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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.253928294392870339269323930919392773239285160.04
210.353967558396619239668750.03
单位质量响应值RSD%判断
383269.85383272.950.01数据可信
供试品溶液-2024011311均一性1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%
5min1263743-2637436.1937.7518.966.197.7518.98
2358763-3587638.4248.42
3309115-3091157.2597.26
4435054-43505410.21610.22
5336645-3366457.9057.91
6276834-2768346.5016.50
10min1600874-60087414.11015.044.0814.1215.064.09
2651097-65109715.28915.31
3618934-61893414.53414.55
4672946-67294615.80215.82
5653667-65366715.34915.37
6646306-64630615.17715.19
15min1707650-70765016.61717.011.9816.6617.061.99
2717964-71796416.85916.91
3709624-70962416.66316.71
4740291-74029117.38417.44
5735143-73514317.26317.31
6734926-73492617.25817.31
20min1747294-74729417.54817.691.0117.6317.771.02
2749479-74947917.59917.69
3743751-74375117.46517.55
4763843-76384317.93718.03
5756188-75618817.75717.85
6758218-75821817.80517.89
30min1768063-76806318.03618.231.2618.1618.361.27
2773034-77303418.15218.28
3764164-76416417.94418.07
4787416-78741618.49018.63
5776744-77674418.24018.37
6787400-78740018.49018.62
45min1779506-77950618.30418.480.5418.4718.650.54
2790675-79067518.56718.74
3790589-79058918.56518.73
4784918-78491818.43118.61
5787335-78733518.48818.66
6787884-78788418.50118.67
60min1787857-78785718.50118.651.0918.7018.861.08
2792427-79242718.60818.82
3808941-80894118.99619.20
4784253-78425318.41618.63
5798019-79801918.73918.95
6794778-79477818.66318.87
极限1810965-81096519.04318.741.3919.2918.991.35
2786232-78623218.46218.71
3812381-81238119.07619.32
4790042-79004218.55218.81
5792625-79262518.61218.87
6795817-79581718.68718.94
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.253948056394953539481573945456394381539470040.06
210.353972179397065539714170.03
单位质量响应值RSD%判断
385073.56383711.790.26数据可信
供试品溶液-2024011311均一性2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%
5min1393708-3937089.2189.277.099.229.277.11
2422094-4220949.8839.88
3406691-4066919.5229.52
4421849-4218499.8779.88
5383745-3837458.9858.98
6347857-3478578.1458.14
10min1668197-66819715.64515.571.3815.6715.591.38
2669707-66970715.68015.70
3662887-66288715.52115.54
4677876-67787615.87215.89
5660693-66069315.46915.49
6651016-65101615.24315.26
15min1727634-72763417.03717.010.4817.0917.070.47
2727741-72774117.03917.10
3723259-72325916.93416.99
4727169-72716917.02617.08
5722015-72201516.90516.96
6731647-73164717.13117.18
20min1744957-74495717.44217.450.7217.5417.540.72
2746458-74645817.47717.57
3740114-74011417.32917.42
4749427-74942717.54717.64
5738584-73858417.29317.38
6752533-75253317.62017.71
30min1763488-76348817.87617.891.0018.0118.021.00
2765028-76502817.91218.05
3751811-75181117.60317.73
4765473-76547317.92318.06
5763323-76332317.87218.00
6775662-77566218.16118.29
45min1764138-76413817.89118.111.3818.0618.281.38
2781986-78198618.30918.48
3762705-76270517.85818.03
4775622-77562218.16018.33
5767888-76788817.97918.15
6789553-78955318.48618.66
60min1775181-77518118.15018.261.7218.3618.481.69
2789376-78937618.48218.70
3770890-77089018.04918.26
4773962-77396218.12118.34
5767727-76772717.97518.19
6802705-80270518.79419.00
极限1785164-78516418.38418.411.6018.6418.661.58
2789107-78910718.47618.73
3775435-77543518.15618.41
4788622-78862218.46518.72
5771263-77126318.05818.31
6807063-80706318.89619.15
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.253992423399253939903263983582398004039877820.15
210.354029653403094140302970.03
单位质量响应值RSD%判断
389051.90389400.680.07数据可信
供试品溶液-2024011312均一性1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%
5min1387781-3877818.9678.5812.708.978.5812.69
2434841-43484110.05510.05
3404588-4045889.3559.36
4327453-3274537.5727.57
5361013-3610138.3488.35
6310800-3108007.1877.19
10min1650560-65056015.04315.082.5015.0615.102.51
2672301-67230115.54515.57
3648023-64802314.98415.00
4635233-63523314.68814.71
5670367-67036715.50115.52
6635550-63555014.69614.71
15min1714050-71405016.51116.491.8516.5616.541.84
2721172-72117216.67616.73
3693820-69382016.04316.10
4703091-70309116.25716.31
5730971-73097116.90216.96
6715998-71599816.55616.60
20min1748510-74851017.30817.022.2017.4017.112.20
2750811-75081117.36117.45
3725081-72508116.76616.86
4714720-71472016.52616.61
5751410-75141017.37517.47
6725380-72538016.77316.86
30min1773380-77338017.88317.563.5018.0117.683.48
2776154-77615417.94718.08
3713620-71362016.50116.63
4740367-74036717.11917.24
5778967-77896718.01218.14
6773495-77349517.88518.01
45min1775425-77542517.93017.742.2718.1017.912.26
2784318-78431818.13618.31
3735090-73509016.99717.16
4762043-76204317.62117.78
5771338-77133817.83518.00
6775529-77552917.93218.09
60min1783086-78308618.10718.072.5018.3218.282.49
2800963-80096318.52118.73
3747276-74727617.27917.48
4772102-77210217.85318.05
5793426-79342618.34618.56
6792324-79232418.32118.52
极限1751266-75126617.37117.734.0717.6217.984.03
2753941-75394117.43317.69
3725012-72501216.76417.00
4764670-76467017.68117.92
5803462-80346218.57818.83
6803626-80362618.58218.83
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.254029489403170140276664027178402425740280580.07
210.354066540406738140669600.02
单位质量响应值RSD%判断
392981.27392943.000.01数据可信
供试品溶液-2024011312均一性2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%
5min1466729-46672910.6899.606.5310.699.606.53
2384612-3846128.8098.81
3421525-4215259.6549.65
4413465-4134659.4709.47
5404234-4042349.2589.26
6423887-4238879.7089.71
10min1692375-69237515.85715.421.9515.8815.441.96
2653748-65374814.97314.99
3666357-66635715.26215.28
4670863-67086315.36515.39
5677705-67770515.52115.54
6679701-67970115.56715.59
15min1734863-73486316.83116.612.2016.8916.662.20
2734899-73489916.83116.88
3729173-72917316.70016.76
4715903-71590316.39616.45
5738769-73876916.92016.98
6696970-69697015.96316.02
20min1756816-75681617.33317.091.3917.4317.181.39
2753264-75326417.25217.34
3745554-74555417.07517.17
4738854-73885416.92217.01
5752653-75265317.23817.33
6729513-72951316.70816.80
30min1770068-77006817.63717.432.1217.7717.562.11
2768489-76848917.60117.73
3758198-75819817.36517.50
4755090-75509017.29417.42
5780616-78061617.87818.01
6733884-73388416.80816.94
45min1756171-75617117.31917.531.9317.4917.691.92
2775564-77556417.76317.93
3746307-74630717.09317.26
4768302-76830217.59617.76
5787059-78705918.02618.20
6757730-75773017.35417.52
60min1783970-78397017.95517.583.0118.1717.793.00
2775095-77509517.75217.96
3798114-79811418.27918.49
4733373-73337316.79617.00
5760434-76043417.41617.63
6753842-75384217.26517.47
极限1784204-78420417.96117.771.3218.2118.021.30
2784438-78443817.96618.21
3777972-77797217.81818.07
4756730-75673017.33117.58
5777435-77743517.80618.06
6773921-77392117.72517.97
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢超君 于 2024-01-26 15:19:03 完成)
生成报告数据部分下载报告( 于 2026-01-02 02:04:06 完成)
Current page cost:90 ms