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%
128.072877912876922874722873352873182875220.08
228.182880892885372883130.11
单位质量响应值RSD%判断
10243.0410231.120.09数据可信
供试品溶液-SDR361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%
5min172112-7211212.29913.678.6712.3013.678.65
286102-8610214.68514.68
388329-8832915.06515.06
479627-7962713.58013.58
582877-8287714.13514.13
671982-7198212.27712.28
10min1163948-16394827.96230.557.1427.9830.587.14
2188595-18859532.16532.19
3166192-16619228.34428.37
4186860-18686031.86931.89
5194850-19485033.23233.26
6174401-17440129.74429.76
15min1246878-24687842.10542.706.3842.1742.776.38
2253359-25335943.21143.29
3226721-22672138.66838.74
4258814-25881444.14144.22
5273959-27395946.72446.80
6242296-24229641.32441.39
20min1291045-29104549.63849.187.1649.7849.327.15
2299272-29927251.04151.19
3256106-25610643.67943.82
4306915-30691552.34552.49
5305985-30598552.18652.34
6270838-27083846.19246.33
30min1294786-29478650.27650.126.5250.5050.356.51
2307173-30717352.38952.62
3264486-26448645.10845.32
4311398-31139853.10953.35
5308178-30817852.56052.80
6277185-27718547.27447.49
45min1296833-29683350.62550.596.3250.9350.906.31
2308470-30847052.61052.93
3268058-26805845.71846.00
4313683-31368353.49953.82
5312211-31221153.24853.58
6280400-28040047.82348.12
60min1298427-29842750.89750.776.3751.2951.176.37
2310030-31003052.87653.29
3269245-26924545.92046.28
4314915-31491553.70954.12
5313121-31312153.40353.82
6280403-28040347.82348.20
极限1309013-30901352.70353.432.3753.1853.902.40
2321351-32135154.80755.31
3305567-30556752.11552.55
4321018-32101854.75055.25
5316948-31694854.05654.56
6305632-30563252.12652.58
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%
128.074982604982734979144979164978454980420.05
228.184989224995044992130.09
单位质量响应值RSD%判断
17742.8617715.150.12数据可信
供试品溶液-SDR361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%
5min1119383-11938311.10712.489.5111.1112.489.52
2145541-14554113.54113.54
3148292-14829213.79713.80
4133608-13360812.43112.43
5139268-13926812.95812.96
6118706-11870611.04411.04
10min1280026-28002626.05428.657.6926.0728.677.69
2325618-32561830.29630.32
3284436-28443626.46426.49
4322197-32219729.97730.00
5337184-33718431.37231.39
6297943-29794327.72127.74
15min1427019-42701939.73040.286.8039.7940.356.80
2438384-43838440.78740.86
3389985-38998536.28436.35
4448943-44894341.77041.84
5476611-47661144.34444.42
6416863-41686338.78538.85
20min1505986-50598647.07746.547.7647.2146.687.75
2520544-52054448.43248.57
3440108-44010840.94841.08
4535076-53507649.78449.92
5533434-53343449.63149.78
6466370-46637043.39143.52
30min1511300-51130047.57247.357.2247.7847.567.21
2533241-53324149.61349.83
3452793-45279342.12842.32
4542204-54220450.44750.67
5537420-53742050.00250.23
6476303-47630344.31544.52
45min1513758-51375847.80047.656.9948.0947.947.00
2534460-53446049.72650.03
3457424-45742442.55942.82
4544260-54426050.63850.95
5541978-54197850.42650.74
6480753-48075344.72945.00
60min1516010-51601048.01047.777.0848.3848.157.07
2536647-53664749.93050.32
3458492-45849242.65843.00
4546042-54604250.80451.20
5543191-54319150.53950.94
6480497-48049744.70645.06
极限1536713-53671349.93650.782.0450.3851.232.07
2558144-55814451.93052.40
3537887-53788750.04550.45
4557869-55786951.90452.38
5550483-55048351.21751.70
6533578-53357849.64450.07
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%
128.072886982886762884872887502885692886360.04
228.182863112868962866040.15
单位质量响应值RSD%判断
10282.7210170.480.78数据可信
供试品溶液-SDR361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%
5min164192-6419210.96012.7814.0410.9612.7814.05
281562-8156213.92513.93
363261-6326110.80110.80
486824-8682414.82414.82
569296-6929611.83111.83
684093-8409314.35714.36
10min1180456-18045630.80930.935.8930.8330.955.89
2188327-18832732.15332.18
3160545-16054527.41027.43
4186458-18645831.83431.86
5189037-18903732.27432.29
6182155-18215531.10031.12
15min1240619-24061941.08140.595.7341.1540.665.73
2233743-23374339.90739.98
3218594-21859437.32137.38
4233811-23381139.91940.00
5260483-26048344.47344.55
6239191-23919140.83740.91
20min1266963-26696345.57944.976.9845.7245.116.97
2257219-25721943.91544.06
3246595-24659542.10142.23
4255757-25575743.66643.81
5298491-29849150.96251.11
6255310-25531043.58943.73
30min1272152-27215246.46546.605.9946.6846.815.98
2272133-27213346.46246.68
3261752-26175244.68944.89
4259910-25991044.37544.59
5304615-30461552.00752.24
6266986-26698645.58345.80
45min1276898-27689847.27547.295.9947.5747.595.99
2276439-27643947.19747.49
3266275-26627545.46145.73
4263321-26332144.95745.25
5309019-30901952.75953.08
6270068-27006846.10946.40
60min1276392-27639247.18947.355.9047.5647.735.89
2278289-27828947.51347.89
3267640-26764045.69446.04
4261507-26150744.64745.01
5308331-30833152.64253.05
6271983-27198346.43646.81
极限1308475-30847552.66652.083.1053.1252.533.10
2305173-30517352.10252.55
3306218-30621852.28152.70
4288830-28883049.31249.75
5317955-31795554.28554.78
6303528-30352851.82252.27
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.074992484993324991404996224993684993420.04
228.184958224965934962080.11
单位质量响应值RSD%判断
17789.1717608.520.73数据可信
供试品溶液-SDR361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%
5min1105891-1058919.86911.6315.149.8711.6315.14
2135859-13585912.66212.66
3103655-1036559.6619.66
4146054-14605413.61213.61
5115061-11506110.72410.72
6142461-14246113.27813.28
10min1310393-31039328.92928.996.1428.9529.006.14
2323690-32369030.16830.19
3274017-27401725.53925.55
4319954-31995429.82029.84
5325346-32534630.32330.34
6312653-31265329.14029.16
15min1415059-41505938.68438.176.0238.7538.246.01
2402498-40249837.51337.58
3374966-37496634.94735.01
4402202-40220237.48637.56
5450801-45080142.01542.08
6411875-41187538.38738.46
20min1460061-46006142.87842.337.4343.0142.467.42
2441968-44196841.19241.33
3424104-42410439.52739.64
4440668-44066841.07141.21
5518942-51894248.36648.50
6439113-43911340.92641.06
30min1468880-46888043.70043.806.3643.9044.006.35
2467463-46746343.56843.77
3450103-45010341.95042.13
4447260-44726041.68541.89
5528178-52817849.22749.45
6457823-45782342.67042.87
45min1474364-47436444.21144.326.4344.4844.596.41
2473590-47359044.13944.41
3456355-45635542.53342.79
4451525-45152542.08342.36
5534970-53497049.86050.16
6462065-46206543.06543.34
60min1473042-47304244.08844.326.3344.4444.676.32
2475734-47573444.33944.69
3457787-45778742.66642.99
4448725-44872541.82242.16
5533423-53342349.71650.10
6464363-46436343.27943.63
极限1540686-54068650.39349.742.7950.8150.162.80
2532807-53280749.65850.08
3536610-53661050.01350.41
4506530-50653047.20947.62
5551287-55128751.38151.85
6533952-53395249.76550.18
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%
128.072880932879832878232873102872042876830.14
228.182878962877752878360.03
单位质量响应值RSD%判断
10248.7710214.190.24数据可信
供试品溶液-SDR925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%
5min177246-7724613.18214.588.6513.1814.588.64
289513-8951315.27515.27
387045-8704514.85414.85
490187-9018715.39015.39
593259-9325915.91415.91
675304-7530412.85012.85
10min1176253-17625330.07731.924.3130.1031.954.30
2185145-18514531.59431.62
3192437-19243732.83832.86
4185039-18503931.57631.60
5183863-18386331.37531.40
6199709-19970934.07934.10
15min1238370-23837040.67743.908.0540.7543.988.04
2278296-27829647.49047.57
3288390-28839049.21249.29
4244512-24451241.72541.80
5246341-24634142.03742.12
6247624-24762442.25642.33
20min1263547-26354744.97347.876.9945.1148.026.98
2306083-30608352.23152.39
3305077-30507752.06052.22
4268063-26806345.74445.89
5269064-26906445.91446.06
6271211-27121146.28146.43
30min1268133-26813345.75648.986.5845.9749.216.57
2311570-31157053.16853.41
3309200-30920052.76353.01
4274566-27456646.85347.08
5274074-27407446.76946.99
6284584-28458448.56348.79
45min1268208-26820845.76849.116.3746.0649.436.36
2311401-31140153.13953.47
3309401-30940152.79853.13
4276737-27673747.22447.53
5275905-27590547.08247.39
6285259-28525948.67848.98
60min1269065-26906545.91549.276.3346.2849.666.33
2311915-31191553.22753.65
3310577-31057752.99853.42
4278178-27817847.47047.85
5276531-27653147.18947.57
6286100-28610048.82149.21
极限1295312-29531250.39351.722.7950.8452.192.81
2313241-31324153.45353.96
3312407-31240753.31153.82
4302003-30200351.53552.00
5292857-29285749.97550.44
6302530-30253051.62552.09
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.074989764987194983874975494973944982050.15
228.184983314982574982940.02
单位质量响应值RSD%判断
17748.6617682.540.27数据可信
供试品溶液-SDR925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%
5min1128387-12838711.95413.319.3611.9513.319.37
2150532-15053214.01614.02
3144953-14495313.49713.50
4151888-15188814.14214.14
5157187-15718714.63614.64
6124584-12458411.60011.60
10min1311519-31151929.00630.013.8129.0330.043.80
2316763-31676329.49429.52
3329799-32979930.70830.73
4317604-31760429.57229.60
5314475-31447529.28129.31
6343846-34384632.01632.04
15min1409548-40954838.13341.408.5738.2041.488.56
2484232-48423245.08745.16
3501235-50123546.67146.74
4420972-42097239.19739.27
5424195-42419539.49739.57
6427895-42789539.84239.91
20min1453562-45356242.23245.157.4942.3645.297.48
2532181-53218149.55249.70
3530574-53057449.40249.55
4460785-46078542.90443.04
5464413-46441343.24243.38
6468143-46814343.58943.73
30min1460498-46049842.87746.117.0743.0846.337.07
2540766-54076650.35150.58
3536501-53650149.95450.19
4470780-47078043.83544.04
5472381-47238143.98444.20
6490456-49045645.66745.88
45min1460798-46079842.90546.206.8843.1846.496.87
2540168-54016850.29650.61
3536590-53659049.96350.28
4473498-47349844.08844.37
5474735-47473544.20344.49
6491278-49127845.74346.03
60min1462227-46222743.03846.316.8343.3846.686.82
2540820-54082050.35650.75
3537965-53796550.09150.49
4475527-47552744.27744.63
5475334-47533444.25944.62
6492181-49218145.82846.19
极限1518371-51837148.26649.362.4148.6849.812.44
2545125-54512550.75751.24
3541887-54188750.45650.94
4529030-52903049.25949.69
5512779-51277947.74548.18
6533541-53354149.67950.12
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.072885482885322873632879412873322879430.21
228.182873302872532872920.02
单位质量响应值RSD%判断
10258.0310194.890.44数据可信
供试品溶液-SDR925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%
5min189761-8976115.32514.524.2315.3214.524.22
281460-8146013.90813.91
385417-8541714.58314.58
485451-8545114.58914.59
587864-8786415.00115.00
680424-8042413.73113.73
10min1182958-18295831.23631.903.4831.2631.933.48
2194763-19476333.25233.28
3179715-17971530.68330.71
4183584-18358431.34331.37
5185075-18507531.59831.62
6195132-19513233.31533.34
15min1252563-25256343.12042.933.4443.2043.003.43
2246899-24689942.15342.23
3260346-26034644.44944.52
4237245-23724540.50540.58
5259772-25977244.35144.43
6251775-25177542.98543.06
20min1299422-29942251.12048.966.8251.2749.106.81
2268974-26897445.92246.07
3303116-30311651.75151.90
4263140-26314044.92645.07
5309258-30925852.80052.95
6276581-27658147.22147.37
30min1307004-30700452.41549.986.7752.6550.216.76
2274592-27459246.88147.11
3309855-30985552.90153.14
4269290-26929045.97646.19
5314185-31418553.64153.88
6281533-28153348.06648.29
45min1307507-30750752.50150.336.7752.8250.646.75
2277208-27720847.32847.63
3312238-31223853.30853.63
4271746-27174646.39546.69
5317732-31773254.24654.58
6282325-28232548.20148.51
60min1308998-30899852.75550.336.7553.1650.726.73
2277163-27716347.32047.70
3312160-31216053.29553.71
4271094-27109446.28446.66
5316233-31623353.99054.41
6283006-28300648.31848.71
极限1325234-32523455.52752.584.4456.0253.064.44
2300183-30018351.25051.71
3317743-31774354.24854.75
4290420-29042049.58350.03
5316184-31618453.98254.49
6297905-29790550.86151.33
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.074996524995514981454987884978454987960.17
228.184976854975614976230.02
单位质量响应值RSD%判断
17769.7217658.730.45数据可信
供试品溶液-SDR925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%
5min1150817-15081714.04413.315.2114.0413.315.20
2134859-13485912.55812.56
3148050-14805013.78613.79
4142527-14252713.27213.27
5148067-14806713.78813.79
6133118-13311812.39612.40
10min1312140-31214029.06629.783.6229.0929.803.61
2333780-33378031.08131.10
3307278-30727828.61328.64
4314161-31416129.25429.28
5316873-31687329.50729.53
6334474-33447431.14631.17
15min1434416-43441640.45240.363.5740.5240.443.56
2425288-42528839.60239.68
3449174-44917441.82741.90
4408570-40857038.04638.12
5449586-44958641.86541.94
6433783-43378340.39340.47
20min1518805-51880548.31146.237.1348.4546.367.11
2463451-46345143.15643.29
3526531-52653149.03049.17
4454355-45435542.30942.44
5537103-53710350.01450.16
6478306-47830644.53944.68
30min1531090-53109049.45547.097.1449.6747.307.12
2471455-47145543.90144.11
3536981-53698150.00350.23
4463610-46361043.17143.38
5545092-54509250.75850.98
6485755-48575545.23345.45
45min1531035-53103549.44947.357.1149.7547.647.09
2475781-47578144.30444.59
3540184-54018450.30150.61
4467014-46701443.48843.76
5550208-55020851.23551.54
6486688-48668845.32045.61
60min1532962-53296249.62947.317.1050.0147.687.08
2475051-47505144.23644.59
3539726-53972650.25950.65
4465405-46540543.33843.69
5547447-54744750.97851.37
6487812-48781245.42545.79
极限1567564-56756452.85150.124.2353.3250.584.23
2524352-52435248.82749.26
3551964-55196451.39851.87
4510867-51086747.57147.99
5554587-55458751.64352.12
6520256-52025648.44648.89
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%
128.072871002872072872752872772871532872020.03
228.182872172870772871470.04
单位质量响应值RSD%判断
10231.6410189.740.30数据可信
供试品溶液-SDR926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%
5min184894-8489414.51614.1018.3314.5214.1018.31
282326-8232614.07714.08
3107850-10785018.44218.44
468574-6857411.72611.73
585667-8566714.64814.65
665480-6548011.19711.20
10min1181917-18191731.10631.056.8531.1331.076.86
2193356-19335633.06233.09
3199242-19924234.06934.10
4170355-17035529.12929.15
5175842-17584230.06830.09
6168795-16879528.86328.88
15min1243384-24338441.61742.715.2841.6942.795.28
2272782-27278246.64446.72
3248334-24833442.46342.55
4236475-23647540.43540.50
5241239-24123941.25041.32
6256603-25660343.87743.94
20min1268957-26895745.99046.876.9546.1447.026.94
2295646-29564650.55350.71
3262667-26266744.91445.07
4249351-24935142.63742.77
5270117-27011746.18846.33
6297829-29782950.92751.07
30min1273724-27372446.80548.096.9347.0348.326.91
2299722-29972251.25051.49
3265586-26558645.41345.65
4256547-25654743.86844.07
5285761-28576148.86349.08
6306242-30624252.36552.59
45min1277064-27706447.37648.256.8047.6848.556.78
2299688-29968851.24451.57
3265196-26519645.34745.66
4256493-25649343.85844.14
5290007-29000749.58949.89
6304442-30444252.05752.37
60min1277191-27719147.39848.506.5847.7848.886.57
2301013-30101351.47151.88
3267785-26778545.78946.17
4259056-25905644.29744.65
5290888-29088849.74050.12
6305722-30572252.27652.68
极限1297479-29747950.86751.763.5151.3252.233.51
2303456-30345651.88952.39
3296242-29624250.65551.12
4289166-28916649.44549.87
5316898-31689854.18754.65
6313073-31307353.53354.02
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.074969684971404971864973014971044971400.03
228.184972584969224970900.05
单位质量响应值RSD%判断
17710.7217639.820.29数据可信
供试品溶液-SDR926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%
5min1141970-14197013.24912.8819.4613.2512.8819.46
2137098-13709812.79412.79
3183832-18383217.15617.16
4113774-11377410.61810.62
5142755-14275513.32213.32
6108433-10843310.11910.12
10min1310934-31093429.01728.957.1229.0428.977.13
2331197-33119730.90930.93
3341521-34152131.87231.90
4290615-29061527.12127.14
5299411-29941127.94227.96
6287565-28756526.83726.85
15min1417737-41773738.98540.205.5439.0640.275.53
2472350-47235044.08144.15
3428290-42829039.97040.05
4408968-40896838.16638.23
5413643-41364338.60338.67
6443692-44369241.40741.47
20min1463799-46379943.28344.147.4643.4244.277.43
2513263-51326347.90048.05
3451576-45157642.14342.29
4428408-42840839.98140.11
5463250-46325043.23243.37
6517276-51727648.27448.40
30min1476414-47641444.46145.287.3144.6745.497.29
2519796-51979648.50948.74
3456071-45607142.56242.78
4438801-43880140.95141.14
5490567-49056745.78245.99
6529624-52962449.42649.64
45min1475628-47562844.38745.347.3544.6745.627.33
2519915-51991548.52048.83
3454682-45468242.43342.72
4439082-43908240.97741.24
5497210-49721046.40146.68
6528454-52845449.31749.61
60min1475453-47545344.37145.487.1044.7345.847.08
2521374-52137448.65749.04
3458691-45869142.80743.17
4442110-44211041.25941.59
5497939-49793946.46946.83
6528620-52862049.33349.71
极限1519440-51944048.47649.423.0948.9149.863.09
2527055-52705549.18749.66
3521780-52178048.69449.13
4510568-51056847.64848.05
5552808-55280851.59052.03
6545708-54570850.92751.39
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%
128.072876202877252877222875272877802876750.04
228.182882462880782881620.05
单位质量响应值RSD%判断
10248.4910225.760.16数据可信
供试品溶液-SDR926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%
5min180541-8054113.73613.6812.5313.7413.6812.52
280193-8019313.67713.68
361302-6130210.45510.46
483985-8398514.32414.32
591039-9103915.52715.53
684172-8417214.35614.36
10min1196125-19612533.44932.304.5333.4732.324.53
2184718-18471831.50431.53
3174499-17449929.76129.78
4194355-19435533.14733.17
5196714-19671433.55033.58
6189768-18976832.36532.39
15min1270029-27002946.05444.302.6046.1344.382.59
2258444-25844444.07844.15
3260519-26051944.43244.50
4263639-26363944.96445.04
5255449-25544943.56743.65
6250507-25050742.72442.80
20min1307792-30779252.49450.742.1752.6550.892.17
2299865-29986551.14251.29
3296214-29621450.51950.66
4299552-29955251.08951.24
5291700-29170049.75049.90
6289944-28994449.45049.60
30min1310812-31081253.00951.442.4453.2551.682.43
2304815-30481551.98652.22
3303092-30309251.69351.92
4305523-30552352.10752.35
5292121-29212149.82150.06
6293450-29345050.04850.28
45min1314168-31416853.58251.782.3453.9152.102.33
2306956-30695652.35252.67
3302360-30236051.56851.88
4306168-30616852.21752.54
5296684-29668450.60050.92
6295141-29514150.33650.65
60min1313066-31306653.39452.061.6853.8152.461.68
2308138-30813852.55352.96
3304751-30475151.97552.37
4305887-30588752.16952.58
5298854-29885450.97051.37
6300824-30082451.30651.70
极限1323539-32353955.18053.511.7955.6954.011.79
2313566-31356653.47953.97
3313203-31320353.41753.90
4315282-31528253.77254.27
5309919-30991952.85753.35
6307099-30709952.37652.86
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%
128.074976264977014977704975204978664976970.03
228.184994504991624993060.05
单位质量响应值RSD%判断
17730.5717718.450.05数据可信
供试品溶液-SDR926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%
5min1133948-13394812.46612.4613.0712.4712.4613.07
2132922-13292212.37012.37
3101335-1013359.4319.43
4140519-14051913.07713.08
5153037-15303714.24214.24
6141570-14157013.17513.18
10min1336157-33615731.28430.265.1331.3030.285.13
2315682-31568229.37929.40
3296826-29682627.62427.64
4334609-33460931.14031.16
5342143-34214331.84131.86
6325518-32551830.29430.32
15min1466379-46637943.40341.682.8243.4841.762.81
2445280-44528041.44041.51
3450428-45042841.91941.98
4455731-45573142.41242.49
5438835-43883540.84040.92
6430731-43073140.08640.16
20min1534046-53404649.70047.992.2849.8548.132.28
2520687-52068748.45748.60
3513178-51317847.75847.89
4519336-51933648.33148.48
5504608-50460846.96147.11
6502154-50215446.73246.87
30min1539117-53911750.17248.812.0850.4049.032.07
2529147-52914749.24549.46
3524577-52457748.81949.03
4529357-52935749.26449.49
5516372-51637248.05648.28
6508125-50812547.28847.51
45min1543522-54352250.58248.872.4450.8949.182.43
2531884-53188449.49949.80
3523044-52304448.67748.97
4530426-53042649.36449.67
5512038-51203847.65247.96
6510047-51004747.46747.76
60min1541370-54137050.38249.071.8550.7849.451.85
2533271-53327149.62850.01
3526360-52636048.98549.36
4529135-52913549.24349.63
5514615-51461547.89248.27
6518726-51872648.27548.65
极限1561798-56179852.28350.741.7052.7651.211.70
2543935-54393550.62151.09
3544246-54424650.65051.11
4547039-54703950.91051.38
5540098-54009850.26450.73
6534341-53434149.72850.18
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