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%
110.043042697304485130474893052819305167230479060.15
210.013006444300726930068560.02
单位质量响应值RSD%判断
303576.29300385.210.75数据可信
供试品溶液-2026010911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%
5min135181-351811.1601.104.631.161.104.72
234485-344851.1371.14
334287-342871.1311.13
433142-331421.0931.09
532550-325501.0741.07
630910-309101.0201.02
10min139485-394851.3021.283.751.301.283.68
237302-373021.2301.23
340999-409991.3521.35
437257-372571.2291.23
538803-388031.2801.28
639676-396761.3091.31
15min141149-411491.3571.371.981.361.381.83
240369-403691.3311.34
342419-424191.3991.40
442420-424201.3991.40
541248-412481.3601.36
641970-419701.3841.39
20min142109-421091.3891.372.241.391.382.38
240512-405121.3361.34
343044-430441.4201.43
441697-416971.3751.38
540825-408251.3471.35
641175-411751.3581.36
30min140886-408861.3491.341.841.361.351.72
240644-406441.3411.35
341574-415741.3711.38
441143-411431.3571.36
539351-393511.2981.31
640711-407111.3431.35
45min138975-389751.2861.291.851.301.301.89
239065-390651.2881.30
340265-402651.3281.34
438154-381541.2581.27
538580-385801.2721.28
639297-392971.2961.31
60min137811-378111.2471.263.301.261.273.11
238775-387751.2791.29
340006-400061.3201.33
438144-381441.2581.27
536218-362181.1951.21
637712-377121.2441.26
极限135634-356341.1751.233.351.191.253.23
236774-367741.2131.23
339321-393211.2971.31
437139-371391.2251.24
537617-376171.2411.25
638102-381021.2571.27
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%
110.043020323302373730214443024150302575730230820.08
210.013011927302087730164020.21
单位质量响应值RSD%判断
301103.78301338.860.06数据可信
供试品溶液-2026010911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%
5min134545-345451.1421.163.011.141.162.86
233541-335411.1091.11
334436-344361.1391.14
435806-358061.1841.18
536039-360391.1921.19
636065-360651.1931.19
10min139432-394321.3041.331.081.311.330.96
240760-407601.3481.35
340299-402991.3331.33
440161-401611.3281.33
540054-400541.3241.33
640074-400741.3251.33
15min137317-373171.2341.344.171.241.354.14
241649-416491.3771.38
341521-415211.3731.38
441833-418331.3831.39
540926-409261.3531.36
640613-406131.3431.35
20min141548-415481.3741.361.551.381.371.57
241655-416551.3771.38
341942-419421.3871.39
441220-412201.3631.37
540126-401261.3271.33
641024-410241.3561.36
30min140018-400181.3231.321.471.331.331.46
240160-401601.3281.34
340598-405981.3421.35
440513-405131.3401.35
539050-390501.2911.30
639607-396071.3101.32
45min136411-364111.2041.283.181.211.293.22
239023-390231.2901.30
339226-392261.2971.31
440049-400491.3241.33
538846-388461.2841.29
638329-383291.2671.28
60min138232-382321.2641.272.091.281.282.16
237811-378111.2501.26
339788-397881.3161.33
438775-387751.2821.29
537718-377181.2471.26
637888-378881.2531.26
极限137749-377491.2481.242.341.261.262.16
237068-370681.2261.24
338986-389861.2891.30
438320-383201.2671.28
537083-370831.2261.24
636667-366671.2121.23
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%
110.043006525300715130118733014987301804730117170.17
210.013051890305403030529600.05
单位质量响应值RSD%判断
299971.81304991.011.18数据可信
供试品溶液-2026011011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%
5min135415-354151.1661.106.601.171.106.71
233297-332971.0961.10
330100-301000.9910.99
431307-313071.0311.03
534703-347031.1431.14
635159-351591.1581.16
10min138947-389471.2831.322.041.281.321.97
241096-410961.3531.35
339870-398701.3131.31
439279-392791.2931.30
540057-400571.3191.32
640704-407041.3401.34
15min138994-389941.2841.373.051.291.373.04
241961-419611.3821.39
341383-413831.3631.37
441773-417731.3761.38
542258-422581.3921.40
642407-424071.3961.40
20min141938-419381.3811.364.331.391.374.52
242892-428921.4121.42
342505-425051.4001.41
437927-379271.2491.25
541118-411181.3541.36
641842-418421.3781.38
30min141670-416701.3721.382.011.381.391.81
242296-422961.3931.40
341626-416261.3711.38
443339-433391.4271.43
541304-413041.3601.37
641005-410051.3501.36
45min142602-426021.4031.353.921.411.363.73
242049-420491.3851.39
340050-400501.3191.33
442932-429321.4141.42
539491-394911.3001.31
639484-394841.3001.31
60min139990-399901.3171.331.961.331.341.99
241333-413331.3611.37
340122-401221.3211.33
441516-415161.3671.38
540695-406951.3401.35
639498-394981.3011.31
极限139191-391911.2911.305.911.301.325.85
241548-415481.3681.38
341348-413481.3621.38
441010-410101.3501.36
538629-386291.2721.29
635433-354331.1671.18
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%
110.043010430300537430077373004758300630530069210.08
210.013053562305865330561080.12
单位质量响应值RSD%判断
299494.12305305.491.36数据可信
供试品溶液-2026011011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%
5min135168-351681.1581.126.711.161.126.78
236200-362001.1921.19
330128-301280.9920.99
434401-344011.1331.13
535163-351631.1581.16
632201-322011.0611.06
10min140088-400881.3201.313.451.321.313.42
240674-406741.3401.34
337276-372761.2281.23
439764-397641.3101.31
541211-412111.3571.36
639329-393291.2951.30
15min140898-408981.3471.342.491.351.352.38
242149-421491.3881.39
339569-395691.3031.31
439676-396761.3071.31
541004-410041.3511.35
641496-414961.3671.37
20min142615-426151.4041.382.991.411.383.03
243052-430521.4181.42
341204-412041.3571.36
443147-431471.4211.43
540312-403121.3281.33
640720-407201.3411.35
30min142308-423081.3941.326.981.401.336.86
234643-346431.1411.15
341638-416381.3721.38
441477-414771.3661.37
540263-402631.3261.33
640364-403641.3301.34
45min141468-414681.3661.314.581.381.324.74
240622-406221.3381.35
340236-402361.3251.33
436240-362401.1941.20
540087-400871.3201.33
639282-392821.2941.30
60min140178-401781.3231.291.821.341.301.97
238234-382341.2591.27
339057-390571.2871.30
439191-391911.2911.30
539728-397281.3091.32
638605-386051.2721.28
极限139349-393491.2961.282.411.311.292.32
238101-381011.2551.27
339453-394531.3001.31
439494-394941.3011.31
539395-393951.2981.31
637288-372881.2281.24
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