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%
110.221675321675941674701674421673571674790.06
210.161674971679411677190.19
单位质量响应值RSD%判断
16387.3816507.780.52数据可信
供试品溶液-X013993批-依折麦布-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114953-149538.1556.9515.378.166.9515.41
212124-121246.6126.61
311118-111186.0646.06
415338-153388.3658.37
512203-122036.6556.66
610688-106885.8295.83
10min121670-2167011.81910.945.7911.8610.985.79
220922-2092211.41111.45
320121-2012110.97411.01
419864-1986410.83410.88
519398-1939810.58010.62
618353-1835310.01010.04
15min125389-2538913.84712.974.8913.9613.074.88
224220-2422013.20913.31
324577-2457713.40413.50
422309-2230912.16712.27
522741-2274112.40312.50
623497-2349712.81512.90
20min127566-2756615.03413.187.6515.2213.357.61
224222-2422213.21113.38
324269-2426913.23613.41
422443-2244312.24012.41
522585-2258512.31812.48
623932-2393213.05213.21
30min114729-147298.0337.812.658.308.052.63
214124-141247.7037.95
314664-146647.9988.24
413729-137297.4887.73
514172-141727.7297.96
614470-144707.8928.12
45min117080-170809.3159.142.219.639.432.21
216743-167439.1329.42
317110-171109.3329.62
416227-162278.8509.13
516429-164298.9609.24
617007-170079.2769.55
60min120637-2063711.25511.022.6811.6211.362.63
220331-2033111.08811.43
320393-2039311.12211.46
419146-1914610.44210.78
520528-2052811.19611.52
620194-2019411.01411.34
极限117274-172749.4219.062.759.859.462.79
216610-166109.0599.46
317065-170659.3079.71
416231-162318.8529.24
516266-162668.8719.26
616252-162528.8649.25
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%
111.143088273089183087433083373081033085860.12
211.073088653095803092220.17
单位质量响应值RSD%判断
27700.7227933.330.60数据可信
供试品溶液-X013993批-阿托伐他汀钙-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min185753-8575325.46422.7714.9025.4622.7714.90
277214-7721422.92822.93
378719-7871923.37523.38
491037-9103727.03327.03
566817-6681719.84119.84
660485-6048517.96117.96
10min1263387-26338778.21264.9821.6278.3565.1121.61
2215106-21510663.87564.00
3206261-20626161.24861.38
4280757-28075783.37083.52
5197610-19761058.67958.79
6149912-14991244.51644.62
15min1320166-32016695.07290.935.7395.6591.415.80
2300394-30039489.20189.68
3311932-31193292.62793.10
4328527-32852797.55598.17
5295904-29590487.86788.30
6280299-28029983.23483.58
20min1331952-33195298.57297.912.5299.6898.902.58
2324947-32494796.49297.47
3333056-33305698.90099.88
4342744-342744101.776102.93
5318411-31841194.55195.48
6327233-32723397.17097.98
30min1315674-31567493.73897.362.8095.3998.902.77
2320308-32030895.11496.63
3339388-339388100.780102.31
4336128-33612899.812101.53
5330572-33057298.16299.61
6325209-32520996.56997.92
45min1319539-31953994.88696.932.4997.0699.012.49
2319686-31968694.92996.97
3333643-33364399.074101.17
4337988-337988100.364102.64
5319627-31962794.91296.91
6328141-32814197.44099.33
60min1320840-32084095.27296.641.4997.9799.261.48
2318523-31852394.58497.15
3328644-32864497.589100.23
4329494-32949497.842100.67
5330076-33007698.015100.54
6325197-32519796.56698.99
极限1327455-32745597.23696.732.06100.4799.892.13
2321969-32196995.60798.70
3331219-33121998.354101.54
4335339-33533999.577102.95
5320025-32002595.03098.10
6318593-31859394.60597.57
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%
110.221687221688241686561682801682791685520.16
210.161683121701241692180.76
单位质量响应值RSD%判断
16492.3716655.310.70数据可信
供试品溶液-X013993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%
5min18571-85714.6396.0415.204.646.0415.18
213017-130177.0457.05
312442-124426.7346.73
411921-119216.4526.45
59748-97485.2765.28
611292-112926.1126.11
10min115443-154438.3588.773.168.388.803.21
216635-166359.0049.04
316261-162618.8018.84
416688-166889.0329.07
515705-157058.5008.53
616440-164408.8988.93
15min116143-161438.7378.812.708.818.892.69
216990-169909.1969.28
315991-159918.6558.74
416624-166248.9989.08
516053-160538.6898.77
615852-158528.5808.66
20min115960-159608.6388.691.528.768.821.54
215958-159588.6378.78
316355-163558.8528.99
416338-163388.8438.98
515919-159198.6168.74
615760-157608.5308.66
30min115777-157778.5398.462.358.718.642.28
215076-150768.1608.35
315612-156128.4508.63
416211-162118.7748.96
515589-155898.4378.61
615572-155728.4288.61
45min115195-151958.2248.442.858.448.662.85
216303-163038.8249.06
315391-153918.3308.56
415908-159088.6108.84
515572-155728.4288.65
615166-151668.2098.43
60min115269-152698.2648.382.858.538.662.84
216246-162468.7939.08
315348-153488.3078.58
415505-155058.3928.67
515634-156348.4628.73
614932-149328.0828.35
极限115131-151318.1908.312.678.508.632.66
216127-161278.7299.06
315400-154008.3358.66
415331-153318.2988.63
515104-151048.1758.49
614999-149998.1188.43
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%
111.143099283100603097923091763092033096320.14
211.073112403137213124800.57
单位质量响应值RSD%判断
27794.6128227.641.10数据可信
供试品溶液-X013993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%
5min165825-6582519.41235.8646.6319.4135.8646.64
2228977-22897767.52567.53
3125709-12570937.07237.07
490757-9075726.76426.76
5117734-11773434.72034.72
6100508-10050829.64029.64
10min1233149-23314968.75674.6711.4768.8674.8711.53
2295597-29559787.17287.55
3268412-26841279.15579.36
4250942-25094274.00374.15
5211510-21151062.37462.57
6259548-25954876.54176.71
15min1284970-28497084.03886.734.9284.5387.355.01
2315040-31504092.90593.76
3298793-29879388.11488.76
4298558-29855888.04588.60
5272169-27216980.26380.80
6295154-29515487.04187.63
20min1299429-29942988.30289.682.7389.2690.782.75
2303014-30301489.35990.73
3314991-31499192.89194.03
4309170-30917091.17492.22
5291144-29114485.85986.84
6306867-30686790.49591.57
30min1307267-30726790.61390.682.8692.0692.282.76
2295637-29563787.18389.06
3312408-31240892.12993.78
4316225-31622593.25594.81
5298251-29825187.95489.42
6315245-31524592.96694.54
45min1301664-30166488.96191.262.6190.9193.362.71
2321598-32159894.83997.20
3311176-31117691.76693.93
4313672-31367292.50294.58
5299609-29960988.35590.31
6308940-30894091.10793.20
60min1305201-30520190.00491.742.1092.4594.342.21
2323105-32310595.28498.17
3311482-31148291.85694.53
4312144-31214492.05194.64
5306178-30617890.29292.73
6308337-30833790.92993.53
极限1300985-30098588.76190.912.4691.7194.022.56
2320517-32051794.52197.93
3311908-31190891.98295.17
4308547-30854790.99194.09
5299988-29998888.46791.41
6307661-30766190.72993.83
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%
110.221694551696121695471694691696921695550.06
210.161708621719141713880.44
单位质量响应值RSD%判断
16590.5116868.901.18数据可信
供试品溶液-X013993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%
5min113545-135457.2635.7722.947.265.7822.90
211081-110815.9425.94
311002-110025.9005.90
411315-113156.0676.07
56109-61093.2763.28
611561-115616.1996.20
10min116736-167368.9748.446.969.018.477.00
216368-163688.7778.81
315828-158288.4878.52
415919-159198.5368.57
513613-136137.3007.32
615947-159478.5518.59
15min118292-182929.8098.925.169.909.005.20
216560-165608.8808.96
316457-164578.8258.90
416214-162148.6948.78
515797-157978.4718.53
616535-165358.8678.95
20min116409-164098.7998.562.628.948.692.63
216227-162278.7018.83
316077-160778.6218.75
416090-160908.6288.76
515763-157638.4538.56
615231-152318.1678.30
30min115939-159398.5478.531.888.748.711.86
215903-159038.5288.71
316306-163068.7448.92
415968-159688.5628.74
515986-159868.5728.72
615381-153818.2488.42
45min116051-160518.6078.511.038.858.741.04
215811-158118.4788.71
315894-158948.5238.75
415973-159738.5658.79
515914-159148.5348.73
615581-155818.3558.58
60min115896-158968.5248.521.918.818.791.80
216116-161168.6428.92
315653-156538.3948.67
415965-159658.5618.83
516251-162518.7148.96
615429-154298.2738.54
极限115681-156818.4098.313.118.748.632.97
215707-157078.4238.74
315486-154868.3048.62
415620-156208.3768.70
515946-159468.5518.85
614569-145697.8128.13
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%
111.143108653112983110253109643111553110610.06
211.073144123157683150900.31
单位质量响应值RSD%判断
27922.8928463.411.36数据可信
供试品溶液-X013993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%
5min1104894-10489430.73517.9948.0030.7317.9947.99
275950-7595022.25422.25
369847-6984720.46620.47
453133-5313315.56815.57
518120-181205.3095.31
646422-4642213.60213.60
10min1181913-18191353.30242.3023.2653.4742.4023.32
2159572-15957246.75646.88
3144505-14450542.34142.45
4161631-16163147.35947.45
584385-8438524.72524.75
6134278-13427839.34439.42
15min1241397-24139770.73159.4314.2271.2059.7614.30
2210678-21067861.73062.11
3200046-20004658.61558.96
4212027-21202762.12562.47
5152760-15276044.76044.93
6200061-20006158.61958.91
20min1240460-24046070.45666.516.8571.3267.186.99
2232360-23236068.08368.81
3229891-22989167.35968.03
4238110-23811069.76870.46
5197781-19778157.95158.37
6223441-22344165.47066.09
30min1257653-25765375.49475.272.9076.7576.313.03
2256897-25689775.27276.38
3262068-26206876.78777.84
4265227-26522777.71378.80
5243476-24347671.34072.08
6256115-25611575.04376.03
45min1274564-27456480.44979.591.7282.1281.051.84
2267548-26754878.39379.92
3271327-27132779.50080.98
4275913-27591380.84482.36
5264717-26471777.56478.70
6275822-27582280.81782.22
60min1272077-27207779.72080.481.6181.8482.381.50
2271549-27154979.56581.52
3268940-26894078.80180.72
4279754-27975481.97083.93
5277102-27710281.19382.76
6278675-27867581.65383.50
极限1273943-27394380.26779.981.3382.8382.321.28
2272555-27255579.86082.26
3270753-27075379.33281.69
4276680-27668081.06983.49
5276552-27655281.03183.05
6267240-26724078.30380.61
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%
110.221708141716901720701722211724031718400.37
210.161689791701651695720.50
单位质量响应值RSD%判断
16814.0916690.160.53数据可信
供试品溶液-X013993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%
5min16815-68153.6494.3213.763.654.3213.75
26886-68863.6873.69
37768-77684.1604.16
48317-83174.4544.45
59257-92574.9574.96
69338-93385.0005.00
10min111775-117756.3056.895.916.336.925.91
212152-121526.5076.53
313022-130226.9737.00
413018-130186.9717.00
513480-134807.2187.25
613737-137377.3567.38
15min113299-132997.1217.232.767.187.302.79
213127-131277.0297.09
313416-134167.1847.25
413528-135287.2447.31
513438-134387.1967.26
614207-142077.6087.68
20min113249-132497.0957.383.817.197.493.85
213343-133437.1457.24
314132-141327.5677.67
413516-135167.2387.34
513891-138917.4387.55
614617-146177.8277.94
30min113490-134907.2247.414.417.367.554.44
213109-131097.0207.15
314248-142487.6307.77
413391-133917.1717.31
513998-139987.4967.64
614740-147407.8938.05
45min113400-134007.1757.222.857.357.402.88
212913-129136.9157.09
313382-133827.1667.35
413563-135637.2637.45
513485-134857.2217.41
614106-141067.5537.75
60min113730-137307.3527.312.967.577.542.90
213304-133047.1247.34
314254-142547.6337.86
413514-135147.2367.46
513175-131757.0557.29
613926-139267.4577.70
极限113405-134057.1787.242.397.437.512.44
213113-131137.0227.27
313912-139127.4507.72
413310-133107.1277.39
513524-135247.2427.51
613900-139007.4437.72
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%
111.143139723152313158553161673163673155180.31
211.073114983133773124380.43
单位质量响应值RSD%判断
28322.9828223.850.25数据可信
供试品溶液-X013993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%
5min1189635-18963555.40244.5822.3355.4044.5822.33
2156404-15640445.69345.69
3147484-14748443.08743.09
4153964-15396444.98044.98
591006-9100626.58726.59
6177016-17701651.71551.71
10min1299426-29942687.47783.398.0787.7883.648.08
2290217-29021784.78685.04
3255077-25507774.52074.76
4272715-27271579.67379.92
5274689-27468980.25080.40
6320497-32049793.63393.92
15min1313226-31322691.50890.054.8692.3090.764.89
2312657-31265791.34292.07
3286321-28632183.64884.30
4298660-29866087.25387.95
5307767-30776789.91490.51
6330703-33070396.61497.42
20min1316671-31667192.51593.213.7493.8294.423.76
2318287-31828792.98794.22
3309134-30913490.31391.43
4308275-30827590.06291.24
5320800-32080093.72194.81
6341081-34108199.646100.99
30min1320478-32047893.62794.064.1695.4495.784.16
2315679-31567992.22593.97
3314651-31465191.92593.54
4308900-30890090.24591.92
5325250-32525095.02196.63
6346795-346795101.316103.21
45min1319067-31906793.21592.982.8395.5595.232.87
2311767-31176791.08293.34
3309371-30937190.38292.51
4315203-31520392.08694.26
5319512-31951293.34595.49
6334711-33471197.785100.25
60min1324612-32461294.83593.242.2397.6996.012.28
2315474-31547492.16594.93
3321571-32157193.94696.58
4313132-31313291.48194.17
5311003-31100390.85993.52
6329159-32915996.16399.17
极限1318639-31863993.09092.412.3196.4795.692.33
2307141-30714189.73193.01
3317348-31734892.71395.87
4309606-30960690.45193.65
5317407-31740792.73095.89
6327682-32768295.73299.27
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