塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.89 3028885302772930248993025533302771430269520.06
29.943019313302072130200170.04
单位质量响应值RSD%判断
306061.88303824.650.52数据可信
供试品溶液-8149402批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117407-174070.5690.5618.170.570.5617.98
218379-183790.6000.60
313147-131470.4290.43
418553-185530.6060.61
514364-143640.4690.47
621828-218280.7130.71
10min137468-374681.2241.196.071.221.186.07
237164-371641.2141.21
332542-325421.0631.06
437086-370861.2111.21
534973-349731.1421.14
638671-386711.2631.26
15min141822-418221.3661.361.801.371.361.72
242424-424241.3861.39
340231-402311.3141.32
441892-418921.3681.37
541483-414831.3551.36
641856-418561.3671.37
20min142150-421501.3771.391.171.381.391.06
243144-431441.4091.41
341743-417431.3631.37
442680-426801.3941.40
542699-426991.3951.40
642326-423261.3821.39
30min141843-418431.3671.381.151.371.391.42
242532-425321.3891.40
342631-426311.3921.40
442832-428321.3991.41
542187-421871.3781.38
641573-415731.3581.36
45min141851-418511.3671.360.911.381.370.80
241790-417901.3651.37
342001-420011.3721.38
441746-417461.3641.37
541582-415821.3581.37
640944-409441.3371.35
60min140448-404481.3211.331.171.331.341.13
241050-410501.3411.35
341061-410611.3411.35
440855-408551.3341.35
541391-413911.3521.36
640071-400711.3091.32
极限139539-395391.2911.281.491.301.291.34
239357-393571.2851.30
339127-391271.2781.29
439151-391511.2791.29
539699-396991.2971.31
638068-380681.2431.26
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.89 3013796301462730125793015392301342130139630.04
29.943012207301335430127800.03
单位质量响应值RSD%判断
304748.53303096.580.39数据可信
供试品溶液-8149402批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19310-93100.3050.5428.240.310.5428.13
216430-164300.5380.54
315287-152870.5010.50
418452-184520.6050.60
515889-158890.5210.52
623655-236550.7750.78
10min129898-298980.9801.159.350.981.159.42
234988-349881.1471.15
333293-332931.0911.09
437538-375381.2301.23
535132-351321.1511.15
639259-392591.2871.29
15min139665-396651.3001.352.461.301.352.48
241426-414261.3581.36
340135-401351.3151.32
442385-423851.3891.39
541389-413891.3561.36
641584-415841.3631.37
20min142305-423051.3861.391.931.391.392.04
242881-428811.4051.41
342127-421271.3811.38
442605-426051.3961.40
543082-430821.4121.42
640812-408121.3371.34
30min142704-427041.3991.394.061.411.404.03
242928-429281.4071.41
343690-436901.4321.44
441827-418271.3711.38
543762-437621.4341.44
639140-391401.2831.29
45min141163-411631.3491.364.781.361.384.64
242558-425581.3951.40
343536-435361.4271.44
441476-414761.3591.37
543126-431261.4131.42
638036-380361.2471.26
60min139422-394221.2921.325.031.301.334.97
241547-415471.3621.37
342142-421421.3811.39
439868-398681.3071.32
542177-421771.3821.39
636967-369671.2111.22
极限136893-368931.2091.273.901.221.294.05
239869-398691.3071.32
339549-395491.2961.31
438146-381461.2501.26
540992-409921.3431.36
637823-378231.2401.25
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.89 3012679301466530137023011509301039030125890.06
29.943007232300895830080950.05
单位质量响应值RSD%判断
304609.61302625.250.47数据可信
供试品溶液-20211229批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133723-337231.1061.214.751.111.214.54
236775-367751.2061.21
338470-384701.2621.26
438519-385191.2641.26
537118-371181.2181.22
637066-370661.2161.22
10min140014-400141.3131.438.911.311.439.02
251107-511071.6771.68
341660-416601.3671.37
442995-429951.4101.41
542954-429541.4091.41
642436-424361.3921.39
15min143318-433181.4211.451.531.421.461.72
244086-440861.4461.45
344166-441661.4491.45
445217-452171.4831.49
544880-448801.4721.48
643945-439451.4421.45
20min148905-489051.6041.523.961.611.533.96
248627-486271.5951.60
344980-449801.4761.48
445948-459481.5071.51
544833-448331.4711.48
645358-453581.4881.49
30min145937-459371.5071.491.871.521.501.84
245296-452961.4861.49
344889-448891.4731.48
446215-462151.5161.52
544276-442761.4521.46
646475-464751.5251.53
45min145798-457981.5021.471.971.511.481.90
244412-444121.4571.47
343497-434971.4271.44
445408-454081.4901.50
544587-445871.4631.47
645645-456451.4971.51
60min145595-455951.4961.482.071.511.502.23
244720-447201.4671.48
344212-442121.4501.46
446433-464331.5231.54
544224-442241.4511.46
645904-459041.5061.52
极限146101-461011.5121.491.151.531.501.17
245239-452391.4841.50
344582-445821.4631.48
445486-454861.4921.51
545565-455651.4951.51
644949-449491.4751.49
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.89 3014846301151230132223016404301631930144610.07
29.943007515300579530066550.05
单位质量响应值RSD%判断
304798.89302480.380.54数据可信
供试品溶液-20211229批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138206-382061.2531.216.031.251.215.96
238872-388721.2751.28
337717-377171.2371.24
438121-381211.2501.25
533396-333961.0951.10
634760-347601.1401.14
10min143343-433431.4221.402.791.421.402.81
243756-437561.4351.44
343212-432121.4171.42
442804-428041.4041.41
541524-415241.3621.36
640686-406861.3351.34
15min144041-440411.4451.451.841.451.461.72
245713-457131.5001.50
344831-448311.4711.47
444066-440661.4451.45
543934-439341.4411.44
643433-434331.4251.43
20min145443-454431.4911.492.201.501.502.11
246343-463431.5201.53
346556-465561.5271.53
444822-448221.4701.48
545011-450111.4761.48
643906-439061.4401.45
30min145305-453051.4861.490.921.491.501.09
245944-459441.5071.52
345994-459941.5091.52
445725-457251.5001.51
545527-455271.4931.50
644908-449081.4731.48
45min144910-449101.4731.480.771.481.490.79
245648-456481.4971.51
344693-446931.4661.48
445237-452371.4841.49
544881-448811.4721.48
645258-452581.4851.49
60min145280-452801.4851.490.971.501.510.81
245945-459451.5071.52
345998-459981.5091.52
445685-456851.4991.51
544908-449081.4731.49
645241-452411.4841.50
极限144254-442541.4521.473.041.471.483.07
245617-456171.4961.51
346545-465451.5271.54
442677-426771.4001.41
544482-444821.4591.47
645641-456411.4971.51
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