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%
127.341103489110515411064941105259110539311051580.10
227.251105216110802911066220.18
单位质量响应值RSD%判断
40422.7540609.980.33数据可信
供试品溶液-2024032721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%
5min1146012-1460125.8379.0027.775.849.0027.78
2158454-1584546.3346.33
3247547-2475479.8959.90
4265596-26559610.61710.62
5226247-2262479.0449.04
6306926-30692612.26912.27
10min1502337-50233720.08123.837.8920.0923.847.90
2599331-59933123.95823.97
3609506-60950624.36524.38
4625175-62517524.99125.01
5626280-62628025.03525.05
6613418-61341824.52124.54
15min1597353-59735323.87923.730.7323.9223.780.72
2591314-59131423.63723.69
3600532-60053224.00624.06
4590953-59095323.62323.68
5590301-59030123.59723.65
6590856-59085623.61923.68
20min1607124-60712424.26924.503.2024.3524.603.19
2576014-57601423.02623.12
3628001-62800125.10425.20
4626882-62688225.05925.16
5620118-62011824.78924.88
6619538-61953824.76624.87
30min1567798-56779822.69722.951.0522.8223.081.07
2569500-56950022.76522.89
3584127-58412723.35023.49
4575388-57538823.00123.14
5576726-57672623.05423.19
6570783-57078322.81722.96
45min1569356-56935622.76023.413.6522.9223.583.62
2594487-59448723.76423.93
3614323-61432324.55724.73
4576389-57638923.04123.22
5557914-55791422.30222.48
6601730-60173024.05424.23
60min1574856-57485622.97922.790.7423.1823.010.71
2569515-56951522.76622.97
3563292-56329222.51722.74
4568181-56818122.71322.93
5573449-57344922.92323.14
6571774-57177422.85623.08
极限1577283-57728323.07622.971.0023.3123.221.00
2573193-57319322.91323.16
3578230-57823023.11423.37
4582194-58219423.27323.53
5566430-56643022.64322.89
6570420-57042022.80223.06
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%
127.341910336191162219161671916517191553819140360.15
227.251913596191829519159460.18
单位质量响应值RSD%判断
70008.6370309.940.31数据可信
供试品溶液-2024032721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%
5min1249150-2491505.4348.4728.645.438.4728.63
2269861-2698615.8865.89
3424741-4247419.2649.26
4459687-45968710.02610.03
5389955-3899558.5058.50
6536681-53668111.70511.70
10min1883160-88316019.26224.0310.0619.2724.0510.07
21117950-111795024.38224.39
31109343-110934324.19524.21
41180123-118012325.73825.76
51171885-117188525.55925.57
61149297-114929725.06625.09
15min11210701-121070126.40526.891.4026.4526.941.42
21224177-122417726.69926.75
31229078-122907826.80626.86
41262566-126256627.53727.60
51234578-123457826.92626.98
61236304-123630426.96427.03
20min11284359-128435928.01228.442.7928.1028.542.80
21243235-124323527.11527.21
31312211-131221128.61928.72
41346751-134675129.37329.48
51328043-132804328.96529.07
61309938-130993828.57028.68
30min11297076-129707628.28928.211.3328.4228.351.34
21272556-127255627.75427.89
31299078-129907828.33328.48
41316001-131600128.70228.86
51301970-130197028.39628.55
61273309-127330927.77127.92
45min11295715-129571528.25928.882.5428.4429.072.53
21343167-134316729.29429.48
31364903-136490329.76829.96
41321470-132147028.82129.02
51275325-127532527.81528.01
61344280-134428029.31929.52
60min11320828-132082828.80728.750.1729.0328.990.15
21318063-131806328.74728.98
31317815-131781528.74128.99
41320340-132034028.79729.05
51315623-131562328.69428.94
61315742-131574228.69628.95
极限11311768-131176828.61028.531.2728.8828.821.25
21313851-131385128.65528.94
31317206-131720628.72829.02
41328597-132859728.97729.27
51283250-128325027.98828.28
61293834-129383428.21828.52
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%
127.341110945110724811055211105029110474011066970.24
227.251113117111118611121520.13
单位质量响应值RSD%判断
40479.0440812.920.59数据可信
供试品溶液-2024032821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%
5min1221551-2215518.8288.9118.428.838.9118.41
2149765-1497655.9685.97
3228144-2281449.0919.09
4221322-2213228.8198.82
5247973-2479739.8819.88
6272535-27253510.86010.86
10min1569804-56980422.70523.963.7422.7223.983.75
2592622-59262223.61423.62
3637189-63718925.39025.41
4593072-59307223.63223.65
5604487-60448724.08724.10
6610784-61078424.33824.36
15min1605685-60568524.13524.010.9924.1924.070.97
2612410-61241024.40324.45
3603558-60355824.05024.11
4599575-59957523.89123.95
5597474-59747423.80823.86
6596829-59682923.78223.84
20min1584721-58472123.29923.401.5123.3923.501.51
2584350-58435023.28523.37
3591058-59105823.55223.65
4580267-58026723.12223.22
5603444-60344424.04624.14
6580125-58012523.11623.21
30min1554084-55408422.07922.222.0922.2122.352.08
2566638-56663822.57922.71
3560280-56028022.32622.46
4573835-57383522.86623.00
5543684-54368421.66421.80
6546741-54674121.78621.92
45min1551098-55109821.96022.713.9222.1322.883.88
2605835-60583524.14124.31
3550689-55068921.94322.12
4569206-56920622.68122.85
5586808-58680823.38323.56
6556195-55619522.16322.34
60min1542490-54249021.61722.041.4821.8222.251.46
2562038-56203822.39622.60
3549360-54936021.89022.10
4547586-54758621.82022.03
5562725-56272522.42322.63
6554647-55464722.10122.31
极限1577527-57752723.01322.461.6023.2522.711.57
2567976-56797622.63222.88
3562796-56279622.42622.67
4562219-56221922.40322.65
5549959-54995921.91422.16
6561599-56159922.37822.63
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%
127.341923411191665419129191912066191165919153420.26
227.251926842192300219249220.15
单位质量响应值RSD%判断
70056.4070639.340.59数据可信
供试品溶液-2024032821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%
5min1382730-3827308.3258.3718.928.338.3718.89
2254495-2544955.5365.54
3392216-3922168.5318.53
4379760-3797608.2608.26
5428908-4289089.3309.33
6471382-47138210.25310.25
10min11011206-101120621.99623.855.9522.0123.865.96
21069322-106932223.26023.27
31183900-118390025.75225.77
41065003-106500323.16623.18
51085528-108552823.61223.63
61163497-116349725.30825.33
15min11234733-123473326.85827.061.7926.9127.111.78
21277808-127780827.79527.84
31250839-125083927.20827.27
41219990-121999026.53726.59
51223084-122308426.60426.66
61256783-125678327.33727.40
20min11267496-126749627.57027.680.8227.6727.780.82
21267786-126778627.57727.67
31289516-128951628.04928.15
41259645-125964527.39927.50
51278847-127884727.81727.92
61272663-127266327.68327.79
30min11259208-125920827.39027.601.2627.5327.751.25
21262060-126206027.45227.59
31281004-128100427.86428.01
41294657-129465728.16128.30
51251126-125112627.21427.36
61265881-126588127.53527.69
45min11275157-127515727.73728.201.9127.9228.391.89
21337954-133795429.10329.29
31275991-127599127.75527.95
41296618-129661828.20428.39
51311597-131159728.53028.72
61281304-128130427.87128.07
60min11278847-127884727.81728.050.6128.0528.290.61
21293461-129346128.13528.37
31286747-128674727.98928.23
41284039-128403927.93028.17
51299993-129999328.27728.52
61294645-129464528.16128.40
极限11316492-131649228.63628.241.0428.9228.521.03
21295503-129550328.17928.46
31300355-130035528.28528.57
41298903-129890328.25328.54
51275191-127519127.73828.02
61302683-130268328.33628.63
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%
127.341113195111160111107251110471110934611110680.13
227.251104420110665811055390.15
单位质量响应值RSD%判断
40638.9240570.240.12数据可信
供试品溶液-2024032921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%
5min1412253-41225316.44418.4918.7016.4418.4918.69
2560172-56017222.34422.34
3486765-48676519.41619.42
4472695-47269518.85418.85
5529856-52985621.13421.13
6320048-32004812.76612.77
10min1615330-61533024.54424.701.5024.5724.741.51
2625274-62527424.94024.98
3634662-63466225.31525.35
4619044-61904424.69224.72
5610962-61096224.37024.40
6610960-61096024.36924.39
15min1590418-59041823.55023.791.5223.6223.861.53
2597657-59765723.83923.92
3601292-60129223.98424.06
4611420-61142024.38824.46
5587729-58772923.44323.52
6589469-58946923.51223.57
20min1632905-63290525.24524.313.0325.3524.423.00
2614105-61410524.49524.61
3614406-61440624.50724.62
4591972-59197223.61223.73
5583333-58333323.26723.38
6620003-62000324.73024.83
30min1557375-55737522.23222.662.5722.3822.812.56
2551415-55141521.99422.15
3591023-59102323.57423.73
4575340-57534022.94923.10
5560107-56010722.34122.49
6573534-57353422.87723.02
45min1563666-56366622.48322.691.7122.6722.881.69
2574809-57480922.92723.12
3551226-55122621.98722.18
4573515-57351522.87623.07
5573379-57337922.87023.06
6576430-57643022.99223.17
60min1556497-55649722.19722.342.3822.4222.572.36
2566022-56602222.57722.81
3571768-57176822.80623.04
4575501-57550122.95523.18
5542209-54220921.62721.86
6548283-54828321.86922.09
极限1589465-58946523.51222.744.8623.7723.004.82
2611108-61110824.37524.65
3541152-54115221.58521.85
4574166-57416622.90223.17
5564502-56450222.51622.78
6540340-54034021.55321.81
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%
127.341926907192401819222791921447192009919229500.14
227.251910520191520019128600.18
单位质量响应值RSD%判断
70334.6770196.700.14数据可信
供试品溶液-2024032921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%
5min1650269-65026914.16116.1417.9214.1616.1417.92
2887158-88715819.32019.32
3758638-75863816.52116.52
4769086-76908616.74816.75
5852742-85274218.57018.57
6528941-52894111.51911.52
10min11157156-115715625.19924.932.2925.2224.952.30
21122843-112284324.45224.48
31180818-118081825.71425.74
41130543-113054324.62024.65
51163209-116320925.33125.36
61113812-111381224.25524.27
15min11222403-122240326.62026.911.5126.6926.981.49
21208310-120831026.31326.39
31249814-124981427.21727.29
41258030-125803027.39627.46
51231491-123149126.81826.89
61244338-124433827.09827.16
20min11315337-131533728.64428.201.9328.7528.311.90
21287519-128751928.03828.15
31298727-129872728.28228.40
41276746-127674627.80427.92
51261666-126166627.47527.59
61329318-132931828.94829.05
30min11260216-126021627.44427.801.9927.6027.961.98
21246078-124607827.13627.30
31309808-130980828.52328.69
41291171-129117128.11828.28
51256941-125694127.37227.54
61294346-129434628.18728.34
45min11288248-128824828.05428.181.2428.2628.391.21
21296573-129657328.23528.44
31264864-126486427.54527.76
41303523-130352328.38728.59
51302078-130207828.35528.56
61309338-130933828.51328.71
60min11290810-129081028.11028.251.0328.3628.501.03
21298466-129846628.27628.53
31308007-130800728.48428.74
41317367-131736728.68828.94
51284672-128467227.97628.23
61284380-128438027.97028.22
极限11328200-132820028.92428.272.7729.2228.572.75
21347059-134705929.33529.64
31248144-124814427.18127.48
41295821-129582128.21928.52
51296717-129671728.23828.54
61272540-127254027.71228.01
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%
127.341101763110309511035531103210111085011044940.33
227.251102925109526410990940.50
单位质量响应值RSD%判断
40398.4640333.720.12数据可信
供试品溶液-2024032421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%
5min1443770-44377017.80518.7114.1217.8118.7114.12
2499048-49904820.02320.02
3502859-50285920.17620.18
4352998-35299814.16314.16
5542424-54242421.76421.76
6456524-45652418.31718.32
10min1594241-59424123.84324.592.3423.8724.622.35
2615672-61567224.70224.74
3633811-63381125.43025.46
4602043-60204324.15624.18
5622955-62295524.99525.03
6608798-60879824.42724.46
15min1608740-60874024.42424.903.3624.4924.983.35
2637626-63762625.58325.66
3617797-61779724.78824.86
4648085-64808526.00326.07
5622382-62238224.97225.05
6589447-58944723.65023.72
20min1580023-58002323.27223.883.8723.3823.993.85
2580834-58083423.30523.42
3590406-59040623.68923.81
4580152-58015223.27723.38
5600171-60017124.08124.20
6639102-63910225.64325.75
30min1568843-56884322.82422.521.7022.9722.681.70
2559006-55900622.42922.58
3575068-57506823.07323.23
4553761-55376122.21822.36
5562426-56242622.56622.73
6549308-54930822.04022.19
45min1581328-58132823.32522.894.3623.5123.084.32
2598759-59875924.02424.22
3590083-59008323.67623.87
4570715-57071522.89923.08
5545589-54558921.89122.09
6536325-53632521.51921.71
60min1555516-55551622.28922.012.7022.5122.242.65
2537418-53741821.56321.80
3544522-54452221.84822.08
4575687-57568723.09823.32
5540137-54013721.67221.91
6538646-53864621.61221.84
极限1593682-59368223.82022.933.0224.0823.202.98
2589102-58910223.63623.91
3563760-56376022.62022.89
4572394-57239422.96623.23
5548475-54847522.00622.28
6561804-56180422.54122.80
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%
127.341907224190841619098931908963192275919114510.34
227.251910533189600019032660.54
单位质量响应值RSD%判断
69914.0869844.620.08数据可信
供试品溶液-2024032421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%
5min1672004-67200414.71516.2415.1914.7216.2415.17
2803456-80345617.59317.59
3821470-82147017.98817.99
4560677-56067712.27712.28
5865449-86544918.95118.95
6726288-72628815.90415.90
10min11045371-104537122.89124.063.4122.9224.093.42
21093185-109318523.93823.97
31141555-114155524.99725.03
41072192-107219223.47823.50
51138437-113843724.92924.96
61103161-110316124.15624.18
15min11192957-119295726.12227.022.9326.1927.092.91
21228953-122895326.91126.98
31252134-125213427.41827.49
41296213-129621328.38328.44
51222049-122204926.75926.83
61212683-121268326.55426.62
20min11212595-121259526.55227.523.4426.6627.633.43
21227032-122703226.86926.98
31259609-125960927.58227.70
41260346-126034627.59827.70
51244778-124477827.25727.37
61336329-133632929.26229.37
30min11263599-126359927.66927.561.5527.8227.721.54
21229562-122956226.92427.08
31285832-128583228.15628.32
41270962-127096227.83127.98
51247973-124797327.32727.49
61254691-125469127.47427.63
45min11313502-131350228.76228.302.6528.9628.502.62
21323456-132345628.98029.18
31323661-132366128.98529.19
41291016-129101628.27028.47
51255135-125513527.48427.69
61246879-124687927.30327.51
60min11282227-128222728.07728.011.3828.3228.261.35
21266269-126626927.72827.98
31283699-128369928.10928.37
41310953-131095328.70628.95
51268797-126879727.78328.04
61263887-126388727.67627.93
极限11334030-133403029.21228.850.8629.5029.150.84
21327165-132716529.06129.36
31318062-131806228.86229.17
41308606-130860628.65528.95
51311930-131193028.72829.03
61305155-130515528.57928.88
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
127.341102795110489611041181105260110394211042020.09
227.251106443110401411052280.16
单位质量响应值RSD%判断
40387.7840558.830.30数据可信
供试品溶液-2024032521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%
5min1515132-51513220.61417.3313.5420.6117.3313.53
2472677-47267718.91518.91
3348147-34814713.93213.93
4430257-43025717.21717.22
5392796-39279615.71815.72
6439693-43969317.59517.60
10min1621724-62172424.87923.892.6524.9123.922.66
2606367-60636724.26524.30
3575018-57501823.01023.03
4589979-58997923.60923.64
5595087-59508723.81323.84
6593869-59386923.76523.79
15min1592610-59261023.71424.064.2923.7924.134.26
2555131-55513122.21422.29
3627535-62753525.11225.17
4619987-61998724.81024.88
5609809-60980924.40324.47
6602544-60254424.11224.18
20min1564515-56451522.59023.583.5822.7123.693.55
2576407-57640723.06623.17
3618417-61841724.74724.85
4611566-61156624.47324.58
5584010-58401023.37023.48
6580831-58083123.24323.35
30min1551431-55143122.06622.664.4022.2222.804.38
2563889-56388922.56522.71
3555736-55573622.23922.38
4615864-61586424.64524.80
5559840-55984022.40322.55
6550224-55022422.01822.17
45min1541097-54109721.65322.552.9321.8422.742.91
2580898-58089823.24623.43
3562136-56213622.49522.68
4574461-57446122.98823.18
5575675-57567523.03723.22
6546607-54660721.87322.06
60min1545954-54595421.84721.812.3022.0722.042.29
2538451-53845121.54721.77
3562750-56275022.51922.74
4556845-55684522.28322.51
5530306-53030621.22121.44
6536577-53657721.47221.69
极限1580897-58089723.24622.772.7223.5123.022.70
2564003-56400322.57022.83
3587091-58709123.49323.75
4575366-57536623.02423.29
5561694-56169422.47722.73
6544395-54439521.78522.04
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%
127.341908688191204719113491913151191041719111300.09
227.251915767191117719134720.17
单位质量响应值RSD%判断
69902.3470219.160.32数据可信
供试品溶液-2024032521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%
5min1893065-89306519.50516.1714.3219.5116.1714.32
2819997-81999717.90917.91
3591900-59190012.92712.93
4723962-72396215.81215.81
5676224-67622414.76914.77
6735919-73591916.07316.07
10min11151893-115189325.15823.797.4725.1923.817.48
21219215-121921526.62826.66
3998792-99879221.81421.84
41036825-103682522.64522.67
51068866-106886623.34523.37
61058745-105874523.12423.15
15min11222344-122234426.69726.791.9826.7726.861.96
21206234-120623426.34526.42
31264623-126462327.62027.68
41242029-124202927.12727.19
51226672-122667226.79126.85
61197764-119776426.16026.23
20min11223650-122365026.72527.542.6926.8427.652.68
21278724-127872427.92828.05
31299924-129992428.39128.50
41293767-129376728.25728.37
51237580-123758027.03027.14
61231411-123141126.89527.00
30min11252614-125261427.35827.822.8827.5227.982.87
21283873-128387328.04128.21
31266730-126673027.66627.82
41342479-134247929.32129.48
51252844-125284427.36327.52
61242979-124297927.14727.30
45min11254066-125406627.39027.971.8527.6028.171.85
21310597-131059728.62428.84
31285066-128506628.06728.26
41292181-129218128.22228.43
51290891-129089128.19428.39
61249970-124997027.30027.50
60min11274247-127424727.83027.831.3428.0928.081.33
21284024-128402428.04428.30
31295249-129524928.28928.53
41284469-128446928.05428.31
51252264-125226427.35027.60
61256042-125604227.43327.68
极限11342940-134294029.33128.793.1629.6329.083.15
21385902-138590230.26930.57
31320112-132011228.83229.12
41297727-129772728.34328.64
51294270-129427028.26828.56
61268430-126843027.70327.99
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%
127.341107144110386011051591106248110746211059750.14
227.251113330111227411128020.07
单位质量响应值RSD%判断
40452.6340836.770.67数据可信
供试品溶液-2024032621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%
5min1466841-46684118.60318.6117.4918.6018.6117.50
2370520-37052014.76514.76
3552007-55200721.99722.00
4518956-51895620.68020.68
5365447-36544714.56314.56
6528605-52860521.06421.06
10min1594235-59423523.67923.633.4723.7123.663.48
2560220-56022022.32422.35
3605448-60544824.12624.16
4605723-60572324.13724.17
5577513-57751323.01323.04
6614900-61490024.50324.54
15min1595481-59548123.72923.952.6323.8024.022.65
2597958-59795823.82823.89
3607535-60753524.20924.29
4622638-62263824.81124.89
5575335-57533522.92622.99
6606998-60699824.18824.26
20min1564173-56417322.48223.415.9622.5923.525.92
2651544-65154425.96326.06
3603880-60388024.06424.18
4559057-55905722.27822.39
5572717-57271722.82222.92
6573768-57376822.86422.98
30min1543519-54351921.65822.052.4721.8122.202.48
2540531-54053121.53921.68
3574230-57423022.88223.04
4565975-56597522.55322.71
5545170-54517021.72421.86
6551193-55119321.96422.12
45min1541345-54134521.57222.062.1821.7622.242.17
2544460-54446021.69621.88
3574394-57439422.88923.08
4555583-55558322.13922.33
5557808-55780822.22822.40
6547274-54727421.80822.00
60min1533912-53391221.27621.571.9121.5021.791.91
2541213-54121321.56721.78
3560115-56011522.32022.55
4544316-54431621.69021.92
5533904-53390421.27521.49
6533645-53364521.26521.49
极限1546117-54611721.76221.781.5122.0222.041.50
2547411-54741121.81422.07
3561704-56170422.38322.65
4538470-53847021.45721.72
5544613-54461321.70221.95
6540532-54053221.53921.80
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%
127.341915983191065519120881914675191637119139540.14
227.251927437192454119259890.11
单位质量响应值RSD%判断
70005.6370678.500.68数据可信
供试品溶液-2024032621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%
5min1753864-75386416.39916.6717.9316.4016.6717.92
2602089-60208913.09813.10
3913110-91311019.86419.86
4864974-86497418.81618.82
5602537-60253713.10713.11
6861979-86197918.75118.75
10min11081203-108120323.52023.296.1923.5523.326.21
2973152-97315221.17021.19
31154890-115489025.12325.16
41085527-108552723.61423.65
51015373-101537322.08822.11
61114552-111455224.24624.28
15min11212314-121231426.37226.352.1126.4426.422.12
21204348-120434826.19926.26
31250015-125001527.19227.27
41225759-122575926.66526.74
51173930-117393025.53725.60
61201446-120144626.13626.21
20min11232259-123225926.80627.485.4426.9227.595.40
21384202-138420230.11130.21
31304368-130436828.37528.50
41219318-121931826.52526.64
51234038-123403826.84526.95
61204148-120414826.19526.31
30min11246703-124670327.12027.351.8627.2827.501.86
21261564-126156427.44427.59
31292840-129284028.12428.29
41273132-127313227.69527.85
51236730-123673026.90327.05
61231557-123155726.79126.95
45min11254831-125483127.29727.511.2127.5027.721.22
21261091-126109127.43327.63
31290518-129051828.07428.29
41270496-127049627.63827.84
51265580-126558027.53127.72
61246176-124617627.10927.31
60min11264463-126446327.50727.611.4127.7527.861.41
21298357-129835728.24428.49
31279583-127958327.83628.10
41270144-127014427.63027.88
51252528-125252827.24727.48
61251159-125115927.21727.47
极限11273252-127325227.69827.511.2927.9927.801.28
21272933-127293327.69127.98
31284374-128437427.94028.25
41238999-123899926.95327.25
51263969-126396927.49627.78
61253402-125340227.26627.56
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