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%
111.861776651771271774731769081768441772030.21
211.841784251772321778280.48
单位质量响应值RSD%判断
14941.2315019.260.37数据可信
长期12月-供试品溶液-2023122121批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1136197-13619777.85182.884.3677.8582.884.36
2145161-14516182.97582.98
3155229-15522988.73088.73
4145758-14575883.31683.32
5141159-14115980.68880.69
6146470-14647083.72383.72
10min1170149-17014997.25897.390.9997.6997.850.98
2171272-17127297.90098.36
3171445-17144597.99998.49
4169257-16925796.74997.21
5172355-17235598.51998.97
6167769-16776995.89896.36
15min1174336-17433699.65299.680.69100.62100.680.69
2172667-17266798.69899.70
3175256-175256100.178101.22
4176131-176131100.678101.68
5173794-17379499.342100.34
6174085-17408599.508100.51
20min1169889-16988997.11099.411.2698.64100.971.25
2173224-17322499.016100.57
3174703-17470399.862101.46
4175663-175663100.410101.97
5174375-17437599.674101.22
6175673-175673100.416101.97
30min1169561-16956196.92296.161.1198.9998.271.07
2167481-16748195.73397.84
3165738-16573894.73796.89
4169005-16900596.60598.72
5170731-17073197.59199.69
6166840-16684095.36797.48
45min1166977-16697795.44596.371.3898.0599.011.36
2165670-16567094.69897.33
3171223-17122397.872100.55
4168011-16801196.03698.69
5168219-16821996.15598.80
6171482-17148298.020100.66
60min1168346-16834696.22896.450.8599.3699.620.84
2167209-16720995.57898.74
3169884-16988497.107100.33
4169527-16952796.903100.09
5170399-17039997.401100.58
6167003-16700395.46098.64
极限1167666-16766695.83997.021.4699.51100.731.43
2169352-16935296.803100.50
3174023-17402399.473103.23
4169519-16951996.898100.62
5170678-17067897.561101.28
6167102-16710295.51799.23
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%
111.161882721896441887481881521880501885730.35
211.181892581888531890560.16
单位质量响应值RSD%判断
16897.2216910.200.06数据可信
长期12月-供试品溶液-2023122121批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min190401-9040148.01254.229.2148.0154.229.21
2103049-10304954.72954.73
3113761-11376160.41860.42
4103259-10325954.84054.84
5110111-11011158.48058.48
691973-9197348.84748.85
10min1149777-14977779.54685.064.4879.8185.364.49
2157789-15778983.80184.11
3164432-16443287.32987.66
4162109-16210986.09686.40
5170499-17049990.55190.88
6156377-15637783.05183.32
15min1167686-16768689.05792.242.4889.7793.012.49
2169278-16927889.90390.67
3174393-17439392.62093.44
4177631-17763194.33995.12
5178027-17802794.55095.38
6175044-17504492.96593.70
20min1169331-16933189.93193.412.3791.1394.702.38
2173387-17338792.08593.35
3174823-17482392.84894.18
4179815-17981595.49996.81
5177938-17793894.50295.86
6179990-17999095.59296.84
30min1173088-17308891.92691.551.2193.6393.351.19
2171018-17101890.82792.61
3169194-16919489.85891.71
4173754-17375492.28094.12
5175041-17504192.96494.84
6172128-17212891.41793.20
45min1172168-17216891.43892.071.3993.6594.391.37
2170336-17033690.46592.75
3174271-17427192.55594.91
4172695-17269591.71894.07
5173212-17321291.99294.39
6177502-17750294.27196.56
60min1174241-17424192.53992.161.0095.2694.991.00
2171623-17162391.14893.94
3173407-17340792.09694.96
4174654-17465492.75895.62
5175822-17582293.37896.28
6171457-17145791.06093.87
极限1173003-17300391.88192.770.8795.1296.100.90
2174002-17400292.41295.71
3176443-17644393.70897.08
4175209-17520993.05396.43
5176220-17622093.59097.01
6173144-17314491.95695.27
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%
111.861778441784361784221780141783901782210.16
211.841788461787551788000.04
单位质量响应值RSD%判断
15027.0715101.350.35数据可信
长期12月-供试品溶液-2023122221批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1139829-13982979.48281.039.6179.4881.039.61
2148405-14840584.35784.36
3156322-15632288.85788.86
4154543-15454387.84687.85
5119611-11961167.98967.99
6136630-13663077.66377.66
10min1181583-181583103.21698.982.37103.6699.432.36
2171264-17126497.35097.82
3173716-17371698.74499.24
4174940-17494099.44099.93
5173612-17361298.68599.06
6169638-16963896.42696.86
15min1179788-179788102.19599.681.44103.21100.681.42
2175719-17571999.882100.89
3173053-17305398.36799.41
4173584-17358498.66999.71
5176312-176312100.219101.15
6173767-17376798.77399.74
20min1179454-179454102.00599.191.93103.59100.741.92
2175243-17524399.612101.18
3171709-17170997.60399.19
4176468-176468100.308101.90
5173976-17397698.892100.37
6170105-17010596.69198.21
30min1173805-17380598.79497.561.13100.9499.661.09
2172150-17215097.85499.97
3168342-16834295.68997.82
4170841-17084197.11099.26
5173077-17307798.381100.41
6171579-17157997.52999.58
45min1173228-17322898.46696.871.10101.1699.521.09
2171748-17174897.625100.29
3168384-16838495.71398.38
4169550-16955096.37699.06
5170816-17081697.09599.67
6168799-16879995.94998.54
60min1173944-17394498.87396.911.66102.12100.101.64
2174193-17419399.015102.22
3167897-16789795.43698.63
4168738-16873895.91499.14
5168528-16852895.79598.91
6169677-16967796.44899.58
极限1175036-17503699.49496.411.88103.29100.141.84
2169112-16911296.12799.88
3167891-16789195.43399.16
4168806-16880695.95399.71
5171084-17108497.248100.90
6165732-16573294.20697.87
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%
111.161888371894311894001892081886941891140.18
211.181895061900201897630.20
单位质量响应值RSD%判断
16945.7016973.430.12数据可信
长期12月-供试品溶液-2023122221批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min188088-8808846.62952.0118.8946.6352.0118.89
2104732-10473255.44055.44
3121795-12179564.47264.47
4112492-11249259.54759.55
570321-7032137.22437.22
692079-9207948.74248.74
10min1167716-16771688.78085.615.0789.0485.905.10
2163382-16338286.48686.79
3169144-16914489.53689.89
4166792-16679288.29188.62
5149126-14912678.93979.15
6154190-15419081.62081.89
15min1177567-17756793.99592.532.2894.7593.302.32
2175592-17559292.94993.74
3174143-17414392.18293.04
4179408-17940894.96995.79
5167817-16781788.83489.48
6174293-17429392.26292.99
20min1181004-18100495.81494.002.7897.0995.282.79
2177897-17789794.16995.47
3175145-17514592.71394.08
4185368-18536898.12499.47
5172383-17238391.25192.39
6173631-17363191.91193.15
30min1176804-17680493.59193.231.8095.4095.041.79
2175599-17559992.95394.78
3171794-17179490.93992.82
4181322-18132295.98297.88
5174425-17442592.33193.98
6176818-17681893.59895.35
45min1177825-17782594.13193.301.8096.4695.621.79
2175719-17571993.01695.36
3171764-17176490.92393.31
4180929-18092995.77498.20
5174116-17411692.16894.33
6177129-17712993.76396.03
60min1179330-17933094.92893.172.1897.7896.002.17
2178457-17845794.46697.33
3171076-17107690.55993.45
4178955-17895594.72997.69
5171259-17125990.65693.33
6176922-17692293.65396.44
极限1178840-17884094.66992.751.8898.0596.101.85
2172635-17263591.38494.77
3171890-17189090.99094.39
4179582-17958295.06198.55
5175137-17513792.70895.88
6173177-17317791.67194.98
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%
111.861799851801271799541802201805791801730.14
211.841792781787881790330.20
单位质量响应值RSD%判断
15191.6515121.030.33数据可信
长期12月-供试品溶液-2023122321批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1156691-15669188.52577.7610.7888.5277.7610.78
2129216-12921673.00373.00
3149290-14929084.34484.34
4145720-14572082.32782.33
5120844-12084468.27368.27
6124109-12410970.11770.12
10min1172506-17250697.46097.084.5397.9597.514.54
2162527-16252791.82292.23
3180901-180901102.203102.67
4175879-17587999.36699.82
5162266-16226691.67592.05
6176874-17687499.928100.32
15min1173956-17395698.27998.833.0399.3199.803.03
2168102-16810294.97295.89
3182946-182946103.358104.39
4173435-17343597.98598.99
5172017-17201797.18498.07
6179102-179102101.186102.13
20min1176999-17699999.99898.162.46101.5899.682.48
2166085-16608593.83295.28
3173979-17397998.29299.90
4178173-178173100.662102.22
5172537-17253797.47798.91
6174686-17468698.692100.20
30min1171791-17179197.05696.861.9999.1998.932.01
2165204-16520493.33595.30
3173128-17312897.81199.97
4173093-17309397.79299.90
5170486-17048696.31998.29
6174983-17498398.859100.91
45min1172282-17228297.33396.381.90100.0198.991.90
2164714-16471493.05895.54
3172920-17292097.694100.39
4169164-16916495.57298.23
5171346-17134696.80599.31
6173170-17317097.835100.44
60min1170795-17079596.49395.332.3199.7198.472.30
2160875-16087590.88993.89
3170602-17060296.38499.63
4169467-16946795.74398.93
5169997-16999796.04299.09
6170658-17065896.41699.56
极限1169342-16934295.67295.932.8999.4299.602.87
2160422-16042290.63394.14
3172530-17253097.473101.25
4172204-17220497.289101.01
5170174-17017496.14299.72
6174104-17410498.363102.05
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%
111.161903291903691913911913221908741908570.27
211.181891981905091898540.49
单位质量响应值RSD%判断
17101.8816981.570.50数据可信
长期12月-供试品溶液-2023122321批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108956-10895657.39853.5821.6457.4053.5821.64
287299-8729945.98945.99
3135805-13580571.54271.54
4111386-11138658.67858.68
594249-9424949.65149.65
672556-7255638.22338.22
10min1162506-16250685.60886.704.7585.9387.004.79
2154831-15483181.56581.82
3177101-17710193.29793.69
4169996-16999689.55489.88
5161048-16104884.84085.12
6161977-16197785.33085.54
15min1174813-17481392.09292.332.3692.8993.112.42
2170645-17064589.89690.60
3183050-18305096.43197.35
4174689-17468992.02692.85
5174506-17450691.93092.68
6173855-17385591.58792.27
20min1181218-18121895.46693.361.9896.7794.651.99
2173140-17314091.21092.42
3175729-17572992.57494.03
4181463-18146395.59596.93
5177435-17743593.47394.73
6174323-17432391.83493.03
30min1177661-17766193.59293.070.6795.4394.880.68
2174610-17461091.98593.70
3175913-17591392.67194.64
4177489-17748993.50295.37
5177074-17707493.28395.06
6177227-17722793.36395.07
45min1177608-17760893.56492.580.9495.9294.910.96
2174272-17427291.80794.03
3175565-17556592.48894.97
4174902-17490292.13994.52
5177924-17792493.73196.03
6174173-17417391.75593.98
60min1175691-17569192.55491.891.0595.4394.731.04
2172073-17207390.64893.38
3173229-17322991.25794.25
4174810-17481092.09094.99
5177106-17710693.30096.12
6173676-17367691.49394.23
极限1175359-17535992.37992.411.5795.7795.761.57
2170549-17054989.84693.08
3175046-17504692.21595.72
4178783-17878394.18397.59
5176939-17693993.21296.55
6175798-17579892.61195.85
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%
111.861764641764511766021763821768921765580.12
211.841771191768511769850.11
单位质量响应值RSD%判断
14886.8514948.060.30数据可信
中间条件12月-供试品溶液-2023122121批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1147375-14737584.59581.5511.3684.6081.5511.36
2142710-14271081.91781.92
3158317-15831790.87690.88
4113515-11351565.15965.16
5154544-15454488.71088.71
6135922-13592278.02178.02
10min1167997-16799796.43296.911.9996.9097.362.02
2170357-17035797.78798.24
3174832-174832100.356100.86
4165519-16551995.01095.37
5166603-16660395.63296.12
6167686-16768696.25496.69
15min1169586-16958697.34498.622.2398.3599.622.25
2171145-17114598.23999.24
3179465-179465103.015104.08
4169344-16934497.20698.10
5170188-17018897.69098.71
6171150-17115098.24299.21
20min1167262-16726296.01098.431.9197.5699.971.93
2173609-17360999.654101.20
3176594-176594101.367103.00
4169307-16930797.18498.61
5171106-17110698.21799.78
6170957-17095798.13199.65
30min1173202-17320299.42098.821.55101.50100.911.58
2172579-17257999.062101.16
3176800-176800101.485103.68
4169850-16985097.49699.47
5170516-17051697.87899.99
6170035-17003597.60299.66
45min1166294-16629495.45597.722.5598.09100.352.55
2172731-17273199.150101.80
3177238-177238101.737104.50
4165851-16585195.20097.71
5168322-16832296.61999.28
6170955-17095598.130100.73
60min1163343-16334393.76196.002.0596.9299.182.04
2165727-16572795.12998.33
3173000-17300099.304102.63
4165635-16563595.07698.12
5166414-16641495.52498.72
6169365-16936597.218100.36
极限1164946-16494694.68196.741.6498.36100.461.63
2169980-16998097.571101.30
3172230-17223098.862102.74
4170109-17010997.645101.21
5168045-16804596.460100.18
6165937-16593795.25098.94
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%
111.161882061878961869431872611873501875310.28
211.181878961881751880360.11
单位质量响应值RSD%判断
16803.8516818.960.07数据可信
中间条件12月-供试品溶液-2023122121批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1105801-10580156.49956.2125.2856.5056.2025.27
2110849-11084959.19559.19
3118542-11854263.30363.30
461344-6134432.75832.76
5140960-14096075.27475.27
694024-9402450.21050.21
10min1162823-16282386.95086.595.8187.2686.905.87
2169546-16954690.54090.87
3164508-16450887.84988.20
4144062-14406276.93177.11
5169591-16959190.56490.98
6162386-16238686.71687.00
15min1171855-17185591.77392.552.5192.5793.352.59
2175021-17502193.46394.30
3176623-17662394.31995.16
4165403-16540388.32788.94
5177214-17721494.63495.56
6173771-17377192.79693.56
20min1172624-17262492.18394.221.5793.4995.531.62
2177986-17798695.04796.40
3179159-17915995.67397.04
4175736-17573693.84594.95
5179153-17915395.67097.12
6174017-17401792.92794.20
30min1180278-18027896.27195.411.2198.0997.241.27
2177794-17779494.94496.82
3180572-18057296.42898.32
4176697-17669794.35895.98
5180794-18079496.54698.52
6175899-17589993.93295.72
45min1173022-17302292.39694.541.4294.7596.901.46
2177614-17761494.84897.25
3179900-17990096.06998.50
4175157-17515793.53695.68
5178630-17863095.39197.91
6177938-17793895.02197.34
60min1170184-17018490.88092.751.4193.7595.631.41
2171494-17149491.58094.51
3176447-17644794.22597.19
4173411-17341192.60495.27
5175364-17536493.64796.69
6175173-17517393.54596.39
极限1171256-17125691.45393.211.5294.8296.611.51
2175356-17535693.64297.08
3175279-17527993.60197.09
4176177-17617794.08197.26
5177751-17775194.92198.49
6171408-17140891.53494.90
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%
111.861780891773001766991779341771111774270.33
211.841780491785991783240.22
单位质量响应值RSD%判断
14960.1215061.150.48数据可信
中间条件12月-供试品溶液-2023122221批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1131099-13109974.78678.3111.9974.7978.3111.99
2111634-11163463.68263.68
3153425-15342587.52287.52
4129554-12955473.90473.90
5154646-15464688.21888.22
6143282-14328281.73681.74
10min1170187-17018797.08497.251.9597.5097.681.98
2167076-16707695.30995.66
3175778-175778100.273100.76
4170193-17019397.08797.50
5172468-17246898.38598.87
6167125-16712595.33795.79
15min1173864-17386499.18199.062.13100.14100.042.13
2172662-17266298.49699.38
3177713-177713101.377102.42
4174425-17442599.501100.45
5176205-176205100.517101.55
6167046-16704695.29296.28
20min1172342-17234298.31399.751.9399.82101.271.93
2171723-17172397.96099.39
3174799-17479999.715101.32
4172349-17234998.31799.82
5178644-178644101.908103.50
6179293-179293102.278103.79
30min1174010-17401099.26599.331.84101.32101.411.77
2179510-179510102.402104.38
3174052-17405299.288101.45
4171977-17197798.105100.15
5175076-17507699.873102.03
6170086-17008697.02699.11
45min1168973-16897396.39196.271.2198.9998.901.22
2168537-16853796.14298.69
3172378-17237898.334101.05
4167532-16753295.56998.16
5168800-16880096.29299.01
6166318-16631894.87797.50
60min1170372-17037297.18996.561.50100.3399.721.48
2170224-17022497.105100.18
3169973-16997396.962100.22
4167609-16760995.61398.74
5172302-17230298.290101.54
6165108-16510894.18697.33
极限1167983-16798395.82695.321.5699.5199.021.54
2167866-16786695.76099.38
3170675-17067597.362101.16
4165722-16572294.53798.19
5167368-16736895.47699.27
6162922-16292292.93996.61
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%
111.161874031877841878441881921879511878350.16
211.181888241888071888160.01
单位质量响应值RSD%判断
16831.0916888.730.25数据可信
中间条件12月-供试品溶液-2023122221批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186597-8659746.11150.2017.9846.1150.2017.99
266466-6646635.39235.39
3106978-10697856.96356.96
492333-9233349.16549.17
5114813-11481361.13561.14
698435-9843552.41452.41
10min1155754-15575482.93683.743.1883.1984.023.22
2151284-15128480.55580.75
3162567-16256786.56386.88
4154663-15466382.35582.63
5164120-16412087.39087.73
6155179-15517982.62982.92
15min1171297-17129791.21291.381.5291.9392.121.55
2169999-16999990.52191.16
3172411-17241191.80592.60
4172590-17259091.90092.63
5175548-17554893.47594.30
6167861-16786189.38290.13
20min1173713-17371392.49894.342.6893.7295.592.67
2174170-17417092.74293.89
3175032-17503293.20194.51
4173845-17384592.56993.81
5181670-18167096.73598.08
6184598-18459898.29499.54
30min1176719-17671994.09994.661.9995.8496.441.92
2184266-18426698.11899.78
3175254-17525493.31995.14
4174265-17426592.79294.55
5178531-17853195.06496.95
6177575-17757594.55596.35
45min1172072-17207291.62492.401.1993.8894.701.21
2173250-17325092.25294.46
3174253-17425392.78695.13
4170367-17036790.71792.99
5175652-17565293.53195.94
6175550-17555093.47695.79
60min1173505-17350592.38892.251.2495.1695.071.22
2175314-17531493.35196.07
3170945-17094591.02493.88
4170474-17047490.77493.55
5175593-17559393.49996.43
6173691-17369192.48795.32
极限1170934-17093491.01990.980.7794.3094.310.75
2172548-17254891.87895.12
3171142-17114291.12994.49
4168497-16849789.72193.00
5170865-17086590.98294.43
6171188-17118891.15494.51
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%
111.861785521781431781631779361780121781610.14
211.841802281804401803340.09
单位质量响应值RSD%判断
15022.0115230.910.98数据可信
中间条件12月-供试品溶液-2023122321批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1150182-15018285.01977.4310.6785.0277.4310.67
2117440-11744066.48366.48
3135263-13526376.57376.57
4152438-15243886.29686.30
5143390-14339081.17481.17
6121984-12198469.05669.06
10min1171498-17149897.08696.680.9197.5697.110.88
2172652-17265297.73998.11
3168920-16892095.62796.05
4168894-16889495.61296.09
5171622-17162297.15697.61
6171062-17106296.83997.22
15min1173103-17310397.99598.031.2199.0199.001.20
2171712-17171297.20798.12
3173259-17325998.08399.04
4170298-17029896.40797.42
5176384-17638499.852100.84
6174209-17420998.62199.54
20min1175203-17520399.18397.931.37100.7499.441.34
2174128-17412898.575100.03
3173517-17351798.22999.73
4168485-16848595.38096.93
5173978-17397898.490100.04
6172616-17261697.71999.19
30min1168915-16891595.62496.310.9697.7398.370.90
2172813-17281397.83099.83
3169501-16950195.95598.00
4168526-16852695.40397.48
5169754-16975496.09998.19
6171265-17126596.95498.97
45min1170772-17077296.67597.191.5299.3199.781.49
2173458-17345898.196100.74
3170856-17085696.72399.30
4169025-16902595.68698.29
5176048-17604899.662102.29
6169908-16990896.18698.74
60min1172265-17226597.52096.340.96100.7099.470.96
2168499-16849995.38898.48
3171864-17186497.293100.41
4168955-16895595.64698.78
5170549-17054996.54999.73
6168952-16895295.64598.73
极限1171253-17125396.94796.391.55100.66100.061.49
2169689-16968996.06299.68
3170925-17092596.762100.42
4165630-16563093.76497.43
5170505-17050596.524100.24
6173633-17363398.295101.91
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%
111.161888501879241890781883371882411884860.25
211.181911381920281915830.33
单位质量响应值RSD%判断
16889.4317136.231.03数据可信
中间条件12月-供试品溶液-2023122321批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1107196-10719656.56948.9919.7456.5748.9919.74
284659-8465944.67644.68
386937-8693745.87845.88
4122267-12226764.52264.52
583542-8354244.08744.09
672381-7238138.19738.20
10min1163668-16366886.37184.782.3186.6885.052.35
2163845-16384586.46486.71
3160171-16017184.52584.78
4163516-16351686.29086.65
5157770-15777083.25883.50
6154965-15496581.77881.99
15min1172579-17257991.07391.291.4791.8792.041.45
2173668-17366891.64892.38
3175919-17591992.83693.56
4170898-17089890.18691.02
5175437-17543792.58193.29
6169445-16944589.41990.09
20min1176105-17610592.93492.631.4894.2393.881.45
2178047-17804793.95995.20
3177704-17770493.77895.02
4171608-17160890.56191.90
5176628-17662893.21094.43
6173134-17313491.36692.53
30min1170992-17099290.23692.011.3692.0593.771.31
2178222-17822294.05195.81
3174560-17456092.11893.88
4173193-17319391.39793.24
5174851-17485192.27294.01
6174258-17425891.95993.63
45min1173763-17376391.69892.961.7794.0295.231.73
2179903-17990394.93897.22
3177467-17746793.65395.93
4173397-17339791.50593.85
5179293-17929394.61696.87
6173057-17305791.32593.51
60min1174582-17458292.13092.040.9894.9694.830.97
2173845-17384591.74194.55
3177554-17755493.69896.49
4173315-17331591.46194.32
5174499-17449992.08694.86
6172672-17267291.12293.81
极限1173442-17344291.52892.071.2094.8795.371.12
2175227-17522792.47095.79
3176283-17628393.02896.34
4170769-17076990.11893.48
5174852-17485292.27395.56
6176200-17620092.98496.18
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