替米沙坦氨氯地平片项目信息
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10000
标示量(mg)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.042966529495297322962829599296240.30
214.972919829308292530.27
单位质量响应值RSD%判断
1969.681954.110.57数据可信
供试品溶液-24A2941批-氨氯地平-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124462-2446280.82987.056.6680.8387.056.66
224610-2461081.31881.32
327053-2705389.39089.39
425999-2599985.90885.91
529178-2917896.41296.41
626761-2676188.42588.43
10min128523-2852394.24794.401.9994.7094.882.00
227867-2786792.08092.53
327927-2792792.27892.77
428852-2885295.33595.81
529039-2903995.95296.49
629207-2920796.50897.00
15min128678-2867894.76094.891.6495.7395.901.65
227856-2785692.04493.01
329107-2910796.17797.19
428819-2881995.22696.23
529157-2915796.34297.41
628683-2868394.77695.80
20min128618-2861894.56195.082.5496.0696.612.50
228509-2850994.20195.68
327830-2783091.95893.50
429110-2911096.18797.72
528572-2857294.40996.01
630004-3000499.141100.70
30min127115-2711589.59592.022.9091.6294.092.87
227825-2782591.94193.94
327630-2763091.29793.35
427122-2712289.61891.69
528124-2812492.92995.06
629286-2928696.76998.87
45min126454-2645487.41190.932.3889.9393.502.36
227447-2744790.69293.20
327189-2718989.84092.40
427956-2795692.37494.94
527747-2774791.68394.33
628320-2832093.57796.22
60min127440-2744090.66991.511.7393.6894.591.72
227328-2732890.29993.31
327414-2741490.58393.64
427830-2783091.95895.04
527550-2755091.03294.19
628600-2860094.50297.66
极限127611-2761191.23491.342.5394.7594.932.48
227065-2706589.43092.94
326603-2660387.90391.47
428071-2807192.75496.35
528056-2805692.70496.36
628453-2845394.01697.70
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数625
标示量(mg)80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%
111.159130519127949155169164759151709146010.18
211.099045119058239051670.11
单位质量响应值RSD%判断
82027.0081620.110.36数据可信
供试品溶液-24A2941批-替米沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156546-565466.2206.086.906.226.086.91
258802-588026.4686.47
355021-550216.0526.05
450277-502775.5305.53
559677-596776.5646.56
651499-514995.6655.66
10min1146981-14698116.16716.275.8916.2016.305.89
2159624-15962417.55817.59
3144375-14437515.88015.91
4140372-14037215.44015.47
5157304-15730417.30217.34
6138816-13881615.26915.30
15min1245869-24586927.04425.466.2927.1725.586.29
2239972-23997226.39526.53
3232621-23262125.58725.71
4209774-20977423.07423.19
5242537-24253726.67726.81
6217881-21788123.96524.08
20min1310857-31085734.19233.314.5234.4733.584.52
2310366-31036634.13834.42
3303154-30315433.34533.61
4275476-27547630.30130.55
5307543-30754333.82834.11
6309547-30954734.04834.30
30min1374101-37410141.14943.298.9341.6143.748.86
2404497-40449744.49244.96
3414903-41490345.63746.09
4334710-33471036.81637.23
5397986-39798643.77644.24
6435116-43511647.86048.30
45min1435251-43525147.87551.968.3748.5752.658.30
2473051-47305152.03352.75
3495245-49524554.47455.18
4429818-42981847.27747.89
5465072-46507251.15551.87
6536014-53601458.95859.66
60min1490229-49022953.92259.037.3454.8860.007.27
2517514-51751456.92357.93
3537015-53701559.06860.07
4523529-52352957.58558.46
5544161-54416159.85460.85
6607393-60739366.80967.84
极限1576866-57686663.45169.797.4264.7171.107.32
2651567-65156771.66872.99
3575472-57547263.29864.63
4647677-64767771.24072.44
5683999-68399975.23576.56
6671347-67134773.84475.25
替米沙坦氨氯地平片项目信息
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10000
标示量(mg)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.042944429305291892934729296293160.32
214.972924929281292650.08
单位质量响应值RSD%判断
1949.201954.910.21数据可信
供试品溶液-24A2941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%
5min125238-2523883.81286.073.5083.8186.073.50
227391-2739190.96290.96
324863-2486382.56782.57
426208-2620887.03387.03
525538-2553884.80884.81
626277-2627787.26387.26
10min125839-2583985.80891.514.3086.2791.994.28
228199-2819993.64594.15
327751-2775192.15792.62
426695-2669588.65189.13
529246-2924697.12297.59
627610-2761091.68992.17
15min127254-2725490.50790.813.3291.4591.803.30
227559-2755991.52092.55
327328-2732890.75391.72
425669-2566985.24386.22
528121-2812193.38694.40
628146-2814693.46994.46
20min126927-2692789.42190.981.4090.8792.471.39
227133-2713390.10591.64
327392-2739290.96592.44
427649-2764991.81993.27
527271-2727190.56392.09
628001-2800192.98894.50
30min127164-2716490.20890.421.0892.1592.421.05
227354-2735490.83992.87
327303-2730390.67092.65
427304-2730490.67392.63
526690-2669088.63490.67
627551-2755191.49393.52
45min126145-2614586.82491.002.4689.2793.502.42
227542-2754291.46394.00
327248-2724890.48792.97
427625-2762591.73994.20
528053-2805393.16095.69
627802-2780292.32794.87
60min126276-2627687.25989.631.3190.1892.641.31
227155-2715590.17893.23
327179-2717990.25893.24
427156-2715690.18293.15
527044-2704489.81092.85
627134-2713490.10893.16
极限126546-2654688.15689.492.6291.5792.992.52
227397-2739790.98294.53
327425-2742591.07594.56
427642-2764291.79595.27
525759-2575985.54289.08
626911-2691189.36892.92
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数625
标示量(mg)80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%
111.159066059092529066169051809057239066750.18
211.099069919069449069680.01
单位质量响应值RSD%判断
81316.1481782.510.41数据可信
供试品溶液-24A2941批-替米沙坦-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%
5min151252-512525.6566.7918.595.666.7918.58
283009-830099.1619.16
354767-547676.0446.04
457363-573636.3316.33
557968-579686.3986.40
664887-648877.1617.16
10min1108763-10876312.00312.749.1612.0312.779.19
2136296-13629615.04215.09
3110824-11082412.23112.26
4112705-11270512.43912.47
5108361-10836111.95911.99
6115622-11562212.76012.80
15min1161352-16135217.80717.684.6717.9117.784.69
2169871-16987118.74818.88
3161897-16189717.86817.97
4154396-15439617.04017.14
5148877-14887716.43116.53
6164582-16458218.16418.27
20min1191504-19150421.13520.935.0321.3321.135.00
2188943-18894320.85221.09
3194477-19447721.46321.66
4195845-19584521.61421.81
5170980-17098018.87019.06
6196019-19601921.63321.84
30min1211465-21146523.33822.744.2423.6523.064.21
2204253-20425322.54222.90
3208267-20826722.98523.31
4210662-21066223.24923.57
5189260-18926020.88721.19
6212381-21238123.43923.77
45min1215745-21574523.81023.972.2624.2524.422.27
2217867-21786724.04524.52
3215477-21547723.78124.23
4221602-22160224.45724.90
5209460-20946023.11723.53
6223099-22309924.62225.08
60min1219892-21989224.26824.082.4224.8424.662.44
2221673-22167324.46525.08
3218504-21850424.11524.69
4221418-22141824.43625.02
5207718-20771822.92423.47
6220044-22004424.28524.88
极限1223832-22383224.70324.673.1425.4125.393.14
2225851-22585124.92625.67
3227911-22791125.15325.87
4227354-22735425.09225.81
5209549-20954923.12723.80
6226915-22691525.04325.78
替米沙坦氨氯地平片项目信息
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10000
标示量(mg)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.042921829263292532932429324292760.16
214.972914729282292140.33
单位质量响应值RSD%判断
1946.541951.500.18数据可信
供试品溶液-24A2941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%
5min117099-1709956.87257.541.9656.8757.531.96
217253-1725357.38457.38
317322-1732257.61457.61
416799-1679955.87455.87
517760-1776059.07059.07
617558-1755858.39958.40
10min121548-2154871.66971.400.8671.9971.720.86
221320-2132070.91171.23
321320-2132070.91171.23
421294-2129470.82571.14
521743-2174372.31872.65
621577-2157771.76672.09
15min122828-2282875.92775.531.3476.6476.241.34
222281-2228174.10774.82
322719-2271975.56476.28
422433-2243374.61375.32
522875-2287576.08376.81
623110-2311076.86577.59
20min123843-2384379.30378.811.3280.4479.951.32
223213-2321377.20778.33
323402-2340277.83678.97
423800-2380079.16080.28
523972-2397279.73280.88
623942-2394279.63280.78
30min123575-2357578.41181.522.2979.9983.092.25
224234-2423480.60382.16
324512-2451281.52883.09
425201-2520183.81985.38
524693-2469382.13083.73
624839-2483982.61584.21
45min125464-2546484.69484.362.3386.7186.392.29
225243-2524383.95985.96
324244-2424480.63682.66
425607-2560785.17087.19
525793-2579385.78887.84
625829-2582985.90887.96
60min125955-2595586.32787.961.9988.8190.451.96
226342-2634287.61490.08
326027-2602786.56789.03
426761-2676189.00891.51
527344-2734490.94793.48
626239-2623987.27289.80
极限124926-2492682.90584.901.8985.8787.881.84
225218-2521883.87686.83
325499-2549984.81187.76
426027-2602786.56789.56
525318-2531884.20987.24
626163-2616387.01990.03
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数625
标示量(mg)80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%
111.159063349094149114049089619066769085580.24
211.099040699037919039300.03
单位质量响应值RSD%判断
81485.0281508.570.03数据可信
供试品溶液-24A2941批-替米沙坦-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%
5min1216403-21640323.89825.447.2023.9025.447.20
2247174-24717427.29627.30
3212334-21233423.44923.45
4227895-22789525.16725.17
5224692-22469224.81424.81
6253471-25347127.99227.99
10min1440945-44094548.69550.254.4248.8350.394.43
2478505-47850552.84352.99
3430933-43093347.59047.72
4448324-44832449.51049.65
5451269-45126949.83549.97
6480113-48011353.02153.18
15min1573940-57394063.38266.113.6163.7966.533.62
2627531-62753169.30169.75
3584693-58469364.57064.96
4590565-59056565.21865.63
5592057-59205765.38365.80
6622794-62279468.77869.23
20min1666421-66642173.59576.803.5774.3577.593.57
2739176-73917681.63082.46
3678261-67826174.90375.66
4693828-69382876.62277.40
5695106-69510676.76377.54
6700050-70005077.30978.14
30min1720976-72097679.62083.053.3580.7884.263.34
2792868-79286887.55988.84
3755207-75520783.40084.57
4764274-76427484.40285.60
5734531-73453181.11782.32
6744271-74427182.19383.45
45min1812991-81299189.78286.493.2391.3988.163.19
2817286-81728690.25692.03
3760823-76082384.02185.65
4775063-77506385.59387.26
5769030-76903084.92786.58
6763807-76380784.35086.07
60min1839059-83905992.66090.822.9894.7792.972.91
2848804-84880493.73796.01
3840141-84014192.78094.88
4808746-80874689.31391.46
5812672-81267289.74691.87
6784795-78479586.66888.85
极限1811900-81190089.66193.344.1392.2896.004.03
2863121-86312195.31898.11
3906327-906327100.089102.70
4839263-83926392.68395.33
5818732-81873290.41693.04
6831914-83191491.87194.54
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