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%
128.272848062845142851302840152851972847320.18
228.322874612867802871200.17
单位质量响应值RSD%判断
10071.8810138.420.47数据可信
加速3月-供试品溶液-SDR926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%
5min173752-7375211.82111.2210.0111.8211.2210.01
267453-6745310.81110.81
370245-7024511.25911.26
479982-7998212.81912.82
569641-6964111.16211.16
658825-588259.4289.43
10min1155659-15565924.94827.088.6024.9727.108.60
2150086-15008624.05524.07
3178059-17805928.53928.56
4189772-18977230.41630.44
5171135-17113527.42927.45
6169160-16916027.11227.13
15min1227669-22766936.49040.114.9336.5540.184.93
2248900-24890039.89339.95
3259334-25933441.56541.63
4262854-26285442.12942.20
5250339-25033940.12340.19
6252552-25255240.47840.54
20min1254329-25432940.76345.536.0840.8945.676.06
2308489-30848949.44449.57
3286017-28601745.84245.98
4284404-28440445.58345.73
5285569-28556945.77045.90
6285762-28576245.80145.93
30min1265105-26510542.49047.206.0242.6847.406.00
2320553-32055351.37751.58
3298728-29872847.87948.09
4292442-29244246.87247.09
5294425-29442547.18947.40
6295664-29566447.38847.59
45min1269737-26973743.23247.775.8643.4948.065.84
2324004-32400451.93052.22
3303313-30331348.61448.91
4293879-29387947.10247.40
5298502-29850247.84348.13
6298961-29896147.91648.20
60min1271718-27171843.55047.955.6743.8848.315.65
2324379-32437951.99052.37
3303239-30323948.60248.97
4294361-29436147.17947.55
5300201-30020148.11548.48
6301167-30116748.27048.63
极限1319294-31929451.17551.643.0251.5852.093.00
2335570-33557053.78454.25
3326013-32601352.25252.71
4306637-30663749.14749.60
5326451-32645152.32252.77
6319267-31926751.17151.61
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%
128.274943934931884938434927244936714935640.13
228.324974084964024969050.15
单位质量响应值RSD%判断
17458.9317546.080.36数据可信
加速3月-供试品溶液-SDR926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%
5min197905-979058.5598.0711.218.568.0711.22
288505-885057.7387.74
391780-917808.0248.02
4107890-1078909.4329.43
590984-909847.9547.95
676677-766776.7046.70
10min1228820-22882020.00521.628.7220.0221.638.72
2219404-21940419.18219.19
3258505-25850522.60022.61
4279951-27995124.47524.49
5250608-25060821.91021.92
6246445-24644521.54621.56
15min1355605-35560531.08934.045.0631.1434.085.06
2381349-38134933.34033.38
3402431-40243135.18335.23
4412700-41270036.08136.14
5390453-39045334.13634.19
6393293-39329334.38434.43
20min1412938-41293836.10140.385.9436.2040.495.92
2497948-49794843.53443.63
3466436-46643640.77940.89
4466462-46646240.78140.90
5461983-46198340.38940.50
6465663-46566340.71140.82
30min1443649-44364938.78643.316.1838.9543.486.17
2539369-53936947.15547.33
3503417-50341744.01244.19
4493727-49372743.16543.35
5494717-49471743.25143.43
6497419-49741943.48743.66
45min1455235-45523539.79944.306.1940.0244.556.18
2553170-55317048.36148.61
3515680-51568045.08445.33
4501928-50192843.88244.14
5506429-50642944.27544.52
6508032-50803244.41544.66
60min1456013-45601339.86744.486.2540.1644.806.23
2555459-55545948.56248.89
3516080-51608045.11945.44
4504344-50434444.09344.42
5508996-50899644.49944.82
6511616-51161644.72945.05
极限1538137-53813747.04748.263.1947.4048.663.19
2578147-57814750.54550.96
3560496-56049649.00249.40
4528839-52883946.23446.64
5558790-55879048.85349.25
6547926-54792647.90348.30
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.272856762856582853052851922856252854910.08
228.322909082908442908760.02
单位质量响应值RSD%判断
10098.7310271.051.20数据可信
长期3月-供试品溶液-SDR926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%
5min152125-521258.2908.9919.008.298.9919.00
254776-547768.7118.71
350534-505348.0368.04
450657-506578.0568.06
578200-7820012.43612.44
652793-527938.3968.40
10min1130402-13040220.73823.2615.6620.7523.2815.66
2146428-14642823.28723.30
3140885-14088522.40522.42
4134949-13494921.46121.47
5191508-19150830.45630.48
6133442-13344221.22121.24
15min1211808-21180833.68435.198.2533.7335.248.27
2230738-23073836.69536.75
3229105-22910536.43536.49
4198526-19852631.57231.62
5248636-24863639.54139.61
6208667-20866733.18533.23
20min1283507-28350745.08643.108.3445.1943.218.33
2286313-28631345.53345.65
3295972-29597247.06947.18
4239586-23958638.10238.20
5273008-27300843.41743.55
6247608-24760839.37739.48
30min1305824-30582448.63646.169.1848.8246.359.16
2303397-30339748.25048.44
3327860-32786052.14052.33
4257800-25780040.99841.16
5280237-28023744.56644.78
6266541-26654142.38842.56
45min1313619-31361949.87546.738.7050.1446.998.68
2306279-30627948.70848.98
3326649-32664951.94752.22
4261418-26141841.57441.81
5283024-28302445.01045.29
6272043-27204343.26343.50
60min1311449-31144949.53046.898.4649.8747.238.44
2307733-30773348.93949.29
3328239-32823952.20052.56
4262968-26296841.82042.12
5285079-28507945.33645.70
6273808-27380843.54443.86
极限1334132-33413253.13751.373.5053.5651.783.50
2325426-32542651.75352.19
3336685-33668553.54353.99
4311267-31126749.50149.87
5309741-30974149.25949.69
6320704-32070451.00251.39
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%
128.274955024954274947854948394959854953080.11
228.325008895015745012320.10
单位质量响应值RSD%判断
17520.6217698.870.72数据可信
长期3月-供试品溶液-SDR926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%
5min165162-651625.6626.2821.185.666.2821.15
270563-705636.1326.13
363397-633975.5095.51
464215-642155.5805.58
5103050-1030508.9558.95
667200-672005.8395.84
10min1185269-18526916.09918.3617.3416.1118.3717.34
2211314-21131418.36218.37
3200837-20083717.45217.46
4195392-19539216.97916.99
5283768-28376824.65824.67
6190959-19095916.59316.60
15min1325034-32503428.24429.739.2528.2829.779.26
2357128-35712831.03331.07
3349861-34986130.40130.44
4307725-30772526.74026.78
5394076-39407634.24334.30
6318855-31885527.70727.74
20min1452391-45239139.31137.868.1239.3937.958.12
2460424-46042440.00940.10
3470111-47011140.85040.94
4386210-38621033.56033.64
5448871-44887139.00539.12
6396234-39623434.43134.51
30min1512384-51238444.52442.299.2444.6742.449.22
2509996-50999644.31644.48
3549000-54900047.70547.86
4431698-43169837.51237.65
5472580-47258041.06541.24
6444281-44428138.60638.75
45min1532736-53273646.29243.269.1946.5243.489.17
2520641-52064145.24145.47
3555704-55570448.28848.52
4438694-43869438.12038.32
5481494-48149441.84042.09
6457855-45785539.78539.99
60min1529585-52958546.01843.419.2046.3243.719.17
2523895-52389545.52445.83
3560530-56053048.70749.02
4440353-44035338.26538.53
5482761-48276141.95042.27
6460293-46029339.99740.27
极限1573538-57353849.83847.924.2550.2148.294.25
2559397-55939748.60948.99
3580837-58083750.47250.87
4524197-52419745.55045.88
5529556-52955646.01646.40
6541360-54136047.04247.38
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%
128.275824405826615829905811465816515821780.14
228.325849225850835850020.02
单位质量响应值RSD%判断
20593.4920656.850.22数据可信
加速3月-供试品溶液-TAWW4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%
5min187076-870766.8385.9315.446.845.9315.44
289766-897667.0497.05
370259-702595.5175.52
471773-717735.6365.64
558204-582044.5714.57
675677-756775.9435.94
10min1220899-22089917.34617.819.9517.3617.839.94
2231330-23133018.16518.18
3251752-25175219.76919.78
4252540-25254019.83119.84
5203983-20398316.01816.03
6200648-20064815.75615.77
15min1338197-33819726.55726.368.0726.6026.408.07
2350258-35025827.50427.55
3348735-34873527.38527.43
4369024-36902428.97829.02
5313194-31319424.59424.63
6294921-29492123.15923.20
20min1441456-44145634.66633.167.7334.7533.247.72
2464134-46413436.44636.53
3420014-42001432.98233.07
4438107-43810734.40334.49
5394187-39418730.95431.03
6375864-37586429.51529.59
30min1520507-52050740.87339.014.7641.0239.154.76
2527989-52798941.46141.61
3474065-47406537.22637.37
4500169-50016939.27639.42
5485968-48596838.16138.29
6472213-47221337.08137.20
45min1568592-56859244.64942.224.4344.8642.424.43
2565189-56518944.38244.60
3514079-51407940.36840.57
4533959-53395941.92942.14
5527209-52720941.39941.59
6516679-51667940.57340.76
60min1590610-59061046.37843.954.2646.6644.224.25
2586826-58682646.08146.37
3534443-53444341.96742.24
4558280-55828043.83944.12
5544287-54428742.74043.00
6543502-54350242.67942.93
极限1619919-61991948.68047.081.8249.0447.421.83
2602941-60294147.34647.71
3593076-59307646.57246.91
4589644-58964446.30246.66
5595914-59591446.79547.13
6595649-59564946.77447.10
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.271009406100759710084881007162100860710082520.09
228.321013002101225910126300.06
单位质量响应值RSD%判断
35665.0935756.710.19数据可信
加速3月-供试品溶液-TAWW4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%
5min1109179-1091794.6784.0117.304.684.0117.26
2113906-1139064.8814.88
389312-893123.8273.83
488594-885943.7963.80
568987-689872.9562.96
691350-913503.9143.91
10min1295114-29511412.64512.9910.7012.6513.0010.69
2311102-31110213.33013.34
3340642-34064214.59614.60
4337530-33753014.46314.47
5268215-26821511.49311.50
6266799-26679911.43211.44
15min1471172-47117220.18919.918.9020.2219.948.91
2486623-48662320.85120.88
3486016-48601620.82520.86
4513796-51379622.01522.05
5427208-42720818.30518.33
6403408-40340817.28617.31
20min1631905-63190527.07625.668.5027.1425.728.50
2661557-66155728.34728.41
3597421-59742125.59925.66
4623061-62306126.69726.76
5551457-55145723.62923.68
6527500-52750022.60322.66
30min1773348-77334833.13731.235.9433.2431.345.93
2784814-78481433.62833.74
3681102-68110229.18429.29
4735264-73526431.50531.62
5709383-70938330.39630.49
6689604-68960429.54929.64
45min1876877-87687737.57335.115.1737.7435.275.17
2866395-86639537.12437.29
3777680-77768033.32333.48
4813261-81326134.84735.01
5797107-79710734.15534.30
6785038-78503833.63833.78
60min1935458-93545840.08337.575.1140.3137.795.11
2928987-92898739.80640.04
3831066-83106635.61035.82
4870387-87038737.29537.52
5844700-84470036.19436.40
6850705-85070536.45236.65
极限11007475-100747543.16941.452.4743.4641.732.48
2985264-98526442.21742.51
3947903-94790340.61640.89
4950066-95006640.70940.99
5954340-95434040.89241.15
6959686-95968641.12141.38
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%
128.275812965820995814835825365813605817550.10
228.325801235798685799960.04
单位质量响应值RSD%判断
20578.5320480.080.34数据可信
长期3月-供试品溶液-TAWW4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%
5min1111099-1110998.7656.6623.928.766.6623.93
291110-911107.1887.19
372310-723105.7055.70
474413-744135.8715.87
556684-566844.4724.47
6100674-1006747.9427.94
10min1242120-24212019.10116.848.1119.1216.868.12
2210089-21008916.57416.59
3217036-21703617.12317.13
4218974-21897417.27517.29
5192198-19219815.16315.17
6200502-20050215.81815.83
15min1334586-33458626.39625.325.4926.4425.365.48
2309330-30933024.40424.44
3349368-34936827.56327.60
4304585-30458524.02924.07
5318581-31858125.13425.17
6308850-30885024.36624.41
20min1402236-40223631.73331.735.1531.8231.825.14
2388100-38810030.61830.70
3424799-42479933.51333.60
4377209-37720929.75929.84
5392195-39219530.94131.02
6428862-42886233.83433.91
30min1464591-46459136.65338.306.6436.8038.436.62
2465435-46543536.71936.85
3528807-52880741.71941.86
4452771-45277135.72035.85
5478588-47858837.75737.88
6522293-52229341.20541.34
45min1505192-50519239.85641.845.9540.0642.045.95
2525657-52565741.47041.66
3575297-57529745.38745.60
4494276-49427638.99539.18
5521006-52100641.10341.29
6560550-56055044.22344.43
60min1527373-52737341.60643.625.5841.8843.895.57
2552123-55212343.55843.82
3595498-59549846.98047.27
4516536-51653640.75141.00
5543801-54380142.90243.16
6582456-58245645.95146.23
极限1580764-58076445.81846.643.1846.1646.983.19
2581363-58136345.86546.20
3624386-62438649.25949.62
4578290-57829045.62345.94
5579016-57901645.68046.01
6602999-60299947.57247.93
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%
128.271007558100963110105081009184101090410095570.13
228.321008032100777610079040.02
单位质量响应值RSD%判断
35711.2535589.830.25数据可信
长期3月-供试品溶液-TAWW4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%
5min1139619-1396195.9934.5025.615.994.5025.58
2111971-1119714.8064.81
387841-878413.7703.77
491423-914233.9243.92
569163-691632.9692.97
6129416-1294165.5555.55
10min1322870-32287013.85812.158.8213.8712.168.81
2276903-27690311.88511.89
3288283-28828312.37312.38
4293973-29397312.61812.62
5251181-25118110.78110.79
6265052-26505211.37611.39
15min1458480-45848019.67918.996.0119.7119.016.01
2422779-42277918.14618.17
3488103-48810320.95020.98
4421858-42185818.10718.13
5439588-43958818.86818.89
6423302-42330218.16918.20
20min1563878-56387824.20224.365.6024.2724.425.59
2541922-54192223.26023.32
3606717-60671726.04126.10
4532156-53215622.84122.90
5555536-55553623.84423.90
6605595-60559525.99326.05
30min1674723-67472328.96030.497.0629.0730.597.04
2676763-67676329.04829.14
3780724-78072433.51033.61
4662611-66261128.44028.54
5703634-70363430.20130.30
6764204-76420432.80132.90
45min1760938-76093832.66034.596.4132.8134.746.40
2797465-79746534.22834.37
3882948-88294837.89738.06
4750528-75052832.21432.36
5792440-79244034.01334.16
6851009-85100936.52636.68
60min1821215-82121535.24837.215.9435.4637.425.92
2868944-86894437.29637.50
3943722-94372240.50640.73
4810529-81052934.78934.99
5848907-84890736.43636.64
6908418-90841838.99039.21
极限1932616-93261640.02941.053.6140.3041.323.61
2940754-94075440.37840.64
31016061-101606143.61143.90
4931716-93171639.99040.25
5936549-93654940.19840.46
6980060-98006042.06542.35
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%
128.271161950116021411579861156178115630611585270.22
228.321155218115567711554480.03
单位质量响应值RSD%判断
40980.7940799.720.32数据可信
加速3月-供试品溶液-TYN28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%
5min1120782-1207824.7845.2619.374.785.2619.37
2136753-1367535.4175.42
389063-890633.5283.53
4155749-1557496.1696.17
5134815-1348155.3405.34
6159307-1593076.3106.31
10min1414229-41422916.40715.1516.6616.4215.1616.64
2310234-31023412.28812.30
3310524-31052412.29912.31
4460354-46035418.23418.24
5366084-36608414.50014.51
6432978-43297817.15017.16
15min1576541-57654122.83623.119.2422.8723.149.25
2528240-52824020.92320.95
3566062-56606222.42122.45
4653357-65335725.87925.92
5532430-53243021.08921.12
6643620-64362025.49325.53
20min1737537-73753729.21329.454.4529.2929.524.46
2767555-76755530.40230.47
3729868-72986828.90928.97
4779464-77946430.87430.96
5687551-68755127.23327.30
6758512-75851230.04430.13
30min11012759-101275940.11437.904.7440.2438.034.72
2975374-97537438.63338.75
3999766-99976639.59939.71
4934167-93416737.00137.14
5905379-90537935.86135.97
6914279-91427936.21336.35
45min11127198-112719844.64742.585.1344.8442.775.09
21110890-111089044.00144.18
31130617-113061744.78244.96
41029801-102980140.78940.99
51050435-105043541.60641.78
61001414-100141439.66539.86
60min11167674-116767446.25044.574.5146.5144.834.48
21160712-116071245.97446.23
31174759-117475946.53146.78
41089542-108954243.15543.42
51110370-111037043.98044.22
61048837-104883741.54341.80
极限11222552-122255248.42447.762.2948.7648.082.28
21235647-123564748.94249.27
31225679-122567948.54748.88
41188735-118873547.08447.42
51199651-119965147.51747.83
61162030-116203046.02646.35
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%
128.272009281201033720107832004111201002720089080.14
228.322003012200594720044800.11
单位质量响应值RSD%判断
71061.4870779.660.29数据可信
加速3月-供试品溶液-TYN28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%
5min1158667-1586673.4233.7219.173.423.7219.14
2178524-1785243.8523.85
3115293-1152932.4882.49
4202186-2021864.3624.36
5175493-1754933.7863.79
6205438-2054384.4324.43
10min1557892-55789212.03710.9816.3512.0410.9916.36
2408630-4086308.8178.82
3415170-4151708.9588.96
4609118-60911813.14213.15
5497802-49780210.74010.75
6565612-56561212.20412.21
15min1801866-80186617.30117.298.2417.3317.318.26
2725027-72502715.64315.66
3782117-78211716.87516.89
4895853-89585319.32919.36
5743712-74371216.04616.07
6859091-85909118.53618.56
20min11046230-104623022.57322.523.9922.6322.583.99
21078038-107803823.26023.31
31032077-103207722.26822.32
41096437-109643723.65723.72
5977115-97711521.08221.13
61033544-103354422.30022.36
30min11477780-147778031.88429.995.3731.9830.085.35
21416742-141674230.56730.65
31460408-146040831.51031.59
41363144-136314429.41129.51
51332909-133290928.75928.84
61287791-128779127.78527.88
45min11728500-172850037.29435.226.2637.4435.366.23
21690917-169091736.48336.62
31725303-172530337.22537.36
41567099-156709933.81133.96
51610037-161003734.73834.87
61471064-147106431.73931.88
60min11849087-184908739.89638.185.7040.1038.385.67
21825091-182509139.37839.58
31856337-185633740.05240.25
41718299-171829937.07437.28
51774216-177421638.28038.47
61593037-159303734.37134.57
极限12002546-200254643.20742.363.0143.4842.623.00
22015183-201518343.47943.74
32004802-200480243.25543.52
41926857-192685741.57441.84
51967089-196708942.44242.70
61862774-186277440.19140.44
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%
128.271155992115581011553221153417115565311552390.10
228.321160696116347711620860.17
单位质量响应值RSD%判断
40864.4941034.110.30数据可信
长期3月-供试品溶液-TYN28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%
5min1142444-1424445.6345.8230.995.635.8231.04
2163234-1632346.4566.46
366096-660962.6142.61
4202395-2023958.0058.01
5140644-1406445.5635.56
6168765-1687656.6756.67
10min1406644-40664416.08315.145.2516.0915.155.26
2376267-37626714.88214.89
3351622-35162213.90713.91
4386693-38669315.29415.31
5374437-37443714.81014.82
6401384-40138415.87515.89
15min1564506-56450622.32722.155.9922.3622.185.99
2521666-52166620.63320.67
3516281-51628120.42020.45
4597851-59785123.64623.68
5577897-57789722.85722.89
6581635-58163523.00523.04
20min1689949-68994927.28927.904.6427.3627.974.64
2710935-71093528.11928.19
3674109-67410926.66226.72
4767422-76742230.35330.43
5691922-69192227.36727.44
6697698-69769827.59527.67
30min1912435-91243536.08836.706.0936.2136.826.07
2991965-99196539.23439.35
3938472-93847237.11837.22
4991220-99122039.20439.33
5868170-86817034.33734.46
6865312-86531234.22434.35
45min11029730-102973040.72742.056.3640.9142.236.34
21139766-113976645.07945.26
31123510-112351044.43744.60
41100952-110095243.54443.74
51012959-101295940.06440.24
6972202-97220238.45238.63
60min11079109-107910942.68044.175.9542.9344.425.93
21192827-119282747.17847.44
31186239-118623946.91847.16
41139667-113966745.07645.34
51073439-107343942.45642.70
61029450-102945040.71640.96
极限11150962-115096245.52247.343.3345.8447.663.32
21245806-124580649.27449.61
31230892-123089248.68449.00
41184771-118477146.85947.20
51214530-121453048.03748.35
61154371-115437145.65745.97
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%
128.272004138200485720046782003695200531020045360.04
228.322014394201833120163620.14
单位质量响应值RSD%判断
70906.8371199.220.30数据可信
长期3月-供试品溶液-TYN28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%
5min1180608-1806083.8904.1231.803.894.1231.75
2214683-2146834.6234.62
383852-838521.8061.81
4264418-2644185.6945.69
5183014-1830143.9413.94
6220832-2208324.7564.76
10min1535192-53519211.52611.025.2211.5311.035.24
2505774-50577410.89210.90
3466528-46652810.04710.05
4519467-51946711.18711.20
5503089-50308910.83410.84
6540003-54000311.62911.64
15min1764576-76457616.46616.556.5916.4916.576.60
2718225-71822515.46715.49
3698881-69888115.05115.07
4824692-82469217.76017.79
5802212-80221217.27617.30
6802120-80212017.27417.30
20min1952940-95294020.52221.315.4020.5821.365.40
21000508-100050821.54721.60
3934004-93400420.11420.16
41087131-108713123.41223.47
5981139-98113921.12921.18
6980160-98016021.10821.16
30min11308079-130807928.17028.956.2728.2629.046.25
21447205-144720531.16631.25
31347136-134713629.01129.09
41441712-144171231.04831.14
51269396-126939627.33727.43
61252283-125228326.96927.06
45min11548345-154834533.34534.756.4333.4834.886.41
21736305-173630537.39237.53
31691153-169115336.42036.55
41681065-168106536.20336.35
51551440-155144033.41133.55
61472280-147228031.70631.84
60min11686201-168620136.31337.925.9836.5038.125.96
21887583-188758340.65040.85
31854990-185499039.94840.14
41810442-181044238.98939.20
51702562-170256236.66636.86
61622984-162298434.95235.14
极限11865923-186592340.18442.063.6740.4342.323.67
22038752-203875243.90644.18
32007111-200711143.22443.48
41951263-195126342.02242.30
51985085-198508542.75043.00
61871005-187100540.29340.54
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