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%
111.061698131691941688161699211697751695040.29
211.101705471706031705750.03
单位质量响应值RSD%判断
15325.8615367.120.20数据可信
供试品溶液-2023122121批-瑞舒伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1148913-14891383.08887.494.6883.0987.494.68
2155111-15511186.54686.55
3160791-16079189.71589.72
4163935-16393591.47091.47
5164258-16425891.65091.65
6147793-14779382.46382.46
10min1176844-17684498.67297.184.1899.1397.674.17
2178349-17834999.51299.99
3164665-16466591.87792.38
4184846-184846103.137103.65
5171536-17153695.71196.22
6168789-16878994.17894.64
15min1178808-17880899.76898.182.21100.7899.212.22
2177136-17713698.83599.87
3174070-17407097.12598.13
4181287-181287101.151102.23
5174061-17406197.12098.16
6170439-17043995.09996.08
20min1172992-17299296.52397.672.7998.0999.242.78
2176801-17680198.648100.23
3169223-16922394.42095.97
4183536-183536102.406104.05
5175023-17502397.65699.24
6172729-17272996.37697.89
30min1174855-17485597.56397.362.7899.6699.472.78
2177403-17740398.984101.12
3174377-17437797.29699.37
4181432-181432101.232103.44
5171574-17157495.73297.85
6167266-16726693.32895.37
45min1174734-17473497.49597.432.36100.14100.092.35
2171650-17165095.77498.46
3173420-17342096.76299.38
4182676-182676101.927104.70
5171726-17172695.81798.47
6173535-17353596.82699.39
60min1171210-17121095.52996.362.5098.7199.562.50
2175651-17565198.007101.22
3170304-17030495.02398.17
4180099-180099100.489103.83
5170043-17004394.87898.06
6168889-16888994.23497.34
极限1175167-17516797.73796.132.22101.4599.872.21
2172001-17200195.97099.73
3169828-16982894.75898.44
4178331-17833199.502103.40
5167955-16795593.71397.43
6170490-17049095.12798.75
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%
111.151867471876651845971868651863611864470.62
211.091894951889471892210.21
单位质量响应值RSD%判断
16721.7017062.311.43数据可信
供试品溶液-2023122121批-依折麦布-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114492-144927.7036.729.697.706.729.67
211685-116856.2116.21
311398-113986.0586.06
412919-129196.8676.87
513561-135617.2087.21
611815-118156.2806.28
10min117068-170689.0728.535.469.118.575.43
215790-157908.3938.43
315018-150187.9828.02
417187-171879.1359.17
515524-155248.2518.29
615745-157458.3698.40
15min117215-172159.1508.625.949.248.705.88
214990-149907.9678.05
316735-167358.8958.97
415680-156808.3348.42
515442-154428.2088.29
617197-171979.1419.22
20min116026-160268.5188.642.058.668.782.00
216754-167548.9059.03
316139-161398.5788.71
416542-165428.7928.93
515858-158588.4298.56
616243-162438.6338.77
30min115336-153368.1518.436.218.348.626.03
217309-173099.2009.37
315881-158818.4418.62
416521-165218.7818.97
515711-157118.3518.53
614440-144407.6757.86
45min115405-154058.1888.272.428.428.492.35
215309-153098.1378.36
315711-157118.3518.57
415480-154808.2288.46
515176-151768.0668.29
616225-162258.6248.85
60min116801-168018.9308.475.499.218.745.36
216083-160838.5488.82
314904-149047.9228.19
417086-170869.0829.36
515293-152938.1298.40
615442-154428.2088.48
极限116798-167988.9288.564.839.268.884.70
215787-157878.3918.71
315966-159668.4868.80
416556-165568.8009.13
514758-147587.8448.16
616739-167398.8979.21
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%
111.061722661727481736861734671741991732730.45
211.101751381743051747220.34
单位质量响应值RSD%判断
15666.6415740.720.34数据可信
供试品溶液-2023122121批-瑞舒伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1154215-15421584.08990.384.9084.0990.394.90
2170034-17003492.71592.72
3176661-17666196.32996.33
4170558-17055893.00193.00
5161072-16107287.82887.83
6162025-16202588.34888.35
10min1174219-17421994.99798.282.4395.4698.782.43
2177256-17725696.65397.17
3185346-185346101.064101.60
4177996-17799697.05797.57
5183843-183843100.245100.73
6182765-18276599.657100.15
15min1171958-17195893.76498.222.5794.7699.262.57
2180831-18083198.60299.65
3185948-185948101.393102.49
4178888-17888897.54398.60
5181311-18131198.86499.91
6181795-18179599.128100.17
20min1172093-17209393.83898.233.2295.3599.823.21
2178528-17852897.34798.95
3188250-188250102.648104.31
4177533-17753396.80498.40
5185349-185349101.066102.66
6179132-17913297.67699.27
30min1171915-17191593.74197.932.6295.78100.072.62
2179320-17932097.77999.92
3185378-185378101.082103.31
4177055-17705596.54498.68
5181655-18165599.052101.21
6182293-18229399.400101.54
45min1169847-16984792.61396.933.1195.1799.623.10
2175435-17543595.66098.34
3185956-185956101.397104.19
4176633-17663396.31398.99
5177058-17705896.54599.25
6181677-18167799.064101.75
60min1170556-17055693.00096.352.1996.0799.572.19
2174048-17404894.90498.12
3178157-17815797.144100.50
4177313-17731396.68499.89
5181566-18156699.003102.25
6178567-17856797.368100.61
极限1165969-16596990.49995.232.9394.0998.982.90
2171939-17193993.75497.50
3177637-17763796.861100.76
4174980-17498095.41299.16
5180476-18047698.409102.20
6176822-17682296.416100.20
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%
111.151893961902541926791924281926881914890.82
211.091909991935841922920.96
单位质量响应值RSD%判断
17173.9017339.220.68数据可信
供试品溶液-2023122121批-依折麦布-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111552-115526.0106.638.996.016.629.00
213212-132126.8746.87
313965-139657.2657.27
413981-139817.2747.27
511465-114655.9655.96
612238-122386.3676.37
10min115960-159608.3038.342.438.348.382.44
216390-163908.5278.57
315654-156548.1448.18
415924-159248.2848.32
516617-166178.6458.68
615674-156748.1548.19
15min115055-150557.8328.545.327.918.625.29
216872-168728.7788.86
316924-169248.8058.89
417219-172198.9589.04
516862-168628.7728.85
615610-156108.1218.20
20min115892-158928.2688.534.448.398.664.41
215715-157158.1768.31
316351-163518.5078.64
417059-170598.8759.01
517486-174869.0979.23
615847-158478.2448.37
30min115223-152237.9208.362.928.098.542.90
216153-161538.4048.58
316451-164518.5598.74
415859-158598.2518.44
516425-164258.5458.73
616316-163168.4888.66
45min116174-161748.4158.384.568.638.614.41
216372-163728.5188.74
316786-167868.7338.96
416218-162188.4378.67
514685-146857.6407.87
616453-164538.5608.78
60min115314-153147.9678.252.078.238.522.03
215871-158718.2578.53
316000-160008.3248.60
415825-158258.2338.51
516322-163228.4928.76
615822-158228.2318.50
极限115043-150437.8267.892.978.138.202.84
214732-147327.6647.98
314637-146377.6157.94
415232-152327.9248.25
515770-157708.2048.52
615561-155618.0968.41
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%
111.061676591682301674471675161684561678620.27
211.101692741699071695900.27
单位质量响应值RSD%判断
15177.4015278.380.47数据可信
供试品溶液-2023122221批-瑞舒伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1159077-15907789.45191.265.8689.4591.265.86
2155884-15588487.65687.66
3172743-17274397.13697.14
4170892-17089296.09596.09
5166893-16689393.84693.85
6148304-14830483.39383.39
10min1171188-17118896.26198.931.5496.7699.431.53
2176709-17670999.36699.85
3179277-179277100.810101.35
4175034-17503498.42498.96
5176507-17650799.25299.77
6176841-17684199.44099.90
15min1171118-17111896.22299.141.6697.25100.201.67
2176266-17626699.117100.16
3179571-179571100.975102.08
4177826-17782699.994101.07
5177658-17765899.900100.97
6175411-17541198.63699.65
20min1168855-16885594.95099.032.3796.52100.642.36
2177867-177867100.017101.61
3179417-179417100.889102.55
4178350-178350100.289101.92
5178828-178828100.558102.19
6173348-17334897.47699.04
30min1170013-17001395.60198.341.9597.69100.501.96
2174997-17499798.403100.55
3180305-180305101.388103.61
4174981-17498198.394100.59
5176028-17602898.983101.17
6173032-17303297.29899.40
45min1164576-16457692.54397.483.0895.17100.193.05
2172739-17273997.13499.83
3180360-180360101.419104.20
4173725-17372597.688100.43
5176948-17694899.500102.24
6171837-17183796.62699.27
60min1165488-16548893.05696.232.1896.2099.482.16
2171031-17103196.17399.40
3175385-17538598.621101.97
4168124-16812494.53997.82
5173631-17363197.635100.92
6173177-17317797.380100.56
极限1160051-16005189.99995.452.9593.6599.232.91
2169942-16994295.56199.33
3174166-17416697.936101.83
4172490-17249096.994100.80
5171651-17165196.522100.35
6170142-17014295.67399.40
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%
111.151858291852411853371850331857581854400.19
211.091860801859971860380.04
单位质量响应值RSD%判断
16631.3916775.290.61数据可信
供试品溶液-2023122221批-依折麦布-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113836-138367.4376.4210.877.446.4210.86
210708-107085.7555.76
312467-124676.7016.70
412550-125506.7456.75
511750-117506.3156.32
610324-103245.5495.55
10min115494-154948.3288.152.648.378.192.64
215468-154688.3148.35
315157-151578.1478.18
415313-153138.2308.27
514406-144067.7437.78
615195-151958.1678.20
15min114947-149478.0348.162.078.128.242.06
214849-148497.9818.06
315173-151738.1558.24
415747-157478.4648.55
515206-152068.1738.25
615128-151288.1318.21
20min115869-158698.5298.436.048.668.555.98
217256-172569.2759.40
315674-156748.4248.55
415875-158758.5328.66
514825-148257.9688.09
614590-145907.8427.96
30min115439-154398.2988.072.078.488.242.05
214526-145267.8077.98
315065-150658.0978.27
414820-148207.9658.14
515049-150498.0888.26
615150-151508.1438.31
45min115315-153158.2317.922.678.468.142.64
214484-144847.7858.00
314284-142847.6777.90
415108-151088.1208.34
514580-145807.8368.05
614673-146737.8868.10
60min115402-154028.2787.753.678.558.013.59
214378-143787.7287.99
314069-140697.5627.82
413864-138647.4527.72
514372-143727.7257.98
614444-144447.7638.02
极限113431-134317.2197.683.577.547.993.37
214516-145167.8028.11
314005-140057.5277.83
414910-149108.0148.32
514443-144437.7638.06
614437-144377.7608.06
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%
111.061658311667601657881663321657101660840.28
211.101677021677171677100.01
单位质量响应值RSD%判断
15016.6415109.010.44数据可信
供试品溶液-2023122221批-瑞舒伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1152350-15235086.60791.793.8186.6191.803.81
2158864-15886490.31090.31
3170560-17056096.95996.96
4159971-15997190.94090.94
5161853-16185392.00992.01
6165242-16524293.93693.94
10min1176690-176690100.44499.821.59100.93100.331.59
2173718-17371898.75499.26
3179153-179153101.844102.38
4171922-17192297.73398.24
5177958-177958101.165101.68
6174090-17409098.96699.49
15min1176885-176885100.55599.892.37101.59100.952.35
2177439-177439100.870101.92
3180492-180492102.605103.71
4170097-17009796.69697.74
5178217-178217101.312102.39
6171113-17111397.27498.35
20min1176613-176613100.40099.472.28102.00101.092.26
2170643-17064397.00698.62
3179567-179567102.079103.75
4174725-17472599.327100.91
5178386-178386101.408103.04
6169969-16996996.62398.24
30min1174128-17412898.98799.662.27101.14101.832.25
2179914-179914102.277104.43
3179001-179001101.758104.00
4170099-17009996.69798.83
5176982-176982100.610102.81
6171719-17171997.61899.77
45min1173864-17386498.83798.501.83101.54101.231.82
2171604-17160497.553100.27
3176999-176999100.620103.43
4168798-16879895.95798.63
5176539-176539100.358103.12
6171845-17184597.690100.38
60min1151469-15146986.10695.315.3389.3698.585.18
2171720-17172097.619100.88
3173305-17330598.520101.89
4164547-16454793.54196.75
5176453-176453100.309103.63
6168414-16841495.73998.97
极限1168679-16867995.89095.731.9199.6299.531.83
2169786-16978696.519100.32
3163863-16386393.15297.07
4166222-16622294.49398.22
5173282-17328298.507102.38
6168544-16854495.81399.58
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%
111.151823771833901831641836981840131833280.34
211.091847771847721847740.01
单位质量响应值RSD%判断
16441.9716661.320.94数据可信
供试品溶液-2023122221批-依折麦布-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19816-98165.3246.349.645.326.349.65
212652-126526.8636.86
312092-120926.5596.56
410906-109065.9165.92
511942-119426.4786.48
612721-127216.9006.90
10min115190-151908.2398.552.538.278.592.56
216058-160588.7108.75
315762-157628.5508.59
415504-155048.4108.44
515783-157838.5618.60
616322-163228.8538.89
15min116688-166889.05210.2916.669.1310.3716.51
216539-165398.9719.06
315772-157728.5558.64
422626-2262612.27312.35
519349-1934910.49510.58
622849-2284912.39412.48
20min119661-1966110.6649.957.4810.7910.097.36
216915-169159.1759.31
317955-179559.7399.87
418359-183599.95810.11
520216-2021610.96611.11
616940-169409.1899.34
30min116386-163868.8889.125.769.079.325.58
218142-181429.84110.03
317206-172069.3339.52
417542-175429.5159.72
516063-160638.7138.92
615595-155958.4598.67
45min116318-163188.8518.673.199.098.923.12
215388-153888.3478.59
315646-156468.4878.72
415560-155608.4408.70
516444-164448.9209.17
616556-165568.9809.23
60min113313-133137.2218.155.727.508.445.61
215004-150048.1388.43
315439-154398.3748.66
415331-153318.3168.62
515522-155228.4198.72
615514-155148.4158.72
极限116274-162748.8278.524.309.158.864.15
216184-161848.7789.11
314477-144777.8538.18
416120-161208.7449.09
515696-156968.5148.86
615492-154928.4038.75
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%
111.061672741688231683031687671681561682650.38
211.101693071689591691330.15
单位质量响应值RSD%判断
15213.8315237.210.11数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1169500-16950095.32693.741.7395.3393.741.73
2166658-16665893.72893.73
3162786-16278691.55091.55
4165188-16518892.90192.90
5170466-17046695.86995.87
6165431-16543193.03893.04
10min1175600-17560098.757100.821.6999.29101.341.67
2178708-178708100.505101.03
3180812-180812101.688102.20
4176157-17615799.07099.59
5181030-181030101.810102.34
6183333-183333103.106103.62
15min1176775-17677599.417100.391.89100.50101.471.87
2176577-17657799.306100.39
3184814-184814103.939105.01
4175335-17533598.60899.67
5178508-178508100.392101.49
6179034-179034100.688101.78
20min1174273-17427398.010100.972.8899.64102.622.85
2176026-17602698.996100.63
3186608-186608104.948106.60
4175709-17570998.818100.43
5179787-179787101.111102.77
6184863-184863103.966105.62
30min1173190-17319097.40199.301.8299.58101.501.81
2174154-17415497.943100.12
3180570-180570101.552103.79
4173872-17387297.78599.95
5178238-178238100.240102.46
6179402-179402100.895103.12
45min1172243-17224396.86997.351.0799.58100.101.08
2170093-17009395.66098.38
3175158-17515898.508101.31
4172756-17275697.15799.86
5173595-17359597.629100.40
6174718-17471898.261101.05
60min1169793-16979395.49197.391.8198.75100.681.79
2171708-17170896.56899.82
3177107-17710799.604102.95
4169897-16989795.54998.80
5175665-17566598.793102.11
6174821-17482198.319101.65
极限1169061-16906195.07996.382.4498.86100.212.37
2171409-17140996.400100.19
3176388-17638899.200103.10
4169767-16976795.47699.25
5165649-16564993.16097.03
6175946-17594698.951102.83
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%
111.151892421877231880601873981885591881960.39
211.091875461880811878140.21
单位质量响应值RSD%判断
16878.5716935.440.24数据可信
供试品溶液-2023122321批-依折麦布-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112842-128426.8196.047.366.826.047.36
211257-112575.9775.98
311203-112035.9495.95
411175-111755.9345.93
511519-115196.1176.12
610258-102585.4475.45
10min115544-155448.2548.063.878.298.103.84
214618-146187.7627.80
315245-152458.0958.13
415803-158038.3918.42
515563-155638.2648.30
614324-143247.6067.64
15min116380-163808.6988.314.798.788.394.76
214678-146787.7947.87
315413-154138.1848.26
416690-166908.8628.94
515464-154648.2118.29
615263-152638.1058.18
20min115677-156778.3248.312.128.468.442.11
215507-155078.2348.35
315155-151558.0478.17
415997-159978.4948.62
515550-155508.2578.38
616041-160418.5188.64
30min115569-155698.2677.883.388.458.063.32
215194-151948.0688.23
314477-144777.6877.86
415063-150637.9988.17
514302-143027.5947.77
614483-144837.6907.86
45min115104-151048.0207.465.388.247.675.31
213830-138307.3447.55
314420-144207.6577.87
414459-144597.6787.90
513333-133337.0807.29
613117-131176.9657.17
60min114789-147897.8537.652.868.127.912.82
214382-143827.6377.89
313854-138547.3567.61
414296-142967.5917.85
514976-149767.9528.21
614169-141697.5247.77
极限115079-150798.0077.744.388.328.034.24
215516-155168.2398.53
314248-142487.5667.86
414452-144527.6747.98
513715-137157.2837.58
614392-143927.6427.93
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%
111.061690881690891686901689211682761688130.21
211.101703301703441703370.01
单位质量响应值RSD%判断
15263.3815345.680.39数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1167189-16718993.54291.455.7393.5491.455.73
2160062-16006289.55489.55
3149184-14918483.46883.47
4169397-16939794.77794.78
5175831-17583198.37798.38
6159027-15902788.97588.97
10min1184215-184215103.068101.281.39103.59101.791.39
2179762-179762100.576101.07
3180029-180029100.726101.19
4177206-17720699.14699.67
5182442-182442102.076102.62
6182456-182456102.083102.58
15min1187238-187238104.759100.672.76105.85101.742.75
2177885-17788599.526100.58
3174185-17418597.45698.48
4175474-17547498.17799.25
5182018-182018101.838102.95
6182760-182760102.254103.31
20min1187159-187159104.715100.472.15106.39102.102.15
2178143-17814399.670101.28
3176130-17613098.544100.11
4178174-17817499.688101.31
5179204-179204100.264101.94
6178622-17862299.938101.57
30min1185574-185574103.82899.892.32106.08102.082.31
2177422-17742299.267101.43
3175721-17572198.315100.43
4173969-17396997.33599.51
5177675-17767599.408101.64
6180827-180827101.172103.36
45min1182879-182879102.320100.031.34105.15102.781.35
2179620-179620100.497103.21
3177163-17716399.122101.78
4176025-17602598.485101.20
5177908-17790899.539102.33
6179155-179155100.237102.98
60min1178706-17870699.98599.321.25103.39102.621.26
2177104-17710499.089102.36
3174021-17402197.364100.57
4176912-17691298.982102.25
5177599-17759999.366102.71
6180737-180737101.122104.43
极限1182111-182111101.89099.481.74105.85103.331.72
2177073-17707399.072102.89
3178253-17825399.732103.48
4172568-17256896.551100.37
5177940-17794099.557103.45
6178862-178862100.073103.94
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%
111.151879011894571891671884661891381888260.34
211.091888091897501892800.36
单位质量响应值RSD%判断
16935.0717067.630.56数据可信
供试品溶液-2023122321批-依折麦布-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19274-92744.8975.6714.104.905.6614.07
210475-104755.5315.53
39997-99975.2795.28
410528-105285.5595.56
513659-136597.2137.21
610441-104415.5135.51
10min114710-147107.7688.005.127.798.035.16
214920-149207.8797.91
314635-146357.7287.76
415414-154148.1398.17
516607-166078.7698.81
614601-146017.7107.74
15min115047-150477.9468.141.868.028.221.90
215270-152708.0638.14
315326-153268.0938.17
415551-155518.2128.29
515890-158908.3918.48
615436-154368.1518.22
20min115484-154848.1768.151.338.298.271.32
215116-151167.9828.10
315384-153848.1248.24
415453-154538.1608.28
515424-154248.1458.28
615755-157558.3198.44
30min115504-155048.1878.231.928.358.401.93
215357-153578.1098.27
315277-152778.0678.23
415604-156048.2408.41
515672-156728.2768.46
616116-161168.5108.68
45min114502-145027.6587.844.617.868.054.51
214418-144187.6137.82
315349-153498.1058.31
414022-140227.4047.62
514905-149057.8718.10
615895-158958.3938.61
60min114338-143387.5717.793.857.828.053.81
214055-140557.4227.67
314672-146727.7488.00
414645-146457.7337.99
515570-155708.2228.49
615265-152658.0618.32
极限115168-151688.0107.993.628.308.293.56
215084-150847.9658.26
315499-154998.1848.48
414136-141367.4657.76
515740-157408.3128.63
615167-151678.0098.31
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