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%
128.061157097115566011560101156950115675011564930.06
228.021163271116244611628580.06
单位质量响应值RSD%判断
41215.0041501.000.49数据可信
供试品溶液-2024032121批-沙库巴曲-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138303-383031.6173.9768.121.623.9768.10
26900-69000.2910.29
3148379-1483796.2646.26
495493-954934.0314.03
598684-986844.1664.17
6176953-1769537.4707.47
10min194563-945633.99211.8665.753.9911.8765.76
256300-563002.3772.38
3391676-39167616.53516.55
4253403-25340310.69810.70
5348950-34895014.73114.74
6541423-54142322.85722.87
15min1186060-1860607.85519.4852.107.8619.5052.12
2185332-1853327.8247.83
3578365-57836524.41624.45
4430224-43022418.16218.19
5611189-61118925.80225.83
6777352-77735232.81732.87
20min1334586-33458614.12526.1838.9314.1526.2438.97
2352552-35255214.88314.90
3707086-70708629.85029.93
4584422-58442224.67224.73
5828681-82868134.98435.06
6913155-91315538.55038.65
30min1585485-58548524.71735.0629.5424.7635.1629.59
2525816-52581622.19822.24
3832248-83224835.13435.26
4835086-83508635.25435.35
51087627-108762745.91546.05
61116403-111640347.13047.30
45min1721309-72130930.45139.4825.2530.5439.6425.31
2633265-63326526.73426.81
3909502-90950238.39538.58
4945462-94546239.91440.07
51206113-120611350.91751.13
61195280-119528050.46050.71
60min1786042-78604233.18341.4023.6233.3241.6223.69
2675350-67535028.51128.63
3949854-94985440.09940.35
4990239-99023941.80442.03
51253878-125387852.93453.23
61228393-122839351.85852.19
90min1864933-86493336.51443.5121.2736.7143.8121.35
2729698-72969830.80530.98
3999613-99961342.20042.52
41036864-103686443.77244.06
51286322-128632254.30354.69
61267051-126705153.49053.91
120min1920398-92039838.85544.5519.6139.1144.9219.70
2761289-76128932.13932.36
31020039-102003943.06243.45
41054536-105453644.51844.88
51299495-129949554.85955.33
61275731-127573153.85654.36
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1960399-96039940.54445.4118.0340.8645.8518.13
2794737-79473733.55133.83
31040245-104024543.91544.37
41073335-107333545.31245.75
51304373-130437355.06555.63
61281075-128107554.08254.68
极限11148599-114859948.48950.537.1248.8851.057.31
21093792-109379246.17546.51
31169807-116980749.38449.92
41167662-116766249.29449.81
51309989-130998955.30255.96
61291597-129159754.52655.21
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.062003665200123619996811999450200171020011480.09
228.022009153200960720093800.02
单位质量响应值RSD%判断
71316.7571712.350.40数据可信
供试品溶液-2024032121批-缬沙坦钠-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146089-460891.0632.7570.171.062.7570.17
25488-54880.1270.13
3190725-1907254.3994.40
4119123-1191232.7482.75
5126677-1266772.9222.92
6226202-2262025.2175.22
10min1120187-1201872.7728.5667.202.778.5767.23
265101-651011.5021.50
3513847-51384711.85211.86
4334248-3342487.7107.71
5473284-47328410.91710.92
6721135-72113516.63316.64
15min1247899-2478995.71814.5553.815.7214.5753.84
2238369-2383695.4985.50
3779550-77955017.98118.01
4583296-58329613.45413.47
5860398-86039819.84619.87
61076552-107655224.83124.87
20min1462331-46233110.66420.1441.1010.6820.1841.15
2469654-46965410.83310.84
3981907-98190722.64822.71
4815149-81514918.80218.84
51203639-120363927.76327.82
61306614-130661430.13830.22
30min1841847-84184719.41828.2132.2619.4528.2832.31
2732883-73288316.90416.93
31218357-121835728.10228.20
41213278-121327827.98528.06
51652248-165224838.11038.21
61679018-167901838.72838.86
45min11098747-109874725.34333.4427.6525.4133.5627.70
2936697-93669721.60521.66
31399648-139964832.28432.43
41453965-145396533.53733.65
51922380-192238044.34144.51
61886417-188641743.51143.70
60min11234783-123478328.48136.1125.9128.5936.2925.96
21032942-103294223.82523.92
31504069-150406934.69234.89
41570292-157029236.22036.39
52057652-205765247.46147.70
61993296-199329645.97746.24
90min11379858-137985831.82738.7823.7431.9839.0223.80
21138370-113837026.25726.39
31620714-162071437.38337.64
41686129-168612938.89239.13
52157277-215727749.75950.08
62105610-210561048.56748.91
120min11474028-147402833.99940.0422.3634.2140.3422.43
21194875-119487527.56127.74
31669924-166992438.51838.83
41726789-172678939.82940.13
52202845-220284550.81051.21
62147220-214722049.52749.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min11545271-154527135.64340.9921.1435.9141.3621.21
21240522-124052228.61328.84
31712065-171206539.49039.87
41763609-176360940.67941.04
52222696-222269651.26851.75
62177763-217776350.23150.74
极限11848989-184898942.64845.5810.1642.9746.0210.33
21731483-173148339.93840.21
31918538-191853844.25244.70
41919570-191957044.27644.71
52239636-223963651.65952.23
62198670-219867050.71451.30
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%
128.061158534115860411573761157243115751111578540.06
228.021157550115760211575760.01
单位质量响应值RSD%判断
41263.5141312.490.09数据可信
供试品溶液-2024032221批-沙库巴曲-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1148048-1480486.2615.5433.356.265.5433.35
299627-996274.2134.21
363337-633372.6782.68
4183175-1831757.7467.75
5161773-1617736.8416.84
6129474-1294745.4755.48
10min1566801-56680123.96819.9725.7123.9819.9825.70
2380295-38029516.08216.09
3319641-31964113.51713.52
4391988-39198816.57616.59
5589895-58989524.94524.96
6584898-58489824.73424.74
15min1804381-80438134.01530.4019.3334.0730.4419.33
2616667-61666726.07726.11
3529694-52969422.39922.43
4649173-64917327.45227.49
5867327-86732736.67736.73
6845426-84542635.75135.80
20min1943511-94351139.89837.3811.9040.0137.4811.92
2799984-79998433.82933.91
3719407-71940730.42230.49
4887978-88797837.55037.64
5991703-99170341.93642.05
6961021-96102140.63940.75
30min11098988-109898846.47345.015.7346.6545.165.76
21071836-107183645.32545.46
3945043-94504339.96340.08
41069762-106976245.23745.39
51115418-111541847.16847.35
61084698-108469845.86946.05
45min11178106-117810649.81948.934.2350.0749.164.26
21182460-118246050.00350.21
31061822-106182244.90145.08
41157792-115779248.96049.18
51198458-119845850.67950.94
61164149-116414949.22849.48
60min11217680-121768051.49250.693.9251.8351.003.95
21220435-122043551.60951.90
31107290-110729046.82447.08
41207269-120726951.05251.36
51240237-124023752.44652.79
61199030-119903050.70351.04
90min11262156-126215653.37352.393.7653.7952.783.79
21255713-125571353.10053.48
31150878-115087848.66749.00
41247790-124779052.76553.16
51284912-128491254.33554.77
61231492-123149252.07652.50
120min11277249-127724954.01152.813.7254.5253.293.75
21260470-126047053.30153.77
31162690-116269049.16749.58
41260731-126073153.31353.79
51294941-129494154.75955.28
61236940-123694052.30652.81
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min11287163-128716354.43053.233.5155.0353.803.54
21268038-126803853.62254.18
31178438-117843849.83350.33
41269765-126976553.69554.26
51304244-130424455.15355.77
61245228-124522852.65753.25
极限11301414-130141455.03353.992.5055.7254.652.54
21276797-127679753.99254.64
31222064-122206451.67752.26
41285621-128562154.36555.02
51311417-131141755.45656.16
61263256-126325653.41954.10
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%
128.062003830200480720040182002306200058920031100.09
228.022000884200349620021900.10
单位质量响应值RSD%判断
71386.6771455.750.07数据可信
供试品溶液-2024032221批-缬沙坦钠-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186879-1868794.3163.8333.774.323.8333.68
2127517-1275172.9452.95
376891-768911.7761.78
4230959-2309595.3345.33
5206146-2061464.7614.76
6167053-1670533.8583.86
10min1744753-74475317.20114.4325.4217.2114.4425.40
2515734-51573411.91111.92
3424123-4241239.7959.80
4510352-51035211.78711.80
5773012-77301217.85317.86
6781383-78138318.04618.05
15min11098127-109812725.36222.8218.7425.4022.8518.75
2872628-87262820.15420.18
3731045-73104516.88416.90
4880390-88039020.33320.36
51176774-117677427.17827.22
61168308-116830826.98327.02
20min11330361-133036130.72528.9811.2830.8029.0411.30
21166935-116693526.95127.01
31026052-102605223.69723.74
41235221-123522128.52828.59
51393848-139384832.19232.27
61375306-137530631.76331.84
30min11626861-162686137.57336.695.6737.7036.815.70
21632883-163288337.71237.82
31413431-141343132.64432.73
41573408-157340836.33936.45
51653616-165361638.19138.33
61632423-163242337.70237.84
45min11827488-182748842.20741.934.3042.4042.114.32
21891216-189121643.67943.84
31669231-166923138.55238.69
41800906-180090641.59341.76
51862542-186254243.01643.22
61842570-184257042.55542.75
60min11946835-194683544.96344.683.9645.2344.933.99
22004350-200435046.29246.53
31787231-178723141.27741.48
41936865-193686544.73344.97
51983424-198342445.80846.08
61948337-194833744.99845.27
90min12076562-207656247.95947.463.8248.3047.793.84
22110515-211051548.74449.06
31904148-190414843.97744.25
42062112-206211247.62647.94
52120724-212072448.97949.33
62056690-205669047.50047.84
120min12132569-213256949.25348.403.8949.6748.803.91
22137101-213710149.35849.75
31938697-193869744.77545.12
42114973-211497348.84749.24
52166029-216602950.02650.46
62085691-208569148.17048.59
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min12174915-217491550.23149.204.0350.7349.694.05
22156582-215658249.80850.29
31967543-196754345.44245.86
42153672-215367249.74050.22
52213426-221342651.12051.63
62116594-211659448.88449.39
极限12215340-221534051.16550.242.9751.7550.803.00
22185761-218576150.48151.04
32056441-205644147.49547.99
42193338-219333850.65651.21
52241615-224161551.77152.37
62159654-215965449.87850.46
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%
128.061172073117130211711041169987117017011709270.08
228.021156889115398311554360.18
单位质量响应值RSD%判断
41729.4041236.120.85数据可信
供试品溶液-2024032321批-沙库巴曲-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1119429-1194295.0272.6274.545.032.6274.41
211765-117650.4950.50
379564-795643.3493.35
423897-238971.0061.01
5108109-1081094.5504.55
630079-300791.2661.27
10min1257770-25777010.8509.0054.1010.869.0154.12
2101067-1010674.2544.25
3188701-1887017.9427.95
4129634-1296345.4565.46
5422865-42286517.79817.81
6183642-1836427.7297.73
15min1363661-36366115.30617.3432.4015.3317.3632.43
2365620-36562015.38915.40
3329905-32990513.88613.90
4395536-39553616.64816.66
5680214-68021428.63028.67
6336869-33686914.17914.19
20min1477873-47787320.11423.2331.3320.1723.2831.32
2511076-51107621.51121.54
3418053-41805317.59617.64
4580133-58013324.41824.46
5884711-88471137.23737.32
6439003-43900318.47818.52
30min1594839-59483925.03729.4627.2125.1229.5527.21
2691901-69190129.12229.19
3508165-50816521.38921.46
4832487-83248735.03935.12
51010801-101080142.54542.69
6561378-56137823.62823.70
45min1663643-66364327.93334.8226.8128.0634.9626.79
2915305-91530538.52538.64
3585771-58577124.65524.76
41056734-105673444.47844.62
51090709-109070945.90846.13
6651381-65138127.41727.53
60min1709426-70942629.86037.2826.0630.0337.4726.04
21050907-105090744.23344.41
3625287-62528726.31826.47
41108986-110898646.67746.89
51120877-112087747.17847.47
6698738-69873829.41029.56
90min1792531-79253133.35839.6323.3133.5839.8823.30
21113533-111353346.86947.12
3682762-68276228.73728.93
41150715-115071548.43448.72
51151769-115176948.47848.85
6757439-75743931.88132.08
120min1832023-83202335.02040.6121.8635.3040.9321.86
21133182-113318247.69648.03
3713631-71363130.03730.28
41168110-116811049.16649.54
51160274-116027448.83649.29
6781393-78139332.88933.15
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1872707-87270736.73241.6220.0437.0742.0120.06
21149639-114963948.38848.80
3749089-74908931.52931.82
41180789-118078949.69950.15
51167546-116754649.14249.68
6813689-81368934.24834.56
极限11072465-107246545.14048.496.3545.5448.956.48
21212620-121262051.03951.53
31075998-107599845.28945.63
41224994-122499451.56052.09
51215091-121509151.14351.76
61111525-111152546.78447.15
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%
128.062022699202286420223112020222201886420213920.09
228.022002749199923520009920.13
单位质量响应值RSD%判断
72038.2071412.990.62数据可信
供试品溶液-2024032321批-缬沙坦钠-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1151515-1515153.4851.7977.843.481.7977.95
210898-108980.2510.25
399746-997462.2942.29
425362-253620.5830.58
5139761-1397613.2143.21
640217-402170.9250.92
10min1339475-3394757.8076.5158.077.816.5158.09
2126691-1266912.9142.91
3244236-2442365.6175.62
4163714-1637143.7653.77
5582747-58274713.40213.41
6240873-2408735.5405.54
15min1493953-49395311.36013.0036.1711.3813.0136.18
2491482-49148211.30311.31
3440397-44039710.12810.14
4533436-53343612.26812.28
5977053-97705322.47022.50
6454765-45476510.45910.47
20min1665246-66524615.29917.9234.8315.3417.9634.83
2710898-71089816.34916.37
3576533-57653313.25913.29
4807960-80796018.58118.61
51307772-130777230.07630.14
6607894-60789413.98014.01
30min1864536-86453619.88323.8630.0119.9523.9230.01
21013379-101337923.30623.36
3738385-73838516.98117.03
41223572-122357228.14028.20
51567508-156750836.05036.16
6816591-81659118.78018.83
45min11005324-100532423.12029.4629.0923.2229.5729.08
21395256-139525632.08832.18
3886620-88662020.39020.47
41642526-164252637.77537.88
51765434-176543440.60140.78
6990848-99084822.78822.87
60min11094100-109410025.16232.3128.3325.3032.4628.31
21659757-165975738.17138.31
3964820-96482022.18922.30
41772978-177297840.77540.94
51850931-185093142.56842.81
61085570-108557024.96625.09
90min11231861-123186128.33035.0026.1328.5135.2226.12
21816245-181624541.77041.98
31064307-106430724.47724.63
41891218-189121843.49443.73
51932099-193209944.43444.75
61196855-119685527.52527.69
120min11293931-129393129.75836.0525.1229.9836.3225.13
21873821-187382143.09443.37
31110137-111013725.53125.72
41931870-193187044.42944.74
51960309-196030945.08345.47
61235538-123553828.41528.62
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min11355254-135525431.16837.0023.6831.4437.3223.69
21919930-191993044.15544.50
31159954-115995426.67726.91
41967000-196700045.23745.62
51967229-196722945.24245.71
61283415-128341529.51629.77
极限11679676-167967638.62943.189.7738.9543.579.90
22024866-202486646.56846.99
31692728-169272838.92939.21
42056555-205655547.29747.76
52045738-204573847.04847.59
61765312-176531240.59940.90
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