-165942840.27340.38
51567096-156709638.03238.12
61618723-161872339.28539.39
20min12140067-214006751.93745.617.1452.1545.797.14
21826751-182675144.33444.49
31761209-176120942.74342.91
41885635-188563545.76345.96
51845775-184577544.79544.97
61816353-181635344.08144.28
30min12221414-222141453.91251.435.2554.2451.725.24
22177386-217738652.84353.10
31936403-193640346.99547.26
42151455-215145552.21452.51
52196042-219604253.29653.57
62032579-203257949.32949.62
45min12250385-225038554.61553.093.9555.0653.493.96
22216875-221687553.80254.17
32020903-202090349.04549.41
42221846-222184653.92254.34
52244853-224485354.48154.88
62171204-217120452.69353.10
60min12254170-225417054.70753.502.8355.2854.022.85
22233877-223387754.21454.70
32085766-208576650.62051.09
42229132-222913254.09954.63
52236532-223653254.27954.79
62187636-218763653.09253.61
极限12250415-225041554.61654.490.5455.3155.130.58
22236545-223654554.27954.89
32228521-222852154.08454.67
42258102-225810254.80255.46
52257474-225747454.78755.42
62240562-224056254.37655.01
沙库巴曲缬沙坦钠片项目信息
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%
128.531204235120430912017921201253120205712027290.12
228.431216929121601612164720.06
单位质量响应值RSD%判断
42156.6442788.321.06数据可信
供试品溶液-2024032221批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1431327-43132716.75213.5617.3216.7513.5617.33
2309028-30902812.00212.00
3415995-41599516.15716.16
4281531-28153110.93410.93
5323719-32371912.57312.57
6333935-33393512.97012.97
10min1854416-85441633.18529.2711.0233.2229.3011.01
2773302-77330230.03530.06
3829689-82968932.22532.26
4629824-62982424.46224.49
5726698-72669828.22528.25
6708229-70822927.50727.54
15min11137368-113736844.17539.528.9244.2939.628.93
21087162-108716242.22542.32
31037813-103781340.30840.42
4880703-88070334.20634.28
5974903-97490337.86537.96
6986912-98691238.33138.42
20min11247241-124724148.44244.875.5248.6545.055.54
21204176-120417646.76946.96
31137064-113706444.16344.36
41101862-110186242.79642.95
51076483-107648341.81041.98
61164561-116456145.23145.41
30min11307792-130779250.79448.354.7251.1148.644.72
21298620-129862050.43850.73
31201622-120162246.67046.97
41192512-119251246.31646.57
51182049-118204945.91046.18
61287179-128717949.99350.27
45min11312891-131289150.99249.914.2751.4250.314.27
21369315-136931553.18353.59
31261254-126125448.98649.39
41231751-123175147.84048.19
51228319-122831947.70748.08
61307467-130746750.78151.17
60min11311927-131192750.95450.171.8751.5050.681.90
21308448-130844850.81951.34
31280913-128091349.75050.26
41256518-125651848.80249.26
51276563-127656349.58150.06
61316577-131657751.13551.63
极限11307558-130755850.78551.250.8451.4451.860.78
21317123-131712351.15651.79
31306468-130646850.74251.36
41331156-133115651.70152.27
51323631-132363151.40951.99
61330897-133089751.69152.30
沙库巴曲缬沙坦钠片项目信息
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%
128.532041970204607520457742045382204174220441890.11
228.432059325205932520593250.00
单位质量响应值RSD%判断
71650.5172434.930.77数据可信
供试品溶液-2024032221批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1732926-73292617.76314.2817.9217.7614.2817.91
2518709-51870912.57112.57
3704530-70453017.07517.07
4469529-46952911.37911.38
5546401-54640113.24213.24
6563758-56375813.66313.66
10min11457238-145723835.31731.0411.1435.3631.0711.15
21315062-131506231.87131.90
31404839-140483934.04734.09
41066451-106645125.84625.87
51239084-123908430.03030.06
61201794-120179429.12629.16
15min11939764-193976447.01142.058.6347.1342.168.63
21847980-184798044.78744.89
31766162-176616242.80442.92
41516580-151658036.75536.84
51661343-166134340.26440.36
61679272-167927240.69840.79
20min12120715-212071551.39747.525.7251.6247.725.74
22046490-204649049.59849.80
31935425-193542546.90647.11
41850514-185051444.84845.01
51831518-183151844.38844.57
61980383-198038347.99648.18
30min12235692-223569254.18351.344.9054.5251.644.90
22210559-221055953.57453.88
32043604-204360449.52849.84
42022532-202253249.01749.28
52009919-200991948.71249.00
62189058-218905853.05353.35
45min12239042-223904254.26453.054.0754.7253.474.08
22325534-232553456.36156.79
32147685-214768552.05052.47
42093986-209398650.74951.12
52107366-210736651.07351.47
62221131-222113153.83054.24
60min12240859-224085954.30953.361.9154.8953.901.94
22230998-223099854.07054.62
32185957-218595752.97853.52
42140001-214000151.86452.35
52173220-217322052.66953.18
62240457-224045754.29954.83
极限12232721-223272154.11154.570.7654.8155.220.70
22250077-225007754.53255.20
32231910-223191054.09254.75
42270289-227028955.02255.62
52254810-225481054.64755.27
62269895-226989555.01255.66
沙库巴曲缬沙坦钠片项目信息
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%
128.531194905119469811952211192116119216611938210.13
228.431180327117814111792340.14
单位质量响应值RSD%判断
41844.4141478.510.63数据可信
供试品溶液-2024032321批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1338222-33822213.39215.4812.5513.3915.4812.56
2396059-39605915.68215.68
3417216-41721616.51916.52
4328673-32867313.01313.01
5456809-45680918.08718.09
6408448-40844816.17216.17
10min1714192-71419228.27830.206.0928.3130.246.09
2811929-81192932.14832.18
3779531-77953130.86530.90
4721153-72115328.55328.58
5818041-81804132.39032.43
6732267-73226728.99329.03
15min1967356-96735638.30241.098.0238.3941.188.01
21135523-113552344.96045.07
3981122-98112238.84738.95
41082917-108291742.87742.97
51115096-111509644.15144.26
6943931-94393137.37437.47
20min11191494-119149447.17647.668.1447.3547.858.13
21303714-130371451.61951.83
31080706-108070642.79042.98
41288942-128894251.03451.22
51263014-126301450.00850.22
61094517-109451743.33643.52
30min11307535-130753551.77150.515.5752.0550.815.55
21309002-130900251.82952.15
31145098-114509845.33945.63
41346571-134657153.31653.62
51295448-129544851.29251.61
61251112-125111249.53749.82
45min11311769-131176951.93851.133.7452.3451.543.73
21308982-130898251.82852.26
31203095-120309547.63548.02
41346040-134604053.29553.71
51296615-129661551.33851.77
61282393-128239350.77551.16
60min11307614-130761451.77451.262.6552.2951.782.66
21302044-130204451.55352.10
31236732-123673248.96749.46
41341608-134160853.12053.66
51294296-129429651.24651.80
61285126-128512650.88351.39
极限11304622-130462251.65551.861.2552.2852.501.24
21302847-130284751.58552.25
31315109-131510952.07052.67
41339361-133936153.03153.69
51291223-129122351.12551.79
61305588-130558851.69452.31
沙库巴曲缬沙坦钠片项目信息
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%
128.532024583202662720238142026327203110320264910.14
228.432010398200903320097160.05
单位质量响应值RSD%判断
71030.1870689.980.34数据可信
供试品溶液-2024032321批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1570221-57022114.05016.2912.8914.0516.2912.89
2671339-67133916.54116.54
3706630-70663017.41117.41
4552088-55208813.60313.60
5775292-77529219.10319.10
6691493-69149317.03817.04
10min11215985-121598529.96131.976.2329.9932.006.24
21383373-138337334.08634.12
31326263-132626332.67832.72
41219698-121969830.05330.08
51393096-139309634.32534.37
61246323-124632330.70930.75
15min11644201-164420140.51243.477.9640.6143.587.95
21920623-192062347.32347.44
31669822-166982241.14441.25
41845387-184538745.46945.57
51900455-190045546.82646.94
61604678-160467839.53839.64
20min12029078-202907849.99550.508.3150.1850.708.29
22221380-222138054.73454.95
31835238-183523845.21945.42
42196912-219691254.13154.33
52154315-215431553.08153.30
61859251-185925145.81146.00
30min12226769-222676954.86653.555.7655.1753.875.75
22234909-223490955.06755.41
31942820-194282047.87048.17
42296721-229672156.59056.91
52210379-221037954.46354.80
62129588-212958852.47252.77
45min12239786-223978655.18754.203.8955.6154.633.88
22226733-222673354.86655.33
32041670-204167050.30650.72
42293874-229387456.52056.96
52210906-221090654.47654.94
62184460-218446053.82454.24
60min12230138-223013854.94954.392.7855.4954.942.79
22222620-222262054.76455.35
32103789-210378951.83652.36
42290541-229054156.43857.01
52209234-220923454.43455.02
62187912-218791253.90954.44
极限12227445-222744554.88355.031.1855.5555.701.17
22224002-222400254.79855.50
32238526-223852655.15655.79
42280788-228078856.19756.89
52200968-220096854.23154.93
62228985-222898554.92155.57
沙库巴曲缬沙坦钠片项目信息
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%
128.531218104122161012185041216591121673712183090.17
228.431218948121872012188340.02
单位质量响应值RSD%判断
42702.7342871.400.28数据可信
供试品溶液-2024032321批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1386959-38695914.91815.1416.0014.9215.1415.99
2442896-44289617.07417.07
3474321-47432118.28618.29
4390348-39034815.04915.05
5293012-29301211.29611.30
6368925-36892514.22314.22
10min1675439-67543926.03929.2413.9426.0729.2713.94
2840003-84000332.38432.42
3926361-92636135.71335.75
4758863-75886329.25629.29
5665893-66589325.67125.70
6684011-68401126.37026.40
15min1920276-92027635.47839.8812.0935.5739.9812.10
21107725-110772542.70542.81
31237198-123719847.69647.82
41055869-105586940.70640.80
5970269-97026937.40637.49
6915749-91574935.30435.39
20min11099029-109902942.37045.416.7642.5445.606.76
21183037-118303745.60845.81
31299381-129938150.09450.32
41166721-116672144.97945.17
51229408-122940847.39647.56
61089433-108943342.00042.17
30min11228588-122858847.36449.023.6147.6349.313.62
21310595-131059550.52650.83
31298816-129881650.07250.41
41262304-126230448.66448.95
51320339-132033950.90251.17
61209094-120909446.61346.87
45min11279860-127986049.34150.041.9149.7150.441.93
21323926-132392651.04051.46
31295384-129538449.93950.39
41311206-131120650.54950.95
51317855-131785550.80651.19
61259533-125953348.55748.92
60min11283218-128321849.47050.231.4449.9550.741.44
21321090-132109050.93051.46
31288618-128861849.67950.24
41311984-131198450.57951.09
51325316-132531651.09351.59
61287046-128704649.61850.09
极限11294768-129476849.91650.391.0950.5051.011.07
21321055-132105550.92951.57
31285793-128579349.57050.24
41309356-130935650.47851.10
51321205-132120550.93551.55
61309926-130992650.50051.08
沙库巴曲缬沙坦钠片项目信息
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%
128.532054410205907820572872055974205796620569430.09
228.432059671206170920606900.07
单位质量响应值RSD%判断
72097.5572482.940.38数据可信
供试品溶液-2024032321批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1655804-65580415.83916.0516.3815.8416.0516.39
2750273-75027318.12118.12
3805176-80517619.44719.45
4662317-66231715.99616.00
5490294-49029411.84211.84
6623672-62367215.06315.06
10min11148206-114820627.73231.1414.1927.7731.1714.19
21429391-142939134.52334.56
31581549-158154938.19838.24
41286766-128676631.07831.11
51128953-112895327.26727.29
61160696-116069628.03328.07
15min11566240-156624037.82842.5712.2937.9242.6712.29
21888285-188828545.60645.72
32114145-211414551.06151.19
41799146-179914643.45343.56
51650775-165077539.87039.96
61556103-155610337.58337.68
20min11868809-186880945.13648.426.8745.3248.626.88
22018072-201807248.74148.96
32217806-221780653.56553.81
41980730-198073047.83948.04
52089391-208939150.46350.64
61853335-185333544.76244.94
30min12081169-208116950.26452.253.7450.5552.563.75
22231477-223147753.89554.22
32217089-221708953.54753.91
42150355-215035551.93552.24
52244471-224447154.20954.50
62055868-205586849.65349.93
45min12179391-217939152.63753.452.0453.0353.872.06
22264223-226422354.68655.13
32211182-221118253.40553.88
42232002-223200253.90754.33
52248067-224806754.29554.70
62143505-214350551.77052.16
60min12182187-218218752.70453.581.5153.2154.131.51
22253285-225328554.42154.99
32199741-219974153.12853.73
42231103-223110353.88654.43
52257849-225784954.53255.06
62187666-218766652.83753.34
极限12207714-220771453.32153.901.2753.9554.561.25
22266533-226653354.74155.43
32193856-219385652.98653.70
42230465-223046553.87054.53
52258894-225889454.55755.21
62232508-223250853.92054.54
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