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%
127.782843572853382848882848162848042848410.13
227.722869752870372870060.02
单位质量响应值RSD%判断
10253.4610353.750.69数据可信
长期12月-供试品溶液-2024032721批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1133621-13362121.00420.298.6821.0020.298.66
2128128-12812820.14120.14
3122689-12268919.28619.29
4113467-11346717.83617.84
5146981-14698123.10423.10
6129744-12974420.39520.39
10min1240384-24038437.78636.002.8437.8236.042.84
2223801-22380135.18035.21
3228070-22807035.85135.88
4228120-22812035.85935.89
5231633-23163336.41136.45
6222272-22227234.93934.97
15min1292747-29274746.01745.371.7246.1245.471.72
2292387-29238745.96146.05
3291675-29167545.84945.94
4282767-28276744.44944.54
5290325-29032545.63745.74
6281935-28193544.31844.41
20min1319742-31974250.26150.131.3050.4450.301.30
2324708-32470851.04151.21
3317666-31766649.93450.10
4315341-31534149.56949.73
5322126-32212650.63550.81
6313776-31377649.32349.49
30min1320383-32038350.36150.961.6650.6251.211.66
2325369-32536951.14551.40
3330718-33071851.98652.24
4315935-31593549.66249.91
5324158-32415850.95551.21
6328425-32842551.62651.87
45min1320624-32062450.39951.262.3650.7451.602.34
2325224-32522451.12251.46
3338965-33896553.28253.62
4317135-31713549.85150.18
5324671-32467151.03651.38
6330023-33002351.87752.21
60min1319870-31987050.28151.061.9150.7151.491.90
2325012-32501251.08951.51
3332141-33214152.21052.64
4315574-31557449.60650.02
5326615-32661551.34151.77
6329864-32986451.85252.27
极限1319323-31932350.19551.132.2250.7151.642.20
2323895-32389550.91451.42
3331931-33193152.17752.69
4315006-31500649.51650.01
5333068-33306852.35552.87
6328539-32853951.64452.15
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.784940634946754941664940094940784941980.06
227.724961704964894963300.05
单位质量响应值RSD%判断
17789.7017905.120.46数据可信
长期12月-供试品溶液-2024032721批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1228235-22823519.56818.809.3019.5718.809.29
2216359-21635918.55018.55
3203941-20394117.48517.49
4193625-19362516.60116.60
5252291-25229121.63121.63
6221438-22143818.98518.99
10min1413442-41344235.44733.712.9435.4833.742.94
2384392-38439232.95732.99
3391489-39148933.56533.59
4391560-39156033.57133.60
5397696-39769634.09734.13
6380818-38081832.65032.68
15min1504937-50493743.29242.621.8143.3842.701.82
2504188-50418843.22743.31
3502176-50217643.05543.14
4486351-48635141.69841.78
5499608-49960842.83542.93
6485062-48506241.58841.67
20min1551813-55181347.31147.121.4247.4747.281.42
2560656-56065648.06948.23
3546760-54676046.87747.03
4543459-54345946.59446.75
5554992-55499247.58347.75
6539650-53965046.26846.42
30min1553073-55307347.41947.921.6147.6648.161.61
2561822-56182248.16948.41
3568876-56887648.77449.01
4544792-54479246.70946.94
5558326-55832647.86948.11
6566766-56676648.59348.83
45min1553581-55358147.46248.252.3647.7848.562.35
2561762-56176248.16448.48
3584831-58483150.14250.46
4546715-54671546.87447.18
5560195-56019548.02948.35
6569353-56935348.81449.13
60min1552756-55275647.39248.081.9247.7948.481.91
2561615-56161548.15148.55
3572549-57254949.08949.49
4544167-54416746.65547.04
5563619-56361948.32348.73
6570171-57017148.88549.28
极限1551539-55153947.28748.182.2547.7748.662.24
2559904-55990448.00448.48
3573328-57332849.15549.64
4543683-54368346.61447.08
5575752-57575249.36349.85
6567619-56761948.66649.14
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%
127.782842332841492837192842542837702840250.10
227.722870422866332868380.11
单位质量响应值RSD%判断
10224.0810347.690.85数据可信
长期12月-供试品溶液-2024032821批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1142326-14232622.41118.6812.1222.4118.6812.11
2104755-10475516.49516.50
3118330-11833018.63318.63
4123065-12306519.37819.38
5120553-12055318.98318.98
6102678-10267816.16816.17
10min1225345-22534535.48435.343.8835.5235.373.88
2220444-22044434.71234.74
3222119-22211934.97635.01
4223423-22342335.18135.21
5240528-24052837.87537.91
6214676-21467633.80433.83
15min1269586-26958642.45046.014.5942.5546.104.57
2299235-29923547.11947.20
3303105-30310547.72847.82
4303925-30392547.85747.95
5283336-28333644.61544.71
6293814-29381446.26546.35
20min1296471-29647146.68450.434.5446.8550.604.53
2331010-33101052.12252.29
3327913-32791351.63551.80
4330195-33019551.99452.16
5307836-30783648.47348.64
6328192-32819251.67851.84
30min1324258-32425851.05951.880.8851.3052.130.88
2331350-33135052.17652.43
3327859-32785951.62651.88
4330489-33048952.04052.30
5331535-33153552.20552.45
6331255-33125552.16152.41
45min1328773-32877351.77052.151.0152.1052.491.00
2330826-33082652.09352.43
3327885-32788551.63051.97
4331209-33120952.15452.50
5337390-33739053.12753.46
6331047-33104752.12852.46
60min1330067-33006751.97452.000.7152.3952.430.70
2329847-32984751.93952.36
3326966-32696651.48551.91
4330367-33036752.02152.45
5334221-33422152.62853.05
6330095-33009551.97852.40
极限1330558-33055852.05152.562.1552.5553.072.13
2329438-32943851.87552.39
3347591-34759154.73355.25
4329346-32934651.86052.38
5335674-33567452.85753.37
6330132-33013251.98452.49
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%
127.784934774928544927864937074927544931160.10
227.724954174947974951070.09
单位质量响应值RSD%判断
17750.7617861.000.44数据可信
长期12月-供试品溶液-2024032821批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1243462-24346220.92217.4012.2720.9217.4012.26
2178456-17845615.33615.34
3201675-20167517.33117.33
4210272-21027218.07018.07
5206287-20628717.72817.73
6175014-17501415.04015.04
10min1386841-38684133.24433.103.9633.2833.133.96
2378591-37859132.53532.56
3381029-38102932.74432.77
4383330-38333032.94232.97
5413456-41345635.53135.56
6368084-36808431.63231.66
15min1462963-46296339.78643.244.7739.8843.324.75
2516315-51631544.37044.45
3522899-52289944.93645.02
4523607-52360744.99745.08
5486863-48686341.83941.93
6506004-50600443.48443.56
20min1509876-50987643.81747.444.7043.9747.604.68
2571521-57152149.11549.27
3565267-56526748.57748.74
4569995-56999548.98349.14
5529559-52955945.50945.67
6566089-56608948.64848.80
30min1558890-55889048.02948.850.9248.2649.080.92
2572378-57237849.18849.42
3565850-56585048.62748.87
4570228-57022849.00449.25
5571421-57142149.10649.34
6571588-57158849.12049.35
45min1566190-56619048.65649.120.9948.9749.440.98
2571554-57155449.11749.44
3566676-56667648.69849.02
4571489-57148949.11249.44
5581896-58189650.00650.32
6571892-57189249.14749.46
60min1568225-56822548.83148.980.7449.2249.380.73
2569439-56943948.93649.34
3564427-56442748.50548.91
4570035-57003548.98749.39
5577264-57726449.60850.01
6570309-57030949.01049.41
极限1570282-57028249.00849.532.1949.4850.012.17
2568729-56872948.87549.36
3600712-60071251.62352.11
4569079-56907948.90549.39
5579292-57929249.78250.26
6569779-56977948.96549.44
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%
127.782849892850822848122847222844202848050.10
227.722848712846162847440.07
单位质量响应值RSD%判断
10252.1610272.150.14数据可信
长期12月-供试品溶液-2024032921批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1103107-10310716.27315.9424.9516.2715.9424.94
259943-599439.4609.46
384278-8427813.30113.30
4111946-11194617.66817.67
5129723-12972320.47320.47
6117122-11712218.48518.48
10min1214879-21487933.91331.4012.5433.9431.4212.54
2155614-15561424.55924.58
3193003-19300330.46030.48
4191564-19156430.23330.26
5224747-22474735.47035.50
6213900-21390033.75833.79
15min1289213-28921345.64442.489.4345.7342.569.43
2231806-23180636.58436.64
3282438-28243844.57544.65
4249574-24957439.38839.47
5298000-29800047.03147.12
6263891-26389141.64841.74
20min1332363-33236352.45448.708.3952.6148.858.39
2279732-27973244.14844.27
3329131-32913151.94452.09
4280914-28091444.33544.48
5333281-33328152.59952.77
6296185-29618546.74546.90
30min1337867-33786753.32352.102.6353.5752.332.64
2326176-32617651.47851.67
3334175-33417552.74052.97
4314506-31450649.63649.86
5336099-33609953.04453.30
6331915-33191552.38452.62
45min1337481-33748153.26252.501.1353.6052.821.16
2331208-33120852.27252.55
3333249-33324952.59452.92
4326501-32650151.52951.83
5335183-33518352.90053.25
6332234-33223452.43452.76
60min1336885-33688553.16852.671.1953.5953.081.21
2333787-33378752.67953.04
3332595-33259552.49152.90
4328195-32819551.79752.18
5339423-33942353.56954.00
6331640-33164052.34052.75
极限1336521-33652153.11152.490.8453.6252.990.84
2334443-33444352.78353.23
3331716-33171652.35252.85
4329364-32936451.98152.46
5333736-33373652.67153.20
6329905-32990552.06752.56
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%
127.784953294951834949784951104950664951330.03
227.724948434941744945080.10
单位质量响应值RSD%判断
17823.3617839.390.07数据可信
长期12月-供试品溶液-2024032921批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1173761-17376114.91114.6525.8114.9114.6525.82
299204-992048.5138.51
3141342-14134212.12912.13
4189847-18984716.29116.29
5221082-22108218.97218.97
6199353-19935317.10717.11
10min1368376-36837631.61129.2012.7131.6429.2312.72
2265204-26520422.75822.77
3330116-33011628.32828.35
4327227-32722728.08028.11
5384757-38475733.01733.05
6366013-36601331.40931.44
15min1498136-49813642.74739.709.6442.8239.789.64
2397567-39756734.11634.17
3485908-48590841.69741.76
4427548-42754836.68936.76
5513468-51346844.06244.15
6453467-45346738.91338.99
20min1573080-57308049.17845.578.6249.3345.718.62
2480127-48012741.20141.31
3566621-56662148.62348.76
4481873-48187341.35141.49
5575059-57505949.34849.51
6509337-50933743.70843.85
30min1582421-58242149.97948.812.7750.2149.032.79
2560275-56027548.07948.26
3576361-57636149.45949.68
4540989-54098946.42446.63
5580316-58031649.79950.04
6572645-57264549.14049.36
45min1581638-58163849.91249.191.2050.2349.491.23
2569700-56970048.88849.15
3574826-57482649.32849.63
4562298-56229848.25248.53
5578525-57852549.64549.97
6572568-57256849.13449.43
60min1581275-58127549.88149.411.2650.2849.791.29
2575253-57525349.36449.70
3573434-57343449.20849.59
4566000-56600048.57048.93
5586663-58666350.34350.75
6572392-57239249.11949.50
极限1581405-58140549.89249.280.8450.3749.740.85
2577289-57728949.53949.96
3572619-57261949.13849.60
4569032-56903248.83049.27
5575895-57589549.41949.91
6569567-56956748.87649.34
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%
127.782874802873672872452867442870672871810.11
227.722857742857702857720.01
单位质量响应值RSD%判断
10337.6910309.240.20数据可信
长期12月-供试品溶液-SDR926批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100075-10007515.70015.148.7715.7015.148.78
286209-8620913.52513.52
386597-8659713.58613.59
496627-9662715.15915.16
5103315-10331516.20916.21
6106224-10622416.66516.67
10min1192860-19286030.25729.367.3630.2829.387.36
2182747-18274728.67028.69
3162962-16296225.56625.59
4200208-20020831.41031.44
5198775-19877531.18531.21
6185217-18521729.05829.09
15min1239900-23990037.63737.788.3837.7137.858.37
2258096-25809640.49240.56
3211134-21113433.12433.19
4268169-26816942.07242.15
5235144-23514436.89136.97
6232268-23226836.44036.52
20min1282033-28203344.24743.306.7644.3943.446.75
2287171-28717145.05345.19
3259303-25930340.68140.80
4303611-30361147.63247.78
5253532-25353239.77639.92
6270522-27052242.44142.58
30min1324585-32458550.92348.413.7851.1448.623.78
2313777-31377749.22749.44
3301375-30137547.28147.47
4316826-31682649.70549.93
5294017-29401746.12746.33
6300657-30065747.16947.38
45min1327672-32767251.40749.841.9951.7050.122.00
2316417-31641749.64149.94
3309862-30986248.61348.88
4320963-32096350.35450.66
5318435-31843549.95850.24
6312632-31263249.04749.33
60min1329529-32952951.69850.131.8752.0850.501.87
2317523-31752349.81550.19
3312267-31226748.99049.34
4322200-32220050.54950.94
5319587-31958750.13950.51
6315961-31596149.57049.94
极限1331948-33194852.07850.611.8752.5551.071.88
2318656-31865649.99350.45
3314647-31464749.36449.79
4323945-32394550.82251.30
5325670-32567051.09351.54
6320807-32080750.33050.78
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%
127.784967984965994966004961264966994965640.06
227.724947404947804947600.01
单位质量响应值RSD%判断
17874.8717848.480.11数据可信
长期12月-供试品溶液-SDR926批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1166490-16649014.26313.729.4414.2613.729.44
2141870-14187012.15412.15
3142591-14259112.21512.22
4159635-15963513.67613.68
5172649-17264914.79014.79
6177502-17750215.20615.21
10min1325532-32553227.88727.007.8327.9127.037.83
2306319-30631926.24226.26
3272075-27207523.30823.33
4338292-33829228.98129.00
5336587-33658728.83528.86
6312539-31253926.77426.80
15min1406065-40606534.78734.968.9434.8635.038.93
2438998-43899837.60837.67
3354647-35464730.38230.44
4457985-45798539.23439.31
5398407-39840734.13134.20
6392478-39247833.62333.69
20min1480722-48072241.18240.307.2641.3140.427.25
2490439-49043942.01542.14
3440779-44077937.76037.87
4521421-52142144.66944.81
5428927-42892736.74536.87
6459933-45993339.40139.53
30min1558114-55811447.81245.324.0848.0145.514.08
2539371-53937146.20746.40
3517095-51709544.29844.47
4543550-54355046.56546.78
5499972-49997242.83143.02
6515754-51575444.18344.38
45min1562410-56241048.18046.671.9848.4646.941.99
2543615-54361546.57046.84
3531865-53186545.56445.81
4550560-55056047.16547.45
5543931-54393146.59746.86
6536646-53664645.97346.24
60min1566475-56647548.52846.941.9748.8947.291.98
2546050-54605046.77947.13
3535243-53524345.85346.18
4552788-55278847.35647.72
5545394-54539446.72347.06
6541644-54164446.40146.74
极限1573233-57323349.10747.821.8149.5548.251.82
2550391-55039147.15147.58
3544909-54490946.68147.08
4560791-56079148.04248.49
5563972-56397248.31448.73
6556003-55600347.63148.05
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