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%
112.169101090749912199111490890909960.21
212.039086091018909390.13
单位质量响应值RSD%判断
7483.227559.350.72数据可信
供试品溶液-GA5217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%
5min128830-2883030.57426.4615.1130.5726.4615.11
224092-2409225.54925.55
324770-2477026.26826.27
428798-2879830.54030.54
518606-1860619.73119.73
624585-2458526.07226.07
10min173335-7333577.77179.592.2177.9279.722.22
275307-7530779.86279.99
376533-7653381.16281.29
476907-7690781.55981.71
572822-7282277.22777.33
675394-7539479.95480.08
15min182587-8258787.58289.962.3788.1290.492.38
284291-8429189.38989.92
384633-8463389.75290.29
488261-8826193.59994.16
583383-8338388.42688.91
685801-8580190.99191.52
20min185885-8588591.08092.422.4292.0693.402.42
286362-8636291.58692.56
387141-8714192.41293.40
491344-9134496.86997.90
585915-8591591.11192.04
686271-8627191.48992.47
30min187116-8711692.38593.642.3793.8295.082.36
288301-8830193.64295.07
387459-8745992.74994.20
492429-9242998.01999.53
587676-8767692.97994.36
686819-8681992.07093.51
45min189685-8968595.10995.341.5897.0197.251.60
289529-8952994.94496.84
389771-8977195.20197.11
492671-9267198.276100.28
589056-8905694.44296.29
688681-8868194.04595.95
60min190911-9091196.41095.082.0498.7897.462.04
288857-8885794.23196.61
389205-8920594.60096.99
492649-9264998.253100.75
587542-8754292.83795.16
688754-8875494.12296.50
极限190755-9075596.24497.171.6199.10100.031.61
292151-9215197.725100.57
392800-9280098.413101.27
493595-9359599.256102.24
590855-9085596.35099.13
689628-8962895.04997.89
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%
114.762604162600742596932594072598352598850.15
214.812601522601092601300.02
单位质量响应值RSD%判断
17607.3817564.480.18数据可信
供试品溶液-GA5217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%
5min139442-3944214.95213.5213.6814.9513.5213.68
232816-3281612.44012.44
335228-3522813.35513.35
441470-4147015.72115.72
527889-2788910.57210.57
637109-3710914.06814.07
10min1118623-11862344.96945.323.4045.0445.393.41
2120435-12043545.65645.72
3122964-12296446.61546.68
4122627-12262746.48746.57
5111931-11193142.43242.48
6120712-12071245.76145.83
15min1155038-15503858.77460.223.1659.0760.523.17
2160484-16048460.83861.13
3160234-16023460.74361.04
4165303-16530362.66562.98
5151077-15107757.27257.54
6161006-16100661.03661.34
20min1180799-18079968.53969.472.2469.1370.062.25
2182880-18288069.32869.92
3183133-18313369.42470.03
4189941-18994172.00572.63
5177790-17779067.39967.95
6184969-18496970.12070.72
30min1206077-20607778.12279.482.2179.0680.422.22
2211012-21101279.99380.93
3207724-20772478.74679.70
4218305-21830582.75883.74
5206007-20600778.09578.98
6208842-20884279.17080.13
45min1229479-22947986.99487.671.5688.3289.011.58
2231105-23110587.61088.95
3230538-23053887.39588.74
4238168-23816890.28791.69
5227669-22766986.30787.59
6230589-23058987.41488.77
60min1243834-24383492.43591.171.8694.2092.951.86
2237974-23797490.21491.99
3238000-23800090.22492.01
4247796-24779693.93795.79
5235902-23590289.42891.14
6239423-23942390.76392.55
极限1246756-24675693.54393.761.3295.7795.991.34
2246743-24674393.53895.77
3247079-24707993.66695.90
4253367-25336796.04998.37
5243435-24343592.28494.44
6246533-24653393.45995.70
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%
112.169123691019908959125491152911110.17
212.039058590602905940.02
单位质量响应值RSD%判断
7492.687530.670.36数据可信
供试品溶液-GA5217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%
5min127351-2735129.04226.6226.6229.0426.6226.62
232525-3252534.53634.54
323115-2311524.54424.54
417669-1766918.76118.76
517702-1770218.79618.80
632063-3206334.04534.05
10min178170-7817083.00280.045.8283.1580.175.84
278721-7872183.58883.76
378063-7806382.88983.01
470385-7038574.73674.83
569128-6912873.40273.50
677790-7779082.59982.77
15min187906-8790693.34091.832.5693.9092.362.58
288141-8814193.59094.18
388743-8874394.22994.77
485943-8594391.25691.72
582910-8291088.03688.50
685256-8525690.52791.11
20min189576-8957695.11493.092.2596.1494.082.27
289282-8928294.80195.86
389157-8915794.66995.68
487315-8731592.71393.64
585438-8543890.72091.62
685241-8524190.51191.55
30min191047-9104796.67694.272.0498.1895.732.05
289788-8978895.33996.87
389646-8964695.18896.67
488912-8891294.40995.80
587105-8710592.49093.84
686204-8620491.53393.02
45min190995-9099596.62094.901.7398.6196.831.71
289930-8993095.48997.50
389501-8950195.03496.99
490556-9055696.15498.01
588493-8849393.96495.78
686767-8676792.13194.08
60min188690-8869094.17394.591.6696.6497.001.61
289584-8958495.12297.61
390954-9095496.57799.01
488418-8841893.88496.22
590110-9011095.68197.97
686758-8675892.12194.53
极限192603-9260398.32896.871.38101.2799.741.35
290081-9008195.65098.61
391540-9154097.199100.11
492516-9251698.235101.04
589544-8954495.08097.85
691079-9107996.71099.58
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%
114.762594982601232589272599302603942597740.23
214.812589592600012594800.29
单位质量响应值RSD%判断
17599.8617520.590.32数据可信
供试品溶液-GA5217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%
5min139108-3910814.84713.8325.3414.8513.8325.35
247429-4742918.00618.01
334214-3421412.98912.99
426448-2644810.04110.04
525870-258709.8219.82
645457-4545717.25817.26
10min1124747-12474747.36045.266.9947.4345.327.01
2125695-12569547.72047.81
3121117-12111745.98246.05
4108160-10816041.06341.11
5109289-10928941.49141.54
6126232-12623247.92448.01
15min1165967-16596763.00961.053.6363.3261.353.66
2164803-16480362.56762.90
3164631-16463162.50262.80
4154952-15495258.82759.08
5152093-15209357.74258.00
6162459-16245961.67762.00
20min1188577-18857771.59369.222.9472.2269.822.97
2186085-18608570.64771.29
3185704-18570470.50271.11
4176589-17658967.04267.59
5175631-17563166.67867.22
6181331-18133168.84269.48
30min1215939-21593981.98179.772.1082.9680.722.11
2211469-21146980.28481.28
3213676-21367681.12282.08
4208361-20836179.10479.99
5204053-20405377.46878.35
6207246-20724678.68079.66
45min1234645-23464589.08287.351.5190.4888.701.52
2230267-23026787.42088.82
3231797-23179788.00189.37
4231791-23179187.99989.28
5225848-22584885.74387.01
6226121-22612185.84687.22
60min1238091-23809190.39190.621.2992.2392.401.27
2239458-23945890.91092.74
3243822-24382292.56694.37
4237318-23731890.09791.82
5238990-23899090.73292.43
6234499-23449989.02790.83
极限1250564-25056495.12693.631.4197.4295.871.40
2244285-24428592.74295.03
3249729-24972994.80997.08
4248889-24888994.49096.66
5242901-24290192.21794.37
6243432-24343292.41894.66
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%
112.169108991128907749085990837909370.18
212.039032390234902780.07
单位质量响应值RSD%判断
7478.377504.410.25数据可信
供试品溶液-HA0117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%
5min117925-1792519.08522.7816.5119.0822.7716.52
220001-2000121.29521.29
327578-2757829.36229.36
418554-1855419.75419.75
522823-2282324.29924.30
621470-2147022.85922.86
10min168554-6855472.98977.153.1773.0877.263.17
274265-7426579.06979.18
372833-7283377.54577.69
472029-7202976.68976.79
571953-7195376.60876.73
675135-7513579.99680.11
15min181792-8179287.08389.161.9887.5489.661.99
285878-8587891.43491.94
383506-8350688.90889.44
482998-8299888.36788.85
582653-8265388.00088.50
685618-8561891.15791.67
20min181592-8159286.87090.483.2787.7791.433.27
286432-8643292.02392.98
387855-8785593.53994.52
482687-8268788.03688.96
583377-8337788.77189.72
687956-8795693.64694.62
30min185783-8578391.33392.461.8592.6693.861.85
287742-8774293.41894.84
385537-8553791.07192.52
486032-8603291.59892.96
586238-8623891.81793.21
689696-8969695.49996.94
45min189853-8985395.66694.791.7197.4596.651.69
288780-8878094.52396.41
387427-8742793.08394.98
487545-8754593.20895.03
589086-8908694.84996.70
691477-9147797.39599.31
60min190803-9080396.67795.851.8598.9498.181.83
289939-8993995.75798.12
388841-8884194.58896.96
488134-8813493.83696.12
589561-8956195.35597.68
692854-9285498.861101.26
极限191100-9110096.99398.761.9899.74101.581.98
294260-94260100.358103.20
391872-9187297.815100.66
491688-9168897.620100.38
591866-9186697.809100.61
695777-95777101.973104.87
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%
114.762590502599112602122601492596612597970.19
214.812584302588832586560.13
单位质量响应值RSD%判断
17601.4217464.960.56数据可信
供试品溶液-HA0117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%
5min126305-2630510.00211.5116.5110.0011.5116.50
227330-2733010.39210.39
338882-3888214.78414.78
425974-259749.8769.88
533078-3307812.57712.58
630086-3008611.44011.44
10min1103959-10395939.52942.323.7639.5842.383.77
2114349-11434943.48043.53
3114565-11456543.56243.64
4109783-10978341.74441.79
5110589-11058942.05042.11
6114594-11459443.57343.63
15min1146262-14626255.61457.912.5155.8658.182.51
2156625-15662559.55559.82
3155590-15559059.16159.45
4150498-15049857.22557.48
5151117-15111757.46057.73
6153686-15368658.43758.71
20min1165145-16514562.79466.604.0863.3267.164.08
2178664-17866467.93568.50
3185315-18531570.46471.05
4171289-17128965.13065.67
5171788-17178865.32065.88
6178701-17870167.94968.52
30min1199642-19964275.91177.721.6376.7578.611.64
2208723-20872379.36480.27
3204064-20406477.59378.53
4203458-20345877.36278.23
5202860-20286077.13578.02
6207646-20764678.95579.86
45min1228575-22857586.91387.550.6888.1388.830.69
2231260-23126087.93489.24
3228730-22873086.97288.30
4229872-22987287.40688.66
5230442-23044287.62388.90
6232661-23266188.46689.77
60min1242842-24284292.33892.090.8693.9993.810.86
2244184-24418492.84894.59
3241483-24148391.82193.58
4238450-23845090.66892.36
5242334-24233492.14493.86
6243835-24383592.71594.46
极限1246502-24650293.72995.110.9495.8497.280.96
2252631-25263196.06098.27
3249797-24979794.98297.20
4248519-24851994.49696.64
5251021-25102195.44797.62
6252257-25225795.91798.13
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%
112.169147591002912719082791348911850.30
212.039105891022910400.03
单位质量响应值RSD%判断
7498.777567.750.65数据可信
供试品溶液-HA0117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%
5min121788-2178823.06925.3313.3223.0725.3313.31
223117-2311724.47624.48
324699-2469926.15126.15
422003-2200323.29723.30
521903-2190323.19123.19
630016-3001631.78131.78
10min173512-7351277.83476.854.2277.9576.974.21
275689-7568980.13980.26
373010-7301077.30377.43
472756-7275677.03477.15
566708-6670870.63070.75
673796-7379678.13578.29
15min184270-8427089.22588.221.4589.7388.731.46
283724-8372488.64689.17
382141-8214186.97087.49
481803-8180386.61387.11
583084-8308487.96988.44
684883-8488389.87490.42
20min186106-8610691.16990.921.7492.1291.871.74
285215-8521590.22591.19
384746-8474689.72990.68
484268-8426889.22290.16
586448-8644891.53192.44
688418-8841893.61694.62
30min184112-8411289.05792.072.3690.4693.472.34
288013-8801393.18894.61
386342-8634291.41892.82
485249-8524990.26191.64
588883-8888394.10995.48
689119-8911994.35995.83
45min187657-8765792.81193.431.8594.6695.291.83
287319-8731992.45394.34
387050-8705092.16894.03
486787-8678791.89093.72
590359-9035995.67297.51
690255-9025595.56197.50
60min187091-8709192.21194.182.1494.5396.512.12
288596-8859693.80596.15
390060-9006095.35597.67
486501-8650191.58793.88
589993-8999395.28497.60
691442-9144296.81899.23
极限188501-8850193.70496.571.9396.4899.381.90
290594-9059495.92098.74
390784-9078496.12298.92
491078-9107896.43399.18
593208-9320898.688101.48
693083-9308398.556101.46
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%
114.762621662614162615942620052615732617510.13
214.812596192600952598570.13
单位质量响应值RSD%判断
17733.8117546.050.76数据可信
供试品溶液-HA0117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%
5min130893-3089311.67612.7013.5911.6812.7013.61
231790-3179012.01512.01
334757-3475713.13613.14
430591-3059111.56211.56
531197-3119711.79111.79
642404-4240416.02616.03
10min1111656-11165642.19942.524.4542.2642.594.45
2115864-11586443.79043.85
3115174-11517443.52943.59
4113541-11354142.91242.97
5102887-10288738.88538.94
6115979-11597943.83343.91
15min1152708-15270857.71557.462.1857.9857.732.20
2154567-15456758.41758.70
3152500-15250057.63657.92
4150452-15045256.86257.13
5146342-14634255.30955.56
6155619-15561958.81559.11
20min1177280-17728067.00166.861.6267.5667.431.64
2177173-17717366.96167.53
3176232-17623266.60567.18
4176151-17615166.57567.13
5172899-17289965.34665.88
6181756-18175668.69369.29
30min1200328-20032875.71277.551.3676.6178.451.36
2207595-20759578.45979.36
3205551-20555177.68678.59
4204753-20475377.38578.27
5204809-20480977.40678.26
6208173-20817378.67779.61
45min1230181-23018186.99586.730.8388.2788.020.81
2227386-22738685.93987.24
3227234-22723485.88187.17
4229210-22921086.62887.90
5231216-23121687.38688.63
6231688-23168887.56488.89
60min1238229-23822990.03791.301.4191.7493.021.40
2240638-24063890.94792.67
3244802-24480292.52194.24
4237935-23793589.92591.64
5241574-24157491.30192.98
6246239-24623993.06494.83
极限1240631-24063190.94493.971.9893.1096.151.94
2247592-24759293.57595.76
3248121-24812193.77595.96
4248063-24806393.75395.91
5254852-25485296.31998.46
6252585-25258595.46297.70
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