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%
112.909673696505967449665796685966650.10
212.869651796583965500.05
单位质量响应值RSD%判断
7493.417507.780.14数据可信
供试品溶液-GA47051批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117165-1716518.25325.5022.2218.2525.5022.23
231342-3134233.32933.33
321770-2177023.15023.15
429077-2907730.92030.92
520767-2076722.08322.08
623732-2373225.23625.24
10min161752-6175265.66672.214.7965.7672.334.81
270422-7042274.88675.05
368101-6810172.41772.53
468247-6824772.57372.73
568071-6807172.38672.50
670815-7081575.30475.43
15min182158-8215887.36589.111.2187.7989.601.24
284857-8485790.23690.78
383545-8354588.84089.32
483285-8328588.56489.08
584372-8437289.72090.19
684594-8459489.95690.46
20min184948-8494890.33292.141.6791.1993.081.69
289132-8913294.78195.77
386975-8697592.48893.41
485801-8580191.23992.20
587015-8701592.53093.45
686037-8603791.49092.44
30min186817-8681792.32094.031.6493.6395.421.64
289774-8977495.46496.93
390512-9051296.24997.63
487465-8746593.00994.43
588409-8840994.01395.40
687570-8757093.12094.53
45min187738-8773893.29993.830.8995.0795.690.91
289529-8952995.20497.15
387407-8740792.94794.81
488435-8843594.04095.92
588586-8858694.20196.05
687701-8770193.26095.14
60min186575-8657592.06293.060.8294.3095.400.85
288519-8851994.13096.55
387578-8757893.12995.46
487322-8732292.85795.21
587003-8700392.51894.84
688103-8810393.68796.03
极限187068-8706892.58795.161.5795.2897.961.57
290132-9013295.84598.74
391164-9116496.94299.74
488911-8891194.54697.36
590063-9006395.77298.56
689561-8956195.23898.05
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100607-202305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%
115.432676192673012676732676292673942675230.07
215.522669762669842669800.01
单位质量响应值RSD%判断
17337.8517202.320.56数据可信
供试品溶液-GA47051批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12038-20380.7871.3029.310.791.3029.26
24129-41291.5941.59
32798-27981.0801.08
43981-39811.5371.54
52740-27401.0581.06
64574-45741.7661.77
10min18320-83203.2123.565.373.223.565.40
29683-96833.7383.75
39083-90833.5063.51
49633-96333.7193.73
59256-92563.5733.58
69305-93053.5923.60
15min112292-122924.7455.105.884.775.135.86
213902-139025.3675.39
312973-129735.0085.03
414382-143825.5525.58
513002-130025.0195.04
612743-127434.9194.95
20min114271-142715.5095.753.245.555.803.28
215137-151375.8435.90
314642-146425.6525.70
415138-151385.8445.90
515574-155746.0126.06
614536-145365.6115.66
30min115997-159976.1756.513.356.256.593.32
216768-167686.4736.56
317726-177266.8436.92
416970-169706.5516.63
517041-170416.5786.66
616662-166626.4326.51
45min117896-178966.9087.223.017.017.332.99
218227-182277.0367.15
318901-189017.2967.41
419114-191147.3797.49
518674-186747.2097.32
619402-194027.4907.60
60min119269-192697.4387.500.857.587.650.90
219399-193997.4897.64
319397-193977.4887.63
419746-197467.6237.78
519410-194107.4937.64
619365-193657.4757.62
极限119854-198547.6647.812.027.848.001.99
219635-196357.5807.77
320285-202857.8318.01
420503-205037.9158.11
520390-203907.8718.06
620712-207127.9958.18
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%
112.909612896095961909612696322961720.10
212.869637296159962660.16
单位质量响应值RSD%判断
7455.197485.690.29数据可信
供试品溶液-GA47051批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128042-2804229.94022.6621.6629.9422.6621.67
218870-1887020.14720.15
320742-2074222.14622.15
416983-1698318.13218.13
517154-1715418.31518.31
625568-2556827.29827.30
10min167039-6703971.57669.795.4571.7369.905.46
267302-6730271.85771.96
369886-6988674.61674.73
459568-5956863.59963.69
564259-6425968.60868.70
664120-6412068.46068.60
15min185495-8549591.28189.901.3591.7990.361.38
284721-8472190.45590.91
384390-8439090.10190.59
482087-8208787.64388.05
584202-8420289.90190.34
684296-8429690.00190.48
20min185758-8575891.56292.560.9892.5393.470.97
287970-8797093.92494.84
386677-8667792.54393.48
486070-8607091.89592.74
586272-8627292.11192.99
687388-8738893.30294.23
30min188633-8863394.63295.311.0796.0596.681.07
289620-8962095.68597.07
388618-8861894.61696.01
488185-8818594.15395.46
589842-8984295.92297.27
690708-9070896.84798.24
45min188636-8863694.63594.081.2596.5395.931.25
289401-8940195.45297.31
386485-8648592.33894.21
487288-8728893.19694.97
587931-8793193.88295.71
688968-8896894.98996.87
60min186266-8626692.10494.921.8894.4797.241.83
291131-9113197.29999.64
389482-8948295.53897.87
489560-8956095.62197.86
587806-8780693.74996.04
689170-8917095.20597.56
极限187080-8708092.97395.852.1795.8098.642.07
289481-8948195.53798.36
388332-8833294.31097.12
491655-9165597.858100.58
592189-9218998.428101.19
689896-8989695.98098.81
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%
115.432659602662302661582659372661052660780.05
215.522660472661282660880.03
单位质量响应值RSD%判断
17244.2017144.850.41数据可信
供试品溶液-GA47051批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13258-32581.2631.0419.991.261.0420.12
22333-23330.9050.90
32964-29641.1491.15
42252-22520.8730.87
52064-20640.8000.80
63271-32711.2681.27
10min19229-92293.5783.415.663.583.425.59
28959-89593.4743.48
39194-91943.5653.57
47894-78943.0613.07
58594-85943.3323.34
68905-89053.4533.46
15min112961-129615.0254.912.765.054.932.82
212895-128955.0005.02
312784-127844.9574.98
412232-122324.7434.76
512182-121824.7234.74
612852-128524.9835.01
20min114079-140795.4595.602.585.515.652.58
214864-148645.7635.81
314641-146415.6775.73
414173-141735.4955.54
514117-141175.4735.52
614847-148475.7575.81
30min116384-163846.3526.614.816.436.684.76
216613-166136.4416.52
318462-184627.1587.23
416456-164566.3806.45
516771-167716.5036.57
617594-175946.8226.90
45min117910-179106.9447.081.227.057.191.25
218514-185147.1787.29
318326-183267.1057.22
418108-181087.0217.12
518273-182737.0857.19
618436-184367.1487.26
60min118909-189097.3317.582.247.477.722.24
220080-200807.7857.93
319917-199177.7227.87
419582-195827.5927.73
519197-191977.4437.58
619569-195697.5877.73
极限119641-196417.6157.704.137.807.884.02
218308-183087.0987.28
320056-200567.7767.96
420414-204147.9158.09
520374-203747.8998.08
620400-204007.9108.09
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%
112.909601496193960319599796005960480.09
212.869597996158960680.14
单位质量响应值RSD%判断
7445.587470.300.24数据可信
供试品溶液-DA619批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130942-3094233.09131.709.8633.0931.709.86
227667-2766729.58929.59
332583-3258334.84634.85
424853-2485326.57926.58
529805-2980531.87531.88
631972-3197234.19334.19
10min174392-7439279.56082.081.6779.7382.241.67
277339-7733982.71282.86
377676-7767683.07283.25
476844-7684482.18282.32
577874-7787483.28483.44
676355-7635581.65981.83
15min185628-8562891.57692.801.5392.1493.361.52
285535-8553591.47792.04
385594-8559491.54092.13
487567-8756793.65094.19
588420-8842094.56295.14
687865-8786593.96994.55
20min186280-8628092.27494.511.8193.2995.551.79
287985-8798594.09795.12
387838-8783893.94094.99
490798-9079897.10598.12
587716-8771693.80994.86
689622-8962295.84896.90
30min189841-8984196.08293.751.4597.5695.251.41
287700-8770093.79295.28
386234-8623492.22493.74
488167-8816794.29295.79
587214-8721493.27394.79
686805-8680592.83594.36
45min186627-8662792.64592.901.2294.6194.871.20
287010-8701093.05495.01
388163-8816394.28796.27
484996-8499690.90092.87
587005-8700593.04995.03
687371-8737193.44095.43
60min188295-8829594.42994.061.9296.8596.491.88
285052-8505290.96093.38
388417-8841794.55997.01
490273-9027396.54498.97
587683-8768393.77496.22
687960-8796094.07096.53
极限186820-8682092.85194.171.3195.7597.091.28
287115-8711593.16796.05
389376-8937695.58598.51
489485-8948595.70198.61
587452-8745293.52796.45
688096-8809694.21697.15
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%
115.432658532659542657092656692657682657910.05
215.522661592663962662780.07
单位质量响应值RSD%判断
17225.6017157.090.29数据可信
供试品溶液-DA619批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13492-34921.3541.359.831.351.359.84
23089-30891.1981.20
33857-38571.4961.50
43068-30681.1901.19
53640-36401.4121.41
63792-37921.4711.47
10min18152-81523.1613.313.503.173.313.45
28885-88853.4463.45
38747-87473.3923.40
48207-82073.1833.19
58671-86713.3633.37
68478-84783.2883.30
15min111224-112244.3534.381.884.384.401.88
211237-112374.3584.38
311516-115164.4664.49
411253-112534.3644.39
510956-109564.2494.27
611519-115194.4674.49
20min112450-124504.8285.012.214.875.062.21
213241-132415.1355.18
313028-130285.0525.10
412923-129235.0115.06
512785-127854.9585.00
613146-131465.0985.14
30min114394-143945.5825.751.695.655.821.67
214966-149665.8045.87
315138-151385.8705.94
414813-148135.7445.81
514882-148825.7715.84
614748-147485.7195.79
45min116368-163686.3476.271.876.446.371.83
216126-161266.2546.35
316578-165786.4296.53
415677-156776.0796.18
516126-161266.2546.35
616190-161906.2786.38
60min117784-177846.8976.791.487.026.921.46
217107-171076.6346.76
317578-175786.8176.95
417760-177606.8877.02
517345-173456.7266.86
617455-174556.7696.90
极限117838-178386.9177.020.897.087.190.89
218094-180947.0177.18
318200-182007.0587.23
418248-182487.0767.24
518018-180186.9877.15
618241-182417.0747.24
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%
112.909625495905961959641096234962000.20
212.869585595873958640.02
单位质量响应值RSD%判断
7457.367454.430.03数据可信
供试品溶液-DA619批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131668-3166833.87730.457.5733.8830.457.57
229105-2910531.13531.14
325021-2502126.76626.77
428119-2811930.08130.08
527908-2790829.85529.85
628958-2895830.97830.98
10min175431-7543180.69380.773.6180.8680.923.60
276951-7695182.31982.47
378649-7864984.13584.27
472890-7289077.97578.13
571687-7168776.68876.84
677417-7741782.81782.97
15min184679-8467990.58691.501.5291.1692.061.52
285825-8582591.81292.38
386464-8646492.49593.05
483968-8396889.82590.37
584815-8481590.73191.26
687457-8745793.55894.13
20min184573-8457390.47393.192.2291.5094.202.20
288690-8869094.87795.90
387784-8778493.90894.92
485569-8556991.53892.53
586425-8642592.45493.44
689625-8962595.87796.91
30min184695-8469590.60394.712.9192.0896.192.88
291622-9162298.01399.51
388880-8888095.08096.57
489208-8920895.43196.88
586387-8638792.41393.86
690420-9042096.72798.24
45min185131-8513191.06994.021.9793.0095.971.96
289000-8900095.20897.20
387959-8795994.09596.06
487888-8788894.01995.94
587133-8713393.21195.12
690226-9022696.52098.52
60min185634-8563491.60894.121.6393.9996.541.61
289682-8968295.93898.40
387238-8723893.32395.76
487825-8782593.95196.35
588689-8868994.87697.25
688840-8884095.03797.52
极限186179-8617992.19194.141.5795.0497.041.57
289288-8928895.51698.46
388345-8834594.50897.41
486609-8660992.65195.51
588029-8802994.17097.02
689578-8957895.82798.78
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%
115.432661062662722659272663772665002662360.09
215.522654032651582652800.07
单位质量响应值RSD%判断
17254.4417092.780.67数据可信
供试品溶液-DA619批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13594-35941.3951.257.241.401.257.27
23239-32391.2571.26
33115-31151.2091.21
43011-30111.1691.17
52980-29801.1571.16
63357-33571.3031.30
10min18558-85583.3223.325.393.333.325.37
28902-89023.4563.46
39218-92183.5783.58
47979-79793.0973.10
58161-81613.1683.17
68454-84543.2823.29
15min111858-118584.6034.423.714.634.443.74
211266-112664.3734.40
311471-114714.4534.48
410637-106374.1294.15
511388-113884.4214.44
611676-116764.5334.56
20min112651-126514.9114.963.374.965.013.37
213205-132055.1265.17
313149-131495.1045.15
412133-121334.7104.75
512505-125054.8544.90
613090-130905.0825.13
30min114670-146705.6955.781.945.775.851.90
215302-153025.9406.01
315072-150725.8515.92
414786-147865.7405.81
514501-145015.6295.70
614933-149335.7975.87
45min116079-160796.2426.392.006.346.492.01
216995-169956.5976.70
316556-165566.4276.53
416206-162066.2916.39
516328-163286.3396.43
616586-165866.4396.54
60min117244-172446.6946.761.496.826.891.48
217928-179286.9607.09
317361-173616.7406.87
417214-172146.6826.81
517399-173996.7546.88
617411-174116.7596.89
极限117719-177196.8796.971.167.047.141.14
218053-180537.0087.18
317935-179356.9627.13
417715-177156.8777.04
518167-181677.0527.21
618179-181797.0577.22
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