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%
110.181775131778491778501780201778591778180.11
210.191788411795261791840.28
单位质量响应值RSD%判断
17467.3917584.300.48数据可信
供试品溶液-2022091401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%
5min112052-120526.1745.914.646.175.904.62
211895-118956.0936.09
310660-106605.4615.46
411749-117496.0186.02
511714-117146.0006.00
611100-111005.6865.69
10min117533-175338.9819.074.039.029.104.02
219107-191079.7889.82
317574-175749.0029.03
417560-175608.9959.03
517437-174378.9328.97
617046-170468.7328.76
15min117639-176399.0369.091.279.129.171.23
217477-174778.9539.04
318133-181339.2899.37
417632-176329.0329.12
517754-177549.0949.18
617811-178119.1249.20
20min117401-174018.9149.062.269.059.202.21
217548-175488.9899.13
317739-177399.0879.22
417450-174508.9399.07
517523-175238.9769.11
618470-184709.4619.59
30min116888-168888.6518.771.318.838.951.28
217173-171738.7978.98
317373-173738.8999.08
417034-170348.7268.91
516877-168778.6458.83
617371-173718.8989.08
45min117014-170148.7158.691.548.958.921.50
216703-167038.5568.79
317271-172718.8479.08
417181-171818.8019.03
517012-170128.7148.95
616612-166128.5098.74
60min116556-165568.4818.611.738.768.891.66
216923-169238.6698.95
317174-171748.7979.08
417086-170868.7529.03
516604-166048.5058.79
616509-165098.4578.74
极限116454-164548.4298.460.578.768.790.55
216623-166238.5158.85
316405-164058.4038.73
416454-164548.4298.76
516623-166238.5158.84
616539-165398.4728.80
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%
111.101588581590541591201592961591151590890.10
211.161602431605771604100.15
单位质量响应值RSD%判断
14332.3414373.660.21数据可信
供试品溶液-2022091401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%
5min190094-9009451.84832.0839.2351.8532.0839.23
260768-6076834.97134.97
326772-2677215.40715.41
464268-6426836.98636.99
539449-3944922.70322.70
653066-5306630.53930.54
10min1132979-13297976.52869.0610.5376.8269.2410.59
2131901-13190175.90876.10
3100138-10013857.62857.71
4118934-11893468.44568.65
5111586-11158664.21764.34
6124525-12452571.66371.83
15min1146986-14698684.58984.455.0385.3085.015.08
2151230-15123087.03187.65
3133934-13393477.07877.48
4149438-14943886.00086.59
5143713-14371382.70683.19
6155156-15515689.29189.86
20min1151861-15186187.39589.064.1188.5890.094.14
2158517-15851791.22592.32
3144250-14425083.01583.85
4156391-15639190.00291.07
5154582-15458288.96189.90
6162875-16287593.73394.80
30min1153270-15327088.20591.004.9689.8792.534.93
2164590-16459094.72096.33
3150187-15018786.43187.73
4151339-15133987.09488.66
5159954-15995492.05293.49
6169468-16946897.52799.11
45min1160388-16038892.30293.893.1994.4695.923.17
2163153-16315393.89396.03
3157765-15776590.79292.57
4158854-15885491.41993.47
5168154-16815496.77198.72
6170549-17054998.149100.28
60min1161887-16188793.16495.762.0895.8498.322.08
2169062-16906297.29499.95
3162980-16298093.79396.07
4165485-16548595.23597.79
5169253-16925397.40499.89
6169747-16974797.688100.36
极限1166641-16664195.90098.221.7199.09101.311.70
2172456-17245699.247102.44
3169214-16921497.381100.18
4168618-16861897.038100.12
5173338-17333899.754102.78
6173785-173785100.012103.23
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%
110.181772401772961773111771061769981771900.08
210.191768311776191772250.32
单位质量响应值RSD%判断
17405.7017392.050.06数据可信
供试品溶液-2022091403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%
5min112145-121456.2676.585.786.276.585.77
212461-124616.4306.43
314131-141317.2917.29
412911-129116.6626.66
512714-127146.5606.56
612177-121776.2836.28
10min117940-179409.2579.621.979.299.661.98
218735-187359.6679.70
318896-188969.7509.79
418896-188969.7509.79
518598-185989.5969.63
618835-188359.7199.75
15min118169-181699.3759.561.309.469.641.31
218440-184409.5159.60
318642-186429.6199.71
418622-186229.6099.70
518379-183799.4839.57
618857-188579.7309.82
20min117770-177709.1699.290.829.319.440.81
218218-182189.4009.54
318004-180049.2909.44
418076-180769.3279.47
517954-179549.2649.41
618038-180389.3079.45
30min117433-174338.9958.931.009.189.130.97
217296-172968.9249.12
317334-173348.9449.14
417081-170818.8139.01
517179-171798.8649.06
617563-175639.0629.26
45min116545-165458.5378.801.938.789.041.85
217113-171138.8309.07
316762-167628.6498.90
417267-172678.9099.15
517346-173468.9509.19
617304-173048.9299.17
60min115852-158528.1798.572.498.478.862.43
216552-165528.5418.83
316536-165368.5328.83
416885-168858.7129.01
516906-169068.7239.02
616935-169358.7389.03
极限115746-157468.1258.422.338.468.762.28
216112-161128.3138.65
316388-163888.4568.80
416384-163848.4548.80
516438-164388.4828.82
616890-168908.7159.06
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%
111.101582121582501581791579851579831581220.09
211.161580431584261582340.18
单位质量响应值RSD%判断
14245.2314178.670.34数据可信
供试品溶液-2022091403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%
5min135834-3583420.82731.8829.5820.8331.8829.58
250737-5073729.48929.49
374716-7471643.42543.43
438235-3823522.22222.22
570659-7065941.06741.07
658902-5890234.23434.23
10min1109540-10954063.66572.307.1863.7872.487.23
2124850-12485072.56372.73
3134897-13489778.40378.64
4119389-11938969.38969.51
5127769-12776974.26074.49
6129935-12993575.51975.71
15min1137984-13798480.19785.804.2580.6786.384.29
2148336-14833686.21486.78
3155771-15577190.53591.21
4147010-14701085.44385.95
5144099-14409983.75184.39
6152529-15252988.65189.26
20min1149463-14946386.86990.162.6487.7891.222.69
2156936-15693691.21292.26
3160437-16043793.24794.43
4154607-15460789.85890.84
5151573-15157388.09589.20
6157761-15776191.69192.79
30min1155927-15592790.62592.883.0592.0294.443.06
2161942-16194294.12195.67
3164840-16484095.80697.50
4159532-15953292.72194.20
5152433-15243388.59590.19
6164196-16419695.43197.04
45min1155964-15596490.64795.092.7592.5597.162.76
2166968-16696897.04399.12
3165745-16574596.33298.56
4166831-16683196.96398.96
5160265-16026593.14795.23
6165869-16586996.40498.55
60min1154139-15413989.58694.423.2391.9997.023.23
2165392-16539296.12798.74
3164881-16488195.83098.59
4166225-16622596.61199.15
5157653-15765391.62994.23
6166469-16646996.75399.43
极限1160839-16083993.48095.222.2496.3898.342.26
2164201-16420195.43498.58
3167817-16781797.536100.83
4163843-16384395.22698.30
5158623-15862392.19295.31
6167663-16766397.446100.66
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%
110.181757151756771757161756201756771756810.03
210.191758921761471760200.11
单位质量响应值RSD%判断
17257.4717273.800.07数据可信
供试品溶液-2022092001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%
5min111551-115516.0066.466.856.016.466.80
212794-127946.6526.65
311204-112045.8265.83
413023-130236.7716.77
512638-126386.5716.57
613336-133366.9346.93
10min119515-1951510.1479.971.9510.1810.011.96
219555-1955510.16810.20
318619-186199.6819.71
419403-1940310.08910.13
518936-189369.8469.88
619034-190349.8979.94
15min119608-1960810.1959.912.5010.2910.002.50
218877-188779.8159.91
318728-187289.7389.82
419652-1965210.21810.31
518483-184839.6109.70
618986-189869.8729.97
20min118910-189109.8339.673.409.989.813.38
219251-1925110.01010.16
317986-179869.3529.49
419296-1929610.03310.18
517996-179969.3579.50
618106-181069.4149.56
30min119192-191929.9799.325.3510.189.525.28
218648-186489.6969.90
317000-170008.8399.03
418361-183619.5479.75
516781-167818.7268.92
617593-175939.1489.35
45min117673-176739.1899.191.739.459.441.75
217792-177929.2519.51
317554-175549.1279.37
418153-181539.4399.70
517225-172258.9569.20
617607-176079.1559.41
60min116390-163908.5228.983.888.839.283.78
217927-179279.3219.63
317231-172318.9599.25
418079-180799.4009.71
516660-166608.6638.96
617329-173299.0109.31
极限118016-180169.3689.034.139.729.394.04
217688-176889.1979.56
317177-171778.9319.27
418140-181409.4329.80
516257-162578.4538.80
616954-169548.8159.17
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%
111.103126163126233126703125393126083126110.02
211.163136533135123135820.04
单位质量响应值RSD%判断
28163.1528098.750.17数据可信
供试品溶液-2022092001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%
5min1112749-11274933.10631.3718.9333.1131.3618.93
2121428-12142835.65535.65
376871-7687122.57122.57
4105805-10580531.06731.07
591523-9152326.87426.87
6132547-13254738.91938.92
10min1231337-23133767.92767.263.2668.1167.443.27
2242182-24218271.11171.31
3221403-22140365.01065.14
4226325-22632566.45566.63
5229987-22998767.53067.68
6223211-22321165.54165.76
15min1272140-27214079.90879.282.7080.4779.832.68
2276039-27603981.05381.65
3269548-26954879.14779.63
4276561-27656181.20681.75
5269091-26909179.01279.54
6256595-25659575.34375.92
20min1285271-28527183.76383.494.0184.7784.483.97
2296394-29639487.02988.07
3283104-28310483.12784.05
4293365-29336586.14087.13
5284015-28401583.39584.36
6263904-26390477.48978.49
30min1307358-30735890.24987.653.4591.7289.103.44
2310194-31019491.08192.61
3291724-29172485.65887.05
4302674-30267488.87390.34
5296277-29627786.99588.42
6282809-28280983.04084.47
45min1302903-30290388.94190.912.9190.9192.852.86
2313778-31377892.13494.17
3312181-31218191.66593.53
4313420-31342092.02993.99
5320234-32023494.02995.94
6295215-29521586.68388.57
60min1287026-28702684.27991.034.7386.7493.474.62
2319888-31988893.92896.47
3313580-31358092.07694.45
4322459-32245994.68397.16
5320205-32020594.02196.45
6296856-29685687.16589.54
极限1320312-32031294.05294.501.4796.9997.451.50
2327917-32791796.28599.35
3318433-31843393.50196.39
4326202-32620295.78298.78
5322612-32261294.72897.68
6315481-31548192.63495.49
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%
110.181789531796991799811803191804811798870.34
210.191779621778761779190.04
单位质量响应值RSD%判断
17670.6317460.160.85数据可信
供试品溶液-2022092001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%
5min112299-122996.2866.325.506.296.325.50
213182-131826.7376.74
312074-120746.1716.17
411388-113885.8215.82
512164-121646.2176.22
613113-131136.7026.70
10min118704-187049.5609.661.999.599.691.98
218258-182589.3329.37
319323-193239.8769.91
418920-189209.6709.70
519047-190479.7359.77
619132-191329.7799.82
15min118696-186969.5569.811.539.649.901.52
219113-191139.7699.86
319513-195139.97310.06
419460-194609.94610.03
519154-191549.7909.88
619188-191889.8079.90
20min118565-185659.4899.551.779.639.701.72
218140-181409.2729.42
318785-187859.6019.75
419017-190179.7209.86
519015-190159.7199.86
618617-186179.5159.66
30min117858-178589.1279.392.389.329.592.35
217937-179379.1689.36
318337-183379.3729.57
419024-190249.7239.92
518501-185019.4569.65
618605-186059.5099.71
45min117846-178469.1219.172.479.379.422.42
217541-175418.9659.21
318160-181609.2829.53
418210-182109.3079.56
518522-185229.4679.72
617351-173518.8689.12
60min117359-173598.8729.032.389.179.332.32
217245-172458.8149.11
317979-179799.1899.49
418292-182929.3499.65
517764-177649.0799.38
617340-173408.8639.16
极限116513-165138.4408.753.188.789.103.10
216593-165938.4818.83
317653-176539.0239.38
417819-178199.1079.46
517255-172558.8199.17
616923-169238.6499.00
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%
111.103180483193413198003203113204073195810.30
211.163155913151323153620.11
单位质量响应值RSD%判断
28791.0828258.241.33数据可信
供试品溶液-2022092001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%
5min1102109-10210929.57130.0220.2829.5730.0220.29
2138375-13837540.07340.07
399996-9999628.95928.96
486339-8633925.00425.00
580055-8005523.18423.18
6115117-11511733.33833.34
10min1219025-21902563.42965.182.6963.5965.342.72
2229851-22985166.56566.79
3229519-22951966.46966.63
4220822-22082263.95064.09
5219067-21906763.44263.57
6232045-23204567.20067.39
15min1262639-26263976.06078.732.3476.5879.262.36
2278793-27879380.73881.33
3275627-27562779.82180.35
4271703-27170378.68579.18
5266067-26606777.05377.53
6276403-27640380.04680.60
20min1287778-28777883.34083.620.3884.2884.590.37
2289592-28959283.86684.91
3287603-28760383.29084.26
4290235-29023584.05284.98
5289187-28918783.74884.66
6288147-28814783.44784.45
30min1300267-30026786.95788.371.2188.3689.801.19
2304476-30447688.17689.68
3301527-30152787.32288.76
4307039-30703988.91890.32
5309254-30925489.56090.93
6308332-30833289.29390.76
45min1317563-31756391.96691.062.1993.8592.982.11
2311142-31114290.10692.10
3313676-31367690.84092.76
4308361-30836189.30191.19
5326719-32671994.61896.49
6309231-30923189.55391.52
60min1320829-32082992.91292.530.8395.3194.960.80
2320053-32005392.68795.18
3316017-31601791.51893.94
4318064-31806492.11194.50
5323617-32361793.71996.12
6318433-31843392.21894.68
极限1313847-31384790.89092.581.4593.8095.521.39
2313829-31382990.88593.90
3321207-32120793.02195.96
4322276-32227693.33196.23
5322780-32278093.47796.40
6324068-32406893.85096.82
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