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%
127.841136834114175511422361142973113877611405150.23
227.891145433114750611464700.13
单位质量响应值RSD%判断
40966.7741106.850.25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%
5min1210611-2106118.96110.6623.508.9610.6623.48
2325919-32591913.86713.87
3185120-1851207.8767.88
4268924-26892411.44211.44
5308486-30848613.12513.12
6204885-2048858.7178.72
10min1530892-53089222.58724.8811.7422.6024.9011.74
2609483-60948325.93125.95
3568149-56814924.17224.19
4664955-66495528.29128.31
5647752-64775227.55927.58
6488033-48803320.76420.78
15min1779682-77968233.17236.7311.9633.2236.7811.96
2843678-84367835.89535.96
3979431-97943141.67141.72
4981033-98103341.73941.81
5868064-86806436.93337.00
6727303-72730330.94430.99
20min1967797-96779741.17644.6512.7341.2844.7712.72
21007602-100760242.86943.00
31206389-120638951.32751.45
41214164-121416451.65851.79
51019353-101935343.36943.50
6881703-88170337.51337.61
30min11138286-113828648.42950.428.7548.6150.628.75
21164720-116472049.55449.75
31309018-130901855.69355.90
41307515-130751555.62955.85
51143767-114376748.66348.86
61047250-104725044.55644.72
45min11207455-120745551.37252.415.7251.6352.695.74
21244205-124420552.93653.22
31308193-130819355.65855.96
41306602-130660255.59155.91
51200056-120005651.05851.34
61124068-112406847.82548.06
60min11234656-123465652.53053.074.5752.8753.444.60
21259523-125952353.58853.96
31310817-131081755.77056.16
41300857-130085755.34655.75
51222954-122295452.03252.40
61155550-115555049.16449.48
极限11335096-133509656.80355.481.6557.2355.931.66
21310671-131067155.76456.22
31311924-131192455.81756.30
41301915-130191555.39155.89
51293667-129366755.04055.49
61270480-127048054.05454.45
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%
127.841966772197384419753471977665197129819729850.22
227.891989694199272319912080.11
单位质量响应值RSD%判断
70868.7171395.050.53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%
5min1357093-3570938.2819.9624.518.289.9624.52
2562542-56254213.04513.05
3312239-3122397.2417.24
4463161-46316110.74110.74
5533610-53361012.37412.37
6347633-3476338.0628.06
10min1911450-91145021.13623.3211.9621.1523.3411.97
21047286-104728624.28624.31
3976799-97679922.65222.66
41147160-114716026.60226.62
51115654-111565425.87225.89
6836159-83615919.39019.40
15min11339485-133948531.06234.4712.1231.1134.5212.11
21451488-145148833.66033.72
31689088-168908839.17039.22
41692604-169260439.25139.31
51494482-149448234.65734.72
61250357-125035728.99629.04
20min11663331-166333138.57241.9312.9138.6742.0412.90
21734913-173491340.23240.35
32080834-208083448.25448.37
42097437-209743748.63948.77
51755344-175534440.70640.83
61516765-151676535.17435.27
30min11955804-195580445.35547.358.9145.5247.548.91
22004774-200477446.49046.68
32258115-225811552.36552.56
42259294-225929452.39352.60
51971397-197139745.71645.91
61802400-180240041.79741.95
45min12074065-207406548.09749.215.9348.3449.475.95
22142574-214257449.68649.95
32257381-225738152.34852.63
42260777-226077752.42752.72
52063780-206378047.85948.12
61934101-193410144.85145.07
60min12119421-211942149.14949.824.7449.4750.164.77
22169923-216992350.32050.67
32261915-226191552.45352.82
42247061-224706152.10952.49
52104258-210425848.79749.14
61987315-198731546.08646.38
极限12307264-230726453.50552.261.6553.9152.691.66
22264486-226448652.51352.94
32267737-226773752.58853.05
42249960-224996052.17652.65
52236161-223616151.85652.28
62195725-219572550.91951.29
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%
127.841144047113983711419581141270114140511417030.14
227.891150151114518911476700.31
单位质量响应值RSD%判断
41009.4541149.870.25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%
5min1304539-30453912.94312.1916.7712.9412.1916.78
2204719-2047198.7018.70
3311906-31190613.25613.26
4304296-30429612.93312.93
5257193-25719310.93110.93
6338835-33883514.40114.40
10min1622042-62204226.43828.1011.7426.4628.1211.74
2531744-53174422.60022.61
3736643-73664331.30831.33
4712855-71285530.29730.32
5717583-71758330.49830.52
6645362-64536227.42927.45
15min1967650-96765041.12740.2310.4541.1940.3010.46
2807918-80791834.33834.39
31071510-107151045.54145.62
41018974-101897443.30843.38
5957581-95758140.69940.77
6855605-85560536.36536.43
20min11204437-120443751.19049.409.2551.3249.539.25
21045999-104599944.45744.57
31276760-127676054.26454.41
41228454-122845452.21152.36
51207251-120725151.31051.45
61010885-101088542.96443.09
30min11278887-127888754.35553.355.0354.5753.565.03
21237427-123742752.59352.78
31290034-129003454.82855.07
41299316-129931655.22355.45
51291102-129110254.87455.10
61134611-113461148.22348.42
45min11271989-127198954.06253.943.3954.3754.253.40
21288966-128896654.78355.05
31281120-128112054.45054.78
41298143-129814355.17355.50
51291553-129155354.89355.21
61183313-118331350.29350.57
60min11279244-127924454.37054.132.7254.7754.522.72
21289152-128915254.79155.15
31278823-127882354.35254.77
41296848-129684855.11855.53
51292400-129240054.92955.33
61204511-120451151.19451.56
极限11278330-127833054.33154.640.6554.8255.120.62
21294368-129436855.01355.47
31272644-127264454.08954.60
41290944-129094454.86755.37
51289024-128902454.78655.28
61288217-128821754.75155.20
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%
127.841980073197221419760271974434197490819755310.15
227.891987917198340519856610.17
单位质量响应值RSD%判断
70960.1771196.160.24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%
5min1526382-52638212.21611.4517.3012.2211.4617.32
2347023-3470238.0538.05
3538139-53813912.48912.49
4523562-52356212.15012.15
5441545-44154510.24710.25
6584645-58464513.56813.57
10min11071463-107146324.86626.4111.9324.8926.4311.92
2910343-91034321.12621.14
31270021-127002129.47429.49
41227121-122712128.47828.50
51237391-123739128.71628.73
61112843-111284325.82625.85
15min11668077-166807738.71137.8310.4638.7737.9010.45
21390067-139006732.25932.31
31846134-184613442.84342.91
41752528-175252840.67140.74
51649188-164918838.27338.34
61475091-147509134.23334.30
20min12077813-207781348.22046.529.3248.3546.659.32
21802556-180255641.83241.93
32203758-220375851.14351.28
42119280-211928049.18249.32
52083024-208302448.34148.47
61741789-174178940.42240.54
30min12209178-220917851.26950.275.1851.4850.475.19
22134368-213436849.53349.70
32227950-222795051.70451.93
42243074-224307452.05552.27
52230551-223055151.76551.97
61951335-195133545.28545.47
45min12196274-219627450.96950.833.5251.2651.113.52
22220888-222088851.54051.80
32212766-221276651.35251.66
42242770-224277052.04852.35
52231404-223140451.78452.08
62036468-203646847.26147.53
60min12211490-221149051.32251.022.8551.7051.392.86
22222344-222234451.57451.91
32210169-221016951.29251.69
42240898-224089852.00552.40
52232846-223284651.81852.20
62073070-207307048.11048.45
极限12207684-220768451.23451.560.6651.7052.020.63
22238057-223805751.93952.37
32200483-220048351.06751.55
42229000-222900051.72952.21
52230770-223077051.77052.24
62225214-222521451.64152.07
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%
127.841144860114507211451391140787113924011430200.25
227.891141029113773711393830.21
单位质量响应值RSD%判断
41056.7540852.740.36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%
5min1379406-37940616.17511.0535.1316.1711.0535.14
2172724-1727247.3637.36
3329706-32970614.05614.06
4246833-24683310.52310.52
5141952-1419526.0526.05
6284533-28453312.13012.13
10min1713327-71332730.41025.6819.7230.4425.7019.73
2481583-48158320.53120.54
3600328-60032825.59325.62
4575499-57549924.53424.55
5476675-47667520.32120.33
6767015-76701532.69932.72
15min11050747-105074744.79538.6214.7544.8738.6814.75
2723269-72326930.83430.88
3846526-84652636.08936.15
4844140-84414035.98736.05
5899688-89968838.35538.40
61071705-107170545.68845.76
20min11236776-123677652.72546.2912.7352.8846.4212.74
2885964-88596437.77037.87
3989449-98944942.18242.31
41034544-103454444.10444.22
51155700-115570049.26949.38
61212308-121230851.68251.83
30min11283445-128344554.71551.048.1354.9651.258.14
21050515-105051544.78544.95
31116395-111639547.59347.79
41187637-118763750.63150.82
51262374-126237453.81754.01
61283599-128359954.72254.96
45min11278613-127861354.50952.365.0354.8452.655.06
21132400-113240048.27648.51
31176638-117663850.16250.44
41230460-123046052.45652.73
51266880-126688054.00954.29
61284464-128446454.75855.09
60min11278150-127815054.48953.073.3454.9153.443.38
21171176-117117649.92950.24
31226032-122603252.26752.63
41248289-124828953.21653.58
51264020-126402053.88754.26
61281281-128128154.62355.04
极限11277579-127757954.46554.671.3254.9855.141.29
21283239-128323954.70655.11
31308925-130892555.80156.25
41290036-129003654.99655.45
51257987-125798753.63054.09
61276839-127683954.43354.94
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
127.841984656198743219873511979059197551819828030.27
227.891973013196846219707380.17
单位质量响应值RSD%判断
71221.3770661.100.56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%
5min1655408-65540815.24010.3136.3115.2410.3136.31
2289513-2895136.7326.73
3567206-56720613.18913.19
4420802-4208029.7859.78
5236462-2364625.4985.50
6490109-49010911.39611.40
10min11231615-123161528.63824.1119.9528.6624.1219.97
2825327-82532719.19119.20
31033181-103318124.02424.05
4987995-98799522.97322.99
5819887-81988719.06419.07
61322811-132281130.75830.78
15min11813283-181328342.16336.3214.8942.2436.3814.90
21243846-124384628.92228.97
31459468-145946833.93634.00
41452706-145270633.77933.83
51552042-155204236.08836.13
61850934-185093443.03843.11
20min12134001-213400149.62043.5312.8949.7643.6412.89
21523544-152354435.42635.52
31704922-170492239.64339.76
41780033-178003341.39041.50
51995980-199598046.41146.51
62093454-209345448.67748.82
30min12217055-221705551.55148.018.3051.7848.208.31
21806970-180697042.01642.17
31921741-192174144.68544.87
42045908-204590847.57247.75
52181745-218174550.73050.91
62214920-221492051.50251.72
45min12209782-220978251.38249.255.2551.6949.525.28
21948048-194804845.29645.52
32023037-202303747.04047.30
42118884-211888449.26949.53
52190136-219013650.92551.19
62219043-221904351.59851.91
60min12208566-220856651.35449.933.5151.7550.283.56
22015921-201592146.87547.17
32110671-211067149.07849.42
42149572-214957249.98250.32
52182920-218292050.75851.11
62216292-221629251.53451.93
极限12208763-220876351.35951.531.3151.8451.961.29
22213571-221357151.47051.84
32261611-226161152.58753.01
42230869-223086951.87352.30
52174366-217436650.55950.99
62206771-220677151.31251.79
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%
127.841150598114880711518191151240115089811506720.10
227.891166045116852511672850.16
单位质量响应值RSD%判断
41331.6141853.170.89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%
5min1274405-27440511.51911.4624.4811.5211.4624.48
2227036-2270369.5319.53
3245499-24549910.30610.31
4200739-2007398.4278.43
5388886-38888616.32516.33
6301073-30107312.63912.64
10min1622794-62279426.14426.7515.1326.1626.7715.14
2575823-57582324.17324.19
3551315-55131523.14423.16
4576246-57624624.19024.20
5805938-80593833.83333.86
6691378-69137829.02329.04
15min1886378-88637837.20939.4913.4037.2739.5613.40
2837863-83786335.17335.23
3783294-78329432.88232.94
4985707-98570741.37941.43
51111643-111164346.66646.75
61040010-104001043.65943.73
20min11045893-104589343.90646.6713.3344.0346.8013.34
2985150-98515041.35641.47
3916033-91603338.45438.56
41220427-122042751.23351.36
51263233-126323353.02953.19
61239744-123974452.04352.19
30min11180228-118022849.54550.549.0549.7450.759.06
21108007-110800746.51346.70
31049026-104902644.03744.21
41305891-130589154.82055.03
51281964-128196453.81654.07
61298971-129897154.53054.76
45min11227547-122754751.53151.706.2851.8151.996.30
21154740-115474048.47548.74
31123350-112335047.15747.41
41303945-130394554.73955.04
51280882-128088253.77054.11
61298775-129877554.52154.84
60min11240352-124035252.06952.274.4952.4452.654.52
21187487-118748749.85050.19
31170109-117010949.12049.45
41297855-129785554.48354.87
51278901-127890153.68754.12
61296812-129681254.43954.85
极限11267518-126751853.20953.720.8153.6654.180.83
21275294-127529453.53653.96
31277849-127784953.64354.05
41294646-129464654.34854.83
51273219-127321953.44953.97
61289499-128949954.13254.63
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%
127.841989804198838819931831991864199214219910760.10
227.892009629201349420115620.14
单位质量响应值RSD%判断
71518.5372124.850.60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%
5min1469028-46902810.77210.7425.3610.7710.7425.37
2386415-3864158.8758.87
3419143-4191439.6279.63
4340220-3402207.8147.81
5674071-67407115.48215.48
6517919-51791911.89511.90
10min11070868-107086824.59525.1915.3524.6125.2115.35
2990752-99075222.75522.77
3945884-94588421.72421.74
4991157-99115722.76422.78
51391428-139142831.95731.98
61191682-119168227.37027.39
15min11525234-152523435.03037.2313.6035.0937.3013.60
21443480-144348033.15333.21
31344357-134435730.87630.93
41699175-169917539.02539.08
51920024-192002444.09844.18
61794448-179444841.21341.28
20min11801747-180174741.38144.0313.5441.5044.1513.54
21694973-169497338.92939.04
31574290-157429036.15736.26
42108008-210800848.41548.53
52182028-218202850.11550.27
62140682-214068249.16549.30
30min12033685-203368546.70847.699.3046.8947.889.31
21903355-190335543.71543.89
31803933-180393341.43141.60
42256388-225638851.82352.02
52216926-221692650.91751.15
62244138-224413851.54251.76
45min12114193-211419348.55748.796.4848.8249.076.50
21986190-198619045.61745.86
31934442-193444244.42944.66
42253290-225329051.75252.03
52212989-221298950.82651.15
62246042-224604251.58551.89
60min12135618-213561849.04949.344.6949.3949.704.73
22044482-204448246.95647.28
32013594-201359446.24746.55
42242699-224269951.50951.88
52210519-221051950.76951.18
62242502-224250251.50451.89
极限12192306-219230650.35150.820.8050.7851.260.82
22203855-220385550.61651.02
32209630-220963050.74951.13
42238769-223876951.41851.87
52202139-220213950.57751.07
62229045-222904551.19551.67
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