非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.462060137205858420602302059344206049520597580.04
210.782100224210083121005280.03
单位质量响应值RSD%判断
196917.59194854.170.75数据可信
供试品溶液-250602批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1204692-2046929.3958.6314.439.408.6314.44
2175602-1756028.0608.06
3149847-1498476.8786.88
4175486-1754868.0558.05
5194714-1947148.9378.94
6227868-22786810.45910.46
10min1796484-79648436.55934.004.1436.5834.024.14
2734248-73424833.70233.72
3711339-71133932.65132.67
4724428-72442833.25233.27
5753109-75310934.56834.59
6724908-72490833.27433.30
15min11290280-129028059.22456.043.5659.3356.143.57
21208394-120839455.46655.56
31167153-116715353.57353.66
41201107-120110755.13155.22
51252117-125211757.47357.57
61206604-120660455.38455.48
20min11568239-156823971.98368.673.1472.2268.893.14
21523471-152347169.92870.14
31441707-144170766.17566.38
41463715-146371567.18567.40
51511943-151194369.39969.62
61467914-146791467.37867.60
30min11795142-179514282.39879.941.9582.7980.311.95
21755003-175500380.55580.93
31748695-174869580.26680.62
41705839-170583978.29978.66
51740460-174046079.88880.27
61704451-170445178.23578.61
45min11946737-194673789.35687.311.8889.9387.861.88
21919862-191986288.12388.67
31930300-193030088.60289.13
41865593-186559385.63286.17
51891292-189129286.81187.37
61859468-185946885.35085.89
60min12024884-202488492.94390.891.8293.7291.631.82
21998919-199891991.75192.50
32007145-200714592.12992.86
41941272-194127289.10589.83
51970816-197081690.46191.21
61937708-193770888.94289.68
极限12074166-207416695.20593.331.7396.1994.271.73
22055754-205575494.36095.31
32058748-205874894.49795.43
41988586-198858691.27792.20
52024668-202466892.93393.88
61997536-199753691.68892.62
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.462078772207951920795502077458207855820787710.05
210.782096236209752620968810.05
单位质量响应值RSD%判断
198735.28194515.861.52数据可信
供试品溶液-250602批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1180478-1804788.2548.9416.448.258.9416.43
2245005-24500511.20511.20
3178326-1783268.1558.16
4187716-1877168.5858.58
5223310-22331010.21210.21
6158605-1586057.2537.25
10min1715702-71570232.73034.665.4632.7534.685.47
2776181-77618135.49635.52
3717579-71757932.81632.83
4747584-74758434.18834.21
5826212-82621237.78437.81
6763934-76393434.93634.95
15min11195339-119533954.66556.733.1654.7656.833.16
21256330-125633057.45457.56
31205908-120590855.14855.24
41227462-122746256.13456.23
51301561-130156159.52359.63
61256874-125687457.47957.57
20min11483138-148313867.82768.971.5268.0469.191.53
21507345-150734568.93469.17
31497549-149754968.48668.70
41510808-151080869.09269.31
51550506-155050670.90771.15
61499092-149909268.55668.78
30min11720903-172090378.70079.621.2879.0680.001.28
21736981-173698179.43579.82
31737850-173785079.47579.84
41745611-174561179.83080.20
51782065-178206581.49781.89
61723275-172327578.80879.18
45min11878891-187889185.92586.431.0986.4686.981.09
21881687-188168786.05386.61
31900540-190054086.91587.46
41894149-189414986.62387.17
51921940-192194087.89488.47
61862701-186270185.18585.73
60min11955407-195540789.42489.870.9490.1590.620.94
21955833-195583389.44490.20
31975580-197558090.34791.08
41971347-197134790.15390.90
51992621-199262191.12691.90
61940515-194051588.74389.48
极限12017396-201739692.25992.400.9393.1993.340.93
22007596-200759691.81192.76
32029790-202979092.82693.76
42026336-202633692.66893.61
52047717-204771793.64694.62
61994134-199413491.19592.13
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.462094267209303620941492092775209307420934600.04
210.782049698207454620621220.86
单位质量响应值RSD%判断
200139.58191291.473.20数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-250603批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1445061-44506120.45613.3435.8620.4613.3435.87
2176952-1769528.1338.13
3364224-36422416.74116.74
4312981-31298114.38514.39
5191089-1910898.7838.78
6251188-25118811.54511.55
10min11165860-116586053.58641.3616.6753.6341.3916.68
2751835-75183534.55634.57
3955702-95570243.92743.96
4823332-82333237.84237.87
5795984-79598436.58636.61
6906904-90690441.68441.71
15min11489516-148951668.46260.977.2768.6361.107.29
21209688-120968855.60055.70
31331262-133126261.18861.32
41294414-129441459.49559.61
51267324-126732458.25058.35
61367217-136721762.84162.96
20min11630020-163002074.92071.272.8775.2471.532.91
21512696-151269669.52769.75
31551210-155121071.29871.57
41532961-153296170.45970.71
51510890-151089069.44469.67
61565863-156586371.97172.23
30min11784368-178436882.01480.611.1282.5081.031.15
21760695-176069580.92681.30
31757320-175732080.77181.20
41732908-173290879.64980.05
51731855-173185579.60179.99
61755840-175584080.70381.12
45min11914661-191466188.00387.280.7988.6787.880.79
21918069-191806988.15988.71
31898311-189831187.25187.86
41879571-187957186.39086.97
51892704-189270486.99487.56
61890483-189048386.89287.49
60min11976490-197649090.84590.660.8291.7191.450.81
22000071-200007191.92892.68
31977065-197706590.87191.67
41956672-195667289.93490.71
51965636-196563690.34691.10
61958618-195861890.02390.81
极限12023083-202308392.98693.020.8994.0594.010.87
22055919-205591994.49595.45
32029799-202979993.29594.30
42013267-201326792.53593.51
52016523-201652392.68593.64
62004518-200451892.13393.12
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.462083538208222520861052083552208199220834820.08
210.782179672218274221812070.10
单位质量响应值RSD%判断
199185.66202338.311.12数据可信
供试品溶液-250603批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1552730-55273024.75526.4110.5624.7626.4110.55
2538040-53804024.09724.10
3528274-52827423.66023.66
4590329-59032926.43926.44
5650928-65092829.15329.15
6678079-67807930.36930.37
10min11153349-115334951.65553.095.2451.7153.155.25
21123578-112357850.32250.38
31130842-113084250.64750.70
41199502-119950253.72253.78
51219832-121983254.63354.70
61285713-128571357.58357.65
15min11494053-149405366.91466.121.9467.0866.291.95
21445635-144563564.74664.91
31439465-143946564.47064.63
41479486-147948666.26266.44
51485880-148588066.54866.73
61513228-151322867.77367.97
20min11656153-165615374.17472.871.2574.4973.191.25
21609706-160970672.09472.40
31600534-160053471.68371.99
41631259-163125973.05973.38
51624537-162453772.75873.09
61640264-164026473.46373.81
30min11825179-182517981.74580.071.1482.2380.561.14
21778988-177898879.67680.15
31769326-176932679.24379.71
41794975-179497580.39280.88
51774556-177455679.47779.97
61783527-178352779.87980.39
45min11955360-195536087.57585.801.0988.2486.461.08
21915240-191524085.77886.42
31901196-190119685.14985.79
41917534-191753485.88186.55
51899350-189935085.06685.74
61905164-190516485.32786.01
60min12014267-201426790.21388.660.9591.0789.510.94
21976706-197670688.53189.37
31967967-196796788.14088.97
41985105-198510588.90789.76
51963395-196339587.93588.80
61969635-196963588.21489.09
极限12069599-206959992.69190.871.0493.7591.921.03
22028157-202815790.83591.87
32022465-202246590.58091.61
42026301-202630190.75291.81
52013922-201392290.19891.25
62012558-201255890.13791.21
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