氢氯噻嗪坎地沙坦酯片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.014553994545954544294544144542284546130.11
212.064523674535874529770.20
单位质量响应值RSD%判断
37852.8737560.280.55数据可信
中间条件6月-供试品溶液-2024082321批-氢氯噻嗪-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%
5min1385115-38511573.31766.0315.9873.3266.0415.98
2267674-26767450.95950.96
3320674-32067461.04961.05
4313995-31399559.77859.78
5376248-37624871.62971.63
6417440-41744079.47179.47
10min1468310-46831089.15683.038.3489.2883.148.35
2384000-38400073.10573.19
3411898-41189878.41678.52
4420100-42010079.97880.08
5456559-45655986.91987.04
6476006-47600690.62190.75
15min1478629-47862991.12087.365.0891.3987.605.10
2432150-43215082.27282.48
3440107-44010783.78784.02
4444376-44437684.59984.83
5468060-46806089.10889.37
6489850-48985093.25793.54
20min1481305-48130591.63089.233.8292.0589.623.83
2452056-45205686.06286.41
3452959-45295986.23386.61
4457075-45707587.01787.39
5472494-47249489.95390.37
6496290-49629094.48394.92
30min1484862-48486292.30791.162.5492.8891.702.57
2473520-47352090.14890.64
3467081-46708188.92289.44
4470856-47085689.64190.16
5476234-47623490.66591.23
6500429-50042995.27195.87
45min1487153-48715392.74392.351.7193.4793.051.73
2486837-48683792.68393.32
3477131-47713190.83591.50
4480799-48079991.53492.20
5478952-47895291.18291.90
6499744-49974495.14095.90
60min1487254-48725492.76392.571.7593.6593.421.76
2490724-49072493.42394.22
3479509-47950991.28892.10
4479998-47999891.38192.20
5479403-47940391.26892.13
6500657-50065795.31496.23
极限1515734-51573498.18499.250.7899.22100.250.76
2525242-52524299.995100.94
3524352-52435299.825100.79
4518387-51838798.69099.66
5519324-51932498.86899.89
6524949-52494999.939101.01
氢氯噻嗪坎地沙坦酯片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.521523691526751526651526051527051526040.09
216.491525751529421527580.17
单位质量响应值RSD%判断
9237.539263.670.20数据可信
中间条件6月-供试品溶液-2024082321批-坎地沙坦酯-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%
5min178156-7815647.42944.1615.4447.4344.1615.44
256570-5657034.33034.33
368015-6801541.27541.28
466601-6660140.41740.42
578981-7898147.93047.93
688274-8827453.56953.57
10min1119588-11958872.57267.938.6672.6568.008.67
297189-9718958.97959.04
3106506-10650664.63464.70
4107670-10767065.34065.41
5118721-11872172.04672.13
6121914-12191473.98474.07
15min1131989-13198980.09877.275.1980.3077.455.20
2117692-11769271.42271.58
3123531-12353174.96575.14
4123992-12399275.24575.42
5131879-13187980.03180.23
6134858-13485881.83982.05
20min1138281-13828183.91682.113.6784.2582.433.70
2128574-12857478.02678.30
3132050-13205080.13580.44
4132716-13271680.53980.84
5138492-13849284.04484.38
6141759-14175986.02786.38
30min1144271-14427187.55186.722.2988.0287.172.32
2139303-13930384.53784.94
3140326-14032685.15785.59
4140850-14085085.47585.91
5144826-14482687.88888.36
6147818-14781889.70490.20
45min1147830-14783089.71189.161.3790.3389.751.40
2145387-14538788.22988.77
3144907-14490787.93788.51
4145652-14565288.38988.97
5147520-14752089.52390.14
6150207-15020791.15491.80
60min1148988-14898890.41490.031.2391.1890.781.26
2147558-14755889.54690.24
3146937-14693789.16989.89
4146761-14676189.06289.79
5148239-14823989.95990.73
6151674-15167492.04492.84
极限1154094-15409493.51294.660.7694.4395.560.74
2156610-15661095.03995.88
3157067-15706795.31796.19
4155455-15545594.33895.21
5155591-15559194.42195.34
6157115-15711595.34696.29
氢氯噻嗪坎地沙坦酯片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.014514484514094517214515044516514515470.03
212.064505614504244504920.03
单位质量响应值RSD%判断
37597.5937354.230.46数据可信
中间条件6月-供试品溶液-2024082521批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1340188-34018865.16364.453.3265.1664.453.32
2352461-35246167.51467.51
3320626-32062661.41661.42
4336179-33617964.39564.39
5341595-34159565.43265.43
6327720-32772062.77462.77
10min1449375-44937586.07784.932.8686.1985.042.86
2456976-45697687.53387.65
3435496-43549683.41983.52
4445530-44553085.34185.45
5450825-45082586.35586.46
6421985-42198580.83180.94
15min1479566-47956691.86090.002.1692.1190.252.17
2482453-48245392.41392.67
3458267-45826787.78188.02
4469186-46918689.87290.12
5471090-47109090.23790.49
6458643-45864387.85388.09
20min1486757-48675793.23892.251.5593.6492.651.55
2492414-49241494.32194.73
3470509-47050990.12690.51
4481151-48115192.16492.56
5479740-47974091.89492.30
6479068-47906891.76592.15
30min1497868-49786895.36694.841.5295.9395.391.52
2506225-50622596.96797.54
3483665-48366592.64693.18
4492465-49246594.33194.88
5492860-49286094.40794.96
6497484-49748495.29395.83
45min1507621-50762197.23496.611.5197.9597.321.50
2514090-51409098.47399.20
3493124-49312494.45795.15
4501866-50186696.13296.84
5499820-49982095.74096.45
6509654-50965497.62498.32
60min1511380-51138097.95497.231.6198.8498.101.61
2517544-51754499.135100.03
3495807-49580794.97195.82
4506036-50603696.93197.80
5501157-50115795.99696.87
6513612-51361298.38299.24
极限1512422-51242298.15499.470.8799.20100.510.87
2525747-525747100.706101.77
3520501-52050199.701100.71
4516425-51642598.92199.95
5520603-52060399.721100.75
6520174-52017499.639100.66
氢氯噻嗪坎地沙坦酯片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.521524651524761525911525721526121525430.05
216.491523651521661522660.10
单位质量响应值RSD%判断
9233.849233.840.00数据可信
中间条件6月-供试品溶液-2024082521批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167324-6732440.93040.721.8140.9340.721.81
268087-6808741.39441.39
365060-6506039.55339.55
467046-6704640.76140.76
566129-6612940.20340.20
668214-6821441.47141.47
10min1112567-11256768.43667.751.8768.5067.821.87
2113078-11307868.74668.82
3111034-11103467.50467.57
4111356-11135667.69967.77
5113052-11305268.73068.80
6107577-10757765.40265.47
15min1129643-12964378.81778.271.4479.0078.451.43
2131159-13115979.73979.92
3126030-12603076.62076.80
4128929-12892978.38378.56
5129481-12948178.71978.90
6127194-12719477.32877.51
20min1138494-13849484.19884.241.3484.5184.551.34
2141122-14112285.79686.11
3135477-13547782.36482.67
4138967-13896784.48684.80
5138023-13802383.91284.22
6139318-13931884.69985.01
30min1147821-14782189.86889.811.4190.3290.261.41
2150519-15051991.50991.97
3144795-14479588.02988.47
4147239-14723989.51589.97
5146428-14642889.02289.47
6149554-14955490.92291.37
45min1151805-15180592.29092.311.4292.8992.911.41
2154618-15461894.00194.61
3149339-14933990.79191.38
4151205-15120591.92692.53
5149954-14995491.16591.77
6154081-15408193.67494.27
60min1152694-15269492.83192.951.4093.5993.711.40
2155777-15577794.70595.47
3150301-15030191.37692.12
4152886-15288692.94893.70
5150889-15088991.73492.49
6154817-15481794.12294.88
极限1154035-15403593.64695.040.9894.5695.960.97
2158545-15854596.38897.31
3156906-15690695.39296.29
4155633-15563394.61895.53
5155934-15593494.80195.71
6156960-15696095.42496.34
氢氯噻嗪坎地沙坦酯片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.014493684495874493664495874494204494660.03
212.064487224488614487920.03
单位质量响应值RSD%判断
37424.3137213.270.40数据可信
中间条件6月-供试品溶液-2024082721批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1246298-24629847.37759.5215.0847.3859.5215.08
2351820-35182067.67467.67
3357958-35795868.85568.86
4328270-32827063.14463.14
5260559-26055950.12050.12
6311511-31151159.92159.92
10min1418129-41812980.42982.444.9180.5182.544.92
2441918-44191885.00585.12
3446729-44672985.93186.05
4431696-43169683.03983.14
5391145-39114575.23975.32
6442006-44200685.02285.12
15min1464855-46485589.41789.412.7789.6389.652.78
2467793-46779389.98290.24
3472001-47200190.79291.05
4468810-46881090.17890.42
5439747-43974784.58884.80
6475840-47584091.53091.77
20min1476749-47674991.70592.771.3692.0793.151.37
2479073-47907392.15292.56
3485035-48503593.29993.71
4482083-48208392.73193.13
5476798-47679891.71492.06
6493848-49384894.99495.39
30min1488218-48821893.91195.131.3494.4395.671.35
2492384-49238494.71395.27
3497780-49778095.75096.32
4495171-49517195.24995.80
5488064-48806493.88294.38
6505584-50558497.25297.80
45min1502779-50277996.71297.641.3097.3898.341.32
2506400-50640097.40998.12
3511599-51159998.40999.13
4506435-50643597.41598.12
5499999-49999996.17796.84
6518446-51844699.726100.44
60min1509057-50905797.92098.931.2798.7599.791.28
2512586-51258698.59999.48
3519219-51921999.874100.76
4511688-51168898.42699.30
5508326-50832697.77998.60
6524993-524993100.985101.87
极限1514617-51461798.98999.621.2599.98100.651.26
2512882-51288298.65599.70
3524990-524990100.984102.04
4512419-51241998.56699.60
5515348-51534899.130100.11
6527215-527215101.412102.46
氢氯噻嗪坎地沙坦酯片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.521524611524831524811523741522331524060.08
216.491522121521881522000.02
单位质量响应值RSD%判断
9225.549229.840.04数据可信
中间条件6月-供试品溶液-2024082721批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151370-5137031.25138.9914.3431.2538.9914.33
274010-7401045.02545.02
371083-7108343.24443.24
468794-6879441.85141.85
554587-5458733.20933.21
664683-6468339.35039.35
10min1103274-10327462.82865.595.5162.8865.655.52
2113544-11354469.07669.15
3113145-11314568.83368.90
4109138-10913866.39566.46
598328-9832859.81959.87
6109434-10943466.57566.64
15min1127064-12706477.30177.672.7977.4677.852.80
2130231-13023179.22779.42
3130361-13036179.30679.49
4128073-12807377.91478.09
5120913-12091373.55973.71
6129431-12943178.74178.92
20min1137800-13780083.83284.571.1084.1284.881.10
2139144-13914484.65084.97
3139363-13936384.78385.10
4138087-13808784.00684.32
5137906-13790683.89684.17
6141808-14180886.27086.58
30min1146251-14625188.97389.771.2889.4090.211.28
2146966-14696689.40889.87
3147934-14793489.99790.46
4147294-14729489.60890.06
5145821-14582188.71289.13
6151070-15107091.90592.36
45min1151423-15142392.12092.611.1292.6993.201.13
2151345-15134592.07292.68
3153004-15300493.08193.69
4151608-15160892.23292.83
5150678-15067891.66692.23
6155337-15533794.50195.11
60min1153360-15336093.29893.660.9394.0394.420.94
2153198-15319893.19993.97
3155030-15503094.31495.08
4153338-15333893.28594.04
5152517-15251792.78593.50
6156337-15633795.10995.87
极限1155824-15582494.79794.860.9895.6895.760.98
2154855-15485594.20795.13
3157398-15739895.75596.68
4154949-15494994.26595.17
5154380-15438093.91894.79
6158119-15811996.19397.11
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