利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.933161593170073166093167243157903164580.16
210.013162363168213165280.14
单位质量响应值RSD%判断
31868.8831621.180.56数据可信
供试品溶液-JPS7638批-pH1.2(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1219751-21975162.05362.311.9062.0562.311.90
2219164-21916461.88761.89
3216777-21677761.21361.21
4217376-21737661.38261.38
5223044-22304462.98362.98
6227937-22793764.36564.36
10min1273768-27376877.30677.801.5477.4177.901.54
2272081-27208176.83076.93
3271325-27132576.61776.72
4276091-27609177.96278.06
5276974-27697478.21278.32
6282906-28290679.88779.99
15min1293990-29399083.01783.761.6183.2583.991.61
2293131-29313182.77483.01
3291233-29123382.23882.47
4297324-29732483.95884.19
5300100-30010084.74284.98
6303857-30385785.80386.04
20min1306588-30658886.57486.811.4386.9487.191.43
2303447-30344785.68786.06
3302120-30212085.31285.68
4308957-30895787.24387.62
5309390-30939087.36587.74
6314095-31409588.69489.08
30min1319559-31955990.23790.681.2390.7591.191.23
2316947-31694789.49990.01
3317349-31734989.61390.12
4322714-32271491.12891.65
5327323-32732392.42992.95
6322786-32278691.14891.68
45min1326884-32688492.30592.601.2192.9793.271.21
2323899-32389991.46292.12
3323920-32392091.46892.13
4329375-32937593.00993.68
5329178-32917892.95393.63
6334323-33432394.40695.09
60min1326849-32684992.29593.061.4193.1193.881.41
2325733-32573391.98092.79
3325276-32527691.85192.66
4335302-33530294.68295.51
5328911-32891192.87893.71
6335315-33531594.68695.53
极限1327375-32737592.44492.791.1893.4293.771.18
2325671-32567191.96392.93
3324830-32483091.72592.69
4330599-33059993.35494.34
5327689-32768992.53393.52
6335375-33537594.70395.70
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.933172563169763173263170233168533170870.07
210.013169363171793170580.06
单位质量响应值RSD%判断
31932.2331674.130.58数据可信
供试品溶液-JPS7638批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1244466-24446668.90668.113.4168.9168.113.41
2255741-25574172.08472.08
3231772-23177265.32865.33
4241921-24192168.18968.19
5239825-23982567.59867.60
6236124-23612466.55566.55
10min1291772-29177282.24082.262.4682.3582.372.47
2303613-30361385.57785.70
3282215-28221579.54679.65
4293383-29338382.69482.81
5292951-29295182.57282.68
6287127-28712780.93181.04
15min1312605-31260588.11287.942.1188.3688.192.11
2321877-32187790.72590.99
3301881-30188185.08985.33
4314267-31426788.58088.83
5312512-31251288.08688.34
6308783-30878387.03587.28
20min1322441-32244190.88490.852.1691.2891.242.16
2332208-33220893.63794.05
3311559-31155987.81788.20
4325195-32519591.66192.06
5324089-32408991.34991.75
6318320-31832089.72390.11
30min1332178-33217893.62994.101.7094.1894.651.70
2341784-34178496.33696.91
3325426-32542691.72692.26
4336842-33684294.94395.50
5335968-33596894.69795.25
6330799-33079993.24093.78
45min1338395-33839595.38195.891.9096.0996.601.91
2347561-34756197.96598.70
3330058-33005893.03193.71
4340284-34028495.91496.62
5346828-34682897.75898.47
6338138-33813895.30996.00
60min1340049-34004995.84796.641.7896.7197.501.78
2349777-34977798.58999.48
3333043-33304393.87394.71
4347167-34716797.85498.72
5346236-34623697.59198.46
6340941-34094196.09996.95
极限1339724-33972495.75696.871.8996.7897.891.89
2350504-35050498.79499.85
3333491-33349193.99994.99
4348762-34876298.30399.34
5347486-34748697.94498.98
6342019-34201996.40397.42
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.933162283159243158853162893160533160760.06
210.013178603179253178920.02
单位质量响应值RSD%判断
31830.4131757.440.17数据可信
供试品溶液-JPS7638批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1244678-24467868.98567.951.7368.9867.941.73
2247232-24723269.70569.70
3241052-24105267.96267.96
4237241-23724166.88866.89
5238448-23844867.22867.23
6237334-23733466.91466.91
10min1293043-29304382.62181.961.3482.7482.071.34
2294340-29434082.98783.10
3292847-29284782.56682.68
4290767-29076781.97982.09
5289571-28957181.64281.75
6283575-28357579.95180.06
15min1311917-31191787.94287.471.3288.1987.721.32
2314692-31469288.72588.98
3312845-31284588.20488.45
4309588-30958887.28687.53
5309557-30955787.27787.52
6302935-30293585.41085.65
20min1321804-32180490.73090.531.3591.1390.931.35
2325753-32575391.84392.25
3324031-32403191.35891.76
4320817-32081790.45190.85
5320925-32092590.48290.88
6313241-31324188.31588.70
30min1333774-33377494.10593.861.1594.6694.401.15
2336567-33656794.89295.45
3335519-33551994.59795.15
4333427-33342794.00794.55
5332262-33226293.67894.22
6325799-32579991.85692.39
45min1338107-33810795.32695.961.1896.0396.671.18
2343243-34324396.77497.49
3344043-34404397.00097.71
4343103-34310396.73597.44
5340098-34009895.88896.59
6333612-33361294.05994.75
60min1340108-34010895.89096.591.0496.7697.461.04
2344591-34459197.15498.03
3346089-34608997.57798.45
4344472-34447297.12197.98
5343637-34363796.88597.75
6336639-33663994.91295.76
极限1340698-34069896.05796.801.0797.0897.821.07
2345509-34550997.41398.45
3346238-34623897.61998.65
4345885-34588597.51998.54
5344517-34451797.13398.16
6337108-33710895.04596.05
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.933138893138813138623137653130063136810.13
210.013148163150253149200.05
单位质量响应值RSD%判断
31589.2231460.540.29数据可信
供试品溶液-JPS7638批-pH1.2(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1209488-20948859.56762.372.6359.5762.372.63
2223866-22386663.65663.66
3225876-22587664.22764.23
4220678-22067862.74962.75
5217783-21778361.92661.93
6218367-21836762.09262.09
10min1266939-26693975.90478.442.3276.0078.552.32
2283417-28341780.58980.70
3282295-28229580.27080.38
4277416-27741678.88378.99
5271698-27169877.25777.36
6273470-27347077.76177.86
15min1287139-28713981.64784.192.4581.8784.422.45
2304457-30445786.57286.81
3303900-30390086.41386.65
4298282-29828284.81685.05
5290689-29068982.65782.89
6292076-29207683.05183.28
20min1297719-29771984.65687.292.3685.0287.672.36
2314835-31483589.52389.91
3315082-31508289.59389.98
4308645-30864587.76388.14
5300421-30042185.42485.79
6305240-30524086.79487.17
30min1309553-30955388.02191.072.6688.5291.582.65
2328722-32872293.47194.01
3329737-32973793.76094.29
4322107-32210791.59092.11
5311262-31126288.50789.02
6320179-32017991.04291.56
45min1316478-31647889.99092.692.8890.6493.372.88
2337365-33736595.92996.62
3336564-33656495.70196.39
4327648-32764893.16693.84
5317277-31727790.21790.88
6320586-32058691.15891.83
60min1317285-31728590.21992.972.9391.0293.802.92
2338669-33866996.30097.15
3337509-33750995.97096.82
4328981-32898193.54594.38
5318120-31812090.45791.27
6321258-32125891.34992.17
极限1316335-31633589.94992.992.9590.9093.982.95
2338191-33819196.16497.17
3338203-33820396.16797.18
4329234-32923493.61794.60
5319605-31960590.87991.84
6320682-32068291.18592.16
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