依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.521828371834621830651835811836641833220.20
210.471823621828151825880.18
单位质量响应值RSD%判断
17426.0517439.160.06数据可信
供试品溶液-2024011221批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19533-95334.9094.707.374.914.717.38
28946-89464.6074.61
39428-94284.8554.86
48052-80524.1474.15
59994-99945.1475.15
68860-88604.5634.56
10min114612-146127.5257.812.367.557.832.38
215285-152857.8727.90
315229-152297.8437.87
415446-154467.9547.98
515537-155378.0018.03
614854-148547.6507.67
15min114835-148357.6408.002.837.718.072.80
215767-157678.1208.19
315797-157978.1358.21
415800-158008.1378.20
515864-158648.1708.24
615124-151247.7897.86
20min114720-147207.5817.742.007.697.861.99
215407-154077.9348.05
315331-153317.8958.01
415150-151507.8027.91
514782-147827.6127.73
614817-148177.6317.74
30min114166-141667.2957.612.387.457.772.35
214685-146857.5637.72
315130-151307.7927.95
415053-150537.7527.91
514935-149357.6917.85
614699-146997.5707.72
45min114397-143977.4147.542.607.617.742.57
215013-150137.7317.93
314553-145537.4957.70
414900-149007.6737.87
514920-149207.6847.89
614029-140297.2257.42
60min114001-140017.2107.512.517.457.762.49
214531-145317.4837.73
314826-148267.6357.88
414752-147527.5977.84
515028-150287.7397.99
614383-143837.4077.64
极限114030-140307.2257.484.567.507.764.43
214791-147917.6177.90
314555-145557.4967.78
415455-154557.9598.24
514798-147987.6217.91
613557-135576.9827.26
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.741456371455371462151462461472551461780.47
210.731483621484971484300.07
单位质量响应值RSD%判断
13610.6113833.181.15数据可信
供试品溶液-2024011221批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120632-2063212.44715.1825.2812.4515.1825.28
221754-2175413.12313.12
331721-3172119.13619.14
420211-2021112.19312.19
534766-3476620.97320.97
621927-2192713.22813.23
10min165853-6585339.72741.348.1539.8041.428.17
264253-6425338.76238.83
374092-7409244.69744.80
470097-7009742.28742.35
575364-7536445.46545.58
661455-6145537.07437.15
15min191675-9167555.30455.706.2755.5956.026.30
288133-8813353.16853.46
397382-9738258.74759.10
494415-9441556.95757.26
598852-9885259.63460.00
683553-8355350.40550.68
20min1106421-10642164.20062.664.3164.8063.294.34
2100917-10091760.88061.46
3107723-10772364.98665.67
4104515-10451563.05063.67
5107364-10736464.76965.47
696314-9631458.10358.66
30min1112103-11210367.62868.284.6768.5869.254.70
2109717-10971766.18967.11
3114869-11486969.29770.34
4113687-11368768.58469.55
5122134-12213473.67974.74
6106622-10662264.32165.20
45min1123550-12355074.53473.985.6975.8675.335.68
2121635-12163573.37874.67
3121674-12167473.40274.83
4121549-12154973.32674.68
5134564-13456481.17882.65
6112813-11281368.05669.30
60min1125284-12528475.58076.785.2777.3278.545.28
2125500-12550075.71077.41
3126925-12692576.57078.40
4125101-12510175.46977.23
5140248-14024884.60786.53
6120598-12059872.75374.37
极限1132938-13293880.19781.254.8382.3683.434.82
2133938-13393880.80082.92
3132301-13230179.81382.07
4140689-14068984.87387.05
5143174-14317486.37288.76
6125015-12501575.41777.44
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.521844121847351850931851491851211849020.18
210.471839401832601836000.27
单位质量响应值RSD%判断
17576.2417535.820.17数据可信
供试品溶液-2024011222批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19362-93624.7875.5210.214.795.5210.22
211948-119486.1106.11
312154-121546.2156.22
410018-100185.1235.12
510341-103415.2885.29
610916-109165.5825.58
10min116394-163948.3838.581.628.418.611.65
217155-171558.7728.81
316927-169278.6568.69
416926-169268.6558.68
516675-166758.5278.56
616628-166288.5038.53
15min116270-162708.3208.452.198.398.532.12
216061-160618.2138.30
316421-164218.3978.48
416931-169318.6588.73
516970-169708.6788.75
616529-165298.4528.53
20min115928-159288.1458.252.038.268.372.01
216074-160748.2208.35
316232-162328.3008.43
416732-167328.5568.68
515916-159168.1398.26
615865-158658.1138.24
30min114944-149447.6427.912.227.818.082.20
215575-155757.9648.14
315271-152717.8097.98
415874-158748.1178.29
515772-157728.0658.24
615397-153977.8738.04
45min114853-148537.5957.871.897.808.081.89
215590-155907.9728.19
315471-154717.9118.13
415677-156778.0178.23
515380-153807.8658.08
615324-153247.8368.05
60min114564-145647.4477.692.757.707.952.70
215281-152817.8148.08
314514-145147.4227.68
415446-154467.8998.16
515390-153907.8708.13
615009-150097.6757.93
极限115138-151387.7417.681.568.037.981.53
215033-150337.6877.99
315078-150787.7108.01
415143-151437.7448.05
515185-151857.7658.07
614558-145587.4447.74
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.741503241507281506381506371509071506470.15
210.731493241494731493980.08
单位质量响应值RSD%判断
14026.7213923.390.53数据可信
供试品溶液-2024011222批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135055-3505520.76321.4812.3520.7621.4812.35
240336-4033623.89123.89
340587-4058724.04024.04
439412-3941223.34423.34
530658-3065818.15918.16
631556-3155618.69118.69
10min178723-7872346.62844.824.3446.7444.944.34
277023-7702345.62145.75
374957-7495744.39844.53
479203-7920346.91247.04
573394-7339443.47243.57
670729-7072941.89342.00
15min196795-9679557.33256.033.5757.7156.403.56
291108-9110853.96454.35
391805-9180554.37754.76
499990-9999059.22559.62
595002-9500256.27056.61
692917-9291755.03555.37
20min1108624-10862464.33962.633.4965.0363.303.49
2102645-10264560.79761.48
3103134-10313461.08761.77
4111832-11183266.23966.96
5103469-10346961.28561.94
6104696-10469662.01262.65
30min1111959-11195966.31466.613.4967.3667.643.44
2107884-10788463.90064.92
3107928-10792863.92664.95
4117242-11724269.44370.53
5114482-11448267.80868.80
6115274-11527468.27869.26
45min1121142-12114271.75372.082.8473.1773.482.80
2117375-11737569.52270.90
3117834-11783469.79471.17
4124669-12466973.84275.32
5124864-12486473.95875.33
6124265-12426573.60374.97
60min1124459-12445973.71873.713.7775.5475.513.72
2119935-11993571.03872.80
3117640-11764069.67971.44
4127780-12778075.68577.57
5128863-12886376.32678.11
6128017-12801775.82577.60
极限1132824-13282478.67377.162.2780.9079.362.26
2127191-12719175.33677.50
3125945-12594574.59876.75
4132666-13266678.57980.88
5131270-13127077.75279.96
6131703-13170378.00980.20
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.521833611831301836901837471838961835650.17
210.471843701843321843510.02
单位质量响应值RSD%判断
17449.1417607.550.64数据可信
供试品溶液-2024011223批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110886-108865.5765.785.525.585.785.54
210744-107445.5035.50
310948-109485.6075.61
411165-111655.7185.72
512409-124096.3566.36
611588-115885.9355.94
10min115471-154717.9248.031.667.958.061.68
215839-158398.1128.14
315811-158118.0988.13
415330-153307.8527.88
516021-160218.2068.24
615570-155707.9758.01
15min115323-153237.8488.092.077.928.172.06
215638-156388.0098.09
316251-162518.3238.40
415934-159348.1618.24
515992-159928.1918.27
615661-156618.0218.10
20min115812-158128.0997.983.058.228.102.98
215556-155567.9678.09
316072-160728.2328.35
415911-159118.1498.27
515394-153947.8858.01
614753-147537.5567.68
30min114910-149107.6377.732.037.807.902.00
214982-149827.6737.84
315293-152937.8338.00
415495-154957.9368.10
515259-152597.8157.99
614655-146557.5067.67
45min115047-150477.7077.712.917.917.922.84
215021-150217.6937.90
315898-158988.1438.35
414866-148667.6147.82
514925-149257.6447.86
614617-146177.4877.69
60min114731-147317.5457.541.947.797.791.89
215035-150357.7017.95
314946-149467.6557.91
414813-148137.5877.84
514288-142887.3187.57
614475-144757.4147.66
极限114465-144657.4097.502.787.707.802.70
214640-146407.4987.79
314485-144857.4197.72
415452-154527.9148.21
514541-145417.4487.74
614322-143227.3357.62
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.741495971497851497531498261498261497570.07
210.731503931502051502990.09
单位质量响应值RSD%判断
13943.8514007.360.33数据可信
供试品溶液-2024011223批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125867-2586715.32018.5527.9415.3218.5427.94
219744-1974411.69411.69
325712-2571215.22915.23
435732-3573221.16321.16
539292-3929223.27223.27
641529-4152924.59724.60
10min165217-6521738.62742.107.5738.7142.207.62
265202-6520238.61838.68
369970-6997041.44241.53
473055-7305543.26943.39
578912-7891246.73846.87
674131-7413143.90644.04
15min189754-8975453.15955.125.1853.4655.455.20
286593-8659351.28751.57
397449-9744957.71758.03
493194-9319455.19755.55
599573-9957358.97559.36
691788-9178854.36454.74
20min1105556-10555662.51962.054.3563.1162.694.33
299687-9968759.04259.61
3111138-11113865.82566.46
4104979-10497962.17762.84
5107716-10771663.79864.51
699491-9949158.92659.61
30min1112964-11296466.90667.024.9567.8568.014.91
2109181-10918164.66665.56
3122244-12224472.40273.40
4109587-10958764.90665.92
5117215-11721569.42470.49
6107785-10778563.83964.85
45min1122034-12203472.27871.726.8273.5973.086.72
2118472-11847270.16871.42
3136588-13658880.89882.30
4113485-11348567.21568.59
5120804-12080471.55073.01
6115188-11518868.22369.59
60min1126031-12603174.64572.406.2676.3674.156.14
2123121-12312172.92274.56
3134949-13494979.92781.78
4113410-11341067.17068.91
5118591-11859170.23972.09
6117295-11729569.47171.21
极限1132823-13282378.66876.043.5680.8078.203.53
2125310-12531074.21876.27
3135289-13528980.12982.43
4127016-12701675.22977.35
5125822-12582274.52276.77
6124018-12401873.45375.58
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.521832261834001836661836311838071835460.13
210.471846831840591843710.24
单位质量响应值RSD%判断
17447.3417609.460.66数据可信
供试品溶液-2024011821批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19973-99735.1084.926.685.114.926.68
210026-100265.1355.14
310330-103305.2915.29
49189-91894.7064.71
59488-94884.8604.86
68592-85924.4014.40
10min116278-162788.3378.451.248.378.481.21
216862-168628.6368.66
316523-165238.4638.49
416442-164428.4218.45
516356-163568.3778.40
616555-165558.4798.50
15min116356-163568.3778.552.408.458.622.37
216820-168208.6158.69
316491-164918.4468.52
417438-174388.9319.00
516667-166678.5378.61
616421-164218.4118.48
20min116113-161138.2538.311.518.378.431.47
216232-162328.3148.44
316016-160168.2038.33
416537-165378.4708.59
516463-164638.4328.55
615930-159308.1598.28
30min115913-159138.1508.221.818.328.381.75
216129-161298.2618.43
315595-155957.9878.16
416467-164678.4348.60
516160-161608.2778.44
616009-160098.1998.36
45min115534-155347.9567.951.548.178.171.51
215425-154257.9008.12
315558-155587.9688.18
415922-159228.1558.37
515552-155527.9658.18
615186-151867.7787.99
60min114092-140927.2187.743.767.477.993.67
215354-153547.8648.12
314918-149187.6417.90
415678-156788.0308.29
515502-155027.9408.20
615088-150887.7287.98
极限114464-144647.4087.702.707.708.002.63
214832-148327.5977.90
314951-149517.6587.96
415691-156918.0378.34
515152-151527.7618.06
615079-150797.7238.02
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.742991202982222995112993582987862989990.18
210.733002552992682997620.24
单位质量响应值RSD%判断
27839.7627936.810.25数据可信
供试品溶液-2024011821批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129738-297388.8268.6425.518.838.6425.54
238202-3820211.33911.34
337356-3735611.08811.09
419724-197245.8545.85
524935-249357.4017.40
624739-247397.3437.34
10min1121059-12105935.93135.358.0035.9835.408.02
2128171-12817138.04238.11
3127466-12746637.83337.89
4102510-10251030.42630.46
5114691-11469134.04134.08
6120729-12072935.83335.87
15min1167082-16708249.59149.952.4149.8450.192.43
2175112-17511251.97452.25
3166446-16644649.40249.67
4165457-16545749.10949.31
5164497-16449748.82449.05
6171113-17111350.78851.03
20min1190388-19038856.50856.532.2257.0357.052.21
2192504-19250457.13757.70
3184233-18423354.68255.23
4187087-18708755.52956.00
5192581-19258157.15957.66
6195963-19596358.16358.69
30min1213244-21324463.29262.893.2264.1363.723.19
2213327-21332763.31764.20
3200810-20081059.60260.45
4208689-20868961.94062.72
5213683-21368363.42364.24
6221511-22151165.74666.59
45min1226767-22676767.30666.123.2668.5067.313.22
2221930-22193065.87067.10
3211435-21143562.75563.94
4218647-21864764.89666.02
5225464-22546466.91968.09
6232403-23240368.97970.19
60min1219247-21924765.07467.064.5866.6468.614.51
2226823-22682367.32368.92
3213708-21370863.43064.96
4221601-22160165.77367.26
5231188-23118868.61870.16
6243062-24306272.14273.74
极限1241526-24152671.68772.952.8773.6174.882.84
2243123-24312372.16174.13
3237676-23767670.54472.43
4247098-24709873.34075.19
5247083-24708373.33675.26
6258195-25819576.63478.63
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.521850591842151847331848331838731845430.27
210.471857901854581856240.13
单位质量响应值RSD%判断
17542.1117729.130.75数据可信
供试品溶液-2024012021批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19716-97164.9464.845.564.954.845.56
210350-103505.2695.27
38950-89504.5564.56
49508-95084.8404.84
59614-96144.8944.89
68942-89424.5524.55
10min114918-149187.5947.872.647.627.902.65
215902-159028.0958.12
315560-155607.9217.95
415822-158228.0548.08
515576-155767.9297.96
615026-150267.6497.67
15min115877-158778.0828.132.428.158.202.40
216173-161738.2338.31
316270-162708.2838.35
416401-164018.3498.42
515667-156677.9768.05
615401-154017.8407.91
20min115044-150447.6587.882.647.778.002.63
215675-156757.9808.10
315833-158338.0608.18
415976-159768.1338.25
515349-153497.8147.93
615016-150167.6447.76
30min115039-150397.6567.742.057.817.902.02
214903-149037.5877.75
315348-153487.8137.97
415527-155277.9048.07
514841-148417.5557.71
615539-155397.9108.06
45min114847-148477.5587.601.857.767.801.82
214857-148577.5637.77
315199-151997.7377.94
415265-152657.7717.98
514842-148427.5567.76
614512-145127.3887.59
60min114094-140947.1757.533.017.427.772.92
214544-145447.4047.65
315287-152877.7828.03
415167-151677.7217.97
514645-146457.4557.70
614972-149727.6227.86
极限114394-143947.3287.461.457.617.741.43
214629-146297.4477.74
314606-146067.4357.73
415024-150247.6487.94
514691-146917.4797.76
614526-145267.3957.68
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.743012423005373009413000713011593007900.17
210.733021773011463016620.25
单位质量响应值RSD%判断
28006.5228113.890.28数据可信
供试品溶液-2024012021批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126566-265667.83710.5613.847.8410.5613.84
238576-3857611.37911.38
335441-3544110.45510.45
441112-4111212.12812.13
536190-3619010.67610.68
636920-3692010.89110.89
10min1117949-11794934.79437.024.0234.8437.084.04
2129028-12902838.06238.13
3129286-12928638.13838.20
4130778-13077838.57838.65
5124240-12424036.64936.71
6121763-12176335.91935.98
15min1169217-16921749.91751.333.6850.1551.603.68
2177806-17780652.45152.73
3182151-18215153.73254.00
4177635-17763552.40052.68
5172534-17253450.89651.16
6164745-16474548.59848.86
20min1185065-18506554.59257.444.6755.1157.994.67
2200250-20025059.07159.64
3204192-20419260.23460.80
4199327-19932758.79959.37
5197774-19777458.34158.89
6181714-18171453.60454.13
30min1208537-20853761.51662.671.9862.3363.542.00
2210957-21095762.23063.12
3219655-21965564.79665.70
4212240-21224062.60863.51
5214569-21456963.29564.17
6208722-20872261.57162.40
45min1226267-22626766.74667.233.0267.9168.453.02
2233108-23310868.76470.00
3237042-23704269.92571.19
4225246-22524666.44567.69
5228725-22872567.47168.69
6217141-21714164.05465.22
60min1225639-22563966.56168.192.2868.0969.782.29
2231226-23122668.20969.83
3240305-24030570.88772.54
4229769-22976967.77969.40
5233096-23309668.76170.36
6226921-22692166.93968.46
极限1249310-24931073.54473.441.4975.4475.411.51
2248291-24829173.24375.24
3254062-25406274.94576.99
4247273-24727372.94374.94
5251558-25155874.20776.19
6243258-24325871.75873.66
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