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%
128.071141863114136811401891140414114108911409850.07
228.181150272114852211493970.11
单位质量响应值RSD%判断
40647.8440787.690.25数据可信
供试品溶液-2024032221批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1174953-1749537.5027.5843.577.507.5843.57
2320545-32054513.74513.74
3144697-1446976.2056.20
4191355-1913558.2058.21
5120920-1209205.1855.18
6108596-1085964.6574.66
10min1495068-49506821.22823.3016.2321.2423.3116.22
2629709-62970927.00127.02
3465081-46508119.94219.95
4628071-62807126.93126.94
5435095-43509518.65718.67
6606895-60689526.02326.03
15min1616457-61645726.43326.303.3226.4826.363.30
2622551-62255126.69526.76
3609661-60966126.14226.19
4574666-57466624.64124.70
5628023-62802326.92926.97
6629288-62928826.98327.03
20min1600923-60092325.76726.124.0625.8626.214.07
2646164-64616427.70727.82
3621526-62152626.65126.74
4571423-57142324.50224.60
5603148-60314825.86325.95
6611338-61133826.21426.31
30min1588441-58844125.23224.652.1325.3724.792.09
2560729-56072924.04424.20
3587552-58755225.19425.33
4569851-56985124.43524.58
5580132-58013224.87625.00
6562760-56276024.13124.27
45min1582945-58294524.99625.172.2825.1725.352.26
2587443-58744325.18925.39
3584443-58444325.06125.23
4567045-56704524.31524.50
5591716-59171625.37225.54
6608274-60827426.08226.26
60min1579041-57904124.82924.093.7025.0524.313.69
2573279-57327924.58224.82
3574337-57433724.62724.84
4558407-55840723.94424.17
5522428-52242822.40122.61
6563089-56308924.14524.37
极限1570775-57077524.47424.201.8224.7324.471.83
2573133-57313324.57624.86
3568831-56883124.39124.65
4565355-56535524.24224.50
5544783-54478323.36023.61
6564070-56407024.18724.45
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%
128.071976788197655719741731975042197594819757020.06
228.181989082198644819877650.10
单位质量响应值RSD%判断
70384.8270538.150.16数据可信
供试品溶液-2024032221批-沙库巴曲-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1285966-2859666.6956.7247.296.696.7247.26
2537561-53756112.58412.58
3221712-2217125.1905.19
4320990-3209907.5147.51
5180582-1805824.2274.23
6175062-1750624.0984.10
10min1853200-85320019.97422.4618.8519.9822.4718.86
21167873-116787327.34027.36
3797317-79731718.66518.67
41117970-111797026.17226.18
5747969-74796917.51017.52
61071843-107184325.09225.10
15min11178326-117832627.58528.604.5527.6328.654.58
21304968-130496830.55030.62
31185980-118598027.76427.80
41212366-121236628.38228.44
51173582-117358227.47427.51
61276050-127605029.87329.92
20min11231995-123199528.84129.844.1128.9329.944.12
21364224-136422431.93732.05
31256583-125658329.41729.50
41230925-123092528.81628.92
51255238-125523829.38529.47
61309679-130967930.66030.76
30min11285571-128557130.09530.160.6430.2330.300.64
21289240-128924030.18130.35
31288736-128873630.17030.30
41298618-129861830.40130.55
51293392-129339230.27930.41
61274289-127428929.83129.98
45min11280706-128070629.98230.411.7330.1730.611.72
21308190-130819030.62530.85
31291340-129134030.23130.42
41270951-127095129.75329.96
51312142-131214230.71730.90
61331595-133159531.17331.37
60min11302126-130212630.48330.152.3530.7230.402.35
21313668-131366830.75331.03
31302685-130268530.49630.73
41290112-129011230.20230.45
51229057-122905728.77229.01
61290629-129062930.21430.47
极限11276211-127621129.87629.971.6130.1730.261.63
21310902-131090230.68831.01
31277423-127742329.90530.19
41290041-129004130.20030.50
51248085-124808529.21829.50
61277691-127769129.91130.21
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%
128.071141488114141711407071140518114246011413180.07
228.181147067114640311467350.05
单位质量响应值RSD%判断
40659.7140693.220.06数据可信
供试品溶液-2024032321批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1406658-40665817.45514.2016.1617.4514.2016.16
2345565-34556514.83314.83
3355725-35572515.26915.27
4332978-33297814.29214.29
5291179-29117912.49812.50
6252613-25261310.84310.84
10min1518667-51866722.26324.379.5422.2924.409.54
2620162-62016226.61926.64
3549523-54952323.58723.61
4635372-63537227.27227.30
5581634-58163424.96524.99
6501507-50150721.52621.54
15min1647012-64701227.77227.142.8827.8427.212.88
2599553-59955325.73425.80
3651424-65142427.96128.03
4632208-63220827.13627.21
5631810-63181027.11927.18
6632282-63228227.13927.19
20min1629367-62936727.01426.831.9327.1326.941.92
2602298-60229825.85225.96
3637144-63714427.34827.46
4630613-63061327.06827.18
5623789-62378926.77526.88
6627398-62739826.93027.03
30min1626423-62642326.88825.942.8727.0526.092.86
2600581-60058125.77925.93
3624320-62432026.79826.95
4588297-58829725.25125.41
5586437-58643725.17125.32
6600036-60003625.75525.90
45min1597982-59798225.66725.581.4425.8725.781.43
2592112-59211225.41525.61
3597977-59797725.66725.87
4589998-58999825.32425.53
5610815-61081526.21826.41
6586593-58659325.17825.37
60min1576683-57668324.75324.442.2825.0024.682.25
2543918-54391823.34623.59
3567524-56752424.36024.60
4576359-57635924.73924.98
5574648-57464824.66524.90
6577052-57705224.76925.00
极限1566487-56648724.31524.631.0724.6024.921.04
2570891-57089124.50424.78
3580047-58004724.89725.18
4574524-57452424.66024.95
5569624-56962424.45024.73
6582016-58201624.98225.25
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%
128.071976423197660819758861975667197878419766740.07
228.181985833198310319844680.10
单位质量响应值RSD%判断
70419.4570421.150.01数据可信
供试品溶液-2024032321批-沙库巴曲-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1586741-58674113.74411.6115.1713.7411.6115.14
2534933-53493312.53012.53
3507052-50705211.87711.88
4532352-53235212.47012.47
5425493-4254939.9679.97
6386231-3862319.0479.05
10min1863852-86385220.23522.8411.0920.2622.8611.08
21099570-109957025.75625.78
3930379-93037921.79321.81
41092182-109218225.58325.60
51006554-100655423.57723.59
6857456-85745620.08520.10
15min11188950-118895027.85028.333.1127.9128.383.11
21176222-117622227.55227.62
31210459-121045928.35428.41
41251386-125138629.31229.38
51257289-125728929.45129.51
61171203-117120327.43427.48
20min11256323-125632329.42829.723.1029.5329.833.10
21222958-122295828.64628.76
31256566-125656629.43429.54
41313882-131388230.77630.89
51320129-132012930.92231.03
61243053-124305329.11729.21
30min11340003-134000331.38830.811.3131.5430.961.31
21298494-129849430.41630.57
31316646-131664630.84130.99
41315542-131554230.81530.98
51326691-132669131.07631.23
61294227-129422730.31630.46
45min11311234-131123430.71430.701.8730.9230.911.87
21295959-129595930.35630.56
31305288-130528830.57530.78
41313694-131369430.77230.99
51355120-135512031.74231.95
61283275-128327530.05930.25
60min11312142-131214230.73530.531.5830.9930.781.57
21264431-126443129.61829.88
31298331-129833130.41230.67
41318699-131869930.88931.16
51318655-131865530.88831.15
61307241-130724130.62130.86
极限11276713-127671329.90630.110.5330.2130.420.54
21282950-128295030.05230.36
31280041-128004129.98330.29
41293141-129314130.29030.61
51292735-129273530.28130.59
61287765-128776530.16430.46
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%
128.071142201114215711426891143060114281111425840.04
228.181143432114332911433800.01
单位质量响应值RSD%判断
40704.8140574.170.23数据可信
供试品溶液-2024032121批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1171008-1710087.3477.3535.997.357.3636.00
2160897-1608976.9126.91
3112724-1127244.8434.84
4287138-28713812.33612.34
5168704-1687047.2487.25
6126527-1265275.4365.44
10min1483032-48303220.75222.5315.6720.7622.5415.66
2470763-47076320.22520.24
3569663-56966324.47424.48
4628082-62808226.98427.00
5583888-58388825.08525.10
6411203-41120317.66617.68
15min1644453-64445327.68727.271.7927.7327.321.77
2649393-64939327.89927.94
3631392-63139227.12627.17
4622765-62276526.75526.82
5638864-63886427.44727.50
6622152-62215226.72926.77
20min1608003-60800326.12127.022.8926.2127.122.86
2637325-63732527.38127.47
3637618-63761827.39327.49
4603698-60369825.93626.05
5643085-64308527.62827.73
6644023-64402327.66827.75
30min1590246-59024625.35825.691.5525.4925.821.54
2607447-60744726.09726.23
3583196-58319625.05525.19
4601021-60102125.82125.97
5601930-60193025.86026.01
6603632-60363225.93326.06
45min1573731-57373124.64925.301.4624.8325.481.45
2597729-59772925.68025.86
3587059-58705925.22125.40
4591152-59115225.39725.59
5587220-58722025.22825.42
6595752-59575225.59525.77
60min1580170-58017024.92524.891.1325.1525.121.10
2578711-57871124.86325.09
3584596-58459625.11525.34
4579151-57915124.88125.12
5567706-56770624.39024.62
6586235-58623525.18625.40
极限1577147-57714724.79524.741.6625.0625.011.64
2560071-56007124.06224.33
3572918-57291824.61424.88
4576207-57620724.75525.04
5580343-58034324.93325.20
6589137-58913725.31025.57
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.071980213198001919798371980473198095119802990.03
228.181982165198202719820960.01
单位质量响应值RSD%判断
70548.5970336.980.22数据可信
供试品溶液-2024032121批-沙库巴曲-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1283551-2835516.6406.5539.406.646.5539.37
2255758-2557585.9895.99
3177636-1776364.1604.16
4489547-48954711.46311.46
5267739-2677396.2696.27
6204927-2049274.7994.80
10min1830381-83038119.44521.4217.4019.4621.4317.40
2807413-80741318.90718.92
3997829-99782923.36623.37
41129755-112975526.45526.47
51017740-101774023.83223.84
6704466-70446616.49616.50
15min11225887-122588728.70628.273.7628.7528.323.79
21202691-120269128.16328.20
31204857-120485728.21328.26
41264956-126495629.62129.68
51218175-121817528.52528.58
61126841-112684126.38726.42
20min11268281-126828129.69929.951.4929.7930.041.49
21297861-129786130.39130.48
31298387-129838730.40430.50
41262698-126269829.56829.68
51290807-129080730.22630.32
61255497-125549729.39929.48
30min11306307-130630730.58930.431.2230.7330.571.22
21319643-131964330.90131.04
31274395-127439529.84229.99
41307821-130782130.62430.79
51298031-129803130.39530.54
61290051-129005130.20830.34
45min11277799-127779929.92130.330.9730.1130.520.97
21314623-131462330.78430.97
31296074-129607430.34930.54
41301159-130115930.46830.68
51286917-128691730.13530.33
61295195-129519530.32930.51
60min11312769-131276930.74030.560.9130.9830.810.88
21309550-130955030.66530.91
31310757-131075730.69330.94
41303908-130390830.53330.80
51281973-128197330.01930.27
61312029-131202930.72330.95
极限11300250-130025030.44730.291.1030.7430.581.07
21271221-127122129.76730.06
31293419-129341930.28730.58
41284206-128420630.07230.39
51299756-129975630.43630.73
61311883-131188330.72031.00
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