厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)0
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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.078962489771898138934689414895940.24
212.188953589168893520.30
单位质量响应值RSD%判断
7422.877335.960.84数据可信
供试品溶液-6040901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%
5min138777-3877741.91346.878.2041.9146.878.20
240867-4086744.17244.17
348717-4871752.65752.66
442329-4232945.75345.75
543691-4369147.22547.22
645819-4581949.52549.52
10min183377-8337790.12193.792.3790.3394.032.38
286146-8614693.11493.33
388812-8881295.99596.26
488884-8888496.07396.30
587235-8723594.29194.53
686197-8619793.16993.42
15min193049-93049100.575100.731.05101.24101.441.05
291915-9191599.349100.04
394099-94099101.710102.45
494244-94244101.867102.58
593633-93633101.206101.91
692227-9222799.687100.40
20min191412-9141298.806100.941.3099.97102.151.30
294404-94404102.040103.22
393538-93538101.104102.36
492562-92562100.049101.27
594646-94646102.301103.51
693756-93756101.339102.55
30min193900-93900101.495101.271.24103.15102.981.23
293696-93696101.274102.97
394790-94790102.457104.21
494110-94110101.722103.44
594190-94190101.808103.53
691447-9144798.843100.56
45min190388-9038897.69999.961.4299.86102.181.41
292614-92614100.105102.30
392726-92726100.226102.50
492802-92802100.308102.54
594402-94402102.037104.27
691955-9195599.393101.61
60min191659-9165999.07398.691.47101.73101.411.41
293459-93459101.018103.72
391826-9182699.253102.02
490147-9014797.438100.17
589744-8974497.00399.75
690998-9099898.358101.07
极限190003-9000397.28398.960.90100.43102.170.90
292251-9225199.712102.92
391909-9190999.343102.61
491559-9155998.964102.18
592128-9212899.580102.81
691485-9148598.885102.09
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)0
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.082611492616922603712606902609552609710.20
215.072644802642192643500.07
单位质量响应值RSD%判断
17305.7717541.470.96数据可信
供试品溶液-6040901批-厄贝沙坦-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%
5min136797-3679714.08015.499.5514.0815.499.56
237108-3710814.19914.20
347035-4703517.99718.00
439253-3925315.02015.02
539933-3993315.28015.28
642701-4270116.33916.34
10min1102204-10220439.10740.853.7339.1840.933.74
2105375-10537540.32140.39
3113992-11399243.61843.71
4107558-10755841.15641.23
5106634-10663440.80240.88
6104860-10486040.12440.21
15min1142015-14201554.34154.912.8054.6155.192.82
2140173-14017353.63653.91
3151440-15144057.94758.26
4143292-14329254.82955.11
5142210-14221054.41554.70
6141869-14186954.28554.57
20min1163296-16329662.48463.562.5363.0264.112.54
2167571-16757164.11964.66
3173334-17333466.32466.92
4161068-16106861.63162.19
5165373-16537363.27863.83
6165940-16594063.49564.05
30min1196170-19617075.06274.612.3775.9175.482.36
2194201-19420174.30975.17
3203021-20302177.68478.61
4192772-19277273.76274.63
5194563-19456374.44875.32
6189126-18912672.36773.24
45min1215285-21528582.37783.471.7883.6084.711.80
2220613-22061384.41585.65
3224864-22486486.04287.36
4216178-21617882.71883.95
5217025-21702583.04284.28
6214854-21485482.21283.44
60min1234358-23435889.67588.512.6691.3190.182.64
2237609-23760990.91992.57
3238116-23811691.11392.86
4224376-22437685.85587.50
5225355-22535586.23087.89
6228120-22812087.28888.93
极限1244292-24429293.47694.041.8095.5696.151.81
2249735-24973595.55997.67
3252531-25253196.62898.83
4241728-24172892.49594.57
5244532-24453293.56895.66
6241788-24178892.51894.60
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)0
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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.078920989410889348923189454892480.24
212.188859588401884980.16
单位质量响应值RSD%判断
7394.207265.851.24数据可信
供试品溶液-6040902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%
5min145508-4550849.52256.849.1149.5256.849.11
249854-4985454.25254.25
357032-5703262.06362.06
454710-5471059.53659.54
557107-5710762.14462.14
649188-4918853.52753.53
10min186008-8600893.59596.912.2193.8497.192.22
288905-8890596.74797.02
388589-8858996.40496.71
488563-8856396.37596.67
591825-9182599.925100.24
690416-9041698.39298.66
15min190608-9060898.601101.752.1199.32102.522.11
296393-96393104.896105.65
392724-92724100.903101.70
493371-93371101.607102.39
594862-94862103.230104.04
693081-93081101.292102.05
20min194486-94486102.821103.161.36104.03104.441.35
296652-96652105.178106.46
393412-93412101.652102.95
493935-93935102.221103.51
596096-96096104.573105.90
694227-94227102.539103.80
30min193832-93832102.109103.182.20103.83104.972.18
298490-98490107.178108.98
393421-93421101.662103.47
492758-92758100.940102.74
595828-95828104.281106.13
694541-94541102.881104.66
45min193619-93619101.877102.431.89104.11104.741.88
297175-97175105.747108.09
393363-93363101.599103.91
492296-92296100.438102.74
595218-95218103.617105.99
693079-93079101.290103.58
60min190278-9027898.242101.432.98100.98104.252.94
297123-97123105.690108.56
391484-9148499.554102.38
491182-9118299.225102.03
595922-95922104.383107.27
693237-93237101.462104.26
极限194264-94264102.579101.031.51105.81104.361.47
294110-94110102.412105.81
391075-9107599.109102.43
491411-9141199.474102.78
593729-93729101.997105.41
692447-92447100.602103.91
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)0
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.082640292637342628062639162640072636980.20
215.072650452658532654490.22
单位质量响应值RSD%判断
17486.6017614.400.52数据可信
供试品溶液-6040902批-厄贝沙坦-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%
5min143113-4311316.37719.5612.2916.3819.5612.29
248574-4857418.45118.45
360253-6025322.88822.89
454942-5494220.87020.87
555036-5503620.90620.91
647013-4701317.85817.86
10min1112305-11230542.66044.583.3542.7444.683.37
2116356-11635644.19944.29
3123530-12353046.92447.04
4119863-11986345.53145.64
5117243-11724344.53644.64
6114909-11490943.64943.74
15min1147560-14756056.05257.432.8156.3557.752.82
2154554-15455458.70959.02
3156724-15672459.53359.88
4153255-15325558.21658.55
5148842-14884256.53956.87
6146180-14618055.52855.84
20min1173854-17385466.04065.962.5066.6266.572.50
2177623-17762367.47268.08
3177944-17794467.59468.24
4175370-17537066.61667.24
5170097-17009764.61365.22
6167020-16702063.44464.03
30min1201001-20100176.35275.852.7677.2676.782.74
2208810-20881079.31980.26
3202195-20219576.80677.79
4196952-19695274.81475.77
5194641-19464173.93774.87
6194437-19443773.85974.76
45min1225592-22559285.69484.172.3186.9885.482.29
2228493-22849386.79688.14
3223894-22389485.04986.42
4217693-21769382.69384.02
5216056-21605682.07183.37
6217689-21768982.69283.96
60min1233026-23302688.51888.752.4290.2390.482.41
2242428-24242892.08993.86
3236722-23672289.92291.72
4232636-23263688.36990.11
5231481-23148187.93189.64
6225517-22551785.66587.35
极限1249387-24938794.73293.971.7796.8996.151.76
2254505-25450596.67798.91
3248809-24880994.51396.76
4244184-24418492.75694.94
5244106-24410692.72694.88
6243230-24323092.39494.51
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