叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.431939111940041938631938341938001938820.05
217.491939781938121938950.07
单位质量响应值RSD%判断
11123.4711086.050.24数据可信
供试品溶液-24070804批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1110044-110044100.108100.820.96100.11100.820.96
2110899-110899100.886100.89
3111337-111337101.284101.28
4110089-110089100.149100.15
5112648-112648102.477102.48
6109914-10991499.99099.99
10min1109910-10991099.986100.851.18101.10101.971.18
2110490-110490100.514101.63
3111739-111739101.650102.78
4110387-110387100.420101.53
5113071-113071102.862104.00
6109587-10958799.692100.80
15min1109556-10955699.664100.031.42101.89102.271.41
2109831-10983199.914102.15
3109705-10970599.800102.05
4109061-10906199.214101.44
5112988-112988102.786105.07
6108588-10858898.784101.00
20min1108099-10809998.33998.771.26101.67102.121.25
2108416-10841698.627101.98
3109357-10935799.483102.85
4107050-10705097.384100.72
5110857-110857100.848104.27
6107646-10764697.927101.24
30min1107260-10726097.57597.881.62102.00102.321.59
2108717-10871798.901103.34
3109153-10915399.298103.77
4105282-10528295.776100.19
5109287-10928799.419103.96
6105845-10584596.288100.69
45min1105504-10550495.97896.530.91101.49102.060.92
2106244-10624496.651102.19
3106092-10609296.513102.09
4105167-10516795.671101.15
5107902-10790298.159103.81
6105726-10572696.180101.65
60min1104159-10415994.75495.161.54101.33101.771.51
2104970-10497095.492102.11
3105091-10509195.602102.25
4102869-10286993.581100.12
5107318-10731897.628104.37
6103225-10322593.905100.45
90min1102432-10243293.18394.301.40100.81101.971.37
2103059-10305993.754101.43
3105025-10502595.542103.25
4102039-10203992.826100.41
5105667-10566796.126103.95
6103736-10373694.370101.96
极限1101004-10100491.88493.271.77100.55101.981.71
2101264-10126492.121100.84
3104605-10460595.160103.93
4101728-10172892.543101.15
5105066-10506695.580104.47
6101480-10148092.317100.95
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.001947891947061946851945881945771946690.05
215.991945821945731945780.01
单位质量响应值RSD%判断
12166.8112168.730.02数据可信
供试品溶液-24070804批-叶酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117551-1755114.79914.694.3514.8014.694.36
216734-1673414.11014.11
316849-1684914.20714.21
418723-1872315.78715.79
516913-1691314.26114.26
617739-1773914.95814.96
10min130602-3060225.80425.804.4925.9725.964.49
229813-2981325.13925.30
328978-2897824.43524.59
432957-3295727.79027.97
530068-3006825.35425.51
631165-3116526.27926.44
15min136583-3658330.84732.554.6331.3033.004.61
238347-3834732.33532.77
336911-3691131.12431.55
441477-4147734.97435.46
538981-3898132.86933.31
639313-3931333.14933.61
20min143649-4364936.80537.143.7637.6037.953.76
243758-4375836.89737.69
341825-4182535.26736.04
446775-4677539.44140.31
543411-4341136.60537.41
644833-4483337.80438.63
30min149342-4934241.60642.543.0442.8143.773.06
250724-5072442.77143.98
349297-4929741.56842.73
453054-5305444.73646.05
549118-4911841.41742.63
651199-5119943.17244.42
45min153780-5378045.34847.123.3047.0148.813.31
255708-5570846.97448.65
354506-5450645.96047.59
458744-5874449.53451.34
555237-5523746.57648.25
657295-5729548.31250.04
60min156396-5639647.55449.432.8549.7251.652.87
258463-5846349.29751.50
357695-5769548.64950.79
461410-6141051.78254.14
558586-5858649.40051.59
659148-5914849.87452.14
90min159245-5924549.95652.543.1352.6555.303.12
261864-6186452.16454.91
362130-6213052.38955.07
464928-6492854.74857.68
561829-6182952.13554.87
663827-6382753.82056.64
极限164590-6459054.46356.993.6857.7260.343.64
265674-6567455.37758.71
367079-6707956.56259.82
471665-7166560.42963.97
567783-6778357.15560.47
668719-6871957.94561.36
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.431940011939921943361942081941691941410.08
217.491932321934171933240.07
单位质量响应值RSD%判断
11138.3211053.400.55数据可信
供试品溶液-24070805批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1110494-110494100.599101.181.92100.60101.181.91
2110743-110743100.826100.83
3112106-112106102.067102.07
4114898-114898104.609104.61
5109371-10937199.57799.58
6109198-10919899.41999.42
10min1111018-111018101.076100.211.22102.19101.341.22
2108460-10846098.74799.87
3111951-111951101.926103.06
4110436-110436100.546101.71
5109813-10981399.979101.09
6108753-10875399.014100.12
15min1109343-10934399.55199.390.97101.79101.630.98
2108284-10828498.587100.80
3110494-110494100.599102.87
4110154-110154100.290102.57
5108972-10897299.214101.43
6107779-10777998.127100.33
20min1108761-10876199.02198.121.10102.37101.461.09
2107108-10710897.516100.83
3109482-10948299.678103.06
4107608-10760897.972101.37
5107506-10750697.879101.20
6106174-10617496.66699.96
30min1107306-10730697.69797.021.20102.14101.451.20
2105889-10588996.407100.80
3108262-10826298.567103.06
4107179-10717997.581102.06
5106098-10609896.597101.00
6104649-10464995.27899.65
45min1106153-10615396.64796.421.11102.18101.941.10
2104742-10474295.362100.83
3107854-10785498.196103.78
4106279-10627996.762102.33
5105727-10572796.259101.74
6104695-10469595.320100.75
60min1105661-10566196.19995.091.37102.81101.681.35
2103124-10312493.889100.42
3106146-10614696.641103.32
4105392-10539295.954102.60
5103202-10320293.960100.51
6103161-10316193.923100.41
90min1103793-10379394.49894.440.92102.17102.070.94
2102895-10289593.681101.25
3105063-10506395.655103.41
4104670-10467095.297103.00
5102994-10299493.771101.36
6102938-10293893.720101.25
极限1103056-10305693.82793.331.66102.55102.021.61
2101254-10125492.187100.80
3105185-10518595.766104.58
4102789-10278993.584102.35
5102610-10261093.421102.06
6100197-10019791.22499.80
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.001948071948571953591950621950151950200.12
215.991942991939631941310.13
单位质量响应值RSD%判断
12188.7512140.780.28数据可信
供试品溶液-24070805批-叶酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124018-2401820.25720.815.5420.2620.815.54
225170-2517021.22921.23
322220-2222018.74118.74
425285-2528521.32621.33
525276-2527621.31821.32
626050-2605021.97121.97
10min141586-4158635.07534.956.1135.3035.186.10
240509-4050934.16634.40
336931-3693131.14831.36
442468-4246835.81836.06
542934-4293436.21236.45
644175-4417537.25837.50
15min149981-4998142.15542.167.0842.7742.787.06
248709-4870941.08241.70
343775-4377536.92137.48
451392-5139243.34543.98
552151-5215143.98544.62
653947-5394745.50046.16
20min155513-5551346.82146.296.7047.9047.386.69
253796-5379645.37346.44
348207-4820740.65941.62
456058-5605847.28148.40
556804-5680447.91049.04
658914-5891449.68950.85
30min160698-6069851.19450.586.9452.8052.186.91
256820-5682047.92349.50
353461-5346145.09046.51
461722-6172252.05853.70
561961-6196152.25953.92
665123-6512354.92656.64
45min164395-6439554.31254.266.8356.4856.426.81
261893-6189352.20254.31
357171-5717148.21950.14
466292-6629255.91258.13
566301-6630155.92058.16
669929-6992958.98061.31
60min166760-6676056.30755.766.7459.0858.526.73
263458-6345853.52256.21
358820-5882049.61052.06
467820-6782057.20160.04
568050-6805057.39560.26
671758-7175860.52263.50
90min168636-6863657.88957.967.1761.2961.357.14
265916-6591655.59558.88
360689-6068951.18654.19
470560-7056059.51262.99
571858-7185860.60764.11
674692-7469262.99766.65
极限173230-7323061.76464.745.1865.8168.775.22
275509-7550963.68667.59
371638-7163860.42163.99
478038-7803865.81969.96
581100-8110068.40272.58
681009-8100968.32572.68
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.431941361942721937821939661941891940690.11
217.491936331935221935780.05
单位质量响应值RSD%判断
11134.1911067.920.43数据可信
供试品溶液-23FA175批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130236-3023627.51524.2623.1527.5224.2623.15
232130-3213029.23929.24
327351-2735124.89024.89
432093-3209329.20529.21
520215-2021518.39618.40
617938-1793816.32416.32
10min149322-4932244.88440.8012.0045.1941.0712.06
250922-5092246.34046.66
341873-4187338.10538.38
448572-4857244.20144.53
539580-3958036.01936.22
638743-3874335.25735.44
15min161374-6137455.85153.7011.9456.6654.4211.99
264748-6474858.92259.76
359527-5952754.17154.87
467163-6716361.12061.94
549579-4957945.11845.72
651669-5166947.02047.59
20min168900-6890062.70058.719.9264.1360.039.97
267730-6773061.63663.13
369612-6961263.34864.65
468216-6821662.07863.57
556938-5693851.81552.92
655684-5568450.67351.77
30min175033-7503368.28163.759.2770.4065.729.04
276607-7660769.71471.89
372987-7298766.41968.43
459171-5917153.84756.03
566100-6610060.15261.83
670412-7041264.07665.73
45min174548-7454867.84065.6511.0970.7268.3310.57
277397-7739770.43373.39
371638-7163865.19267.94
456588-5658851.49654.28
574208-7420867.53169.88
678450-7845071.39173.76
60min179812-7981272.63063.1333.2776.2666.5431.56
283175-8317575.69179.43
322832-2283220.77824.25
475356-7535668.57571.93
573756-7375667.11970.22
681292-8129273.97777.14
90min181958-8195874.58363.3338.0679.0267.4435.72
275394-7539468.61073.19
378752-7875271.66675.36
415918-1591814.48618.60
580814-8081473.54277.39
684728-8472877.10481.09
极限183968-8396876.41276.272.3681.6881.082.11
282045-8204574.66280.00
381248-8124873.93778.43
486515-8651578.73083.01
583682-8368276.15280.82
685387-8538777.70482.55
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.001946061948101947931945801948151947210.07
215.991947111941921944520.19
单位质量响应值RSD%判断
12170.0612160.850.06数据可信
供试品溶液-23FA175批-叶酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
90min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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