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125
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%
128.562896452894562898882899722898252897570.08
228.562894632897712896170.08
单位质量响应值RSD%判断
10145.5510140.650.04数据可信
影响因素30天-供试品溶液-2024032721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%
5min119789-1978913.62521.1546.2213.6321.1546.20
244360-4436030.54330.54
344412-4441230.57930.58
413676-136769.4169.42
520449-2044914.08014.08
641587-4158728.63428.63
10min176876-7687652.93170.6920.3552.9570.7220.37
2122099-12209984.06884.12
3123230-12323084.84784.90
488958-8895861.25061.27
586151-8615159.31759.34
6118659-11865981.70081.75
15min1151475-151475104.294115.5214.30104.41115.6814.32
2191941-191941132.156132.35
3186209-186209128.210128.40
4157673-157673108.562108.68
5132721-13272191.38291.50
6186683-186683128.536128.72
20min1209896-209896144.519142.3211.28144.80142.6611.29
2229757-229757158.193158.60
3212974-212974146.638147.04
4203402-203402140.047140.35
5162952-162952112.197112.47
6221198-221198152.300152.70
30min1250277-250277172.322166.2610.97172.85166.8510.96
2262204-262204180.534181.21
3237597-237597163.592164.24
4252402-252402173.785174.32
5190080-190080130.875131.34
6256319-256319176.482177.13
45min1272135-272135187.372179.9110.12188.18180.7610.12
2281708-281708193.963194.94
3257948-257948177.604178.53
4273253-273253188.142188.96
5209655-209655144.353145.03
6273059-273059188.008188.95
60min1284910-284910196.168188.139.60197.29189.299.61
2293376-293376201.997203.30
3270714-270714186.393187.61
4285512-285512196.582197.72
5221817-221817152.727153.65
6283058-283058194.893196.15
极限1306831-306831211.261207.103.43212.71208.573.47
2309336-309336212.986214.62
3301022-301022207.261208.79
4302938-302938208.580210.04
5280662-280662193.243194.42
6303948-303948209.276210.86
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125
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%
128.565022985023665026135025415023265024290.03
228.565024215022985023600.02
单位质量响应值RSD%判断
17592.0517589.640.01数据可信
影响因素30天-供试品溶液-2024032721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%
5min123274-232748.73014.0348.078.7314.0348.05
254343-5434320.38320.38
353094-5309419.91519.91
415861-158615.9495.95
524543-245439.2069.21
653344-5334420.00920.01
10min198672-9867237.01049.3220.8737.0249.3520.88
2156974-15697458.87958.91
3158037-15803759.27759.31
4112558-11255842.21942.23
5109314-10931441.00241.02
6153453-15345357.55857.59
15min1201712-20171275.65983.6215.3875.7483.7315.39
2257077-25707796.42696.56
3247881-24788192.97693.11
4206624-20662477.50177.58
5172572-17257264.72964.81
6251815-25181594.45294.58
20min1285992-285992107.271105.8312.53107.47106.0712.54
2317533-317533119.102119.39
3291025-291025109.159109.45
4275401-275401103.299103.51
5216722-21672281.28981.48
6306155-306155114.834115.12
30min1359573-359573134.870129.3412.32135.25129.7612.31
2379278-379278142.261142.75
3337279-337279126.508126.98
4359058-359058134.677135.06
5263119-26311998.69299.02
6370734-370734139.057139.53
45min1410077-410077153.814146.6511.90154.42147.2911.89
2428579-428579160.753161.48
3384325-384325144.154144.83
4410923-410923154.131154.74
5300598-300598112.750113.24
6411431-411431154.321155.03
60min1443731-443731166.437158.3811.45167.30159.2611.45
2462196-462196173.363174.36
3417437-417437156.574157.49
4442467-442467165.963166.83
5327997-327997123.027123.71
6439694-439694164.922165.89
极限1496859-496859186.364182.084.56187.50183.234.60
2505557-505557189.627190.91
3482523-482523180.987182.17
4489698-489698183.678184.82
5443105-443105166.202167.09
6494891-494891185.626186.87
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125
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%
128.562903802903272906422906442905812905150.06
228.562903652902922903280.02
单位质量响应值RSD%判断
10172.0910165.550.05数据可信
影响因素30天-供试品溶液-2024032721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%
5min131621-3162121.71714.1867.4021.7214.1867.41
28454-84545.8065.81
323038-2303815.82215.82
439307-3930726.99527.00
519380-1938013.31013.31
62104-21041.4451.44
10min1104388-10438871.69256.7631.7971.7356.7831.80
272038-7203849.47549.48
373734-7373450.63950.67
4123771-12377185.00485.05
569710-6971047.87647.90
652213-5221335.85935.86
15min1149065-149065102.375102.8812.55102.53102.9912.57
2139110-13911095.53895.63
3163489-163489112.282112.39
4180133-180133123.712123.90
5135716-13571693.20893.31
6131253-13125390.14290.20
20min1180449-180449123.929130.6711.11124.26130.9611.12
2188926-188926129.751130.00
3205313-205313141.006141.30
4223796-223796153.699154.09
5165170-165170113.436113.69
6177932-177932122.201122.41
30min1215398-215398147.932158.259.48148.46158.769.47
2229419-229419157.561158.03
3236084-236084162.139162.67
4256173-256173175.935176.58
5196811-196811135.167135.61
6248636-248636170.759171.18
45min1245245-245245168.430174.688.48169.21175.458.47
2265476-265476182.325183.05
3253880-253880174.361175.16
4273538-273538187.861188.80
5216288-216288148.543149.21
6271653-271653186.567187.27
60min1246679-246679169.415181.078.24170.48182.148.23
2277617-277617190.663191.70
3264231-264231181.470182.56
4283737-283737194.866196.12
5229192-229192157.405158.32
6280466-280466192.620193.63
极限1292369-292369200.794205.533.09202.14206.893.12
2300972-300972206.703208.05
3294954-294954202.570203.97
4316197-316197217.159218.74
5290937-290937199.811200.99
6300140-300140206.131207.46
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125
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%
128.565034105033885036435033345038235035200.05
228.565035905036985036440.02
单位质量响应值RSD%判断
17630.2517634.590.02数据可信
影响因素30天-供试品溶液-2024032721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%
5min136795-3679513.7699.0472.6513.779.0472.67
28350-83503.1253.12
327908-2790810.44310.44
448570-4857018.17518.17
521974-219748.2238.22
61416-14160.5300.53
10min1133207-13320749.84639.5733.7349.8739.5833.75
292923-9292334.77234.78
396166-9616635.98536.00
4162635-16263560.85860.89
584557-8455731.64131.65
664974-6497424.31324.31
15min1196150-19615073.39974.4914.4173.5174.5814.43
2185984-18598469.59569.66
3221846-22184683.01583.09
4244404-24440491.45691.59
5173601-17360164.96265.03
6172471-17247164.53964.58
20min1244217-24421791.38697.4913.0091.6197.7013.02
2260122-26012297.33897.52
3285978-285978107.013107.23
4312664-312664116.999117.28
5218892-21889281.90982.08
6241322-24132290.30390.45
30min1302994-302994113.380123.2311.30113.76123.6011.30
2331104-331104123.899124.24
3344109-344109128.766129.16
4375028-375028140.336140.81
5270910-270910101.375101.69
6351725-351725131.616131.92
45min1361566-361566135.298141.9610.05135.87142.5410.04
2400558-400558149.889150.44
3383402-383402143.469144.08
4416411-416411155.821156.53
5311776-311776116.667117.15
6402564-402564150.640151.16
60min1372160-372160139.262150.929.81140.06151.739.81
2430673-430673161.158161.96
3409024-409024153.057153.90
4442672-442672165.648166.62
5339853-339853127.173127.85
6425460-425460159.207159.98
极限1462916-462916173.223179.344.09174.25180.414.13
2488320-488320182.729183.80
3471415-471415176.404177.51
4512410-512410191.744192.99
5459131-459131171.807172.69
6481462-481462180.163181.20
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125
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%
128.562906502906642905752905202904402905700.04
228.562909152913242911200.10
单位质量响应值RSD%判断
10174.0210193.280.14数据可信
影响因素30天-供试品溶液-2024032721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%
5min117156-1715611.76517.9078.4511.7717.9078.43
243352-4335229.73029.73
344152-4415230.27930.28
43857-38572.6452.65
52959-29592.0292.03
645132-4513230.95130.95
10min1103468-10346870.95771.2024.2370.9871.2324.25
2118343-11834381.15881.21
3117285-11728580.43280.48
468389-6838946.90046.90
580481-8048155.19355.20
6134965-13496592.55792.61
15min1177529-177529121.747120.9010.79121.88121.0510.81
2192912-192912132.296132.48
3186599-186599127.967128.15
4156736-156736107.487107.57
5149599-149599102.593102.69
6194390-194390133.310133.52
20min1225499-225499154.644149.423.82154.98149.773.86
2217269-217269149.000149.40
3222299-222299152.449152.85
4208943-208943143.290143.55
5207028-207028141.977142.24
6226280-226280155.179155.61
30min1259790-259790178.160170.493.28178.76171.083.26
2235581-235581161.558162.21
3246618-246618169.127169.78
4245598-245598168.427168.93
5252850-252850173.401173.90
6251156-251156172.239172.93
45min1281842-281842193.283184.103.85194.18184.993.82
2251329-251329172.357173.28
3264278-264278181.238182.17
4268565-268565184.178184.96
5274822-274822188.469189.26
6269909-269909185.099186.07
60min1295830-295830202.876192.814.33204.09194.004.29
2260854-260854178.890180.10
3275036-275036188.615189.85
4286612-286612196.554197.64
5287825-287825197.386198.49
6280731-280731192.521193.80
极限1309800-309800212.456209.332.09214.01210.842.07
2294342-294342201.855203.36
3301579-301579206.818208.37
4311857-311857213.867215.28
5306620-306620210.275211.71
6307284-307284210.731212.33
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125
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%
128.565034515037585033655037555033995035460.04
228.565039875041655040760.03
单位质量响应值RSD%判断
17631.1617649.720.08数据可信
影响因素30天-供试品溶液-2024032721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%
5min121849-218498.17212.2177.108.1712.2077.12
254774-5477420.48720.49
352975-5297519.81419.81
45786-57862.1642.16
53639-36391.3611.36
656782-5678221.23821.24
10min1135096-13509650.53050.3123.9750.5450.3323.99
2154057-15405757.62257.66
3148012-14801255.36155.39
491532-9153234.23634.24
5102180-10218038.21838.22
6176238-17623865.91865.95
15min1240797-24079790.06588.9210.9390.1689.0210.96
2262024-26202498.00598.14
3248795-24879593.05793.18
4213935-21393580.01880.08
5198968-19896874.42074.49
6261878-26187897.95098.10
20min1310269-310269116.050113.063.66116.30113.323.69
2305881-305881114.409114.70
3306166-306166114.515114.80
4294141-294141110.018110.21
5284029-284029106.235106.43
6313232-313232117.158117.47
30min1379604-379604141.983135.293.09142.42135.733.07
2345960-345960129.399129.88
3355577-355577132.997133.47
4360174-360174134.716135.09
5364801-364801136.447136.81
6364162-364162136.208136.71
45min1432255-432255161.676152.644.16162.35153.304.13
2382153-382153142.937143.64
3397734-397734148.765149.46
4410436-410436153.515154.12
5416161-416161155.657156.25
6409777-409777153.269154.00
60min1468181-468181175.114164.784.85176.06165.704.81
2406771-406771152.145153.08
3427229-427229159.797160.74
4450334-450334168.439169.30
5450430-450430168.474169.33
6440440-440440164.738165.72
极限1508004-508004190.009185.042.60191.25186.242.58
2473612-473612177.145178.34
3487426-487426182.312183.52
4506701-506701189.521190.66
5496033-496033185.531186.67
6496614-496614185.749187.01
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125
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%
128.562913032915612914132917422914242914890.06
228.562912192914732913460.07
单位质量响应值RSD%判断
10206.2010201.190.04数据可信
影响因素30天-供试品溶液-2024032721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%
5min136887-3688725.24712.6165.0925.2512.6165.08
220492-2049214.02514.03
325984-2598417.78417.78
411563-115637.9147.91
512487-124878.5478.55
63120-31202.1352.14
10min1115225-11522578.86460.9836.2978.9161.0036.30
2106822-10682273.11373.14
3106310-10631072.76272.79
478631-7863153.81853.83
599455-9945568.07168.08
628136-2813619.25719.26
15min1178536-178536122.197108.2715.55122.37108.3915.57
2179051-179051122.549122.69
3153701-153701105.199105.35
4163031-163031111.584111.69
5162520-162520111.235111.36
6112254-11225476.83176.87
20min1224033-224033153.336137.9710.29153.71138.2810.30
2200831-200831137.456137.81
3177851-177851121.728122.05
4217578-217578148.918149.21
5213699-213699146.263146.58
6175521-175521120.133120.30
30min1257138-257138175.995164.329.49176.63164.869.48
2225680-225680154.464155.04
3205038-205038140.335140.86
4264103-264103180.762181.30
5255573-255573174.923175.48
6232971-232971159.454159.82
45min1277154-277154189.694179.747.30190.62180.557.29
2246069-246069168.419169.25
3236887-236887162.134162.90
4284572-284572194.771195.61
5275208-275208188.362189.21
6255792-255792175.073175.70
60min1289241-289241197.967192.145.51199.21193.255.51
2263120-263120180.089181.21
3265136-265136181.469182.50
4296372-296372202.848204.01
5297141-297141203.374204.54
6273386-273386187.115188.04
极限1312444-312444213.848206.492.91215.42207.912.94
2293411-293411200.821202.24
3294711-294711201.711203.05
4311156-311156212.967214.47
5304098-304098208.136209.64
6294297-294297201.428202.66
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125
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%
128.565050505055435048315054025050225051700.06
228.565041105042535041820.03
单位质量响应值RSD%判断
17688.0317653.430.14数据可信
影响因素30天-供试品溶液-2024032721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%
5min150571-5057118.8839.3364.6918.889.3364.68
226809-2680910.01010.01
334788-3478812.98912.99
415981-159815.9675.97
516965-169656.3356.33
64818-48181.7991.80
10min1149679-14967955.88943.5636.4355.9243.5736.43
2140442-14044252.44052.46
3140176-14017652.34052.36
4102141-10214138.13838.15
5130848-13084848.85748.87
636632-3663213.67813.68
15min1237821-23782188.80079.8715.9388.9279.9515.95
2246520-24652092.04892.15
3205454-20545476.71476.82
4221569-22156982.73282.81
5221196-22119682.59282.68
6150801-15080156.30756.33
20min1308374-308374115.144104.9010.66115.42105.1210.67
2285613-285613106.645106.90
3244993-24499391.47891.71
4305552-305552114.090114.30
5298731-298731111.543111.77
6242359-24235990.49490.61
30min1371249-371249138.620130.5210.14139.08130.9210.12
2335892-335892125.419125.85
3292015-292015109.035109.42
4389791-389791145.544145.95
5372128-372128138.949139.36
6336296-336296125.569125.84
45min1419025-419025156.459148.988.19157.16149.608.18
2375469-375469140.196140.84
3352828-352828131.742132.31
4440358-440358164.425165.07
5418909-418909156.416157.06
6387446-387446144.668145.15
60min1450438-450438168.189163.756.89169.15164.616.89
2409356-409356152.849153.73
3403119-403119150.520151.31
4472336-472336176.365177.28
5470222-470222175.576176.48
6425755-425755158.972159.69
极限1505205-505205188.638182.903.73189.87184.033.76
2475583-475583177.578178.71
3467717-467717174.641175.68
4513128-513128191.597192.81
5498500-498500186.135187.34
6478832-478832178.791179.78
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125
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%
128.562904902904532903702905712905702904910.03
228.562901362899982900670.04
单位质量响应值RSD%判断
10171.2510156.410.11数据可信
影响因素30天-供试品溶液-2024032721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%
5min123595-2359516.21317.5723.3616.2117.5723.36
226626-2662618.29518.30
321150-2115014.53314.53
425943-2594317.82617.83
519647-1964713.50013.50
636456-3645625.05025.05
10min183348-8334857.27067.6413.9557.3067.6713.95
2103887-10388771.38371.41
398793-9879367.88367.91
4108334-10833474.43974.47
581029-8102955.67755.70
6115267-11526779.20279.24
15min1143560-14356098.643113.369.8798.77113.509.87
2182653-182653125.505125.65
3160163-160163110.051110.19
4177123-177123121.705121.86
5149451-149451102.691102.81
6176878-176878121.537121.71
20min1179274-179274123.183142.728.72123.47143.058.72
2227868-227868156.573156.93
3201480-201480138.441138.76
4225696-225696155.081155.44
5200776-200776137.957138.24
6211126-211126145.069145.45
30min1219295-219295150.682166.716.20151.17167.286.21
2264006-264006181.404182.02
3237940-237940163.494164.05
4251019-251019172.480173.10
5237509-237509163.197163.71
6245951-245951168.998169.62
45min1246136-246136169.125182.604.51169.87183.444.53
2282576-282576194.164195.09
3263403-263403180.990181.81
4270028-270028185.542186.44
5262557-262557180.408181.20
6269762-269762185.359186.26
60min1263127-263127180.800192.433.77181.83193.583.79
2294576-294576202.409203.65
3278581-278581191.419192.54
4283626-283626194.885196.10
5275553-275553189.338190.43
6284838-284838195.718196.93
极限1295552-295552203.080208.521.83204.41209.991.86
2311969-311969214.361215.94
3299716-299716205.941207.39
4304770-304770209.414210.95
5303520-303520208.555209.96
6305258-305258209.749211.28
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125
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%
128.565028885034465030905033065033055032070.05
228.565019875020855020360.02
单位质量响应值RSD%判断
17619.2917578.290.17数据可信
影响因素30天-供试品溶液-2024032721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%
5min135730-3573013.39613.1822.6813.4013.1822.67
235828-3582813.43213.43
330164-3016411.30911.31
433700-3370012.63512.63
526038-260389.7629.76
649541-4954118.57418.57
10min1109642-10964241.10747.8213.6641.1347.8513.66
2135991-13599150.98551.01
3128016-12801647.99548.01
4136440-13644051.15451.17
5104773-10477339.28139.30
6150505-15050556.42756.46
15min1190691-19069171.49382.4810.3971.5882.5810.39
2247049-24704992.62392.73
3213313-21331379.97480.07
4234220-23422087.81387.92
5197857-19785774.18074.26
6236777-23677788.77188.90
20min1243615-24361591.335106.799.6191.55107.039.61
2317831-317831119.160119.42
3276386-276386103.621103.85
4312065-312065116.998117.25
5272878-272878102.306102.51
6286246-286246107.318107.59
30min1313810-313810117.652130.526.87118.01130.946.88
2385442-385442144.508144.97
3341827-341827128.156128.56
4360611-360611135.199135.65
5338698-338698126.983127.36
6348442-348442130.636131.09
45min1364029-364029136.480149.455.51137.04150.085.52
2431362-431362161.724162.43
3395904-395904148.431149.05
4406356-406356152.349153.02
5391138-391138146.644147.23
6402881-402881151.046151.72
60min1403017-403017151.097162.994.80151.88163.884.82
2465013-465013174.341175.31
3433287-433287162.446163.31
4442760-442760165.998166.92
5422934-422934158.565159.40
6441491-441491165.522166.44
极限1475156-475156178.143184.452.56179.18185.612.58
2512570-512570192.171193.43
3488692-488692183.218184.35
4497624-497624186.567187.77
5485764-485764182.121183.22
6492112-492112184.501185.70
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125
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%
128.562935712922832919582916022914802921790.29
228.562907322906662906990.02
单位质量响应值RSD%判断
10230.3610178.540.36数据可信
影响因素30天-供试品溶液-2024032721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%
5min115621-1562110.69124.7758.9310.6924.7758.93
244023-4402330.12930.13
34358-43582.9832.98
442421-4242129.03329.03
554478-5447837.28437.28
656288-5628838.52338.52
10min166303-6630345.37770.5031.4245.3970.5431.44
2128753-12875388.11788.17
359314-5931440.59440.60
4108109-10810973.98974.04
5122252-12225283.66883.73
6133358-13335891.26991.33
15min1147624-147624101.032118.2113.81101.13118.3713.84
2184206-184206126.069126.27
3141502-14150296.84396.92
4171409-171409117.311117.48
5191261-191261130.897131.10
6200313-200313137.092137.31
20min1205046-205046140.332146.656.37140.59147.006.42
2228127-228127156.128156.54
3191960-191960131.376131.61
4214572-214572146.851147.22
5224549-224549153.679154.10
6221404-221404151.527151.97
30min1237009-237009162.207172.064.65162.70172.664.64
2269746-269746184.612185.28
3254463-254463174.152174.61
4257600-257600176.299176.91
5245959-245959168.332169.01
6243665-243665166.762167.46
45min1282240-282240193.162189.143.20193.93190.023.16
2288866-288866197.697198.67
3279878-279878191.546192.29
4271759-271759185.989186.90
5265007-265007181.368182.32
6270412-270412185.067186.04
60min1277732-277732190.077196.673.18191.17197.883.17
2299696-299696205.109206.41
3292356-292356200.086201.15
4290894-290894199.085200.30
5275799-275799188.754190.01
6287747-287747196.931198.22
极限1300289-300289205.515209.311.89206.92210.841.90
2313692-313692214.688216.33
3307728-307728210.606212.00
4305161-305161208.849210.40
5298405-298405204.226205.80
6309730-309730211.976213.59
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125
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%
128.565092745063875059455043955043685060740.40
228.565039095037365038220.03
单位质量响应值RSD%判断
17719.6817640.830.32数据可信
影响因素30天-供试品溶液-2024032721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%
5min123672-236728.83418.7455.208.8318.7455.22
260856-6085622.71122.71
38610-86103.2133.21
458215-5821521.72521.73
573363-7336327.37827.38
676504-7650428.55128.55
10min188935-8893533.19051.3631.5033.2051.3931.51
2174360-17436065.06965.11
379554-7955429.68929.69
4143630-14363053.60153.64
5159240-15924059.42759.47
6180004-18000467.17667.22
15min1200154-20015474.69588.0214.3774.7788.1314.40
2254109-25410994.83194.98
3193890-19389072.35872.41
4230148-23014885.88986.01
5257916-25791696.25296.40
6278866-278866104.070104.23
20min1285070-285070106.385112.217.17106.58112.487.21
2322737-322737120.442120.75
3267105-26710599.68199.86
4297917-297917111.180111.45
5313694-313694117.067117.37
6317601-317601118.525118.86
30min1342292-342292127.740137.355.06128.11137.805.06
2397708-397708148.421148.93
3371461-371461138.625138.97
4375714-375714140.213140.67
5358847-358847133.918134.42
6362271-362271135.196135.73
45min1430371-430371160.610158.023.63161.19158.703.61
2445445-445445166.236166.99
3431316-431316160.963161.54
4414147-414147154.555155.24
5401953-401953150.005150.73
6417338-417338155.746156.50
60min1431725-431725161.115169.423.89161.97170.363.89
2475981-475981177.631178.66
3466208-466208173.984174.82
4460545-460545171.871172.82
5434364-434364162.100163.07
6455085-455085169.833170.85
极限1488514-488514182.308187.022.34183.43188.252.34
2516694-516694192.825194.15
3507391-507391189.353190.48
4501906-501906187.306188.54
5486388-486388181.515182.76
6506007-506007188.837190.14
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