坎地沙坦酯氢氯噻嗪片项目信息
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(%)99.70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%
112.014716694719564721014725364724574721440.08
212.124704134704344704240.01
单位质量响应值RSD%判断
39312.5738813.860.91数据可信
加速2月-供试品溶液-24032701批-氢氯噻嗪-pH6.8(内含0.35%吐温20)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1400772-40077273.65063.1612.8373.6563.1612.83
2346450-34645063.66863.67
3383557-38355770.48770.49
4341721-34172162.79862.80
5301108-30110855.33555.33
6288544-28854453.02653.03
10min1453768-45376883.38980.275.3683.5180.385.36
2450780-45078082.84082.95
3460837-46083784.68984.81
4436906-43690680.29180.40
5417853-41785376.78976.88
6400603-40060373.61973.71
15min1467692-46769285.94884.192.5286.2184.422.54
2464169-46416985.30185.55
3472301-47230186.79587.05
4452915-45291583.23383.47
5444535-44453581.69381.91
6446979-44697982.14282.35
20min1476359-47635987.54186.311.5887.9586.691.59
2470069-47006986.38586.77
3477440-47744087.74088.14
4466118-46611885.65986.04
5457283-45728384.03584.39
6470715-47071586.50486.85
30min1487204-48720489.53488.681.4290.0889.211.42
2478465-47846587.92888.46
3483916-48391688.93089.48
4479351-47935188.09188.61
5473709-47370987.05487.55
6492803-49280390.56391.06
45min1494189-49418990.81890.961.9391.5291.631.90
2485568-48556889.23389.91
3490866-49086690.20790.90
4490860-49086090.20690.87
5495134-49513490.99191.63
6513121-51312194.29794.94
60min1496374-49637491.21992.252.6092.0793.082.56
2488902-48890289.84690.67
3495236-49523691.01091.86
4498482-49848291.60792.42
5507308-50730893.22994.02
6525696-52569696.60897.41
极限1543699-54369999.91699.310.60100.92100.290.61
2539659-53965999.174100.15
3542145-54214599.631100.63
4537531-53753198.78399.75
5536000-53600098.50199.45
6543474-54347499.875100.84
坎地沙坦酯氢氯噻嗪片项目信息
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
116.013037743037973040073043483040673039990.08
215.853025903022003023950.10
单位质量响应值RSD%判断
18988.0719078.550.34数据可信
加速2月-供试品溶液-24032701批-坎地沙坦酯-pH6.8(内含0.35%吐温20)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1147428-14742843.48336.6712.6343.4836.6712.63
2123529-12352936.43436.43
3136251-13625140.18740.19
4122938-12293836.26036.26
5110452-11045232.57732.58
6105311-10531131.06131.06
10min1231376-23137668.24364.176.1968.3264.246.19
2220674-22067465.08765.15
3230744-23074468.05768.12
4217763-21776364.22864.29
5208573-20857361.51861.57
6196358-19635857.91557.97
15min1270203-27020379.69577.633.2379.8877.803.25
2265934-26593478.43678.61
3273491-27349180.66580.85
4261654-26165477.17477.34
5257456-25745675.93576.09
6250421-25042173.86074.01
20min1291887-29188786.09185.341.4386.4185.641.44
2288828-28882885.18885.49
3295888-29588887.27187.59
4288976-28897685.23285.53
5285686-28568684.26284.55
6284720-28472083.97784.25
30min1312614-31261492.20492.800.8892.6793.240.87
2311765-31176591.95492.40
3316549-31654993.36593.82
4315012-31501292.91193.35
5312958-31295892.30592.73
6318989-31898994.08494.50
45min1320910-32091094.65196.161.7595.2796.761.73
2321307-32130794.76895.36
3324670-32467095.76096.38
4325060-32506095.87596.47
5327880-32788096.70797.28
6336420-33642099.22599.79
60min1321403-32140394.79696.822.1595.5797.582.12
2323590-32359095.44196.19
3326171-32617196.20396.98
4326173-32617396.20396.96
5331403-33140397.74698.48
6340889-340889100.544101.28
极限1338822-33882299.93499.940.59100.87100.860.59
2340316-340316100.375101.29
3338858-33885899.945100.88
4336484-33648499.244100.16
5336840-33684099.349100.25
6341689-341689100.780101.68
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