依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.261713301712651705241703501707711708480.26
211.201698821702601700710.16
单位质量响应值RSD%判断
15173.0015184.910.06数据可信
供试品溶液-CLB05410批-瑞舒伐他汀钙-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%
5min179419-7941944.80244.343.2044.8044.343.20
275979-7597942.86142.86
375670-7567042.68742.69
478706-7870644.40044.40
579345-7934544.76044.76
682441-8244146.50746.51
10min1110108-11010862.11465.072.9762.3665.322.97
2113163-11316363.83864.08
3114744-11474464.72964.97
4116337-11633765.62865.87
5119293-11929367.29667.54
6118429-11842966.80867.07
15min1124075-12407569.99373.763.4870.5974.363.47
2129658-12965873.14373.74
3130480-13048073.60674.20
4129024-12902472.78573.40
5133742-13374275.44776.07
6137482-13748277.55678.19
20min1132290-13229074.62878.083.3175.6179.103.30
2135787-13578776.60077.60
3139425-13942578.65379.66
4138372-13837278.05979.07
5138487-13848778.12379.17
6146112-14611282.42583.49
30min1134286-13428675.75481.093.4777.1582.543.46
2143690-14369081.05982.48
3145739-14573982.21483.66
4144236-14423681.36782.82
5145609-14560982.14183.62
6148950-14895084.02685.54
45min1141016-14101679.55084.023.4581.3785.923.43
2149093-14909384.10685.98
3152280-15228085.90487.80
4146447-14644782.61484.52
5148685-14868583.87685.81
6156131-15613188.07790.06
60min1140511-14051179.26584.734.1181.5387.104.07
2149906-14990684.56586.91
3154283-15428387.03489.41
4149008-14900884.05886.42
5148629-14862983.84586.24
6158888-15888889.63292.11
极限1147402-14740283.15386.772.7085.8589.602.70
2151342-15134285.37588.19
3155790-15579087.88490.74
4152573-15257386.07088.90
5158269-15826989.28392.15
6157462-15746288.82891.80
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.951838161839931836091840891838841838780.10
210.931838951840861839900.08
单位质量响应值RSD%判断
16792.5116833.490.18数据可信
供试品溶液-CLB05410批-依折麦布-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%
5min116003-160038.5458.567.088.558.567.07
216974-169749.0639.06
316356-163568.7338.73
416042-160428.5668.57
513895-138957.4197.42
616965-169659.0599.06
10min122430-2243011.97712.214.2112.0212.264.22
223893-2389312.75812.81
322454-2245411.99012.04
423789-2378912.70212.75
521380-2138011.41611.46
623263-2326312.42212.47
15min126594-2659414.20013.662.8314.3113.772.82
225702-2570213.72413.85
325970-2597013.86713.98
424862-2486213.27513.39
524641-2464113.15713.26
625680-2568013.71213.83
20min126411-2641114.10214.074.3514.3014.264.31
226157-2615713.96714.16
325551-2555113.64313.84
428333-2833315.12915.32
524994-2499413.34613.52
626651-2665114.23114.43
30min127586-2758614.73015.343.5415.0015.613.49
228438-2843815.18515.46
330516-3051616.29416.56
429149-2914915.56415.84
528110-2811015.01015.26
628568-2856815.25415.53
45min129964-2996416.00016.071.8516.3516.421.83
230799-3079916.44616.80
330181-3018116.11616.47
429526-2952615.76616.13
529466-2946615.73416.07
630643-3064316.36216.72
60min130192-3019216.12116.312.5916.5616.752.57
231216-3121616.66817.12
331323-3132316.72517.17
430487-3048716.27916.73
529185-2918515.58416.01
630833-3083316.46416.91
极限131130-3113016.62216.881.4017.1517.411.34
231660-3166016.90517.45
331826-3182616.99417.53
431922-3192217.04517.59
532094-3209417.13717.65
631009-3100916.55817.10
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.261703891711511698821702561704271704210.28
211.201700441697671699060.12
单位质量响应值RSD%判断
15135.0815170.180.17数据可信
供试品溶液-CLB05410批-瑞舒伐他汀钙-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%
5min179166-7916644.73743.275.7144.7443.275.71
282452-8245246.59446.59
379285-7928544.80444.80
472579-7257941.01541.01
574572-7457242.14142.14
671402-7140240.34940.35
10min1115374-11537465.19863.932.4365.4564.162.44
2116979-11697966.10566.36
3113812-11381264.31564.56
4111119-11111962.79463.02
5109827-10982762.06362.30
6111621-11162163.07763.30
15min1127629-12762972.12372.882.7572.7373.482.74
2133137-13313775.23675.86
3128939-12893972.86473.47
4128154-12815472.42073.00
5123452-12345269.76370.34
6132495-13249574.87375.45
20min1138834-13883478.45576.962.2279.4777.962.22
2139020-13902078.56079.60
3137931-13793177.94578.96
4133494-13349475.43876.42
5131700-13170074.42475.39
6136106-13610676.91477.90
30min1135954-13595476.82879.292.7778.2880.722.75
2142988-14298880.80382.28
3145396-14539682.16383.61
4138989-13898978.54379.94
5136145-13614576.93678.32
6142407-14240780.47481.89
45min1148294-14829483.80183.702.8785.6885.572.86
2154302-15430287.19689.13
3147971-14797183.61985.52
4145824-14582482.40584.24
5141741-14174180.09881.91
6150581-15058185.09486.96
60min1149368-14936884.40884.903.2486.7587.233.21
2156660-15666088.52990.94
3152058-15205885.92888.29
4146392-14639282.72685.02
5143393-14339381.03283.28
6153563-15356386.77989.12
极限1154766-15476687.45886.421.6190.2789.221.63
2155829-15582988.05990.96
3152356-15235686.09788.94
4151601-15160185.67088.42
5149028-14902884.21686.92
6153942-15394286.99389.81
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.951839561839211839601836271845651840060.19
210.931842331835101838720.28
单位质量响应值RSD%判断
16804.2016822.690.08数据可信
供试品溶液-CLB05410批-依折麦布-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%
5min114456-144567.7198.2413.047.728.2413.02
218338-183389.7929.79
316972-169729.0629.06
415185-151858.1088.11
515133-151338.0808.08
612546-125466.6996.70
10min124244-2424412.94512.185.8112.9912.225.84
223900-2390012.76112.82
322606-2260612.07012.12
422319-2231911.91711.96
523225-2322512.40112.45
620557-2055710.97611.01
15min123829-2382912.72313.322.8012.8413.442.80
225589-2558913.66313.79
325371-2537113.54713.66
424516-2451613.09013.20
525575-2557513.65613.77
624835-2483513.26113.36
20min125823-2582313.78813.901.3013.9714.081.29
226487-2648714.14314.34
325771-2577113.76013.95
425625-2562513.68213.87
526191-2619113.98514.17
626268-2626814.02614.20
30min127944-2794414.92115.112.8415.1815.382.79
227330-2733014.59314.87
329414-2941415.70615.97
429097-2909715.53615.80
528272-2827215.09615.36
627766-2776614.82615.08
45min130240-3024016.14715.891.9816.4916.241.95
230087-3008716.06516.43
328927-2892715.44615.80
429702-2970215.85916.21
530401-3040116.23316.58
629235-2923515.61015.94
60min129925-2992515.97816.272.3916.4116.712.32
231077-3107716.59317.04
330746-3074616.41716.86
429508-2950815.75616.19
530164-3016416.10616.55
631405-3140516.76917.19
极限130212-3021216.13216.852.9116.6617.382.85
232375-3237517.28717.83
331476-3147616.80717.34
431323-3132316.72517.25
532786-3278617.50618.04
631175-3117516.64617.16
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