沙库巴曲缬沙坦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对照品来源中检院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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.581029881029911028681027291028231028800.11
215.631043131043911043520.06
单位质量响应值RSD%判断
6603.346676.390.78数据可信
供试品溶液-25091101批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116072-1607215.69219.9836.9015.6919.9836.90
210765-1076510.51010.51
324351-2435123.77523.77
431252-3125230.51230.51
515704-1570415.33215.33
624651-2465124.06824.07
10min174522-7452272.75873.786.9172.7873.816.92
268847-6884767.21767.23
378774-7877476.91076.95
484042-8404282.05382.10
573583-7358371.84171.87
673623-7362371.88071.92
15min183829-8382981.84581.513.0581.9981.673.06
281891-8189179.95380.08
384248-8424882.25482.42
487557-8755785.48585.67
583458-8345881.48381.63
679959-7995978.06678.23
20min184100-8410082.10982.963.1482.3983.253.15
283701-8370181.72081.98
386006-8600683.97084.28
489287-8928787.17487.50
585397-8539783.37683.66
681329-8132979.40479.69
30min187949-8794985.86785.242.9186.2985.672.90
288118-8811886.03286.43
388268-8826886.17986.62
489684-8968487.56188.04
587471-8747185.40185.82
682366-8236680.41680.84
45min187814-8781485.73686.492.4786.3087.062.46
290565-9056588.42188.96
387940-8794085.85986.45
490088-9008887.95688.58
590239-9023988.10388.67
684867-8486782.85883.41
60min190336-9033688.19887.692.4788.9088.402.46
291649-9164989.48090.17
389533-8953387.41488.15
491069-9106988.91489.68
590758-9075888.61089.32
685526-8552683.50284.20
极限193126-9312690.92290.572.0591.7891.432.04
293221-9322191.01591.85
394591-9459192.35293.23
492963-9296390.76391.68
593613-9361391.39792.25
689086-8908686.97787.81
沙库巴曲缬沙坦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57323100856对照品来源ZZ对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.471520608152102115238531522900152157415219910.09
222.511556573155686015567160.02
单位质量响应值RSD%判断
67734.3669156.641.47数据可信
供试品溶液-25091101批-沙库巴曲缬沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176563-765632.2622.6326.612.262.6326.66
254890-548901.6221.62
395257-952572.8142.81
498048-980482.8972.90
583542-835422.4682.47
6125512-1255123.7083.71
10min1634236-63423618.73818.767.6818.7418.767.69
2553360-55336016.34916.35
3648815-64881519.16919.17
4692990-69299020.47420.48
5611752-61175218.07418.08
6668509-66850919.75119.76
15min11158984-115898434.24233.413.7834.2833.443.78
21081146-108114631.94231.97
31101260-110126032.53732.57
41197303-119730335.37435.41
51137602-113760233.61033.64
61108518-110851832.75132.79
20min11498561-149856144.27543.942.9444.3744.032.94
21450713-145071342.86142.94
31469770-146977043.42443.52
41556470-155647045.98646.08
51509789-150978944.60744.70
61437432-143743242.46942.56
30min11689008-168900849.90249.760.2650.0749.920.27
21681162-168116249.67049.82
31678320-167832049.58649.75
41688687-168868749.89250.07
51682046-168204649.69649.86
61685687-168568749.80449.97
45min11694712-169471250.07050.010.1150.3250.260.12
21690764-169076449.95450.19
31691073-169107349.96350.21
41694645-169464550.06850.33
51691976-169197649.98950.24
61692394-169239450.00250.25
60min11691182-169118249.96649.900.1450.3050.220.15
21685543-168554349.79950.12
31687730-168773049.86450.19
41691755-169175549.98350.32
51687823-168782349.86750.20
61688745-168874549.89450.22
极限11691422-169142249.97349.860.2350.3950.270.24
21684184-168418449.75950.16
31688337-168833749.88250.29
41691805-169180549.98450.41
51682463-168246349.70850.12
61687518-168751849.85850.27
沙库巴曲缬沙坦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对照品来源中检院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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.581040211039791041051041341040531040580.07
215.631044301043811044060.04
单位质量响应值RSD%判断
6678.956679.850.01数据可信
供试品溶液-25091102批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114998-1499814.55615.3716.8714.5615.3716.87
215493-1549315.03615.04
314696-1469614.26314.26
412482-1248212.11412.11
516898-1689816.40016.40
620437-2043719.83519.83
10min146968-4696845.58445.479.8945.6145.509.90
242158-4215840.91540.94
343921-4392142.62642.65
446043-4604344.68644.71
546457-4645745.08845.11
655561-5556153.92353.96
15min171697-7169769.58466.729.3269.6866.829.32
261078-6107859.27859.37
363284-6328461.41961.51
471300-7130069.19869.29
566583-6658364.62064.72
678561-7856176.24576.37
20min186863-8686384.30379.809.0584.5280.029.05
272856-7285670.70870.90
375230-7523073.01273.21
487857-8785785.26785.48
579437-7943777.09577.31
691106-9110688.42188.67
30min192257-9225789.53884.009.5989.8984.349.59
275003-7500372.79273.10
379458-7945877.11677.43
492925-9292590.18690.54
584093-8409381.61481.95
695582-9558292.76593.16
45min191427-9142788.73285.239.1889.2485.719.18
277447-7744775.16475.60
380228-8022877.86378.31
495331-9533192.52193.02
585455-8545582.93683.41
697012-9701294.15294.70
60min193099-9309990.35585.399.2391.0186.029.22
277868-7786875.57376.13
380650-8065078.27378.85
495357-9535792.54693.20
584129-8412981.64982.26
696792-9679293.93994.65
极限191295-9129588.60485.109.1989.4185.879.18
277183-7718374.90875.59
380717-8071778.33879.05
494373-9437391.59192.40
584866-8486682.36483.11
697662-9766294.78395.65
沙库巴曲缬沙坦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57323100856对照品来源ZZ对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.471551957154966815508371550442154997215505750.06
222.511554716156481015597630.46
单位质量响应值RSD%判断
69006.4569292.000.30数据可信
供试品溶液-25091102批-沙库巴曲缬沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1317263-3172639.2779.7811.189.289.7811.20
2348396-34839610.18810.19
3350666-35066610.25410.25
4267557-2675577.8247.82
5348261-34826110.18410.18
6373966-37396610.93510.94
10min1978391-97839128.60928.764.0628.6228.774.06
21003505-100350529.34429.36
31003640-100364029.34829.36
4905165-90516526.46826.48
5999870-99987029.23729.25
61009935-100993529.53229.55
15min11442712-144271242.18741.611.9542.2541.681.96
21437752-143775242.04242.11
31418395-141839541.47641.54
41368924-136892440.02940.09
51435786-143578641.98442.05
61434412-143441241.94442.01
20min11662466-166246648.61348.731.2148.7548.861.21
21693955-169395549.53349.67
31674913-167491348.97749.11
41639181-163918147.93248.06
51678774-167877449.08949.23
61649514-164951448.23448.37
30min11691665-169166549.46649.821.1849.6850.031.18
21716577-171657750.19550.41
31713923-171392350.11750.33
41693468-169346849.51949.72
51730634-173063450.60650.82
61675878-167587849.00549.22
45min11680067-168006749.12749.771.0949.4250.061.09
21718638-171863850.25550.56
31711634-171163450.05050.35
41689479-168947949.40349.69
51724183-172418350.41750.72
61687657-168765749.34949.65
60min11688055-168805549.36149.671.1749.7450.061.16
21720464-172046450.30950.69
31709148-170914849.97850.36
41680806-168080649.14949.52
51718479-171847950.25150.64
61675584-167558448.99649.38
极限11674566-167456648.96649.501.3549.4349.961.35
21708662-170866249.96350.43
31710001-171000150.00350.47
41672220-167222048.89849.35
51720538-172053850.31150.78
61669923-166992348.83149.29
沙库巴曲缬沙坦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对照品来源中检院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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.581048541049481049401049591051451049690.11
215.631047601046531047060.08
单位质量响应值RSD%判断
6737.426699.040.41数据可信
供试品溶液-25091501批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160997-6099758.85763.8815.4458.8663.8815.44
258881-5888156.81656.82
354761-5476152.84052.84
483105-8310580.19080.19
569813-6981367.36467.36
669663-6966367.21967.22
10min184453-8445381.49182.122.8181.5982.232.83
284261-8426181.30581.40
382293-8229379.40679.49
489314-8931486.18186.31
584217-8421781.26381.38
686104-8610483.08483.20
15min185057-8505782.07383.442.6082.3183.682.62
285929-8592982.91583.14
384640-8464081.67181.89
490866-9086687.67987.96
586043-8604383.02583.27
686298-8629883.27183.52
20min185737-8573782.72983.762.3183.1084.152.33
286505-8650583.47183.84
385200-8520082.21182.57
490677-9067787.49687.92
585704-8570482.69883.08
687038-8703883.98584.37
30min186669-8666983.62984.181.7584.1484.701.77
286629-8662983.59084.10
386070-8607083.05183.54
489935-8993586.78087.35
586024-8602483.00683.53
688115-8811585.02485.55
45min186194-8619483.17084.411.8783.8285.071.88
287281-8728184.21984.87
386249-8624983.22483.86
490608-9060887.43088.14
586940-8694083.89084.55
687593-8759384.52085.19
60min186279-8627983.25284.571.8484.0485.381.86
286263-8626383.23784.02
386532-8653283.49784.27
490326-9032687.15788.02
588044-8804484.95685.76
688431-8843185.32986.14
极限191218-9121888.01888.301.4088.9489.241.42
291432-9143288.22589.15
390043-9004386.88487.79
493867-9386790.57491.58
591531-9153188.32089.26
690959-9095987.76888.72
沙库巴曲缬沙坦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57323100856对照品来源ZZ对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.471606971160527716076661605995160735616066530.07
222.511600885160097616009300.01
单位质量响应值RSD%判断
71502.1471120.840.38数据可信
供试品溶液-25091501批-沙库巴曲缬沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1167461-1674614.7486.5519.314.756.5519.31
2271359-2713597.6947.69
3204239-2042395.7915.79
4287968-2879688.1658.17
5239158-2391586.7816.78
6215437-2154376.1096.11
10min1879514-87951424.93824.704.5924.9524.714.59
2901813-90181325.57125.58
3864135-86413524.50224.51
4919289-91928926.06626.08
5856282-85628224.28024.29
6805022-80502222.82622.84
15min11416653-141665340.16939.053.5540.2239.103.55
21419376-141937640.24640.30
31383254-138325439.22239.27
41393491-139349139.51239.57
51362597-136259738.63638.69
61287252-128725236.50036.55
20min11691417-169141747.96047.441.3648.0847.551.37
21696796-169679648.11248.23
31678784-167878447.60147.72
41672902-167290247.43547.56
51663871-166387147.17947.29
61633700-163370046.32346.43
30min11706946-170694648.40048.320.7148.6048.510.72
21714835-171483548.62448.83
31700443-170044348.21648.41
41719416-171941648.75448.96
51689839-168983947.91548.11
61692294-169229447.98548.17
45min11710645-171064548.50548.361.0148.7848.631.02
21723205-172320548.86149.14
31691290-169129047.95648.23
41726873-172687348.96549.25
51692786-169278647.99848.27
61688040-168804047.86448.13
60min11704395-170439548.32848.270.8248.6948.630.82
21720427-172042748.78249.15
31687774-168777447.85648.21
41716681-171668148.67649.04
51694318-169431848.04248.40
61690433-169043347.93248.28
极限11702858-170285848.28448.050.9548.7248.490.95
21706829-170682948.39748.84
31682533-168253347.70848.14
41715655-171565548.64749.09
51685224-168522447.78448.22
61675174-167517447.49947.92
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