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%
128.031150276114873811482271149571114771311489050.09
227.971144271114707711456740.18
单位质量响应值RSD%判断
40988.4140960.820.05数据可信
加速6月-供试品溶液-2024032121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%
5min1284944-28494411.26310.8623.3211.2610.8623.32
2336853-33685313.31513.31
3207783-2077838.2138.21
4200613-2006137.9307.93
5263717-26371710.42410.42
6355160-35516014.03814.04
10min1681680-68168026.94524.8010.0626.9624.8210.07
2678997-67899726.83926.86
3550941-55094121.77721.79
4569734-56973422.52022.53
5593162-59316223.44623.46
6690201-69020127.28227.30
15min1991290-99129039.18336.337.1639.2536.407.17
2891968-89196835.25735.32
3839362-83936233.17733.23
4921558-92155836.42636.48
5869354-86935434.36334.42
61001891-100189139.60239.67
20min11197403-119740347.33043.777.0147.4643.897.02
21080726-108072642.71842.84
31054993-105499341.70141.81
41058476-105847641.83841.95
51038244-103824441.03941.15
61213948-121394847.98448.12
30min11286067-128606750.83448.325.2651.0448.515.27
21223240-122324048.35148.55
31240615-124061549.03849.21
41141053-114105345.10245.28
51152683-115268345.56245.74
61291388-129138851.04551.26
45min11287258-128725850.88149.793.0851.1750.073.09
21278518-127851850.53650.81
31281960-128196050.67250.93
41232736-123273648.72648.98
51192698-119269847.14447.40
61285337-128533750.80551.11
60min11282492-128249250.69350.251.9851.0750.611.99
21274106-127410650.36150.72
31286705-128670550.85951.20
41280146-128014650.60050.94
51220870-122087048.25748.59
61283716-128371650.74151.13
极限11285395-128539550.80851.110.6051.2751.550.55
21289023-128902350.95151.40
31299505-129950551.36551.79
41300661-130066151.41151.83
51299336-129933651.35951.78
61284134-128413450.75851.23
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%
128.031996121198973919872391987485198671519894600.20
227.971980069198479719824330.17
单位质量响应值RSD%判断
70976.1070877.120.10数据可信
加速6月-供试品溶液-2024032121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%
5min1483283-48328310.42610.0824.3110.4310.0824.29
2580824-58082412.53112.53
3347920-3479207.5067.51
4336535-3365357.2607.26
5448121-4481219.6689.67
6607411-60741113.10413.10
10min11170682-117068225.25623.2610.2325.2723.2810.24
21171987-117198725.28425.31
3945595-94559520.40020.41
4980881-98088121.16121.17
51013058-101305821.85621.87
61188153-118815325.63325.65
15min11708569-170856936.86134.217.3836.9234.277.38
21532871-153287133.07033.13
31444889-144488931.17231.22
41595793-159579334.42734.47
51496413-149641332.28332.34
61736188-173618837.45637.52
20min12066349-206634944.57941.157.1544.7041.277.15
21864451-186445140.22440.34
31811981-181198139.09239.19
41823346-182334639.33739.44
51785533-178553338.52138.63
62094014-209401445.17645.30
30min12220887-222088747.91345.505.3848.1145.685.38
22107449-210744945.46645.65
32140417-214041746.17746.34
41970713-197071342.51642.69
51981363-198136342.74642.92
62232547-223254748.16548.37
45min12220095-222009547.89646.773.2448.1747.033.25
22201550-220155047.49647.76
32199689-219968947.45647.70
42118205-211820545.69845.94
52047322-204732244.16944.41
62220003-222000347.89448.18
60min12218609-221860947.86447.422.1348.2247.762.13
22201024-220102447.48547.82
32221821-222182147.93348.25
42216843-221684347.82648.14
52104559-210455945.40445.72
62225862-222586248.02148.38
极限12222458-222245847.94748.230.5748.3848.640.53
22222178-222217847.94148.36
32249759-224975948.53648.94
42247344-224734448.48448.88
52243138-224313848.39348.78
62228292-222829248.07348.52
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%
128.031153424115050411542231153158115423911531100.14
227.971158464115951411589890.07
单位质量响应值RSD%判断
41138.4241436.860.52数据可信
加速6月-供试品溶液-2024032221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%
5min1235321-2353219.23110.9719.549.2310.9719.55
2220342-2203428.6448.64
3294981-29498111.57111.57
4366913-36691314.39314.39
5308522-30852212.10312.10
6251959-2519599.8849.88
10min1548175-54817521.50425.7813.9321.5225.8013.93
2655044-65504425.69625.71
3630326-63032624.72624.75
4798584-79858431.32731.35
5723790-72379028.39328.41
6587507-58750723.04723.06
15min1856430-85643033.59637.9712.5033.6538.0312.49
21013815-101381539.77039.83
3908169-90816935.62535.69
41118020-111802043.85743.93
51082560-108256042.46642.53
6828923-82892332.51732.57
20min1982263-98226338.53245.2212.4438.6445.3412.44
21238508-123850848.58448.71
31184339-118433946.45946.58
41271187-127118749.86650.02
51276379-127637950.06950.21
6963094-96309437.78037.89
30min11092452-109245242.85448.409.4743.0348.609.47
21312392-131239251.48251.69
31316208-131620851.63251.83
41281031-128103150.25250.48
51324291-132429151.94952.17
61076389-107638942.22442.40
45min11170477-117047745.91549.296.2946.1649.576.30
21308846-130884651.34351.63
31310978-131097851.42751.71
41289217-128921750.57350.89
51318089-131808951.70652.01
61141722-114172244.78745.03
60min11228591-122859148.19550.014.5548.5150.374.58
21310971-131097151.42651.80
31319294-131929451.75352.12
41288323-128832350.53850.94
51321447-132144751.83752.23
61179884-117988446.28446.60
极限11277183-127718350.10150.951.4450.5051.401.46
21312859-131285951.50151.96
31322258-132225851.86952.32
41285615-128561550.43250.92
51310565-131056551.41151.89
61284676-128467650.39550.79
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%
128.031994755199776619975531998287199469519966110.09
227.972004303200472320045130.02
单位质量响应值RSD%判断
71231.2271666.540.44数据可信
加速6月-供试品溶液-2024032221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%
5min1398166-3981668.52710.2120.088.5310.2120.08
2373152-3731527.9927.99
3504956-50495610.81410.81
4628493-62849313.46013.46
5527499-52749911.29711.30
6427038-4270389.1469.15
10min1941985-94198520.17424.2514.1920.1924.2714.18
21126000-112600024.11524.13
31084963-108496323.23623.25
41384496-138449629.65129.67
51243928-124392826.64026.66
61012504-101250421.68421.70
15min11478480-147848031.66435.7912.6131.7135.8512.62
21750424-175042437.48837.54
31564945-156494533.51533.57
41931985-193198541.37641.45
51872401-187240140.10040.16
61428616-142861630.59630.65
20min11692939-169293936.25742.6212.5736.3642.7412.57
22138896-213889645.80745.92
32046409-204640943.82743.94
42195337-219533747.01647.16
52208153-220815347.29147.42
61659408-165940835.53935.64
30min11880261-188026140.26845.619.5940.4345.799.60
22266649-226664948.54348.74
32273256-227325648.68548.87
42215251-221525147.44347.66
52285893-228589348.95649.16
61855693-185569339.74239.90
45min12015163-201516343.15846.466.6343.3946.736.65
22259792-225979248.39748.67
32269678-226967848.60848.88
42232870-223287047.82048.12
52281143-228114348.85449.14
61957733-195773341.92842.16
60min12117229-211722945.34347.184.7245.6447.524.75
22271965-227196548.65749.01
32277823-227782348.78349.13
42231462-223146247.79048.17
52284724-228472448.93149.30
62033511-203351143.55043.85
极限12208152-220815247.29148.071.3247.6748.491.36
22266155-226615548.53348.97
32282287-228228748.87849.31
42226834-222683447.69148.15
52262142-226214248.44748.90
62221698-222169847.58147.95
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%
128.031142216115366611532981156581115342211518370.49
227.971161060116789211644760.42
单位质量响应值RSD%判断
41093.0141633.040.93数据可信
加速6月-供试品溶液-2024032321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%
5min1206664-2066648.0929.4819.468.099.4819.46
2262861-26286110.29310.29
3250903-2509039.8259.82
4280776-28077610.99410.99
5165486-1654866.4806.48
6286428-28642811.21611.22
10min1569590-56959022.30423.2314.6222.3223.2414.63
2549686-54968621.52421.54
3658057-65805725.76825.78
4610065-61006523.88923.91
5462297-46229718.10218.11
6709373-70937327.77727.80
15min1835530-83553032.71733.3211.7832.7733.3811.77
2762768-76276829.86829.92
3975920-97592038.21538.27
4870593-87059334.09034.15
5718006-71800628.11528.16
6942999-94299936.92536.99
20min11075234-107523442.10341.119.8842.2141.229.88
2927716-92771636.32736.43
31204382-120438247.16047.28
41058349-105834941.44241.56
5939078-93907836.77236.86
61094610-109461042.86242.99
30min11264036-126403649.49646.437.5449.6746.617.54
21072651-107265142.00242.17
31288894-128889450.47050.67
41232591-123259148.26548.45
51099887-109988743.06943.22
61156784-115678445.29745.49
45min11274268-127426849.89748.124.9550.1548.374.97
21151922-115192245.10645.34
31284586-128458650.30150.59
41278187-127818750.05150.31
51158429-115842945.36145.58
61225599-122559947.99148.26
60min11276575-127657549.98749.082.6650.3349.422.69
21210287-121028747.39247.70
31287252-128725250.40550.78
41277009-127700950.00450.35
51215576-121557647.59947.90
61254312-125431249.11649.47
极限11272322-127232249.82150.180.9250.2550.600.94
21280855-128085550.15550.54
31288964-128896450.47350.93
41301156-130115650.95051.38
51270397-127039749.74550.12
61275504-127550449.94550.38
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%
128.031977245199329319938662000793199243019915250.44
227.971995820201198620039030.58
单位质量响应值RSD%判断
71049.7771644.730.59数据可信
加速6月-供试品溶液-2024032321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%
5min1349184-3491847.4898.8120.447.498.8120.41
2444505-4445059.5339.53
3424436-4244369.1039.10
4479257-47925710.27910.28
5273966-2739665.8765.88
6492479-49247910.56210.56
10min1976359-97635920.94021.8314.9220.9521.8414.92
2942080-94208020.20520.22
31131637-113163724.27024.29
41045074-104507422.41422.43
5789189-78918916.92616.94
61222272-122227226.21426.23
15min11439534-143953430.87431.4111.7830.9231.4611.79
21310317-131031728.10228.15
31680265-168026536.03736.09
41493111-149311132.02332.08
51238640-123864026.56526.60
61625872-162587234.87034.93
20min11857526-185752639.83938.8110.0339.9438.9110.03
21593346-159334634.17334.27
32077989-207798944.56744.68
41819390-181939039.02139.13
51617592-161759234.69334.77
61890136-189013640.53840.66
30min12189009-218900946.94843.867.7247.1144.027.72
21841576-184157639.49639.65
32222086-222208647.65747.85
42123822-212382245.55045.72
51894392-189439240.62940.77
61998439-199843942.86143.05
45min12207240-220724047.33945.405.2447.5845.645.25
21979003-197900342.44442.66
32217543-221754347.56047.83
42202961-220296147.24747.50
51988551-198855142.64942.86
62105550-210555045.15845.42
60min12205560-220556047.30346.342.8047.6346.662.84
22081982-208198244.65244.94
32220777-222077747.62947.98
42200894-220089447.20347.53
52091091-209109144.84845.13
62163614-216361446.40346.74
极限12199166-219916647.16647.490.9847.5747.881.00
22213727-221372747.47847.84
32222251-222225147.66148.09
42253070-225307048.32248.73
52193906-219390647.05347.41
62203060-220306047.24947.66
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.031160731116193511594111156919115503611588060.25
227.971147415114367411455440.24
单位质量响应值RSD%判断
41341.6340956.170.67数据可信
长期6月-供试品溶液-2024032121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%
5min1295575-29557511.63411.839.8611.6311.829.86
2297286-29728611.70111.70
3315194-31519412.40612.41
4344099-34409913.54413.54
5297163-29716311.69611.70
6253387-2533879.9739.97
10min1654037-65403725.74325.505.0225.7625.525.01
2658974-65897425.93725.96
3690300-69030027.17027.19
4619836-61983624.39724.42
5664380-66438026.15026.17
6600388-60038823.63123.65
15min1941359-94135937.05236.265.7537.1136.325.74
2974497-97449738.35738.42
3972751-97275138.28838.35
4922803-92280336.32236.39
5857612-85761233.75633.82
6857699-85769933.75933.82
20min11175326-117532646.26143.768.6946.3943.888.68
21192480-119248046.93647.06
31138015-113801544.79344.92
41180710-118071046.47346.60
51022245-102224540.23640.36
6961364-96136437.84037.95
30min11280633-128063350.40648.387.1050.6148.587.09
21285226-128522650.58750.79
31235772-123577248.64048.84
41299251-129925151.13951.34
51209531-120953147.60847.79
61065039-106503941.92042.10
45min11283589-128358950.52349.973.1950.8150.243.21
21289192-128919250.74351.03
31280760-128076050.41150.70
41309018-130901851.52351.81
51261507-126150749.65349.92
61193042-119304246.95947.20
60min11296569-129656951.03350.671.1451.4051.031.16
21288328-128832850.70951.08
31283288-128328850.51150.88
41306797-130679751.43651.81
51285286-128528650.58950.94
61263282-126328249.72350.05
极限11270883-127088350.02250.661.3650.4851.101.35
21286043-128604350.61951.08
31281965-128196550.45950.91
41308797-130879751.51551.97
51306570-130657051.42751.86
61267863-126786349.90450.31
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.031994737199970219987371999258199327319971410.15
227.971989011197613819825740.46
单位质量响应值RSD%判断
71250.1270882.160.37数据可信
长期6月-供试品溶液-2024032121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%
5min1505122-50512210.87611.0610.0810.8811.0610.08
2506054-50605410.89610.90
3539915-53991511.62511.63
4590769-59076912.72012.72
5508041-50804110.93910.94
6432387-4323879.3109.31
10min11117625-111762524.06423.965.1224.0823.985.12
21135883-113588324.45724.48
31188545-118854525.59125.61
41062075-106207522.86822.89
51140491-114049124.55724.57
61031895-103189522.21822.23
15min11620840-162084034.89934.195.8534.9634.255.84
21685645-168564536.29536.35
31675476-167547636.07636.14
41591565-159156534.26934.33
51473983-147398331.73731.80
61479680-147968031.86031.91
20min12029317-202931743.69541.268.9743.8141.388.96
22066410-206641044.49344.61
31960815-196081542.22042.34
42034228-203422843.80043.92
51757143-175714337.83437.95
61649543-164954335.51735.62
30min12212369-221236947.63645.717.3547.8345.897.35
22226048-222604847.93148.12
32132076-213207645.90746.10
42251442-225144248.47748.67
52083728-208372844.86645.04
61831693-183169339.43939.60
45min12217197-221719747.74047.173.3348.0147.443.34
22221942-222194247.84248.12
32208871-220887147.56147.83
42271776-227177648.91549.19
52166679-216667946.65246.90
62059118-205911844.33644.57
60min12235688-223568848.13847.821.1848.4948.161.21
22223356-222335647.87348.23
32217151-221715147.73948.09
42254882-225488248.55148.90
52217587-221758747.74848.08
62176012-217601246.85347.16
极限12208788-220878847.55947.931.2947.9948.351.29
22222977-222297747.86448.30
32214108-221410847.67348.10
42262256-226225648.71049.14
52257585-225758548.61049.02
62189860-218986047.15147.53
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%
128.031140806114970811491781148144114786511471400.32
227.971149096114645211477740.17
单位质量响应值RSD%判断
40925.4441035.900.20数据可信
长期6月-供试品溶液-2024032221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%
5min1296995-29699511.73812.6511.1411.7412.6611.14
2274951-27495110.86610.87
3306904-30690412.12912.13
4372351-37235114.71614.72
5320068-32006812.64912.65
6349621-34962113.81713.82
10min1609516-60951624.08927.409.8024.1127.429.79
2612399-61239924.20324.22
3711916-71191628.13628.16
4778768-77876830.77830.80
5724979-72497928.65228.67
6722043-72204328.53628.56
15min1861107-86110734.03238.2410.3434.0938.3110.34
2862870-86287034.10234.16
31015563-101556340.13640.20
41092335-109233543.17043.25
51054448-105444841.67341.74
6919277-91927736.33136.40
20min11010819-101081939.94944.9810.7140.0745.1110.70
21045080-104508041.30341.42
31242581-124258149.10849.24
41258358-125835849.73249.88
51245226-124522649.21349.35
61026149-102614940.55540.69
30min11113377-111337744.00248.047.0844.1848.257.08
21175794-117579446.46946.65
31295476-129547651.19951.41
41302368-130236851.47151.70
51276566-127656650.45150.67
61130239-113023944.66844.87
45min11174921-117492146.43449.833.7546.6950.123.77
21270927-127092750.22850.49
31298509-129850951.31951.62
41304583-130458351.55951.88
51270631-127063150.21750.52
61245966-124596649.24249.52
60min11205511-120551147.64350.502.8147.9850.872.83
21287253-128725350.87451.22
31297896-129789651.29451.68
41297873-129787351.29351.70
51282692-128269250.69351.08
61295021-129502151.18151.54
极限11288375-128837550.91851.230.8751.3351.680.86
21300910-130091051.41351.84
31294969-129496951.17951.65
41301642-130164251.44251.93
51279642-127964250.57351.05
61311770-131177051.84352.28
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%
128.031976461199662719905371987691198520619873040.38
227.971985531198728219864060.07
单位质量响应值RSD%判断
70899.1871019.160.12数据可信
长期6月-供试品溶液-2024032221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%
5min1505721-50572110.90511.7911.6010.9111.8011.61
2466723-46672310.06410.06
3522863-52286311.27511.28
4640324-64032413.80813.81
5547153-54715311.79911.80
6598671-59867112.91012.91
10min11044519-104451922.52425.719.9722.5425.729.97
21051221-105122122.66922.69
31222736-122273626.36726.39
41339943-133994328.89528.92
51253210-125321027.02427.04
61240581-124058126.75226.77
15min11476186-147618631.83235.9310.6731.8936.0010.66
21479968-147996831.91431.97
31749854-174985437.73437.80
41887916-188791640.71140.78
51821124-182112439.27139.34
61583442-158344234.14534.21
20min11745862-174586237.64842.3810.8037.7642.5010.79
21800881-180088138.83438.94
32147292-214729246.30446.43
42173532-217353246.87047.01
52153204-215320446.43246.56
61770586-177058638.18138.30
30min11914906-191490641.29345.267.3441.4645.457.35
22024233-202423343.65143.82
32239625-223962548.29548.50
42252964-225296448.58348.80
52213028-221302847.72247.93
61948880-194888042.02642.21
45min12025921-202592143.68746.923.8543.9347.193.87
22188638-218863847.19647.44
32244268-224426848.39548.68
42255929-225592948.64748.95
52195534-219553447.34547.63
62145849-214584946.27346.53
60min12077691-207769144.80347.552.8845.1247.892.90
22215142-221514247.76748.09
32243885-224388548.38748.75
42242564-224256448.35948.74
52218221-221822147.83448.20
62231937-223193748.13048.46
极限12227893-222789348.04248.310.8448.4348.740.83
22247118-224711848.45748.86
32238006-223800648.26048.70
42249674-224967448.51248.97
52212684-221268447.71448.16
62266480-226648048.87449.29
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%
128.031150453115421411536711152475115252511526680.13
227.971134018113961411368160.35
单位质量响应值RSD%判断
41122.6540644.120.83数据可信
长期6月-供试品溶液-2024032321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%
5min1314224-31422412.44810.0920.1512.4510.0920.16
2177425-1774257.0297.03
3308963-30896312.24012.24
4229018-2290189.0739.07
5248434-2484349.8429.84
6250628-2506289.9299.93
10min1659245-65924526.11722.828.5526.1422.848.55
2545325-54532521.60421.62
3611488-61148824.22524.25
4560143-56014322.19122.21
5531344-53134421.05021.07
6548967-54896721.74821.76
15min1915017-91501736.25033.129.7836.3133.189.78
2861675-86167534.13734.18
3943186-94318637.36637.43
4772670-77267030.61030.66
5758245-75824530.03930.09
6765841-76584130.34030.39
20min11093819-109381943.33339.9411.2043.4640.0511.19
21092691-109269143.28943.39
31141851-114185145.23645.36
4918942-91894236.40536.51
5912638-91263836.15536.26
6888868-88886835.21435.32
30min11259778-125977849.90845.889.1250.1046.069.12
21259476-125947649.89650.07
31240588-124058849.14849.35
41071478-107147842.44842.61
51081642-108164242.85143.01
61035634-103563441.02841.19
45min11284272-128427250.87848.535.5651.1648.785.58
21262785-126278550.02750.29
31296989-129698951.38251.66
41216454-121645448.19248.43
51138409-113840945.10045.33
61151138-115113845.60445.83
60min11274662-127466250.49849.873.4250.8650.203.45
21278705-127870550.65851.00
31309689-130968951.88552.25
41277130-127713050.59550.91
51196783-119678347.41247.72
61215861-121586148.16848.47
极限11274428-127442850.48850.880.8250.9451.300.84
21281583-128158350.77251.20
31301207-130120751.54952.00
41292378-129237851.19951.60
51281544-128154450.77051.16
61274885-127488550.50650.89
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%
128.031991886199856419990221993215199345519952280.17
227.971962966197488219689240.43
单位质量响应值RSD%判断
71181.8870394.140.79数据可信
长期6月-供试品溶液-2024032321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%
5min1537679-53767911.6239.3320.8011.629.3320.82
2296748-2967486.4156.41
3524505-52450511.33811.34
4386455-3864558.3548.35
5419560-4195609.0709.07
6425386-4253869.1959.20
10min11135447-113544724.54521.398.6624.5621.408.65
2934277-93427720.19620.21
31048398-104839822.66322.68
4961805-96180520.79120.81
5911417-91141719.70219.72
6944929-94492920.42620.44
15min11582044-158204434.19931.139.9834.2631.189.98
21482440-148244032.04632.09
31627428-162742835.18035.24
41328512-132851228.71828.77
51304810-130481028.20628.25
61316178-131617828.45228.50
20min11888996-188899640.83437.5711.3240.9537.6811.30
21881544-188154440.67340.77
31972763-197276342.64542.76
41581596-158159634.18934.29
51573061-157306134.00534.10
61530426-153042633.08333.18
30min12174532-217453247.00643.179.2847.1943.349.28
22175224-217522447.02147.19
32142671-214267146.31846.50
41845241-184524139.88840.04
51860873-186087340.22640.38
61783548-178354838.55538.71
45min12219806-221980647.98545.675.8248.2545.905.83
22182123-218212347.17147.41
32242526-224252648.47648.74
42094438-209443845.27545.49
51961526-196152642.40242.62
61974834-197483442.69042.91
60min12203826-220382647.64046.953.5047.9847.273.52
22206207-220620747.69148.01
32260014-226001448.85449.20
42203544-220354447.63447.93
52060768-206076844.54744.84
62098153-209815345.35545.64
极限12202151-220215147.60347.980.7048.0348.380.70
22214411-221441147.86948.27
32244882-224488248.52748.95
42230538-223053848.21748.59
52216784-221678447.92048.28
62209996-220999647.77348.14
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