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%
111.311706431696561696641697391698211699050.25
211.361703341707441705390.17
单位质量响应值RSD%判断
15022.5515012.240.05数据可信
供试品溶液-2023122121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%
5min192529-9252952.75946.986.7152.7646.986.71
282053-8205346.78646.79
378230-7823044.60644.61
484135-8413547.97347.97
579886-7988645.55045.55
677568-7756844.22844.23
10min1134497-13449776.68974.812.3476.9875.072.36
2134456-13445676.66576.93
3127192-12719272.52472.77
4132174-13217475.36475.63
5130504-13050474.41274.67
6128348-12834873.18373.43
15min1145911-14591183.19784.702.1583.9285.382.14
2152762-15276287.10387.79
3143980-14398082.09682.75
4150202-15020285.64486.33
5150159-15015985.61986.29
6148298-14829884.55885.21
20min1159152-15915290.74789.351.7691.9390.501.76
2159179-15917990.76291.93
3152004-15200486.67187.78
4155590-15559088.71689.88
5158107-15810790.15191.29
6156209-15620989.06990.19
30min1158339-15833990.28391.461.0391.9793.101.02
2163253-16325393.08594.76
3159367-15936790.86992.46
4160175-16017591.33092.98
5160599-16059991.57293.21
6160648-16064891.60093.22
45min1158967-15896790.64192.171.6592.8394.321.63
2163157-16315793.03095.22
3158758-15875890.52292.62
4164452-16445293.76995.93
5164405-16440593.74295.89
6160158-16015891.32093.45
60min1158301-15830190.26291.551.8392.9594.221.80
2164954-16495494.05596.76
3157393-15739389.74492.34
4158831-15883190.56493.25
5161021-16102191.81394.49
6162911-16291192.89095.52
极限1159452-15945290.91891.191.8494.1194.371.82
2163115-16311593.00796.24
3154601-15460188.15291.25
4160661-16066191.60794.79
5159889-15988991.16794.35
6161888-16188892.30795.46
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%
111.081868091870581867221872901858811867520.29
211.171873411861421867420.46
单位质量响应值RSD%判断
16854.8716718.170.58数据可信
供试品溶液-2023122121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%
5min117664-176649.4477.8910.689.457.9010.69
214056-140567.5177.52
314503-145037.7567.76
414828-148287.9307.93
512920-129206.9106.91
614578-145787.7977.80
10min122209-2220911.87811.377.0911.9311.417.09
221297-2129711.39011.43
321686-2168611.59811.64
423171-2317112.39212.44
518900-1890010.10810.15
620248-2024810.82910.87
15min124642-2464213.17912.782.5913.3012.892.57
223392-2339212.51012.62
324171-2417112.92713.03
423497-2349712.56612.68
524498-2449813.10213.20
623191-2319112.40312.51
20min125779-2577913.78713.632.2413.9813.812.23
226268-2626814.04814.22
325206-2520613.48013.66
425694-2569413.74113.92
524596-2459613.15413.32
625401-2540113.58513.76
30min126687-2668714.27315.013.5214.5415.263.45
229481-2948115.76716.02
327976-2797614.96215.22
428663-2866315.32915.59
527318-2731814.61014.85
628281-2828115.12515.37
45min130507-3050716.31616.202.0016.6616.542.01
230829-3082916.48816.83
330509-3050916.31716.65
430793-3079316.46816.81
529316-2931615.67916.00
629805-2980515.94016.27
60min130530-3053016.32816.352.3816.7716.782.35
231857-3185717.03817.47
330527-3052716.32616.75
430391-3039116.25316.69
529601-2960115.83116.24
630567-3056716.34816.77
极限130352-3035216.23316.714.1816.7617.234.12
232664-3266417.46918.00
330615-3061516.37316.89
433020-3302017.66018.19
529782-2978215.92816.42
631083-3108316.62417.13
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%
111.311671681683051673751679921672761676230.30
211.361680461678821679640.07
单位质量响应值RSD%判断
14820.7814785.560.17数据可信
供试品溶液-2023122221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%
5min187653-8765350.70248.3911.1050.7048.3811.09
296163-9616355.62555.62
375196-7519643.49743.50
489970-8997052.04252.04
571816-7181641.54141.54
681099-8109946.91146.91
10min1128012-12801274.04871.524.1874.3371.794.20
2125267-12526772.46072.77
3118582-11858268.59368.83
4130708-13070875.60775.90
5118202-11820268.37368.60
6121107-12110770.05370.31
15min1138851-13885180.31780.383.0181.0181.052.99
2133552-13355277.25277.96
3136633-13663379.03479.66
4146139-14613984.53385.24
5138836-13883680.30980.92
6139779-13977980.85481.50
20min1142677-14267782.53084.384.4283.6785.504.38
2138803-13880380.28981.43
3148252-14825285.75586.82
4155491-15549189.94391.12
5140171-14017181.08182.14
6149905-14990586.71187.81
30min1144710-14471083.70687.204.6685.3088.784.59
2140605-14060581.33282.92
3155699-15569990.06391.60
4158709-15870991.80493.48
5149761-14976186.62888.14
6154986-15498689.65091.23
45min1144160-14416083.38887.995.1685.4590.055.07
2140861-14086181.48083.52
3157632-15763291.18193.22
4158637-15863791.76293.95
5152640-15264088.29390.28
6158743-15874391.82493.90
60min1147169-14716985.12989.214.4587.6591.764.38
2144656-14465683.67586.17
3160853-16085393.04495.59
4158645-15864591.76794.47
5154282-15428289.24391.72
6159705-15970592.38094.97
极限1155215-15521589.78389.692.8892.7892.742.87
2148969-14896986.17089.13
3158690-15869091.79394.85
4159898-15989892.49295.70
5150444-15044487.02390.00
6157125-15712590.88893.99
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%
111.081838791840741842711837661849811841940.27
211.171846521842601844560.16
单位质量响应值RSD%判断
16624.0116513.520.48数据可信
供试品溶液-2023122221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%
5min114759-147597.9978.508.628.008.508.62
217783-177839.6369.64
314657-146577.9427.94
416173-161738.7638.76
514300-143007.7487.75
616500-165008.9408.94
10min119905-1990510.78511.377.5010.8311.417.49
224045-2404513.02913.08
319763-1976310.70810.75
420976-2097611.36611.41
520531-2053111.12411.17
620643-2064311.18511.23
15min123898-2389812.94913.181.9513.0513.291.95
224371-2437113.20513.33
324543-2454313.29813.40
425054-2505413.57513.69
524334-2433413.18513.29
623724-2372412.85512.97
20min125410-2541013.76813.842.6313.9414.022.62
225417-2541713.77213.97
325910-2591014.03914.22
426470-2647014.34214.53
524438-2443813.24113.42
625584-2558413.86214.05
30min128166-2816615.26115.132.7515.5115.392.69
227210-2721014.74315.02
328760-2876015.58315.84
428521-2852115.45415.72
526793-2679314.51714.77
628069-2806915.20915.47
45min128613-2861315.50416.113.1915.8416.453.12
228791-2879115.60015.96
330010-3001016.26116.60
430615-3061516.58816.94
529421-2942115.94116.27
630910-3091016.74817.09
60min130549-3054916.55316.802.7316.9817.232.69
230440-3044016.49416.94
332251-3225117.47517.91
431685-3168517.16817.61
529992-2999216.25116.67
631107-3110716.85517.29
极限133839-3383918.33517.055.3518.8517.585.20
231535-3153517.08717.62
331788-3178817.22417.75
431879-3187917.27317.81
528620-2862015.50716.02
631127-3112716.86617.40
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%
111.311688411682791694061683151682021686090.31
211.361695511699501697500.17
单位质量响应值RSD%判断
14907.9614942.780.17数据可信
供试品溶液-2023122221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%
5min165128-6512837.36442.419.0137.3642.419.01
270528-7052840.46240.46
381431-8143146.71746.72
470056-7005640.19240.19
581711-8171146.87846.88
674714-7471442.86442.86
10min1124385-12438571.36070.991.9971.5771.222.00
2121035-12103569.43969.66
3125231-12523171.84672.11
4120711-12071169.25369.48
5127036-12703672.88173.14
6123988-12398871.13371.37
15min1137265-13726578.75080.431.8379.3581.061.83
2141009-14100980.89881.51
3141372-14137281.10681.76
4141097-14109780.94881.56
5143441-14344182.29382.96
6136939-13693978.56379.20
20min1140385-14038580.54085.433.4981.5886.513.47
2147404-14740484.56785.63
3148752-14875285.34086.45
4151880-15188087.13488.19
5156049-15604989.52690.65
6149003-14900385.48486.55
30min1142422-14242281.70887.723.9383.2089.273.90
2157093-15709390.12591.66
3152030-15203087.22188.80
4153369-15336987.98989.53
5160053-16005391.82393.44
6152428-15242887.44988.99
45min1141961-14196181.44488.624.1383.3990.664.09
2158079-15807990.69192.72
3157697-15769790.47292.54
4155430-15543089.17191.20
5159132-15913291.29593.42
6154494-15449488.63490.66
60min1144511-14451182.90789.374.0385.3091.904.00
2160647-16064792.16494.70
3156400-15640089.72892.30
4154586-15458688.68791.21
5162440-16244093.19395.83
6156045-15604589.52492.05
极限1150205-15020586.17489.592.2289.0392.622.24
2160265-16026591.94594.99
3156634-15663489.86292.93
4155936-15593689.46192.48
5158717-15871791.05794.21
6155251-15525189.06892.09
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%
111.081893101874191873341870821874101877110.49
211.171876481886801881640.39
单位质量响应值RSD%判断
16941.4316845.480.41数据可信
供试品溶液-2023122221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%
5min113037-130376.9288.008.766.938.008.75
214468-144687.6897.69
316426-164268.7298.73
414485-144857.6987.70
516441-164418.7378.74
615420-154208.1958.19
10min119549-1954910.38911.074.3310.4311.114.34
220630-2063010.96311.01
320961-2096111.13911.19
420206-2020610.73810.78
522039-2203911.71211.76
621547-2154711.45111.50
15min123693-2369312.59113.062.1012.6913.162.11
224592-2459213.06913.17
324531-2453113.03613.15
425154-2515413.36713.47
525023-2502313.29813.41
624451-2445112.99413.10
20min125195-2519513.38913.913.1713.5614.093.17
225535-2553513.57013.75
326047-2604713.84214.02
426002-2600213.81813.99
526878-2687814.28414.47
627412-2741214.56714.75
30min127504-2750414.61614.971.6914.8615.221.69
228494-2849415.14215.39
327972-2797214.86515.12
428410-2841015.09815.35
528774-2877415.29115.56
627830-2783014.79015.05
45min127875-2787514.81315.923.4715.1416.263.44
230142-3014216.01816.35
330385-3038516.14716.49
430253-3025316.07716.41
530744-3074416.33816.69
630311-3031116.10816.45
60min128906-2890615.36116.434.0515.7716.854.01
231112-3111216.53416.96
330706-3070616.31816.75
430639-3063916.28216.71
532775-3277517.41717.86
631313-3131316.64017.07
极限130793-3079316.36416.611.7816.8517.121.76
232263-3226317.14517.66
331339-3133916.65417.18
431034-3103416.49217.01
531307-3130716.63717.18
630745-3074516.33916.86
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