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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.601149937114885411477441147302114713111481940.11
228.641128546113274711306460.27
单位质量响应值RSD%判断
40146.6439477.861.19数据可信
加速3月-供试品溶液-2024032121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%
5min120393-203930.8303.2038.160.833.2038.17
293462-934623.8023.80
396484-964843.9253.93
474520-745203.0323.03
5101047-1010474.1114.11
686025-860253.5003.50
10min1141985-1419855.77612.4436.275.7812.4436.27
2318442-31844212.95512.96
3336033-33603313.67113.68
4207941-2079418.4608.46
5409059-40905916.64216.65
6421261-42126117.13917.14
15min1454193-45419318.47821.4617.9018.4921.4917.91
2564176-56417622.95322.98
3543619-54361922.11622.15
4377331-37733115.35115.37
5599022-59902224.37024.41
6626985-62698525.50825.54
20min1684244-68424427.83828.8513.1127.8828.9113.12
2782072-78207231.81831.88
3732409-73240929.79729.86
4533190-53319021.69221.74
5749465-74946530.49130.57
6773409-77340931.46531.54
30min1878532-87853235.74237.557.5835.8337.667.59
21058099-105809943.04843.17
3911037-91103737.06437.18
4861752-86175235.05935.14
5924252-92425237.60237.73
6904558-90455836.80136.93
45min1968265-96826539.39341.006.8139.5441.186.81
21141757-114175746.45146.64
3978044-97804439.79139.97
4991912-99191240.35540.49
51012990-101299041.21241.40
6954220-95422038.82139.01
60min11013722-101372241.24242.846.5741.4643.086.56
21181681-118168148.07548.34
31019319-101931941.47041.71
41035373-103537342.12342.33
51076493-107649343.79644.05
6991149-99114940.32440.58
极限11203156-120315648.94948.691.8949.2349.001.91
21231331-123133150.09550.44
31208184-120818449.15449.47
41172030-117203047.68347.96
51192345-119234548.50948.84
61173363-117336347.73748.06
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.602010360200930620099392010351200997620099860.03
228.641989273199358419914280.16
单位质量响应值RSD%判断
70279.2369533.100.76数据可信
加速3月-供试品溶液-2024032121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%
5min122879-228790.5012.2039.760.502.2039.78
2124391-1243912.7232.72
3122738-1227382.6872.69
496415-964152.1102.11
5129291-1292912.8302.83
6107401-1074012.3512.35
10min1178748-1787483.9138.8337.463.918.8337.46
2422457-4224579.2479.25
3447588-4475889.7979.80
4269418-2694185.8975.90
5548669-54866912.01012.01
6552262-55226212.08912.09
15min1609920-60992013.35115.6918.7713.3615.7018.79
2776640-77664017.00017.02
3739193-73919316.18116.20
4502128-50212810.99111.00
5822229-82222917.99818.02
6849968-84996818.60518.63
20min1946651-94665120.72221.5713.8820.7521.6213.90
21100910-110091024.09824.15
31020371-102037122.33522.38
4727597-72759715.92715.96
51048066-104806622.94223.00
61069649-106964923.41423.47
30min11256999-125699927.51529.098.5527.5829.178.56
21546349-154634933.84933.94
31317215-131721528.83328.92
41225005-122500526.81526.87
51330574-133057429.12629.22
61296736-129673628.38528.48
45min11444220-144422031.61333.067.9631.7233.187.95
21743667-174366738.16838.31
31469589-146958932.16832.30
41472947-147294732.24232.34
51521110-152111033.29633.44
61409426-140942630.85230.99
60min11553389-155338934.00335.447.7334.1735.627.72
21849761-184976140.49040.70
31571536-157153634.40034.59
41584629-158462934.68734.84
51659733-165973336.33136.53
61494622-149462232.71632.91
极限11933741-193374142.32942.092.6442.5542.342.65
22006108-200610843.91344.19
31942441-194244142.51942.76
41874537-187453741.03341.25
51912087-191208741.85542.11
61868888-186888840.90941.16
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.601162135116208711613841161822116182011618500.03
228.641159329116009911597140.05
单位质量响应值RSD%判断
40624.1340492.810.23数据可信
加速3月-供试品溶液-2024032121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%
5min122815-228150.9111.9092.980.911.9093.13
211384-113840.4550.45
325097-250971.0021.00
4128648-1286485.1375.14
569440-694402.7732.77
628778-287781.1491.15
10min1197910-1979107.90310.3841.927.9010.3841.93
2143158-1431585.7175.72
3227784-2277849.0969.10
4443589-44358917.71417.72
5331126-33112613.22313.23
6215389-2153898.6018.60
15min1394042-39404215.73519.4928.7015.7519.5128.72
2353361-35336114.11114.12
3422513-42251316.87216.89
4729272-72927229.12229.16
5574342-57434222.93522.96
6454654-45465418.15618.17
20min1542107-54210721.64826.6623.0521.6926.7223.07
2530465-53046521.18321.22
3590644-59064423.58623.63
4939650-93965037.52337.61
5729656-72965629.13729.20
6673471-67347126.89326.94
30min1814003-81400332.50536.4013.7332.5836.5013.76
2756189-75618930.19730.27
3860178-86017834.34934.43
41097726-109772643.83543.98
5957439-95743938.23338.35
6983405-98340539.27039.36
45min1945767-94576737.76741.109.9637.9041.2610.00
2877133-87713335.02635.15
31037666-103766641.43741.58
41161327-116132746.37546.60
51065661-106566142.55542.73
61088434-108843443.46443.62
60min1999070-99907039.89543.218.7840.0943.448.82
2939708-93970837.52537.70
31106008-110600844.16644.38
41197037-119703747.80148.10
51113004-111300444.44544.69
61138278-113827845.45445.68
极限11179543-117954347.10248.072.1647.3648.372.24
21174909-117490946.91747.16
31197153-119715347.80548.09
41241918-124191849.59349.97
51224501-122450148.89749.22
61204881-120488148.11448.42
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.602016756201570120149022015733201613620158460.04
228.642011476201338420124300.07
单位质量响应值RSD%判断
70484.1370266.410.22数据可信
加速3月-供试品溶液-2024032121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%
5min128685-286850.6241.3393.440.621.3393.64
215297-152970.3330.33
330549-305490.6640.66
4165917-1659173.6083.61
589102-891021.9371.94
638057-380570.8270.83
10min1253322-2533225.5087.4745.085.517.4845.12
2181848-1818483.9543.95
3298432-2984326.4896.49
4607217-60721713.20313.21
5443030-4430309.6339.64
6278247-2782476.0506.05
15min1524157-52415711.39714.4331.4711.4114.4431.50
2465429-46542910.12010.13
3570789-57078912.41112.42
41028792-102879222.36922.40
5783644-78364417.03917.06
6609076-60907613.24313.25
20min1740680-74068016.10520.2225.4916.1320.2625.52
2715931-71593115.56615.59
3820374-82037417.83717.87
41352987-135298729.41829.48
51020540-102054022.19022.24
6928383-92838320.18620.22
30min11146275-114627524.92328.4415.8624.9828.5115.89
21059481-105948123.03623.09
31231175-123117526.76926.83
41637795-163779535.61135.72
51380311-138031130.01230.10
61392831-139283130.28430.35
45min11397579-139757930.38833.4711.4630.4933.5811.50
21287900-128790028.00328.09
31548713-154871333.67433.78
41791093-179109338.94439.12
51599013-159901334.76734.90
61610383-161038335.01535.13
60min11518539-151853933.01836.1910.0633.1736.3710.10
21422989-142298930.94031.08
31701104-170110436.98737.15
41890042-189004241.09541.33
51715637-171563737.30337.50
61739287-173928737.81737.99
极限11881042-188104240.89942.143.1941.1042.383.28
21872369-187236940.71140.90
31924390-192439041.84242.07
42036160-203616044.27244.58
51979590-197959043.04243.30
61935963-193596342.09442.33
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.601170518117026011694361166638116564211684990.19
228.641182306118126511817860.07
单位质量响应值RSD%判断
40856.6141263.480.71数据可信
加速3月-供试品溶液-2024032221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%
5min147204-472041.8622.6451.851.862.6451.95
274131-741312.9242.92
353866-538662.1252.12
498112-981123.8703.87
5111009-1110094.3794.38
617055-170550.6730.67
10min1235365-2353659.28411.9524.629.2911.9524.63
2292132-29213211.52311.53
3353167-35316713.93113.93
4382565-38256515.09115.10
5357611-35761114.10614.11
6196818-1968187.7647.76
15min1438154-43815417.28321.5018.5617.3021.5218.57
2562335-56233522.18222.21
3617647-61764724.36324.39
4630558-63055824.87324.90
5621044-62104424.49724.53
6400000-40000015.77815.79
20min1591493-59149323.33228.9415.0023.3829.0015.02
2784144-78414430.93130.99
3801142-80114231.60231.67
4820737-82073732.37432.45
5810531-81053131.97232.04
6593315-59331523.40423.44
30min1833136-83313632.86436.8910.4632.9537.0010.48
21006320-100632039.69539.81
31002095-100209539.52839.65
41028519-102851940.57140.70
5943326-94332637.21037.34
6797213-79721331.44731.53
45min1960751-96075137.89740.067.9638.0440.247.99
21075846-107584642.43742.62
31071915-107191542.28242.47
41094652-109465243.17943.37
51003692-100369239.59139.78
6887332-88733235.00135.13
60min11009444-100944439.81841.826.6140.0242.066.64
21113957-111395743.94144.19
31105774-110577443.61843.87
41133692-113369244.71944.99
51044856-104485641.21541.47
6953834-95383437.62537.81
极限11186219-118621946.79147.090.7947.0647.400.85
21197811-119781147.24847.57
31196418-119641847.19347.52
41207447-120744747.62947.97
51194579-119457947.12147.44
61180806-118080646.57846.83
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.602024268202486920247622021483202071020232180.10
228.642043485204147120424780.07
单位质量响应值RSD%判断
70741.8971315.570.58数据可信
加速3月-供试品溶液-2024032221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%
5min161047-610471.3151.9249.171.321.9249.20
2102169-1021692.2012.20
371216-712161.5341.53
4131179-1311792.8262.83
5142388-1423883.0673.07
627838-278380.6000.60
10min1307417-3074176.6238.5725.196.628.5725.23
2384228-3842288.2788.28
3466695-46669510.05410.06
4506128-50612810.90410.91
5466942-46694210.05910.06
6254444-2544445.4825.48
15min1586870-58687012.64315.8519.2812.6615.8719.28
2760465-76046516.38316.40
3841083-84108318.12018.14
4858782-85878218.50118.52
5836017-83601718.01118.03
6531914-53191411.45911.47
20min1811308-81130817.47821.7415.5017.5121.7815.51
21076677-107667723.19523.24
31111088-111108823.93623.99
41132328-113232824.39424.45
51117281-111728124.07024.12
6806098-80609817.36617.40
30min11182769-118276925.48128.5210.7625.5428.6010.79
21415669-141566930.49830.58
31430673-143067330.82130.91
41456564-145656431.37931.47
51342247-134224728.91629.01
61114750-111475024.01524.07
45min11427051-142705130.74332.088.0230.8532.218.04
21565106-156510633.71733.85
31579238-157923834.02234.16
41602957-160295734.53334.68
51471910-147191031.71031.85
61288561-128856127.76027.86
60min11544161-154416133.26634.336.5633.4234.516.59
21663056-166305635.82836.02
31665713-166571335.88536.08
41700599-170059936.63636.84
51566968-156696833.75833.95
61420753-142075330.60830.75
极限11901573-190157340.96640.950.8941.1841.190.94
21905183-190518341.04441.29
31904857-190485741.03741.29
41920039-192003941.36441.63
51904215-190421541.02341.27
61869472-186947240.27440.47
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.601161727116139711617161160786116103511613320.04
228.641171833117241511721240.04
单位质量响应值RSD%判断
40606.0140926.120.56数据可信
加速3月-供试品溶液-2024032221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%
5min173157-731572.9073.0343.452.913.0343.38
2110108-1101084.3754.37
3103781-1037814.1234.12
416585-165850.6590.66
574405-744052.9562.96
679516-795163.1593.16
10min1299605-29960511.90311.8043.8711.9111.8143.86
2431517-43151717.14417.15
3405289-40528916.10216.11
471867-718672.8552.86
5332699-33269913.21813.22
6241303-2413039.5879.59
15min1552283-55228321.94222.5522.9621.9722.5722.98
2672528-67252826.71926.76
3695885-69588527.64727.68
4329280-32928013.08213.09
5586618-58661823.30623.33
6568435-56843522.58422.61
20min1743755-74375529.54929.3218.8729.6129.3818.88
2777904-77790430.90630.99
3910959-91095936.19236.27
4487095-48709519.35219.38
5723632-72363228.75028.82
6784881-78488131.18331.24
30min11000292-100029239.74136.9812.1039.8537.1012.12
2885207-88520735.16935.30
31100877-110087743.73843.88
4767902-76790230.50930.57
5898899-89889935.71335.83
6932274-93227437.03937.15
45min11121903-112190344.57340.769.3944.7540.939.40
2945316-94531637.55737.75
31161791-116179146.15846.37
4920853-92085336.58536.70
51009471-100947140.10640.28
6996262-99626239.58139.75
60min11173260-117326046.61342.818.9446.8643.068.95
2983810-98381039.08739.34
31202556-120255647.77748.07
4969927-96992738.53538.71
51090550-109055043.32743.57
61045508-104550841.53841.78
极限11225878-122587848.70447.842.4249.0348.152.49
21194580-119458047.46047.78
31250611-125061149.68650.06
41171007-117100746.52446.76
51197437-119743747.57447.89
61184985-118498547.07947.39
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.602014989201397520144422013919201379020142230.03
228.642037928203866320382960.03
单位质量响应值RSD%判断
70427.3871169.550.75数据可信
加速3月-供试品溶液-2024032221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%
5min197406-974062.1052.2641.582.112.2641.64
2146662-1466623.1703.17
3146123-1461233.1583.16
427884-278840.6030.60
5102276-1022762.2112.21
6106548-1065482.3032.30
10min1400635-4006358.6598.5945.668.668.5945.63
2580009-58000912.53612.54
3557001-55700112.03912.04
485829-858291.8551.86
5442811-4428119.5719.57
6317064-3170646.8536.86
15min1759318-75931816.41216.8524.4216.4316.8724.44
2925579-92557920.00520.03
3978365-97836521.14621.17
4434416-4344169.3899.39
5806331-80633117.42817.45
6774174-77417416.73316.75
20min11043604-104360422.55622.3520.4022.6022.4020.42
21093618-109361823.63723.70
31304951-130495128.20528.27
4656842-65684214.19714.22
51017644-101764421.99522.04
61088770-108877023.53223.58
30min11452496-145249631.39429.0113.9531.4829.0913.97
21280423-128042327.67427.77
31627249-162724935.17135.28
41067487-106748723.07223.12
51295397-129539727.99828.08
61329656-132965628.73928.82
45min11686998-168699836.46233.1110.7636.6033.2410.78
21418426-141842630.65730.80
31771041-177104138.27838.44
41341329-134132928.99129.07
51511222-151122232.66332.79
61461778-146177831.59431.72
60min11816719-181671939.26635.6710.3939.4635.8610.41
21512801-151280132.69732.89
31881036-188103640.65640.89
41452747-145274731.39931.53
51675061-167506136.20436.39
61564577-156457733.81634.00
极限11993746-199374643.09241.923.4043.3542.173.46
21925065-192506541.60741.86
32039621-203962144.08344.38
41864968-186496840.30940.49
51928217-192821741.67641.92
61885855-188585540.76041.00
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.601162594116219511610841162280116183711619980.05
228.641173081117303511730580.01
单位质量响应值RSD%判断
40629.3040958.730.58数据可信
加速3月-供试品溶液-2024032321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%
5min150071-500711.9882.1436.921.992.1436.96
256319-563192.2362.24
373877-738772.9332.93
416728-167280.6640.66
564810-648102.5732.57
661569-615692.4442.44
10min1252500-25250010.02511.9128.4010.0311.9228.40
2432267-43226717.16217.17
3337694-33769413.40713.41
4177053-1770537.0297.03
5300516-30051611.93111.94
6300489-30048911.93011.93
15min1523860-52386020.79920.8613.9420.8220.8813.96
2639646-63964625.39625.43
3546542-54654221.69921.73
4414803-41480316.46916.48
5533288-53328821.17321.20
6493928-49392819.61019.63
20min1682645-68264527.10326.848.9227.1626.908.93
2763415-76341530.31030.38
3716044-71604428.42928.49
4590710-59071023.45323.49
5666055-66605526.44426.50
6637474-63747425.30925.37
30min1871667-87166734.60733.595.4034.7133.705.42
2906685-90668535.99836.12
3863328-86332834.27634.39
4773348-77334830.70430.78
5834193-83419333.12033.22
6827485-82748532.85332.95
45min1954966-95496637.91536.723.9738.0736.883.99
2965293-96529338.32538.51
3929202-92920236.89237.06
4861320-86132034.19734.33
5913932-91393236.28536.44
6924695-92469536.71336.87
60min1996179-99617939.55138.493.2039.7738.713.22
2996558-99655839.56639.81
3978781-97878138.86039.09
4915785-91578536.35936.55
5951965-95196537.79538.01
6977988-97798838.82939.04
极限11204215-120421547.81046.811.2548.1047.101.26
21179189-117918946.81747.13
31173992-117399246.61046.90
41161176-116117646.10246.35
51184855-118485547.04247.32
61171221-117122146.50046.78
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.602022357202251120209112021781202185220218820.04
228.642037717203793120378240.01
单位质量响应值RSD%判断
70695.1771153.070.46数据可信
加速3月-供试品溶液-2024032321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%
5min171132-711321.5351.5932.081.531.5932.14
277359-773591.6691.67
393206-932062.0112.01
428342-283420.6110.61
589239-892391.9251.93
684078-840781.8141.81
10min1336678-3366787.2648.5028.987.278.5028.98
2573640-57364012.37612.38
3441247-4412479.5209.52
4228496-2284964.9304.93
5393183-3931838.4838.49
6390939-3909398.4348.44
15min1719168-71916815.51615.4114.7815.5315.4214.79
2877222-87722218.92618.95
3742877-74287716.02716.05
4555387-55538711.98211.99
5728387-72838715.71515.73
6661385-66138514.26914.29
20min1960520-96052020.72320.299.5920.7620.339.62
21066830-106683023.01723.07
3999324-99932421.56021.61
4814078-81407817.56417.59
5930921-93092120.08520.13
6871367-87136718.80018.84
30min11261494-126149427.21726.225.9627.2926.295.98
21307346-130734628.20628.30
31250296-125029626.97527.06
41106712-110671223.87723.94
51195762-119576225.79825.88
61168848-116884825.21825.29
45min11430884-143088430.87129.654.2530.9929.774.26
21436107-143610730.98431.12
31393596-139359630.06730.19
41282016-128201627.65927.76
51348688-134868829.09829.22
61354118-135411829.21529.33
60min11529576-152957633.00031.673.6333.1731.843.65
21507868-150786832.53232.72
31493661-149366132.22632.40
41385777-138577729.89830.04
51433445-143344530.92631.09
61456574-145657431.42531.59
极限11934082-193408241.72840.561.6241.9540.781.62
21878147-187814740.52140.77
31877238-187723840.50140.73
41849649-184964939.90640.10
51886722-188672240.70640.93
61853708-185370839.99440.21
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.601169522116869211688971168646116746711686450.07
228.641177185117692311770540.02
单位质量响应值RSD%判断
40861.7141098.250.41数据可信
加速3月-供试品溶液-2024032321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%
5min1112034-1120344.4282.5156.684.432.5156.76
219305-193050.7630.76
359857-598572.3662.37
426631-266311.0531.05
573085-730852.8882.89
689957-899573.5553.56
10min1414128-41412816.36712.1926.0716.3712.2026.07
2305104-30510412.05812.06
3296193-29619311.70611.71
4170197-1701976.7276.73
5313743-31374312.40012.40
6351606-35160613.89613.90
15min1636522-63652225.15721.6012.1725.1921.6212.18
2570153-57015322.53422.55
3486984-48698419.24719.27
4476912-47691218.84918.86
5504228-50422819.92819.95
6603591-60359123.85523.88
20min1757431-75743129.93528.679.4230.0128.739.43
2780252-78025230.83730.90
3640361-64036125.30825.36
4688293-68829327.20327.25
5672095-67209526.56326.62
6813971-81397132.17032.24
30min1859156-85915633.95635.8810.9134.0835.9910.88
2974707-97470738.52238.63
3795946-79594631.45731.56
4965840-96584038.17238.26
5812604-81260432.11632.22
61038971-103897141.06241.18
45min1912447-91244736.06239.2611.0136.2439.4310.99
21046991-104699141.37941.55
3887981-88798135.09535.24
41084742-108474242.87143.02
5891661-89166135.24035.40
61136760-113676044.92745.12
60min1948059-94805937.46941.0610.3137.7141.3010.28
21087485-108748542.98043.22
3943411-94341137.28637.49
41129246-112924644.63044.85
5944182-94418237.31637.53
61181750-118175046.70546.97
极限11182388-118238846.73047.182.2147.0447.492.24
21197446-119744647.32647.64
31159236-115923645.81546.09
41216321-121632148.07248.37
51177477-117747746.53646.81
61230360-123036048.62648.97
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.602027630202654520262872026864202432920263310.07
228.642045179204484020450100.02
单位质量响应值RSD%判断
70850.7371403.980.56数据可信
加速3月-供试品溶液-2024032321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%
5min1149816-1498163.2231.8851.953.221.8851.95
230809-308090.6630.66
383436-834361.7951.79
442559-425590.9160.92
596892-968922.0842.08
6119876-1198762.5792.58
10min1561245-56124512.0748.8227.6212.088.8227.63
2406125-4061258.7378.74
3391034-3910348.4128.42
4217915-2179154.6884.69
5410027-4100278.8218.82
6472327-47232710.16110.17
15min1883334-88333419.00316.0613.5719.0316.0813.57
2782613-78261316.83716.85
3660739-66073914.21514.23
4639417-63941713.75613.77
5678068-67806814.58814.61
6834434-83443417.95117.97
20min11069166-106916623.00121.7510.4723.0621.7910.48
21089560-108956023.44023.48
3887218-88721819.08719.13
4947833-94783320.39120.42
5921729-92172919.82919.87
61149320-114932024.72624.78
30min11258852-125885227.08228.1411.3527.1828.2311.34
21403754-140375430.19930.28
31141089-114108924.54924.62
41370740-137074029.48929.56
51157149-115714924.89424.97
61517973-151797332.65732.75
45min11373731-137373129.55431.8711.5729.6932.0011.55
21556008-155600833.47533.61
31314786-131478628.28528.40
41604415-160441534.51634.63
51315556-131555628.30228.42
61724828-172482837.10737.25
60min11450344-145034431.20234.0411.1831.3934.2211.16
21653319-165331935.56835.76
31423492-142349230.62430.78
41712124-171212436.83437.01
51418021-141802130.50630.67
61836630-183663039.51239.72
极限11904006-190400640.96241.272.8041.2041.512.83
21925021-192502141.41441.66
31854402-185440239.89440.11
41950769-195076941.96842.20
51874473-187447340.32640.54
62002045-200204543.07143.35
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