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对照品来源工作对照品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%
1 10.081775491772641773361772181774101773550.08
2 10.131772071773201772640.05
单位质量响应值RSD%判断
17594.7417498.910.39数据可信
供试品溶液-2023120822批-依折麦布-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%
5min17176-71763.6714.6615.203.674.6615.25
210121-101215.1785.18
39142-91424.6774.68
49745-97454.9864.99
57749-77493.9653.96
610706-107065.4785.48
10min115547-155477.9547.931.797.977.961.77
215483-154837.9227.95
315608-156087.9868.01
415934-159348.1528.18
515120-151207.7367.76
615313-153137.8357.87
15min115509-155097.9358.041.148.008.101.15
215705-157058.0358.11
315747-157478.0578.13
416010-160108.1918.26
515549-155497.9558.02
615715-157158.0408.11
20min115348-153487.8537.852.017.967.962.02
215402-154027.8808.00
315241-152417.7987.91
415895-158958.1328.25
514980-149807.6647.77
615182-151827.7687.89
30min114928-149287.6387.660.907.797.810.94
214939-149397.6437.80
314953-149537.6507.81
415212-152127.7837.95
514803-148037.5747.73
614937-149377.6427.80
45min114481-144817.4097.521.447.607.721.44
214801-148017.5737.78
314455-144557.3967.60
415022-150227.6867.89
514711-147117.5277.72
614716-147167.5297.73
60min114431-144317.3837.401.087.627.641.11
214703-147037.5237.77
314386-143867.3607.60
414554-145547.4467.70
514254-142547.2937.53
614402-144027.3697.61
极限114868-148687.6077.411.907.887.691.84
214609-146097.4747.76
314132-141327.2307.51
414656-146567.4997.79
514275-142757.3047.58
614356-143567.3457.63
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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
1 10.881546541544431545491543611546321545280.09
2 10.911543461543531543500.01
单位质量响应值RSD%判断
14202.9414147.570.28数据可信
供试品溶液-2023120822批-阿托伐他汀钙-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%
5min1100475-10047558.54864.767.1858.5564.767.18
2120488-12048870.20970.21
3104199-10419960.71860.72
4114425-11442566.67666.68
5108817-10881763.40963.41
6118414-11841469.00169.00
10min1151124-15112488.06185.402.9488.3985.762.90
2141541-14154182.47782.87
3151120-15112088.05988.40
4146830-14683085.55985.93
5147156-14715685.74986.10
6141531-14153182.47182.85
15min1149950-14995087.37788.063.4088.1988.893.35
2144527-14452784.21785.07
3157650-15765091.86492.69
4151766-15176688.43589.28
5156055-15605590.93491.76
6146753-14675385.51486.36
20min1149271-14927186.98187.753.4388.2889.073.39
2143767-14376783.77485.09
3155793-15579390.78292.12
4154281-15428189.90191.24
5154880-15488090.25091.58
6145544-14554484.81086.13
30min1154969-15496990.30289.652.2892.0891.462.25
2151406-15140688.22590.01
3158699-15869992.47594.32
4155529-15552990.62892.46
5153927-15392789.69491.53
6148612-14861286.59788.39
45min1155173-15517390.42190.702.2692.7193.002.24
2150602-15060287.75790.03
3158957-15895792.62594.98
4157401-15740191.71994.06
5159156-15915692.74195.07
6152575-15257588.90791.18
60min1155602-15560290.67191.281.3493.4694.091.28
2157356-15735691.69394.45
3157760-15776091.92894.80
4153243-15324389.29692.15
5156498-15649891.19394.04
6159396-15939692.88195.64
极限1168432-16843298.14799.831.79101.44103.151.76
2168732-16873298.321101.59
3172405-172405100.462103.84
4176805-176805103.026106.37
5170607-17060799.414102.77
6170950-17095099.614102.89
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对照品来源工作对照品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%
1 10.081770011769531771971771771772451771150.08
2 10.131772221772201772210.01
单位质量响应值RSD%判断
17570.9317494.670.31数据可信
供试品溶液-2023120822批-依折麦布-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%
5min18359-83594.2804.2412.254.284.2412.21
29239-92394.7314.73
36768-67683.4663.47
49474-94744.8514.85
58229-82294.2144.21
67577-75773.8803.88
10min115126-151267.7457.801.487.777.821.47
214977-149777.6697.70
315221-152217.7947.81
415103-151037.7337.76
515627-156278.0028.03
615296-152967.8327.85
15min115438-154387.9057.971.067.978.041.04
215700-157008.0398.11
315750-157508.0658.13
415444-154447.9087.98
515712-157128.0458.11
615392-153927.8817.95
20min115014-150147.6887.791.607.807.901.56
215292-152927.8307.94
315646-156468.0118.12
415193-151937.7797.89
515010-150107.6867.80
615075-150757.7197.83
30min114247-142477.2957.542.037.457.701.99
214672-146727.5137.67
315087-150877.7257.88
414653-146537.5037.66
515005-150057.6837.84
614732-147327.5437.70
45min113562-135626.9447.352.967.147.552.89
214390-143907.3687.57
314608-146087.4807.67
414758-147587.5577.76
514542-145427.4467.64
614283-142837.3147.51
60min113863-138637.0987.291.557.337.531.51
214175-141757.2587.50
314417-144177.3827.62
414286-142867.3157.56
514219-142197.2817.52
614487-144877.4187.65
极限113227-132276.7737.103.297.047.383.23
214219-142197.2817.56
314312-143127.3287.61
414202-142027.2727.55
513801-138017.0677.35
613428-134286.8767.15
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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
1 10.881540591543561541391539231542571541470.11
2 10.911539581539091539340.03
单位质量响应值RSD%判断
14167.9214109.440.30数据可信
供试品溶液-2023120822批-阿托伐他汀钙-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%
5min1112938-11293865.98053.4125.5565.9853.4125.55
2100688-10068858.82358.82
366904-6690439.08639.09
4108628-10862863.46263.46
5102144-10214459.67459.67
657279-5727933.46333.46
10min1149707-14970787.46182.796.1787.8383.086.22
2139450-13945081.46981.80
3138924-13892481.16281.38
4142961-14296183.52083.87
5151721-15172188.63888.97
6127475-12747574.47374.66
15min1151959-15195988.77785.594.6889.6386.354.73
2142931-14293183.50284.28
3148097-14809786.52187.19
4146956-14695685.85486.67
5154093-15409390.02490.85
6135029-13502978.88679.49
20min1153315-15331589.56986.253.2990.9187.483.34
2144572-14457284.46185.70
3150378-15037887.85389.00
4150129-15012987.70889.00
5147662-14766286.26687.59
6139769-13976981.65582.69
30min1153468-15346889.65887.842.5491.5089.552.56
2144281-14428184.29186.00
3151252-15125288.36490.00
4149930-14993087.59189.37
5154879-15487990.48392.29
6148275-14827586.62588.12
45min1149503-14950387.34288.003.3189.6890.203.27
2144897-14489784.65186.83
3145410-14541084.95187.08
4153670-15367089.77692.04
5157636-15763692.09394.40
6152631-15263189.16991.14
60min1154763-15476390.41589.322.8493.2492.012.77
2145720-14572085.13287.78
3150607-15060787.98790.59
4152404-15240489.03791.80
5156360-15636091.34894.17
6157527-15752792.03094.50
极限1155448-15544890.81595.403.3394.1498.593.17
2167521-16752197.868100.99
3169403-16940398.968102.06
4166827-16682797.463100.72
5160416-16041693.71897.04
6160196-16019693.58996.57
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对照品来源工作对照品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%
1 10.081773841774211774941775861774431774660.05
2 10.131776701777011776860.02
单位质量响应值RSD%判断
17605.7517540.570.27数据可信
供试品溶液-2023120822批-依折麦布-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%
5min112486-124866.3795.4914.676.385.5014.64
211940-119406.1006.10
311330-113305.7885.79
410781-107815.5085.51
58134-81344.1554.16
69849-98495.0325.03
10min118028-180289.2109.101.389.259.131.42
218106-181069.2509.28
317782-177829.0849.12
417750-177509.0689.10
517418-174188.8988.92
617737-177379.0619.09
15min117767-177679.0779.211.499.169.291.52
218467-184679.4349.52
318162-181629.2789.36
417867-178679.1289.21
517796-177969.0919.16
618073-180739.2339.31
20min116988-169888.6798.901.878.829.041.79
217270-172708.8238.96
317853-178539.1209.25
417567-175678.9749.11
517672-176729.0289.15
617199-171998.7868.92
30min117320-173208.8488.881.999.039.061.96
217416-174168.8979.08
318008-180089.2009.38
417353-173538.8659.05
517132-171328.7528.93
617018-170188.6948.87
45min116283-162838.3188.622.108.558.852.05
216901-169018.6348.87
317369-173698.8739.11
416867-168678.6178.85
517010-170108.6908.91
616777-167778.5718.80
60min116276-162768.3158.562.568.608.842.50
216812-168128.5898.87
317465-174658.9229.21
416690-166908.5268.81
516924-169248.6468.92
616368-163688.3628.64
极限116639-166398.5008.552.278.838.882.26
217041-170418.7069.04
317355-173558.8669.20
416515-165158.4378.76
516389-163898.3738.69
616487-164878.4238.74
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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
1 10.881527051525441524721526151524511525570.07
2 10.911536491538981537740.12
单位质量响应值RSD%判断
14021.7814094.780.37数据可信
供试品溶液-2023120822批-阿托伐他汀钙-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%
5min181016-8101647.60237.0515.0847.6037.0515.07
259054-5905434.69834.70
354959-5495932.29232.29
462335-6233536.62536.63
556378-5637833.12533.13
664621-6462137.96937.97
10min1132711-13271177.97574.672.8178.2474.882.84
2125171-12517173.54573.74
3124088-12408872.90973.09
4128886-12888675.72875.93
5123304-12330472.44872.63
6128361-12836175.42075.63
15min1146053-14605385.81586.311.2586.5186.931.25
2148403-14840387.19587.80
3146187-14618785.89386.48
4149128-14912887.62188.25
5144093-14409384.66385.25
6147529-14752986.68287.31
20min1142032-14203283.45287.833.0584.6388.932.99
2148418-14841887.20488.29
3147596-14759686.72187.78
4155125-15512591.14592.26
5151575-15157589.05990.12
6152165-15216589.40690.52
30min1156922-15692292.20192.492.6193.8494.082.57
2151934-15193489.27090.84
3161570-16157094.93296.48
4162868-16286895.69497.31
5155966-15596691.63993.19
6155275-15527591.23392.84
45min1150558-15055888.46292.783.0890.6194.893.01
2155089-15508991.12493.19
3160812-16081294.48696.56
4164347-16434796.56398.71
5160016-16001694.01996.08
6156675-15667592.05694.17
60min1153053-15305389.92893.423.0792.5796.043.00
2153417-15341790.14192.71
3163058-16305895.80698.40
4163714-16371496.19198.88
5162626-16262695.55298.14
6158138-15813892.91595.54
极限1155745-15574591.50995.142.1094.6598.272.04
2164383-16438396.58599.66
3162280-16228095.34998.48
4164843-16484396.855100.07
5160598-16059894.36197.47
6163667-16366796.16499.31
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对照品来源工作对照品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%
1 10.081775981776111775131775011774721775390.04
2 10.131770361770181770270.01
单位质量响应值RSD%判断
17613.0017475.520.56数据可信
供试品溶液-2023120822批-依折麦布-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%
5min19698-96984.9635.438.044.965.448.08
211521-115215.8955.90
310209-102095.2245.22
411482-114825.8755.88
59706-97064.9674.97
611105-111055.6835.68
10min117816-178169.1179.171.799.149.201.80
217859-178599.1399.17
318409-184099.4209.45
418070-180709.2479.28
517436-174368.9228.95
617950-179509.1859.22
15min118008-180089.2159.181.439.299.261.42
217877-178779.1489.23
318265-182659.3469.43
418156-181569.2919.37
517626-176269.0199.10
617684-176849.0499.13
20min118057-180579.2409.002.459.379.132.42
216887-168878.6418.78
317963-179639.1929.33
417667-176679.0409.18
517326-173268.8668.99
617575-175758.9939.13
30min117075-170758.7388.771.878.928.951.83
216929-169298.6638.85
317644-176449.0299.21
417390-173908.8999.08
516930-169308.6638.84
616819-168198.6078.79
45min116208-162088.2948.523.218.528.753.14
215960-159608.1678.40
317119-171198.7608.99
417339-173398.8739.11
516782-167828.5888.81
616453-164538.4198.65
60min116349-163498.3668.502.818.648.772.79
215883-158838.1288.40
317111-171118.7569.04
417082-170828.7419.03
516505-165058.4468.72
616679-166798.5358.81
极限116556-165568.4728.492.518.798.822.50
216358-163588.3718.69
316908-169088.6528.98
417280-172808.8429.18
516255-162558.3188.64
616239-162398.3108.63
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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
1 10.881541061537451537941538461538531538690.10
2 10.911531941533251532600.07
单位质量响应值RSD%判断
14142.3714047.660.48数据可信
供试品溶液-2023120822批-阿托伐他汀钙-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%
5min139581-3958123.19636.7321.7923.2036.7321.79
277210-7721045.24745.25
360599-6059935.51335.51
465581-6558138.43238.43
558030-5803034.00734.01
675048-7504843.98043.98
10min1117627-11762768.93374.774.0569.0674.974.09
2129292-12929275.76976.02
3131572-13157277.10577.30
4128676-12867675.40875.62
5127009-12700974.43174.62
6131306-13130676.94977.19
15min1142254-14225483.36586.752.2983.8887.382.32
2146943-14694386.11386.79
3150799-15079988.37389.00
4146934-14693486.10886.74
5150544-15054488.22388.83
6150744-15074488.34089.01
20min1154492-15449290.53790.892.5091.5191.992.47
2148783-14878387.19188.34
3159213-15921393.30394.42
4152882-15288289.59390.70
5157950-15795092.56393.66
6157227-15722792.14093.30
30min1156451-15645191.68593.572.1493.1695.182.14
2157170-15717092.10693.74
3162244-16224495.08096.71
4156518-15651891.72493.33
5164426-16442696.35897.97
6161191-16119194.46396.14
45min1150497-15049788.19693.283.4590.1895.403.43
2157434-15743492.26194.41
3161325-16132594.54196.70
4157756-15775692.45094.57
5167041-16704197.891100.03
6160964-16096494.33096.53
60min1156774-15677491.87494.722.3894.3597.372.39
2157797-15779792.47495.13
3165932-16593297.24199.93
4161637-16163794.72497.36
5161954-16195494.91097.60
6165737-16573797.12799.85
极限1164574-16457496.44596.811.7199.4399.981.65
2162373-16237395.15598.33
3167801-16780198.336101.56
4167298-16729898.042101.20
5167654-16765498.250101.46
6161466-16146694.62497.89
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