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%
128.032829402856012855052861782861092852670.47
227.972873202878132875660.13
单位质量响应值RSD%判断
10177.2010281.230.72数据可信
加速6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%
5min169323-6932310.97617.9521.8810.9817.9521.87
2109430-10943017.32717.33
3142761-14276122.60422.60
4126808-12680820.07820.08
5110407-11040717.48117.48
6121504-12150419.23819.24
10min1164869-16486926.10534.0313.2026.1234.0613.21
2217364-21736434.41634.45
3239754-23975437.96138.00
4239077-23907737.85437.89
5226614-22661435.88135.91
6201857-20185731.96131.99
15min1234110-23411037.06843.759.6037.1343.849.61
2300967-30096747.65447.74
3289857-28985745.89446.00
4282889-28288944.79144.89
5296301-29630146.91547.00
6253918-25391840.20440.29
20min1278184-27818444.04648.266.4744.1748.426.48
2327100-32710051.79151.96
3309933-30993349.07349.25
4303639-30363948.07748.25
5323764-32376451.26351.43
6286168-28616845.31045.46
30min1311320-31132049.29350.912.3549.4951.152.38
2326607-32660751.71351.97
3319008-31900850.51050.77
4325319-32531951.50951.76
5331376-33137652.46852.72
6315483-31548349.95250.18
45min1320207-32020750.70051.491.0350.9851.811.06
2324068-32406851.31151.65
3327294-32729451.82252.17
4325020-32502051.46251.80
5330154-33015452.27552.61
6324290-32429051.34651.66
60min1320632-32063250.76751.580.9651.1351.991.00
2325314-32531451.50951.93
3327500-32750051.85552.28
4329071-32907152.10352.53
5328046-32804651.94152.37
6324076-32407651.31351.71
极限1323395-32339551.20551.621.0051.6552.121.03
2323639-32363951.24351.75
3330594-33059452.34552.86
4327161-32716151.80152.31
5328690-32869052.04352.56
6322788-32278851.10951.59
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%
128.034897004946484940464944994951794936140.46
227.974938514961504950000.33
单位质量响应值RSD%判断
17610.2017697.530.35数据可信
加速6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%
5min1116122-11612210.06516.8022.5510.0716.8022.55
2187135-18713516.22016.22
3245597-24559721.28721.29
4217465-21746518.84918.85
5188669-18866916.35316.35
6208125-20812518.04018.04
10min1281741-28174124.42031.9713.3624.4432.0013.36
2373294-37329432.35632.38
3410975-41097535.62235.66
4411681-41168135.68335.71
5389055-38905533.72233.75
6346353-34635330.02130.05
15min1399186-39918634.60041.2210.0134.6641.3010.01
2519901-51990145.06345.14
3499201-49920143.26943.36
4487170-48717042.22642.32
5511651-51165144.34844.43
6436522-43652237.83637.92
20min1477436-47743641.38245.416.5741.5045.566.57
2562995-56299548.79848.95
3533278-53327846.22346.39
4523026-52302645.33445.50
5556133-55613348.20448.36
6490814-49081442.54242.69
30min1535951-53595146.45448.002.5646.6448.222.59
2563221-56322148.81849.06
3548236-54823647.51947.76
4559746-55974648.51748.75
5573515-57351549.71049.95
6541953-54195346.97547.19
45min1550347-55034747.70248.551.1147.9648.861.14
2558109-55810948.37548.69
3563329-56332948.82749.15
4559742-55974248.51648.83
5569093-56909349.32749.65
6560428-56042848.57648.87
60min1551335-55133547.78848.681.1048.1349.061.13
2562063-56206348.71849.12
3564035-56403548.88949.29
4568479-56847949.27449.67
5565665-56566549.03049.43
6558114-55811448.37548.75
极限1558745-55874548.43048.750.9548.8549.210.97
2557840-55784048.35248.83
3570680-57068049.46449.95
4563505-56350548.84349.32
5566102-56610249.06849.55
6557546-55754648.32648.78
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.032845412853562856822846462836602847770.28
227.972812712849582831140.93
单位质量响应值RSD%判断
10159.7210122.060.27数据可信
加速6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%
5min1110728-11072817.68417.0921.4217.6817.0921.43
2118052-11805218.85418.85
3102372-10237216.35016.35
4128797-12879720.57020.57
5118432-11843218.91518.91
663818-6381810.19210.19
10min1187113-18711329.88432.2918.5329.9132.3218.53
2217957-21795734.81034.84
3188574-18857430.11730.14
4236163-23616337.71837.75
5241545-24154538.57738.61
6141782-14178222.64422.66
15min1238864-23886438.14941.8213.7138.2341.9013.71
2292150-29215046.65946.75
3251425-25142540.15540.23
4297744-29774447.55347.65
5284434-28443445.42745.52
6206334-20633432.95433.01
20min1272575-27257543.53346.659.1143.6846.809.13
2313777-31377750.11350.28
3284568-28456845.44845.59
4318748-31874850.90751.08
5310550-31055049.59849.77
6252373-25237340.30740.42
30min1304365-30436548.61049.845.1048.8350.075.13
2321655-32165551.37251.62
3314327-31432750.20150.42
4328953-32895352.53752.80
5318799-31879950.91651.17
6284228-28422845.39445.57
45min1319905-31990551.09251.651.3651.3951.961.40
2323429-32342951.65551.99
3327435-32743552.29552.60
4329228-32922852.58152.93
5322574-32257451.51851.86
6317702-31770250.74050.99
60min1327276-32727652.26952.160.9952.6552.551.01
2322405-32240551.49151.91
3329294-32929452.59252.98
4329507-32950752.62653.06
5328198-32819852.41752.84
6322741-32274151.54551.88
极限1330087-33008752.71852.431.1853.1952.911.16
2320427-32042751.17651.68
3329877-32987752.68553.16
4329725-32972552.66153.18
5330390-33039052.76753.28
6329065-32906552.55552.98
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%
128.034921394943084939784941684923684933920.22
227.974874044939374906700.95
单位质量响应值RSD%判断
17602.2817542.720.24数据可信
加速6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%
5min1190142-19014216.55715.9522.1216.5615.9522.11
2202281-20228117.61417.61
3174544-17454415.19915.20
4221908-22190819.32319.32
5203200-20320017.69417.69
6106902-1069029.3099.31
10min1320677-32067727.92430.2118.8927.9530.2418.89
2374483-37448332.60932.64
3322947-32294728.12128.15
4405963-40596335.35035.38
5416220-41622036.24336.27
6241302-24130221.01221.03
15min1409891-40989135.69239.2113.9535.7739.2913.96
2503485-50348543.84243.93
3431977-43197737.61537.69
4513235-51323544.69144.78
5489771-48977142.64842.74
6353409-35340930.77430.82
20min1468742-46874240.81743.739.3240.9543.879.34
2540527-54052747.06847.22
3489034-48903442.58442.72
4549795-54979547.87548.04
5533047-53304746.41646.58
6431834-43183437.60337.70
30min1523810-52381045.61246.705.2545.8146.915.29
2553943-55394348.23648.47
3540237-54023747.04247.25
4565077-56507749.20549.45
5548279-54827947.74347.98
6486302-48630242.34642.51
45min1550505-55050547.93748.481.5648.2148.771.60
2559024-55902448.67848.99
3564194-56419449.12949.41
4568702-56870249.52149.85
5551432-55143248.01748.34
6546504-54650447.58847.82
60min1563926-56392649.10549.041.0749.4649.421.10
2556030-55603048.41848.81
3567961-56796149.45749.82
4570474-57047449.67550.09
5564739-56473949.17649.57
6556233-55623348.43548.75
极限1569253-56925349.56949.341.1350.0149.801.11
2553618-55361848.20848.69
3568957-56895749.54349.99
4569887-56988749.62450.12
5569917-56991749.62750.11
6567923-56792349.45349.85
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%
128.032891772891632900312893042892402893830.13
227.972858582863872861220.14
单位质量响应值RSD%判断
10324.0510229.600.65数据可信
加速6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%
5min1117476-11747618.51418.4412.5518.5118.4412.56
2126430-12643019.92519.93
3129443-12944320.40020.40
4117943-11794318.58818.59
5122025-12202519.23119.23
688597-8859713.96313.96
10min1184735-18473529.11434.1311.3029.1534.1611.28
2236082-23608237.20737.24
3239677-23967737.77337.81
4238285-23828537.55437.58
5194879-19487930.71330.75
6205667-20566732.41332.44
15min1235941-23594137.18442.898.0437.2642.988.03
2275926-27592643.48643.58
3287138-28713845.25345.35
4287909-28790945.37545.47
5255885-25588540.32840.41
6290188-29018845.73445.81
20min1266201-26620141.95347.297.7542.0947.457.74
2295676-29567646.59946.77
3322399-32239950.81050.98
4308585-30858548.63348.80
5282138-28213844.46544.62
6325392-32539251.28251.44
30min1303904-30390447.89550.143.3848.1150.383.38
2312184-31218449.20049.45
3330146-33014652.03152.29
4325079-32507951.23351.48
5310236-31023648.89349.12
6327190-32719051.56551.80
45min1324813-32481351.19151.400.5451.4851.720.57
2325849-32584951.35451.68
3329449-32944951.92152.27
4326412-32641251.44351.78
5324667-32466751.16851.47
6325611-32561151.31751.64
60min1333549-33354952.56851.601.0952.9452.011.07
2326066-32606651.38851.80
3329565-32956551.94052.37
4326638-32663851.47851.90
5324164-32416451.08851.48
6324539-32453951.14851.56
极限1327787-32778751.65951.400.7752.1251.890.77
2324231-32423151.09951.60
3330133-33013352.02952.55
4325960-32596051.37251.88
5325240-32524051.25851.73
6323352-32335250.96051.46
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.035002295004365010325010624989835003480.17
227.974930564943714937140.19
单位质量响应值RSD%判断
17850.4517651.560.80数据可信
加速6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%
5min1200159-20015917.25517.2612.8417.2517.2612.83
2216492-21649218.66318.66
3223326-22332619.25219.25
4202108-20210817.42317.42
5208415-20841517.96617.97
6150907-15090713.00913.01
10min1316488-31648827.28332.0411.4427.3132.0711.43
2404937-40493734.90734.94
3412077-41207735.52335.55
4409958-40995835.34035.37
5334132-33413228.80428.83
6352539-35253930.39030.41
15min1402783-40278334.72240.308.4134.8040.388.40
2473721-47372140.83740.93
3494400-49440042.61942.71
4494973-49497342.66942.76
5437771-43777137.73837.82
6501230-50123043.20843.28
20min1456101-45610139.31844.477.9739.4544.627.96
2507877-50787743.78143.94
3554970-55497047.84148.00
4530894-53089445.76545.92
5484169-48416941.73741.88
6561035-56103548.36448.51
30min1522737-52273745.06247.273.5745.2647.493.58
2537216-53721646.31046.54
3570586-57058649.18749.43
4560152-56015248.28748.52
5533986-53398646.03246.24
6565340-56534048.73548.96
45min1557565-55756548.06448.450.6748.3448.750.70
2561154-56115448.37448.68
3568240-56824048.98549.31
4563032-56303248.53648.85
5559001-55900148.18848.48
6562983-56298348.53248.84
60min1572032-57203249.31248.660.8649.6649.040.84
2562855-56285548.52048.91
3568416-56841649.00049.41
4563156-56315648.54648.94
5559235-55923548.20848.58
6561008-56100848.36148.75
极限1565538-56553848.75248.500.8149.1948.970.81
2558481-55848148.14348.61
3570095-57009549.14549.63
4561922-56192248.44048.92
5561541-56154148.40748.86
6558289-55828948.12748.59
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%
128.032891922897972898792898272901052897600.12
227.972893062899052896060.15
单位质量响应值RSD%判断
10337.5010354.170.12数据可信
长期6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%
5min1120072-12007218.79720.148.7318.8020.148.72
2128302-12830220.08520.09
3128026-12802620.04220.04
4150382-15038223.54223.54
5124847-12484719.54419.54
6120344-12034418.83918.84
10min1213093-21309333.35934.387.1933.3934.427.19
2207600-20760032.49932.53
3234365-23436536.68936.72
4244401-24440138.26038.30
5207104-20710432.42132.45
6211317-21131733.08133.11
15min1280600-28060043.92743.495.7744.0143.585.77
2256377-25637740.13540.22
3302936-30293647.42347.52
4285776-28577644.73744.84
5267866-26786641.93342.02
6273302-27330242.78442.87
20min1323281-32328150.60848.454.4650.7748.624.45
2285565-28556544.70444.86
3320998-32099850.25150.42
4305326-30532647.79847.98
5306883-30688348.04148.20
6314990-31499049.31149.47
30min1327373-32737351.24950.241.2451.4950.481.23
2318089-31808949.79650.02
3319484-31948450.01450.27
4316980-31698049.62249.88
5319625-31962550.03650.27
6323974-32397450.71750.96
45min1327621-32762151.28850.691.5551.6251.021.53
2330141-33014151.68251.99
3318525-31852549.86450.20
4321814-32181450.37950.72
5318169-31816949.80850.13
6326452-32645251.10551.43
60min1324760-32476050.84051.062.2951.2651.472.26
2339952-33995253.21853.62
3319330-31933049.99050.41
4326227-32622751.07051.49
5320028-32002850.09950.50
6326691-32669151.14251.55
极限1327660-32766051.29451.211.6251.7951.711.59
2333506-33350652.20952.70
3318379-31837949.84150.35
4324758-32475850.84051.35
5331226-33122651.85252.34
6327297-32729751.23751.73
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%
128.034976744991834993654994895001334991690.19
227.974988144996024992080.12
单位质量响应值RSD%判断
17808.3817847.980.16数据可信
长期6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%
5min1205646-20564617.65018.958.9217.6518.958.92
2219914-21991418.87518.87
3220160-22016018.89618.90
4258779-25877922.21122.21
5213859-21385918.35518.36
6206087-20608717.68817.69
10min1366108-36610831.42232.407.3331.4532.437.33
2355882-35588230.54530.58
3402825-40282534.57434.61
4421165-42116536.14836.18
5355602-35560230.52130.55
6363459-36345931.19531.22
15min1482970-48297041.45341.005.9741.5341.085.97
2439970-43997037.76237.84
3522297-52229744.82844.92
4492266-49226642.25042.35
5459429-45942939.43239.51
6469201-46920140.27140.35
20min1556745-55674547.78545.714.5847.9445.874.57
2490864-49086442.13042.28
3553954-55395447.54547.71
4523307-52330744.91545.08
5528658-52865845.37445.52
6542038-54203846.52246.67
30min1564930-56493048.48747.431.4248.7247.661.41
2545486-54548646.81847.03
3550455-55045547.24547.49
4545907-54590746.85447.10
5549499-54949947.16347.39
6559136-55913647.99048.22
45min1564708-56470848.46847.881.5448.7848.191.51
2568557-56855748.79849.09
3549402-54940247.15447.48
4553775-55377547.53047.85
5548123-54812347.04547.35
6562390-56239048.26948.58
60min1560534-56053448.11048.262.1548.5048.652.12
2583959-58395950.12050.50
3550955-55095547.28847.69
4562768-56276848.30248.70
5551300-55130047.31747.70
6564299-56429948.43348.82
极限1565983-56598348.57748.421.6849.0548.881.64
2575170-57517049.36649.82
3548089-54808947.04247.52
4560888-56088848.14048.62
5571283-57128349.03249.49
6563156-56315648.33548.80
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%
128.032858232860602860942858592858242859320.05
227.972874582880892877740.16
单位质量响应值RSD%判断
10200.9310288.670.61数据可信
长期6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%
5min1102519-10251916.20816.7521.5816.2116.7521.58
2131736-13173620.82720.83
3134934-13493421.33221.33
476846-7684612.14912.15
594230-9423014.89714.90
695402-9540215.08215.08
10min1224392-22439235.47534.209.2635.5034.239.26
2227367-22736735.94535.98
3241020-24102038.10438.14
4190747-19074730.15630.18
5193309-19330930.56130.59
6221037-22103734.94434.97
15min1292446-29244646.23445.327.0646.3245.407.07
2304402-30440248.12448.22
3311846-31184649.30149.40
4283451-28345144.81244.88
5261132-26113241.28341.36
6266634-26663442.15342.24
20min1323142-32314251.08649.694.9851.2549.854.98
2325834-32583451.51251.69
3324156-32415651.24751.43
4324367-32436751.28051.43
5294669-29466946.58546.73
6293662-29366246.42646.58
30min1325316-32531651.43051.051.4851.6851.291.50
2327519-32751951.77852.04
3323202-32320251.09651.36
4325415-32541551.44651.68
5313991-31399149.64049.86
6322048-32204850.91451.14
45min1326114-32611451.55651.101.3651.8951.431.37
2326744-32674451.65652.00
3321934-32193450.89551.25
4325071-32507151.39151.71
5314931-31493149.78850.09
6324499-32449951.30151.62
60min1335015-33501552.96351.291.8953.3851.701.89
2327191-32719151.72752.16
3321188-32118850.77851.21
4323046-32304651.07151.47
5317167-31716750.14250.53
6322936-32293651.05451.46
极限1325689-32568951.48951.091.3852.0051.591.39
2329910-32991052.15652.68
3318922-31892250.41950.94
4321672-32167250.85451.34
5318172-31817250.30150.77
6324531-32453151.30651.79
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%
128.034938054938074947014941934939664940940.08
227.974968174977114972640.13
单位质量响应值RSD%判断
17627.3317778.480.61数据可信
长期6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%
5min1174564-17456415.08915.6222.3415.0915.6222.36
2226031-22603119.53819.54
3232033-23203320.05620.06
4129243-12924311.17111.17
5159811-15981113.81413.81
6162420-16242014.03914.04
10min1385594-38559433.33032.149.4733.3532.169.47
2390556-39055633.75933.79
3416013-41601335.95935.99
4326912-32691228.25728.28
5331611-33161128.66428.69
6380226-38022632.86632.89
15min1504240-50424043.58542.687.2443.6742.767.24
2524353-52435345.32445.41
3538714-53871446.56546.66
4488487-48848742.22442.29
5449402-44940238.84538.92
6457414-45741439.53839.62
20min1556918-55691848.13946.885.1148.2947.035.11
2562942-56294248.65948.82
3560239-56023948.42648.60
4560464-56046448.44548.58
5508552-50855243.95844.09
6504796-50479643.63343.78
30min1559885-55988548.39548.061.6748.6348.291.68
2565872-56587248.91249.16
3557713-55771348.20748.46
4561286-56128648.51648.73
5539813-53981346.66046.87
6551440-55144047.66547.88
45min1565267-56526748.86048.271.4849.1748.581.48
2563811-56381148.73449.06
3556792-55679248.12848.46
4561877-56187748.56748.86
5542812-54281246.91947.21
6560257-56025748.42748.72
60min1577933-57793349.95548.401.8950.3548.791.90
2564195-56419548.76849.18
3555437-55543748.01048.42
4558637-55863748.28748.67
5546276-54627647.21947.58
6557079-55707948.15248.53
极限1562378-56237848.61048.181.3549.0948.651.36
2567764-56776449.07649.57
3550474-55047447.58248.07
4554802-55480247.95648.41
5548224-54822447.38747.83
6560563-56056348.45448.91
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%
128.032432245024152382241924201.04
227.972863072870542866800.19
单位质量响应值RSD%判断
86.3410249.55139.06数据不可信!(响应值差异过大,请重新称样测定!)
长期6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%
5min169115-69115653.734964.1229.35653.73964.1229.35
265750-65750621.905621.91
3129952-1299521229.1681229.17
4137788-1377881303.2861303.29
5105857-1058571001.2631001.26
6103116-103116975.337975.34
10min1196460-1964601858.2431923.0114.351859.331924.6214.36
2168111-1681111590.1001591.14
3240370-2403702273.5722275.62
4235957-2359572231.8312234.00
5198021-1980211873.0081874.68
6180926-1809261711.3131712.94
15min1282774-2827742674.6562554.709.822678.842559.529.82
2248344-2483442348.9952352.68
3281250-2812502660.2412666.08
4309592-3095922928.3182934.21
5262082-2620822478.9382483.73
6236512-2365122237.0812241.56
20min1307905-3079052912.3612835.415.762921.012844.485.77
2300887-3008872845.9802853.58
3301690-3016902853.5752863.85
4320840-3208403034.7083045.48
5298725-2987252825.5312834.45
6268572-2685722540.3242548.53
30min1317071-3170712999.0593020.712.993012.563034.503.00
2326331-3263313086.6463098.99
3323234-3232343057.3523072.38
4325854-3258543082.1343097.96
5322531-3225313050.7033064.33
6301139-3011392848.3642860.80
45min1325660-3256603080.2993069.461.293098.803088.291.29
2329413-3294133115.7973133.29
3322636-3226363051.6963071.82
4325539-3255393079.1543100.12
5326573-3265733088.9353107.65
6317264-3172643000.8843018.07
60min1325926-3259263082.8153077.700.873106.453101.650.87
2328350-3283503105.7433128.42
3322759-3227593052.8593078.07
4326547-3265473088.6893114.79
5327536-3275363098.0433121.91
6321193-3211933038.0473060.24
极限1326756-3267563090.6663071.470.943119.433100.550.93
2328867-3288673110.6333138.49
3322849-3228493053.7113084.01
4324191-3241913066.4043097.65
5325455-3254553078.3603107.39
6320243-3202433029.0613056.31
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%
128.032879642895532896122893522897502892460.26
227.974966674967364967020.01
单位质量响应值RSD%判断
10319.1617758.3837.47数据不可信!(响应值差异过大,请重新称样测定!)
长期6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%
5min1116213-11621313.62320.3630.3013.6220.3630.31
2109907-10990712.88412.88
3223412-22341226.18926.19
4236467-23646727.72027.72
5180639-18063921.17521.18
6175242-17524220.54320.54
10min1336358-33635839.42940.9214.5839.4540.9514.58
2287379-28737933.68833.71
3413178-41317848.43548.48
4406718-40671847.67747.72
5339623-33962339.81239.85
6311037-31103736.46136.50
15min1487576-48757657.15654.369.6957.2454.469.70
2427181-42718150.07650.15
3483844-48384456.71856.84
4528557-52855761.96062.09
5449519-44951952.69552.80
6405662-40566247.55447.65
20min1530395-53039562.17560.475.8962.3660.675.89
2518905-51890560.82960.99
3518921-51892160.83061.05
4553156-55315664.84465.07
5512618-51261860.09260.28
6461281-46128154.07454.25
30min1545538-54553863.95164.433.0464.2464.723.04
2561454-56145465.81666.08
3556399-55639965.22465.54
4561894-56189465.86866.20
5554613-55461365.01465.30
6517862-51786260.70660.97
45min1562004-56200465.88165.571.3566.2765.971.35
2569060-56906066.70867.08
3556268-55626865.20865.64
4560761-56076165.73566.18
5561611-56161165.83566.23
6546527-54652764.06664.43
60min1563949-56394966.10965.821.0966.6166.331.09
2567382-56738266.51166.99
3557168-55716865.31465.85
4562965-56296565.99366.55
5566045-56604566.35466.86
6551304-55130464.62665.10
极限1563995-56399566.11465.700.9066.7366.320.89
2567510-56751066.52667.12
3556789-55678965.26965.92
4559468-55946865.58366.25
5561482-56148265.82066.44
6553452-55345264.87865.46
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