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%
110.001741911740621739641742271741121741110.07
210.011768591771901770240.14
单位质量响应值RSD%判断
17411.1017684.721.11数据可信
供试品溶液-2023120821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%
5min111453-114535.8605.438.765.865.438.74
210867-108675.5605.56
311042-110425.6495.65
410764-107645.5075.51
510707-107075.4785.48
68790-87904.4974.50
10min117075-170758.7368.552.778.778.582.79
216771-167718.5818.61
317196-171968.7988.83
416630-166308.5088.54
516750-167508.5708.60
615883-158838.1268.15
15min116938-169388.6668.621.548.758.701.55
216609-166098.4988.58
317161-171618.7808.86
417084-170848.7418.82
516791-167918.5918.67
616510-165108.4478.52
20min116309-163098.3448.522.378.478.642.37
216549-165498.4678.59
317412-174128.9099.04
416681-166818.5358.66
516433-164338.4088.53
616521-165218.4538.57
30min116469-164698.4268.242.138.608.412.14
215752-157528.0598.23
316493-164938.4388.62
416258-162588.3188.49
515801-158018.0848.26
615853-158538.1118.27
45min115512-155127.9368.193.038.168.412.95
215579-155797.9718.19
316364-163648.3728.60
416774-167748.5828.80
515830-158308.0998.32
616029-160298.2018.41
60min115715-157158.0408.141.818.318.401.80
215846-158468.1078.37
316383-163838.3828.65
416104-161048.2398.51
515761-157618.0648.33
615615-156157.9898.24
极限115908-159088.1398.293.708.458.603.59
215909-159098.1408.45
316420-164208.4018.72
417337-173378.8709.18
515804-158048.0868.39
615849-158498.1098.41
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2500
标示量(mg)20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%
111.211598351599151598281600531596431598550.10
211.241628451627661628060.04
单位质量响应值RSD%判断
14260.0414484.521.11数据可信
供试品溶液-2023120821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%
5min132494-3249418.67617.9814.8118.6817.9814.79
228791-2879116.54816.55
330031-3003117.26017.26
434190-3419019.65119.65
537776-3777621.71221.71
624403-2440314.02614.03
10min177621-7762144.61342.354.2144.7242.454.24
272310-7231041.56041.65
373386-7338642.17942.27
472645-7264541.75341.86
576883-7688344.18944.31
669293-6929339.82639.90
15min1101351-10135158.25254.813.9958.6055.143.99
291863-9186352.79953.12
393666-9366653.83554.17
493115-9311553.51853.86
598806-9880656.78957.16
693329-9332953.64153.94
20min1111479-11147964.07362.042.4564.7562.682.47
2106093-10609360.97761.59
3107200-10720061.61362.24
4104512-10451260.06960.71
5110530-11053063.52764.21
6107816-10781661.96862.56
30min1121692-12169269.94367.583.2970.9768.563.28
2113554-11355465.26566.22
3114638-11463865.88866.86
4114247-11424765.66466.64
5121837-12183770.02671.06
6119523-11952368.69669.64
45min1126091-12609172.47172.894.2073.8974.254.16
2120581-12058169.30470.62
3123019-12301970.70572.04
4124723-12472371.68573.02
5133861-13386176.93778.36
6132634-13263476.23277.55
60min1126692-12669272.81773.744.6274.6475.514.57
2121398-12139869.77471.48
3124910-12491071.79273.52
4125995-12599572.41674.15
5137289-13728978.90780.76
6133559-13355976.76378.51
极限1137578-13757879.07378.513.6881.3080.683.65
2131556-13155675.61277.70
3132313-13231376.04778.18
4133162-13316276.53578.67
5142112-14211281.67983.97
6142820-14282082.08684.26
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%
110.001749261754411757011759181759771755930.25
210.011749991767531758760.71
单位质量响应值RSD%判断
17559.3017570.030.05数据可信
供试品溶液-2023120821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%
5min112095-120956.1825.808.056.185.808.05
211881-118816.0736.07
310744-107445.4915.49
412457-124576.3676.37
510317-103175.2735.27
610539-105395.3875.39
10min116978-169788.6788.571.348.718.601.36
216710-167108.5418.57
316775-167758.5748.60
416954-169548.6658.70
516360-163608.3628.39
616799-167998.5868.62
15min116740-167408.5568.541.328.648.621.32
216861-168618.6188.70
316967-169678.6728.75
416524-165248.4468.53
516371-163718.3678.44
616753-167538.5638.64
20min116799-167998.5868.431.828.728.561.81
216420-164208.3928.52
316889-168898.6328.76
416107-161078.2328.36
516286-162868.3248.45
616482-164828.4248.55
30min116334-163348.3488.281.088.538.451.08
216128-161288.2438.42
316435-164358.4008.57
416057-160578.2078.38
515971-159718.1638.33
616236-162368.2988.47
45min116063-160638.2108.311.748.438.531.72
216443-164438.4048.63
316518-165188.4438.66
416043-160438.2008.42
515905-159058.1298.34
616550-165508.4598.68
60min115973-159738.1648.161.828.438.421.78
215715-157158.0328.30
316206-162068.2838.55
415930-159308.1428.41
515602-156027.9748.23
616375-163758.3698.63
极限116094-160948.2268.043.578.548.353.46
215911-159118.1328.45
316169-161698.2648.58
414895-148957.6137.93
515144-151447.7408.04
616145-161458.2528.56
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2500
标示量(mg)20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%
111.211612621616731615531612611609541613410.18
211.241612811627591620200.65
单位质量响应值RSD%判断
14392.6014414.590.11数据可信
供试品溶液-2023120821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%
5min125901-2590114.85316.3034.3414.8516.2934.33
219910-1991011.41811.42
327124-2712415.55515.55
437847-3784721.70421.70
542153-4215324.17324.17
617555-1755510.06710.07
10min174180-7418042.54040.599.0742.6240.689.11
262330-6233035.74435.81
370990-7099040.71140.80
473816-7381642.33142.45
579149-7914945.38945.52
664177-6417736.80336.86
15min198795-9879556.65653.815.3456.9754.125.38
286673-8667349.70449.97
394190-9419054.01554.33
494040-9404053.92954.28
599524-9952457.07457.46
689741-8974151.46451.72
20min1114843-11484365.85961.705.5066.4962.325.53
299503-9950357.06257.60
3108527-10852762.23762.85
4106434-10643461.03761.69
5113352-11335265.00465.71
6102936-10293659.03159.58
30min1127952-12795273.37668.674.2174.3869.634.24
2114347-11434765.57466.43
3121031-12103169.40770.37
4119087-11908768.29369.29
5121362-12136269.59770.66
6114706-11470665.78066.65
45min1134928-13492877.37774.852.0278.7876.182.06
2127384-12738473.05174.27
3131166-13116675.22076.56
4131376-13137675.34076.71
5129442-12944274.23175.68
6128813-12881373.87075.11
60min1138993-13899379.70875.903.3381.5577.663.30
2128290-12829073.57075.20
3134644-13464477.21478.98
4134199-13419976.95978.75
5127390-12739073.05474.92
6130636-13063674.91676.57
极限1143324-14332482.19278.962.8484.4781.142.79
2136714-13671478.40180.44
3141417-14141781.09883.29
4134526-13452677.14679.37
5133353-13335376.47478.74
6136839-13683978.47380.54
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%
110.001776851774191774451773131772681774260.10
210.011768431770291769360.08
单位质量响应值RSD%判断
17742.6017675.920.27数据可信
供试品溶液-2023120822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%
5min19546-95464.8395.239.064.845.239.08
211905-119056.0356.04
310184-101845.1635.16
410159-101595.1505.15
510781-107815.4655.47
69321-93214.7254.73
10min115464-154647.8398.094.147.878.124.13
216825-168258.5298.56
315823-158238.0218.05
416652-166528.4428.47
515787-157878.0038.03
615152-151527.6817.71
15min115877-158778.0498.181.428.128.251.43
216496-164968.3628.44
316173-161738.1998.27
415934-159348.0788.15
516252-162528.2398.31
616041-160418.1328.20
20min115801-158018.0108.094.038.138.213.99
217209-172098.7248.85
315389-153897.8017.92
415930-159308.0768.20
515633-156337.9258.05
615765-157657.9928.11
30min115387-153877.8007.921.387.968.081.42
215839-158398.0298.21
315853-158538.0378.20
415750-157507.9848.15
515479-154797.8478.01
615429-154297.8227.98
45min115195-151957.7037.941.707.918.151.68
215802-158028.0118.23
315793-157938.0068.21
415900-159008.0608.27
515804-158048.0128.22
615520-155207.8688.07
60min115441-154417.8288.002.848.078.252.74
215557-155577.8868.15
315992-159928.1078.36
415752-157527.9858.24
515338-153387.7758.03
616552-165528.3918.64
极限115176-151767.6937.831.117.988.131.10
215454-154547.8348.14
315689-156897.9538.25
415479-154797.8478.15
515386-153867.8008.10
615537-155377.8768.17
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2500
标示量(mg)20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%
111.211629481626381628541628991620911626860.22
211.241632051628471630260.16
单位质量响应值RSD%判断
14512.5814504.090.05数据可信
供试品溶液-2023120822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%
5min117281-172819.83915.9436.899.8415.9436.88
240422-4042223.01323.01
323672-2367213.47713.48
440597-4059723.11323.11
527227-2722715.50115.50
618739-1873910.66910.67
10min163702-6370236.26741.119.8236.3241.209.88
280482-8048245.82145.95
371454-7145440.68140.76
480330-8033045.73445.86
571696-7169640.81940.90
665598-6559837.34737.41
15min191371-9137152.02055.665.1052.2855.985.16
2104626-10462659.56759.95
397911-9791155.74356.04
4101251-10125157.64558.03
598524-9852456.09256.41
692938-9293852.91253.18
20min1104792-10479259.66162.413.9360.2163.044.00
2115887-11588765.97866.69
3106747-10674760.77461.38
4113838-11383864.81165.51
5108559-10855961.80662.43
6107921-10792161.44262.00
30min1115365-11536565.68169.103.0566.5670.073.12
2124857-12485771.08572.16
3121433-12143369.13570.08
4125672-12567271.54972.61
5120538-12053868.62669.59
6120385-12038568.53969.44
45min1124169-12416970.69375.353.2371.9376.703.27
2135103-13510376.91878.39
3133318-13331875.90277.23
4135971-13597177.41278.87
5133794-13379476.17377.52
6131741-13174175.00476.29
60min1127394-12739472.52975.502.1774.1677.272.23
2134119-13411976.35878.26
3132012-13201275.15876.91
4135630-13563077.21879.11
5132385-13238575.37077.14
6134113-13411376.35478.05
极限1131600-13160074.92478.942.5876.9681.132.60
2140671-14067180.08882.41
3139217-13921779.26081.43
4139449-13944979.39281.71
5139390-13939079.35981.55
6141567-14156780.59882.72
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%
110.001746281743571740471741591739451742270.16
210.011750911763821757360.52
单位质量响应值RSD%判断
17422.7017556.040.54数据可信
供试品溶液-2023120822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%
5min110284-102845.2795.367.425.285.367.45
210158-101585.2145.21
310288-102885.2815.28
411782-117826.0486.05
59437-94374.8444.84
610678-106785.4815.48
10min115518-155187.9668.011.158.008.041.15
215787-157878.1048.13
315678-156788.0488.08
415733-157338.0768.11
515294-152947.8517.88
615648-156488.0328.06
15min116159-161598.2958.361.508.378.441.49
215981-159818.2038.28
316212-162128.3228.40
416677-166778.5618.64
516287-162878.3608.43
616456-164568.4478.52
20min116068-160688.2488.201.618.378.321.58
215740-157408.0808.20
316444-164448.4418.56
415935-159358.1808.31
515850-158508.1368.25
615805-158058.1138.24
30min115921-159218.1738.061.668.348.221.63
215268-152687.8378.00
315701-157018.0608.23
415862-158628.1428.31
515895-158958.1598.32
615509-155097.9618.13
45min116219-162198.3268.101.898.548.311.86
215851-158518.1378.34
315938-159388.1818.39
415794-157948.1078.32
515464-154647.9388.15
615434-154347.9238.13
60min115403-154037.9078.021.318.168.281.32
215796-157968.1088.36
315728-157288.0738.33
415893-158938.1588.42
515467-154677.9408.19
615467-154677.9408.19
极限115962-159628.1947.951.928.498.251.85
215139-151397.7718.07
315590-155908.0038.30
415515-155157.9648.27
515511-155117.9628.26
615205-152057.8058.10
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2500
标示量(mg)20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%
111.211591811592541599671594171595891594820.20
211.241613461612201612830.06
单位质量响应值RSD%判断
14226.7614349.020.61数据可信
供试品溶液-2023120822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%
5min126123-2612315.10214.568.6615.1014.568.65
222346-2234612.91912.92
324534-2453414.18414.18
423188-2318813.40613.41
527334-2733415.80215.80
627591-2759115.95115.95
10min173142-7314242.28540.646.2542.3740.726.25
265918-6591838.10938.18
371210-7121041.16841.25
465749-6574938.01138.09
577018-7701844.52644.61
668744-6874439.74239.83
15min1101162-10116258.48455.736.2858.8056.046.28
290362-9036252.24052.52
395216-9521655.04755.35
491413-9141352.84853.13
5106043-10604361.30661.64
694214-9421454.46754.78
20min1115528-11552866.78963.496.1267.4364.116.12
2102024-10202458.98259.56
3108712-10871262.84963.46
4102817-10281759.44160.02
5118764-11876468.66069.34
6111130-11113064.24764.86
30min1128114-12811474.06671.225.9575.0872.195.95
2114853-11485366.39967.30
3121214-12121470.07771.04
4115844-11584466.97267.88
5133762-13376277.33178.39
6125385-12538572.48873.46
45min1140616-14061681.29378.034.7682.7279.404.78
2132586-13258676.65177.92
3132834-13283476.79478.15
4125515-12551572.56373.84
5143612-14361283.02584.51
6134711-13471177.87979.25
60min1136313-13631378.80677.744.6380.6879.534.64
2133162-13316276.98478.68
3132159-13215976.40478.18
4125071-12507172.30673.99
5144095-14409583.30585.25
6135977-13597778.61180.42
极限1143002-14300282.67380.793.1684.9983.023.22
2134880-13488077.97780.10
3140332-14033281.12983.33
4134339-13433977.66479.75
5145495-14549584.11486.52
6140402-14040281.17083.41
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