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%
128.272848732853452850872848422852502850790.08
228.322809652802662806160.18
单位质量响应值RSD%判断
10084.159908.761.25数据可信
加速3月-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%
5min117107-171072.7722.4889.962.772.4890.01
217675-176752.8642.86
316650-166502.6982.70
438217-382176.1926.19
52062-20620.3340.33
6-0.0000.00
10min163247-6324710.24812.2037.7610.2512.2037.79
282981-8298113.44513.45
382853-8285313.42513.43
4122784-12278419.89519.91
560666-606669.8309.83
639128-391286.3406.34
15min1134711-13471121.82722.9117.3021.8522.9317.34
2146585-14658523.75123.78
3141680-14168022.95622.98
4183090-18309029.66629.71
5134381-13438121.77421.79
6107781-10778117.46417.47
20min1179485-17948529.08229.4510.0629.1429.5110.09
2177159-17715928.70528.77
3183007-18300729.65329.72
4209822-20982233.99734.09
5187883-18788330.44330.50
6153193-15319324.82224.86
30min1207826-20782633.67434.787.5633.7834.897.57
2202099-20209932.74632.86
3223618-22361836.23336.35
4226471-22647136.69536.84
5234976-23497638.07338.18
6192771-19277131.23531.32
45min1226576-22657636.71238.495.1136.8738.665.13
2234318-23431837.96738.14
3245031-24503139.70239.88
4241027-24102739.05439.26
5255520-25552041.40241.57
6222899-22289936.11636.25
60min1241198-24119839.08140.724.1539.3140.964.18
2248443-24844340.25540.49
3260353-26035342.18542.43
4265453-26545343.01143.29
5253198-25319841.02641.26
6239231-23923138.76338.96
极限1287832-28783246.63746.921.7446.9347.221.76
2286971-28697146.49846.80
3285217-28521746.21446.53
4295465-29546547.87448.22
5296363-29636348.02048.32
6285470-28547046.25546.51
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%
128.274946584951704948274951294947054948980.05
228.324920304916864918580.05
单位质量响应值RSD%判断
17506.1217367.870.57数据可信
加速3月-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%
5min118880-188801.6571.5299.241.661.5299.28
219931-199311.7491.75
318391-183911.6141.61
446804-468044.1074.11
5-0.0000.00
6-0.0000.00
10min176020-760206.6718.2740.596.678.2740.60
2102452-1024528.9918.99
3103183-1031839.0559.06
4159811-15981114.02414.03
576824-768246.7426.74
647039-470394.1284.13
15min1171812-17181215.07716.1019.0015.0916.1219.02
2189952-18995216.66916.69
3183117-18311716.06916.09
4243383-24338321.35821.39
5176686-17668615.50515.52
6135929-13592911.92811.94
20min1234932-23493220.61721.2411.6220.6621.2811.65
2235148-23514820.63520.68
3241178-24117821.16521.21
4287442-28744225.22525.29
5252530-25253022.16122.20
6201051-20105117.64317.67
30min1279538-27953824.53125.799.4824.6025.879.50
2274037-27403724.04824.13
3305600-30560026.81826.90
4318160-31816027.92028.03
5328656-32865628.84128.92
6257227-25722722.57322.63
45min1311752-31175227.35829.387.4727.4729.507.48
2325263-32526328.54428.66
3348341-34834130.56930.69
4344856-34485630.26330.42
5372207-37220732.66332.79
6306238-30623826.87426.97
60min1340531-34053129.88331.706.6830.0431.876.70
2349170-34917030.64230.81
3383319-38331933.63833.81
4395037-39503734.66734.87
5364198-36419831.96032.14
6334949-33494929.39429.53
极限1444430-44443039.00139.732.6639.2139.952.69
2446335-44633539.16839.39
3443395-44339538.91039.14
4467888-46788841.06041.32
5468438-46843841.10841.34
6445628-44562839.10639.29
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%
128.272852512846842846072850152848462848810.10
228.322912682909852911260.07
单位质量响应值RSD%判断
10077.1510279.871.41数据可信
加速3月-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%
5min132872-328725.2314.3923.935.234.4023.95
221767-217673.4643.46
318260-182602.9062.91
426035-260354.1434.14
533592-335925.3465.35
633151-331515.2755.28
10min1102536-10253616.31712.6338.3116.3312.6438.30
230548-305484.8614.87
359621-596219.4889.49
494818-9481815.08915.10
5111987-11198717.82117.83
676627-7662712.19412.20
15min1160106-16010625.47922.4819.0825.5122.5019.08
2139877-13987722.25922.27
389666-8966614.26914.29
4143891-14389122.89822.93
5164369-16436926.15726.20
6149532-14953223.79623.82
20min1198194-19819431.54029.7010.0431.6229.7710.05
2198116-19811631.52731.58
3151273-15127324.07324.12
4182498-18249829.04229.11
5188255-18825529.95830.04
6201451-20145132.05832.13
30min1226612-22661236.06235.446.3436.1935.566.37
2226766-22676636.08636.19
3194533-19453330.95731.04
4227725-22772536.23936.36
5226585-22658536.05836.19
6234110-23411037.25537.38
45min1245384-24538439.04938.916.0239.2439.086.04
2251484-25148440.02040.18
3214958-21495834.20734.34
4252088-25208840.11640.30
5250478-25047839.86040.05
6252660-25266040.20740.39
60min1256666-25666640.84541.572.9741.1041.813.00
2265923-26592342.31842.55
3248004-24800439.46639.66
4263592-26359241.94742.19
5269701-26970142.91943.18
6263415-26341541.91942.17
极限1287377-28737745.73246.871.7946.0647.181.80
2296357-29635747.16147.46
3289659-28965946.09546.35
4300090-30009047.75548.07
5299909-29990947.72648.06
6293814-29381446.75647.08
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%
128.274946014944004945054949854942154945410.06
228.325035745032795034260.05
单位质量响应值RSD%判断
17493.4917776.341.14数据可信
加速3月-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%
5min143001-430013.7313.1126.423.733.1026.41
227020-270202.3452.34
322197-221971.9261.93
434831-348313.0223.02
542775-427753.7123.71
644929-449293.8993.90
10min1131390-13139011.4018.7740.6511.418.7840.67
236306-363063.1503.15
373301-733016.3616.36
4122490-12249010.62910.63
5146575-14657512.71912.73
696366-963668.3628.37
15min1211982-21198218.39516.3020.2718.4216.3220.28
2186350-18635016.17016.18
3115326-11532610.00710.02
4191934-19193416.65516.68
5223709-22370919.41219.44
6197666-19766617.15217.17
20min1270967-27096723.51322.2710.9023.5722.3210.91
2273511-27351123.73423.77
3202107-20210717.53817.57
4252601-25260121.91921.97
5265458-26545823.03523.09
6275454-27545423.90223.95
30min1324001-32400128.11527.717.4328.2127.807.45
2327849-32784928.44928.52
3271761-27176123.58223.64
4326358-32635828.32028.41
5329479-32947928.59028.69
6336653-33665329.21329.30
45min1365986-36598631.75831.587.1331.9031.717.15
2374428-37442832.49132.61
3311795-31179527.05627.15
4377284-37728432.73932.87
5377873-37787332.79032.94
6376448-37644832.66632.80
60min1393156-39315634.11634.494.1734.3134.684.20
2405644-40564435.20035.38
3366550-36655031.80731.95
4404764-40476435.12335.31
5413681-41368135.89736.10
6401224-40122434.81635.01
极限1450059-45005939.05440.652.7939.3140.882.80
2468629-46862940.66540.90
3456744-45674439.63439.83
4481294-48129441.76442.01
5482859-48285941.90042.16
6470810-47081040.85441.10
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.272851772848542849662852622852112850940.07
228.322856112855552855830.02
单位质量响应值RSD%判断
10084.6810084.150.01数据可信
加速3月-供试品溶液-2024032821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%
5min14107-41070.6602.0379.050.662.0279.09
217169-171692.7572.76
326982-269824.3334.33
419348-193483.1073.11
52519-25190.4050.40
65538-55380.8890.89
10min180353-8035312.9058.9892.9412.918.9892.91
223435-234353.7643.77
3120578-12057819.36519.37
4103375-10337516.60216.61
53614-36140.5800.58
64141-41410.6650.67
15min1142364-14236422.86421.7331.9422.8921.7531.98
2116717-11671718.74518.76
3191700-19170030.78830.83
4177592-17759228.52228.55
582078-8207813.18213.18
6101544-10154416.30816.31
20min1205093-20509332.93931.4618.0233.0031.5218.08
2191577-19157730.76830.81
3242119-24211938.88538.98
4223268-22326835.85835.94
5147848-14784823.74523.77
6165390-16539026.56226.59
30min1242893-24289339.01039.0410.6539.1339.1410.71
2229374-22937436.83836.93
3288352-28835246.31146.47
4253782-25378240.75840.90
5214830-21483034.50334.57
6229074-22907436.79036.86
45min1265136-26513642.58243.628.0742.7643.798.12
2251904-25190440.45740.61
3312247-31224750.14850.38
4277029-27702944.49244.70
5255037-25503740.96041.08
6268106-26810643.05943.19
60min1275444-27544444.23745.647.2044.4945.897.25
2263460-26346042.31342.54
3321251-32125151.59451.91
4290010-29001046.57746.86
5270770-27077043.48743.68
6284285-28428545.65745.86
极限1306784-30678449.27149.483.2349.6049.803.31
2302545-30254548.59048.88
3326974-32697452.51352.92
4310106-31010649.80450.16
5300478-30047848.25848.52
6301524-30152448.42648.71
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%
128.274946144945054945184948174945184945940.03
228.324950884957634954260.10
单位质量响应值RSD%判断
17495.3717493.860.01数据可信
加速3月-供试品溶液-2024032821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%
5min16195-61950.5421.4471.050.541.4470.98
220833-208331.8221.82
333542-335422.9342.93
423465-234652.0522.05
52508-25080.2190.22
611966-119661.0471.05
10min197059-970598.4896.1995.718.496.1995.70
228849-288492.5232.53
3157178-15717813.74813.75
4134086-13408611.72811.73
52777-27770.2430.24
64579-45790.4010.40
15min1191268-19126816.72915.9232.8716.7415.9332.90
2155041-15504113.56113.57
3261782-26178222.89722.92
4239284-23928420.92920.95
5109510-1095109.5789.58
6135305-13530511.83411.84
20min1289697-28969725.33823.9819.5025.3824.0219.54
2266687-26668723.32623.36
3345841-34584130.24930.31
4312860-31286027.36427.42
5202264-20226417.69117.71
6227479-22747919.89619.92
30min1368693-36869332.24831.6412.9632.3331.7213.01
2343341-34334130.03030.10
3444094-44409438.84338.96
4373278-37327832.64932.75
5308420-30842026.97627.02
6332894-33289429.11729.17
45min1422415-42241536.94637.2010.2237.0937.3410.26
2397665-39766534.78234.90
3508725-50872544.49644.68
4423763-42376337.06437.22
5385783-38578333.74233.83
6413696-41369636.18436.29
60min1448007-44800739.18540.009.1439.3940.209.17
2427360-42736037.37937.56
3538134-53813447.06847.32
4456042-45604239.88840.11
5423080-42308037.00537.15
6451602-45160239.49939.66
极限1508276-50827644.45644.485.2344.7244.745.29
2500056-50005643.73743.98
3559320-55932048.92149.25
4507735-50773544.40944.70
5483818-48381842.31742.53
6491998-49199843.03343.26
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%
128.272852882853392856472856662856142855110.07
228.322858752859172858960.02
单位质量响应值RSD%判断
10099.4310095.200.03数据可信
加速3月-供试品溶液-2024032821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%
5min125039-250394.0162.8457.954.022.8457.90
24166-41660.6680.67
326363-263634.2294.23
45155-51550.8270.83
521159-211593.3943.39
624503-245033.9303.93
10min132798-327985.2619.8341.815.279.8441.78
245538-455387.3047.31
361783-617839.9109.92
469122-6912211.08711.09
551760-517608.3028.31
6106794-10679417.13017.14
15min138373-383736.15521.5837.726.1721.6037.70
2148983-14898323.89723.91
3142745-14274522.89622.92
4161295-16129525.87225.89
5130129-13012920.87320.89
6185637-18563729.77629.81
20min1138761-13876122.25730.5314.9622.2830.5915.00
2192780-19278030.92230.97
3207701-20770133.31533.38
4204717-20471732.83632.90
5180039-18003928.87828.93
6218164-21816434.99335.08
30min1226659-22665936.35638.327.8936.4238.427.91
2224192-22419235.96036.06
3269357-26935743.20543.32
4234926-23492637.68237.80
5223840-22384035.90436.01
6254333-25433340.79540.94
45min1261088-26108841.87842.226.6142.0042.396.61
2242993-24299338.97639.14
3294312-29431247.20747.40
4254631-25463140.84341.02
5257841-25784141.35741.52
6268458-26845843.06043.27
60min1275543-27554344.19744.586.0944.3944.826.09
2253676-25367640.68940.92
3306127-30612749.10249.37
4280097-28009744.92745.18
5272348-27234843.68443.92
6279769-27976944.87545.16
极限1303497-30349748.68148.652.6648.9548.962.68
2294172-29417247.18547.48
3315775-31577550.65051.00
4306263-30626349.12449.45
5294796-29479647.28547.59
6305269-30526948.96549.32
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%
128.274950074954844955514954694959064954830.07
228.324961704961754961720.01
单位质量响应值RSD%判断
17526.8117520.200.03数据可信
加速3月-供试品溶液-2024032821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%
5min131546-315462.7551.9358.402.751.9358.41
24327-43270.3780.38
330908-309082.6992.70
46912-69120.6040.60
527157-271572.3712.37
631886-318862.7842.78
10min139763-397633.4726.9044.043.486.9044.03
256720-567204.9534.95
378028-780286.8136.82
492453-924538.0738.07
567163-671635.8655.87
6139742-13974212.20212.21
15min147906-479064.18315.8539.184.1915.8639.17
2202511-20251117.68317.69
3189738-18973816.56816.58
4222083-22208319.39219.41
5173101-17310115.11515.13
6253621-25362122.14622.17
20min1188939-18893916.49823.2216.1916.5223.2616.21
2273327-27332723.86723.91
3286870-28687025.05025.09
4291709-29170925.47225.52
5246407-24640721.51621.56
6308223-30822326.91426.98
30min1328275-32827528.66530.798.3928.7130.878.40
2335807-33580729.32329.40
3400232-40023234.94935.03
4353963-35396330.90831.00
5324416-32441628.32828.40
6373275-37327532.59532.70
45min1406324-40632435.48035.617.1435.5735.747.14
2380172-38017233.19733.32
3463175-46317540.44540.59
4396971-39697134.66434.80
5391087-39108734.15034.27
6408901-40890135.70535.87
60min1443145-44314538.69638.586.8338.8538.776.82
2404038-40403835.28135.46
3495181-49518143.24043.45
4445043-44504338.86139.06
5426673-42667337.25737.44
6436702-43670238.13338.35
极限1499889-49988943.65143.363.3043.8743.613.31
2477968-47796841.73641.98
3523251-52325145.69145.97
4502236-50223643.85644.12
5481227-48122742.02142.26
6494617-49461743.19043.47
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%
128.272855442852732851952856502855022854330.07
228.322853312852132852720.03
单位质量响应值RSD%判断
10096.6710073.160.17数据可信
加速3月-供试品溶液-2024032921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%
5min134339-343395.5153.3678.415.513.3678.41
23859-38590.6200.62
339660-396606.3696.37
4-0.0000.00
529554-295544.7464.75
618001-180012.8912.89
10min1108125-10812517.36414.0633.0717.3714.0633.06
282229-8222913.20613.21
3119069-11906919.12219.13
445056-450567.2367.24
5106939-10693917.17417.18
663838-6383810.25210.26
15min1175340-17534028.15925.5013.0628.2025.5313.08
2160678-16067825.80425.83
3184008-18400829.55129.59
4141875-14187522.78522.80
5162532-16253226.10226.14
6128195-12819520.58820.61
20min1225969-22596936.29033.399.3936.3733.469.41
2208938-20893833.55533.62
3230292-23029236.98437.08
4205592-20559233.01733.07
5200474-20047432.19532.28
6176033-17603328.27028.33
30min1258368-25836841.49339.297.2741.6439.417.27
2252322-25232240.52240.64
3257467-25746741.34841.50
4254160-25416040.81740.92
5230421-23042137.00537.14
6215060-21506034.53834.64
45min1275816-27581644.29542.635.9244.5142.825.92
2272185-27218543.71243.90
3275608-27560844.26244.48
4276261-27626144.36744.54
5254479-25447940.86841.06
6238264-23826438.26438.43
60min1287148-28714846.11544.685.1146.4044.945.13
2284151-28415145.63445.90
3287497-28749746.17146.47
4288397-28839746.31646.56
5268408-26840843.10543.37
6253548-25354840.71940.94
极限1303520-30352048.74447.882.3049.1148.212.31
2298974-29897448.01448.35
3302381-30238148.56148.93
4304432-30443248.89149.21
5288270-28827046.29546.63
6291128-29112846.75447.05
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%
128.274956704955434951514955974955494955020.05
228.324953024949034951020.06
单位质量响应值RSD%判断
17527.4817482.420.19数据可信
加速3月-供试品溶液-2024032921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%
5min140902-409023.5752.0982.683.582.0982.64
22738-27380.2390.24
346666-466664.0794.08
4-0.0000.00
534101-341012.9812.98
619061-190611.6661.67
10min1136612-13661211.9429.5734.3011.959.5734.33
2104062-1040629.0969.10
3150999-15099913.19913.21
454832-548324.7934.79
5132722-13272211.60211.61
677445-774456.7706.77
15min1230916-23091620.18518.1913.8220.2118.2213.84
2214092-21409218.71418.73
3242747-24274721.21921.25
4186725-18672516.32216.33
5210079-21007918.36418.39
6164328-16432814.36414.38
20min1307248-30724826.85824.6010.6026.9224.6510.62
2286265-28626525.02325.07
3315123-31512327.54627.61
4279931-27993124.47024.50
5268124-26812423.43823.49
6231975-23197520.27820.32
30min1367264-36726432.10430.278.6532.2130.368.66
2361231-36123131.57631.66
3367668-36766832.13932.25
4363415-36341531.76731.84
5321691-32169128.12028.21
6296653-29665325.93126.00
45min1406835-40683535.56334.247.2935.7234.387.29
2406265-40626535.51335.65
3410503-41050335.88336.05
4413197-41319736.11936.25
5370455-37045532.38332.52
6343105-34310529.99230.11
60min1436542-43654238.16037.106.5038.3837.306.51
2438937-43893738.36938.57
3442585-44258538.68838.91
4446408-44640839.02239.21
5405133-40513335.41435.61
6376935-37693532.94933.11
极限1484791-48479142.37741.563.5642.6641.823.57
2481005-48100542.04642.31
3485161-48516142.41042.70
4492452-49245243.04743.30
5449210-44921039.26739.52
6460088-46008840.21840.44
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%
128.272860482861662863452860032849882859100.19
228.322840592840592840590.00
单位质量响应值RSD%判断
10113.5510030.330.59数据可信
加速3月-供试品溶液-2024032921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%
5min14941-49410.7953.4285.060.793.4285.15
244723-447237.1927.19
326583-265834.2754.27
45484-54840.8820.88
539212-392126.3066.31
66535-65351.0511.05
10min176437-7643712.29213.0551.3712.2913.0651.37
2117692-11769218.92618.94
371391-7139111.48011.49
45946-59460.9560.96
5116899-11689918.79818.81
698585-9858515.85315.85
15min1169707-16970727.29026.1516.6227.3126.1816.65
2178201-17820128.65628.70
3158807-15880725.53725.56
4111155-11115517.87417.88
5187978-18797830.22830.27
6169817-16981727.30827.34
20min1213688-21368834.36234.226.8934.4334.296.93
2215425-21542534.64234.73
3223900-22390036.00436.07
4185616-18561629.84829.88
5226960-22696036.49736.59
6211247-21124733.97034.04
30min1250676-25067640.31039.973.2740.4340.103.30
2245125-24512539.41839.57
3259526-25952641.73341.86
4236373-23637338.01038.09
5254453-25445340.91841.07
6245322-24532239.44939.58
45min1268460-26846043.17043.202.4443.3643.392.45
2262959-26295942.28542.50
3279005-27900544.86645.06
4263743-26374342.41142.56
5273875-27387544.04144.26
6263795-26379542.42042.62
60min1280061-28006145.03544.992.1445.3045.262.14
2274109-27410944.07844.36
3290452-29045246.70646.98
4277403-27740344.60844.82
5281700-28170045.29945.59
6274987-27498744.22044.49
极限1299627-29962748.18248.261.1448.5248.611.13
2294097-29409747.29347.65
3303979-30397948.88249.23
4301513-30151348.48548.78
5302198-30219848.59548.97
6299443-29944348.15248.49
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%
128.274964654962534971924964364967894966270.08
228.324930704932604931650.03
单位质量响应值RSD%判断
17567.2817414.020.62数据可信
加速3月-供试品溶液-2024032921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%
5min16947-69470.6082.4083.130.612.4083.08
257150-571505.0005.00
332667-326672.8582.86
48350-83500.7310.73
550725-507254.4384.44
68541-85410.7470.75
10min198181-981818.5899.1751.848.599.1851.82
2150559-15055913.17213.18
391913-919138.0418.05
46702-67020.5860.59
5151808-15180813.28113.29
6130065-13006511.37911.38
15min1230803-23080320.19219.1717.1620.2119.2017.20
2237633-23763320.79020.82
3213559-21355918.68318.70
4147094-14709412.86912.87
5253819-25381922.20622.24
6232102-23210220.30620.33
20min1300591-30059126.29825.987.2426.3526.037.27
2296284-29628425.92125.99
3311832-31183227.28127.33
4256800-25680022.46622.49
5318366-31836627.85327.92
6297933-29793326.06526.12
30min1367900-36790032.18631.783.9032.2831.873.92
2352531-35253130.84230.95
3380835-38083533.31833.41
4341943-34194329.91529.98
5373359-37335932.66432.78
6362869-36286931.74631.84
45min1408714-40871435.75735.832.9935.9035.983.00
2392201-39220134.31234.47
3427050-42705037.36137.51
4402135-40213535.18135.29
5418710-41871036.63136.80
6408446-40844635.73335.88
60min1436763-43676338.21138.382.6138.4238.592.59
2421537-42153736.87937.10
3457247-45724740.00340.22
4437329-43732938.26038.43
5441361-44136138.61338.84
6438281-43828138.34438.55
极限1483767-48376742.32342.311.8942.5942.581.87
2465353-46535340.71240.99
3488197-48819742.71142.99
4488460-48846042.73442.97
5487970-48797042.69142.98
6488137-48813742.70542.98
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