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%
112.309193992238923089201292064921120.17
212.379231892415923660.08
单位质量响应值RSD%判断
7488.787466.940.21数据可信
供试品溶液-2023061621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%
5min123279-2327924.83025.9523.3924.8325.9523.39
229681-2968131.65831.66
326668-2666828.44528.44
429028-2902830.96230.96
514179-1417915.12415.12
623126-2312624.66724.67
10min177569-7756982.73685.032.9682.8685.162.98
281990-8199087.45287.61
380347-8034785.70085.84
480130-8013085.46885.62
576251-7625181.33181.41
682022-8202287.48687.61
15min185208-8520890.88493.491.8691.4294.051.85
287197-8719793.00693.60
386680-8668092.45493.03
488886-8888694.80795.39
588243-8824394.12294.60
689699-8969995.67596.24
20min188579-8857994.48095.840.8495.4796.860.85
290340-9034096.35897.42
389305-8930595.25496.29
490294-9029496.30997.37
590178-9017896.18597.14
690435-9043596.46097.50
30min191632-9163297.73697.411.2899.2098.911.26
290303-9030396.31997.86
390336-9033696.35497.86
491074-9107497.14198.68
591152-9115297.22498.66
693469-9346999.696101.22
45min191535-9153597.63397.182.0799.5999.172.04
289012-8901294.94296.97
390694-9069496.73698.73
491750-9175097.86299.89
589423-8942395.38097.30
694226-94226100.503102.52
60min193399-9339999.62199.421.83102.06101.901.81
291361-9136197.44799.95
392315-9231598.465100.94
493708-9370899.951102.46
592266-9226698.413100.81
696229-96229102.640105.16
极限194432-94432100.72399.962.02103.66102.941.99
291347-9134797.432100.42
392788-9278898.969101.94
494670-94670100.977103.99
592480-9248098.641101.53
696611-96611103.047106.08
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%
114.812686092691372692722690142689222689910.10
214.842693782694272694020.02
单位质量响应值RSD%判断
18162.8018153.770.04数据可信
供试品溶液-2023061621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%
5min125686-256869.4309.9423.669.439.9423.66
234175-3417512.54712.55
329852-2985210.96010.96
431330-3133011.50311.50
515930-159305.8495.85
625452-254529.3449.34
10min1106761-10676139.19641.185.2939.2441.235.30
2117901-11790143.28643.35
3112900-11290041.45041.51
4115142-11514242.27342.33
5103223-10322337.89737.93
6117089-11708942.98843.03
15min1145172-14517253.29955.632.9653.5455.882.96
2152211-15221155.88356.16
3149511-14951154.89255.15
4156576-15657657.48657.75
5149225-14922554.78755.01
6156459-15645957.44357.70
20min1170469-17046962.58664.451.8263.1064.981.83
2177261-17726165.08065.64
3173503-17350363.70064.24
4179168-17916865.78066.34
5175186-17518664.31864.81
6177667-17766765.22965.78
30min1202528-20252874.35774.991.6975.1875.851.68
2202413-20241374.31475.20
3200524-20052473.62174.48
4205389-20538975.40776.29
5204284-20428475.00175.82
6210397-21039777.24678.12
45min1223213-22321381.95182.482.1283.1583.712.11
2220086-22008680.80382.06
3221693-22169381.39382.62
4228371-22837183.84585.11
5222068-22206881.53082.72
6232464-23246485.34786.61
60min1241466-24146688.65288.781.7590.2690.421.74
2236744-23674486.91988.58
3239648-23964887.98589.61
4243563-24356389.42291.10
5240363-24036388.24789.84
6249086-24908691.45093.14
极限1252365-25236592.65492.392.0994.7094.472.08
2245082-24508289.98092.07
3248523-24852391.24393.31
4254740-25474093.52695.65
5249160-24916091.47793.52
6259952-25995295.43997.58
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%
112.309224292191922499227392295922500.05
212.379211492112921130.01
单位质量响应值RSD%判断
7500.007446.480.51数据可信
供试品溶液-2023061421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%
5min127312-2731229.15028.9431.0029.1528.9431.00
213533-1353314.44414.44
322662-2266224.18724.19
434032-3403236.32236.32
528054-2805429.94229.94
637126-3712639.62439.62
10min179409-7940984.75284.724.1684.9084.864.20
276301-7630181.43581.51
378036-7803683.28783.41
480069-8006985.45785.64
576983-7698382.16382.31
685460-8546091.21091.41
15min186920-8692092.76992.921.0593.3493.481.08
286741-8674192.57893.06
387207-8720793.07593.61
488185-8818594.11994.73
585554-8555491.31191.87
687740-8774093.64494.30
20min190340-9034096.41996.351.0197.4597.381.00
290408-9040896.49197.43
390953-9095397.07398.08
491386-9138697.53598.61
588828-8882894.80595.82
689739-8973995.77796.90
30min190702-9070296.80596.960.5398.3298.480.52
291195-9119597.33198.76
391231-9123197.37098.86
491243-9124397.38398.95
590044-9004496.10397.59
690690-9069096.79298.39
45min190787-9078796.89697.530.6098.9099.520.62
291223-9122397.36199.27
390759-9075996.86698.84
492047-9204798.241100.29
591633-9163397.79999.77
691815-9181597.993100.08
60min191179-9117997.31498.131.0599.80100.621.00
293213-9321399.485101.88
392608-9260898.839101.30
490635-9063596.73499.28
591630-9163097.796100.26
692402-9240298.620101.19
极限190572-9057296.66697.350.6099.64100.330.64
290817-9081796.92899.82
391151-9115197.284100.24
491456-9145697.610100.64
591159-9115997.293100.24
692138-9213898.338101.41
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%
114.812695702694272693632697432693532694910.07
214.842690552692172691360.05
单位质量响应值RSD%判断
18196.5618135.850.24数据可信
供试品溶液-2023061421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%
5min133000-3300012.11011.5730.9312.1111.5730.94
214765-147655.4195.42
326765-267659.8229.82
440752-4075214.95514.96
533345-3334512.23712.24
640537-4053714.87614.88
10min1113379-11337941.60841.836.0641.6741.896.08
2106112-10611238.94138.97
3110552-11055240.57140.62
4116037-11603742.58442.66
5111449-11144940.90040.96
6126356-12635646.37046.44
15min1153179-15317956.21456.412.5256.4856.682.56
2148969-14896954.66954.89
3151544-15154455.61455.87
4157079-15707957.64557.93
5152041-15204155.79656.06
6159482-15948258.52758.83
20min1181088-18108866.45666.261.5967.0166.811.62
2176383-17638364.73065.22
3180323-18032366.17566.71
4183931-18393167.50068.08
5178395-17839565.46866.01
6183183-18318367.22567.82
30min1209327-20932776.81976.630.8677.7077.510.90
2206899-20689975.92876.75
3208846-20884676.64377.50
4210066-21006677.09178.00
5206532-20653275.79476.67
6211135-21113577.48378.42
45min1230033-23003384.41884.680.7785.6885.940.80
2228916-22891684.00885.21
3229294-22929484.14785.39
4231855-23185585.08786.39
5230765-23076584.68785.94
6233626-23362685.73787.06
60min1242374-24237488.94789.321.0390.6491.001.00
2245620-24562090.13891.76
3244824-24482489.84691.51
4239795-23979588.00189.72
5241623-24162388.67290.35
6246024-24602490.28792.04
极限1249810-24981091.67692.100.8593.8194.240.87
2249963-24996391.73293.80
3250893-25089392.07394.19
4251487-25148792.29194.46
5248851-24885191.32493.44
6254859-25485993.52995.73
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%
112.309206791925920509216392111920630.10
212.379168091860917700.14
单位质量响应值RSD%判断
7484.807418.760.63数据可信
供试品溶液-2023061521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%
5min123885-2388525.56622.0533.7325.5722.0533.71
232122-3212234.38234.38
313178-1317814.10514.11
414225-1422515.22615.23
519237-1923720.59120.59
620944-2094422.41822.42
10min178638-7863884.17283.273.5984.3083.383.61
279236-7923684.81284.98
377778-7777883.25183.32
474444-7444479.68379.76
574842-7484280.10980.21
681815-8181587.57287.68
15min187259-8725993.39993.561.9393.9594.091.95
288185-8818594.39194.99
386040-8604092.09592.58
486745-8674592.84993.32
585862-8586291.90492.41
690368-9036896.72797.28
20min190451-9045196.81696.382.3097.8397.382.32
291866-9186698.33199.40
388451-8845194.67595.62
488765-8876595.01195.95
587782-8778293.95994.92
692957-9295799.498100.53
30min191609-9160998.05697.621.5699.5699.101.58
291797-9179798.25799.82
390857-9085797.25198.67
490083-9008396.42297.84
589425-8942595.71897.15
693428-93428100.003101.53
45min194062-94062100.68198.842.32102.67100.802.33
294122-94122100.745102.80
392256-9225698.748100.65
490751-9075197.13799.03
588927-8892795.18597.10
693915-93915100.524102.55
60min193193-9319399.75198.821.16102.24101.281.17
292577-9257799.092101.65
393532-93532100.114102.51
490899-9089997.29699.68
591181-9118197.59799.98
692564-9256499.078101.61
极限191745-9174598.20197.761.92101.19100.721.91
290948-9094897.348100.40
392076-9207698.555101.46
490071-9007196.40999.28
589069-8906995.33798.21
694100-94100100.722103.75
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%
114.812691812690002690332689172685812689420.09
214.842685702685712685700.01
单位质量响应值RSD%判断
18159.4918097.710.25数据可信
供试品溶液-2023061521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%
5min128020-2802010.3048.7537.3510.308.7537.35
238652-3865214.21414.21
314394-143945.2935.29
415881-158815.8405.84
521535-215357.9197.92
624323-243238.9458.94
10min1108223-10822339.79839.356.1639.8539.406.18
2113117-11311741.59841.67
3104364-10436438.37938.41
498182-9818236.10636.14
5102582-10258237.72437.76
6115609-11560942.51542.56
15min1149666-14966655.03955.043.3855.2955.283.40
2153256-15325656.35956.64
3145998-14599853.69053.91
4144733-14473353.22553.43
5146511-14651153.87954.11
6157838-15783858.04458.30
20min1176201-17620164.79764.473.3265.3264.993.35
2180307-18030766.30766.87
3170508-17050862.70363.19
4170068-17006862.54263.02
5170937-17093762.86163.36
6183906-18390667.63068.18
30min1204630-20463075.25175.152.2176.1075.992.24
2207575-20757576.33477.23
3201362-20136274.05074.85
4199912-19991273.51674.31
5201126-20112673.96374.77
6211538-21153877.79278.68
45min1231903-23190385.28183.892.5786.5185.112.58
2233780-23378085.97187.25
3225443-22544382.90584.08
4223312-22331282.12283.28
5220358-22035881.03582.22
6233930-23393086.02687.30
60min1241037-24103788.64088.071.1390.2989.701.17
2241662-24166288.87090.57
3240507-24050788.44590.03
4235322-23532286.53888.11
5236841-23684187.09788.68
6241474-24147488.80190.51
极限1247315-24731590.94990.711.8693.0492.781.88
2246421-24642190.62092.77
3247158-24715890.89192.92
4243135-24313589.41191.41
5241334-24133488.74990.77
6254626-25462693.63795.79
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