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%
1 27.671132600113139411315621130560113200611316240.07
2 27.671132205113221511322100.01
单位质量响应值RSD%判断
40897.1440918.320.04数据可信
供试品溶液-2024032121批-缬沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12957-29570.1170.2459.720.120.2459.48
25807-58070.2300.23
312965-129650.5130.51
42899-28990.1150.11
55723-57230.2270.23
66579-65790.2600.26
10min113999-139990.5540.6552.240.550.6552.29
229927-299271.1851.19
318604-186040.7370.74
419468-194680.7710.77
511745-117450.4650.47
64515-45150.1790.18
15min156151-561512.2231.8263.242.221.8263.24
276079-760793.0123.01
325596-255961.0131.02
425847-258471.0231.02
580579-805793.1903.19
611450-114500.4530.45
20min183372-833723.3012.5272.193.312.5272.17
276965-769653.0473.05
329859-298591.1821.19
428551-285511.1301.13
5140195-1401955.5515.56
622261-222610.8810.88
30min1164120-1641206.4984.1777.446.514.1777.39
289205-892053.5323.54
334948-349481.3841.39
439695-396951.5721.58
5240847-2408479.5369.55
662384-623842.4702.47
45min1233683-2336839.2525.8870.389.275.8970.32
2105057-1050574.1594.18
342616-426161.6871.70
474087-740872.9332.94
5315330-31533012.48412.52
6119751-1197514.7414.75
60min1257287-25728710.1866.6666.8510.226.6866.82
2120222-1202224.7604.79
351621-516212.0442.05
485469-854693.3843.40
5347291-34729113.75013.80
6147137-1471375.8255.84
90min1291880-29188011.5569.2746.4611.619.3146.43
2139524-1395245.5245.56
3313186-31318612.40012.41
4100181-1001813.9663.98
5376251-37625114.89614.97
6184171-1841717.2927.32
120min1311295-31129512.32512.0722.3312.4012.1222.39
2300574-30057411.90011.94
3354873-35487314.05014.08
4259958-25995810.29210.32
5397367-39736715.73215.83
6204752-2047528.1068.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1476602-47660218.86918.496.8318.9618.566.94
2458840-45884018.16618.23
3469539-46953918.59018.65
4415914-41591416.46716.51
5514939-51493920.38720.51
6466151-46615118.45618.51
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%
1 27.671960926195886619585071959660196116719598250.07
2 27.671957270195856619579180.05
单位质量响应值RSD%判断
70828.5170759.600.07数据可信
供试品溶液-2024032121批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15298-52980.1150.2563.130.110.2563.93
210895-108950.2350.24
324914-249140.5380.54
45158-51580.1110.11
510379-103790.2240.22
611934-119340.2580.26
10min127657-276570.5980.6954.030.600.6953.78
259757-597571.2921.29
335613-356130.7700.77
437672-376720.8140.81
523411-234110.5060.51
67810-78100.1690.17
15min1109906-1099062.3761.9565.172.381.9565.07
2147756-1477563.1943.20
348388-483881.0461.05
448992-489921.0591.06
5163489-1634893.5343.53
621712-217120.4690.47
20min1164328-1643283.5522.6874.893.562.6974.75
2149314-1493143.2273.24
355565-555651.2011.20
453333-533331.1531.16
5280725-2807256.0686.07
641918-419180.9060.91
30min1322454-3224546.9704.4079.746.984.4279.59
2170855-1708553.6933.71
362444-624441.3501.36
473205-732051.5821.59
5473494-47349410.23410.25
6120032-1200322.5942.60
45min1447662-4476629.6766.0972.639.706.1072.62
2196796-1967964.2544.27
373200-732001.5821.59
4137447-1374472.9712.98
5609012-60901213.16313.20
6226061-2260614.8864.89
60min1486064-48606410.5066.7869.8010.546.8169.77
2219241-2192414.7394.77
386132-861321.8621.87
4154832-1548323.3473.36
5663635-66363514.34414.40
6272636-2726365.8935.91
90min1541705-54170511.7099.3348.7011.769.3748.65
2250479-2504795.4145.45
3583109-58310912.60312.62
4174796-1747963.7783.80
5709417-70941715.33415.41
6331254-3312547.1607.19
120min1570452-57045212.33012.1223.7512.4112.1723.83
2557691-55769112.05412.10
3652897-65289714.11214.15
4477725-47772510.32610.35
5743122-74312216.06216.17
6361134-3611347.8067.84
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1884627-88462719.12118.677.7919.2218.747.91
2844869-84486918.26118.32
3863394-86339418.66218.72
4757699-75769916.37716.42
5966424-96642420.88921.02
6866057-86605718.71918.77
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%
1 27.671130984113150811306791131190112974211308210.06
2 27.671130028113280811314180.18
单位质量响应值RSD%判断
40868.1240889.700.04数据可信
供试品溶液-2024032121批-缬沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12222-22220.0880.2046.820.090.2045.95
28379-83790.3320.33
33157-31570.1250.13
44121-41210.1630.16
57348-73480.2910.29
65837-58370.2310.23
10min114420-144200.5710.71100.320.570.71100.39
234148-341481.3531.35
33047-30470.1210.12
45002-50020.1980.20
546142-461421.8281.83
65076-50760.2010.20
15min138087-380871.5092.23113.301.512.23113.22
2140604-1406045.5715.57
34005-40050.1590.16
415034-150340.5960.60
5133016-1330165.2705.27
66343-63430.2510.25
20min1122200-1222004.8413.88101.524.853.88101.50
2223398-2233988.8518.86
34963-49630.1970.20
425529-255291.0111.01
5203028-2030288.0448.06
68044-80440.3190.32
30min1223602-2236028.8596.07100.768.876.08100.74
2328417-32841713.01213.04
37137-71370.2830.28
430870-308701.2231.23
5318241-31824112.60912.63
611498-114980.4560.46
45min1273615-27361510.8409.5769.5810.879.6069.59
2418798-41879816.59316.64
346826-468261.8551.86
440377-403771.6001.61
5415539-41553916.46316.51
6254478-25447810.08210.08
60min1304227-30422712.05310.7265.0812.1010.7565.13
2447951-44795117.74817.82
366815-668152.6472.65
452297-522972.0722.08
5449905-44990517.82517.90
6301725-30172511.95411.97
90min1334889-33488913.26812.5750.7013.3312.6350.81
2476094-47609418.86318.97
3125420-1254204.9694.98
4131774-1317745.2215.23
5496635-49663519.67619.78
6339144-33914413.43713.48
120min1354470-35447014.04413.6644.3914.1313.7344.51
2497982-49798219.73019.87
3157974-1579746.2596.28
4170080-1700806.7386.76
5508794-50879420.15820.29
6378866-37886615.01015.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1505731-50573120.03719.6110.0320.1519.7110.30
2543080-54308021.51721.69
3441765-44176517.50217.53
4433902-43390217.19117.22
5552607-55260721.89422.06
6492980-49298019.53219.62
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%
1 27.671958064195943619578311957294195725219579750.05
2 27.671957268195841119578400.05
单位质量响应值RSD%判断
70761.6670756.780.01数据可信
供试品溶液-2024032121批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13688-36880.0800.1947.730.080.1948.16
214522-145220.3140.31
35736-57360.1240.12
47084-70840.1530.15
513346-133460.2890.29
69671-96710.2090.21
10min128562-285620.6180.76103.860.620.76103.68
267395-673951.4571.46
35349-53490.1160.12
48652-86520.1870.19
592368-923681.9972.00
68447-84470.1830.18
15min174989-749891.6222.40114.901.622.40114.89
2280748-2807486.0716.07
36918-69180.1500.15
428574-285740.6180.62
5265289-2652895.7375.74
610616-106160.2300.23
20min1240437-2404375.1994.16102.505.204.16102.48
2441692-4416929.5529.56
38644-86440.1870.19
448938-489381.0581.06
5400128-4001288.6538.67
613295-132950.2880.29
30min1434201-4342019.3906.42101.849.406.43101.83
2641494-64149413.87213.90
311582-115820.2500.25
457523-575231.2441.25
5617702-61770213.35813.39
618388-183880.3980.40
45min1523803-52380311.32710.0570.3711.3610.0770.44
2811262-81126217.54317.60
386071-860711.8611.86
472056-720561.5581.56
5800325-80032517.30717.36
6494766-49476610.69910.70
60min1576655-57665512.47011.0866.3312.5211.1266.39
2855993-85599318.51118.59
3120509-1205092.6062.61
489421-894211.9341.94
5856809-85680918.52818.61
6573516-57351612.40212.42
90min1624674-62467413.50912.7752.8313.5812.8352.92
2901762-90176219.50119.61
3220575-2205754.7704.78
4228199-2281994.9354.95
5935010-93501020.22020.33
6633020-63302013.68913.73
120min1654837-65483714.16113.6747.5214.2513.7547.65
2938306-93830620.29120.44
3267474-2674745.7845.80
4287617-2876176.2206.24
5950801-95080120.56120.70
6694707-69470715.02315.09
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1945270-94527020.44119.8211.4020.5619.9211.68
21019498-101949822.04722.23
3804414-80441417.39517.42
4787288-78728817.02517.05
51033803-103380322.35622.53
6909703-90970319.67219.76
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%
1 27.671133991113488011351131134856113217611342030.11
2 27.671138582113922711389040.05
单位质量响应值RSD%判断
40990.3541160.250.30数据可信
供试品溶液-2024032221批-缬沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119363-193630.7630.9432.490.760.9332.66
223154-231540.9130.91
329805-298051.1751.18
418564-185640.7320.73
535851-358511.4141.41
615581-155810.6140.61
10min117389-173890.6860.7857.650.690.7857.42
219390-193900.7650.77
340590-405901.6001.60
410089-100890.3980.40
522363-223630.8820.88
69109-91090.3590.36
15min189417-894173.5262.0198.063.532.0198.04
2132518-1325185.2255.23
342864-428641.6901.69
410388-103880.4100.41
520728-207280.8170.82
69621-96210.3790.38
20min1192884-1928847.6053.06111.867.613.06111.75
2183633-1836337.2417.25
344211-442111.7431.75
413083-130830.5160.52
520485-204850.8080.81
610595-105950.4180.42
30min1216297-2162978.5295.4365.288.555.4465.28
2250864-2508649.8929.92
349764-497641.9621.97
4137337-1373375.4155.42
521643-216430.8530.86
6149676-1496765.9025.90
45min1233760-2337609.2179.4547.409.259.4747.35
2364565-36456514.37514.41
357140-571402.2532.27
4285671-28567111.26411.28
5166961-1669616.5836.59
6330039-33003913.01413.03
60min1243698-2436989.60911.3231.209.6611.3531.22
2395211-39521115.58315.65
3176885-1768856.9756.99
4319548-31954812.60012.63
5212031-2120318.3608.38
6374736-37473614.77614.81
90min1256874-25687410.12913.2622.7310.2013.3122.71
2428405-42840516.89216.98
3329788-32978813.00413.03
4356052-35605214.03914.09
5240503-2405039.4839.52
6405381-40538115.98416.04
120min1376042-37604214.82714.7617.4014.9114.8417.47
2451774-45177417.81417.93
3351483-35148313.85913.91
4377014-37701414.86614.94
5264366-26436610.42410.47
6425164-42516416.76416.85
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1483447-48344719.06219.217.0519.1719.327.14
2527033-52703320.78120.93
3431769-43176917.02517.10
4512028-51202820.18920.29
5467607-46760718.43818.50
6501808-50180819.78619.90
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%
1 27.671963223196462019612781966624195931719630120.15
2 27.671969006196956619692860.03
单位质量响应值RSD%判断
70943.6971170.440.23数据可信
供试品溶液-2024032221批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128989-289890.6240.8032.960.620.8032.99
239427-394270.8490.85
346624-466241.0041.00
427994-279940.6030.60
555425-554251.1941.19
624199-241990.5210.52
10min129882-298820.6430.7264.190.640.7263.87
234061-340610.7330.73
373422-734221.5811.58
415155-151550.3260.33
534594-345940.7450.75
614187-141870.3060.31
15min1175891-1758913.7882.08103.923.792.08103.69
2259923-2599235.5975.60
378616-786161.6931.70
416176-161760.3480.35
533082-330820.7120.72
615710-157100.3380.34
20min1377630-3776308.1323.17116.038.143.18115.99
2354465-3544657.6337.65
380896-808961.7421.75
421018-210180.4530.45
532909-329090.7090.71
617528-175280.3770.38
30min1420769-4207699.0615.7366.749.085.7466.76
2485965-48596510.46510.49
390071-900711.9401.95
4270710-2707105.8305.83
534307-343070.7390.74
6295802-2958026.3706.37
45min1444219-4442199.5669.9348.549.609.9448.52
2698958-69895815.05215.09
3100820-1008202.1712.18
4553578-55357811.92111.93
5319712-3197126.8856.89
6648345-64834513.96213.97
60min1458924-4589249.88311.7931.829.9411.8331.82
2750943-75094316.17116.24
3334341-3343417.2007.22
4614643-61464313.23613.27
5401948-4019488.6568.67
6724689-72468915.60615.64
90min1478623-47862310.30713.6623.3310.3813.7223.32
2803992-80399217.31317.41
3620986-62098613.37313.40
4678629-67862914.61414.67
5448711-4487119.6639.70
6775303-77530316.69616.76
120min1707502-70750215.23615.1118.0015.3215.1918.07
2841339-84133918.11818.24
3654885-65488514.10314.15
4712141-71214115.33515.41
5485946-48594610.46510.51
6808172-80817217.40317.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1902716-90271619.43919.557.6719.5519.667.77
2979688-97968821.09721.25
3795334-79533417.12717.20
4963625-96362520.75120.86
5863133-86313318.58718.65
6943200-94320020.31120.43
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 27.671133426113126711326701130111113160411318160.12
2 27.671137791113462411362080.20
单位质量响应值RSD%判断
40904.0841062.810.28数据可信
供试品溶液-2024032221批-缬沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115930-159300.6300.7238.140.630.7237.91
211625-116250.4590.46
319613-196130.7750.78
428324-283241.1191.12
523895-238950.9440.94
610521-105210.4160.42
10min125245-252450.9980.9761.871.000.9761.77
247405-474051.8731.87
310449-104490.4130.41
434556-345561.3661.37
522115-221150.8740.88
66799-67990.2690.27
15min1125280-1252804.9512.7082.094.952.7082.06
2145595-1455955.7545.76
366867-668672.6422.64
441673-416731.6471.65
523054-230540.9110.91
67244-72440.2860.29
20min1222773-2227738.8044.6271.258.814.6271.19
2224288-2242888.8648.88
373848-738482.9182.92
444745-447451.7681.78
569411-694112.7432.75
666001-660012.6082.61
30min1246323-2463239.7346.0571.579.766.0771.52
2328896-32889612.99713.03
380627-806273.1863.20
449021-490211.9371.95
5101978-1019784.0304.04
6111673-1116734.4134.42
45min1262385-26238510.3698.8059.6510.418.8259.67
2433603-43360317.13517.19
3278745-27874511.01611.03
455901-559012.2092.22
5179607-1796077.0987.11
6126014-1260144.9804.99
60min1276923-27692310.94410.6142.6111.0010.6542.65
2472675-47267518.67918.76
3305871-30587112.08812.12
4198924-1989247.8617.88
5203391-2033918.0388.07
6153506-1535066.0666.09
90min1295254-29525411.66812.6534.7111.7512.7134.73
2499745-49974519.74919.86
3339660-33966013.42313.48
4365942-36594214.46114.49
5242798-2427989.5959.64
6177353-1773537.0097.04
120min1305569-30556912.07613.5931.3812.1713.6731.41
2518579-51857920.49320.64
3362675-36267514.33214.41
4396895-39689515.68515.74
5266957-26695710.55010.61
6212934-2129348.4158.46
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1468690-46869018.52219.367.1518.6419.467.30
2552283-55228321.82522.00
3505944-50594419.99420.10
4484818-48481819.15919.24
5472252-47225218.66318.74
6455371-45537117.99618.05
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%
1 27.671958693195993119579891955289195916119582130.10
2 27.671966421196137719638990.19
单位质量响应值RSD%判断
70770.2670975.750.21数据可信
供试品溶液-2024032221批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123567-235670.5090.6340.310.510.6440.44
220244-202440.4370.44
329480-294800.6360.64
447948-479481.0351.04
538387-383870.8290.83
616788-167880.3620.36
10min147027-470271.0150.9668.701.020.9668.50
292741-927412.0022.00
315416-154160.3330.33
462357-623571.3461.35
538349-383490.8280.83
610873-108730.2350.24
15min1244693-2446935.2832.8285.725.292.8385.70
2287081-2870816.1986.20
3125603-1256032.7122.71
475714-757141.6351.64
540340-403400.8710.87
611476-114760.2480.25
20min1429187-4291879.2664.8672.449.284.8672.41
2437932-4379329.4559.47
3138058-1380582.9812.99
480946-809461.7481.75
5133503-1335032.8822.89
6129972-1299722.8062.81
30min1467866-46786610.1016.3172.8410.136.3272.85
2635434-63543413.71913.75
3149227-1492273.2223.23
486736-867361.8731.88
5195063-1950634.2114.22
6217975-2179754.7064.71
45min1493228-49322810.6499.1260.7910.699.1460.77
2831850-83185017.96018.01
3528146-52814611.40311.42
496211-962112.0772.09
5341411-3414117.3717.39
6242243-2422435.2305.24
60min1514463-51446311.10710.8943.6711.1710.9343.72
2900331-90033119.43819.52
3574755-57475512.40912.44
4365581-3655817.8937.91
5379968-3799688.2048.23
6290225-2902256.2666.29
90min1541075-54107511.68212.7835.9811.7612.8436.00
2943279-94327920.36620.48
3630413-63041313.61113.67
4670496-67049614.47614.51
5441434-4414349.5319.57
6326262-3262627.0447.08
120min1555876-55587612.00213.5933.2612.1013.6733.29
2974441-97444121.03821.19
3666813-66681314.39714.48
4720215-72021515.55015.60
5478019-47801910.32110.38
6380440-3804408.2148.26
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1859145-85914518.54919.438.2018.6719.548.35
21034105-103410522.32722.51
3933829-93382920.16220.26
4878966-87896618.97719.06
5861135-86113518.59218.67
6833530-83353017.99618.05
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