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(%)99.7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%
111.524425374421124420224421584418954421450.06
211.634409194410954410070.03
单位质量响应值RSD%判断
38380.6437919.780.86数据可信
供试品溶液-2024082321批-氢氯噻嗪-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%
5min1286858-28685853.97860.6411.5453.9860.6411.54
2363343-36334368.37068.37
3366697-36669769.00169.00
4285490-28549053.72053.72
5332178-33217862.50562.51
6298904-29890456.24456.24
10min1424609-42460979.89885.206.8079.9985.306.80
2478749-47874990.08590.20
3483795-48379591.03591.15
4422138-42213879.43379.52
5479720-47972090.26890.37
6427577-42757780.45680.55
15min1486903-48690391.62094.033.1891.8494.273.19
2515978-51597897.09197.35
3510864-51086496.12896.40
4492288-49228892.63392.85
5513733-51373396.66896.92
6478430-47843090.02590.25
20min1526232-52623299.02097.941.5799.4098.341.58
2530777-53077799.875100.30
3522019-52201998.22798.65
4514284-51428496.77297.15
5521550-52155098.13998.55
6508168-50816895.62196.00
30min1538988-538988101.420100.381.59101.96100.941.59
2546028-546028102.745103.34
3531500-531500100.011100.60
4535186-535186100.705101.24
5522911-52291198.39598.97
6526207-52620799.01699.55
45min1539450-539450101.507100.811.66102.22101.541.66
2549502-549502103.399104.16
3533781-533781100.441101.20
4537916-537916101.219101.92
5523144-52314498.43999.18
6530774-53077499.875100.58
60min1539178-539178101.456100.871.67102.34101.771.66
2549727-549727103.441104.38
3533837-533837100.451101.38
4537850-537850101.206102.08
5522460-52246098.31099.22
6533374-533374100.364101.23
极限1538052-538052101.244100.871.88102.29101.931.88
2552974-552974104.052105.16
3532813-532813100.259101.35
4535930-535930100.845101.89
5521718-52171898.17199.24
6534821-534821100.636101.67
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(%)99.8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%
116.031531751530661532481533301531701531980.07
216.111530541531571531060.05
单位质量响应值RSD%判断
9556.969503.790.40数据可信
供试品溶液-2024082321批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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(%)99.7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%
111.524404184402654403734396764403194402100.07
211.634382984389184386080.10
单位质量响应值RSD%判断
38212.6737713.500.93数据可信
供试品溶液-2024082321批-氢氯噻嗪-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%
5min1271655-27165551.36963.7715.6351.3763.7715.63
2412995-41299578.09678.10
3362214-36221468.49468.49
4368034-36803469.59469.59
5297277-29727756.21456.21
6311234-31123458.85358.85
10min1424954-42495480.35887.786.8080.4487.886.81
2510309-51030996.49896.63
3477903-47790390.37090.48
4481470-48147091.04591.16
5437980-43798082.82182.91
6452590-45259085.58385.68
15min1495743-49574393.74497.372.1493.9697.622.16
2529919-529919100.206100.50
3514718-51471897.33297.60
4515002-51500297.38597.65
5516021-51602197.57897.81
6518006-51800697.95398.19
20min1533173-533173100.821100.780.65101.20101.190.63
2533068-533068100.802101.26
3531597-531597100.523100.95
4527217-52721799.695100.13
5535358-535358101.235101.63
6537196-537196101.582101.99
30min1541527-541527102.401101.640.84102.95102.220.82
2536029-536029101.362101.99
3538187-538187101.770102.36
4529337-529337100.096100.69
5538794-538794101.884102.45
6541170-541170102.334102.91
45min1540749-540749102.254101.600.79102.97102.350.77
2535828-535828101.324102.12
3538561-538561101.840102.60
4529381-529381100.104100.87
5539458-539458102.010102.74
6539634-539634102.043102.79
60min1539482-539482102.014101.410.81102.90102.330.80
2535636-535636101.287102.25
3537232-537232101.589102.52
4528030-52803099.849100.78
5537336-537336101.609102.51
6539967-539967102.106103.02
极限1538666-538666101.860101.220.77102.92102.320.75
2534368-534368101.047102.18
3536017-536017101.359102.46
4527674-52767499.782100.88
5536276-536276101.408102.48
6538846-538846101.894102.98
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(%)99.8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%
116.031530771528831533241530101531631530910.11
216.111527711528241527980.03
单位质量响应值RSD%判断
9550.289484.670.49数据可信
供试品溶液-2024082321批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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(%)99.7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%
111.524386144394914396014397284391304393130.11
211.634365524369664367590.07
单位质量响应值RSD%判断
38134.8137554.511.09数据可信
供试品溶液-2024082521批-氢氯噻嗪-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%
5min1332174-33217463.01164.105.5063.0164.105.50
2370922-37092270.36170.36
3346161-34616165.66465.66
4334440-33444063.44163.44
5323671-32367161.39861.40
6320040-32004060.70960.71
10min1475549-47554990.20890.613.3390.3190.713.33
2507044-50704496.18296.30
3482893-48289391.60191.71
4466778-46677888.54488.65
5469222-46922289.00889.11
6464402-46440288.09388.19
15min1522568-52256899.12799.651.4299.3899.911.42
2537961-537961102.047102.32
3518763-51876398.40598.67
4523521-52352199.30899.56
5530155-530155100.566100.82
6519020-51902098.45498.70
20min1531837-531837100.885101.750.74101.31102.180.75
2542308-542308102.871103.32
3534682-534682101.425101.85
4537680-537680101.993102.41
5538928-538928102.230102.65
6533051-533051101.115101.53
30min1533861-533861101.269102.270.73101.86102.870.74
2544686-544686103.322103.94
3539387-539387102.317102.91
4541343-541343102.688103.28
5540072-540072102.447103.04
6535559-535559101.591102.17
45min1533917-533917101.280102.200.78102.04102.960.79
2544774-544774103.339104.13
3538941-538941102.233103.00
4541749-541749102.765103.53
5538765-538765102.199102.96
6534464-534464101.383102.13
60min1531764-531764100.871102.060.93101.80102.990.93
2544979-544979103.378104.34
3538017-538017102.057102.99
4541775-541775102.770103.70
5538321-538321102.115103.04
6533277-533277101.158102.08
极限1531948-531948100.906101.810.86102.00102.910.87
2544238-544238103.237104.37
3535792-535792101.635102.74
4539575-539575102.353103.46
5535974-535974101.670102.77
6532607-532607101.031102.12
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(%)99.8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%
116.031527641529031532151529401527281529100.13
216.111522541522881522710.02
单位质量响应值RSD%判断
9538.999451.960.65数据可信
供试品溶液-2024082521批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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