奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检所对照品使用方法直接使用
对照品含量(%) 99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.063939739406394653967539755395400.42
216.013946439347394060.21
单位质量响应值RSD%判断
2462.022461.340.02数据可信
供试品溶液-410453批-氨氯地平-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%
5min129368-2936877.34878.323.0477.3578.323.04
231124-3112481.97281.97
329385-2938577.39277.39
430361-3036179.96379.96
528511-2851175.09075.09
629683-2968378.17778.18
10min130717-3071780.90180.191.9181.0380.321.90
230634-3063480.68280.82
330018-3001879.06079.19
431396-3139682.68982.82
529887-2988778.71578.84
630036-3003679.10779.24
15min134595-3459591.11489.982.8191.3890.242.81
234515-3451590.90391.17
332955-3295586.79587.06
435543-3554393.61193.88
533199-3319987.43787.69
634180-3418090.02190.28
20min134658-3465891.28090.871.3491.7091.281.34
235219-3521992.75893.18
334103-3410389.81890.22
434629-3462991.20491.63
533912-3391289.31589.72
634487-3448790.83091.24
30min134567-3456791.04091.741.4291.6192.301.42
235488-3548893.46694.04
334100-3410089.81090.37
435092-3509292.42393.00
534635-3463591.21991.77
635108-3510892.46593.03
45min135049-3504992.31092.291.6293.0393.011.62
235559-3555993.65394.39
334737-3473791.48892.19
435709-3570994.04894.78
534149-3414989.93990.64
635045-3504592.29993.02
60min134852-3485291.79191.781.4392.6692.651.43
234776-3477691.59192.48
334504-3450490.87491.73
435817-3581794.33395.22
534470-3447090.78591.64
634662-3466291.29192.16
极限136744-3674496.77496.081.4997.8097.101.49
237086-3708697.67598.72
336235-3623595.43396.44
437016-3701697.49098.54
535924-3592494.61495.62
635875-3587594.48595.51
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100864-202205对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.044579814566184568414598204565834575690.31
2 11.084556334562134559230.09
单位质量响应值RSD%判断
41446.4741148.290.52数据可信
供试品溶液-410453批-奥美沙坦酯-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%
5min1207725-20772545.18044.983.2645.1844.983.25
2216786-21678647.15147.15
3201408-20140843.80643.81
4209408-20940845.54645.55
5197409-19740942.93642.94
6208097-20809745.26145.26
10min1271450-27145059.04060.172.6559.1260.252.64
2289867-28986763.04663.12
3269626-26962658.64358.72
4278575-27857560.59060.67
5273172-27317259.41459.49
6277319-27731960.31660.39
15min1357340-35734077.72176.961.9777.8977.141.97
2360597-36059778.42978.61
3345516-34551675.14975.32
4359853-35985378.26778.44
5345070-34507075.05275.22
6354756-35475677.15977.33
20min1378101-37810182.23681.981.7282.5482.291.72
2383390-38339083.38783.70
3369232-36923280.30780.60
4382909-38290983.28283.59
5368855-36885580.22580.52
6379149-37914982.46482.77
30min1400843-40084387.18385.941.7887.6286.381.78
2399823-39982386.96187.41
3384022-38402283.52483.95
4401354-40135487.29487.74
5389824-38982484.78685.22
6395030-39503085.91886.36
45min1403267-40326787.71086.941.5988.3087.531.60
2405932-40593288.29088.89
3388986-38898684.60485.17
4404080-40408087.88788.48
5395722-39572286.06986.64
6400425-40042587.09287.68
60min1402172-40217287.47286.441.4888.2087.171.48
2400788-40078887.17187.92
3388931-38893184.59285.30
4401793-40179387.38988.13
5391089-39108985.06185.78
6399852-39985286.96787.70
极限1420303-42030391.41591.021.0492.2991.901.04
2421962-42196291.77692.67
3414009-41400990.04690.90
4424381-42438192.30293.19
5414415-41441590.13590.99
6415881-41588190.45391.33
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检所对照品使用方法直接使用
对照品含量(%) 99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.067920378880789837893178711789420.23
216.017934279671795060.30
单位质量响应值RSD%判断
4915.444966.020.73数据可信
供试品溶液-410314批-氨氯地平-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%
5min158615-5861576.91978.282.2576.9278.282.25
260360-6036079.20979.21
359906-5990678.61378.61
461851-6185181.16581.17
558908-5890877.30377.30
658264-5826476.45876.46
10min163687-6368783.57587.032.3183.7087.162.31
267687-6768788.82488.96
366251-6625186.93987.07
467973-6797389.19989.33
566400-6640087.13587.26
665943-6594386.53586.66
15min165334-6533485.73688.101.6586.0088.371.65
267861-6786189.05289.33
367398-6739888.44488.72
468385-6838589.74090.02
566383-6638387.11387.39
667441-6744188.50188.77
20min166852-6685287.72888.742.8888.1489.172.87
263981-6398183.96084.39
368664-6866490.10690.53
468920-6892090.44290.88
568419-6841989.78490.20
668920-6892090.44290.86
30min168041-6804189.28891.152.6489.8491.722.63
269726-6972691.49992.07
371596-7159693.95394.53
470712-7071292.79393.38
566610-6661087.41087.98
670079-7007991.96392.53
45min169390-6939091.05891.512.7291.7692.232.70
267314-6731488.33489.06
372936-7293695.71296.44
470544-7054492.57393.31
568768-6876890.24290.96
669442-6944291.12791.85
60min171398-7139893.69493.321.3194.5594.201.31
270024-7002491.89092.76
372496-7249695.13496.02
471687-7168794.07394.97
570824-7082492.94093.81
670260-7026092.20093.08
极限172507-7250795.14995.371.2896.1696.401.28
273469-7346996.41197.43
372412-7241295.02496.07
474075-7407597.20698.26
572052-7205294.55295.57
671561-7156193.90794.94
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100864-202205对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.044632124618334628414626244608564622730.21
2 11.084641614644004642800.04
单位质量响应值RSD%判断
41872.5541902.530.06数据可信
供试品溶液-410314批-奥美沙坦酯-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%
5min1157593-15759333.79335.543.1633.7935.543.16
2171417-17141736.75736.76
3165617-16561735.51335.51
4171463-17146336.76736.77
5164050-16405035.17735.18
6164259-16425935.22235.22
10min1247826-24782653.14254.932.2853.2054.982.28
2263046-26304656.40556.47
3255705-25570554.83154.89
4262588-26258856.30756.37
5253661-25366154.39354.45
6254047-25404754.47654.53
15min1293915-29391563.02564.581.6163.1764.731.61
2304100-30410065.20965.36
3302163-30216364.79364.94
4308009-30800966.04766.20
5298330-29833063.97164.12
6300589-30058964.45664.61
20min1320931-32093168.81870.531.5069.0770.791.50
2332718-33271871.34571.61
3330699-33069970.91271.17
4334215-33421571.66671.93
5325564-32556469.81170.07
6329387-32938770.63170.89
30min1348832-34883274.80176.751.5775.1777.121.57
2359644-35964477.11977.50
3364053-36405378.06478.44
4361733-36173377.56777.95
5353750-35375075.85576.23
6359399-35939977.06677.44
45min1372593-37259379.89680.991.2580.3881.491.25
2375035-37503580.41980.93
3385745-38574582.71683.22
4379951-37995181.47381.99
5375005-37500580.41380.91
6377757-37775781.00381.51
60min1382102-38210281.93582.471.0782.5683.111.07
2381410-38141081.78682.43
3391933-39193384.04384.69
4386937-38693782.97183.62
5382329-38232981.98382.62
6382854-38285482.09682.73
极限1396460-39646085.01385.781.1085.7786.551.10
2403057-40305786.42887.21
3402004-40200486.20286.99
4406308-40630887.12587.91
5396280-39628084.97585.74
6395986-39598684.91285.69
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检所对照品使用方法直接使用
对照品含量(%) 99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.063976839849397613989039768398070.15
216.014057940322404500.45
单位质量响应值RSD%判断
2478.642526.551.36数据可信
供试品溶液-SD018YD批-氨氯地平-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%
5min133800-3380087.57378.297.7687.5778.297.76
227139-2713970.31570.31
331084-3108480.53680.54
429846-2984677.32877.33
528345-2834573.43973.44
631081-3108180.52880.53
10min134000-3400088.09182.405.3888.2482.535.38
229128-2912875.46875.59
332536-3253684.29884.43
431234-3123480.92581.05
531030-3103080.39680.52
632888-3288885.21085.34
15min136876-3687695.54391.724.0195.8491.994.01
234117-3411788.39488.64
334153-3415388.48788.76
435309-3530991.48391.75
534565-3456589.55589.81
637389-3738996.87297.15
20min137977-3797798.39593.563.4798.8593.983.48
234768-3476890.08190.47
336415-3641594.34894.77
435303-3530391.46791.88
535160-3516091.09791.50
637051-3705195.99696.43
30min138137-3813798.81094.523.9299.4395.093.92
234775-3477590.09990.64
336703-3670395.09495.67
435656-3565692.38292.95
535465-3546591.88792.44
638142-3814298.82399.42
45min137899-3789998.19394.603.1798.9795.343.18
235267-3526791.37492.06
336573-3657394.75795.50
435977-3597793.21393.94
535484-3548491.93692.65
637872-3787298.12398.89
60min137656-3765697.56394.073.6598.5194.963.66
235008-3500890.70391.55
335930-3593093.09293.99
436054-3605493.41394.29
535037-3503790.77891.64
638164-3816498.88099.81
极限138630-38630100.08797.483.02101.1998.523.02
235983-3598393.22994.22
337158-3715896.27397.32
437345-3734596.75897.79
537448-3744897.02598.04
639169-39169101.483102.57
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100864-202205对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.042311202309282311332321632314882313660.22
2 11.082347122340692343900.20
单位质量响应值RSD%判断
20957.0721154.330.67数据可信
供试品溶液-SD018YD批-奥美沙坦酯-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%
5min1120673-12067351.47847.057.6451.4847.057.64
2100760-10076042.98342.98
3113061-11306148.23148.23
4107214-10721445.73745.74
5101716-10171643.39143.39
6118364-11836450.49350.49
10min1153853-15385365.63262.284.7565.7262.364.76
2140539-14053959.95360.02
3144923-14492361.82361.90
4135785-13578557.92558.00
5148956-14895663.54363.62
6151892-15189264.79664.88
15min1183840-18384078.42576.124.2078.6276.304.20
2173550-17355074.03574.21
3177104-17710475.55175.73
4171908-17190873.33573.51
5173302-17330273.92974.11
6190952-19095281.45981.65
20min1192916-19291682.29680.193.4182.6280.503.42
2184179-18417978.56978.86
3186244-18624479.45079.76
4182735-18273577.95378.25
5183196-18319678.15078.45
6198610-19861084.72585.05
30min1201691-20169186.04083.523.6786.5083.973.67
2191194-19119481.56281.99
3193031-19303182.34682.79
4188506-18850680.41580.84
5193027-19302782.34482.78
6207312-20731288.43888.91
45min1205987-20598787.87284.813.2888.4885.393.29
2194053-19405382.78183.34
3194894-19489483.14083.72
4193027-19302782.34482.90
5196819-19681983.96184.53
6208060-20806088.75789.37
60min1204735-20473587.33884.443.6788.0985.163.67
2194020-19402082.76783.47
3190466-19046681.25181.97
4192916-19291682.29682.99
5196640-19664083.88584.59
6208848-20884889.09389.86
极限1217436-21743692.75789.922.8093.6590.782.80
2205044-20504487.47088.31
3205328-20532887.59188.44
4208351-20835188.88189.71
5210052-21005289.60790.46
6218505-21850593.21394.13
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检所对照品使用方法直接使用
对照品含量(%) 99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.064038340343402264030240429403370.20
216.014026040428403440.30
单位质量响应值RSD%判断
2511.642519.930.24数据可信
供试品溶液-SD005YD批-氨氯地平-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%
5min129905-2990577.06879.085.0977.0779.085.09
228537-2853773.54373.54
331457-3145781.06881.07
429631-2963176.36276.36
532430-3243083.57583.58
632162-3216282.88582.88
10min134970-3497090.12189.491.2290.2589.621.21
234618-3461889.21489.34
334397-3439788.64588.78
434260-3426088.29188.42
534682-3468289.37989.52
635422-3542291.28691.42
15min135832-3583292.34390.862.0892.6291.142.07
235948-3594892.64292.91
334153-3415388.01688.30
435272-3527290.89991.17
534610-3461089.19389.48
635736-3573692.09592.39
20min135627-3562791.81492.151.0092.2592.581.00
235914-3591492.55492.98
335118-3511890.50390.93
435912-3591292.54992.97
535813-3581392.29492.73
636159-3615993.18593.63
30min135811-3581192.28992.790.8992.8793.380.88
236035-3603592.86693.45
335715-3571592.04192.62
436436-3643693.89994.48
536336-3633693.64194.23
635711-3571192.03192.63
45min135740-3574092.10693.561.2592.8494.301.25
236317-3631793.59394.33
336095-3609593.02093.75
437063-3706395.51596.25
536523-3652394.12394.87
636095-3609593.02093.77
60min136234-3623493.37993.670.7094.2794.560.69
236417-3641793.85094.74
336741-3674194.68595.57
435970-3597092.69893.59
536339-3633993.64994.55
636383-3638393.76394.67
极限136725-3672594.64494.551.2095.6995.601.19
236731-3673194.65995.71
335860-3586092.41593.46
436708-3670894.60095.65
537035-3703595.44396.50
637079-3707995.55696.62
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100864-202205对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.042331862333392331892334042339992334230.15
2 11.082333482338122335800.15
单位质量响应值RSD%判断
21143.3921081.230.21数据可信
供试品溶液-SD005YD批-奥美沙坦酯-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%
5min1104982-10498244.66445.348.4744.6645.348.47
293839-9383939.92339.92
3110011-11001146.80346.80
498905-9890542.07842.08
5116165-11616549.42149.42
6115488-11548849.13349.13
10min1157777-15777767.12566.821.7467.2066.891.75
2153511-15351165.31065.38
3156860-15686066.73566.81
4154791-15479165.85465.92
5158109-15810967.26667.35
6161272-16127268.61268.69
15min1176737-17673775.19174.942.1575.3875.122.14
2175563-17556374.69274.87
3170297-17029772.45172.64
4176602-17660275.13475.31
5175560-17556074.69074.88
6182114-18211477.47977.67
20min1184906-18490678.66678.701.3978.9879.021.39
2184008-18400878.28478.58
3181695-18169577.30077.61
4188351-18835180.13280.44
5183351-18335178.00578.32
6187644-18764479.83180.16
30min1190660-19066081.11481.941.4181.5682.391.41
2193259-19325982.22082.65
3189484-18948480.61481.05
4197188-19718883.89284.33
5191560-19156081.49781.95
6193497-19349782.32182.78
45min1192780-19278082.01683.441.4082.5984.021.39
2198056-19805684.26184.83
3195122-19512283.01383.59
4200505-20050585.30385.88
5195622-19562283.22583.81
6194686-19468682.82783.42
60min1190562-19056281.07383.621.9081.7984.341.88
2200144-20014485.14985.86
3199062-19906284.68985.40
4199048-19904884.68385.40
5196801-19680183.72784.45
6193662-19366282.39283.13
极限1201721-20172185.82087.381.1286.6788.241.11
2207447-20744788.25689.11
3206086-20608687.67788.53
4207509-20750988.28389.14
5205974-20597487.63088.49
6203544-20354486.59687.47
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