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100309-201404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%
112.309213892130922049217992053921410.07
212.379147291843916580.29
单位质量响应值RSD%判断
7491.147409.700.78数据可信
供试品溶液-2023061621批-氢氯噻嗪-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121497-2149723.01432.6021.7423.0132.6021.74
237094-3709439.71239.71
330056-3005632.17732.18
425057-2505726.82526.83
538539-3853941.25941.26
630465-3046532.61532.62
10min174036-7403679.26179.504.9879.3879.675.00
278759-7875984.31784.52
375274-7527480.58780.75
468470-6847073.30273.44
577103-7710382.54582.75
671929-7192977.00577.17
15min182174-8217487.97387.082.1988.4887.642.18
283514-8351489.40890.03
382961-8296188.81689.38
480346-8034686.01686.52
579258-7925884.85285.47
679788-7978885.41985.97
20min185309-8530991.33091.351.4092.2892.341.36
285570-8557091.60992.68
385707-8570791.75692.76
487144-8714493.29494.22
583551-8355189.44890.49
684673-8467390.64991.62
30min187974-8797494.18394.690.8495.5996.140.83
289143-8914395.43496.96
388797-8879795.06496.53
489210-8921095.50696.90
587306-8730693.46894.96
688258-8825894.48795.92
45min190243-9024396.61294.601.6498.4996.521.59
288253-8825394.48296.48
389730-8973096.06398.00
488197-8819794.42296.30
586354-8635492.44894.41
687388-8738893.55595.46
60min191417-9141797.86997.171.09100.2399.571.10
291696-9169698.168100.64
391690-9169098.161100.58
489304-8930495.60797.95
590371-9037196.74999.17
690119-9011996.47998.85
极限199737-99737106.776100.914.02109.63103.793.92
294303-94303100.959103.92
393966-93966100.598103.51
487910-8791094.11496.94
595403-95403102.136105.04
694215-94215100.864103.72
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100607-201804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%
114.812628192629262629232628422624372627890.08
214.842622072619442620760.08
单位质量响应值RSD%判断
17744.0217660.110.34数据可信
供试品溶液-2023061621批-厄贝沙坦-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134431-3443112.96719.6926.0012.9719.6925.99
266952-6695225.21525.21
352687-5268719.84219.84
440215-4021515.14515.15
567865-6786525.55825.56
651495-5149519.39319.39
10min1155338-15533858.50160.187.3958.5760.287.42
2175734-17573466.18266.31
3162281-16228161.11661.22
4143009-14300953.85853.93
5169303-16930363.76163.89
6153116-15311657.66457.76
15min1198597-19859774.79374.613.1575.1575.013.17
2207308-20730878.07378.53
3203517-20351776.64677.05
4191593-19159372.15572.50
5194446-19444673.23073.68
6193220-19322072.76873.15
20min1221038-22103883.24483.261.0783.9884.041.08
2224086-22408684.39285.24
3223276-22327684.08784.88
4221205-22120583.30784.01
5218392-21839282.24883.06
6218520-21852082.29683.05
30min1242605-24260591.36691.120.5892.5192.310.59
2242967-24296791.50392.77
3243619-24361991.74892.96
4241790-24179091.06092.18
5239805-23980590.31291.54
6240990-24099090.75891.92
45min1253409-25340995.43594.201.2997.0495.851.27
2251107-25110794.56896.30
3253994-25399495.65697.32
4248650-24865093.64395.22
5246068-24606892.67194.35
6247613-24761393.25394.87
60min1256840-25684096.72797.041.2798.8199.161.29
2262004-26200498.672100.87
3259405-25940597.69399.84
4252445-25244595.07297.12
5258881-25888197.49699.64
6256414-25641496.56798.65
极限1275728-275728103.84198.973.60106.41101.573.54
2263522-26352299.244101.94
3262933-26293399.022101.66
4246679-24667992.90195.42
5266868-266868100.504103.13
6261053-26105398.314100.88
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100309-201404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%
112.309206892107918929210792064920480.10
212.379219392055921240.11
单位质量响应值RSD%判断
7483.587447.370.35数据可信
供试品溶液-2023061421批-氢氯噻嗪-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123749-2374925.37333.3725.0325.3733.3725.03
236075-3607538.54238.54
319635-1963520.97820.98
434727-3472737.10237.10
539885-3988542.61342.61
633351-3335135.63235.63
10min170554-7055475.37978.916.3075.5179.086.33
273457-7345778.48178.67
369212-6921273.94574.05
477724-7772483.04083.23
581123-8112386.67186.88
671071-7107175.93276.11
15min181076-8107686.62186.124.6487.1286.684.67
280781-8078186.30686.89
374131-7413179.20179.68
482165-8216587.78488.39
585561-8556191.41392.06
679909-7990985.37485.93
20min185234-8523491.06389.203.3492.0090.193.37
283201-8320188.89189.91
379064-7906484.47185.34
485402-8540291.24392.28
586448-8644892.36093.46
681590-8159087.17088.15
30min187217-8721793.18291.922.5994.5793.362.63
286922-8692292.86794.33
382485-8248588.12689.42
486684-8668492.61294.11
588599-8859994.65896.22
684327-8432790.09491.51
45min187366-8736693.34193.962.1495.2095.862.19
289071-8907195.16397.09
385269-8526991.10192.83
486946-8694692.89294.85
590735-9073596.94098.98
688307-8830794.34696.22
60min191009-9100997.23394.941.9899.5697.302.00
288726-8872694.79497.20
386937-8693792.88395.07
487410-8741093.38895.81
590971-9097197.19399.72
688106-8810694.13296.47
极限195023-95023101.52299.541.83104.33102.381.77
294287-94287100.735103.61
392733-9273399.075101.73
490143-9014396.30899.20
593023-9302399.385102.39
693807-93807100.223103.04
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100607-201804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%
114.812625482623142621292622682625842623690.08
214.842622652623522623080.03
单位质量响应值RSD%判断
17715.6717675.740.16数据可信
供试品溶液-2023061421批-厄贝沙坦-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141051-4105115.46622.4726.2815.4722.4726.28
270702-7070226.63626.64
339109-3910914.73414.73
468291-6829125.72825.73
575476-7547628.43528.43
663211-6321123.81423.81
10min1159314-15931460.02066.116.5560.1066.226.56
2174414-17441465.70965.84
3176436-17643666.47066.54
4189795-18979571.50371.63
5186181-18618170.14270.28
6166748-16674862.82162.94
15min1206039-20603977.62379.693.3978.0080.133.42
2211828-21182879.80480.27
3203902-20390276.81877.22
4220178-22017882.95083.44
5220050-22005082.90283.39
6207077-20707778.01478.45
20min1230752-23075286.93386.802.5687.7087.642.58
2229069-22906986.29987.16
3223805-22380584.31685.11
4238307-23830789.78090.68
5235960-23596088.89689.80
6224517-22451784.58485.41
30min1248240-24824093.52292.892.0394.7294.172.05
2248801-24880193.73395.03
3238721-23872189.93691.15
4248786-24878693.72895.08
5252390-25239095.08596.44
6242492-24249291.35692.60
45min1252375-25237595.08095.961.9696.7597.701.97
2257752-25775297.10598.87
3247441-24744193.22194.88
4252466-25246695.11496.93
5261588-26158898.551100.38
6256600-25660096.67198.37
60min1262505-26250598.89696.941.79101.0499.161.77
2257797-25779797.12299.37
3251852-25185294.88397.01
4252755-25275595.22397.52
5262506-26250698.896101.22
6256516-25651696.64098.83
极限1269159-269159101.40399.351.80104.04102.061.72
2267544-267544100.794103.53
3261902-26190298.669101.27
4255929-25592996.41999.19
5262423-26242398.865101.68
6265317-26531799.955102.62
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100309-201404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%
112.309244392330923449233592301923510.06
212.379192792328921280.31
单位质量响应值RSD%判断
7508.217447.700.58数据可信
供试品溶液-2023061521批-氢氯噻嗪-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141047-4104743.78235.7623.0943.7835.7623.08
218522-1852219.75619.76
333808-3380836.06036.06
436474-3647438.90438.90
535582-3558237.95237.95
635701-3570138.07938.08
10min178207-7820783.41781.214.6683.6481.394.70
269480-6948074.10974.21
378454-7845483.68183.86
478382-7838283.60483.80
574752-7475279.73279.92
677532-7753282.69782.89
15min184110-8411089.71387.822.8890.3588.402.91
278668-7866883.90984.38
385496-8549691.19291.79
482463-8246387.95788.57
581168-8116886.57587.16
682100-8210087.56988.17
20min185050-8505090.71690.632.6391.8091.662.66
281559-8155986.99287.88
388498-8849894.39495.45
485566-8556691.26692.32
584428-8442890.05391.07
684722-8472290.36691.41
30min188112-8811293.98293.991.8195.5295.461.85
285184-8518490.85992.18
389952-8995295.94597.47
488120-8812093.99195.50
588844-8884494.76396.23
688504-8850494.40095.89
45min191022-9102297.08696.020.8999.0997.970.95
288726-8872694.63796.41
390667-9066796.70798.71
489815-8981595.79897.78
590030-9003096.02897.97
689902-8990295.89197.86
60min188349-8834994.23596.861.8496.7399.281.80
290431-9043196.45598.71
393532-9353299.763102.25
491034-9103497.09999.56
590453-9045396.47998.90
691052-9105297.11899.56
极限195409-95409101.765101.610.45104.73104.520.48
294766-94766101.079103.81
395229-95229101.573104.56
494791-94791101.106104.05
595799-95799102.181105.09
695601-95601101.970104.90
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100607-201804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%
114.812627492628972627482624382623212626310.10
214.842628242628622628430.02
单位质量响应值RSD%判断
17733.3617711.790.09数据可信
供试品溶液-2023061521批-厄贝沙坦-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176462-7646228.76322.9726.0828.7622.9726.08
230100-3010011.32311.32
363061-6306123.72223.72
467445-6744525.37125.37
563898-6389824.03624.04
665422-6542224.61024.61
10min1178491-17849167.14363.846.7067.2963.966.73
2148142-14814255.72655.78
3171518-17151864.52064.64
4177873-17787366.91067.04
5167394-16739462.96863.09
6174913-17491365.79765.92
15min1212338-21233879.87577.553.7180.3577.983.75
2192198-19219872.29972.63
3211880-21188079.70380.14
4210097-21009779.03279.49
5203229-20322976.44876.88
6207179-20717977.93478.39
20min1227528-22752885.58984.703.1386.4785.523.17
2212966-21296680.11180.81
3233566-23356687.86088.70
4229472-22947286.32087.18
5223504-22350484.07584.89
6223968-22396884.25085.09
30min1246955-24695592.89792.312.0294.2093.562.07
2235546-23554688.60589.70
3249474-24947493.84495.12
4246800-24680092.83894.13
5246603-24660392.76494.00
6247039-24703992.92894.19
45min1258672-25867297.30496.220.9199.0897.930.97
2251923-25192394.76596.31
3257462-25746296.84998.60
4256109-25610996.34098.09
5255237-25523796.01297.71
6255352-25535296.05597.78
60min1253072-25307295.19897.531.6597.4699.721.63
2256859-25685996.62298.64
3265998-265998100.060102.29
4259603-25960397.65499.89
5259627-25962797.66399.84
6260489-26048997.988100.20
极限1268383-268383100.957100.830.46103.69103.510.47
2267236-267236100.526103.02
3267075-267075100.465103.20
4266697-266697100.323103.05
5269475-269475101.368104.04
6269417-269417101.346104.04
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