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对照品来源自制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125
标示量(mg)200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%
127.841160805115744311589781155614115916611584010.17
227.891163928115783511608820.38
单位质量响应值RSD%判断
41609.2341623.590.03数据可信
供试品溶液-2024022221批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1270895-27089511.36510.3217.4711.3610.3217.45
2267468-26746811.22111.22
3220865-2208659.2669.27
4169358-1693587.1057.11
5281737-28173711.82011.82
6264996-26499611.11711.12
10min1613773-61377325.75026.0413.1725.7726.0513.17
2648815-64881527.22027.24
3554166-55416623.24923.26
4530816-53081622.26922.28
5762052-76205231.97131.99
6614146-61414625.76525.78
15min1849891-84989135.65638.5311.8435.7238.5911.84
2966812-96681240.56140.63
3845375-84537535.46635.52
4833475-83347534.96735.02
51116191-111619146.82846.90
6898254-89825437.68537.75
20min11041461-104146143.69347.048.5843.8147.178.58
21195564-119556450.15850.29
31062547-106254744.57744.69
41060890-106089044.50844.62
51282234-128223453.79453.94
61085104-108510445.52445.65
30min11208469-120846950.69953.433.4050.8953.643.41
21320071-132007155.38155.60
31298568-129856854.47954.67
41261985-126198552.94453.13
51309130-130913054.92255.16
61243574-124357452.17252.37
45min11279453-127945353.67754.661.8753.9654.951.88
21324533-132453355.56955.88
31330099-133009955.80256.08
41299321-129932154.51154.78
51313552-131355255.10855.44
61270125-127012553.28653.57
60min11297301-129730154.42654.781.2254.7955.161.23
21316902-131690255.24855.65
31329249-132924955.76656.14
41297465-129746554.43354.79
51308685-130868554.90455.33
61284883-128488353.90554.28
极限11324054-132405455.54855.210.6356.0155.680.60
21314964-131496455.16755.66
31327536-132753655.69456.16
41311689-131168955.03055.48
51306346-130634654.80655.32
61311112-131111255.00555.47
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对照品来源自制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125
标示量(mg)200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%
127.841976038198326419862281981503198423319822530.20
227.891991072198506419880680.22
单位质量响应值RSD%判断
71201.6271282.470.09数据可信
供试品溶液-2024022221批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1456799-45679910.5779.5618.3110.589.5618.30
2450055-45005510.42010.42
3369744-3697448.5618.56
4278095-2780956.4396.44
5477030-47703011.04511.04
6446508-44650810.33810.34
10min11042617-104261724.14024.3713.6024.1624.3813.60
21100774-110077425.48725.50
3936828-93682821.69121.71
4893160-89316020.68020.69
51299536-129953630.08930.11
61041791-104179124.12124.14
15min11445833-144583333.47636.1711.9633.5336.2211.96
21641946-164194638.01738.08
31438974-143897433.31833.37
41418998-141899832.85532.90
51904428-190442844.09444.16
61522244-152224435.24635.30
20min11767617-176761740.92744.118.7941.0444.228.80
22027801-202780146.95147.07
31807424-180742441.84841.95
41795265-179526541.56741.67
52189273-218927350.69050.83
61842949-184294942.67142.79
30min12045378-204537847.35850.273.7247.5450.463.72
22250223-225022352.10152.30
32214322-221432251.27051.45
42159236-215923649.99450.16
52243608-224360851.94852.17
62115122-211512248.97349.16
45min12177051-217705150.40751.261.7950.6751.531.80
22250043-225004352.09752.39
32257949-225794952.28052.54
42205225-220522551.05951.31
52231353-223135351.66451.98
62160534-216053450.02450.29
60min12200355-220035550.94651.461.3251.2951.821.33
22245092-224509251.98252.36
32261245-226124552.35652.70
42213224-221322451.24451.58
52233159-223315951.70652.11
62182494-218249450.53350.89
极限12253110-225311052.16851.930.6152.6052.380.59
22239831-223983151.86052.32
32265574-226557452.45652.89
42234670-223467051.74152.16
52231789-223178951.67452.16
62233258-223325851.70852.14
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对照品来源自制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125
标示量(mg)200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%
127.841156474115462011539671154255115640611551440.11
227.891169219116723111682250.13
单位质量响应值RSD%判断
41492.2441886.880.67数据可信
供试品溶液-2024022221批-缬沙坦钠-pH6.7
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1386019-38601916.16712.2826.7016.1712.2826.71
2251335-25133510.52610.53
3400431-40043116.77016.77
4249524-24952410.45010.45
5225259-2252599.4349.43
6246055-24605510.30510.30
10min1725213-72521330.37226.9820.4130.4027.0020.41
2540181-54018122.62322.64
3874972-87497236.64436.67
4565873-56587323.69923.72
5554907-55490723.24023.26
6603717-60371725.28425.30
15min1897679-89767937.59537.8216.5737.6737.8816.57
2792621-79262133.19533.25
31195086-119508650.05150.14
4820597-82059734.36734.42
5816472-81647234.19434.25
6895861-89586137.51937.58
20min11018673-101867342.66344.4711.4842.8044.6011.50
2958674-95867440.15040.26
31289749-128974954.01554.19
41001229-100122941.93242.05
5997121-99712141.76041.87
61105703-110570346.30846.43
30min11126758-112675847.18950.306.3847.4050.506.39
21188823-118882349.78949.97
31292688-129268854.13954.40
41192342-119234249.93650.12
51115473-111547346.71746.90
61289577-128957754.00854.21
45min11186884-118688449.70751.934.6450.0052.224.65
21259434-125943452.74653.01
31285992-128599253.85854.21
41263224-126322452.90553.17
51151401-115140148.22148.48
61293186-129318654.15954.45
60min11216755-121675550.95852.373.8351.3352.743.83
21264631-126463152.96453.31
31281097-128109753.65354.10
41277634-127763453.50853.86
51169461-116946148.97849.32
61293542-129354254.17454.55
极限11286089-128608953.86254.020.5354.3254.480.51
21296596-129659654.30254.74
31283245-128324553.74354.27
41296200-129620054.28654.73
51281910-128191053.68754.11
61294641-129464154.22054.69
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对照品来源自制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125
标示量(mg)200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%
127.841983016198411719773791975478198010219800180.19
227.891999685199945319995690.01
单位质量响应值RSD%判断
71121.3471694.840.57数据可信
供试品溶液-2024022221批-沙库巴曲-pH6.7
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1657104-65710415.17911.3927.7615.1811.4027.77
2422186-4221869.7539.75
3679923-67992315.70615.71
4415502-4155029.5989.60
5374911-3749118.6618.66
6409940-4099409.4709.47
10min11229631-122963128.40525.2620.7428.4325.2820.75
2912156-91215621.07121.09
31493103-149310334.49134.52
4960085-96008522.17822.19
5939687-93968721.70721.72
61026464-102646423.71223.73
15min11530863-153086335.36335.5116.7435.4435.5816.74
21351246-135124631.21431.27
32040708-204070847.14147.22
41395898-139589832.24632.30
51387589-138758932.05432.10
61518127-151812735.06935.12
20min11724936-172493639.84641.6711.7239.9841.7911.74
21629045-162904537.63137.73
32201666-220166650.85951.02
41700717-170071739.28739.39
51692138-169213839.08939.19
61876015-187601543.33643.45
30min11918596-191859644.32047.136.5244.5247.326.53
22021255-202125546.69146.86
32206117-220611750.96251.21
42024278-202427846.76146.93
51884924-188492443.54243.71
62186202-218620250.50250.69
45min12008217-200821746.39048.684.8646.6648.944.87
22142294-214229449.48749.73
32195699-219569950.72151.05
42147700-214770049.61249.86
51952772-195277245.10945.35
62196941-219694150.75051.02
60min12073657-207365747.90249.183.7648.2549.533.77
22156547-215654749.81750.14
32182137-218213750.40850.82
42171651-217165150.16650.50
51992306-199230646.02346.34
62197935-219793550.77351.13
极限12187380-218738050.52950.770.7250.9651.200.69
22211810-221181051.09351.50
32181858-218185850.40150.90
42203962-220396250.91251.33
52183648-218364850.44350.84
62218338-221833851.24451.68
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对照品来源自制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125
标示量(mg)200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%
127.841169132116848911708061167651116504211682240.19
227.891175816118329711795560.45
单位质量响应值RSD%判断
41962.0742293.150.56数据可信
供试品溶液-2024022221批-缬沙坦钠-pH6.9
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1222758-2227589.23211.5210.699.2311.5210.70
2268904-26890411.14511.14
3305326-30532612.65412.65
4295602-29560212.25112.25
5283141-28314111.73511.73
6291955-29195512.10012.10
10min1531556-53155622.03026.4914.2322.0526.5014.22
2573400-57340023.76423.78
3576227-57622723.88223.90
4684168-68416828.35528.38
5759360-75936031.47231.49
6709661-70966129.41229.43
15min1780912-78091232.36538.0115.0732.4238.0715.07
2788121-78812132.66432.72
3812156-81215633.66033.72
4997937-99793741.35941.43
51084062-108406244.92945.00
61039044-103904443.06343.13
20min1951101-95110139.41845.4814.0339.5245.6014.03
2953521-95352139.51939.63
3968732-96873240.14940.27
41205822-120582249.97550.11
51249882-124988251.80151.95
61254666-125466651.99952.14
30min11121197-112119746.46849.828.0346.6450.028.06
21104981-110498145.79645.97
31116157-111615746.25946.44
41284764-128476453.24753.47
51289618-128961853.44853.68
61295516-129551653.69253.92
45min11182758-118275849.01951.134.6849.2751.424.72
21178382-117838248.83849.09
31182224-118222448.99749.26
41281154-128115453.09753.41
51289457-128945753.44153.76
61288365-128836553.39653.71
60min11211491-121149150.21051.623.1650.5451.993.21
21208410-120841050.08250.42
31208850-120885050.10150.44
41277952-127795252.96553.36
51283095-128309553.17853.59
61282835-128283553.16753.57
极限11296597-129659753.73753.360.5954.1553.820.53
21295596-129559653.69654.12
31287597-128759753.36453.79
41277751-127775152.95653.44
51287116-128711653.34453.84
61281050-128105053.09353.59
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对照品来源自制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125
标示量(mg)200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%
127.841996846199191019973121997641199651019960440.12
227.892020073201490620174900.19
单位质量响应值RSD%判断
71696.9872337.400.63数据可信
供试品溶液-2024022221批-沙库巴曲-pH6.9
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1372873-3728738.54110.7511.028.5410.7511.03
2455098-45509810.42410.42
3518187-51818711.86911.87
4498280-49828011.41311.41
5477894-47789410.94610.95
6492798-49279811.28711.29
10min1906512-90651220.76424.9114.2920.7824.9214.29
2974312-97431222.31722.33
3977242-97724222.38422.40
41161390-116139026.60226.62
51292441-129244129.60329.62
61212108-121210827.76327.78
15min11331630-133163030.50135.7615.1730.5535.8215.17
21336182-133618230.60530.66
31381578-138157831.64531.70
41698396-169839638.90238.96
51844069-184406942.23842.31
61775756-177575640.67440.74
20min11619403-161940337.09242.8414.3037.1942.9614.30
21623597-162359737.18837.29
31641895-164189537.60737.72
42056349-205634947.10047.23
52129975-212997548.78748.92
62152144-215214449.29549.43
30min11903065-190306543.59046.878.0143.7547.068.04
21887224-188722443.22743.39
31900572-190057243.53243.70
42185335-218533550.05550.26
52194477-219447750.26450.48
62207199-220719950.55650.77
45min12018251-201825146.22848.194.9846.4648.455.02
22003399-200339945.88846.13
32003057-200305745.88046.12
42195636-219563650.29150.58
52201649-220164950.42950.73
62200184-220018450.39550.69
60min12061333-206133347.21548.593.4847.5348.943.52
22056030-205603047.09347.41
32046057-204605746.86547.19
42181791-218179149.97450.35
52194030-219403050.25450.64
62189590-218959050.15250.54
极限12220109-222010950.85150.350.7551.2450.780.69
22214747-221474750.72951.12
32193318-219331850.23850.64
42177170-217717049.86850.33
52198365-219836550.35350.82
62186581-218658150.08350.55
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对照品来源自制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125
标示量(mg)200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%
127.841173460116898111734951173502117343611725750.18
227.891182257117911011806840.19
单位质量响应值RSD%判断
42118.3542333.600.37数据可信
供试品溶液-2024022221批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1297150-29715012.28711.4319.1412.2911.4219.14
2301808-30180812.47912.48
3334104-33410413.81513.81
4248857-24885710.29010.29
5183831-1838317.6017.60
6292262-29226212.08412.08
10min1781456-78145632.31229.6113.8732.3329.6213.87
2805235-80523533.29533.32
3791472-79147232.72632.75
4612158-61215825.31125.33
5573577-57357723.71623.73
6732111-73211130.27130.29
15min11126547-112654746.58039.2311.8346.6539.3011.83
2969590-96959040.09140.17
3995532-99553241.16341.24
4865419-86541935.78335.84
5801960-80196033.15933.21
6933801-93380138.61138.68
20min11301043-130104353.79546.1510.2353.9546.2810.23
21094733-109473345.26545.41
31113138-111313846.02646.17
41155808-115580847.79047.91
5949473-94947339.25939.37
61082516-108251644.76044.89
30min11314402-131440254.34850.696.3054.5950.906.30
21177668-117766848.69448.91
31205620-120562049.85050.07
41317609-131760954.48054.68
51122347-112234746.40746.58
61218398-121839850.37850.59
45min11311790-131179054.24052.593.5354.5752.883.53
21229854-122985450.85251.15
31243104-124310451.40051.71
41325209-132520954.79555.08
51223205-122320550.57750.83
61297521-129752153.65053.94
60min11306993-130699354.04153.722.4754.4654.102.46
21262901-126290152.21852.60
31266735-126673552.37752.77
41329407-132940754.96855.35
51289546-128954653.32053.65
61340322-134032255.42055.80
极限11302580-130258053.85954.831.5354.3755.301.50
21341491-134149155.46855.94
31310760-131076054.19754.68
41320171-132017154.58655.06
51323367-132336754.71855.14
61357443-135744356.12756.60
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对照品来源自制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125
标示量(mg)200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%
127.841993865200269619975841996203199895119978600.17
227.892008194201950120138480.40
单位质量响应值RSD%判断
71762.2172206.810.44数据可信
供试品溶液-2024022221批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1500950-50095011.47910.6519.7811.4810.6419.77
2509582-50958211.67711.68
3564460-56446012.93512.93
4418135-4181359.5829.58
5303340-3033406.9516.95
6491101-49110111.25411.25
10min11328992-132899230.45427.8914.0530.4727.9114.05
21373675-137367531.47831.50
31344922-134492230.81930.84
41041357-104135723.86323.88
5969904-96990422.22522.24
61244849-124484928.52628.54
15min11917189-191718943.93336.9411.9744.0037.0011.97
21647488-164748837.75237.82
31694063-169406338.82038.89
41464084-146408433.55033.61
51362202-136220231.21531.26
61586740-158674036.36036.43
20min12218680-221868050.84143.5310.3450.9843.6510.33
21854138-185413842.48842.62
31892805-189280543.37443.51
41969345-196934545.12845.24
51614597-161459736.99937.10
61848043-184804342.34842.47
30min12242744-224274451.39347.786.4951.6247.986.48
21995672-199567245.73145.94
32048883-204888346.95047.16
42245108-224510851.44751.63
51907702-190770243.71543.88
62071183-207118347.46147.66
45min12239021-223902151.30749.693.6851.6249.963.69
22091301-209130147.92248.20
32116883-211688348.50948.80
42267680-226768051.96452.24
52086219-208621947.80648.04
62208597-220859750.61050.89
60min12234939-223493951.21450.722.4551.6151.082.44
22148324-214832449.22949.59
32164507-216450749.60049.97
42263645-226364551.87252.23
52188831-218883150.15750.47
62279553-227955352.23652.60
极限12231676-223167651.13951.881.4451.6252.331.42
22290205-229020552.48052.92
32234478-223447851.20351.65
42252644-225264451.61952.07
52260971-226097151.81052.21
62314703-231470353.04253.49
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