依折麦布阿托伐他汀片项目信息
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%
19.871635291635321636291636981636231636020.05
29.821649131661661655400.54
单位质量响应值RSD%判断
16575.6816857.431.20数据可信
供试品溶液-2023120821批-依折麦布-pH2.0(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158644-5864431.47138.9215.7831.4738.9215.78
266327-6632735.59435.59
365725-6572535.27135.27
480349-8034943.11943.12
590250-9025048.43348.43
673862-7386239.63839.64
10min1136732-13673273.37777.726.3473.5577.936.37
2138349-13834974.24574.44
3137726-13772673.91174.11
4151378-15137881.23781.48
5159671-15967185.68785.96
6145041-14504177.83678.06
15min1165946-16594689.05591.352.6189.6492.002.65
2164107-16410788.06888.68
3170389-17038991.43992.05
4174253-17425393.51394.20
5175254-17525494.05094.80
6171413-17141391.98992.64
20min1177383-17738395.19395.571.4096.2796.721.42
2177291-17729195.14396.24
3178296-17829695.68396.80
4181016-18101697.14298.35
5180389-18038996.80698.07
6174119-17411993.44194.60
30min1171895-17189592.24796.472.2593.8598.152.26
2180423-18042396.82498.45
3180122-18012296.66298.31
4183021-18302198.21899.97
5180595-18059596.91698.72
6182490-18249097.93399.62
45min1179647-17964796.40897.450.7798.5399.670.81
2182163-18216397.75899.92
3180553-18055396.89499.08
4183688-18368898.576100.87
5181591-18159197.45199.79
6181877-18187797.60499.83
60min1176632-17663294.79096.000.8997.4498.760.91
2180737-18073796.99299.70
3177528-17752895.27097.99
4178643-17864395.86998.71
5180181-18018196.69499.58
6179552-17955296.35799.13
极限1173779-17377993.25896.222.3196.4499.522.28
2180080-18008096.64099.89
3179076-17907696.10199.35
4185998-18599899.816103.19
5176430-17643094.68198.10
6180464-18046496.846100.15
依折麦布阿托伐他汀片项目信息
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%
110.851553681555441555261555511555791555140.06
210.841571811580011575910.37
单位质量响应值RSD%判断
14333.0914537.921.01数据可信
供试品溶液-2023120821批-阿托伐他汀-pH2.0(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108953-10895362.34651.1432.0062.3551.1432.00
264090-6409036.67436.67
3105848-10584860.56960.57
4128203-12820373.36273.36
569704-6970439.88739.89
659382-5938233.98033.98
10min1146331-14633183.73579.917.0484.0880.207.13
2133344-13334476.30376.51
3143545-14354582.14182.48
4153676-15367687.93888.35
5133685-13368576.49876.72
6127347-12734772.87273.06
15min1155446-15544688.95188.463.0889.7689.193.17
2149959-14995985.81186.44
3157815-15781590.30691.10
4161590-16159092.46793.36
5149066-14906685.30085.95
6153668-15366887.93388.53
20min1160890-16089092.06691.261.7993.3792.481.90
2158953-15895390.95892.06
3160830-16083092.03293.33
4163502-16350293.56194.97
5155793-15579389.14990.27
6156944-15694489.80890.89
30min1150092-15009285.88789.532.6687.7091.252.58
2157338-15733890.03391.64
3155925-15592589.22591.03
4159170-15917091.08293.01
5154096-15409688.17889.79
6162082-16208292.74894.33
45min1155421-15542188.93689.831.6091.2392.051.55
2157429-15742990.08592.20
3155458-15545888.95891.26
4158358-15835890.61793.05
5154168-15416888.21990.33
6161034-16103492.14894.24
60min1152007-15200786.98388.041.7189.7790.761.58
2155220-15522088.82191.43
3151840-15184086.88789.68
4152972-15297287.53590.47
5152511-15251187.27189.87
6158593-15859390.75293.36
极限1148119-14811984.75887.442.8788.0390.662.81
2153419-15341987.79190.89
3151305-15130586.58189.86
4157572-15757290.16793.59
5148312-14831284.86887.95
6158152-15815290.49993.61
依折麦布阿托伐他汀片项目信息
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%
19.871674631678451682911684281683631680780.25
29.821671651685621678640.59
单位质量响应值RSD%判断
17029.1817094.090.27数据可信
供试品溶液-2023120822批-依折麦布-pH2.0(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177560-7756040.77840.2115.2340.7840.2115.23
292644-9264448.70948.71
366930-6693035.18935.19
468696-6869636.11836.12
587980-8798046.25646.26
665022-6502234.18634.19
10min1148472-14847278.06177.337.0578.2977.557.07
2158529-15852983.34883.62
3141267-14126774.27374.47
4137698-13769872.39672.60
5160066-16006684.15684.41
6136441-13644171.73571.93
15min1171806-17180690.32989.612.8990.9990.272.93
2176755-17675592.93193.66
3166047-16604787.30187.91
4168643-16864388.66689.27
5174977-17497791.99692.72
6164446-16444686.45987.05
20min1176257-17625792.66993.191.1593.8394.341.21
2179957-17995794.61495.86
3177276-17727693.20594.30
4175104-17510492.06393.16
5179386-17938694.31495.55
6175523-17552392.28393.35
30min1178495-17849593.84694.170.4395.5295.840.47
2180535-18053594.91896.69
3179210-17921094.22295.83
4179188-17918894.21095.82
5178752-17875293.98195.74
6178518-17851893.85895.44
45min1179054-17905494.13994.111.2796.3496.301.24
2178872-17887294.04496.35
3182860-18286096.14198.27
4175803-17580392.43094.56
5179026-17902694.12596.41
6178372-17837293.78195.88
60min1176561-17656192.82992.652.7595.5595.362.74
2182167-18216795.77698.60
3177036-17703693.07995.75
4176256-17625692.66895.31
5177880-17788093.52296.33
6167372-16737287.99890.62
极限1178918-17891894.06893.151.2297.3096.381.20
2177102-17710293.11396.47
3178541-17854193.87097.06
4178976-17897694.09897.26
5175945-17594592.50595.83
6173500-17350091.21994.33
依折麦布阿托伐他汀片项目信息
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%
110.851587121591521592331592621594511591620.18
210.841589741602301596020.56
单位质量响应值RSD%判断
14669.3114723.430.27数据可信
供试品溶液-2023120822批-阿托伐他汀-pH2.0(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1114710-11471064.47264.145.7664.4764.145.75
2105811-10581159.47159.47
3111372-11137262.59662.60
4112308-11230863.12263.12
5125727-12572770.66470.66
6114806-11480664.52664.53
10min1151239-15123985.00383.752.3885.3684.102.39
2145180-14518081.59881.93
3148179-14817983.28383.63
4144991-14499181.49281.84
5153897-15389786.49786.89
6150524-15052484.60184.96
15min1160045-16004589.95388.801.5990.7889.621.58
2157429-15742988.48289.27
3153398-15339886.21787.03
4160158-16015890.01690.82
5158960-15896089.34390.22
6157921-15792188.75989.59
20min1161436-16143690.73490.280.9192.0691.600.92
2159789-15978989.80991.08
3158096-15809688.85790.15
4161132-16113290.56491.87
5161221-16122190.61491.98
6162121-16212191.11992.44
30min1158973-15897389.35088.371.3991.1890.181.38
2156729-15672988.08989.86
3153492-15349286.26988.05
4158834-15883489.27291.08
5156333-15633387.86689.74
6158985-15898589.35791.18
45min1158216-15821688.92587.510.9891.2689.820.98
2154222-15422286.68088.94
3154959-15495987.09489.36
4154926-15492687.07589.38
5155021-15502187.12989.49
6156881-15688188.17490.50
60min1154856-15485687.03685.792.2689.8688.582.18
2156317-15631787.85790.60
3149652-14965284.11186.86
4154477-15447786.82389.61
5153185-15318586.09788.94
6147335-14733582.80985.62
极限1156645-15664588.04285.572.0191.3588.841.96
2151047-15104784.89588.13
3149251-14925183.88687.10
4155462-15546287.37790.65
5149886-14988684.24387.57
6151215-15121584.99088.26
依折麦布阿托伐他汀片项目信息
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%
19.871662321664291662901664341663381663450.06
29.821651341660451655900.39
单位质量响应值RSD%判断
16853.6016862.530.04数据可信
供试品溶液-2023120823批-依折麦布-pH2.0(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168949-6894936.68841.8630.6236.6941.8630.62
266314-6631435.28635.29
3103471-10347155.05855.06
460150-6015032.00632.01
558550-5855031.15531.15
6114577-11457760.96760.97
10min1145809-14580977.58679.725.4477.7979.955.51
2146798-14679878.11278.31
3158042-15804284.09584.40
4142758-14275875.96376.14
5143491-14349176.35376.53
6162007-16200786.20586.54
15min1167831-16783189.30490.541.9989.9491.212.07
2171214-17121491.10491.73
3173289-17328992.20892.98
4167560-16756089.16089.76
5166381-16638188.53389.13
6174603-17460392.90893.73
20min1171335-17133591.16992.921.3192.3094.101.31
2177309-17730994.34795.48
3176646-17664693.99595.28
4173094-17309492.10593.20
5175492-17549293.38194.47
6173868-17386892.51693.85
30min1180279-18027995.92894.771.4697.5796.461.36
2181428-18142896.53998.20
3175002-17500293.12094.93
4178346-17834694.89996.51
5178291-17829194.87096.48
6175225-17522593.23995.09
45min1176107-17610793.70895.251.2295.8897.471.24
2181452-18145296.55298.75
3179117-17911795.30997.63
4179495-17949595.51197.64
5176799-17679994.07696.21
6181023-18102396.32498.69
60min1172896-17289691.99994.121.6594.6996.881.62
2177753-17775394.58497.32
3177052-17705294.21197.07
4181159-18115996.39699.06
5174443-17444392.82295.48
6178035-17803594.73497.63
极限1173492-17349292.31693.642.4895.5296.912.43
2173379-17337992.25695.51
3184406-18440698.124101.50
4176233-17623393.77596.98
5175660-17566093.47096.64
6172655-17265591.87195.30
依折麦布阿托伐他汀片项目信息
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%
110.851581581586791584191586741584411584740.14
210.841570681579951575320.42
单位质量响应值RSD%判断
14605.9014532.470.36数据可信
供试品溶液-2023120823批-阿托伐他汀-pH2.0(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1103313-10331358.57462.5111.3658.5762.5111.36
2119074-11907467.50967.51
3118941-11894167.43467.43
488139-8813949.97149.97
5112399-11239963.72563.73
6119636-11963667.82867.83
10min1143884-14388481.57682.753.1281.9083.103.14
2151045-15104585.63686.01
3149532-14953284.77885.15
4138459-13845978.50078.78
5147741-14774183.76284.12
6145092-14509282.26082.64
15min1156956-15695688.98788.971.6089.7789.781.63
2160673-16067391.09491.94
3158975-15897590.13190.98
4153812-15381287.20487.92
5155628-15562888.23489.05
6155563-15556388.19789.03
20min1156764-15676488.87889.161.8990.1590.461.90
2161001-16100191.28092.64
3159954-15995490.68792.03
4154922-15492287.83489.03
5157782-15778289.45590.76
6153198-15319886.85688.18
30min1162817-16281792.31090.212.0094.0892.011.97
2162164-16216491.93993.80
3158470-15847089.84591.70
4158507-15850789.86691.55
5158799-15879990.03291.84
6153949-15394987.28289.09
45min1155608-15560888.22389.281.2490.5091.581.25
2159241-15924190.28292.66
3159079-15907990.19092.54
4156643-15664388.80990.99
5155009-15500987.88390.19
6159236-15923690.27992.57
60min1155838-15583888.35388.640.3791.1291.440.34
2155727-15572788.29091.17
3157053-15705389.04291.89
4156879-15687988.94391.62
5156618-15661888.79591.59
6155999-15599988.44491.24
极限1148821-14882184.37586.652.5887.6489.942.50
2151717-15171786.01789.38
3159804-15980490.60193.95
4154674-15467487.69390.87
5150260-15026085.19088.48
6151722-15172286.01989.30
依折麦布阿托伐他汀片项目信息
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%
19.871648791657131662231663831664681659330.40
29.821656521662681659600.27
单位质量响应值RSD%判断
16811.8516900.200.38数据可信
供试品溶液-2023121221批-依折麦布-pH2.0(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156798-5679830.22628.168.4230.2328.168.42
257914-5791430.82030.82
354520-5452029.01429.01
449326-4932626.25026.25
546318-4631824.64924.65
652564-5256427.97327.97
10min1143851-14385176.55472.463.5676.7272.623.56
2138962-13896273.95274.12
3129898-12989869.12969.29
4135394-13539472.05372.20
5132968-13296870.76270.90
6135916-13591672.33172.49
15min1166662-16666288.69386.682.0289.2987.242.02
2161280-16128085.82986.41
3159271-15927184.76085.31
4163969-16396987.26087.81
5159681-15968184.97885.51
6166405-16640588.55789.11
20min1175705-17570593.50693.831.6994.5994.871.67
2173491-17349192.32893.39
3177635-17763594.53395.55
4180681-18068196.15497.18
5172682-17268291.89792.90
6177708-17770894.57295.62
30min1180996-18099696.32292.602.3897.9394.162.37
2173869-17386992.52994.10
3174111-17411192.65894.20
4172343-17234391.71793.28
5168214-16821489.51991.03
6174511-17451192.87094.45
45min1180711-18071196.17094.811.6998.3196.881.64
2174469-17446992.84894.93
3180135-18013595.86397.92
4179044-17904495.28397.36
5180306-18030695.95497.96
6174237-17423792.72594.82
60min1173323-17332392.23892.881.7794.9195.481.71
2171978-17197891.52294.12
3177400-17740094.40897.00
4179106-17910695.31697.92
5173973-17397392.58495.13
6171402-17140291.21693.82
极限1174464-17446492.84593.352.0096.0396.471.94
2172608-17260891.85894.97
3175170-17517093.22196.33
4181988-18198896.85099.98
5175867-17586793.59296.65
6172390-17239091.74294.85
依折麦布阿托伐他汀片项目信息
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%
110.853092433108863115753119963123763112150.40
210.843122463130793126620.19
单位质量响应值RSD%判断
28683.4128843.360.40数据可信
供试品溶液-2023121221批-阿托伐他汀-pH2.0(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1225623-22562364.79355.5721.0564.7955.5721.05
2223159-22315964.08564.09
3162317-16231746.61346.61
4126563-12656336.34536.35
5200116-20011657.46857.47
6223180-22318064.09164.09
10min1292748-29274884.06980.834.0484.4381.144.10
2282956-28295681.25781.61
3282578-28257881.14981.41
4259697-25969774.57874.78
5283275-28327581.34981.67
6287579-28757982.58582.94
15min1307970-30797088.44187.052.0789.2787.812.13
2300706-30070686.35587.16
3305498-30549887.73188.44
4292519-29251984.00484.62
5302067-30206786.74587.52
6310053-31005389.03989.85
20min1314460-31446090.30490.191.3791.6291.431.34
2312390-31239089.71091.00
3319708-31970891.81193.01
4314656-31465690.36191.44
5306865-30686588.12389.38
6316236-31623690.81492.12
30min1327504-32750494.05090.043.0595.8791.783.06
2315960-31596090.73592.52
3318420-31842091.44293.15
4301511-30151186.58688.17
5304246-30424687.37189.11
6313562-31356290.04791.86
45min1318987-31898791.60490.311.7593.9592.551.73
2309381-30938188.84691.14
3320533-32053392.04894.26
4309830-30983088.97591.04
5318804-31880491.55293.78
6309248-30924888.80891.12
60min1305404-30540487.70488.081.1390.5690.831.04
2303540-30354087.16889.95
3312413-31241389.71792.44
4309122-30912288.77191.33
5306190-30619087.92990.67
6303646-30364687.19990.01
极限1305600-30560087.76087.811.1091.1091.040.98
2301946-30194686.71189.98
3306440-30644088.00191.23
4310642-31064289.20892.26
5307886-30788688.41791.64
6302132-30213286.76490.06
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