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%
128.272888092886032882472887772883682885610.09
228.322889152883102886120.15
单位质量响应值RSD%判断
10207.3210191.100.12数据可信
长期3月-供试品溶液-2024032721批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1111213-11121317.66014.7019.3217.6614.7019.31
281347-8134712.91812.92
3106355-10635516.88916.89
480590-8059012.79712.80
5107339-10733917.04517.05
668619-6861910.89610.90
10min1237745-23774537.75331.6013.7537.7831.6213.74
2175215-17521527.82427.85
3210560-21056033.43633.46
4182810-18281029.03029.05
5218558-21855834.70634.73
6169110-16911026.85426.87
15min1291333-29133346.26342.5610.9246.3642.6410.93
2239988-23998838.10938.18
3280253-28025344.50344.59
4263232-26323241.80041.87
5303948-30394848.26648.35
6229464-22946436.43836.50
20min1316463-31646350.25348.646.8950.4248.796.90
2284804-28480445.22645.36
3320987-32098750.97251.13
4309775-30977549.19149.33
5329422-32942252.31152.48
6276419-27641943.89444.02
30min1332414-33241452.78651.881.2853.0452.111.31
2320580-32058050.90751.11
3327251-32725151.96652.21
4325691-32569151.71951.94
5329820-32982052.37452.63
6324474-32447451.52551.72
45min1333603-33360352.97552.320.8153.3252.640.81
2329990-32999052.40152.69
3327206-32720651.95952.29
4326315-32631551.81852.13
5328977-32897752.24052.58
6330948-33094852.55352.84
60min1334246-33424653.07752.401.0553.5152.801.04
2332572-33257252.81153.19
3326154-32615451.79252.21
4326044-32604451.77552.17
5328902-32890252.22952.66
6331897-33189752.70453.07
极限1333135-33313552.90152.381.1153.4252.871.09
2333089-33308952.89353.36
3325648-32564851.71252.21
4325817-32581751.73952.22
5328479-32847952.16152.68
6332944-33294452.87053.33
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%
128.275002865004675000985000384994755000730.08
228.324991225002694996960.17
单位质量响应值RSD%判断
17689.1817644.630.18数据可信
长期3月-供试品溶液-2024032721批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1190208-19020816.47413.6020.3516.4713.6020.33
2137358-13735811.89711.90
3181543-18154315.72415.72
4134141-13414111.61811.62
5184160-18416015.95015.95
6115081-1150819.9679.97
10min1409760-40976035.49029.5514.3135.5229.5814.32
2299907-29990725.97626.00
3362308-36230831.38031.41
4313252-31325227.13127.15
5376159-37615932.58032.61
6285834-28583424.75724.77
15min1502925-50292543.55939.9711.1943.6540.0411.20
2412585-41258535.73535.80
3482986-48298641.83241.91
4452346-45234639.17939.24
5524787-52478745.45345.53
6393201-39320134.05634.11
20min1545228-54522847.22345.747.1847.3845.887.20
2489566-48956642.40242.52
3554481-55448148.02548.17
4534208-53420846.26946.40
5570766-57076649.43549.59
6474657-47465741.11141.23
30min1572677-57267749.60148.801.4149.8449.011.44
2552189-55218947.82648.02
3565431-56543148.97349.20
4561902-56190248.66748.87
5570952-57095249.45149.69
6557379-55737948.27648.46
45min1576480-57648049.93049.290.8750.2549.590.87
2569859-56985949.35749.63
3564248-56424848.87149.18
4562989-56298948.76249.05
5569863-56986349.35749.68
6571159-57115949.46949.73
60min1576777-57677749.95649.350.9950.3649.730.97
2573694-57369449.68950.04
3564367-56436748.88149.27
4563400-56340048.79749.17
5567030-56703049.11249.52
6573553-57355349.67750.02
极限1575134-57513449.81449.371.1450.3049.831.11
2577109-57710949.98550.42
3563415-56341548.79949.27
4562248-56224848.69749.15
5567596-56759649.16149.65
6574774-57477449.78250.21
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%
128.272883812889572884072883892889492886170.11
228.322876552878752877650.06
单位质量响应值RSD%判断
10209.3010161.190.34数据可信
长期3月-供试品溶液-2024032721批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1101099-10109916.07617.2525.9216.0817.2525.93
2149176-14917623.72123.72
380274-8027412.76512.76
480065-8006512.73212.73
5133671-13367121.25621.26
6106661-10666116.96116.96
10min1200811-20081131.93232.6517.5531.9632.6817.56
2255299-25529940.59640.64
3174038-17403827.67527.70
4178106-17810628.32228.34
5244775-24477538.92338.96
6178917-17891728.45128.48
15min1274582-27458243.66342.8911.6043.7442.9711.61
2307414-30741448.88348.99
3248216-24821639.47039.54
4250404-25040439.81839.89
5304879-30487948.48048.58
6232687-23268737.00137.08
20min1321569-32156951.13449.317.2451.2949.467.25
2329967-32996752.47052.66
3309918-30991849.28249.41
4307085-30708548.83148.97
5324181-32418151.55051.73
6267876-26787642.59642.73
30min1329770-32977052.43851.993.0652.6852.223.08
2330076-33007652.48752.76
3333893-33389353.09453.31
4324103-32410351.53751.75
5335576-33557653.36253.63
6308200-30820049.00849.22
45min1329973-32997352.47152.661.5052.8052.991.52
2330262-33026252.51752.88
3336675-33667553.53653.84
4325268-32526851.72352.02
5337528-33752853.67254.03
6327396-32739652.06152.35
60min1329698-32969852.42752.641.4052.8453.051.41
2329222-32922252.35152.80
3336410-33641053.49453.89
4325736-32573651.79752.19
5337050-33705053.59654.04
6328135-32813552.17852.56
极限1328632-32863252.25752.551.4452.7653.051.46
2328856-32885652.29352.83
3335984-33598453.42753.91
4325404-32540451.74452.22
5336843-33684353.56354.10
6327246-32724652.03752.50
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%
128.274997165011234998014998055009815002850.15
228.324978874989694984280.16
单位质量响应值RSD%判断
17696.6717599.860.39数据可信
长期3月-供试品溶液-2024032721批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1172260-17226014.93616.0826.8514.9416.0826.86
2257335-25733522.31222.31
3135343-13534311.73511.73
4135073-13507311.71111.71
5230216-23021619.96119.96
6182724-18272415.84315.84
10min1344417-34441729.86230.5817.8629.8930.6017.87
2440332-44033238.17938.22
3297506-29750625.79525.81
4304745-30474526.42326.44
5421198-42119836.52036.55
6307641-30764126.67426.70
15min1472740-47274040.98840.2311.8741.0640.3111.88
2530315-53031545.98046.08
3425751-42575136.91436.98
4429896-42989637.27437.34
5526036-52603645.60945.70
6399198-39919834.61234.68
20min1555123-55512348.13146.377.3948.2746.517.40
2569577-56957749.38549.56
3534760-53476046.36646.49
4529940-52994045.94846.07
5558980-55898048.46648.64
6460166-46016639.89840.03
30min1569583-56958349.38548.893.1149.6149.123.13
2569997-56999749.42149.68
3576136-57613649.95350.15
4557142-55714248.30648.51
5579073-57907350.20850.46
6531638-53163846.09546.29
45min1569968-56996849.41949.591.5349.7249.901.55
2571118-57111849.51849.86
3582146-58214650.47450.76
4561132-56113248.65248.94
5582459-58245950.50250.84
6565182-56518249.00449.28
60min1570454-57045449.46149.611.4649.8550.001.47
2568758-56875849.31449.74
3581399-58139950.41050.78
4562311-56231148.75549.12
5583302-58330250.57550.99
6566975-56697549.15949.51
极限1568859-56885949.32249.541.4749.7950.011.48
2568728-56872849.31149.82
3580318-58031850.31650.77
4561348-56134848.67149.12
5582888-58288850.53951.04
6566293-56629349.10049.54
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%
128.272879782888022883692875612880352881490.17
228.322888732890682889700.05
单位质量响应值RSD%判断
10192.7510203.740.08数据可信
长期3月-供试品溶液-2024032821批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193117-9311714.78816.9027.0014.7916.9127.00
2140010-14001022.23522.24
362439-624399.9169.92
4126915-12691520.15620.16
5123273-12327319.57719.58
692877-9287714.75014.75
10min1210964-21096433.50432.8411.0633.5332.8711.07
2222329-22232935.30835.35
3163495-16349525.96525.98
4223527-22352735.49935.53
5219580-21958034.87234.90
6200896-20089631.90531.93
15min1295397-29539746.91243.795.3146.9943.875.32
2276309-27630943.88143.98
3250222-25022239.73839.80
4273773-27377343.47843.57
5277885-27788544.13144.22
6280778-28077844.59144.67
20min1317102-31710250.36049.222.0050.5249.381.98
2306001-30600148.59748.77
3314523-31452349.95050.08
4300626-30062647.74347.91
5307792-30779248.88149.05
6313455-31345549.78049.93
30min1337017-33701753.52252.351.7153.7652.591.69
2327844-32784452.06552.32
3331164-33116452.59352.80
4320198-32019850.85151.10
5329203-32920352.28152.53
6332459-33245952.79853.03
45min1338734-33873453.79552.731.2554.1353.051.24
2329312-32931252.29952.64
3333499-33349952.96453.26
4326552-32655251.86052.19
5331378-33137852.62752.96
6332588-33258852.81953.14
60min1337487-33748753.59752.581.1854.0253.001.17
2328464-32846452.16452.59
3332978-33297852.88153.27
4326607-32660751.86952.28
5329189-32918952.27952.70
6331828-33182852.69853.11
极限1337040-33704053.52652.531.1054.0453.031.09
2328064-32806452.10052.61
3331680-33168052.67553.15
4326740-32674051.89052.39
5329779-32977952.37352.88
6331384-33138452.62853.13
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%
128.274994495003334990764991274986264993220.13
228.325002184997664999920.07
单位质量响应值RSD%判断
17662.6117655.080.04数据可信
长期3月-供试品溶液-2024032821批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1158387-15838713.72415.6927.9513.7215.6927.95
2240889-24088920.87320.87
3102949-1029498.9218.92
4214692-21469218.60318.60
5211629-21162918.33818.34
6157837-15783713.67713.68
10min1361630-36163031.33630.7311.3331.3630.7611.34
2382192-38219233.11733.15
3278542-27854224.13624.15
4383525-38352533.23333.26
5377583-37758332.71832.75
6344520-34452029.85329.88
15min1508466-50846644.05941.155.2344.1341.235.23
2476089-47608941.25441.34
3431896-43189637.42437.48
4471442-47144240.85140.94
5478289-47828941.44441.53
6483491-48349141.89541.97
20min1546482-54648247.35346.252.0547.5046.402.02
2527609-52760945.71845.88
3541619-54161946.93247.05
4516846-51684644.78544.94
5530313-53031345.95246.11
6539783-53978346.77346.92
30min1581373-58137350.37749.291.7550.6049.521.73
2566993-56699349.13149.37
3571218-57121849.49749.69
4551531-55153147.79148.02
5568123-56812349.22949.46
6574032-57403249.74149.96
45min1584702-58470250.66549.681.3050.9849.991.29
2568842-56884249.29149.61
3576908-57690849.99050.27
4562763-56276348.76449.07
5572891-57289149.64249.95
6574051-57405149.74250.05
60min1583033-58303350.52149.541.1950.9249.931.17
2568111-56811149.22849.63
3573887-57388749.72850.09
4563032-56303248.78849.18
5569437-56943749.34349.74
6573076-57307649.65850.04
极限1582979-58297950.51649.531.1351.0050.001.12
2567634-56763449.18649.67
3573508-57350849.69550.14
4564404-56440448.90649.38
5569356-56935649.33549.81
6571688-57168849.53850.01
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%
128.272898202899662900692901072896682899260.07
228.322874462878082876270.09
单位质量响应值RSD%判断
10255.6110156.320.69数据可信
长期3月-供试品溶液-2024032821批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181572-8157212.94517.2323.8112.9517.2323.80
2120900-12090019.18619.19
3140561-14056122.30622.31
4106433-10643316.89016.89
575349-7534911.95811.96
6126643-12664320.09820.10
10min1183288-18328829.08731.9713.6129.1132.0013.62
2231398-23139836.72236.75
3206862-20686232.82832.87
4210144-21014433.34933.38
5156178-15617824.78524.80
6220829-22082935.04535.08
15min1264667-26466742.00142.6911.4242.0742.7811.42
2304563-30456348.33348.43
3249372-24937239.57439.67
4288350-28835045.76045.84
5220457-22045734.98535.05
6286684-28668445.49545.59
20min1321625-32162551.04049.199.2551.1849.349.24
2335377-33537753.22353.40
3275105-27510543.65843.82
4326998-32699851.89352.05
5271748-27174843.12543.24
6328762-32876252.17352.34
30min1326337-32633751.78851.592.8252.0151.822.85
2335493-33549353.24153.50
3314445-31444549.90150.13
4328405-32840552.11652.36
5313569-31356949.76249.95
6332279-33227952.73152.99
45min1327290-32729051.93952.191.4652.2552.511.50
2335119-33511953.18253.53
3327649-32764951.99652.31
4327859-32785952.03052.36
5321903-32190351.08451.36
6333503-33350352.92553.27
60min1327069-32706951.90452.151.0452.3052.561.08
2333712-33371252.95953.40
3327333-32733351.94652.35
4327540-32754051.97952.40
5324488-32448851.49551.85
6331687-33168752.63753.07
极限1326205-32620551.76752.061.0452.2552.561.07
2333562-33356252.93553.46
3327011-32701151.89552.38
4326405-32640551.79952.31
5324484-32448451.49451.94
6330716-33071652.48353.00
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.275018095011245013495022295012015015420.10
228.324989314983864986580.08
单位质量响应值RSD%判断
17741.1417607.980.54数据可信
长期3月-供试品溶液-2024032821批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1137263-13726311.88416.0224.7911.8816.0224.80
2206361-20636117.86617.87
3242181-24218120.96720.97
4181292-18129215.69515.70
5126151-12615110.92210.92
6217207-21720718.80518.80
10min1312962-31296227.09529.9013.9527.1129.9213.96
2397409-39740934.40634.44
3355371-35537130.76630.80
4360981-36098131.25231.28
5265803-26580323.01223.03
6379386-37938632.84632.88
15min1455351-45535139.42240.0711.6339.4940.1511.62
2525122-52512245.46345.55
3428328-42832837.08337.17
4497409-49740943.06343.14
5377845-37784532.71232.77
6493160-49316042.69642.78
20min1554259-55425947.98546.269.4148.1246.409.41
2578800-57880050.11050.27
3472493-47249340.90641.05
4564624-56462448.88349.03
5467995-46799540.51740.63
6567688-56768849.14849.31
30min1562338-56233848.68548.562.9148.9048.782.94
2579208-57920850.14550.39
3542040-54204046.92747.14
4567425-56742549.12549.36
5540379-54037946.78446.96
6573948-57394849.69049.93
45min1566269-56626949.02549.201.4049.3249.501.44
2578477-57847750.08250.41
3565846-56584648.98849.28
4567039-56703949.09249.41
5556218-55621848.15548.41
6575594-57559449.83250.15
60min1563813-56381348.81249.101.1149.1949.481.14
2576953-57695349.95050.36
3566908-56690849.08049.46
4564677-56467748.88749.28
5559040-55904048.39948.74
6571089-57108949.44249.85
极限1563565-56356548.79149.071.0849.2549.531.12
2576531-57653149.91450.41
3565683-56568348.97449.43
4563657-56365748.79949.28
5559707-55970748.45748.87
6571294-57129449.46049.95
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.272888122889022889542888162890612889090.04
228.322879422880002879710.02
单位质量响应值RSD%判断
10219.6310168.470.36数据可信
长期3月-供试品溶液-2024032921批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1112649-11264917.89718.3721.3117.9018.3721.31
2134742-13474221.40821.41
3121861-12186119.36119.36
475271-7527111.95911.96
5104144-10414416.54616.55
6144957-14495723.03023.03
10min1213057-21305733.85033.884.0133.8833.914.02
2207236-20723632.92532.96
3226003-22600335.90735.94
4203501-20350132.33232.35
5209183-20918333.23533.26
6220645-22064535.05635.09
15min1262953-26295341.77742.753.0241.8642.843.01
2258513-25851341.07241.16
3273649-27364943.47743.57
4273623-27362343.47343.55
5280258-28025844.52744.61
6265515-26551542.18442.28
20min1294945-29494546.86047.382.9647.0247.542.95
2286426-28642645.50745.67
3306567-30656748.70748.87
4297380-29738047.24747.39
5310422-31042249.31949.48
6293748-29374846.67046.84
30min1327169-32716951.98051.861.9052.2152.101.90
2319359-31935950.73950.97
3337235-33723553.57953.82
4321558-32155851.08851.31
5327100-32710051.96952.21
6326096-32609651.80952.05
45min1332368-33236852.80652.511.5053.1352.841.49
2326935-32693551.94352.26
3339427-33942753.92754.26
4330431-33043152.49852.81
5327823-32782352.08452.41
6326155-32615551.81952.15
60min1331601-33160152.68452.441.4653.0952.851.46
2326645-32664551.89752.30
3338866-33886653.83854.26
4330078-33007852.44252.84
5327270-32727051.99652.41
6326028-32602851.79952.22
极限1331190-33119052.61952.311.4053.1252.801.40
2325702-32570251.74752.24
3337388-33738853.60454.12
4329049-32904952.27952.76
5326887-32688751.93552.43
6325109-32510951.65352.16
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%
128.275003655003175008415011325011135007540.08
228.324986784988704987740.03
单位质量响应值RSD%判断
17713.2617612.080.41数据可信
长期3月-供试品溶液-2024032921批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1191251-19125116.56917.0922.3816.5717.0822.40
2231528-23152820.05820.06
3209443-20944318.14518.14
4124833-12483310.81510.81
5176894-17689415.32515.32
6249395-24939521.60621.61
10min1364649-36464931.59131.693.9631.6231.723.97
2355174-35517430.77030.80
3387327-38732733.55533.59
4349849-34984930.30930.33
5359095-35909531.11031.14
6378887-37888732.82432.86
15min1452184-45218439.17440.093.1139.2540.173.09
2444704-44470438.52638.61
3469426-46942640.66840.75
4470548-47054840.76540.83
5483814-48381441.91441.99
6455997-45599739.50539.60
20min1507672-50767243.98144.493.0244.1344.643.01
2493498-49349842.75342.90
3528023-52802345.74445.90
4510964-51096444.26744.40
5535537-53553746.39546.54
6505595-50559543.80143.96
30min1565068-56506848.95448.821.9449.1749.041.94
2551025-55102547.73747.96
3582304-58230450.44750.68
4554492-55449248.03748.25
5564922-56492248.94149.17
6563062-56306248.78049.01
45min1573891-57389149.71849.451.4050.0249.751.40
2565279-56527948.97249.27
3585144-58514450.69351.01
4570104-57010449.39049.68
5566822-56682249.10649.41
6563338-56333848.80449.11
60min1573237-57323749.66149.421.4550.0449.801.44
2564827-56482748.93349.31
3585503-58550350.72451.12
4570056-57005649.38649.76
5565955-56595549.03149.42
6563106-56310648.78449.18
极限1572774-57277449.62149.291.3750.0949.761.37
2563258-56325848.79749.26
3582594-58259450.47250.96
4568341-56834149.23749.69
5565464-56546448.98849.46
6561548-56154848.64949.12
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.272880682880072878772878172880802879700.05
228.322872972874572873770.04
单位质量响应值RSD%判断
10186.4210147.490.28数据可信
长期3月-供试品溶液-2024032921批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165486-6548610.43216.5424.2210.4316.5424.23
2108986-10898617.36217.36
399009-9900915.77215.77
488769-8876914.14114.14
5131759-13175920.98920.99
6128996-12899620.54920.55
10min1175499-17549927.95733.518.7527.9733.548.76
2221634-22163435.30735.34
3210147-21014733.47733.50
4211534-21153433.69833.72
5214970-21497034.24534.28
6228416-22841636.38736.42
15min1265391-26539142.27745.115.8442.3445.195.84
2292784-29278446.64146.73
3293597-29359746.77046.85
4296128-29612847.17347.25
5258765-25876541.22241.31
6292399-29239946.57946.67
20min1323022-32302251.45850.375.0951.5950.535.07
2314699-31469950.13250.30
3329187-32918752.44052.60
4319438-31943850.88751.05
5284992-28499245.40045.56
6325809-32580951.90252.07
30min1332685-33268552.99752.022.1453.2252.272.13
2329911-32991152.55552.80
3329950-32995052.56152.81
4326401-32640151.99652.24
5313068-31306849.87250.11
6327480-32748052.16852.43
45min1332612-33261252.98552.992.4153.2953.322.41
2329366-32936652.46852.80
3329432-32943252.47952.81
4330550-33055052.65752.99
5325543-32554351.85952.18
6348242-34824255.47555.82
60min1332074-33207452.90052.410.6053.3052.830.58
2329265-32926552.45252.88
3328603-32860352.34752.77
4329911-32991152.55552.97
5327785-32778552.21652.62
6326304-32630451.98152.42
极限1331267-33126752.77152.300.5253.2652.810.50
2328208-32820852.28452.80
3327672-32767252.19852.71
4329102-32910252.42652.93
5327236-32723652.12952.62
6326515-32651552.01452.54
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%
128.274987924987514986784985254987444986980.03
228.324976544978314977420.03
单位质量响应值RSD%判断
17640.5417575.640.27数据可信
长期3月-供试品溶液-2024032921批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108492-1084929.42815.3525.239.4315.3525.23
2185948-18594816.15916.16
3168054-16805414.60414.60
4150270-15027013.05913.06
5226112-22611219.64919.65
6221151-22115119.21819.22
10min1300068-30006826.07631.358.8726.0931.388.88
2380445-38044533.06133.09
3360522-36052231.33031.35
4362586-36258631.50931.53
5368965-36896532.06432.10
6391889-39188934.05634.09
15min1456802-45680239.69742.375.9139.7642.455.90
2504657-50465743.85543.94
3506036-50603643.97544.05
4509768-50976844.30044.37
5444953-44495338.66738.75
6503369-50336943.74443.83
20min1557362-55736248.43647.395.1848.5647.535.17
2542668-54266847.15947.31
3568262-56826249.38349.53
4550627-55062747.85048.00
5490599-49059942.63442.78
6562248-56224848.86049.02
30min1575083-57508349.97648.992.2150.1849.222.20
2569216-56921649.46649.70
3569988-56998849.53349.76
4562870-56287048.91449.14
5539833-53983346.91247.13
6565478-56547849.14149.38
45min1574658-57465849.93949.892.2650.2350.202.26
2568934-56893449.44149.76
3569257-56925749.46949.78
4570936-57093649.61549.92
5561894-56189448.82949.13
6599123-59912352.06552.39
60min1574259-57425949.90449.400.6350.2849.800.61
2568909-56890949.43949.84
3567747-56774749.33849.74
4569957-56995749.53049.92
5566492-56649249.22949.61
6563598-56359848.97849.39
极限1572486-57248649.75049.300.5250.2149.780.50
2567264-56726449.29649.78
3565949-56594949.18249.66
4568388-56838849.39449.87
5565742-56574249.16449.63
6564205-56420549.03049.52
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