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%
127.342771492770032771562773192771552771560.05
227.252782182782422782300.01
单位质量响应值RSD%判断
10137.3810210.280.51数据可信
加速6月-供试品溶液-2024032721批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1125350-12535019.95519.6126.7719.9619.6226.77
2144700-14470023.03523.04
372755-7275511.58211.58
4166642-16664226.52926.53
5129067-12906720.54720.55
6100734-10073416.03616.04
10min1234109-23410937.26934.2513.8737.3034.2813.88
2233031-23303137.09737.14
3164069-16406926.11926.14
4233490-23349037.17037.21
5233235-23323537.13037.16
6192806-19280630.69430.72
15min1308701-30870149.14444.3810.3549.2444.4710.36
2290234-29023446.20446.30
3239333-23933338.10138.16
4272316-27231643.35143.46
5308724-30872449.14749.24
6253485-25348540.35440.43
20min1320253-32025350.98348.455.6251.1648.625.64
2312393-31239349.73149.91
3284794-28479445.33845.46
4295109-29510946.98047.16
5325079-32507951.75151.93
6288608-28860845.94546.09
30min1337653-33765353.75352.102.1754.0152.352.18
2330359-33035952.59152.85
3321707-32170751.21451.42
4319188-31918850.81351.07
5331734-33173452.81053.07
6323156-32315651.44551.67
45min1334098-33409853.18753.031.1553.5453.371.18
2338770-33877053.93054.28
3328403-32840352.28052.57
4330361-33036152.59252.93
5335770-33577053.45353.81
6331428-33142852.76253.07
60min1334171-33417153.19853.000.8853.6453.420.91
2336597-33659753.58554.02
3329847-32984752.51052.88
4329795-32979552.50252.93
5335456-33545653.40353.84
6331647-33164752.79653.19
极限1334170-33417053.19852.960.7353.7353.470.77
2335728-33572853.44653.97
3329948-32994852.52652.99
4330438-33043852.60453.12
5334525-33452553.25553.79
6331262-33126252.73553.22
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%
127.344794474791774794344789704794504792960.05
227.254804724805814805260.02
单位质量响应值RSD%判断
17530.9417633.980.42数据可信
加速6月-供试品溶液-2024032721批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1213405-21340518.57218.2327.7118.5718.2327.70
2246929-24692921.49021.49
3120392-12039210.47810.48
4285762-28576224.86924.87
5220350-22035019.17719.18
6170127-17012714.80614.81
10min1403032-40303235.07532.1614.1535.1132.1814.17
2401901-40190134.97735.01
3280223-28022324.38724.40
4401471-40147134.93934.98
5400214-40021434.83034.86
6330101-33010128.72828.75
15min1535907-53590746.63941.6810.7746.7341.7610.78
2495026-49502643.08143.18
3408061-40806135.51335.57
4468034-46803440.73240.83
5531238-53123846.23346.32
6435231-43523137.87837.95
20min1549736-54973647.84345.465.7248.0145.625.74
2535953-53595346.64346.81
3488044-48804442.47442.59
4507226-50722644.14344.31
5558930-55893048.64348.81
6494345-49434543.02243.16
30min1573047-57304749.87148.831.8150.1249.061.84
2566273-56627349.28249.53
3551263-55126347.97648.16
4549560-54956047.82748.07
5570248-57024849.62849.88
6555802-55580248.37148.58
45min1575274-57527450.06549.881.0550.4050.201.09
2580434-58043450.51450.84
3564436-56443649.12249.39
4569782-56978249.58749.91
5578563-57856350.35250.68
6570685-57068549.66649.95
60min1576527-57652750.17449.910.9150.5950.300.94
2579956-57995650.47350.88
3567456-56745649.38549.73
4567685-56768549.40549.81
5577075-57707550.22250.64
6572210-57221049.79950.17
极限1577200-57720050.23349.870.7350.7350.340.77
2577103-57710350.22450.72
3568398-56839849.46749.90
4569175-56917549.53450.02
5575962-57596250.12550.62
6570144-57014449.61950.07
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%
127.342776812771142773032770592772262772770.09
227.252774722775392775060.02
单位质量响应值RSD%判断
10141.8110183.710.30数据可信
加速6月-供试品溶液-2024032821批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1135909-13590921.65920.8810.3021.6620.8810.30
2125717-12571720.03520.04
3146984-14698423.42423.42
4114770-11477018.29118.29
5144409-14440923.01423.01
6118355-11835518.86218.86
10min1196316-19631631.28635.749.8231.3235.789.82
2209942-20994233.45833.49
3246670-24667039.31139.35
4209896-20989633.45033.48
5249738-24973839.80039.84
6233118-23311837.15137.18
15min1242921-24292138.71444.829.8338.8044.919.83
2260425-26042541.50341.59
3299919-29991947.79747.90
4268987-26898742.86842.95
5312041-31204149.72949.83
6302951-30295148.28048.37
20min1271730-27173043.30549.137.7843.4649.307.78
2292304-29230446.58446.74
3329739-32973952.54952.73
4304381-30438148.50848.67
5335714-33571453.50253.69
6315668-31566850.30750.48
30min1302512-30251248.21051.823.6548.4452.073.66
2326775-32677552.07752.31
3331473-33147352.82653.10
4324180-32418051.66451.90
5336504-33650453.62853.90
6329374-32937452.49152.75
45min1323380-32338051.53652.731.4351.8453.061.46
2329606-32960652.52852.85
3331683-33168352.85953.22
4331510-33151052.83253.16
5338065-33806553.87654.24
6330892-33089252.73353.08
60min1331154-33115452.77552.731.3453.1753.161.35
2323885-32388551.61752.03
3331836-33183652.88453.33
4330626-33062652.69153.10
5337704-33770453.81954.27
6330190-33019052.62153.05
极限1327683-32768352.22252.650.8152.7053.160.84
2329313-32931352.48252.98
3329531-32953152.51653.05
4330257-33025752.63253.13
5335509-33550953.46954.01
6329902-32990252.57553.10
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%
127.344782734789934786374785234782654785380.07
227.254787934786794787360.02
单位质量响应值RSD%判断
17503.2217568.290.27数据可信
加速6月-供试品溶液-2024032821批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1232293-23229320.27019.4910.5320.2719.4910.54
2213869-21386918.66218.66
3249902-24990221.80621.81
4195541-19554117.06317.06
5247856-24785621.62821.63
6200673-20067317.51117.51
10min1334963-33496329.22933.6010.1429.2633.6310.14
2359679-35967931.38631.42
3425785-42578537.15437.19
4360132-36013231.42531.45
5429241-42924137.45637.49
6400299-40029934.93034.96
15min1416470-41647036.34142.0910.0436.4242.1810.03
2447252-44725239.02739.11
3516108-51610845.03645.13
4457444-45744439.91740.00
5536730-53673046.83546.93
6520112-52011245.38545.47
20min1465602-46560240.62846.128.0740.7746.288.07
2500687-50068743.69043.84
3567878-56787849.55349.73
4516434-51643445.06445.21
5578050-57805050.44150.62
6542734-54273447.35947.52
30min1518306-51830645.22748.703.8645.4448.933.88
2555790-55579048.49848.72
3570891-57089149.81650.07
4556219-55621948.53648.76
5579963-57996350.60850.87
6567292-56729249.50249.74
45min1555380-55538048.46249.741.5348.7550.051.56
2567131-56713149.48849.79
3572605-57260549.96550.30
4573326-57332650.02850.33
5581811-58181150.76951.11
6569746-56974649.71650.04
60min1569800-56980049.72150.010.8450.0950.410.86
2575228-57522850.19450.58
3571948-57194849.90850.33
4570284-57028449.76350.15
5581843-58184350.77251.20
6569382-56938249.68450.09
极限1564900-56490049.29349.700.8449.7450.180.87
2567837-56783749.54950.02
3569007-56900749.65250.16
4568633-56863349.61950.09
5578824-57882450.50851.02
6568218-56821849.58350.07
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%
127.342779192777352780162779312777092778620.05
227.252776512781192778850.12
单位质量响应值RSD%判断
10163.2010197.610.24数据可信
加速6月-供试品溶液-2024032921批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186858-8685813.81818.4519.8913.8218.4519.88
2130128-13012820.70220.70
3135349-13534921.53321.53
489120-8912014.17814.18
5115668-11566818.40218.40
6138642-13864222.05722.06
10min1179120-17912028.49635.7916.1928.5235.8216.19
2249632-24963239.71439.75
3233434-23343437.13737.17
4179141-17914128.50028.52
5250828-25082839.90439.93
6257817-25781741.01641.05
15min1246147-24614739.16045.5711.4039.2345.6611.40
2312800-31280049.76349.86
3307751-30775148.96049.06
4244427-24442738.88638.96
5294099-29409946.78846.89
6313392-31339249.85849.96
20min1284279-28427945.22649.707.6745.3649.867.69
2324174-32417451.57351.76
3334986-33498653.29353.47
4281313-28131344.75444.89
5316078-31607850.28550.46
6333552-33355253.06553.25
30min1324562-32456251.63552.462.8851.8552.712.91
2340830-34083054.22354.49
3332778-33277852.94253.21
4313510-31351049.87650.09
5333506-33350653.05853.32
6333179-33317953.00653.28
45min1332471-33247152.89353.141.5353.1953.481.55
2344188-34418854.75755.12
3332159-33215952.84353.20
4329914-32991452.48652.78
5333238-33323853.01553.36
6332309-33230952.86753.23
60min1331292-33129252.70553.091.2153.0953.521.21
2340977-34097754.24654.70
3331396-33139652.72253.17
4335892-33589253.43753.82
5331006-33100652.66053.10
6331638-33163852.76053.21
极限1336305-33630553.50353.151.2053.9853.671.17
2339876-33987654.07154.61
3330633-33063352.60153.13
4336392-33639253.51753.99
5331491-33149152.73753.26
6329967-32996752.49553.04
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%
127.344797474798264786394798594792394794620.11
227.254799484798144798810.02
单位质量响应值RSD%判断
17537.0217610.310.30数据可信
加速6月-供试品溶液-2024032921批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1146124-14612412.72317.1620.6312.7217.1620.64
2222548-22254819.37819.38
3231539-23153920.16120.16
4149644-14964413.03013.03
5195946-19594617.06117.06
6236851-23685120.62320.62
10min1306463-30646326.68433.6516.4726.7133.6816.46
2429588-42958837.40537.44
3401462-40146234.95634.99
4306121-30612126.65526.68
5431501-43150137.57237.60
6443623-44362338.62738.66
15min1422166-42216636.75942.8911.6136.8242.9711.63
2538317-53831746.87246.97
3529595-52959546.11346.20
4418669-41866936.45436.52
5506427-50642744.09644.19
6540305-54030547.04547.14
20min1488340-48834042.52146.807.8942.6546.957.91
2557896-55789648.57748.75
3577920-57792050.32150.49
4481956-48195641.96542.09
5543879-54387947.35747.52
6574738-57473850.04350.22
30min1557019-55701948.50149.443.0148.7049.683.04
2587652-58765251.16851.42
3572654-57265449.86250.11
4539313-53931346.95947.16
5575505-57550550.11050.35
6574958-57495850.06350.32
45min1572931-57293149.88650.131.5850.1650.451.60
2593799-59379951.70352.04
3572930-57293049.88650.22
4568292-56829249.48249.76
5574638-57463850.03550.36
6571980-57198049.80350.15
60min1570587-57058749.68250.051.2250.0450.451.21
2587309-58730951.13851.56
3569747-56974749.60950.03
4578901-57890150.40650.76
5570392-57039249.66550.08
6571990-57199049.80450.23
极限1585357-58535750.96850.211.4451.4150.691.40
2586624-58662451.07851.59
3569153-56915349.55750.06
4579354-57935450.44550.89
5571215-57121549.73750.23
6568074-56807449.46349.97
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