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%
128.515843055841465844175850595852635846380.09
228.635801205803015802100.03
单位质量响应值RSD%判断
20506.4220265.810.84数据可信
供试品溶液-2024032421批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1152343-15234312.32711.399.8412.3311.399.82
2126542-12654210.23910.24
3128103-12810310.36610.37
4157877-15787712.77512.77
5149091-14909112.06412.06
6130813-13081310.58510.58
10min1375867-37586730.41429.615.3230.4429.645.32
2333466-33346626.98327.01
3367318-36731829.72229.75
4391390-39139031.67031.70
5370205-37020529.95629.98
6357610-35761028.93728.96
15min1551236-55123644.60441.653.9244.7041.743.92
2496994-49699440.21540.30
3497562-49756240.26140.35
4508049-50804941.11041.21
5513175-51317541.52441.62
6521563-52156342.20342.29
20min1628175-62817550.83046.904.4851.0247.094.46
2567005-56700545.88046.05
3571846-57184646.27246.45
4552278-55227844.68844.88
5575230-57523046.54646.73
6583380-58338047.20547.39
30min1649169-64916952.52849.603.7452.8449.893.74
2594365-59436548.09448.37
3607768-60776849.17849.46
4584983-58498347.33547.62
5624854-62485450.56150.85
6616578-61657849.89150.18
45min1648555-64855552.47949.954.1052.9050.354.09
2599600-59960048.51748.90
3616512-61651249.88650.28
4578234-57823446.78947.18
5634366-63436651.33151.73
6626634-62663450.70551.10
60min1651092-65109252.68449.993.9053.2250.503.89
2602655-60265548.76549.25
3614566-61456649.72850.23
4581827-58182747.07947.58
5632479-63247951.17851.69
6624462-62446250.52951.04
极限1653719-65371952.89751.931.4253.5552.551.44
2633379-63337951.25151.85
3647063-64706352.35852.97
4629672-62967250.95151.55
5646528-64652852.31552.94
6640456-64045651.82352.45
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.511009394100883310095521010063100992510095530.05
228.631003619100324510034320.03
单位质量响应值RSD%判断
35410.4935048.270.73数据可信
供试品溶液-2024032421批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1263620-26362013.06512.1010.3513.0712.1010.36
2218372-21837210.82310.82
3219308-21930810.86910.87
4275802-27580213.66913.67
5259991-25999112.88512.89
6227523-22752311.27611.28
10min1650517-65051732.24031.585.1832.2731.615.19
2580040-58004028.74728.77
3637170-63717031.57931.60
4680333-68033333.71833.75
5645825-64582532.00832.04
6629183-62918331.18331.21
15min1954825-95482547.32244.263.9947.4244.353.99
2861643-86164342.70442.79
3860509-86050942.64742.74
4879014-87901443.56543.67
5892138-89213844.21544.31
6909663-90966345.08345.18
20min11088425-108842553.94349.774.6254.1549.974.60
2980168-98016848.57848.76
3987023-98702348.91849.11
4953642-95364247.26347.47
5999150-99915049.51949.72
61017323-101732350.41950.61
30min11124261-112426155.71952.643.9256.0452.943.91
21026432-102643250.87151.16
31050208-105020852.04952.35
41010962-101096250.10450.41
51086841-108684153.86554.17
61073776-107377653.21753.52
45min11123632-112363255.68852.944.2156.1453.364.19
21037465-103746551.41751.82
31063238-106323852.69553.11
4999627-99962749.54249.96
51100390-110039054.53654.96
61085126-108512653.78054.20
60min11128196-112819655.91453.014.1156.4953.554.10
21041159-104115951.60152.12
31062386-106238652.65353.18
41003832-100383249.75150.28
51097880-109788054.41254.96
61083887-108388753.71854.26
极限11133113-113311356.15855.261.3256.8655.921.34
21101058-110105854.56955.20
31121979-112197955.60656.25
41095007-109500754.26954.91
51125071-112507155.75956.43
61114017-111401755.21155.88
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%
128.515873235873055870665865515836885863870.27
228.635796965804545800750.10
单位质量响应值RSD%判断
20567.7720261.091.07数据可信
供试品溶液-2024032421批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1165402-16540213.36512.6921.5913.3712.6921.59
2111899-1118999.0429.04
3143474-14347411.59411.59
4173156-17315613.99213.99
5210277-21027716.99216.99
6138105-13810511.16011.16
10min1382025-38202530.87028.357.5130.9028.387.50
2317884-31788425.68725.71
3332055-33205526.83226.86
4333080-33308026.91526.95
5368983-36898329.81629.85
6371116-37111629.98830.01
15min1521490-52149042.13938.356.5342.2438.446.53
2466018-46601837.65737.73
3442837-44283735.78435.87
4440948-44094835.63135.72
5484721-48472139.16839.27
6491207-49120739.69239.78
20min1577794-57779446.68943.516.6446.8843.686.63
2554429-55442944.80144.96
3496550-49655040.12440.29
4491010-49101039.67739.85
5557015-55701545.01045.20
6553676-55367644.74044.92
30min1623071-62307150.34847.207.4950.6447.477.47
2617142-61714249.86950.13
3537575-53757543.43943.69
4520725-52072542.07842.34
5607576-60757649.09649.39
6598286-59828648.34548.62
45min1629617-62961750.87748.307.1551.2848.677.13
2619786-61978650.08250.45
3555230-55523044.86645.22
4532587-53258743.03643.39
5632636-63263651.12151.52
6616152-61615249.78950.18
60min1630307-63030750.93348.486.4451.4548.976.43
2622070-62207050.26750.75
3557567-55756745.05545.51
4544037-54403743.96144.41
5627825-62782550.73251.25
6618277-61827749.96050.46
极限1640453-64045351.75251.562.1152.3952.152.13
2637448-63744851.51052.10
3613793-61379349.59850.15
4636136-63613651.40451.95
5652000-65200052.68553.31
6648406-64840652.39553.00
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.511014988101567510150771014392101025510140770.22
228.631000816100213710014760.10
单位质量响应值RSD%判断
35569.1734979.951.19数据可信
供试品溶液-2024032421批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1290971-29097114.40313.5322.2814.4013.5322.28
2192042-1920429.5069.51
3249905-24990512.37012.37
4299888-29988814.84414.84
5369010-36901018.26618.27
6238403-23840311.80111.80
10min1671402-67140233.23430.208.0033.2730.238.01
2550288-55028827.23927.26
3576902-57690228.55628.58
4575061-57506128.46528.50
5643299-64329931.84331.88
6643634-64363431.85931.89
15min1911400-91140045.11440.726.9745.2240.816.97
2805877-80587739.89039.97
3765734-76573437.90337.99
4760382-76038237.63837.73
5842610-84261041.70941.82
6849592-84959242.05442.15
20min11005298-100529849.76246.126.8749.9746.306.86
2958733-95873347.45747.63
3859475-85947542.54342.72
4845660-84566041.86042.04
5965464-96546447.79047.99
6955414-95541447.29247.48
30min11083786-108378653.64750.077.8253.9650.367.80
21068018-106801852.86653.14
3928700-92870045.97046.24
4896264-89626444.36444.64
51058670-105867052.40352.71
61033172-103317251.14151.44
45min11092222-109222254.06451.127.4054.5051.527.39
21071896-107189653.05853.45
3957575-95757547.39947.77
4916363-91636345.35945.73
51096475-109647554.27554.70
61062107-106210752.57452.98
60min11094816-109481654.19351.366.7854.7551.876.78
21075574-107557453.24053.75
3960928-96092847.56548.04
4935585-93558546.31146.78
51090721-109072153.99054.54
61067352-106735252.83353.36
极限11113390-111339055.11254.942.0555.7955.572.09
21107252-110725254.80855.44
31069621-106962152.94653.53
41106870-110687054.78955.36
51134735-113473556.16956.84
61127790-112779055.82556.47
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.515966205969415958295943815952125957970.18
228.635980015990395985200.13
单位质量响应值RSD%判断
20897.8320905.340.03数据可信
供试品溶液-2024032521批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1189977-18997714.99311.4915.0814.9911.4915.07
2133449-13344910.53210.53
3137561-13756110.85610.86
4134277-13427710.59710.60
5136247-13624710.75210.75
6142119-14211911.21611.22
10min1379020-37902029.91228.484.3729.9428.504.37
2348848-34884827.53027.55
3336234-33623426.53526.56
4366825-36682528.94928.97
5371892-37189229.34929.37
6362378-36237828.59828.62
15min1479631-47963137.85238.813.8937.9538.903.88
2520306-52030641.06241.15
3481019-48101937.96138.04
4499720-49972039.43739.52
5502420-50242039.65039.74
6467882-46788236.92437.01
20min1525655-52565541.48444.166.5341.6744.346.50
2622257-62225749.10749.28
3565630-56563044.63844.81
4564263-56426344.53144.71
5559097-55909744.12344.30
6520587-52058741.08441.25
30min1570600-57060045.03147.606.3245.3147.876.29
2653815-65381551.59851.88
3630322-63032249.74450.01
4610980-61098048.21748.49
5603092-60309247.59547.87
6549903-54990343.39743.66
45min1608753-60875348.04248.725.1448.4249.105.12
2654605-65460551.66052.06
3636344-63634450.21950.60
4619144-61914448.86249.24
5623932-62393249.24049.62
6561180-56118044.28744.65
60min1616972-61697248.69049.074.1149.1749.564.11
2651761-65176151.43651.95
3636157-63615750.20450.69
4622308-62230849.11149.60
5627812-62781249.54650.04
6575983-57598345.45645.91
极限1641467-64146750.62350.661.5951.2151.251.60
2653776-65377651.59552.22
3651586-65158651.42252.02
4628066-62806649.56650.17
5643820-64382050.80951.41
6632512-63251249.91750.47
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.511029890102851910260521024622102655310271270.21
228.631023048102452410237860.11
单位质量响应值RSD%判断
36026.9035759.200.53数据可信
供试品溶液-2024032521批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1331286-33128616.11512.2615.5516.1112.2615.54
2230549-23054911.21511.21
3236788-23678811.51811.52
4232496-23249611.30911.31
5235650-23565011.46311.46
6245267-24526711.93111.93
10min1658904-65890432.05230.574.2132.0930.604.21
2612828-61282829.81029.84
3584996-58499628.45628.48
4639114-63911431.08931.11
5646158-64615831.43131.46
6629078-62907830.60130.63
15min1829511-82951140.35041.564.4240.4641.664.41
2915519-91551944.53444.63
3836682-83668240.69940.79
4865359-86535942.09442.19
5870347-87034742.33742.43
6808815-80881539.34439.44
20min1910473-91047344.28947.136.7044.4947.326.67
21081524-108152452.60952.80
3977462-97746247.54747.73
4975944-97594447.47347.66
5967970-96797047.08647.28
6899609-89960943.76043.94
30min1985469-98546947.93750.776.4748.2351.066.45
21135068-113506855.21455.52
31089889-108988953.01653.30
41056802-105680251.40751.70
51044894-104489450.82751.12
6950138-95013846.21846.50
45min11053534-105353451.24851.965.2651.6552.365.25
21135164-113516455.21955.65
31099580-109958053.48853.89
41072230-107223052.15752.56
51079945-107994552.53252.94
6968622-96862247.11747.50
60min11064661-106466151.78952.344.1952.3052.864.19
21131214-113121455.02655.58
31100317-110031753.52354.05
41074472-107447252.26652.79
51088191-108819152.93453.46
6997211-99721148.50848.99
极限11115861-111586154.28054.311.4154.9154.951.43
21134298-113429855.17655.85
31132493-113249355.08955.73
41097846-109784653.40354.04
51119673-111967354.46555.11
61099275-109927553.47354.07
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.515937095928665928275936325924715931010.10
228.636024046020886022460.04
单位质量响应值RSD%判断
20803.2621035.490.79数据可信
供试品溶液-2024032521批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1135681-13568110.69912.8114.5310.7012.8114.53
2140879-14087911.10911.11
3160405-16040512.64812.65
4201599-20159915.89715.90
5168148-16814813.25913.26
6168155-16815513.26013.26
10min1314531-31453124.80228.528.7924.8328.558.79
2342439-34243927.00227.03
3378306-37830629.83129.86
4366692-36669228.91528.95
5408076-40807632.17832.21
6359725-35972528.36628.40
15min1437169-43716934.47238.437.4034.5538.527.40
2476205-47620537.55037.64
3534381-53438142.13842.23
4462690-46269036.48536.58
5518422-51842240.87940.98
6495535-49553539.07539.17
20min1499739-49973939.40643.547.7239.5643.727.70
2549710-54971043.34743.51
3607844-60784447.93148.12
4506438-50643839.93440.12
5567436-56743644.74444.94
6581878-58187845.88346.06
30min1545602-54560243.02346.697.8243.2746.967.80
2580244-58024445.75446.02
3640920-64092050.53950.83
4533086-53308642.03642.31
5616570-61657048.61948.91
6635976-63597650.14950.43
45min1558463-55846344.03747.237.3544.3847.617.34
2588426-58842646.39946.77
3643200-64320050.71951.13
4538978-53897842.50042.86
5624679-62467949.25849.66
6640185-64018550.48150.87
60min1571529-57152945.06747.296.4945.5047.776.49
2594075-59407546.84547.31
3642771-64277150.68551.20
4541698-54169842.71543.17
5611182-61118248.19448.70
6636972-63697250.22750.73
极限1625772-62577249.34450.151.7549.8850.741.80
2634107-63410750.00250.57
3643595-64359550.75051.38
4620530-62053048.93149.48
5644171-64417150.79551.41
6647930-64793051.09251.71
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%
128.511021983102053510208331022843102093810214260.10
228.631028791102895510288730.02
单位质量响应值RSD%判断
35826.9435936.880.22数据可信
供试品溶液-2024032521批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1234605-23460511.41513.7814.9011.4213.7814.89
2243872-24387211.86611.87
3281303-28130313.68813.69
4352165-35216517.13617.14
5295916-29591614.39914.40
6291349-29134914.17714.18
10min1546477-54647726.59130.659.0626.6230.689.05
2593715-59371528.88928.92
3661670-66167032.19632.23
4637240-63724031.00731.05
5713066-71306634.69734.73
6626762-62676230.49730.53
15min1757581-75758136.86341.167.6336.9541.267.63
2825037-82503740.14540.24
3931606-93160645.33045.43
4800733-80073338.96239.07
5900825-90082543.83343.94
6859818-85981841.83741.94
20min1865457-86545742.11246.587.9342.2846.767.91
2950980-95098046.27346.45
31056985-105698551.43151.63
4874737-87473742.56342.76
5985762-98576247.96548.17
61009333-100933349.11249.30
30min1943430-94343045.90649.928.1446.1750.228.12
21002199-100219948.76549.05
31115887-111588754.29754.61
4919968-91996844.76445.05
51070024-107002452.06552.38
61104462-110446253.74154.04
45min1971915-97191547.29250.507.4947.6550.907.48
21015582-101558249.41649.81
31117939-111793954.39754.83
4929282-92928245.21745.60
51082968-108296852.69553.12
61109312-110931253.97754.40
60min1989158-98915848.13150.526.7648.6051.046.75
21026328-102632849.93950.44
31116802-111680254.34254.90
4933096-93309645.40345.89
51059833-105983351.57052.12
61103920-110392053.71554.26
极限11089365-108936553.00753.851.7453.5854.481.79
21106785-110678553.85454.47
31118445-111844554.42255.10
41078315-107831552.46953.06
51122278-112227854.60855.27
61125459-112545954.76355.42
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.515913025908675906505899115906665906790.09
228.635855485955075905281.20
单位质量响应值RSD%判断
20718.3120626.200.32数据可信
供试品溶液-2024032621批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1155667-15566712.42111.2718.6212.4211.2718.61
2180274-18027414.38514.38
3114967-1149679.1749.17
4114905-1149059.1699.17
5153813-15381312.27312.27
6127697-12769710.18910.19
10min1381402-38140230.43428.755.7630.4628.775.77
2364990-36499029.12429.16
3335279-33527926.75326.77
4338269-33826926.99227.01
5384070-38407030.64630.67
6357492-35749228.52628.55
15min1541911-54191143.24140.604.1543.3440.684.15
2477822-47782238.12738.22
3511298-51129840.79940.88
4513692-51369240.99041.07
5510647-51064740.74740.84
6497158-49715839.67039.76
20min1622972-62297249.70946.396.2549.9046.576.22
2533597-53359742.57842.76
3586314-58631446.78446.95
4619885-61988549.46349.63
5548936-54893643.80243.99
6576534-57653446.00446.18
30min1655933-65593352.34049.676.2552.6449.956.22
2570618-57061845.53245.81
3641556-64155651.19251.47
4650481-65048151.90452.19
5575052-57505245.88646.17
6641213-64121351.16551.44
45min1657061-65706152.43050.185.5052.8550.575.48
2593950-59395047.39447.77
3645740-64574051.52651.91
4654346-65434652.21352.61
5576413-57641345.99446.38
6645473-64547351.50551.90
60min1657723-65772352.48250.703.7853.0251.213.78
2601260-60126047.97748.46
3646233-64623351.56652.07
4654185-65418552.20052.71
5609414-60941448.62849.12
6643807-64380751.37251.88
极限1658154-65815452.51751.721.6653.1752.341.68
2628124-62812450.12150.71
3650780-65078051.92852.55
4655527-65552752.30752.94
5645627-64562751.51752.11
6650574-65057451.91252.53
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.511021340102115210205211019476102088310206740.08
228.631008843102652410176841.23
单位质量响应值RSD%判断
35800.5635546.070.51数据可信
供试品溶液-2024032621批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1267907-26790713.11211.9618.9113.1111.9618.92
2313959-31395915.36615.37
3198487-1984879.7159.71
4196925-1969259.6389.64
5266172-26617213.02713.03
6223237-22323710.92610.93
10min1659528-65952832.27930.635.7032.3130.665.71
2633978-63397831.02931.06
3584286-58428628.59728.62
4587009-58700928.73028.75
5669269-66926932.75632.79
6620786-62078630.38330.41
15min1939230-93923045.96943.204.1546.0743.304.14
2827889-82788940.52040.62
3888198-88819843.47143.56
4891583-89158343.63743.72
5886376-88637643.38243.48
6863215-86321542.24942.34
20min11079867-107986752.85249.486.2853.0649.676.25
2923441-92344145.19645.39
31015120-101512049.68349.86
41075559-107555952.64152.82
5952194-95219446.60346.80
61019610-101961049.90350.09
30min11137563-113756355.67652.816.4556.0053.126.42
2986134-98613448.26548.56
31113029-111302954.47554.77
41130040-113004055.30855.61
5994214-99421448.66048.96
61113396-111339654.49354.79
45min11138335-113833555.71453.325.4956.1653.745.47
21028275-102827550.32750.73
31119384-111938454.78655.20
41134094-113409455.50655.93
5999507-99950748.91949.33
61117162-111716254.67855.10
60min11138785-113878555.73653.833.8056.3054.363.80
21040188-104018850.91051.42
31119028-111902854.76955.30
41132285-113228555.41855.96
51054790-105479051.62552.14
61114234-111423454.53455.07
极限11140749-114074955.83255.121.4056.5255.781.43
21096506-109650653.66754.29
31128918-112891855.25355.91
41137403-113740355.66856.34
51124030-112403055.01455.65
61129713-112971355.29255.95
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.516011096014206010716008566022516013410.10
228.635850635856635853630.08
单位质量响应值RSD%判断
21092.2820445.792.21数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2024032621批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1162755-16275512.92913.1920.0812.9313.1920.09
2201256-20125615.98815.99
3183469-18346914.57514.57
4134873-13487310.71410.71
5119111-1191119.4629.46
6194724-19472415.46915.47
10min1358096-35809628.44828.786.6628.4828.816.68
2394050-39405031.30431.34
3375433-37543329.82529.86
4333291-33329126.47726.50
5336488-33648826.73126.75
6376452-37645229.90629.94
15min1506404-50640440.22938.693.1340.3238.783.13
2499959-49995939.71739.82
3489220-48922038.86438.96
4483532-48353238.41238.49
5479404-47940438.08438.16
6463711-46371136.83836.94
20min1590737-59073746.92944.465.2447.1144.645.22
2566987-56698745.04245.24
3555803-55580344.15444.34
4581345-58134546.18346.35
5555765-55576544.15144.32
6507068-50706840.28240.46
30min1629172-62917249.98247.955.6550.2748.235.63
2617695-61769549.07049.36
3614393-61439348.80849.09
4629573-62957350.01450.28
5590619-59061946.91947.18
6540378-54037842.92843.20
45min1635535-63553550.48848.635.6850.8849.025.66
2627370-62737049.83950.24
3631536-63153650.17050.56
4635501-63550150.48550.87
5594524-59452447.23047.60
6548646-54864643.58543.95
60min1633364-63336450.31548.765.2250.8249.255.20
2628035-62803549.89250.40
3633384-63338450.31750.82
4637465-63746550.64151.13
5593222-59322247.12647.60
6557483-55748344.28744.75
极限1654167-65416751.96851.311.5152.5951.911.53
2642731-64273151.05951.68
3653947-65394751.95052.57
4652632-65263251.84652.45
5642328-64232851.02751.60
6629495-62949550.00850.57
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.511032278103347910341561033083103416210334320.08
228.631010990101177110113800.06
单位质量响应值RSD%判断
36248.0535325.881.83数据可信
供试品溶液-2024032621批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1281746-28174613.74814.1521.1413.7514.1621.13
2359937-35993717.56317.56
3320445-32044515.63615.64
4232540-23254011.34711.35
5205728-20572810.03910.04
6339965-33996516.58916.59
10min1622227-62222730.36230.786.7830.3930.816.80
2689285-68928533.63433.67
3650896-65089631.76131.80
4579879-57987928.29528.32
5586108-58610828.59928.62
6656211-65621132.02032.06
15min1879016-87901642.89241.293.4642.9941.393.46
2878787-87878742.88142.99
3846747-84674741.31741.42
4839403-83940340.95941.05
5830028-83002840.50140.59
6803452-80345239.20539.31
20min11025028-102502850.01747.375.4450.2147.565.41
2989792-98979248.29748.51
3961260-96126046.90547.10
41010218-101021849.29449.47
5961282-96128246.90647.08
6876666-87666642.77742.97
30min11090216-109021653.19750.995.8753.5051.295.85
21072369-107236952.32752.64
31063864-106386451.91252.21
41092779-109277953.32253.61
51018776-101877649.71149.99
6932350-93235045.49445.78
45min11100217-110021753.68551.715.9054.1152.125.88
21087628-108762853.07153.50
31094234-109423453.39353.81
41104856-110485653.91254.32
51023885-102388549.96150.35
6947400-94740046.22946.62
60min11094908-109490853.42651.845.3353.9752.365.31
21091198-109119853.24553.80
31094741-109474153.41853.95
41104328-110432853.88654.41
51027071-102707150.11650.62
6962054-96205446.94447.44
极限11137990-113799055.52954.881.4256.1955.531.45
21120782-112078254.68955.36
31138080-113808055.53356.19
41135568-113556855.41056.06
51119126-111912654.60855.22
61097258-109725853.54154.14
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