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%
112.679371793918938489396493598938090.17
212.609346193172933160.22
单位质量响应值RSD%判断
7404.037406.030.02数据可信
长期24月-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%
5min149029-4902952.80948.994.4952.8148.994.49
244546-4454647.98147.98
344137-4413747.54047.54
443512-4351246.86746.87
544993-4499348.46248.46
646682-4668250.28150.28
10min182946-8294689.34289.371.6089.6189.621.59
284052-8405290.53390.77
380885-8088587.12287.36
484706-8470691.23791.47
582653-8265389.02689.27
682586-8258688.95489.21
15min188198-8819894.99994.541.9295.7195.231.91
287860-8786094.63595.33
387256-8725693.98494.66
490198-9019897.15397.84
588100-8810094.89395.58
685001-8500191.55592.25
20min189817-8981796.74294.922.0597.9396.092.04
288582-8858295.41296.58
386348-8634893.00694.15
490575-9057597.55998.74
586946-8694693.65094.81
686497-8649793.16694.32
30min186881-8688193.58094.591.4295.2596.231.40
288984-8898495.84597.49
388579-8857995.40997.02
489227-8922796.10797.77
586518-8651893.18994.82
686727-8672793.41495.03
45min187920-8792094.69996.021.1996.8498.141.16
290426-9042697.39899.52
390280-9028097.24199.33
489243-8924396.12498.27
588124-8812494.91997.01
688911-8891195.76797.85
60min191214-9121498.24795.512.03100.8698.111.99
290062-9006297.00699.62
386217-8621792.86595.44
487949-8794994.73097.36
587642-8764294.40096.97
688967-8896795.82798.39
极限189250-8925096.13296.342.1899.2399.402.13
291911-9191198.998102.09
386239-8623992.88995.92
488963-8896395.82398.92
590964-9096497.978101.02
689305-8930596.19199.24
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100607-201804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%
114.712558442557902557002562532558262558830.09
214.802559912561012560460.04
单位质量响应值RSD%判断
17395.1717300.410.39数据可信
长期24月-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%
5min199367-9936738.18735.355.2738.1935.365.27
290830-9083034.90634.91
387830-8783033.75333.75
486958-8695833.41833.42
590826-9082634.90434.90
696167-9616736.95736.96
10min1200602-20060277.09177.001.6577.2877.171.65
2202666-20266677.88478.06
3193948-19394874.53474.70
4201635-20163577.48877.65
5200434-20043477.02677.20
6202886-20288677.96978.15
15min1233512-23351289.73889.281.3790.3189.841.36
2232798-23279889.46490.03
3229496-22949688.19588.74
4236131-23613190.74591.30
5234378-23437890.07190.63
6227603-22760387.46788.04
20min1247559-24755995.13692.991.7696.1693.991.75
2242842-24284293.32494.33
3236425-23642590.85891.84
4245920-24592094.50795.51
5239866-23986692.18093.19
6239175-23917591.91492.93
30min1244359-24435993.90794.341.1595.4195.811.13
2249153-24915395.74997.23
3246698-24669894.80596.24
4247689-24768995.18696.67
5241986-24198692.99594.47
6243004-24300493.38694.86
45min1247521-24752195.12295.811.0397.0997.761.01
2252304-25230496.96098.92
3252710-25271097.11699.03
4248904-24890495.65397.61
5246850-24685094.86496.80
6247612-24761295.15797.10
60min1255431-25543198.16295.232.04100.6197.652.00
2251417-25141796.61999.06
3241271-24127192.72095.12
4245830-24583094.47296.91
5244811-24481194.08096.49
6248021-24802195.31497.73
极限1248827-24882795.62495.842.0798.5698.742.03
2255746-25574698.283101.21
3240579-24057992.45495.31
4248973-24897395.68098.59
5253173-25317397.294100.17
6249076-24907695.71998.61
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%
112.679323193396935979333693156933430.19
212.609355793492935240.05
单位质量响应值RSD%判断
7367.257422.540.53数据可信
长期24月-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%
5min146490-4649050.14448.832.0650.1448.832.06
245628-4562849.21449.21
345272-4527248.83048.83
443659-4365947.09047.09
545067-4506748.60948.61
645535-4553549.11449.11
10min182552-8255289.04088.921.4089.2989.171.40
283824-8382490.41290.66
382593-8259389.08589.33
482322-8232288.79289.03
580363-8036386.67986.92
683013-8301389.53889.78
15min186579-8657993.38493.440.7494.0894.130.74
285973-8597392.73093.43
387038-8703893.87994.57
485883-8588392.63393.31
586793-8679393.61594.29
687545-8754594.42695.12
20min189101-8910196.10495.252.3397.2796.412.31
292136-9213699.378100.54
387343-8734394.20895.37
487717-8771794.61195.75
586805-8680593.62894.77
686777-8677793.59794.76
30min191741-9174198.95295.952.47100.5997.582.44
289307-8930796.32697.98
389933-8993397.00198.63
489578-8957896.61998.23
585247-8524791.94793.56
687918-8791894.82896.46
45min186974-8697493.81094.410.8195.9596.520.79
287494-8749494.37196.51
387139-8713993.98896.10
486990-8699093.82795.93
587740-8774094.63696.71
688834-8883495.81697.92
60min188986-8898695.98095.321.1598.5997.911.13
287780-8778094.67997.29
388383-8838395.33097.91
489717-8971796.76999.34
586777-8677793.59796.14
688623-8862395.58998.18
极限187300-8730094.16294.751.2397.2597.811.18
286736-8673693.55396.64
387074-8707493.91896.98
488024-8802494.94297.99
588230-8823095.16598.18
689705-8970596.75699.82
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%
114.712562342561602558332555542554162558390.15
214.802560182563592561880.10
单位质量响应值RSD%判断
17392.1817310.000.34数据可信
长期24月-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%
5min193971-9397136.10635.192.5336.1135.192.53
292180-9218035.41835.42
390520-9052034.78034.78
487473-8747333.60933.61
592506-9250635.54335.54
692909-9290935.69835.70
10min1199069-19906976.48776.501.1976.6776.671.19
2202036-20203677.62777.80
3198630-19863076.31876.49
4197667-19766775.94876.12
5195695-19569575.19175.37
6201442-20144277.39977.58
15min1229659-22965988.24088.270.9388.8088.820.92
2227277-22727787.32587.89
3229187-22918788.05988.61
4227854-22785487.54788.09
5231923-23192389.11089.66
6232511-23251189.33689.90
20min1245227-24522794.22293.282.1695.2394.282.14
2252330-25233096.95197.95
3239220-23922091.91492.91
4241582-24158292.82293.81
5239240-23924091.92292.92
6239092-23909291.86592.88
30min1256191-25619198.43595.452.5499.9196.922.50
2250568-25056896.27497.76
3250849-25084996.38297.84
4249910-24991096.02197.47
5237682-23768291.32392.78
6245384-24538494.28295.75
45min1244195-24419593.82694.100.6495.7996.040.63
2244997-24499794.13496.10
3244058-24405893.77395.71
4243551-24355193.57895.51
5244698-24469894.01995.93
6247929-24792995.26097.20
60min1248282-24828295.39694.861.3297.8397.271.29
2245368-24536894.27696.71
3247483-24748395.08997.50
4251354-25135496.57698.97
5241616-24161692.83595.22
6247155-24715594.96397.38
极限1244006-24400693.75394.091.1296.6796.981.09
2241839-24183992.92095.83
3242618-24261893.22096.10
4245806-24580694.44597.33
5245562-24556294.35197.20
6249467-24946795.85198.75
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%
112.679405893895940229394193825939480.11
212.609367293770937210.08
单位质量响应值RSD%判断
7415.007438.170.23数据可信
长期24月-供试品溶液-2023061621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%
5min138007-3800740.81928.1131.5840.8228.1131.58
227896-2789629.96029.96
314945-1494516.05116.05
432203-3220334.58534.59
522725-2272524.40624.41
621261-2126122.83422.83
10min169044-6904474.15273.897.7974.3674.037.79
265240-6524070.06770.22
360338-6033864.80264.88
470019-7001975.19975.37
573041-7304178.44578.57
675091-7509180.64680.76
15min176976-7697682.67183.275.8183.2583.785.81
273051-7305178.45578.96
372716-7271678.09678.50
478244-7824484.03384.58
579348-7934885.21885.73
684871-8487191.15091.67
20min178420-7842084.22286.723.4685.2187.643.47
279255-7925585.11886.01
377560-7756083.29884.09
482928-8292889.06390.03
581591-8159187.62788.57
684697-8469790.96391.94
30min180694-8069486.66489.913.2588.0791.273.25
281615-8161587.65388.97
381485-8148587.51388.72
485844-8584492.19593.61
586668-8666893.08094.46
685988-8598892.35093.78
45min180064-8006485.98791.923.7887.8393.733.73
284072-8407290.29292.05
385779-8577992.12593.77
487040-8704093.47995.35
587180-8718093.63095.47
689412-8941296.02797.92
60min184029-8402990.24692.692.1392.5294.962.09
286655-8665593.06695.27
386833-8683393.25795.37
486480-8648092.87895.22
584637-8463790.89993.21
689202-8920295.80198.17
极限186774-8677493.19495.991.9695.9298.721.94
288694-8869495.25697.93
389134-8913495.72898.30
489200-8920095.79998.61
591965-9196598.769101.54
690486-9048697.180100.03
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%
114.712558012560852561092557972556812558950.08
214.802553062550712551880.07
单位质量响应值RSD%判断
17395.9917242.430.63数据可信
长期24月-供试品溶液-2023061621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%
5min165341-6534125.15216.5635.6725.1516.5635.67
246180-4618017.77617.78
322334-223348.5978.60
453912-5391220.75320.75
535523-3552313.67413.67
634862-3486213.42013.42
10min1152850-15285058.83855.518.9958.9655.599.01
2137983-13798353.11553.20
3120786-12078646.49546.54
4147429-14742956.75156.85
5150787-15078758.04358.11
6155365-15536559.80659.87
15min1189455-18945572.92870.986.3073.3571.346.31
2173801-17380166.90267.26
3167729-16772964.56564.84
4186809-18680971.91072.30
5188997-18899772.75273.11
6199562-19956276.81977.18
20min1204558-20455878.74279.403.7079.5380.123.73
2201967-20196777.74478.43
3194174-19417474.74575.34
4212419-21241981.76882.51
5209632-20963280.69581.42
6214874-21487482.71383.46
30min1222459-22245985.63387.613.2686.8188.723.27
2221718-22171885.34786.43
3219354-21935484.43785.41
4233797-23379789.99791.15
5237447-23744791.40292.53
6230823-23082388.85290.02
45min1225640-22564086.85792.043.3988.4693.603.35
2234494-23449490.26591.77
3238804-23880491.92493.32
4244199-24419994.00195.61
5243459-24345993.71695.30
6248101-24810195.50397.11
60min1238408-23840891.77293.411.7093.8195.431.67
2243161-24316193.60295.56
3243374-24337493.68495.54
4244637-24463794.17096.25
5237714-23771491.50593.56
6248743-24874395.75097.84
极限1240527-24052792.58895.141.7395.0997.611.71
2245704-24570494.58097.00
3246607-24660794.92897.25
4247209-24720995.16097.71
5253412-25341297.548100.06
6249415-24941596.00998.57
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%
112.679364293448934389376493400935380.17
212.609322593546933860.25
单位质量响应值RSD%判断
7382.647411.590.28数据可信
长期24月-供试品溶液-2023061621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%
5min130359-3035932.73527.3218.0632.7327.3218.05
220293-2029321.88121.88
331637-3163734.11334.11
424158-2415826.04926.05
522790-2279024.57424.57
622809-2280924.59424.59
10min165472-6547270.59674.076.4670.7674.216.44
262255-6225567.12767.24
367817-6781773.12573.30
469898-6989875.36875.50
573925-7392579.71179.83
672821-7282178.52078.64
15min173855-7385579.63582.513.6580.1583.013.65
273047-7304778.76479.21
376088-7608882.04382.58
477989-7798984.09384.60
580546-8054686.85087.37
677579-7757983.65184.17
20min177784-7778483.87285.873.2984.7986.793.29
275782-7578281.71382.55
379408-7940885.62386.57
479996-7999686.25787.18
582300-8230088.74189.70
682564-8256489.02689.96
30min179099-7909985.29089.172.8986.6290.522.90
280202-8020286.47987.73
384127-8412790.71192.09
484102-8410290.68492.04
584236-8423690.82992.23
684422-8442291.02992.41
45min181085-8108587.43192.123.1989.1993.913.18
283265-8326589.78291.46
387906-8790694.78696.61
487898-8789894.77796.59
586230-8623092.97994.83
686200-8620092.94694.78
60min183115-8311589.62093.412.0891.8295.662.05
287386-8738694.22596.35
386527-8652793.29995.60
488101-8810194.99697.28
587475-8747594.32196.64
687162-8716293.98496.28
极限187791-8779194.66296.062.0397.3198.781.95
291816-9181699.002101.60
387145-8714593.96596.73
487781-8778194.65197.41
589764-8976496.78999.58
690216-9021697.277100.05
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%
114.712558572556742563182555652555902558010.13
214.802559422560042559730.02
单位质量响应值RSD%判断
17389.6017295.470.39数据可信
长期24月-供试品溶液-2023061621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%
5min151734-5173419.88716.1420.2019.8916.1420.21
232762-3276212.59412.59
353384-5338420.52220.52
438951-3895114.97314.97
537726-3772614.50214.50
637300-3730014.33914.34
10min1141136-14113654.25555.275.9254.3555.365.92
2129447-12944749.76149.82
3142278-14227854.69454.80
4145419-14541955.90155.98
5153180-15318058.88558.96
6151278-15127858.15358.23
15min1178160-17816068.48770.113.7568.8670.463.76
2171450-17145065.90866.22
3182847-18284770.28970.67
4186694-18669471.76872.12
5191024-19102473.43273.80
6184049-18404970.75171.11
20min1199302-19930276.61577.983.2877.3378.693.29
2191751-19175173.71274.35
3202660-20266077.90578.63
4205241-20524178.89879.61
5208581-20858180.18180.92
6209619-20961980.58181.30
30min1215609-21560982.88386.452.8383.9887.552.83
2218011-21801183.80784.82
3229265-22926588.13389.25
4230011-23001188.41989.53
5228919-22891988.00089.13
6227578-22757887.48488.60
45min1227973-22797387.63691.813.0989.1593.343.07
2232713-23271389.45890.89
3247002-24700294.95196.51
4245707-24570794.45396.00
5239930-23993092.23293.81
6239612-23961292.11093.67
60min1235358-23535890.47593.891.8992.4295.881.87
2246297-24629794.68096.56
3246065-24606594.59196.62
4248502-24850295.52897.55
5245152-24515294.24096.28
6244009-24400993.80195.82
极限1243012-24301293.41794.841.8995.8297.301.81
2253616-25361697.49499.84
3241375-24137592.78895.29
4244151-24415193.85596.35
5248643-24864395.58298.09
6249525-24952595.92198.41
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