依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.169640029634039623899623909619619628290.09
211.169674609704619689600.22
单位质量响应值RSD%判断
86275.0086824.370.45数据可信
供试品溶液-25080102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%
5min1441549-44154945.80147.2116.2745.8047.2116.27
2432448-43244844.85744.86
3437124-43712445.34245.34
4503779-50377952.25652.26
5348443-34844336.14336.14
6567528-56752858.86858.87
10min1658873-65887368.34370.6911.2168.4270.7711.21
2656690-65669068.11768.19
3677832-67783270.31070.39
4749329-74932977.72677.81
5565280-56528058.63558.70
6780903-78090381.00181.10
15min1748611-74861177.65280.128.2277.8480.328.23
2751811-75181177.98478.17
3772760-77276080.15780.35
4811629-81162984.18884.40
5681199-68119970.65970.82
6868695-86869590.10890.34
20min1794675-79467582.43084.506.0482.7584.826.06
2790490-79049081.99682.31
3820749-82074985.13485.46
4838418-83841886.96787.32
5749434-74943477.73778.01
6893756-89375692.70793.09
30min1838223-83822386.94788.723.9487.4089.193.97
2834917-83491786.60487.06
3868803-86880390.11990.59
4861437-86143789.35589.86
5816553-81655384.69985.10
6912167-91216794.61795.15
45min1865897-86589789.81791.202.9190.4291.822.94
2863379-86337989.55690.16
3898655-89865593.21593.83
4877781-87778191.05091.70
5850207-85020788.19088.74
6919434-91943495.37196.07
60min1877024-87702490.97292.072.5091.7292.842.53
2876529-87652990.92091.67
3909723-90972394.36395.14
4879400-87940091.21892.02
5863070-86307089.52490.22
6920199-92019995.45096.30
极限1905802-90580293.95794.611.4894.8695.531.49
2915313-91531394.94395.84
3930337-93033796.50297.43
4894187-89418792.75293.71
5903479-90347993.71694.56
6923360-92336095.77896.79
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.162121748212118121174852115999211545521183740.14
211.162145241213595321405970.31
单位质量响应值RSD%判断
189818.46191809.770.74数据可信
供试品溶液-25080102批-辛伐他汀-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%
5min1337388-33738815.83421.3133.2815.8321.3133.29
2337280-33728015.82915.83
3345516-34551616.21616.22
4608462-60846228.55628.56
5418313-41831319.63219.63
6677729-67772931.80731.81
10min1582379-58237927.33231.4716.9027.3631.5016.91
2588703-58870327.62927.66
3612808-61280828.76028.79
4794942-79494237.30837.36
5608944-60894428.57928.61
6835084-83508439.19239.24
15min1705403-70540333.10635.649.5333.1835.739.56
2710329-71032933.33733.41
3746935-74693535.05535.13
4816179-81617938.30538.41
5700494-70049432.87532.96
6877619-87761941.18841.31
20min1781707-78170736.68737.855.4536.8138.005.48
2784143-78414336.80136.93
3821456-82145638.55238.69
4823043-82304338.62738.80
5751595-75159535.27435.41
6877332-87733241.17541.36
30min1846367-84636739.72239.774.2639.9139.984.25
2851006-85100639.93940.13
3891181-89118141.82542.02
4829652-82965238.93739.18
5789298-78929837.04337.24
6876851-87685141.15241.41
45min1886193-88619341.59140.864.7941.8541.144.75
2891687-89168741.84842.10
3925259-92525943.42443.69
4834537-83453739.16639.47
5809917-80991738.01138.27
6876685-87668541.14441.47
60min1900993-90099342.28541.345.7442.6141.685.68
2913697-91369742.88143.21
3948563-94856344.51844.86
4832451-83245139.06839.44
5815468-81546838.27138.59
6873623-87362341.00141.39
极限1933198-93319843.79742.376.0344.1942.795.95
2951436-95143644.65345.05
3967303-96730345.39745.81
4841453-84145339.49139.92
5851179-85117939.94740.33
6872793-87279340.96241.42
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.169682689682089671319671849671779675940.07
211.169706459720219713330.11
单位质量响应值RSD%判断
86701.9787037.010.28数据可信
供试品溶液-25080102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%
5min1386671-38667139.96146.9221.5839.9646.9221.58
2419458-41945843.34943.35
3317268-31726832.78832.79
4491241-49124150.76750.77
5585553-58555360.51460.51
6523731-52373154.12554.13
10min1635725-63572565.69972.3012.8265.7772.3812.83
2670827-67082769.32769.40
3572451-57245159.16059.21
4729239-72923975.36375.45
5802712-80271282.95683.06
6786683-78668381.30081.39
15min1762503-76250378.80182.967.7878.9883.167.80
2776171-77617180.21380.40
3712408-71240873.62473.78
4835112-83511286.30586.51
5874932-87493290.42090.66
6855175-85517588.37888.60
20min1818305-81830584.56887.675.5484.8888.005.57
2825399-82539985.30185.62
3780916-78091680.70480.98
4881361-88136191.08491.44
5901525-90152593.16893.56
6882163-88216391.16791.54
30min1865904-86590489.48791.343.3689.9491.833.39
2872377-87237790.15690.62
3838918-83891886.69887.11
4910090-91009094.05394.56
5913890-91389094.44694.99
6902117-90211793.22993.75
45min1894178-89417892.40993.312.1793.0193.952.21
2901837-90183793.20093.81
3869085-86908589.81690.37
4919861-91986195.06395.73
5921070-92107095.18895.89
6911613-91161394.21194.89
60min1905920-90592093.62294.021.6794.3794.811.71
2915707-91570794.63495.40
3880775-88077591.02491.73
4918178-91817894.88995.71
5921757-92175795.25996.12
6916129-91612994.67795.51
极限1921048-92104895.18694.881.0696.0995.821.09
2923969-92396995.48896.41
3899399-89939992.94893.80
4923815-92381595.47296.45
5924156-92415695.50796.53
6916102-91610294.67595.67
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.162128057213053921291442126718212744021283800.08
211.162135489213987621376820.15
单位质量响应值RSD%判断
190715.05191548.570.31数据可信
供试品溶液-25080102批-辛伐他汀-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%
5min1786473-78647336.84822.8363.7536.8522.8363.74
2858299-85829940.21440.21
3645787-64578730.25730.26
4192432-1924329.0169.02
5229479-22947910.75210.75
6210576-2105769.8669.87
10min11389658-138965865.10938.7671.7665.1738.8071.75
21467121-146712168.73968.81
31237567-123756757.98358.03
4272457-27245712.76512.78
5301257-30125714.11514.13
6295152-29515213.82913.85
15min11715979-171597980.39821.17141.5480.5721.27140.95
23883-38830.1820.36
33679-36790.1720.32
4318390-31839014.91714.95
5337189-33718915.79815.84
6331885-33188515.55015.59
20min14301-43010.2028.51106.960.518.65104.34
24539-45390.2130.39
34119-41190.1930.34
4351546-35154616.47116.53
5363047-36304717.01017.08
6362328-36232816.97617.04
30min14849-48490.2279.20106.860.539.35104.45
24908-49080.2300.41
34774-47740.2240.37
4382696-38269617.93018.02
5390755-39075518.30818.40
6390318-39031818.28718.38
45min15373-53730.2529.90106.740.5610.07104.48
25497-54970.2580.44
35416-54160.2540.40
4412445-41244519.32419.44
5422048-42204819.77419.90
6417211-41721119.54719.67
60min15894-58940.27610.56106.660.5810.74104.56
26086-60860.2850.47
35900-59000.2760.42
4440053-44005320.61820.77
5447445-44744520.96421.12
6446397-44639720.91521.07
极限16190-61900.29011.09106.460.6011.30104.44
26423-64230.3010.48
37423-74230.3480.50
4467155-46715521.88722.07
5465062-46506221.78921.98
6468477-46847721.94922.14
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.169689439719379735219728129740049722430.21
211.169762169778449770300.12
单位质量响应值RSD%判断
87118.5587547.490.35数据可信
供试品溶液-25080102批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1426270-42627043.81945.5311.2743.8245.5311.27
2426802-42680243.87443.87
3390836-39083640.17740.18
4406672-40667241.80541.80
5487356-48735650.09950.10
6519770-51977053.43153.43
10min1660503-66050367.89871.118.4667.9771.198.46
2654328-65432867.26367.34
3629269-62926964.68764.75
4690061-69006170.93671.01
5726747-72674774.70774.79
6789768-78976881.18681.27
15min1757079-75707977.82582.075.8478.0182.275.85
2763489-76348978.48478.67
3755278-75527877.64077.81
4819028-81902884.19384.38
5828413-82841385.15885.37
6867156-86715689.14189.37
20min1810512-81051283.31887.534.7983.6387.864.80
2820256-82025684.32084.64
3815253-81525383.80584.11
4878500-87850090.30790.64
5880619-88061990.52590.87
6903988-90398892.92793.30
30min1859023-85902388.30591.513.2488.7691.993.26
2871788-87178889.61790.07
3863260-86326088.74089.18
4922584-92258494.83995.32
5905891-90589193.12393.62
6918868-91886894.45794.98
45min1888649-88864991.35093.542.1591.9594.172.17
2900490-90049092.56793.17
3891270-89127091.62092.21
4933466-93346695.95796.59
5914807-91480794.03994.70
6930938-93093895.69796.38
60min1897356-89735692.24594.221.7493.0095.001.75
2913318-91331893.88694.65
3903846-90384692.91293.66
4937840-93784096.40797.20
5914171-91417193.97494.79
6932638-93263895.87296.72
极限1908144-90814493.35494.801.3594.2695.741.36
2921997-92199794.77895.70
3910226-91022693.56894.47
4939773-93977396.60697.56
5920329-92032994.60795.58
6932790-93279095.88896.89
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.162129295213765821388452137907213813821363690.19
211.162144064215044321472540.22
单位质量响应值RSD%判断
191430.91192406.270.36数据可信
供试品溶液-25080102批-辛伐他汀-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16103-61030.28529.92109.460.2829.92109.48
26309-63090.2940.29
35872-58720.2740.27
41118992-111899252.21352.21
51301642-130164260.73660.74
61408209-140820965.70865.71
10min110833-108330.50513.48238.070.5113.53237.31
210630-106300.4960.50
310544-105440.4920.49
41692530-169253078.97579.06
54212-42120.1970.30
64384-43840.2050.31
15min113406-134060.6260.4251.740.630.5029.88
213356-133560.6230.62
313231-132310.6170.62
44859-48590.2270.45
54652-46520.2170.32
64813-48130.2250.33
20min115326-153260.7150.4854.580.720.5634.73
215590-155900.7270.73
315545-155450.7250.73
45258-52580.2450.46
55108-51080.2380.34
65211-52110.2430.35
30min117695-176950.8260.5556.410.830.6238.17
217890-178900.8350.84
317867-178670.8340.84
45740-57400.2680.49
55594-55940.2610.36
65793-57930.2700.38
45min120422-204220.9530.6258.600.960.7041.73
220649-206490.9630.97
320474-204740.9550.96
46366-63660.2970.52
56133-61330.2860.39
66143-61430.2870.40
60min122618-226181.0550.7059.421.060.7744.56
223278-232781.0861.09
323007-230071.0741.08
47320-73200.3420.56
56443-64430.3010.40
66689-66890.3120.42
极限125050-250501.1690.7659.921.180.8446.08
225510-255101.1901.20
325513-255131.1901.20
47522-75220.3510.57
57662-76620.3580.46
67102-71020.3310.44
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