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DJ333-221017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(%)99.67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%
19.851633571632721630831629701628661631100.13
29.911627121632471629800.24
单位质量响应值RSD%判断
16559.3916446.010.49数据可信
供试品溶液-2022091401批-依折麦布-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%
5min111280-112806.1315.407.236.135.407.20
29156-91564.9774.98
310013-100135.4435.44
49654-96545.2485.25
59781-97815.3175.32
69708-97085.2775.28
10min116133-161338.7698.541.908.808.571.90
215773-157738.5748.60
315567-155678.4628.49
415919-159198.6538.68
515294-152948.3138.34
615561-155618.4598.49
15min116536-165368.9898.782.549.078.862.52
215941-159418.6658.74
316103-161038.7538.83
416754-167549.1079.18
515725-157258.5488.62
615841-158418.6118.69
20min116438-164388.9358.792.299.078.912.26
216354-163548.8909.01
316087-160878.7448.87
416417-164178.9249.05
515458-154588.4038.53
616234-162348.8248.95
30min116294-162948.8578.661.979.048.831.96
215660-156608.5128.69
315837-158378.6098.78
416343-163438.8849.06
515649-156498.5068.68
615769-157698.5728.74
45min116046-160468.7228.543.058.958.763.02
215708-157088.5388.76
316089-160898.7468.97
416049-160498.7248.95
514854-148548.0748.29
615509-155098.4308.65
60min115995-159958.6948.383.068.978.653.01
215158-151588.2398.51
315139-151398.2298.50
416036-160368.7178.99
515029-150298.1698.43
615110-151108.2138.48
极限115629-156298.4958.372.658.828.692.63
215516-155168.4348.75
315154-151548.2378.55
415971-159718.6819.01
514787-147878.0388.35
615331-153318.3348.65
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%
111.001581541583081582761583021581821582440.05
211.051584721586561585640.09
单位质量响应值RSD%判断
14385.8214349.680.18数据可信
供试品溶液-2022091401批-阿托伐他汀钙-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%
5min127092-2709215.57515.904.3515.5815.904.34
228105-2810516.15816.16
328655-2865516.47416.47
426133-2613315.02415.02
526731-2673115.36815.37
629247-2924716.81416.81
10min150019-5001928.75629.205.4528.8429.295.44
248143-4814327.67727.77
354911-5491131.56831.66
449531-4953128.47528.56
548623-4862327.95328.04
653497-5349730.75530.85
15min163845-6384536.70436.316.2436.9536.566.22
256510-5651032.48832.73
368216-6821639.21739.48
463935-6393536.75637.00
561377-6137735.28635.53
665031-6503137.38637.65
20min171956-7195641.36740.515.3741.8240.965.36
264143-6414336.87637.30
374580-7458042.87643.36
470073-7007340.28540.73
568600-6860039.43839.87
673419-7341942.20942.68
30min173176-7317642.06940.835.7342.7541.515.70
263277-6327736.37837.01
373072-7307242.00942.73
470702-7070240.64741.32
571185-7118540.92441.58
674721-7472142.95743.66
45min178704-7870445.24743.284.9346.1644.184.91
268752-6875239.52540.36
375686-7568643.51244.47
474950-7495043.08943.98
574599-7459942.88743.77
678971-7897145.40046.35
60min178855-7885545.33443.275.6546.5044.425.59
267654-6765438.89439.94
373077-7307742.01243.21
476324-7632443.87945.01
577652-7765244.64245.76
678048-7804844.87046.07
极限185725-8572549.28348.142.5550.7049.522.59
280126-8012646.06447.33
383536-8353648.02549.46
484502-8450248.58049.96
582743-8274347.56948.94
685751-8575149.29850.74
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DJ333-221017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(%)99.67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%
19.851631491631401633861631051631031631770.08
29.911662331662641662480.02
单位质量响应值RSD%判断
16566.1916775.780.89数据可信
供试品溶液-2022091401批-依折麦布-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%
5min111308-113086.0856.616.626.086.616.64
211472-114726.1736.17
313351-133517.1847.18
413020-130207.0067.01
512363-123636.6536.65
612203-122036.5666.57
10min116031-160318.6268.522.268.668.562.26
215581-155818.3848.42
315665-156658.4298.47
415578-155788.3838.42
515683-156838.4398.48
616482-164828.8698.91
15min116149-161498.6908.730.908.778.810.90
216116-161168.6728.75
316234-162348.7368.82
416288-162888.7658.85
516083-160838.6548.74
616474-164748.8658.95
20min116594-165948.9298.711.609.068.841.56
216316-163168.7808.91
316011-160118.6168.75
416086-160868.6568.79
515864-158648.5368.67
616276-162768.7588.89
30min116010-160108.6158.451.708.798.631.66
215593-155938.3918.57
315401-154018.2878.47
415772-157728.4878.67
515455-154558.3168.50
616007-160078.6138.80
45min115986-159868.6028.534.198.838.764.09
215825-158258.5158.74
316694-166948.9839.21
415562-155628.3748.60
514760-147607.9428.17
616300-163008.7719.00
60min115523-155238.3538.222.658.638.502.61
215065-150658.1068.38
315206-152068.1828.46
415339-153398.2548.53
514690-146907.9058.17
615875-158758.5428.82
极限115693-156938.4448.183.198.778.503.12
215399-153998.2868.60
315304-153048.2358.56
415027-150278.0868.41
514322-143227.7078.02
615476-154768.3288.66
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%
111.001580091582761584031583751584461583020.12
211.051619191613621616400.25
单位质量响应值RSD%判断
14391.0914628.051.16数据可信
供试品溶液-2022091401批-阿托伐他汀钙-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%
5min131360-3136017.85416.835.5417.8516.835.53
231126-3112617.72117.72
328454-2845416.19916.20
429922-2992217.03517.04
527047-2704715.39815.40
629493-2949316.79116.79
10min152349-5234929.80327.315.3129.9027.405.30
248287-4828727.49127.59
344573-4457325.37625.47
448318-4831827.50827.60
546909-4690926.70626.79
647410-4741026.99127.08
15min163040-6304035.89033.904.2336.1534.144.22
258319-5831933.20233.45
356102-5610231.94032.17
461173-6117334.82735.07
560594-6059434.49734.73
658029-5802933.03733.28
20min171116-7111640.48838.145.0040.9538.574.97
265573-6557337.33237.77
362745-6274535.72236.13
466884-6688438.07838.52
570755-7075540.28240.71
664832-6483236.91037.34
30min169237-6923739.41838.855.8240.1139.495.75
265356-6535637.20837.85
364578-6457836.76537.37
467746-6774638.56939.22
575586-7558643.03243.68
666917-6691738.09738.73
45min172467-7246741.25742.215.7542.1643.075.67
271273-7127340.57741.43
373006-7300641.56442.37
471360-7136040.62641.49
582552-8255246.99847.89
674152-7415242.21643.06
60min170689-7068940.24442.057.4641.3843.157.32
268975-6897539.26940.34
373051-7305141.58942.63
471530-7153040.72341.82
584407-8440748.05449.20
674556-7455642.44643.52
极限179947-7994745.51546.403.7246.8847.733.71
278686-7868644.79746.09
380869-8086946.04047.31
480209-8020945.66446.98
587264-8726449.68151.10
682072-8207246.72548.04
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DJ333-221017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(%)99.67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%
19.851643841641561637651635681634471638640.25
29.911621841623541622690.08
单位质量响应值RSD%判断
16635.9416374.271.13数据可信
供试品溶液-2022091402批-依折麦布-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%
5min111874-118746.4546.397.146.456.397.11
211349-113496.1686.17
310607-106075.7655.77
412704-127046.9056.90
511299-112996.1416.14
612708-127086.9076.91
10min115984-159848.6888.701.358.728.731.37
215633-156338.4978.53
316155-161558.7818.81
416109-161098.7568.79
515892-158928.6388.67
616223-162238.8188.86
15min116344-163448.8838.880.848.978.960.85
216405-164058.9169.00
316325-163258.8738.95
416301-163018.8608.95
516097-160978.7498.83
616507-165078.9729.06
20min115844-158448.6128.702.368.758.842.35
215842-158428.6108.74
316100-161008.7518.88
416479-164798.9579.09
515462-154628.4048.53
616368-163688.8969.03
30min115664-156648.5148.550.668.708.730.68
215602-156028.4808.66
315816-158168.5968.78
415878-158788.6308.82
515679-156798.5228.70
615716-157168.5428.73
45min116041-160418.7198.581.388.958.811.36
215620-156208.4908.72
316025-160258.7108.94
415844-158448.6128.85
515514-155148.4328.66
615693-156938.5298.76
60min115515-155158.4338.481.618.718.761.58
215315-153158.3248.60
315688-156888.5278.80
415974-159748.6828.96
515381-153818.3608.63
615774-157748.5738.85
极限115746-157468.5588.492.268.888.812.23
215168-151688.2448.56
315768-157688.5708.89
416101-161018.7519.08
515241-152418.2848.60
615660-156608.5128.84
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%
111.001588631591481588241587201585981588310.13
211.051575981574041575010.09
单位质量响应值RSD%判断
14439.1814253.480.92数据可信
供试品溶液-2022091402批-阿托伐他汀钙-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%
5min131558-3155818.17018.0411.8118.1718.0411.81
235387-3538720.37520.38
334482-3448219.85419.85
426106-2610615.03115.03
532676-3267618.81418.81
627756-2775615.98115.98
10min152878-5287830.44630.2610.0530.5530.3610.06
257533-5753333.12633.24
358857-5885733.88934.00
446019-4601926.49726.58
553132-5313230.59230.70
646913-4691327.01227.10
15min163542-6354236.58637.3210.1236.8637.5910.12
273401-7340142.26342.56
371040-7104040.90341.20
457571-5757133.14833.38
565451-6545137.68537.96
657886-5788633.33033.57
20min179575-7957545.81842.0310.3746.2942.5010.36
279627-7962745.84846.38
380215-8021546.18646.71
465317-6531737.60838.02
568495-6849539.43839.92
664761-6476137.28837.71
30min165857-6585737.91941.6310.4538.6542.3410.41
283274-8327447.94848.73
378791-7879145.36646.15
465068-6506837.46538.09
573703-7370342.43743.14
667139-6713938.65739.29
45min169728-6972840.14846.349.9941.0947.289.91
291076-9107652.44053.49
387468-8746850.36251.40
481676-8167647.02747.86
578963-7896345.46546.40
673985-7398542.59943.45
60min168420-6842039.39546.2110.9940.5647.4010.90
292039-9203952.99454.34
388392-8839250.89452.21
473873-7387342.53543.63
580085-8008546.11147.30
678695-7869545.31146.39
极限181237-8123746.77550.856.5648.1652.306.60
295550-9555055.01656.65
395095-9509554.75456.35
484584-8458448.70250.03
586477-8647749.79251.24
686961-8696150.07051.40
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DJ333-221017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(%)99.67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%
19.851634101644651654551656851658711649770.63
29.911651231659471655350.36
单位质量响应值RSD%判断
16748.9316703.830.20数据可信
供试品溶液-2022091402批-依折麦布-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%
5min111973-119736.4216.076.266.426.076.25
212132-121326.5066.51
311135-111355.9725.97
411069-110695.9365.94
510172-101725.4555.46
611404-114046.1166.12
10min115905-159058.5308.471.868.578.511.90
216148-161488.6608.70
315492-154928.3088.34
415946-159468.5528.58
515392-153928.2558.28
615925-159258.5418.57
15min116271-162718.7268.660.808.818.740.80
216103-161038.6368.72
316032-160328.5988.68
416247-162478.7138.79
515961-159618.5608.64
616235-162358.7078.79
20min115987-159878.5748.621.208.718.751.18
216041-160418.6038.73
316360-163608.7748.90
416172-161728.6738.80
515782-157828.4648.59
616089-160898.6288.76
30min115868-158688.5108.511.308.698.691.30
215769-157698.4578.64
315997-159978.5798.75
415943-159438.5508.73
515537-155378.3328.50
616130-161308.6508.83
45min115427-154278.2738.431.678.508.661.65
215509-155098.3178.54
315971-159718.5658.79
416037-160378.6018.83
515538-155388.3338.55
615847-158478.4998.72
60min115495-154958.3108.401.568.588.671.52
215431-154318.2768.55
315886-158868.5208.79
415887-158878.5208.79
515387-153878.2528.52
615862-158628.5078.78
极限115354-153548.2348.372.378.558.692.30
215321-153218.2178.54
315772-157728.4588.78
416133-161338.6528.97
515209-152098.1578.47
615885-158858.5198.84
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%
111.001584211597621604471609511609921601150.67
211.051610851614681612760.17
单位质量响应值RSD%判断
14555.9114595.110.20数据可信
供试品溶液-2022091402批-阿托伐他汀钙-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%
5min133615-3361519.05017.857.6819.0517.857.67
234678-3467819.65219.65
331567-3156717.88917.89
431055-3105517.59917.60
530098-3009817.05717.06
627967-2796715.84915.85
10min154896-5489631.11029.214.9831.2229.315.00
253800-5380030.48930.60
350509-5050928.62428.72
451417-5141729.13829.24
550975-5097528.88828.98
647646-4764627.00127.09
15min166124-6612437.47335.804.3337.7536.064.34
267078-6707838.01338.29
361189-6118934.67634.93
462388-6238835.35635.62
561539-6153934.87435.13
660696-6069634.39734.63
20min171368-7136840.44539.644.4440.9340.104.44
275618-7561842.85343.34
368421-6842138.77539.23
468625-6862538.89039.35
567196-6719638.08038.53
668408-6840838.76739.20
30min172962-7296241.34840.874.9142.0641.544.89
278447-7844744.45645.18
370932-7093240.19840.86
470675-7067540.05240.72
567842-6784238.44639.11
671809-7180940.69541.34
45min177096-7709643.69144.244.8644.6345.144.84
285196-8519648.28149.26
377107-7710743.69744.59
477680-7768044.02244.92
573734-7373441.78542.66
677536-7753643.94044.81
60min177859-7785944.12345.505.5445.3146.655.49
288274-8827450.02551.27
380398-8039845.56246.69
480054-8005445.36746.51
574903-7490342.44843.55
680196-8019645.44746.56
极限185760-8576048.60150.053.3850.0351.463.39
293647-9364753.07054.59
387518-8751849.59750.98
489535-8953550.74052.13
585634-8563448.52949.87
687832-8783249.77551.14
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