依折麦布阿托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对照品来源自制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%
111.551938471941001936241936961935471937630.12
211.451931571931761931660.01
单位质量响应值RSD%判断
16776.0216870.390.40数据可信
长期24月-供试品溶液-2024011821批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158092-5809231.00020.3027.2631.0020.3027.26
231009-3100916.54816.55
334224-3422418.26318.26
430625-3062516.34316.34
539928-3992821.30721.31
634417-3441718.36618.37
10min1131946-13194670.41262.007.4370.5862.127.46
2109438-10943858.40158.49
3109299-10929958.32758.43
4119823-11982363.94364.03
5114124-11412460.90161.02
6112504-11250460.03760.14
15min1160604-16060485.70582.763.0186.2783.223.04
2153277-15327781.79582.21
3152379-15237981.31681.74
4161429-16142986.14586.59
5150829-15082980.48980.95
6152005-15200581.11681.55
20min1175076-17507693.42890.881.9894.4791.802.01
2170292-17029290.87591.75
3169460-16946090.43191.31
4173207-17320792.43193.36
5166040-16604088.60689.51
6167764-16776489.52690.41
30min1183951-18395198.16496.731.0699.7298.151.10
2181116-18111696.65198.03
3181044-18104496.61397.99
4182774-18277497.53698.97
5178484-17848495.24796.64
6180217-18021796.17197.55
45min1187887-187887100.26498.900.86102.37100.860.89
2183924-18392498.150100.06
3186601-18660199.578101.49
4184014-18401498.198100.18
5184707-18470798.567100.49
6184893-18489398.667100.58
60min1185848-18584899.17698.841.08101.84101.351.06
2183488-18348897.917100.37
3188195-188195100.429102.90
4182502-18250297.39199.92
5185748-18574899.123101.60
6185482-18548298.981101.45
极限1185826-18582699.16598.811.28102.38101.861.25
2185586-18558699.037102.04
3186874-18687499.724102.75
4185203-18520398.832101.90
5180556-18055696.35299.38
6186879-18687999.727102.74
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.323133763134553128033130943126863130830.11
211.303123973120683122320.08
单位质量响应值RSD%判断
27657.5127631.150.07数据可信
长期24月-供试品溶液-2024011821批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1225689-22568967.57769.228.4967.5869.238.49
2210468-21046863.01963.02
3213361-21336163.88663.89
4237815-23781571.20871.21
5264107-26410779.08079.08
6235703-23570370.57570.58
10min1309753-30975392.74893.361.6393.1293.741.64
2313732-31373293.93994.29
3306531-30653191.78392.14
4307295-30729592.01292.41
5320151-32015195.86196.30
6313231-31323193.78994.18
15min1322351-32235196.52097.691.4397.4198.591.44
2330634-33063499.00099.87
3320659-32065996.01396.88
4324234-32423497.08497.99
5332306-33230699.501100.47
6327316-32731698.00798.92
20min1327554-32755498.07898.631.4199.50100.071.40
2334412-334412100.131101.55
3329677-32967798.714100.11
4322181-32218196.46997.92
5334436-334436100.139101.66
6328106-32810698.24399.70
30min1325781-32578197.54798.530.9499.52100.520.94
2332137-33213799.450101.43
3328508-32850898.364100.31
4325203-32520397.37499.36
5332016-33201699.414101.49
6330747-33074799.034101.04
45min1326807-32680797.85498.351.11100.37100.891.12
2327789-32778998.148100.68
3326770-32677097.843100.34
4324029-32402997.02299.55
5334154-334154100.054102.69
6331172-33117299.161101.71
60min1320729-32072996.03497.541.4499.09100.631.44
2326307-32630797.705100.78
3326381-32638197.727100.76
4320618-32061896.00199.06
5333060-33306099.727102.92
6327457-32745798.049101.15
极限1320262-32026295.89597.011.0899.49100.641.05
2328035-32803598.222101.84
3320256-32025695.89399.47
4325216-32521697.378100.97
5322570-32257096.586100.33
6327539-32753998.073101.72
依折麦布阿托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对照品来源自制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%
111.551936401943331945391944421946751943260.21
211.451943091952941948020.36
单位质量响应值RSD%判断
16824.7617013.280.79数据可信
长期24月-供试品溶液-2024011821批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158650-5865031.12227.5413.0131.1227.5413.02
245049-4504923.90423.90
347352-4735225.12725.13
451047-5104727.08727.09
561674-6167432.72632.73
647612-4761225.26425.26
10min1148840-14884078.97970.849.3779.1570.999.38
2120884-12088464.14564.28
3131023-13102369.52569.66
4134998-13499871.63471.78
5146366-14636677.66777.85
6118883-11888363.08363.22
15min1177060-17706093.95489.123.4194.5789.673.45
2161840-16184085.87886.37
3165954-16595488.06188.59
4167428-16742888.84389.39
5172130-17213091.33891.95
6163289-16328986.64687.14
20min1183879-18387997.57294.781.8398.7195.821.88
2175661-17566193.21194.18
3176901-17690193.86994.88
4177986-17798694.44595.49
5181217-18121796.16097.28
6176064-17606493.42594.40
30min1187308-18730899.39299.000.77101.07100.580.80
2186127-18612798.765100.25
3183966-18396697.61899.15
4186758-18675899.100100.67
5187984-18798499.750101.41
6187331-18733199.404100.90
45min1185295-18529598.32499.120.68100.55101.240.59
2187363-18736399.421101.45
3186718-18671899.079101.16
4187175-18717599.321101.44
5185512-18551298.439100.65
6188670-188670100.114102.16
60min1187385-18738599.43399.440.60102.21102.110.63
2187074-18707499.268101.85
3186204-18620498.806101.44
4189006-189006100.293102.96
5188406-18840699.974102.73
6186367-18636798.892101.49
极限1186310-18631098.86298.850.68102.19102.070.66
2185216-18521698.282101.42
3186643-18664399.039102.22
4188555-188555100.053103.28
5185208-18520898.277101.59
6185792-18579298.587101.74
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.323131163140953138943142693143733139490.16
211.303145723153953149840.19
单位质量响应值RSD%判断
27734.0127874.690.36数据可信
长期24月-供试品溶液-2024011821批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1276847-27684782.41876.5716.6082.4276.5616.60
2170631-17063150.79850.80
3271582-27158280.85180.85
4272132-27213281.01581.01
5282789-28278984.18784.19
6269139-26913980.12480.12
10min1324786-32478696.69093.604.8597.1594.034.91
2284178-28417884.60184.88
3323007-32300796.16096.61
4320171-32017195.31695.77
5320225-32022595.33295.80
6314100-31410093.50993.95
15min1332093-33209398.86597.132.5299.8698.082.59
2309805-30980592.23092.98
3329020-32902097.95198.93
4328433-32843397.77698.76
5330049-33004998.25799.25
6328231-32823197.71698.68
20min1334715-33471599.64697.691.57101.1999.171.64
2319912-31991295.23996.50
3330408-33040898.36499.89
4327941-32794197.62999.15
5330772-33077298.472100.02
6325096-32509696.78298.29
30min1331655-33165598.73598.270.72100.83100.300.80
2326236-32623697.12298.92
3328229-32822997.71599.79
4331627-33162798.727100.79
5332246-33224698.911101.00
6330596-33059698.420100.46
45min1325758-32575896.97997.300.6699.6399.880.69
2324946-32494696.73899.07
3329660-32966098.141100.76
4328440-32844097.778100.39
5324302-32430296.54699.19
6327955-32795597.633100.23
60min1328760-32876097.87397.410.79101.06100.520.83
2325142-32514296.79699.67
3327711-32771197.561100.72
4330252-33025298.317101.47
5328112-32811297.680100.86
6323163-32316396.20799.34
极限1326153-32615397.09796.570.95100.83100.230.99
2321430-32143095.69199.10
3327216-32721697.413101.12
4328056-32805697.664101.37
5321472-32147295.70399.42
6322051-32205195.87699.54
依折麦布阿托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对照品来源自制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%
111.551935831938281939801942401944531940170.18
211.451950421955781953100.20
单位质量响应值RSD%判断
16798.0117057.641.09数据可信
长期24月-供试品溶液-2024012021批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131047-3104716.46625.2918.7416.4725.3018.74
252144-5214427.65627.66
345892-4589224.34024.34
447823-4782325.36425.36
555886-5588629.64029.64
653353-5335328.29728.30
10min1111324-11132459.04368.538.1659.1368.678.18
2137575-13757572.96673.12
3128626-12862668.22068.35
4127136-12713667.42967.57
5141889-14188975.25475.42
6128726-12872668.27368.43
15min1154578-15457881.98486.593.6782.4087.113.71
2169055-16905589.66290.22
3163088-16308886.49787.01
4162947-16294786.42286.94
5170626-17062690.49591.08
6159243-15924384.45884.99
20min1172736-17273691.61493.261.5892.4994.261.62
2177625-17762594.20795.26
3172662-17266291.57592.57
4177744-17774494.27095.27
5179165-17916595.02496.11
6175105-17510592.87193.88
30min1182898-18289897.00497.410.6498.3998.930.66
2183780-18378097.47299.05
3181959-18195996.50698.01
4185395-18539598.32899.85
5183802-18380297.48399.10
6184150-18415097.66899.19
45min1185574-18557498.42398.020.64100.35100.080.59
2183553-18355397.35199.47
3184116-18411697.65099.69
4185825-18582598.556100.62
5183639-18363997.39799.55
6186182-18618298.746100.81
60min1177933-17793394.37196.981.4796.8499.591.50
2183947-18394797.560100.22
3182034-18203496.54699.13
4185351-18535198.305100.92
5184743-18474397.982100.68
6183131-18313197.12799.74
极限1184476-18447697.84197.790.98100.83100.940.96
2181277-18127796.14499.35
3183362-18336297.250100.37
4185510-18551098.389101.55
5185803-18580398.545101.78
6185899-18589998.595101.75
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.323126913129703132073135193138803132530.15
211.303149853152893151370.07
单位质量响应值RSD%判断
27672.5327888.230.55数据可信
长期24月-供试品溶液-2024012021批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1227991-22799167.93370.6915.7067.9370.6915.70
2266521-26652179.41379.41
3247313-24731373.69073.69
4232519-23251969.28269.28
5277285-27728582.62182.62
6171928-17192851.22851.23
10min1313847-31384793.51593.642.9493.8994.032.99
2322188-32218896.00096.44
3311761-31176192.89393.30
4314438-31443893.69194.08
5324694-32469496.74797.21
6298585-29858588.96789.25
15min1319237-31923795.12197.321.9496.0298.241.97
2330404-33040498.44899.42
3321551-32155195.81096.74
4330986-33098698.62299.53
5334974-33497499.810100.81
6322566-32256696.11396.89
20min1331194-33119498.68498.421.58100.1199.871.58
2330179-33017998.38199.90
3320711-32071195.56097.02
4334190-33419099.576101.03
5335566-33556699.986101.54
6329939-32993998.31099.62
30min1334725-33472599.73699.001.15101.71101.001.14
2333118-33311899.257101.32
3324706-32470696.75098.74
4333237-33323799.292101.30
5334860-33486099.776101.88
6332877-33287799.185101.04
45min1332460-33246099.06198.250.93101.59100.800.90
2329704-32970498.240100.86
3324441-32444196.67299.20
4328287-32828797.817100.38
5331158-33115898.673101.33
6332293-33229399.011101.42
60min1317534-31753494.61397.031.8097.69100.131.79
2330662-33066298.525101.69
3319988-31998895.34598.41
4327314-32731497.528100.63
5332308-33230899.016102.22
6326088-32608897.162100.12
极限1329145-32914598.07397.551.35101.68101.181.32
2326094-32609497.164100.88
3320116-32011695.38398.98
4326113-32611397.170100.81
5332991-33299199.219102.98
6329792-32979298.266101.77
依折麦布阿托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对照品来源自制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%
111.551941791948031948921953631954241949320.26
211.451941451944811943130.13
单位质量响应值RSD%判断
16877.2316970.570.39数据可信
长期24月-供试品溶液-2024012021批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145369-4536924.06719.5231.3524.0719.5231.35
225336-2533613.44013.44
348714-4871425.84125.84
425099-2509913.31413.31
528689-2868915.21915.22
647545-4754525.22125.22
10min1120189-12018963.75662.7910.9963.8962.9011.01
2121859-12185964.64264.72
3127455-12745567.61167.75
499447-9944752.75352.83
5106852-10685256.68156.77
6134384-13438471.28671.43
15min1155447-15544782.45983.435.4682.9583.895.50
2164464-16446487.24387.68
3163722-16372286.84987.37
4146913-14691377.93278.30
5147526-14752678.25878.66
6165605-16560587.84888.38
20min1168247-16824789.24991.562.6390.2092.482.66
2178415-17841594.64395.56
3176528-17652893.64294.64
4169572-16957289.95290.75
5168069-16806989.15589.99
6174831-17483192.74293.77
30min1179335-17933595.13196.861.1696.5798.291.19
2184533-18453397.88999.33
3185015-18501598.14499.67
4181663-18166396.36697.67
5181789-18178996.43397.76
6183211-18321197.18798.73
45min1181509-18150996.28598.631.2798.25100.591.24
2187212-18721299.310101.30
3188031-18803199.744101.81
4186751-18675199.065100.90
5186790-18679099.086100.95
6185261-18526198.275100.35
60min1183184-18318497.17398.760.9799.68101.280.96
2187447-18744799.434101.97
3186512-18651298.938101.56
4185078-18507898.178100.56
5188211-18821199.840102.26
6186664-18666499.019101.64
极限1182394-18239496.75498.261.0199.80101.330.96
2186940-18694099.165102.26
3184583-18458397.915101.09
4185188-18518898.236101.17
5187613-18761399.522102.49
6184699-18469997.977101.15
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.323139393151243152903161513152893151590.26
211.303134343130203132270.10
单位质量响应值RSD%判断
27840.9027719.200.31数据可信
长期24月-供试品溶液-2024012021批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1195694-19569458.31068.8910.5758.3168.8910.57
2225883-22588367.30567.30
3270469-27046980.59080.59
4223453-22345366.58166.58
5230799-23079968.77068.77
6240914-24091471.78471.78
10min1301208-30120889.74993.512.4090.0793.892.42
2318868-31886895.01195.39
3322961-32296196.23196.68
4315994-31599494.15594.52
5312903-31290393.23493.62
6311050-31105092.68293.08
15min1316402-31640294.27697.361.7895.1098.261.80
2330372-33037298.43999.34
3332112-33211298.95799.94
4330659-33065998.52499.42
5325879-32587997.10098.00
6325128-32512896.87697.79
20min1320048-32004895.36398.421.9596.7199.871.96
2337953-337953100.698102.15
3333934-33393499.500101.03
4333015-33301599.226100.67
5331267-33126798.706100.15
6325695-32569597.04598.50
30min1326457-32645797.27299.091.0599.15101.081.09
2336503-336503100.266102.27
3335055-33505599.834101.92
4332046-33204698.938100.93
5331861-33186198.883100.87
6333334-33333499.321101.31
45min1322865-32286596.20299.201.5998.62101.741.62
2337413-337413100.537103.10
3337076-337076100.436103.08
4333825-33382599.468102.01
5332780-33278099.156101.69
6333584-33358499.396101.94
60min1324155-32415596.58698.891.3299.54101.991.34
2336444-336444100.248103.37
3333588-33358899.397102.59
4330461-33046198.465101.56
5331754-33175498.851101.94
6335011-33501199.821102.92
极限1322617-32261796.12898.041.2399.62101.681.24
2334574-33457499.691103.37
3328986-32898698.026101.78
4328683-32868397.936101.58
5327708-32770897.645101.28
6331675-33167598.827102.48
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