缬沙坦左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
113.651180741182911182941179351179221181030.16
213.641184461185091184780.04
单位质量响应值RSD%判断
8652.238686.070.28数据可信
供试品溶液-1批-左氨氯地平-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%
5min144750-4475032.59232.777.0832.5932.777.08
245136-4513632.87332.87
340808-4080829.72129.72
447120-4712034.31834.32
549705-4970536.20136.20
642466-4246630.92830.93
10min164375-6437546.88547.226.6546.9447.286.65
265049-6504947.37647.43
358353-5835342.49942.55
469805-6980550.84050.90
569205-6920550.40350.46
662239-6223945.32945.38
15min175454-7545454.95454.597.4955.0954.727.48
274752-7475254.44354.58
366690-6669048.57148.69
478608-7860857.25157.39
582845-8284560.33760.48
671345-7134551.96152.09
20min183454-8345460.78060.895.2761.0061.115.28
281789-8178959.56859.79
378155-7815556.92157.12
487324-8732463.59963.84
590102-9010265.62265.87
680790-8079058.84059.05
30min194258-9425868.64968.044.6868.9768.374.69
290504-9050465.91566.24
388223-8822364.25464.55
496986-9698670.63670.98
599736-9973672.63972.99
690844-9084466.16266.47
45min1104069-10406975.79474.885.0076.2375.325.00
299012-9901272.11172.54
396450-9645070.24570.65
4108212-10821278.81279.27
5109031-10903179.40879.88
6100101-10010172.90473.33
60min1108389-10838978.94179.035.3679.5179.605.36
2105768-10576877.03277.59
3100878-10087873.47073.99
4114845-11484583.64384.24
5115807-11580784.34384.95
6105386-10538676.75477.30
90min1108358-10835878.91882.124.9479.6282.824.94
2110841-11084180.72681.41
3107563-10756378.33978.98
4119208-11920886.82087.55
5120296-12029687.61388.36
6110257-11025780.30180.97
120min1114560-11456083.43583.915.0084.2684.745.01
2112323-11232381.80682.62
3108527-10852779.04179.81
4121978-12197888.83889.71
5122452-12245289.18390.08
6111468-11146881.18381.99
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1120073-12007387.45086.603.7788.4287.573.78
2117322-11732285.44786.40
3113155-11315582.41283.32
4122198-12219888.99890.02
5125247-12524791.21992.26
6115411-11541184.05585.00
缬沙坦左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100651-202006对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.014647383465746746577854651154465367446534930.10
215.994671463467313346722980.03
单位质量响应值RSD%判断
290661.65292201.250.38数据可信
供试品溶液-1批-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%
5min11578674-157867430.16631.546.8630.1731.546.86
21645045-164504531.43431.43
31609423-160942330.75330.75
41605156-160515630.67230.67
51589116-158911630.36530.37
61877020-187702035.86735.87
10min12442654-244265446.67548.345.7546.7348.395.75
22523365-252336548.21748.27
32428738-242873846.40946.46
42506910-250691047.90347.95
52459537-245953746.99847.05
62816809-281680953.82553.88
15min12990207-299020757.13858.624.4757.2758.764.47
23070622-307062258.67558.81
32967835-296783556.71156.84
43027639-302763957.85357.98
53012971-301297157.57357.70
63338386-333838663.79163.94
20min13378470-337847064.55765.993.9564.7866.223.96
23445412-344541265.83666.07
33343604-334360463.89164.11
43424399-342439965.43565.66
53405936-340593665.08265.31
63721996-372199671.12171.38
30min13895350-389535074.43475.663.1774.7676.003.18
23972071-397207175.90076.24
33821316-382131673.01973.35
43952173-395217375.52075.86
53924548-392454874.99275.33
64191793-419179380.09880.47
45min14339529-433952982.92183.602.1383.3884.062.14
24390407-439040783.89484.36
34244741-424474181.11081.56
44405252-440525284.17784.64
54343893-434389383.00583.46
64525871-452587186.48286.99
60min14559842-455984287.13187.571.5387.7288.171.55
24604795-460479587.99088.60
34467521-446752185.36785.95
44632161-463216188.51389.12
54562517-456251787.18287.78
64668730-466873089.21289.86
90min14714225-471422590.08190.401.3690.8291.161.36
24775949-477594991.26192.01
34616180-461618088.20888.94
44796354-479635491.65192.40
54725449-472544990.29691.04
64758326-475832690.92491.72
120min14770218-477021891.15190.961.3092.0491.871.29
24801870-480187091.75692.66
34648819-464881988.83189.71
44827698-482769892.25093.15
54751081-475108190.78691.68
64762633-476263391.00691.96
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限14898358-489835893.60093.571.2494.6494.621.23
24962281-496228194.82195.88
34802473-480247391.76892.79
44960906-496090694.79595.85
54869125-486912593.04194.08
64887276-488727693.38894.49
缬沙坦左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
113.651179301195271194091193721195691191610.59
213.641182021181871181940.01
单位质量响应值RSD%判断
8729.748665.250.53数据可信
供试品溶液-2批-左氨氯地平-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%
5min148317-4831735.07531.898.3235.0831.898.32
241053-4105329.80229.80
348658-4865835.32335.32
443082-4308231.27531.28
542059-4205930.53230.53
640375-4037529.31029.31
10min160952-6095244.24844.606.8444.3144.666.84
257274-5727441.57841.63
369590-6959050.51850.58
460575-6057543.97444.03
559885-5988543.47343.52
660389-6038943.83943.89
15min170641-7064151.28152.066.1651.4152.196.16
268831-6883149.96750.09
380622-8062258.52758.67
470359-7035951.07751.20
569624-6962450.54350.67
670202-7020250.96351.08
20min176611-7661155.61557.485.5455.8357.695.54
276256-7625655.35755.56
387927-8792763.83064.07
478527-7852757.00657.22
577401-7740156.18956.40
678323-7832356.85857.06
30min183685-8368560.75164.026.0261.0664.336.02
284428-8442861.29061.58
398332-9833271.38371.73
487995-8799563.87964.18
586389-8638962.71363.01
688319-8831964.11564.42
45min196781-9678170.25771.405.4170.6771.825.41
293786-9378668.08368.48
3108884-10888479.04479.51
497435-9743570.73271.14
596422-9642269.99770.40
696851-9685170.30870.72
60min1101219-10121973.47974.133.5374.0174.673.55
299528-9952872.25272.76
3109254-10925479.31279.91
4101659-10165973.79974.33
599784-9978472.43772.96
6101247-10124773.50074.03
90min1107253-10725377.86078.214.5778.5178.874.58
2104690-10469075.99976.63
3117605-11760585.37486.10
4106051-10605176.98777.64
5104849-10484976.11476.76
6105982-10598276.93777.59
120min1110793-11079380.42979.725.0581.2180.515.05
2105527-10552776.60777.36
3120488-12048887.46788.34
4108358-10835878.66279.44
5106248-10624877.13077.90
6107474-10747478.02078.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1115247-11524783.66383.215.6084.5884.135.60
2107342-10734277.92478.81
3126236-12623691.64092.66
4114170-11417082.88183.79
5110465-11046580.19181.09
6114278-11427882.95983.87
缬沙坦左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100651-202006对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.014675475467624046717934671698467132346733060.06
215.994692076468951046907930.04
单位质量响应值RSD%判断
291899.19293357.910.36数据可信
供试品溶液-2批-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%
5min11670483-167048331.79031.172.1631.7931.172.16
21656667-165666731.52731.53
31577620-157762030.02230.02
41619180-161918030.81330.81
51666328-166632831.71131.71
61636305-163630531.13931.14
10min12521767-252176747.99047.331.5248.0447.381.51
22531888-253188848.18248.23
32431545-243154546.27346.32
42468924-246892446.98447.04
52498365-249836547.54447.60
62469528-246952846.99647.05
15min13071208-307120858.44657.571.5258.5857.701.52
23088004-308800458.76558.90
32965948-296594856.44356.57
43010078-301007857.28257.41
53002367-300236757.13657.27
63011977-301197757.31957.45
20min13437381-343738165.41464.711.2165.6464.941.21
23461682-346168265.87766.11
33352201-335220163.79364.01
43391641-339164164.54464.77
53382636-338263664.37264.60
63376213-337621364.25064.48
30min13924517-392451774.68474.051.1375.0274.381.13
23963293-396329375.42275.76
33851030-385103073.28673.61
43880309-388030973.84374.18
53870629-387062973.65973.99
63856924-385692473.39873.73
45min14340331-434033182.59781.550.9083.0682.010.90
24321878-432187882.24682.71
34265700-426570081.17781.63
44282257-428225781.49281.95
54262267-426226781.11281.57
64239887-423988780.68681.14
60min14539682-453968286.39185.310.9786.9985.900.96
24524417-452441786.10186.70
34473657-447365785.13585.72
44467511-446751185.01885.61
54469857-446985785.06285.65
64421064-442106484.13484.72
90min14687136-468713689.19788.000.8889.9488.730.88
24647738-464773888.44789.19
34611781-461178187.76388.49
44615845-461584587.84188.57
54614936-461493687.82388.56
64566467-456646786.90187.63
120min14727102-472710289.95888.760.8890.8589.640.88
24668738-466873888.84789.74
34660978-466097888.69989.57
44681240-468124089.08589.96
54641623-464162388.33189.21
64604464-460446487.62488.50
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限14892239-489223993.10092.030.9894.1493.060.97
24781944-478194491.00192.04
34826041-482604191.84192.86
44890041-489004193.05994.09
54792300-479230091.19992.23
64832932-483293291.97292.99
缬沙坦左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
113.651172621168911170081168431166691169350.19
213.641159501158141158820.09
单位质量响应值RSD%判断
8566.678495.750.59数据可信
供试品溶液-3批-左氨氯地平-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%
5min144661-4466133.05335.825.8233.0535.825.83
247277-4727734.98934.99
347901-4790135.45135.45
452757-5275739.04539.05
547398-4739835.07935.08
650442-5044237.33237.33
10min163435-6343546.94849.834.4447.0049.894.44
266124-6612448.93849.00
368778-6877850.90250.96
472309-7230953.51653.58
566350-6635049.10549.16
667010-6701049.59449.66
15min174592-7459255.20559.145.2755.3459.285.27
277683-7768357.49357.63
380420-8042059.51859.66
486180-8618063.78163.94
577506-7750657.36257.50
683037-8303761.45561.60
20min183144-8314461.53465.194.6361.7665.424.63
285482-8548263.26563.50
389201-8920166.01766.26
494425-9442569.88370.14
585835-8583563.52663.76
690377-9037766.88867.13
30min190539-9053967.00772.234.9967.3472.584.99
295427-9542770.62570.97
3100706-10070674.53274.89
4104346-10434677.22677.60
595246-9524670.49170.83
699336-9933673.51873.88
45min1102091-10209175.55780.344.5376.0080.814.53
2105832-10583278.32678.78
3111156-11115682.26682.74
4115821-11582185.71986.22
5105807-10580778.30778.77
6110610-11061081.86282.34
60min1110477-11047781.76484.473.9882.3385.073.98
2112761-11276183.45484.04
3116415-11641586.15886.77
4120716-12071689.34189.99
5108211-10821180.08680.68
6116185-11618585.98886.61
90min1117463-11746386.93489.342.8887.6490.082.90
2119635-11963588.54189.27
3122507-12250790.66791.42
4124901-12490192.43993.24
5116241-11624186.02986.75
6123517-12351791.41492.18
120min1121038-12103889.58091.233.1890.4392.133.18
2121552-12155289.96090.84
3125273-12527392.71493.62
4129617-12961795.92996.88
5118377-11837787.61088.48
6123773-12377391.60492.52
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1121760-12176090.11492.943.5791.1193.983.57
2124053-12405391.81192.84
3127715-12771594.52195.58
4132344-13234497.94799.06
5120149-12014988.92289.93
6127427-12742794.30895.37
缬沙坦左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100651-202006对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.014674633467505146729904670704466592846718610.08
215.994643751464413646439440.01
单位质量响应值RSD%判断
291808.93290428.020.34数据可信
供试品溶液-3批-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%
5min11282339-128233924.53026.245.7524.5326.245.76
21306458-130645824.99124.99
31392223-139222326.63226.63
41330104-133010425.44325.44
51483919-148391928.38628.39
61435285-143528527.45527.46
10min12095919-209591940.09342.064.6240.1342.114.62
22101922-210192240.20740.25
32228098-222809842.62142.67
42141906-214190640.97241.01
52338527-233852744.73344.78
62287401-228740143.75643.80
15min12661054-266105450.90352.974.2351.0153.084.23
22649230-264923050.67750.79
32817694-281769453.89954.01
42693137-269313751.51751.63
52927324-292732455.99756.12
62865823-286582354.82054.94
20min13078716-307871658.89360.883.9059.0961.083.90
23050407-305040758.35158.54
33232830-323283061.84162.05
43095760-309576059.21959.42
53343722-334372263.96264.18
63294500-329450063.02063.23
30min13658397-365839769.98172.003.3670.2772.303.37
23632849-363284969.49269.78
33828537-382853773.23673.54
43668007-366800770.16570.46
53930527-393052775.18775.51
63866362-386636273.95974.27
45min14197226-419722680.28881.972.8880.7082.392.89
24154023-415402379.46279.87
34349186-434918683.19583.63
44177770-417777079.91680.33
54442071-444207184.97285.42
64389109-438910983.95984.40
60min14527100-452710086.59987.662.5987.1488.222.60
24449405-444940585.11285.65
34634461-463446188.65289.22
44467026-446702685.44985.99
54735343-473534390.58291.17
64682788-468278889.57790.15
90min14804732-480473291.90992.292.3892.5992.992.38
24698637-469863789.88090.56
34852854-485285492.83093.55
44693542-469354289.78290.47
54963637-496363794.94995.69
64933623-493362394.37595.10
120min14925909-492590994.22793.982.2795.0794.842.28
24778435-477843591.40692.24
34960325-496032594.88695.76
44776630-477663091.37292.21
55036638-503663896.34597.24
65000304-500030495.65096.54
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限14953551-495355194.75695.092.1395.7596.112.14
24840314-484031492.59093.57
35039899-503989996.40897.44
44856041-485604192.89193.88
55096872-509687297.49898.56
65040539-504053996.42097.46
缬沙坦左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
113.651157711157591158431156961157571157650.05
213.641161181160501160840.05
单位质量响应值RSD%判断
8480.958510.560.25数据可信
供试品溶液-24070302批-左氨氯地平-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%
5min143185-4318532.09431.236.1332.0931.236.13
239341-3934129.23729.24
340093-4009329.79629.80
446069-4606934.23734.24
543184-4318432.09332.09
640248-4024829.91129.91
10min161293-6129345.55144.333.7445.6044.383.74
258258-5825843.29643.34
357265-5726542.55842.61
462735-6273546.62346.68
560670-6067045.08845.14
657678-5767842.86542.91
15min173501-7350154.62453.453.6554.7553.583.65
271435-7143553.08953.21
368038-6803850.56450.68
475460-7546056.08056.21
572921-7292154.19354.32
670203-7020352.17352.29
20min178450-7845058.30259.172.2558.5259.382.25
278720-7872058.50358.71
377967-7796757.94358.15
482142-8214261.04661.27
581626-8162660.66260.88
678781-7878158.54858.76
30min194106-9410669.93768.732.1270.2569.042.12
291557-9155768.04368.35
389301-8930166.36666.67
494187-9418769.99770.33
593928-9392869.80570.12
691774-9177468.20468.51
45min1105220-10522078.19777.271.8778.6377.701.87
2104528-10452877.68278.10
3101887-10188775.72076.13
4106866-10686679.42079.87
5102019-10201975.81876.25
6103318-10331876.78377.20
60min1111744-11174483.04582.401.4583.6182.951.46
2111554-11155482.90483.45
3107880-10788080.17480.71
4111807-11180783.09283.67
5112041-11204183.26683.83
6110208-11020881.90482.45
90min1119625-11962588.90287.171.5689.6087.871.56
2117275-11727587.15687.84
3114132-11413284.82085.49
4117816-11781687.55888.28
5118117-11811787.78188.48
6116832-11683286.82687.51
120min1122641-12264191.14388.661.8791.9989.501.87
2119160-11916088.55789.39
3116098-11609886.28187.09
4120537-12053789.58090.44
5119445-11944588.76889.62
6117954-11795487.66088.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1124349-12434992.41390.771.9793.4291.761.97
2122118-12211890.75591.74
3117754-11775487.51288.47
4123332-12333291.65792.67
5123842-12384292.03693.03
6121447-12144790.25691.23
缬沙坦左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100651-202006对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.014644857464764346438014644146464585946452610.04
215.994665904466374346648240.04
单位质量响应值RSD%判断
290147.47291733.830.39数据可信
供试品溶液-24070302批-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%
5min11367907-136790726.18325.923.1026.1825.923.09
21301705-130170524.91524.92
31372674-137267426.27426.27
41394192-139419226.68626.69
51387240-138724026.55326.55
61301223-130122324.90624.91
10min12231606-223160642.71441.901.6442.7641.951.65
22148213-214821341.11841.16
32210789-221078942.31642.36
42190299-219029941.92441.97
52210866-221086642.31742.36
62144151-214415141.04041.08
15min12821164-282116453.99952.981.2254.1153.101.22
22732805-273280552.30852.42
32778594-277859453.18453.30
42751989-275198952.67552.79
52786300-278630053.33253.45
62737676-273767652.40152.51
20min13218103-321810361.59760.910.9061.8061.110.90
23153534-315353460.36160.56
33197241-319724161.19761.40
43153361-315336160.35760.56
53206051-320605161.36661.57
63163900-316390060.55960.76
30min13812629-381262972.97672.060.9873.2872.360.98
23741208-374120871.60971.91
33778203-377820372.31772.62
43709523-370952371.00371.31
53789840-378984072.54072.85
63757503-375750371.92172.22
45min14331232-433123282.90382.090.9383.3382.520.93
24271000-427100081.75082.17
34293781-429378182.18682.61
44219431-421943180.76381.18
54304687-430468782.39482.82
64313459-431345982.56282.98
60min14643876-464387688.88787.671.1689.4588.231.16
24567686-456768687.42887.98
34580239-458023987.66988.23
44488073-448807385.90586.46
54615740-461574088.34888.91
64586232-458623287.78388.34
90min14897654-489765493.74492.301.2094.4693.011.20
24800726-480072691.88992.59
34814908-481490892.16092.87
44726046-472604690.46091.16
54848591-484859192.80593.52
64846263-484626392.76193.46
120min14989875-498987595.50993.691.2796.3894.551.27
24889039-488903993.57994.43
34865788-486578893.13494.00
44801130-480113091.89792.75
54912609-491260994.03094.90
64909143-490914393.96494.82
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15033741-503374196.34995.221.1497.3896.231.14
24943722-494372294.62695.63
34929827-492982794.36095.38
44900916-490091693.80794.81
55017690-501769096.04297.06
65022019-502201996.12597.14
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