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%
114.07 1134581137221138211139321137441137350.16
214.091141931138971140450.19
单位质量响应值RSD%判断
8083.518094.040.10数据可信
供试品溶液-2024081921批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min179926-7992662.38764.762.3662.3964.762.36
282304-8230464.24364.24
382346-8234664.27664.28
483446-8344665.13565.13
584089-8408965.63765.64
685723-8572366.91266.91
10min187041-8704167.94169.821.7668.0469.931.76
289402-8940269.78469.89
389021-8902169.48769.59
488928-8892869.41469.52
591474-9147471.40171.51
690834-9083470.90271.01
15min190270-9027070.46172.701.8970.6872.921.88
292929-9292972.53772.76
392620-9262072.29672.52
493049-9304972.63172.85
594731-9473173.94474.17
695201-9520174.31074.54
20min193826-9382673.23774.501.8273.5774.851.81
293268-9326872.80273.15
395609-9560974.62974.97
495202-9520274.31174.66
597458-9745876.07276.42
697304-9730475.95276.31
30min196613-9661375.41377.821.9275.8778.281.92
299158-9915877.39977.86
399215-9921577.44477.91
499729-9972977.84578.31
5101590-10159079.29779.78
6101839-10183979.49279.97
45min1101586-10158679.29480.103.1279.8880.703.11
297002-9700275.71676.31
3103348-10334880.67081.27
4102766-10276680.21580.81
5106345-10634583.00983.62
6104665-10466581.69882.31
60min1105192-10519282.10983.521.1282.8284.261.12
2107019-10701983.53584.26
3106538-10653883.16083.89
4106740-10674083.31784.05
5108655-10865584.81285.56
6107888-10788884.21384.96
90min1109291-10929185.30986.781.2386.1687.661.24
2110924-11092486.58387.44
3110844-11084486.52187.39
4110548-11054886.29087.16
5113115-11311588.29389.18
6112372-11237287.71388.60
120min1111913-11191387.35588.901.2988.3589.911.29
2113762-11376288.79889.80
3113671-11367188.72789.74
4112934-11293488.15289.17
5116014-11601490.55691.59
6115024-11502489.78390.82
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1113395-11339588.51289.701.6389.6590.871.62
2115284-11528489.98691.14
3112360-11236087.70488.87
4114589-11458989.44490.61
5117146-11714691.44092.63
6116761-11676191.13992.32
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1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%
115.94 4642323464284346417964642574464236846423810.01
215.954672802467070146717520.04
单位质量响应值RSD%判断
291240.97292899.810.41数据可信
供试品溶液-2024081921批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1332125-3321256.3396.695.596.346.695.61
2349555-3495556.6726.67
3334480-3344806.3846.38
4353626-3536266.7496.75
5346915-3469156.6216.62
6386513-3865137.3777.38
10min1597373-59737311.40111.935.3511.4111.945.34
2610656-61065611.65511.67
3600959-60095911.47011.48
4617739-61773911.79011.80
5637135-63713512.16012.17
6686960-68696013.11113.12
15min1814374-81437415.54316.103.4315.5716.133.44
2831186-83118615.86415.89
3817022-81702215.59415.62
4842423-84242316.07816.11
5874914-87491416.69916.73
6882087-88208716.83516.87
20min1995995-99599519.00919.783.3419.0619.843.35
21019367-101936719.45619.51
31009505-100950519.26719.32
41040970-104097019.86819.93
51080353-108035320.61920.68
61073380-107338020.48620.55
30min11337654-133765425.53026.092.8825.6226.182.88
21339187-133918725.56025.65
31329391-132939125.37325.46
41364962-136496226.05126.14
51421738-142173827.13527.23
61407959-140795926.87226.97
45min11671004-167100431.89333.083.1632.0233.223.16
21710877-171087732.65432.79
31682270-168227032.10832.24
41747626-174762633.35533.49
51807530-180753034.49834.64
61780583-178058333.98434.13
60min11959246-195924637.39438.862.8837.5839.052.88
22016863-201686338.49438.68
31994344-199434438.06438.25
42040478-204047838.94439.13
52113068-211306840.33040.53
62092595-209259539.93940.14
90min12384232-238423245.50547.562.5945.7547.822.59
22467379-246737947.09247.34
32494438-249443847.60947.86
42494546-249454647.61147.87
52571499-257149949.07949.34
62539376-253937648.46648.73
120min12720857-272085751.93053.842.4952.2554.172.50
22781409-278140953.08653.41
32799278-279927853.42753.75
42825780-282578053.93254.27
52911058-291105855.56055.91
62886994-288699455.10155.45
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12952607-295260756.35357.871.8756.7658.301.88
23023641-302364157.70958.13
32992499-299249957.11457.53
43035040-303504057.92658.35
53104563-310456359.25359.69
63085220-308522058.88459.32
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%
114.07 1140351136381140811138401138831138950.16
214.091137681140301138990.17
单位质量响应值RSD%判断
8094.888083.680.10数据可信
供试品溶液-2024082021批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177015-7701560.11162.894.0460.1162.894.03
285140-8514066.45366.45
378344-7834461.14961.15
478147-7814760.99560.99
583306-8330665.02265.02
681512-8151263.62163.62
10min186062-8606267.17368.722.4967.2768.832.49
290033-9003370.27270.38
386584-8658467.58067.68
485847-8584767.00567.11
590949-9094970.98771.10
688829-8882969.33269.44
15min191632-9163271.52071.962.1271.7372.182.12
293608-9360873.06273.29
390357-9035770.52570.74
490180-9018070.38770.60
595226-9522674.32574.55
692171-9217171.94172.16
20min194025-9402573.38873.892.1973.7274.222.19
296135-9613575.03575.38
392476-9247672.17972.51
492734-9273472.38072.71
597887-9788776.40276.75
694734-9473473.94174.28
30min196946-9694675.66876.471.7176.1276.931.72
299113-9911377.35977.83
396211-9621175.09475.55
496775-9677575.53475.99
5100637-10063778.54979.03
698155-9815576.61177.08
45min1101126-10112678.93079.571.6979.5180.161.70
2103768-10376880.99281.60
399877-9987777.95578.53
4100745-10074578.63379.21
5104204-10420481.33381.94
6101971-10197179.59080.18
60min1103960-10396081.14281.861.7081.8582.581.71
2106005-10600582.73883.48
3103130-10313080.49481.20
4103530-10353080.80781.51
5107852-10785284.18084.92
6104839-10483981.82882.55
90min1106788-10678883.35084.821.8584.2085.681.85
2110360-11036086.13887.01
3107122-10712283.61084.45
4107354-10735483.79184.63
5111747-11174787.22088.10
6108659-10865984.81085.67
120min1109118-10911885.16886.721.8386.1587.721.84
2113168-11316888.32989.35
3109147-10914785.19186.17
4110016-11001685.86986.85
5113815-11381588.83489.86
6111372-11137286.92787.93
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1110615-11061586.33788.271.9887.4689.421.98
2115094-11509489.83391.00
3111270-11127086.84887.97
4112373-11237387.70988.83
5116379-11637990.83592.01
6112853-11285388.08389.23
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1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%
115.94 4651534465361246548594656450465594746544800.05
215.954683727468676746852470.05
单位质量响应值RSD%判断
292000.00293745.890.43数据可信
供试品溶液-2024082021批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1291000-2910005.5395.404.415.545.404.43
2281727-2817275.3625.36
3289835-2898355.5175.52
4259606-2596064.9414.94
5288742-2887425.4965.50
6292722-2927225.5725.57
10min1510287-5102879.7139.623.099.729.633.10
2504210-5042109.5979.61
3511873-5118739.7439.75
4474640-4746409.0349.04
5515978-5159789.8219.83
6514982-5149829.8029.81
15min1704657-70465713.41213.302.3813.4413.332.38
2686351-68635113.06413.09
3705707-70570713.43213.46
4672127-67212712.79312.82
5718301-71830113.67213.70
6705647-70564713.43113.46
20min1873112-87311216.61816.502.2116.6716.552.21
2847252-84725216.12616.17
3867849-86784916.51816.57
4843847-84384716.06116.11
5895135-89513517.03817.09
6875120-87512016.65716.70
30min11146088-114608821.81421.752.5221.8921.832.52
21102333-110233320.98121.05
31143926-114392621.77321.85
41124639-112463921.40621.48
51187908-118790822.61022.69
61152868-115286821.94322.02
45min11480471-148047128.17928.102.4128.2928.202.41
21426111-142611127.14427.25
31465885-146588527.90128.01
41460855-146085527.80527.91
51533043-153304329.17929.29
61490620-149062028.37228.48
60min11756895-175689533.44033.332.5633.6033.492.55
21683196-168319632.03732.19
31742730-174273033.17033.33
41738817-173881733.09633.25
51821582-182158234.67134.83
61764330-176433033.58233.74
90min12181570-218157041.52341.362.3841.7441.572.38
22098953-209895339.95140.16
32157221-215722141.06041.27
42161210-216121041.13641.34
52258788-225878842.99343.21
62179567-217956741.48541.70
120min12519985-251998547.96447.552.0948.2547.842.09
22427462-242746246.20346.48
32464356-246435646.90647.19
42491959-249195947.43147.71
52580877-258087749.12349.42
62504570-250457047.67147.96
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12764368-276436852.61652.242.0652.9852.602.05
22672075-267207550.85951.21
32708167-270816751.54651.91
42740906-274090652.16952.53
52838614-283861454.02954.40
62744108-274410852.23052.59
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