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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
19.533573424359612736011503600100359022135922040.32
29.643584394360183935931160.35
单位质量响应值RSD%判断
376936.41372729.880.80数据可信
供试品溶液-2024112621批-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%
5min1342677-3426778.2287.3115.578.237.3115.56
2337737-3377378.1108.11
3331917-3319177.9707.97
4321233-3212337.7137.71
5225200-2252005.4075.41
6267961-2679616.4346.43
10min1578301-57830113.88613.254.2013.9013.274.21
2575577-57557713.82013.84
3549044-54904413.18313.20
4528348-52834812.68612.70
5523118-52311812.56112.57
6557012-55701213.37513.39
15min1686565-68656516.48515.645.0416.5315.685.02
2682243-68224316.38216.43
3626672-62667215.04715.09
4601024-60102414.43114.48
5655326-65532615.73515.78
6656330-65633015.75915.80
20min1735031-73503117.64916.486.7517.7316.566.71
2712149-71214917.10017.18
3626197-62619715.03615.12
4630990-63099015.15115.23
5699137-69913716.78716.86
6715092-71509217.17017.25
30min1760211-76021118.25417.226.5918.3817.336.59
2731465-73146517.56417.69
3667227-66722716.02116.13
4661080-66108015.87315.98
5706864-70686416.97317.09
6775066-77506618.61018.73
45min1778694-77869418.69817.997.3718.8618.147.33
2776329-77632918.64118.80
3691333-69133316.60016.75
4669104-66910416.06616.21
5773151-77315118.56418.71
6806330-80633019.36119.52
60min1792008-79200819.01717.927.2019.2218.127.17
2760289-76028918.25618.46
3698124-69812416.76316.95
4663380-66338015.92916.11
5769062-76906218.46618.66
6795334-79533419.09719.30
极限1816598-81659819.60818.387.1319.8618.617.11
2780937-78093718.75119.00
3711251-71125117.07817.30
4684378-68437816.43316.65
5789687-78968718.96219.19
6809143-80914319.42919.67
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
19.533589759358666735720683540105353597135649140.72
29.643618074362817236231230.20
单位质量响应值RSD%判断
374072.82375842.630.34数据可信
供试品溶液-2024112621批-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%
5min1278877-2788776.6946.9821.496.696.9821.49
2350438-3504388.4128.41
3311137-3111377.4687.47
4329114-3291147.9007.90
5302401-3024017.2587.26
6173264-1732644.1594.16
10min1553444-55344413.28413.806.4713.3013.826.47
2607975-60797514.59314.61
3578266-57826613.88013.90
4601477-60147714.43714.45
5598691-59869114.37014.39
6511029-51102912.26612.28
15min1669682-66968216.07416.352.6516.1216.402.66
2694694-69469416.67516.73
3661398-66139815.87515.92
4697367-69736716.73916.79
5700108-70010816.80516.85
6664144-66414415.94115.98
20min1723007-72300717.35417.421.3217.4317.511.33
2733655-73365517.61017.70
3709739-70973917.03617.12
4726561-72656117.44017.53
5736988-73698817.69017.78
6725616-72561617.41717.49
30min1770438-77043818.49318.222.7818.6118.342.76
2763455-76345518.32518.45
3716516-71651617.19817.32
4767200-76720018.41518.54
5768288-76828818.44118.57
6769560-76956018.47218.58
45min1780136-78013618.72518.752.4918.8918.922.46
2792505-79250519.02219.19
3744922-74492217.88018.04
4779386-77938618.70718.87
5798605-79860519.16919.33
6792472-79247219.02219.17
60min1758760-75876018.21218.794.5818.4118.994.53
2798917-79891719.17619.39
3730324-73032417.53017.73
4772286-77228618.53718.75
5806918-80691819.36819.58
6828840-82884019.89520.09
极限1825731-82573119.82018.975.0520.0619.225.00
2807711-80771119.38719.64
3720397-72039717.29217.53
4766751-76675118.40418.65
5804249-80424919.30419.56
6817874-81787419.63119.87
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
19.533570420357484835739973570635357657535732950.08
29.643649700365663436531670.14
单位质量响应值RSD%判断
374952.26378959.230.76数据可信
供试品溶液-2024112721批-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%
5min1211214-2112145.0437.8920.275.047.8920.28
2298910-2989107.1377.14
3340373-3403738.1278.13
4364265-3642658.6978.70
5374956-3749568.9538.95
6393784-3937849.4029.40
10min1502844-50284412.00613.847.9812.0213.867.98
2546374-54637413.04513.06
3596397-59639714.24014.26
4606064-60606414.47014.49
5597718-59771814.27114.29
6628274-62827415.00115.02
15min1639639-63963915.27216.383.9715.3116.434.00
2668926-66892615.97116.02
3698147-69814716.66916.72
4705896-70589616.85416.91
5691983-69198316.52216.57
6712095-71209517.00217.06
20min1705348-70534816.84117.462.7116.9117.542.74
2707931-70793116.90316.98
3738065-73806517.62217.71
4738388-73838817.63017.72
5752659-75265917.97118.06
6744789-74478917.78317.87
30min1782296-78229618.67818.471.0318.7918.601.00
2771986-77198618.43218.55
3779160-77916018.60318.73
4774736-77473618.49818.63
5773974-77397418.48018.61
6759420-75942018.13218.26
45min1792679-79267918.92618.881.6219.0819.041.61
2801259-80125919.13119.29
3765502-76550218.27718.44
4791363-79136318.89519.06
5796877-79687719.02619.20
6796083-79608319.00719.18
60min1799296-79929619.08419.350.9219.2819.550.94
2813044-81304419.41219.61
3805442-80544219.23119.44
4819611-81961119.56919.78
5816024-81602419.48419.70
6808257-80825719.29819.51
极限1853132-85313220.37019.472.7220.6019.722.66
2786416-78641618.77719.02
3814537-81453719.44819.70
4802929-80292919.17119.43
5820974-82097419.60219.86
6815772-81577219.47719.73
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
19.533597746358100435811673579584357829835835600.23
29.643692439370597136992050.26
单位质量响应值RSD%判断
376029.38383734.961.44数据可信
供试品溶液-2024112721批-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%
5min1357693-3576938.4759.279.258.489.279.24
2384084-3840849.1009.10
3361436-3614368.5648.56
4373605-3736058.8528.85
5422756-42275610.01710.02
6447488-44748810.60310.60
10min1592737-59273714.04414.403.8714.0614.423.87
2604215-60421514.31614.34
3596082-59608214.12414.14
4581187-58118713.77113.79
5629594-62959414.91814.94
6642302-64230215.21915.24
15min1675487-67548716.00516.402.2116.0616.462.21
2693617-69361716.43516.49
3693784-69378416.43916.49
4674356-67435615.97816.03
5703934-70393416.67916.73
6712856-71285616.89016.95
20min1735569-73556917.42917.202.1217.5117.292.09
2736019-73601917.43917.53
3735281-73528117.42217.51
4718791-71879117.03117.12
5697350-69735016.52316.62
6731572-73157217.33417.43
30min1773468-77346818.32718.332.8018.4518.452.77
2756537-75653717.92518.05
3780262-78026218.48818.61
4812782-81278219.25819.38
5763243-76324318.08418.21
6754490-75449017.87718.01
45min1796749-79674918.87819.079.8419.0419.249.75
2783238-78323818.55818.73
3794578-79457818.82718.99
4953221-95322122.58622.75
5713472-71347216.90517.07
6787453-78745318.65818.83
60min1654562-65456215.50918.9515.9215.7219.1615.74
21038648-103864824.61024.82
3776473-77647318.39818.61
4789261-78926118.70118.92
5756496-75649617.92418.13
6782889-78288918.55018.76
极限1739458-73945817.52122.3839.7517.7622.6439.33
21699133-169913340.25940.52
3777426-77742618.42018.67
4740308-74030817.54117.80
5792721-79272118.78319.03
6919095-91909521.77722.03
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