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%
111.311687131692911694521688731696381691930.24
211.361689241696561692900.31
单位质量响应值RSD%判断
14959.5914902.290.28数据可信
供试品溶液-CLB03646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%
5min183030-8303047.61749.264.6947.6249.264.69
289397-8939751.26951.27
379045-7904545.33245.33
488033-8803350.48650.49
588423-8842350.71050.71
687471-8747150.16450.16
10min1121043-12104369.41769.481.5169.6869.751.52
2122762-12276270.40370.69
3117883-11788367.60567.86
4120724-12072469.23469.51
5122827-12282770.44070.72
6121655-12165569.76870.05
15min1132790-13279076.15476.241.8776.8076.901.87
2135113-13511377.48678.16
3129725-12972574.39675.02
4130208-13020874.67375.34
5134481-13448177.12477.80
6135371-13537177.63478.30
20min1141842-14184281.34581.291.6182.4282.381.61
2145101-14510183.21484.32
3140393-14039380.51481.56
4138317-13831779.32480.40
5142736-14273681.85882.96
6142117-14211781.50382.60
30min1147234-14723484.43884.481.6885.9686.011.67
2145016-14501683.16684.73
3145772-14577283.59985.09
4145194-14519483.26884.79
5150831-15083186.50188.06
6149761-14976185.88787.44
45min1152053-15205387.20186.922.4989.2088.922.46
2154554-15455488.63690.67
3150672-15067286.40988.36
4144451-14445182.84284.82
5153990-15399088.31290.35
6153648-15364888.11690.14
60min1150151-15015186.11187.522.7288.5990.012.69
2155297-15529789.06291.58
3149132-14913285.52687.96
4147902-14790284.82187.26
5158433-15843390.86093.39
6154785-15478588.76891.29
极限1155091-15509188.94488.022.1391.9091.002.11
2157682-15768290.43093.45
3149556-14955685.76988.68
4150327-15032786.21289.13
5155946-15594689.43492.47
6152295-15229587.34090.35
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%
111.081839691840751832761843091830521837360.30
211.171822591838851830720.63
单位质量响应值RSD%判断
16582.6716389.620.83数据可信
供试品溶液-CLB03646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%
5min18932-89324.8645.5911.894.865.5911.91
212217-122176.6536.65
39152-91524.9844.98
410351-103515.6375.64
59979-99795.4345.43
610994-109945.9875.99
10min119500-1950010.61911.023.3810.6511.053.38
219890-1989010.83110.87
319588-1958810.66710.69
420720-2072011.28311.31
521200-2120011.54511.58
620532-2053211.18111.21
15min123386-2338612.73512.852.5512.8212.942.55
223284-2328412.68012.78
322732-2273212.37912.47
423877-2387713.00313.10
523807-2380712.96513.06
624486-2448613.33413.43
20min124427-2442713.30213.813.8013.4613.983.79
226508-2650814.43514.60
324546-2454613.36713.52
424517-2451713.35113.52
526076-2607614.20014.37
626116-2611614.22214.39
30min127135-2713514.77714.852.6315.0115.092.58
226157-2615714.24414.49
327658-2765815.06215.29
426864-2686414.62914.87
528184-2818415.34815.59
627654-2765415.05915.31
45min128645-2864515.59915.691.7915.9116.011.77
229693-2969316.17016.50
328916-2891615.74716.06
428103-2810315.30415.63
528773-2877315.66916.00
628728-2872815.64415.98
60min128830-2883015.70016.493.6716.1016.903.63
230535-3053516.62817.05
329311-2931115.96216.36
430429-3042916.57116.98
531986-3198617.41917.84
630618-3061816.67417.09
极限130300-3030016.50016.701.1216.9917.201.13
230792-3079216.76817.28
330746-3074616.74317.23
430437-3043716.57517.07
531239-3123917.01217.53
630455-3045516.58517.10
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%
111.311701091702461701751699051700271700920.08
211.361707681707371707520.02
单位质量响应值RSD%判断
15039.0815030.990.04数据可信
供试品溶液-CLB03646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%
5min178866-7886644.91647.117.3644.9247.117.36
273599-7359941.91641.92
387932-8793250.07950.08
482537-8253747.00747.01
590467-9046751.52351.52
682874-8287447.19847.20
10min1113193-11319364.46668.343.1364.7268.613.12
2121872-12187269.40969.64
3124198-12419870.73371.01
4119267-11926767.92568.19
5121491-12149169.19269.48
6119998-11999868.34168.60
15min1128870-12887073.39475.581.8974.0076.221.89
2134916-13491676.83777.46
3134011-13401176.32276.99
4131880-13188075.10875.75
5131181-13118174.71075.38
6135375-13537577.09977.74
20min1140004-14000479.73580.540.9080.7581.600.91
2140934-14093480.26581.31
3142025-14202580.88681.98
4143191-14319181.55082.61
5140127-14012779.80580.89
6142244-14224481.01182.08
30min1147016-14701683.72985.551.8585.1987.061.83
2150448-15044885.68387.17
3149624-14962485.21486.76
4152632-15263286.92788.44
5147555-14755584.03685.56
6154055-15405587.73889.26
45min1150475-15047585.69986.672.3687.6288.662.32
2156691-15669189.23991.21
3152670-15267086.94988.97
4147648-14764884.08986.08
5149695-14969585.25487.25
6155935-15593588.80890.82
60min1151474-15147486.26886.871.7488.6789.341.70
2154733-15473388.12490.59
3150212-15021285.54988.05
4153264-15326487.28789.75
5149330-14933085.04787.52
6156143-15614388.92791.43
极限1154538-15453888.01387.811.5090.8990.761.46
2154815-15481588.17091.12
3153528-15352887.43790.41
4156525-15652589.14492.09
5149969-14996985.41088.35
6155734-15573488.69491.69
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%
111.081872261859481859641867501863601864500.30
211.171858321858991858660.03
单位质量响应值RSD%判断
16827.6216639.750.80数据可信
供试品溶液-CLB03646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%
5min18251-82514.4273.8230.104.433.8230.06
23142-31421.6861.69
37124-71243.8223.82
47661-76614.1104.11
59491-94915.0925.09
67107-71073.8133.81
10min119764-1976410.60410.992.3310.6311.002.34
220171-2017110.82210.83
320316-2031610.90010.92
420781-2078111.14911.17
521053-2105311.29511.32
620768-2076811.14211.16
15min123431-2343112.57112.983.2312.6513.063.20
224809-2480913.31013.38
325079-2507913.45513.54
424577-2457713.18613.27
524167-2416712.96613.06
623124-2312412.40612.49
20min125748-2574813.81413.750.6113.9713.910.59
225781-2578113.83213.98
325415-2541513.63513.79
425692-2569213.78413.94
525705-2570513.79113.95
625467-2546713.66313.82
30min126992-2699214.48114.781.6514.7115.011.65
227463-2746314.73414.95
328055-2805515.05215.28
428033-2803315.04015.27
527684-2768414.85315.09
627095-2709514.53714.76
45min127606-2760614.81115.312.2615.1215.622.21
228921-2892115.51615.82
328704-2870415.40015.72
427903-2790314.97015.29
529304-2930415.72216.04
628732-2873215.41515.72
60min129185-2918515.65816.172.2616.0516.572.22
229824-2982416.00116.39
330760-3076016.50316.90
431015-3101516.64017.04
529793-2979315.98416.39
630310-3031016.26216.66
极限131042-3104216.65416.382.1917.1316.862.11
230331-3033116.27316.75
330183-3018316.19316.69
431260-3126016.77117.27
529449-2944915.80016.30
630865-3086516.55917.04
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