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%
111.311707441710511704111716951719661711730.38
211.361686531706251696390.83
单位质量响应值RSD%判断
15134.6614933.010.95数据可信
供试品溶液-CLB01071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%
5min179421-7942145.23846.145.7145.2446.145.71
284314-8431448.02548.02
382228-8222846.83646.84
477759-7775944.29144.29
574787-7478742.59842.60
687535-8753549.85949.86
10min1124130-12413070.70368.343.3670.9568.603.36
2123037-12303770.08170.35
3117065-11706566.67966.94
4113664-11366464.74264.99
5119614-11961468.13168.37
6122427-12242769.73370.01
15min1133149-13314975.84175.403.3876.4876.043.37
2137388-13738878.25578.91
3130479-13047974.32074.95
4124590-12459070.96571.57
5135362-13536277.10177.72
6133324-13332475.94076.60
20min1142761-14276181.31580.781.6982.3881.831.70
2145372-14537282.80383.89
3142730-14273081.29882.34
4138348-13834878.80279.80
5140582-14058280.07481.12
6141100-14110080.36981.46
30min1149298-14929885.03986.202.7886.5687.712.76
2156898-15689889.36890.92
3151849-15184986.49287.99
4144943-14494382.55884.00
5154657-15465788.09189.58
6150425-15042585.68187.21
45min1154792-15479288.16887.812.6790.1689.802.65
2158088-15808890.04692.09
3152693-15269386.97388.95
4148099-14809984.35686.25
5159223-15922390.69292.67
6152124-15212486.64988.66
60min1153524-15352487.44687.621.8389.9390.091.79
2157333-15733389.61692.16
3154012-15401287.72490.18
4153675-15367587.53289.90
5155499-15549988.57191.05
6148931-14893184.83087.32
极限1152280-15228086.73788.982.1989.7091.932.15
2156711-15671189.26192.31
3159383-15938390.78393.73
4153093-15309387.20090.05
5160834-16083491.61094.58
6154970-15497088.27091.23
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%
111.081859991862751858481871111853461861160.35
211.171851791855461853620.15
单位质量响应值RSD%判断
16797.4716594.630.86数据可信
供试品溶液-CLB01071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%
5min17800-78004.1945.8921.324.195.8921.35
211448-114486.1566.16
310731-107315.7705.77
411809-118096.3506.35
59295-92954.9985.00
614630-146307.8677.87
10min120185-2018510.85411.092.0910.8811.122.13
220565-2056511.05811.09
320464-2046411.00411.04
420890-2089011.23311.27
520298-2029810.91510.94
621351-2135111.48111.52
15min122021-2202111.84112.443.9611.9212.543.96
224589-2458913.22213.32
323774-2377412.78412.88
422554-2255412.12812.23
522890-2289012.30812.40
622989-2298912.36212.47
20min125431-2543113.67513.244.6413.8213.404.59
224923-2492313.40213.57
325594-2559413.76213.93
425151-2515113.52413.69
522552-2255212.12712.28
624112-2411212.96613.14
30min126057-2605714.01114.763.8814.2414.993.88
228513-2851315.33215.58
327882-2788214.99315.23
426751-2675114.38514.62
526782-2678214.40114.63
628664-2866415.41315.66
45min129474-2947415.84916.022.7716.1516.342.75
230818-3081816.57216.90
329774-2977416.01016.33
428417-2841715.28015.60
529921-2992116.08916.39
630360-3036016.32516.66
60min130403-3040316.34816.352.9916.7416.762.94
231422-3142216.89617.32
330584-3058416.44616.86
431250-3125016.80417.21
529017-2901715.60316.00
629767-2976716.00616.43
极限130147-3014716.21116.672.6516.6917.172.66
231253-3125316.80517.32
331887-3188717.14617.65
431386-3138616.87717.38
529818-2981816.03416.51
631497-3149716.93717.45
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%
111.311712351702481697701699011692451700800.44
211.361689671699521694600.42
单位质量响应值RSD%判断
15038.0214917.250.58数据可信
供试品溶液-CLB01071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%
5min178689-7868944.98744.967.9244.9944.977.92
272341-7234141.35841.36
370258-7025840.16740.17
481343-8134346.50546.50
586154-8615449.25549.26
683116-8311647.51847.52
10min1115894-11589466.25866.754.1266.5167.004.13
2112479-11247964.30664.54
3111121-11112163.52963.75
4118594-11859467.80268.06
5117954-11795467.43667.71
6124499-12449971.17871.44
15min1130111-13011174.38674.412.9775.0075.032.98
2127425-12742572.85073.44
3126274-12627472.19272.77
4131519-13151975.19175.83
5128548-12854873.49274.14
6137061-13706178.35979.02
20min1141008-14100880.61680.403.3881.6581.433.37
2136336-13633677.94578.94
3138374-13837479.11080.09
4143107-14310781.81682.87
5136291-13629177.91978.98
6148641-14864184.98086.07
30min1148222-14822284.74085.401.5886.2286.881.59
2148297-14829784.78386.21
3149267-14926785.33886.75
4150345-15034585.95487.46
5146659-14665983.84785.34
6153478-15347887.74589.31
45min1151902-15190286.84486.433.2088.7988.393.16
2147171-14717184.13986.04
3153801-15380187.93089.82
4153440-15344087.72489.71
5143790-14379082.20784.16
6156969-15696989.74191.80
60min1153576-15357687.80188.321.6090.2390.761.59
2152160-15216086.99289.35
3157758-15775890.19292.57
4154420-15442088.28490.76
5151924-15192486.85789.27
6157099-15709989.81592.37
极限1156012-15601289.19488.242.4492.1191.162.43
2149624-14962485.54288.39
3154683-15468388.43491.31
4156228-15622889.31792.28
5150158-15015885.84788.74
6159308-15930891.07894.13
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%
111.081881661877151869981879391883641878360.29
211.171849731858971854350.36
单位质量响应值RSD%判断
16952.7116601.161.49数据可信
供试品溶液-CLB01071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%
5min111936-119366.3885.8810.156.395.8810.15
29568-95685.1205.12
310727-107275.7415.74
412648-126486.7696.77
510515-105155.6275.63
610499-104995.6195.62
10min120643-2064311.04711.165.6411.0811.205.66
219722-1972210.55510.58
319246-1924610.30010.33
421690-2169011.60811.65
522021-2202111.78511.82
621827-2182711.68111.71
15min122254-2225411.91012.594.6412.0112.684.59
224225-2422512.96413.05
322683-2268312.13912.23
423409-2340912.52812.63
523278-2327812.45812.55
625276-2527613.52713.62
20min124263-2426312.98513.454.5213.1513.624.48
224700-2470013.21913.38
324270-2427012.98913.15
426782-2678214.33314.50
524430-2443013.07413.24
626370-2637014.11214.28
30min127278-2727814.59815.123.6614.8315.363.64
227640-2764014.79215.02
327989-2798914.97915.21
427866-2786614.91315.16
528634-2863415.32415.56
630165-3016516.14316.39
45min130026-3002616.06915.933.9116.3916.263.84
228304-2830415.14715.46
331290-3129016.74517.06
429295-2929515.67816.01
528859-2885915.44415.77
630851-3085116.51016.85
60min130164-3016416.14316.432.5116.5516.842.47
229983-2998316.04616.44
331925-3192517.08517.49
431077-3107716.63117.05
530060-3006016.08716.50
631023-3102316.60317.03
极限130988-3098816.58416.721.8317.0817.221.84
230587-3058716.36916.86
331413-3141316.81117.31
431263-3126316.73117.24
530950-3095016.56317.06
632250-3225017.25917.78
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