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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071151507115206711530441152052115166311520670.06
228.181152803115204311524230.05
单位质量响应值RSD%判断
41042.6440895.070.26数据可信
供试品溶液-TUM57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%
5min1295757-29575712.60413.865.5512.6013.865.56
2343796-34379614.65114.65
3339881-33988114.48514.48
4332681-33268114.17814.18
5325484-32548413.87113.87
6313288-31328813.35113.35
10min1559792-55979223.85624.442.1323.8824.472.12
2588739-58873925.09025.11
3585719-58571924.96124.99
4560416-56041623.88323.91
5573890-57389024.45724.48
6573002-57300224.41924.44
15min1592672-59267225.25825.381.0525.3225.441.04
2606762-60676225.85825.92
3589992-58999225.14325.21
4593868-59386825.30925.37
5591376-59137625.20225.27
6598580-59858025.50925.57
20min1577938-57793824.63025.091.6424.7325.201.63
2598436-59843625.50325.61
3587067-58706725.01925.13
4582921-58292124.84224.95
5583557-58355724.86924.98
6602419-60241925.67325.78
30min1546217-54621723.27823.771.5023.4223.921.50
2559374-55937423.83923.99
3571367-57136724.35024.50
4552560-55256023.54823.70
5558181-55818123.78823.94
6558872-55887223.81723.97
45min1544569-54456923.20824.553.9923.3924.743.97
2579312-57931224.68824.88
3598715-59871525.51525.71
4551678-55167823.51123.70
5596729-59672925.43125.62
6586073-58607324.97625.16
60min1536431-53643122.86123.732.0523.0823.962.05
2557125-55712523.74323.98
3565649-56564924.10624.34
4554661-55466123.63823.86
5568795-56879524.24024.47
6558897-55889723.81824.05
极限1589577-58957725.12624.283.1825.3924.553.13
2563540-56354024.01624.29
3547984-54798423.35323.63
4568936-56893624.24624.51
5592835-59283525.26525.53
6555573-55557323.67723.95
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071998437199884919999361998615199800019987670.04
228.181999990199816819990790.07
单位质量响应值RSD%判断
71206.5270939.640.27数据可信
供试品溶液-TUM57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%
5min1515433-51543311.96313.546.6611.9613.546.66
2621386-62138614.42214.42
3610457-61045714.16814.17
4605415-60541514.05114.05
5580183-58018313.46513.47
6567869-56786913.18013.18
10min11018720-101872023.64324.412.6223.6624.432.62
21077990-107799025.01925.04
31084406-108440625.16825.19
41025414-102541423.79923.82
51063283-106328324.67824.70
61041544-104154424.17324.19
15min11156566-115656626.84227.431.1026.9027.491.11
21185363-118536327.51127.58
31191939-119193927.66327.73
41185222-118522227.50827.57
51190185-119018527.62327.69
61181951-118195127.43227.49
20min11190935-119093527.64028.461.8827.7428.561.88
21224998-122499828.43128.54
31238870-123887028.75328.86
41208539-120853928.04928.16
51241125-124112528.80528.91
61252550-125255029.07029.18
30min11195333-119533327.74228.301.6227.8928.461.63
21223505-122350528.39628.56
31247241-124724128.94729.11
41197381-119738127.79027.95
51227589-122758928.49128.65
61224522-122452228.42028.58
45min11203517-120351727.93229.203.3128.1329.403.30
21262486-126248629.30129.51
31288555-128855529.90630.11
41210327-121032728.09028.29
51302202-130220230.22330.43
61280682-128068229.72329.93
60min11185721-118572127.51928.612.3427.7628.862.34
21239685-123968528.77229.03
31257697-125769729.19029.45
41210221-121022128.08828.34
51257315-125731529.18129.44
61245231-124523128.90029.15
极限11296867-129686730.09929.382.3230.3929.682.28
21254739-125473929.12129.42
31225034-122503428.43228.74
41260986-126098629.26629.56
51303284-130328430.24830.55
61255127-125512729.13029.43
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071143960114492211450661143867114578711447200.08
228.181150860115015311505060.05
单位质量响应值RSD%判断
40780.9040827.040.08数据可信
供试品溶液-TUM57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%
5min1286806-28680612.27213.459.6412.2713.459.65
2328497-32849714.05614.06
3342314-34231414.64714.65
4278788-27878811.92911.93
5350725-35072515.00715.01
6298497-29849712.77212.77
10min1600115-60011525.67826.121.5325.7026.141.53
2621780-62178026.60526.63
3609688-60968826.08826.11
4606648-60664825.95825.98
5602639-60263925.78625.81
6621456-62145626.59126.61
15min1604908-60490825.88326.411.8225.9526.471.81
2631484-63148427.02027.09
3606181-60618125.93826.01
4616586-61658626.38326.45
5614515-61451526.29426.36
6629089-62908926.91826.98
20min1608061-60806126.01826.212.3726.1226.322.37
2611626-61162626.17126.28
3591882-59188225.32625.44
4615186-61518626.32326.43
5611452-61145226.16326.27
6636985-63698527.25627.37
30min1580352-58035224.83224.911.6324.9825.061.62
2566295-56629524.23124.39
3592771-59277125.36425.52
4586368-58636825.09025.24
5578387-57838724.74824.90
6588961-58896125.20125.36
45min1578660-57866024.76025.866.1124.9526.056.06
2580527-58052724.84025.04
3653354-65335427.95628.15
4581242-58124224.87125.06
5581693-58169324.89025.09
6650437-65043727.83128.03
60min1593608-59360825.40025.050.8725.6325.290.85
2582957-58295724.94425.18
3581854-58185424.89725.14
4579880-57988024.81225.05
5585692-58569225.06125.30
6588664-58866425.18825.43
极限1625310-62531026.75625.083.4327.0325.363.38
2580271-58027124.82925.11
3578229-57822924.74225.03
4580711-58071124.84825.12
5584614-58461425.01525.29
6567238-56723824.27124.56
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071984373198583119860671984391198759219856510.07
228.181994262199390219940820.02
单位质量响应值RSD%判断
70739.2670762.310.03数据可信
供试品溶液-TUM57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%
5min1497914-49791411.60912.729.4911.6112.729.48
2570108-57010813.29213.29
3593816-59381613.84413.84
4485084-48508411.30911.31
5607527-60752714.16414.16
6519087-51908712.10212.10
10min11076747-107674725.10425.752.2125.1225.782.22
21120536-112053626.12526.15
31137888-113788826.52926.55
41076505-107650525.09825.12
51104884-110488425.76025.78
61111241-111124125.90825.93
15min11180024-118002427.51228.532.1927.5728.602.20
21237538-123753828.85228.92
31255350-125535029.26829.34
41236148-123614828.82028.88
51206421-120642128.12728.19
61227127-122712728.61028.67
20min11259525-125952529.36529.671.7429.4729.781.73
21256381-125638129.29229.41
31287090-128709030.00830.12
41277864-127786429.79329.90
51248543-124854329.10929.22
61306909-130690930.47030.58
30min11269813-126981329.60529.702.2029.7629.862.19
21241208-124120828.93829.10
31306834-130683430.46830.63
41273477-127347729.69029.85
51246789-124678929.06829.23
61305452-130545230.43630.60
45min11275880-127588029.74630.584.9029.9530.794.87
21270641-127064129.62429.84
31390561-139056132.42032.64
41276800-127680029.76829.98
51258497-125849729.34129.55
61397468-139746832.58132.79
60min11297876-129787630.25930.081.4430.5130.341.44
21275324-127532429.73329.99
31293607-129360730.16030.43
41282507-128250729.90130.16
51270052-127005229.61129.87
61321271-132127130.80531.07
极限11360409-136040931.71730.462.0632.0230.772.03
21299048-129904830.28730.60
31296734-129673430.23330.55
41298303-129830330.26930.58
51285636-128563629.97430.28
61298940-129894030.28430.60
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071154778115531211558191155378115484611552270.04
228.181149492115067411500830.08
单位质量响应值RSD%判断
41155.2240812.030.60数据可信
供试品溶液-TXD90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%
5min1201162-2011628.5709.8214.418.579.8214.39
2244345-24434510.41010.41
3200403-2004038.5388.54
4239885-23988510.22010.22
5211422-2114229.0079.01
6286218-28621812.19312.19
10min1590464-59046425.15525.672.4125.1725.682.41
2603199-60319925.69725.71
3618978-61897826.37026.38
4615053-61505326.20226.22
5581123-58112324.75724.77
6606569-60656925.84125.86
15min1611021-61102126.03125.922.0026.0925.982.00
2599530-59953025.54125.60
3617105-61710526.29026.35
4592983-59298325.26225.32
5626106-62610626.67326.73
6603254-60325425.70025.76
20min1601521-60152125.62625.871.2925.7325.971.29
2615389-61538926.21726.32
3603001-60300125.68925.79
4609994-60999425.98726.09
5597247-59724725.44425.54
6616081-61608126.24626.35
30min1583248-58324824.84724.971.1724.9925.121.18
2596243-59624325.40125.55
3581648-58164824.77924.92
4578727-57872724.65524.80
5584628-58462824.90625.05
6592839-59283925.25625.41
45min1591933-59193325.21725.464.5725.4025.644.55
2646788-64678827.55427.74
3576863-57686324.57524.76
4576831-57683124.57424.76
5582089-58208924.79824.98
6610626-61062626.01426.21
60min1487418-48741820.76523.397.5720.9923.627.51
2573755-57375524.44324.68
3505134-50513421.52021.75
4568812-56881224.23224.46
5577586-57758624.60624.83
6582199-58219924.80325.04
极限1574608-57460824.47924.641.9824.7424.911.99
2579086-57908624.67024.95
3568563-56856324.22224.48
4578612-57861224.65024.92
5569598-56959824.26624.53
6599987-59998725.56125.84
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.072000848200115920031192001614200143420016350.05
228.181993663199490519942840.05
单位质量响应值RSD%判断
71308.6970769.480.54数据可信
供试品溶液-TXD90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%
5min1345581-3455818.0249.2415.098.029.2415.10
2422925-4229259.8209.82
3343530-3435307.9777.98
4413887-4138879.6119.61
5362352-3623528.4148.41
6498756-49875611.58111.58
10min11041774-104177424.19025.063.5324.2025.083.53
21087814-108781425.25925.28
31121539-112153926.04226.06
41093419-109341925.38925.41
51024662-102466223.79323.81
61107236-110723625.71025.73
15min11228006-122800628.51428.411.2928.5728.471.27
21223979-122397928.42128.48
31240506-124050628.80528.86
41215105-121510528.21528.27
51236897-123689728.72128.77
61197573-119757327.80827.87
20min11285731-128573129.85529.701.2429.9629.801.24
21294921-129492130.06830.17
31275650-127565029.62129.73
41283972-128397229.81429.92
51249142-124914229.00529.11
61284552-128455229.82729.94
30min11305142-130514230.30630.021.2130.4630.171.22
21311813-131181330.46030.62
31291780-129178029.99530.15
41274735-127473529.60029.75
51274058-127405829.58429.73
61298410-129841030.14930.31
45min11326596-132659630.80430.713.1531.0130.913.14
21396766-139676632.43332.64
31298805-129880530.15830.36
41285100-128510029.84030.04
51291561-129156129.99030.19
61336503-133650331.03431.24
60min11191385-119138527.66429.363.6927.9229.623.66
21298509-129850930.15230.41
31220855-122085528.34828.60
41282675-128267529.78430.04
51290198-129019829.95930.21
61302842-130284230.25230.51
极限11302390-130239030.24230.391.2030.5430.691.20
21308366-130836630.38030.69
31299752-129975230.18030.48
41309461-130946130.40630.71
51293417-129341730.03330.33
61338124-133812431.07131.38
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071150760115109111490291150128115021511502450.07
228.181155199115523711552180.01
单位质量响应值RSD%判断
40977.7340994.250.03数据可信
供试品溶液-TXD90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%
5min1239892-23989210.21910.073.7910.2210.073.77
2252678-25267810.76410.76
3231885-2318859.8789.88
4229324-2293249.7699.77
5229305-2293059.7689.77
6235072-23507210.01410.01
10min1593707-59370725.29125.411.6325.3125.431.63
2587424-58742425.02325.04
3590971-59097125.17525.19
4605517-60551725.79425.81
5611546-61154626.05126.07
6590126-59012625.13925.16
15min1601621-60162125.62825.671.0625.6925.731.05
2603670-60367025.71525.78
3603793-60379325.72125.78
4605593-60559325.79725.86
5590775-59077525.16625.23
6609773-60977325.97526.03
20min1593924-59392425.30025.421.0025.4025.520.99
2594541-59454125.32725.43
3597257-59725725.44225.54
4607076-60707625.86125.96
5598551-59855125.49725.60
6589370-58937025.10625.21
30min1587522-58752225.02824.780.6425.1724.920.63
2580586-58058624.73224.88
3583606-58360624.86125.00
4582312-58231224.80624.95
5578266-57826624.63324.78
6577686-57768624.60924.75
45min1584656-58465624.90624.871.4425.0925.061.44
2590663-59066325.16125.35
3592193-59219325.22725.41
4587439-58743925.02425.21
5578639-57863924.64924.83
6569904-56990424.27724.46
60min1549342-54934223.40123.383.8623.6323.613.83
2576264-57626424.54824.78
3528849-52884922.52822.76
4535814-53581422.82523.05
5529958-52995822.57522.80
6572580-57258024.39124.62
极限1584113-58411324.88224.550.7625.1524.810.75
2577807-57780724.61424.88
3574223-57422324.46124.73
4575711-57571124.52424.79
5572640-57264024.39424.66
6572712-57271224.39724.66
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071996403199597319929411993991199469419948000.08
228.182003994200396720039800.01
单位质量响应值RSD%判断
71065.1971113.560.05数据可信
供试品溶液-TXD90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%
5min1417188-4171889.6809.603.839.689.603.83
2443256-44325610.28510.29
3407494-4074949.4559.46
4400675-4006759.2979.30
5401480-4014809.3169.32
6411361-4113619.5459.54
10min11064725-106472524.70524.832.1324.7224.852.13
21053381-105338124.44224.46
31055100-105510024.48224.50
41096728-109672825.44825.46
51100875-110087525.54425.56
61050079-105007924.36524.38
15min11201352-120135227.87528.140.8227.9328.190.81
21203772-120377227.93227.99
31218127-121812728.26528.32
41225943-122594328.44628.50
51207442-120744228.01728.07
61219411-121941128.29428.35
20min11263537-126353729.31829.321.0529.4229.421.05
21251806-125180629.04629.15
31273363-127336329.54629.65
41279204-127920429.68229.79
51268321-126832129.42929.53
61244277-124427728.87128.98
30min11295483-129548330.06029.761.0030.2129.920.99
21273061-127306129.53929.69
31295013-129501330.04930.20
41289284-128928429.91630.07
51279299-127929929.68429.84
61263984-126398429.32929.48
45min11305593-130559330.29430.221.5030.5030.421.49
21304766-130476630.27530.48
31325627-132562730.75930.96
41315964-131596430.53530.74
51290751-129075129.95030.15
61270464-127046429.47929.68
60min11255499-125549929.13229.201.7429.3929.461.73
21288034-128803429.88730.14
31236277-123627728.68628.94
41250451-125045129.01529.27
51239046-123904628.75029.00
61282588-128258829.76030.01
极限11312782-131278230.46130.220.4730.7630.530.47
21300454-130045430.17530.48
31299693-129969330.15730.46
41305901-130590130.30130.61
51301474-130147430.19930.50
61295044-129504430.04930.35
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071150925115115111502961150427115033111506260.04
228.181155544115576011556520.02
单位质量响应值RSD%判断
40991.3141009.650.04数据可信
供试品溶液-TYN28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%
5min1369505-36950515.73515.6515.4715.7315.6515.47
2423967-42396718.05418.05
3343546-34354614.62914.63
4298540-29854012.71312.71
5325803-32580313.87413.87
6444330-44433018.92118.92
10min1570496-57049624.29425.344.9524.3225.364.95
2621979-62197926.48626.52
3560897-56089723.88523.91
4574499-57449924.46424.49
5616475-61647526.25226.27
6625816-62581626.64926.68
15min1613643-61364326.13125.931.2726.2026.001.25
2602937-60293725.67525.75
3618986-61898626.35926.42
4612471-61247126.08126.14
5598003-59800325.46525.53
6607218-60721825.85725.93
20min1598865-59886525.50225.831.8925.6125.941.87
2600508-60050825.57225.69
3610015-61001525.97726.08
4602507-60250725.65725.76
5628161-62816126.74926.86
6598807-59880725.49925.62
30min1588798-58879825.07325.010.7725.2325.170.76
2585953-58595324.95225.11
3590458-59045825.14425.30
4586527-58652724.97625.12
5579849-57984924.69224.85
6592757-59275725.24225.40
45min1587011-58701124.99724.881.5925.1925.081.58
2576074-57607424.53124.73
3583606-58360624.85225.05
4582539-58253924.80725.00
5575377-57537724.50224.70
6600715-60071525.58125.78
60min1578227-57822724.62324.730.8924.8624.970.88
2581689-58168924.77025.01
3579359-57935924.67124.91
4583939-58393924.86625.10
5573239-57323924.41124.65
6588224-58822425.04925.29
极限1579458-57945824.67524.711.3324.9524.991.31
2570275-57027524.28424.57
3577901-57790124.60924.88
4589412-58941225.09925.37
5575223-57522324.49524.77
6589302-58930225.09525.38
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071995865199559019945431993940199484519949570.04
228.182003219200360420034120.02
单位质量响应值RSD%判断
71070.7971093.400.03数据可信
供试品溶液-TYN28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%
5min1609872-60987214.15314.0517.1414.1514.0417.14
2712458-71245816.53316.53
3554322-55432212.86312.86
4482769-48276911.20311.20
5529575-52957512.28912.29
6742982-74298217.24117.24
10min1986113-98611322.88424.346.6422.9124.366.64
21123724-112372426.07726.10
3970494-97049422.52122.54
41003001-100300123.27523.29
51100341-110034125.53425.55
61110100-111010025.76125.79
15min11178665-117866527.35227.762.4727.4127.822.48
21220095-122009528.31328.38
31149283-114928326.67026.73
41188614-118861427.58327.64
51225715-122571528.44428.51
61214762-121476228.18928.26
20min11238453-123845328.73929.223.0028.8529.322.99
21283142-128314229.77629.89
31223416-122341628.39028.49
41240147-124014728.77928.88
51324423-132442330.73430.84
61244626-124462628.88229.00
30min11285640-128564029.83429.670.5929.9929.830.59
21286534-128653429.85530.02
31268093-126809329.42729.58
41276688-127668829.62729.78
51282532-128253229.76229.92
61272598-127259829.53229.70
45min11294815-129481530.04729.910.7330.2530.120.73
21277559-127755929.64729.86
31278307-127830729.66429.86
41296295-129629530.08230.28
51287072-128707229.86730.08
61299105-129910530.14730.36
60min11285700-128570029.83629.890.4830.0930.140.47
21288136-128813629.89230.16
31287821-128782129.88530.13
41298608-129860830.13530.39
51279792-127979229.69929.96
61287005-128700529.86630.13
极限11295294-129529430.05830.151.0430.3630.461.01
21277929-127792929.65529.97
31311225-131122530.42830.73
41315925-131592530.53730.84
51297053-129705330.09930.41
61298424-129842430.13130.45
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%
128.071157905115790511581061158608115790711580860.03
228.181151187115099311510900.02
单位质量响应值RSD%判断
41257.0740847.760.71数据可信
供试品溶液-TYN28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%
5min1390309-39030916.60015.708.8116.6015.708.83
2394499-39449916.77816.78
3326375-32637513.88113.88
4328083-32808313.95413.95
5387211-38721116.46816.47
6387953-38795316.50016.50
10min1587877-58787725.00324.964.3225.0324.994.32
2585240-58524024.89124.92
3556406-55640623.66423.69
4561470-56147023.88023.90
5614134-61413426.12026.15
6616621-61662126.22526.25
15min1608262-60826225.87025.790.9025.9425.860.89
2608808-60880825.89325.96
3611060-61106025.98926.05
4611079-61107925.99026.05
5600571-60057125.54325.61
6598563-59856325.45725.53
20min1594469-59446925.28325.261.0025.4025.370.99
2584646-58464624.86524.98
3602112-60211225.60825.71
4591800-59180025.17025.28
5592315-59231525.19225.31
6597817-59781725.42625.54
30min1581063-58106324.71324.740.5524.8724.890.53
2582304-58230424.76624.92
3585679-58567924.90925.06
4584488-58448824.85925.01
5578095-57809524.58724.74
6578193-57819324.59124.75
45min1575754-57575424.48724.710.6924.6824.900.69
2579791-57979124.65924.85
3582975-58297524.79424.98
4580667-58066724.69624.89
5587624-58762424.99225.19
6579499-57949924.64724.84
60min1569540-56954024.22324.480.5324.4624.710.52
2577407-57740724.55824.79
3575734-57573424.48624.72
4577558-57755824.56424.79
5576878-57687824.53524.77
6576310-57631024.51124.75
极限1576169-57616924.50524.411.1224.7824.681.09
2576446-57644624.51724.79
3574828-57482824.44824.72
4579297-57929724.63824.91
5575174-57517424.46324.74
6561217-56121723.86924.15
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.072011107201188720122382012551201145920118480.03
228.181996125199581919959720.02
单位质量响应值RSD%判断
71672.5370829.380.84数据可信
供试品溶液-TYN28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%
5min1648716-64871615.01914.169.9915.0214.169.97
2662309-66230915.33315.33
3530693-53069312.28612.29
4536057-53605712.41112.41
5644943-64494314.93114.93
6648091-64809115.00415.00
10min11038289-103828924.03824.005.2524.0624.025.25
21035594-103559423.97624.00
3972925-97292522.52522.55
4978424-97842422.65222.67
51094918-109491825.34925.37
61099383-109938325.45225.48
15min11197786-119778627.73127.412.2527.8027.482.26
21178827-117882727.29227.36
31149668-114966826.61726.67
41156627-115662726.77826.84
51210148-121014828.01728.08
61210620-121062028.02828.10
20min11251442-125144228.97328.681.7629.0828.791.77
21253035-125303529.01029.12
31219866-121986628.24228.34
41203984-120398427.87427.98
51246220-124622028.85228.97
61258447-125844729.13529.25
30min11275530-127553029.53129.300.6929.6929.460.68
21276811-127681129.56029.72
31261591-126159129.20829.36
41263667-126366729.25629.41
51259249-125924929.15429.32
61256221-125622129.08329.25
45min11277899-127789929.58529.650.4529.7929.860.46
21284473-128447329.73829.95
31280383-128038329.64329.84
41274722-127472229.51229.71
51290317-129031729.87330.08
61276870-127687029.56229.77
60min11268088-126808829.35829.520.6029.6229.780.58
21276281-127628129.54829.81
31282783-128278329.69829.95
41284332-128433229.73429.98
51273923-127392329.49329.75
61265573-126557329.30029.56
极限11288873-128887329.83929.790.9130.1530.090.89
21286055-128605529.77430.08
31296299-129629930.01130.31
41296851-129685130.02430.32
51286572-128657229.78630.10
61264711-126471129.28029.59
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