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%
127.341109181111279211121631113521111100511117320.16
227.251113706111381811137620.01
单位质量响应值RSD%判断
40663.2040872.000.37数据可信
加速6月-供试品溶液-2024032121批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1331781-33178113.18112.6715.7613.1812.6715.76
2336023-33602313.34913.35
3293236-29323611.65011.65
4231120-2311209.1829.18
5372579-37257914.80214.80
6349222-34922213.87413.87
10min1809460-80946032.15827.3913.2132.1827.4113.21
2661387-66138726.27626.30
3652025-65202525.90425.92
4562449-56244922.34522.36
5670181-67018126.62526.65
6780674-78067431.01531.04
15min11124217-112421744.66338.7712.5644.7438.8412.56
2920737-92073736.57936.64
31014548-101454840.30640.37
4819474-81947432.55632.61
5879058-87905834.92334.99
61097086-109708643.58543.66
20min11274356-127435650.62745.4611.4150.7845.5911.41
21100684-110068443.72843.85
31216850-121685048.34348.47
4986323-98632339.18539.29
51009222-100922240.09440.22
61277808-127780850.76550.91
30min11289894-128989451.24548.766.8951.4848.976.91
21256989-125698949.93850.14
31275056-127505650.65550.87
41124708-112470844.68244.85
51115508-111550844.31744.51
61302266-130226651.73651.97
45min11287429-128742951.14749.714.4351.4750.004.46
21277431-127743150.75051.03
31279619-127961950.83751.13
41183772-118377247.02947.28
51177444-117744446.77747.05
61301852-130185251.72052.04
60min11285687-128568751.07850.182.7551.4850.562.79
21275047-127504750.65551.02
31278861-127886150.80651.19
41217714-121771448.37748.70
51222013-122201348.54848.89
61299932-129993251.64452.05
极限11284027-128402751.01251.071.2251.5051.521.19
21270016-127001650.45550.91
31265018-126501850.25650.72
41293110-129311051.37351.78
51305445-130544551.86352.29
61295060-129506051.45051.94
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%
127.341913861192010219195721922365192149919194800.18
227.251923750192508219244160.05
单位质量响应值RSD%判断
70207.7570620.770.42数据可信
加速6月-供试品溶液-2024032121批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1563503-56350312.24611.7616.5312.2511.7616.52
2572896-57289612.45012.45
3492584-49258410.70410.70
4385922-3859228.3868.39
5636106-63610613.82313.82
6595863-59586312.94912.95
10min11390681-139068130.22125.8013.2230.2425.8213.22
21140592-114059224.78624.81
31124437-112443724.43524.45
4966736-96673621.00821.02
51153518-115351825.06725.09
61347777-134777729.28929.31
15min11945805-194580542.28436.5612.8242.3636.6312.82
21588245-158824534.51434.58
31752298-175229838.07938.14
41407888-140788830.59530.64
51509080-150908032.79432.86
61892147-189214741.11841.19
20min12200167-220016747.81242.9111.5747.9543.0411.56
21898129-189812941.24841.37
32099400-209940045.62245.74
41702959-170295937.00737.11
51734280-173428037.68837.81
62213589-221358948.10448.24
30min12232731-223273148.52046.027.1148.7446.217.13
22167689-216768947.10647.29
32201838-220183847.84848.05
41936762-193676242.08842.25
51917008-191700841.65941.84
62249964-224996448.89449.11
45min12227163-222716348.39946.894.6748.7047.164.69
22199874-219987447.80648.07
32208369-220836947.99048.27
42035337-203533744.23044.46
52025111-202511144.00844.26
62251790-225179048.93449.23
60min12223652-222365248.32247.362.9048.7047.712.93
22198741-219874147.78148.13
32209932-220993248.02448.38
42097299-209729945.57745.88
52103300-210330045.70746.03
62242991-224299148.74349.12
极限12221166-222116648.26848.341.2548.7348.761.22
22199132-219913247.78948.22
32185481-218548147.49347.93
42244158-224415848.76849.15
52258103-225810349.07149.47
62237561-223756148.62549.09
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%
127.341110355111013411089421109441110708311091910.12
227.251109913111481711123650.32
单位质量响应值RSD%判断
40570.2640820.730.44数据可信
加速6月-供试品溶液-2024032221批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1279334-27933411.11714.3718.8511.1214.3718.84
2392538-39253815.62215.62
3468046-46804618.62718.63
4380838-38083815.15715.16
5342144-34214413.61713.62
6303715-30371512.08712.09
10min1704881-70488128.05330.6511.7128.0730.6711.71
2756666-75666630.11430.14
3926255-92625536.86336.89
4797611-79761131.74431.77
5770443-77044330.66230.69
6664940-66494026.46426.48
15min1955767-95576738.03841.7511.5238.1041.8211.52
2971380-97138038.65938.74
31238993-123899349.31049.40
41097162-109716243.66543.74
51108757-110875744.12744.20
6921512-92151236.67536.74
20min11201190-120119047.80548.687.1647.9348.837.16
21124116-112411644.73844.88
31308762-130876252.08752.26
41279929-127992950.93951.09
51305558-130555851.95952.11
61119889-111988944.57044.70
30min11285044-128504451.14350.983.0551.3551.203.07
21278039-127803950.86451.08
31308800-130880052.08852.35
41296476-129647651.59851.83
51311117-131111752.18052.41
61205632-120563247.98248.18
45min11302525-130252551.83851.421.9352.1351.741.95
21292468-129246851.43851.74
31307513-130751352.03752.39
41294241-129424151.50951.83
51311978-131197852.21552.54
61243747-124374749.49949.78
60min11288939-128893951.29851.421.1751.6851.821.19
21295840-129584051.57251.96
31297259-129725951.62952.06
41292468-129246851.43851.85
51312117-131211752.22052.63
61266072-126607250.38850.75
极限11294075-129407551.50251.730.6051.9752.210.58
21297574-129757451.64152.11
31298773-129877351.68952.21
41290457-129045751.35851.85
51309731-130973152.12552.62
61308255-130825552.06652.51
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%
127.341921428191961219193171921677191511519194300.14
227.251918543192937119239570.40
单位质量响应值RSD%判断
70205.9370603.930.40数据可信
加速6月-供试品溶液-2024032221批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1477474-47747410.37713.5119.3310.3813.5019.34
2676426-67642614.70114.70
3809169-80916917.58617.59
4658863-65886314.32014.32
5587737-58773712.77412.77
6518714-51871411.27411.27
10min11218193-121819326.47628.9011.9126.4928.9211.92
21306787-130678728.40228.43
31602930-160293034.83834.87
41378270-137827029.95529.98
51330724-133072428.92228.94
61141748-114174824.81524.83
15min11651635-165163535.89739.3411.6135.9639.4211.61
21674589-167458936.39536.47
32139269-213926946.49546.58
41896814-189681441.22541.30
51914135-191413541.60241.67
61585220-158522034.45334.51
20min12073343-207334345.06245.847.5045.1845.977.51
21939435-193943542.15242.28
32263716-226371649.19949.36
42210181-221018148.03648.18
52256239-225623949.03749.18
61911313-191131341.54041.66
30min12229592-222959248.45848.083.2648.6548.293.27
22204146-220414647.90548.11
32259274-225927449.10349.35
42241671-224167148.72048.94
52265877-226587749.24649.47
62072315-207231545.04045.23
45min12249518-224951848.89148.502.0549.1748.802.07
22228566-222856648.43648.72
32260553-226055349.13149.46
42238785-223878548.65848.96
52269121-226912149.31749.62
62143591-214359146.58946.85
60min12227635-222763548.41548.521.3248.7748.891.34
22238252-223825248.64649.01
32243800-224380048.76749.18
42234908-223490848.57348.96
52269234-226923449.31949.70
62180074-218007447.38247.72
极限12232833-223283348.52848.830.7248.9749.280.71
22243689-224368948.76449.21
32244734-224473448.78749.28
42227703-222770348.41748.88
52268959-226895949.31349.78
62261460-226146049.15049.57
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%
127.341106889110796811077811108115110854511078600.06
227.251109616110678611082010.19
单位质量响应值RSD%判断
40521.5840667.930.26数据可信
加速6月-供试品溶液-2024032321批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1351948-35194814.04211.8411.8914.0411.8411.87
2285390-28539011.38611.39
3286420-28642011.42711.43
4326422-32642213.02313.02
5261610-26161010.43710.44
6268176-26817610.69910.70
10min1669388-66938826.70725.465.7026.7325.485.71
2591649-59164923.60523.62
3644558-64455825.71625.73
4688578-68857827.47227.49
5615528-61552824.55824.58
6618743-61874324.68624.70
15min1896554-89655435.77035.444.1635.8435.504.16
2838509-83850933.45433.51
3858042-85804234.23334.30
4931503-93150337.16437.23
5879223-87922335.07835.14
6925663-92566336.93136.99
20min11063822-106382242.44342.096.7442.5742.216.73
2984682-98468239.28639.40
3991256-99125639.54839.67
41181954-118195447.15647.29
51057235-105723542.18042.30
61050242-105024241.90142.02
30min11256696-125669650.13846.606.6550.3446.806.64
21087059-108705943.37043.55
31113929-111392944.44244.63
41272748-127274850.77950.99
51146096-114609645.72645.91
61132150-113215045.16945.36
45min11268118-126811850.59448.134.3850.8848.404.39
21154748-115474846.07146.32
31172890-117289046.79547.05
41278011-127801150.98951.28
51185945-118594547.31647.58
61178663-117866347.02547.29
60min11265442-126544250.48749.152.5450.8549.502.56
21206956-120695648.15448.48
31202984-120298447.99548.33
41276244-127624450.91851.30
51216936-121693648.55248.89
61222629-122262948.77949.12
极限11278619-127861951.01351.351.1551.4651.781.12
21279755-127975551.05851.47
31294398-129439851.64252.06
41272798-127279850.78151.24
51284228-128422851.23751.66
61313273-131327352.39652.82
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%
127.341916459191881319174931917340191821819176650.05
227.251920062191582519179440.16
单位质量响应值RSD%判断
70141.3770383.270.25数据可信
加速6月-供试品溶液-2024032321批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1607240-60724013.22411.0512.4813.2211.0512.48
2487945-48794510.62610.63
3490075-49007510.67310.67
4560183-56018312.20012.20
5445159-4451599.6959.69
6454937-4549379.9089.91
10min11152112-115211225.09123.905.8725.1123.925.88
21016466-101646622.13722.15
31107568-110756824.12124.14
41188554-118855425.88425.90
51056949-105694923.01823.03
61063328-106332823.15723.17
15min11543298-154329833.61033.314.3033.6733.374.29
21441942-144194231.40331.46
31477267-147726732.17232.23
41607015-160701534.99735.06
51509948-150994832.88432.94
61597065-159706534.78134.84
20min11834274-183427439.94739.586.8840.0739.706.88
21696914-169691436.95537.06
31702763-170276337.08337.19
42041431-204143144.45844.58
51819182-181918239.61839.73
61810614-181061439.43139.54
30min12169079-216907947.23843.826.7647.4244.006.75
21873307-187330740.79740.97
31916067-191606741.72841.90
42195218-219521847.80748.00
51968487-196848742.87043.04
61950108-195010842.46942.65
45min12184899-218489947.58345.284.4247.8545.534.43
21989555-198955543.32843.56
32018683-201868343.96344.21
42205131-220513148.02348.30
52044834-204483444.53244.78
62031839-203183944.24944.50
60min12184512-218451247.57446.272.6547.9246.602.66
22081488-208148845.33145.64
32071885-207188545.12145.44
42205191-220519148.02548.38
52098372-209837245.69846.02
62106405-210640545.87346.20
极限12209999-220999948.12948.461.1548.5548.871.12
22213002-221300248.19548.58
32236979-223697948.71749.11
42200633-220063347.92548.36
52220854-222085448.36648.76
62270817-227081749.45449.85
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%
127.341109285110871511117391110982111138911104220.13
227.251110255111270911114820.16
单位质量响应值RSD%判断
40615.2940788.330.31数据可信
长期6月-供试品溶液-2024032121批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1350660-35066013.95313.0316.2313.9513.0316.23
2348730-34873013.87713.88
3404146-40414616.08216.08
4326161-32616112.97912.98
5267497-26749710.64410.64
6267128-26712810.63010.63
10min1761910-76191030.31828.076.7030.3428.096.69
2692941-69294127.57427.60
3707624-70762428.15828.18
4709990-70999028.25228.27
5736543-73654329.30929.33
6622996-62299624.79024.81
15min1974815-97481538.79038.496.0938.8638.566.08
21072904-107290442.69342.76
3926683-92668336.87536.95
4945630-94563037.62937.70
5978991-97899138.95639.02
6905019-90501936.01336.07
20min11060573-106057342.20244.077.0642.3444.207.04
21263324-126332450.27050.41
31096668-109666843.63943.77
41055240-105524041.99042.12
51092477-109247743.47243.60
61077019-107701942.85742.98
30min11180580-118058046.97847.614.7547.1947.824.74
21301518-130151851.79052.01
31188442-118844247.29147.50
41128631-112863144.91145.11
51196327-119632747.60447.81
61183832-118383247.10747.30
45min11253520-125352049.88049.692.9550.1749.982.96
21306830-130683052.00152.31
31227715-122771548.85349.14
41214730-121473048.33748.61
51274489-127448950.71451.00
61215286-121528648.35948.63
60min11294013-129401351.49150.871.7151.8651.241.73
21305497-130549751.94852.35
31266856-126685650.41150.78
41262073-126207350.22050.58
51292427-129242751.42851.80
61249933-124993349.73750.09
极限11275293-127529350.74651.781.1351.2052.241.12
21302886-130288651.84452.33
31308465-130846552.06652.52
41318273-131827352.45752.90
51306335-130633551.98252.44
61296353-129635351.58552.02
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%
127.341923581192066819247161922336192357719229760.09
227.251923101192517919241400.08
单位质量响应值RSD%判断
70335.6370610.640.28数据可信
长期6月-供试品溶液-2024032121批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1603641-60364113.10712.1916.6913.1112.1916.68
2598298-59829812.99112.99
3696389-69638915.12115.12
4558006-55800612.11612.12
5456245-4562459.9069.91
6454741-4547419.8749.87
10min11314194-131419428.53526.376.9028.5626.406.90
21192951-119295125.90225.92
31217359-121735926.43226.46
41224390-122439026.58526.61
51270769-127076927.59227.61
61068088-106808823.19123.21
15min11682241-168224136.52636.226.2236.6036.286.22
21854009-185400940.25640.32
31596846-159684634.67234.74
41629373-162937335.37835.44
51686889-168688936.62736.69
61558139-155813933.83233.89
20min11827021-182702139.67041.467.2039.8041.597.19
22183783-218378347.41647.55
31890159-189015941.04141.17
41817063-181706339.45439.58
51885264-188526440.93441.06
61854886-185488640.27540.39
30min12032037-203203744.12144.784.8744.3244.984.88
22248215-224821548.81549.03
32049181-204918144.49344.69
41942841-194284142.18542.37
52063885-206388544.81345.00
62039473-203947344.28344.46
45min12161083-216108346.92346.773.0047.1947.043.02
22258771-225877149.04449.34
32117567-211756745.97846.25
42097921-209792145.55245.81
52195153-219515347.66347.93
62093284-209328445.45145.70
60min12234633-223463348.52047.851.8448.8748.201.86
22257380-225738049.01449.39
32179691-217969147.32747.67
42175223-217522347.23047.57
52223335-222333548.27548.62
62152778-215277846.74347.07
极限12226399-222639948.34148.930.8148.7749.350.80
22253505-225350548.93049.39
32261538-226153849.10449.53
42279839-227983949.50249.92
52257001-225700149.00649.43
62241619-224161948.67249.08
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%
127.341107100110659911082471108713110941311080140.11
227.251107303110518511062440.14
单位质量响应值RSD%判断
40527.2140596.110.13数据可信
长期6月-供试品溶液-2024032221批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1236236-2362369.43313.4219.019.4313.4219.03
2372215-37221514.86214.86
3418742-41874216.72016.72
4297832-29783211.89211.89
5363819-36381914.52714.53
6327703-32770313.08513.08
10min1612621-61262124.46229.459.6224.4829.479.62
2773402-77340230.88130.91
3812561-81256132.44532.47
4708605-70860528.29428.31
5779564-77956431.12731.15
6738270-73827029.47929.50
15min1901766-90176636.00742.308.1136.0642.378.12
21096588-109658843.78643.86
31148410-114841045.85545.94
41043444-104344441.66441.73
51108793-110879344.27344.35
61057335-105733542.21942.29
20min11099686-109968643.91048.746.7044.0348.896.70
21262233-126223350.40050.55
31286145-128614551.35551.51
41247647-124764749.81849.95
51291713-129171351.57751.73
61137267-113726745.41045.55
30min11227392-122739249.00950.643.6449.2050.863.65
21300733-130073351.93752.17
31287577-128757751.41251.66
41300183-130018351.91552.13
51299652-129965251.89452.13
61193826-119382647.66947.89
45min11252842-125284250.02551.072.4450.3051.382.45
21301777-130177751.97952.30
31297562-129756251.81152.14
41298205-129820551.83652.14
51295791-129579151.74052.06
61227582-122758249.01749.31
60min11269822-126982250.70351.321.2351.0651.711.26
21304147-130414752.07452.48
31291839-129183951.58252.00
41291073-129107351.55251.94
51291938-129193851.58651.99
61262322-126232250.40450.78
极限11286201-128620151.35751.540.4051.8052.020.41
21297764-129776451.81952.31
31285465-128546551.32851.83
41287709-128770951.41751.90
51294478-129447851.68852.18
61293713-129371351.65752.12
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%
127.341915991191428819189641918981192012119176690.13
227.251915009191174419133760.13
单位质量响应值RSD%判断
70141.5170215.630.08数据可信
长期6月-供试品溶液-2024032221批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1396490-3964908.64512.5619.788.6512.5619.75
2639507-63950713.94413.94
3722972-72297215.76415.76
4509881-50988111.11711.12
5625676-62567613.64213.64
6562180-56218012.25812.26
10min11053040-105304022.96027.729.7222.9727.749.74
21333348-133334829.07229.10
31401133-140113330.55030.58
41220936-122093626.62126.64
51344826-134482629.32229.35
61274620-127462027.79227.81
15min11553609-155360933.87539.888.2233.9339.948.22
21895014-189501441.31941.39
31983319-198331943.24443.32
41798664-179866439.21839.28
51917413-191741341.80741.88
61825309-182530939.79939.87
20min11895201-189520141.32345.966.8141.4346.096.82
22182690-218269047.59147.73
32220435-222043548.41448.56
42153687-215368746.95947.09
52233932-223393248.70848.85
61961222-196122242.76242.90
30min12116354-211635446.14547.733.7546.3247.943.76
22245050-224505048.95149.17
32224016-222401648.49248.72
42246221-224622148.97649.18
52245308-224530848.95649.18
62056563-205656344.84145.05
45min12158698-215869847.06848.142.5347.3248.432.55
22246424-224642448.98149.28
32245332-224533248.95749.27
42242095-224209548.88649.17
52238135-223813548.80049.10
62117616-211761646.17246.45
60min12179245-217924547.51648.301.3447.8548.671.37
22246487-224648748.98249.37
32226982-222698248.55748.95
42230517-223051748.63449.00
52231334-223133448.65249.04
62176965-217696547.46647.82
极限12222335-222233548.45548.620.4348.8749.070.43
22243921-224392148.92649.39
32220827-222082748.42348.90
42222605-222260548.46148.91
52234760-223476048.72649.19
62235361-223536148.74049.17
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%
127.341108922110944011075781109109111091311091920.11
227.251103805110532311045640.10
单位质量响应值RSD%判断
40570.3040534.460.07数据可信
长期6月-供试品溶液-2024032321批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1268881-26888110.73912.4316.5610.7412.4416.55
2349243-34924313.94813.95
3398844-39884415.92915.93
4290921-29092111.61911.62
5276875-27687511.05811.06
6283338-28333811.31611.32
10min1660439-66043926.37725.963.8626.3925.973.86
2663767-66376726.51026.53
3674670-67467026.94526.97
4659124-65912426.32426.34
5606078-60607824.20624.22
6635222-63522225.37025.39
15min1968805-96880538.69337.158.2438.7537.228.24
21050561-105056141.95842.03
3871653-87165334.81234.88
4959752-95975238.33138.39
5847138-84713833.83333.89
6883692-88369235.29335.35
20min11178563-117856347.07043.567.8647.2043.697.85
21181980-118198047.20647.34
3992478-99247839.63839.77
41139771-113977145.52145.65
51014975-101497540.53740.65
61036965-103696541.41541.53
30min11290319-129031951.53348.765.7751.7448.965.77
21276987-127698751.00151.22
31123160-112316044.85745.05
41279818-127981851.11451.32
51183133-118313347.25347.44
61172224-117222446.81747.01
45min11294318-129431851.69350.592.5451.9850.872.55
21286462-128646251.37951.68
31245106-124510649.72850.00
41292620-129262051.62551.91
51268211-126821150.65050.91
61213286-121328648.45748.72
60min11282341-128234151.21550.941.5451.5951.301.55
21284780-128478051.31251.70
31270732-127073250.75151.10
41292072-129207251.60351.98
51284750-128475051.31151.66
61238238-123823849.45349.80
极限11292907-129290751.63751.510.9152.1051.960.89
21281195-128119551.16951.64
31304350-130435052.09452.53
41287376-128737651.41651.88
51299300-129930051.89252.32
61272871-127287150.83751.27
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%
127.341921320192031419180401919680192049719199700.07
227.251909861191388419118720.15
单位质量响应值RSD%判断
70225.6870160.440.07数据可信
长期6月-供试品溶液-2024032321批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1458449-4584499.99411.6217.169.9911.6217.16
2599352-59935213.06513.07
3688755-68875515.01415.01
4496193-49619310.81710.82
5471509-47150910.27910.28
6483423-48342310.53810.54
10min11139651-113965124.84424.384.0124.8624.404.03
21144110-114411024.94124.96
31161557-116155725.32125.35
41133247-113324724.70424.72
51039290-103929022.65622.67
61093775-109377523.84423.86
15min11673191-167319136.47434.968.3636.5335.028.35
21813896-181389639.54239.61
31500493-150049332.71032.78
41652721-165272136.02836.09
51457744-145774431.77831.83
61523995-152399533.22233.28
20min12038500-203850044.43841.008.0044.5641.127.99
22037296-203729644.41244.54
31708281-170828137.23937.36
41967131-196713142.88243.00
51748218-174821838.11038.22
61786611-178661138.94739.06
30min12233586-223358648.69145.915.9448.8846.095.93
22205236-220523648.07348.28
31934393-193439342.16942.35
42206564-220656448.10248.29
52035896-203589644.38144.55
62019835-201983544.03144.21
45min12237076-223707648.76747.622.6449.0447.892.66
22220877-222087748.41448.70
32144014-214401446.73846.99
42230595-223059548.62648.90
52184091-218409147.61247.86
62090986-209098645.58245.83
60min12216464-221646448.31847.971.6448.6748.321.66
22221809-222180948.43448.80
32188337-218833747.70448.04
42232048-223204848.65749.01
52212381-221238148.22848.55
62133450-213345046.50846.83
极限12233917-223391748.69848.580.9149.1349.000.89
22213659-221365948.25648.70
32253872-225387249.13349.54
42224810-222481048.49948.93
52245698-224569848.95549.36
62199885-219988547.95648.36
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