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%
112.169217092107923669182391997920930.22
212.039190292200920510.23
单位质量响应值RSD%判断
7573.447651.790.73数据可信
供试品溶液-6051201-1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%
5min134676-3467636.33231.4028.9236.3331.4028.93
219434-1943420.36220.36
337122-3712238.89538.90
437020-3702038.78838.79
533088-3308834.66834.67
618486-1848619.36919.37
10min186420-8642090.54891.362.5490.7391.512.57
284848-8484888.90189.00
387307-8730791.47791.67
490825-9082595.16395.36
588428-8842892.65292.82
685320-8532089.39589.49
15min191411-9141195.77796.881.3196.4197.501.32
292265-9226596.67297.22
391881-9188196.26996.92
494830-9483099.359100.03
592350-9235096.76197.40
692057-9205796.45497.00
20min192364-9236496.77697.261.3997.8998.361.40
292931-9293197.37098.40
392515-9251596.93498.07
495309-9530999.861101.03
591752-9175296.13497.25
692062-9206296.45997.49
30min192263-9226396.67097.390.9698.2798.980.99
292919-9291997.35798.87
392902-9290297.33998.96
494687-9468799.210100.88
592405-9240596.81998.42
692532-9253296.95298.46
45min192284-9228496.69296.980.8098.7799.050.82
291744-9174496.12698.13
392100-9210096.49998.60
493767-9376798.246100.41
592365-9236596.77798.86
693089-9308997.53599.53
60min192791-9279197.22396.761.0299.7999.321.05
291507-9150795.87898.36
391534-9153495.90698.49
493978-9397898.467101.12
592393-9239396.80699.37
691915-9191596.30598.79
极限192353-9235396.76496.310.3999.8199.350.40
291531-9153195.90398.87
391949-9194996.34199.41
492115-9211596.51599.66
591464-9146495.83398.89
692107-9210796.50699.47
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%
114.762662632662682662072661352661432662030.03
214.812663282665512664400.06
单位质量响应值RSD%判断
18035.4317990.550.18数据可信
供试品溶液-6051201-1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%
5min132741-3274112.11811.2725.8212.1211.2725.84
220926-209267.7457.74
338384-3838414.20614.21
436382-3638213.46513.47
533943-3394312.56212.56
620317-203177.5197.52
10min1124996-12499646.26245.695.8846.3245.745.89
2118996-11899644.04144.08
3125261-12526146.36046.43
4132762-13276249.13649.20
5126946-12694646.98347.05
6111693-11169341.33841.38
15min1167688-16768862.06262.363.0962.3562.643.11
2166358-16635861.57061.83
3168927-16892762.52162.82
4176918-17691865.47865.79
5170036-17003662.93163.23
6160985-16098559.58159.83
20min1193092-19309271.46471.642.4172.0772.242.43
2192232-19223271.14671.71
3194173-19417371.86472.48
4201355-20135574.52275.16
5193757-19375771.71072.32
6186833-18683369.14869.69
30min1219005-21900581.05582.031.7182.0182.981.74
2220544-22054481.62482.55
3224606-22460683.12884.10
4227260-22726084.11085.12
5221563-22156382.00182.97
6216869-21686980.26481.15
45min1239049-23904988.47389.301.0489.8490.671.07
2238969-23896988.44389.77
3242473-24247389.74091.13
4245618-24561890.90492.34
5241258-24125889.29190.67
6240361-24036188.95990.25
60min1250874-25087492.84992.931.0494.6694.741.07
2249261-24926192.25294.03
3250420-25042092.68194.52
4255863-25586394.69696.58
5251709-25170993.15894.99
6248462-24846291.95793.69
极限1256473-25647394.92295.070.6397.1997.350.65
2255310-25531094.49196.73
3259048-25904895.87598.18
4258630-25863095.72098.08
5255448-25544894.54296.84
6256337-25633794.87197.07
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%
112.169182092104919109201491754919200.16
212.039190492055919800.12
单位质量响应值RSD%判断
7559.217645.890.81数据可信
供试品溶液-6051201-2-1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%
5min122657-2265723.77131.0330.6423.7731.0330.63
225560-2556026.81626.82
335041-3504136.76336.76
444998-4499847.21047.21
520794-2079421.81621.82
628386-2838629.78129.78
10min185205-8520589.39389.721.5889.5189.881.61
285064-8506489.24589.38
383791-8379187.91088.09
487929-8792992.25192.49
585635-8563589.84489.95
685484-8548489.68689.83
15min192302-9230296.83995.531.7797.4196.141.75
290269-9026994.70695.29
388179-8817992.51493.14
491548-9154896.04896.75
591590-9159096.09296.65
692442-9244296.98697.58
20min193585-9358598.18596.691.8299.2497.771.81
290556-9055695.00796.06
389570-8957093.97395.06
493318-9331897.90599.08
593174-9317497.75498.79
692763-9276397.32398.41
30min191063-9106395.53996.051.4297.0897.611.44
290407-9040794.85196.38
390065-9006594.49296.05
493559-9355998.15899.83
591938-9193896.45797.98
692247-9224796.78198.35
45min193323-9332397.91096.941.5599.9398.981.52
291071-9107195.54897.55
390473-9047394.92096.95
492641-9264197.19599.35
594349-9434998.987101.00
692518-9251897.06699.12
60min191893-9189396.41095.801.1398.9298.331.15
289877-8987794.29596.78
390221-9022194.65697.16
492505-9250597.05299.70
591615-9161596.11898.62
691744-9174496.25498.79
极限190716-9071695.17595.171.1398.1798.181.14
289319-8931993.71096.66
389852-8985294.26997.24
491765-9176596.27699.40
591910-9191096.42899.41
690707-9070795.16698.19
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%
114.762664192666872662672661642661912663460.09
214.812661752661302661520.02
单位质量响应值RSD%判断
18045.1217971.100.30数据可信
供试品溶液-6051201-2-1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%
5min126553-265539.83011.6830.039.8311.6830.02
225358-253589.3889.39
333486-3348612.39712.40
449273-4927318.24118.24
523339-233398.6408.64
631276-3127611.57911.58
10min1121873-12187345.11846.284.1345.1746.344.16
2122609-12260945.39045.44
3126249-12624946.73846.80
4134956-13495649.96150.05
5121517-12151744.98645.03
6122789-12278945.45745.52
15min1169675-16967562.81562.751.7163.0963.041.75
2168411-16841162.34762.62
3167759-16775962.10562.40
4175080-17508064.81665.16
5166973-16697361.81462.08
6169146-16914662.61962.90
20min1197054-19705472.95072.221.7573.5472.831.77
2192248-19224871.17171.76
3191723-19172370.97771.58
4200882-20088274.36875.03
5194069-19406971.84572.42
6194590-19459072.03872.64
30min1218676-21867680.95581.641.6281.9182.601.63
2218836-21883681.01481.96
3217499-21749980.51981.48
4227243-22724384.12785.16
5219343-21934381.20282.14
6221556-22155682.02182.98
45min1244963-24496390.68789.741.4092.0491.111.39
2239912-23991288.81790.16
3237109-23710987.77989.14
4244052-24405290.34991.81
5246143-24614391.12392.47
6242218-24221889.67091.04
60min1251793-25179393.21592.431.2195.0394.251.23
2246294-24629491.17992.97
3246396-24639691.21793.02
4253829-25382993.96995.88
5248960-24896092.16693.96
6250699-25069992.81094.63
极限1255085-25508594.43494.271.1496.7196.561.14
2251249-25124993.01495.26
3251537-25153793.12095.38
4258293-25829395.62198.00
5257243-25724395.23397.49
6254500-25450094.21796.50
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%
112.169204591883921359210991945920230.12
212.039234492349923460.01
单位质量响应值RSD%判断
7567.687676.311.01数据可信
供试品溶液-6051201-2-2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%
5min118452-1845219.31025.4139.9419.3125.4239.94
217097-1709717.89217.89
336287-3628737.97437.97
420398-2039821.34621.35
516408-1640817.17117.17
637072-3707238.79638.80
10min179705-7970583.41186.552.8983.5186.672.88
281692-8169285.49185.58
381237-8123785.01485.20
483151-8315187.01787.12
586525-8652590.54890.63
683906-8390687.80788.00
15min188830-8883092.96093.910.9493.4794.470.94
289680-8968093.85094.37
388713-8871392.83893.45
490170-9017094.36394.90
590884-9088495.11095.65
690148-9014894.34094.97
20min191504-9150495.75995.701.3396.7496.731.31
290911-9091195.13896.12
389868-8986894.04795.13
491000-9100095.23196.24
593476-9347697.82298.84
691941-9194196.21697.32
30min188978-8897893.11594.071.5594.5795.581.54
289316-8931693.46994.93
388523-8852392.63994.19
489733-8973393.90595.40
592414-9241496.71198.21
690402-9040294.60696.19
45min191715-9171595.98095.340.8497.9097.310.81
290641-9064194.85696.78
389814-8981493.99096.00
491503-9150395.75897.72
591780-9178096.04898.03
691147-9114795.38597.44
60min190072-9007294.26095.180.9096.6697.630.90
290755-9075594.97597.38
390006-9000694.19196.67
491941-9194196.21698.65
591270-9127095.51497.98
691662-9166295.92498.46
极限192341-9234196.63596.580.6699.5199.510.66
292637-9263796.94499.82
391510-9151095.76598.72
491764-9176496.03198.95
592266-9226696.55699.50
693190-9319097.523100.54
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%
114.762644872664752665402664902666372661260.35
214.812669842671522670680.05
单位质量响应值RSD%判断
18030.2218032.950.02数据可信
供试品溶液-6051201-2-2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%
5min120472-204727.5699.8634.607.579.8634.61
220809-208097.6947.69
337750-3775013.95713.96
422525-225258.3288.33
519213-192137.1037.10
639205-3920514.49514.49
10min1102602-10260237.93440.675.5337.9740.715.54
2107025-10702539.56939.61
3111572-11157241.25141.32
4105161-10516138.88038.92
5115594-11559442.73842.77
6117981-11798143.62043.69
15min1147440-14744054.51256.532.5654.7456.782.58
2153584-15358456.78357.02
3152128-15212856.24556.52
4149955-14995555.44255.68
5156222-15622257.75958.01
6157986-15798658.41158.70
20min1175538-17553864.90065.862.0965.4066.392.09
2178327-17832765.93166.45
3175465-17546564.87365.43
4174367-17436764.46764.98
5183551-18355167.86368.40
6181495-18149567.10367.69
30min1199053-19905373.59474.801.9174.4275.671.91
2202857-20285775.00175.85
3199024-19902473.58374.47
4200440-20044074.10774.94
5209256-20925677.36678.24
6203335-20333575.17776.10
45min1228146-22814684.35183.801.1585.5485.041.14
2226720-22672083.82385.05
3222046-22204682.09583.34
4225847-22584783.50184.71
5229615-22961584.89486.16
6227531-22753184.12385.42
60min1235597-23559787.10588.081.1088.7289.741.10
2239322-23932288.48390.13
3234286-23428686.62188.28
4239805-23980588.66190.28
5240342-24034288.86090.55
6240061-24006188.75690.47
极限1249640-24964092.29792.301.1394.3594.401.13
2251892-25189293.13095.22
3245131-24513190.63092.72
4247618-24761891.55093.62
5251557-25155793.00695.14
6252115-25211593.21295.37
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%
112.169178491783918749176791926918270.08
212.039196991823918960.12
单位质量响应值RSD%判断
7551.567638.900.82数据可信
供试品溶液-6051201-3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%
5min145895-4589548.19749.7712.7048.2049.7712.70
245314-4531447.58747.59
357230-5723060.10160.10
448841-4884151.29151.29
538753-3875340.69740.70
648332-4833250.75750.76
10min190669-9066995.21895.673.0695.4695.923.08
294017-9401798.73498.97
393194-9319497.86998.17
492812-9281297.46897.72
586749-8674991.10191.30
689147-8914793.61993.87
15min193326-9332698.00899.251.6298.7299.981.64
295490-95490100.280101.01
396171-96171100.996101.79
495370-95370100.154100.90
592118-9211896.73997.40
694571-9457199.315100.04
20min195948-95948100.76199.991.26101.97101.221.29
295295-95295100.076101.31
396252-96252101.081102.38
495740-95740100.543101.79
592921-9292197.58398.73
695138-9513899.911101.13
30min191954-9195496.56798.251.3298.2899.981.34
293484-9348498.17499.91
394591-9459199.336101.14
495155-9515599.929101.68
592402-9240297.03898.67
693773-9377398.477100.20
45min193394-9339498.07998.200.81100.27100.420.80
294135-9413598.857101.08
393805-9380598.511100.81
494065-9406598.784101.03
593567-9356798.261100.38
692096-9209696.71698.93
60min193019-9301997.68598.400.56100.37101.110.59
293840-9384098.548101.27
394097-9409798.818101.61
493974-9397498.688101.43
593075-9307597.744100.35
694190-9419098.915101.61
极限193521-9352198.21399.181.12101.39102.381.14
294535-9453599.278102.49
395357-95357100.141103.42
495154-9515499.928103.16
592811-9281197.467100.56
695268-95268100.047103.24
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%
114.762657652657862654182657492654532656340.07
214.812662052659002660520.09
单位质量响应值RSD%判断
17996.8817964.350.13数据可信
供试品溶液-6051201-3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%
5min150055-5005518.55918.3613.6618.5618.3613.66
245097-4509716.72116.72
360829-6082922.55422.55
451945-5194519.26019.26
540952-4095215.18415.18
648223-4822317.88017.88
10min1129164-12916447.89047.364.5047.9847.464.51
2130134-13013448.25048.33
3134712-13471249.94750.06
4130556-13055648.40648.50
5118866-11886644.07244.15
6123033-12303345.61745.71
15min1164659-16465961.05161.162.6661.3861.482.68
2165030-16503061.18861.51
3170807-17080763.33063.69
4167419-16741962.07462.41
5157530-15753058.40758.70
6164253-16425360.90061.22
20min1191581-19158171.03269.752.2471.6770.382.26
2187166-18716669.39670.03
3192287-19228771.29471.97
4190133-19013370.49671.14
5180916-18091667.07867.67
6186624-18662469.19569.82
30min1209973-20997377.85278.671.8178.8479.651.83
2210758-21075878.14379.12
3216419-21641980.24281.28
4216952-21695280.43981.44
5207082-20708276.78077.70
6211838-21183878.54379.51
45min1234515-23451586.95186.601.1188.3387.981.12
2234251-23425186.85388.22
3235594-23559487.35188.79
4235808-23580887.43188.83
5232277-23227786.12187.43
6228995-22899584.90486.27
60min1245064-24506490.86291.080.7992.6892.890.82
2245189-24518990.90992.71
3247950-24795091.93293.81
4246613-24661391.43793.28
5242362-24236289.86191.60
6246757-24675791.49093.28
极限1255900-25590094.88095.181.3097.1597.441.31
2256355-25635595.04997.31
3260091-26009196.43498.77
4258345-25834595.78798.08
5250718-25071892.95995.15
6258810-25881095.95998.20
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