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)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%
112.909678496873968609643096355966600.26
212.869683696399966180.32
单位质量响应值RSD%判断
7493.027513.060.19数据可信
供试品溶液-GA47051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%
5min118156-1815619.30119.3013.2219.3019.3013.22
219403-1940320.62620.63
315620-1562016.60516.60
418790-1879019.97419.97
521650-2165023.01523.01
615300-1530016.26416.26
10min170586-7058675.03673.334.2075.1373.434.20
271619-7161976.13476.24
363793-6379367.81467.90
471138-7113875.62275.72
568226-6822672.52772.64
668530-6853072.85072.93
15min185199-8519990.57090.731.9191.0491.191.92
288149-8814993.70694.19
383190-8319088.43488.86
484738-8473890.08090.56
585792-8579291.20091.68
685028-8502890.38890.83
20min185839-8583991.25091.451.8592.1792.361.86
289005-8900594.61695.57
384914-8491490.26791.13
485550-8555090.94391.87
586281-8628191.72092.65
684556-8455689.88690.78
30min188109-8810993.66392.541.3595.0493.911.34
288541-8854194.12295.55
387419-8741992.93094.25
485502-8550290.89292.27
586462-8646291.91293.30
686278-8627891.71793.06
45min184733-8473390.07491.851.6591.9293.691.64
287978-8797893.52495.42
386648-8664892.11093.89
486027-8602791.45093.29
588034-8803493.58395.44
685009-8500990.36892.17
60min186546-8654692.00292.021.1694.3094.311.16
288290-8829093.85696.22
386651-8665192.11394.35
485190-8519090.56092.85
586228-8622891.66493.98
686468-8646891.91994.18
极限188713-8871394.30594.321.7297.0697.071.71
291357-9135797.11699.95
388608-8860894.19496.89
487647-8764793.17295.92
589113-8911394.73097.51
686902-8690292.38095.10
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)5
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%
115.432655102655772659352657002649922655430.14
215.522656902652922654910.11
单位质量响应值RSD%判断
17209.5317106.380.43数据可信
供试品溶液-GA47051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%
5min123104-231048.9778.8511.358.988.8511.37
223982-239829.3189.32
320601-206018.0058.00
423882-238829.2799.28
526116-2611610.14710.15
618937-189377.3587.36
10min198155-9815538.13837.384.1738.1837.424.17
298682-9868238.34338.39
389390-8939034.73334.77
4100060-10006038.87838.92
597465-9746537.87037.92
693501-9350136.33036.37
15min1140501-14050154.59255.001.8254.8355.231.83
2144870-14487056.28956.53
3137910-13791053.58553.80
4143747-14374755.85356.09
5142301-14230155.29155.53
6140019-14001954.40454.62
20min1163323-16332363.45963.341.8863.9763.841.89
2166716-16671664.77865.30
3159404-15940461.93662.42
4165082-16508264.14364.66
5164269-16426963.82764.34
6159258-15925861.88062.37
30min1191774-19177474.51473.381.1075.3474.201.10
2190268-19026873.92974.77
3188047-18804773.06673.86
4189606-18960673.67174.51
5186925-18692572.63073.47
6186456-18645672.44873.25
45min1203626-20362679.11979.961.3580.3281.141.35
2206942-20694280.40781.62
3205494-20549479.84581.00
4208141-20814180.87382.08
5208855-20885581.15182.35
6201619-20161978.33979.50
60min1216879-21687984.26883.900.4985.8685.490.50
2217428-21742884.48286.10
3215472-21547283.72285.28
4216027-21602783.93785.55
5215014-21501483.54485.15
6214760-21476083.44585.00
极限1227347-22734788.33687.331.0490.3589.341.05
2225930-22593087.78589.82
3222729-22272986.54188.52
4224985-22498587.41889.45
5226311-22631187.93389.96
6221211-22121185.95287.92
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)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%
112.909685596436964279647996707965810.20
212.869622196595964080.28
单位质量响应值RSD%判断
7486.907496.730.10数据可信
供试品溶液-GA47051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%
5min119169-1916920.40820.4916.7820.4120.4816.78
219473-1947320.73220.73
318826-1882620.04320.04
418833-1883320.05020.05
524651-2465126.24426.24
614503-1450315.44015.44
10min166273-6627370.55673.663.9370.6673.773.94
269021-6902173.48273.59
366470-6647070.76670.87
469962-6996274.48474.58
573664-7366478.42578.56
669766-6976674.27574.35
15min183359-8335988.74689.881.5389.2090.351.54
283870-8387089.29089.76
382702-8270288.04788.50
485706-8570691.24591.72
585719-8571991.25991.78
685190-8519090.69691.14
20min184442-8444289.89991.252.1090.8092.182.10
285324-8532490.83891.76
382932-8293288.29289.19
487043-8704392.66893.60
587307-8730792.95093.93
687240-8724092.87893.78
30min186968-8696892.58992.012.0193.9493.392.00
287946-8794693.63095.00
383789-8378989.20490.54
484735-8473590.21191.60
587648-8764893.31394.76
687465-8746593.11894.48
45min185961-8596191.51792.381.5593.3394.221.56
287099-8709992.72894.57
385033-8503390.52992.31
486242-8624291.81693.66
588876-8887694.62096.53
687441-8744193.09294.92
60min185844-8584491.39291.342.1493.6693.642.13
286335-8633591.91594.22
384784-8478490.26392.50
484267-8426789.71392.02
589150-8915094.91297.30
684406-8440689.86192.16
极限189872-8987295.68094.001.0898.4196.761.06
288125-8812593.82096.58
386922-8692292.54095.23
488548-8854894.27197.02
588059-8805993.75096.61
688231-8823193.93396.68
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)5
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%
115.432647662650252658612660532654112654230.21
215.522657512653732655620.11
单位质量响应值RSD%判断
17201.7517110.950.38数据可信
供试品溶液-GA47051批-厄贝沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124554-245549.5419.5416.339.549.5416.33
225206-252069.7959.79
324964-249649.7019.70
424672-246729.5879.59
530279-3027911.76611.77
617694-176946.8766.88
10min193036-9303636.15237.614.6836.2037.664.68
298047-9804738.10038.15
391606-9160635.59735.65
497598-9759837.92537.97
5104443-10444340.58540.64
696038-9603837.31937.35
15min1137593-13759353.46754.602.1253.7054.842.13
2140828-14082854.72454.96
3136651-13665153.10153.33
4143107-14310755.60955.85
5144227-14422756.04556.31
6140617-14061754.64254.86
20min1160783-16078362.47863.412.2862.9763.922.28
2162232-16223263.04163.55
3157568-15756861.22961.72
4166289-16628964.61865.13
5167525-16752565.09865.64
6164675-16467563.99064.48
30min1188363-18836373.19573.032.1674.0073.862.16
2192273-19227374.71575.54
3181189-18118970.40771.21
4185429-18542972.05572.89
5190999-19099974.21975.09
6189356-18935673.58174.40
45min1204927-20492779.63280.321.7380.8181.511.74
2206690-20669080.31781.52
3201621-20162178.34779.50
4206595-20659580.28081.48
5212460-21246082.55983.80
6207857-20785780.77081.95
60min1214263-21426383.26083.162.2284.8384.762.21
2215493-21549383.73885.34
3209738-20973881.50183.04
4211102-21110282.03183.63
5222580-22258086.49188.14
6210924-21092481.96283.55
极限1228449-22844988.77287.241.3690.7689.251.35
2224213-22421387.12689.15
3219083-21908385.13387.08
4225055-22505587.45389.46
5225378-22537887.57989.66
6224894-22489487.39189.39
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)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%
112.909687196784964499653096408966080.22
212.869632296340963310.02
单位质量响应值RSD%判断
7488.997490.750.02数据可信
供试品溶液-FA4456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%
5min123115-2311524.61523.3315.0724.6223.3315.07
227413-2741329.19229.19
320036-2003621.33621.34
421602-2160223.00423.00
521739-2173923.15023.15
617538-1753818.67618.68
10min170228-7022874.78678.076.6974.9178.186.69
276683-7668381.66081.81
364668-6466868.86568.97
476646-7664681.62181.74
576428-7642881.38981.50
675201-7520180.08280.18
15min186481-8648192.09491.970.5192.5992.480.53
286885-8688592.52493.08
386026-8602691.61092.06
486648-8664892.27292.80
585679-8567991.24091.76
686485-8648592.09892.59
20min189250-8925095.04393.471.7996.0094.431.76
288353-8835394.08895.10
389571-8957195.38596.29
486326-8632691.92992.91
587431-8743193.10694.08
685683-8568391.24492.20
30min190259-9025996.11794.811.8397.5596.251.78
288882-8888294.65196.14
391603-9160397.54998.93
487182-8718292.84194.28
588020-8802093.73395.18
688257-8825793.98595.40
45min189116-8911694.90094.271.9196.8196.171.86
287763-8776393.45995.42
391276-9127697.20099.07
487067-8706792.71894.63
589153-8915394.93996.85
686751-8675192.38294.26
60min188841-8884194.60794.361.4897.0096.741.45
287753-8775393.44995.88
390476-9047696.34898.71
488155-8815593.87796.25
589570-8957095.38497.77
686830-8683092.46694.81
极限191548-9154897.49096.381.67100.3599.231.63
291879-9187997.842100.74
391633-9163397.580100.42
489206-8920694.99697.84
588176-8817693.89996.76
690566-9056696.44499.25
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)5
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%
115.432656552652342653892653272653332653880.07
215.522635902643852639880.22
单位质量响应值RSD%判断
17199.4817009.540.79数据可信
供试品溶液-FA4456批-厄贝沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126319-2631910.2589.7014.3910.269.7014.39
230977-3097712.07412.07
322890-228908.9228.92
424392-243929.5079.51
524287-242879.4669.47
620380-203807.9447.94
10min190476-9047635.26536.456.8035.3236.506.80
2101663-10166339.62539.69
383040-8304032.36732.41
497320-9732037.93337.98
594908-9490836.99337.04
693652-9365236.50336.54
15min1134276-13427652.33751.882.4552.5652.112.47
2138001-13800153.78954.05
3128809-12880950.20650.41
4134855-13485552.56352.80
5131149-13114951.11851.35
6131551-13155151.27551.50
20min1155642-15564260.66559.912.2161.1560.402.23
2159217-15921762.05862.59
3152953-15295359.61760.07
4153124-15312459.68460.18
5152046-15204659.26359.75
6149252-14925258.17458.65
30min1181913-18191370.90569.971.4471.7070.761.45
2182924-18292471.29972.14
3180166-18016670.22470.98
4178198-17819869.45770.26
5177190-17719069.06469.85
6176664-17666468.85969.63
45min1198337-19833777.30676.561.2878.4577.691.27
2198394-19839477.32978.52
3198566-19856677.39678.50
4193196-19319675.30376.45
5196468-19646876.57877.71
6193497-19349775.42076.53
60min1208627-20862781.31781.010.9382.8582.530.94
2209936-20993681.82783.41
3207391-20739180.83582.33
4206717-20671780.57382.09
5209510-20951081.66183.17
6204789-20478979.82181.31
极限1220141-22014185.80584.401.9387.7586.321.92
2222317-22231786.65388.64
3216408-21640884.35086.25
4213012-21301283.02684.95
5211226-21122682.33084.25
6216080-21608084.22286.11
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)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%
112.909660896633964209641996339964840.14
212.869641096358963840.04
单位质量响应值RSD%判断
7479.387494.870.15数据可信
供试品溶液-FA4456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%
5min132218-3221834.32224.3623.2234.3224.3623.22
222426-2242623.89023.89
324884-2488426.50926.51
421632-2163223.04423.04
517546-1754618.69218.69
618476-1847619.68219.68
10min179529-7952984.72280.584.5984.8980.704.62
276054-7605481.02081.14
379045-7904584.20684.34
476053-7605381.01981.13
571311-7131175.96776.06
671845-7184576.53676.63
15min182341-8234187.71890.403.2788.3190.923.25
287934-8793493.67694.20
388641-8864194.42994.98
483533-8353388.98789.51
582386-8238687.76688.24
684317-8431789.82390.30
20min186184-8618491.81292.171.2792.8593.151.29
288027-8802793.77594.77
387730-8773093.45894.48
485543-8554391.12992.09
585502-8550291.08592.00
686155-8615591.78192.71
30min186479-8647992.12693.802.1193.6295.242.11
289056-8905694.87196.33
391354-9135497.31998.81
487217-8721792.91294.33
587518-8751893.23394.60
686686-8668692.34693.74
45min187865-8786593.60293.511.3395.5695.421.33
288876-8887694.67996.62
388426-8842694.20096.18
485860-8586091.46693.35
586968-8696892.64794.48
688698-8869894.49096.34
60min187184-8718492.87793.321.2195.3095.691.23
288354-8835494.12396.53
389208-8920895.03397.48
486323-8632391.96094.30
586819-8681992.48894.78
687700-8770093.42795.75
极限187626-8762693.34894.591.0496.2397.431.00
289732-8973295.59198.47
388635-8863594.42397.35
488176-8817693.93496.74
588535-8853594.31697.08
690035-9003595.91498.70
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)5
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%
115.432644792654202652882650292648912650210.14
215.522646542652102649320.15
单位质量响应值RSD%判断
17175.7017070.360.44数据可信
供试品溶液-FA4456批-厄贝沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135633-3563313.8739.9022.9913.879.9022.99
224611-246119.5829.58
327919-2791910.87010.87
424332-243329.4739.47
519544-195447.6097.61
620526-205267.9927.99
10min1103754-10375440.39636.906.8240.4736.956.84
294825-9482536.91936.97
3100313-10031339.05639.11
493812-9381236.52536.57
586759-8675933.77933.82
689134-8913434.70434.74
15min1130304-13030450.73350.634.0051.0050.874.01
2134857-13485752.50652.74
3137321-13732153.46553.71
4127047-12704749.46549.69
5123573-12357348.11248.32
6127198-12719849.52449.74
20min1153991-15399159.95558.772.1460.4859.262.17
2153295-15329559.68460.18
3153902-15390259.92160.44
4149371-14937158.15758.63
5146329-14632956.97257.42
6148815-14881557.94058.40
30min1175075-17507568.16468.592.1468.9969.372.16
2178739-17873969.59170.38
3182517-18251771.06271.88
4174714-17471468.02468.79
5172682-17268267.23367.96
6173261-17326167.45868.21
45min1195282-19528276.03275.881.5777.2077.001.57
2197863-19786377.03778.18
3196913-19691376.66777.84
4190921-19092174.33475.44
5191294-19129474.47975.55
6197004-19700476.70277.79
60min1204347-20434779.56179.771.3881.1181.281.40
2207389-20738980.74582.27
3209070-20907081.40082.96
4202332-20233278.77780.26
5201931-20193178.62080.06
6204261-20426179.52881.00
极限1213444-21344483.10383.201.1585.0585.111.17
2216183-21618384.16986.10
3215680-21568083.97385.94
4211029-21102982.16384.04
5210529-21052981.96883.80
6215352-21535283.84685.72
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