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%
110.031699851698861699331695621706181699970.23
210.091679761678601679180.05
单位质量响应值RSD%判断
16948.8516642.021.30数据可信
供试品溶液-2023121221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%
5min19230-92304.9305.084.974.935.084.94
29486-94865.0675.07
39081-90814.8504.85
49114-91144.8684.87
510012-100125.3485.35
610175-101755.4355.43
10min117413-174139.3019.330.609.339.360.59
217524-175249.3609.39
317636-176369.4209.45
417488-174889.3419.37
517393-173939.2909.32
617354-173549.2699.30
15min118139-181399.6899.461.509.779.541.48
217310-173109.2469.33
317768-177689.4919.57
417649-176499.4279.51
517702-177029.4559.54
617713-177139.4619.54
20min117918-179189.5719.293.309.709.423.25
217615-176159.4099.54
316361-163618.7398.87
417643-176439.4249.56
517116-171169.1429.28
617723-177239.4669.60
30min117154-171549.1639.182.829.359.362.76
216751-167518.9479.13
317314-173149.2489.43
418034-180349.6339.82
517117-171179.1439.33
616699-166998.9209.11
45min116809-168098.9789.073.819.229.303.72
216773-167738.9599.19
316593-165938.8639.09
418262-182629.7549.99
516914-169149.0349.27
616517-165178.8229.06
60min116153-161538.6289.036.838.919.326.66
216124-161248.6128.90
316354-163548.7359.02
418974-1897410.13510.43
517600-176009.4019.69
616259-162598.6858.97
极限116246-162468.6789.238.649.019.568.41
216305-163058.7099.04
316456-164568.7909.12
419750-1975010.54910.90
518502-185029.88310.22
616368-163688.7439.08
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%
110.733012393010243017283006773020613013460.19
210.782998042986882992460.27
单位质量响应值RSD%判断
28084.4427759.370.83数据可信
供试品溶液-2023121221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%
5min1132545-13254539.21143.4323.5439.2143.4423.54
2159220-15922047.10347.10
3109970-10997032.53332.53
4110423-11042332.66732.67
5177120-17712052.39852.40
6191644-19164456.69556.70
10min1251173-25117374.30675.662.4074.5275.902.42
2255258-25525875.51475.78
3263899-26389978.07178.25
4246691-24669172.98073.16
5257992-25799276.32376.61
6259391-25939176.73777.05
15min1265769-26576978.62479.901.7379.2580.561.77
2265953-26595378.67879.36
3273343-27334380.86481.48
4266139-26613978.73379.32
5273032-27303280.77281.49
6276264-27626481.72982.47
20min1271469-27146980.31081.492.1881.3882.592.21
2270564-27056480.04281.16
3276376-27637681.76282.83
4271747-27174780.39281.42
5275857-27585781.60882.77
6286657-28665784.80386.00
30min1266034-26603478.70281.823.7380.2283.383.72
2265949-26594978.67780.24
3278592-27859282.41783.94
4272939-27293980.74582.22
5283995-28399584.01685.63
6291874-29187486.34788.01
45min1272657-27265780.66284.974.8882.6186.984.84
2276290-27629081.73683.74
3286935-28693584.88586.86
4284840-28484084.26686.19
5290151-29015185.83787.92
6312385-31238592.41494.56
60min1284483-28448384.16088.277.1686.5690.767.05
2265961-26596178.68181.13
3296467-29646787.70590.15
4305125-30512590.26792.65
5311220-31122092.07094.63
6327086-32708696.76499.42
极限1341802-341802101.117100.760.48103.98103.740.51
2338827-338827100.237103.13
3342516-342516101.328104.26
4338596-338596100.169103.06
5340492-340492100.730103.80
6341372-341372100.990104.19
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%
110.031681701684141685881683281684931683990.10
210.091671961672891672420.04
单位质量响应值RSD%判断
16789.5316575.020.91数据可信
供试品溶液-2023121221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%
5min19007-90074.8434.594.714.844.594.75
28134-81344.3744.37
38410-84104.5224.52
49088-90884.8874.89
58302-83024.4644.46
68311-83114.4694.47
10min116398-163988.8188.921.018.848.951.04
216746-167469.0059.03
316586-165868.9198.94
416809-168099.0399.07
516418-164188.8298.85
616614-166148.9348.96
15min116608-166088.9319.011.189.019.081.15
216993-169939.1389.21
316938-169389.1089.18
416812-168129.0409.12
516641-166418.9489.02
616497-164978.8718.95
20min116443-164438.8428.850.998.978.980.96
216585-165858.9189.04
316601-166018.9279.05
416557-165578.9039.03
516445-164458.8438.97
616166-161668.6938.82
30min116329-163298.7818.651.498.968.821.48
216234-162348.7308.90
316164-161648.6928.87
416180-161808.7018.88
515702-157028.4448.62
615877-158778.5388.71
45min115364-153648.2628.402.638.498.632.53
215890-158908.5458.77
314903-149038.0148.24
415807-158078.5008.73
515886-158868.5428.76
615907-159078.5548.77
60min115615-156158.3978.471.848.678.741.77
216026-160268.6188.89
316172-161728.6968.96
415465-154658.3168.59
515706-157068.4468.71
615496-154968.3338.60
极限115733-157338.4608.391.848.788.701.77
216042-160428.6268.94
315723-157238.4558.77
415323-153238.2408.56
515406-154068.2848.60
615343-153438.2508.56
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%
110.733014353018543021903017003014743017310.11
210.783003952996443000200.18
单位质量响应值RSD%判断
28120.3227831.170.74数据可信
供试品溶液-2023121221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%
5min1161872-16187247.79544.0914.6347.7944.0914.63
2138594-13859440.92240.92
3131083-13108338.70438.70
4126734-12673437.42037.42
5184789-18478954.56154.56
6152959-15295945.16345.16
10min1244703-24470372.25275.193.8772.5275.443.89
2256580-25658075.75975.99
3255614-25561475.47475.69
4247832-24783273.17673.38
5272523-27252380.46680.77
6250715-25071574.02774.28
15min1259423-25942376.59878.773.6177.2779.443.63
2268463-26846379.26779.92
3270380-27038079.83380.47
4257795-25779576.11876.73
5283530-28353083.71684.47
6261155-26115577.11077.77
20min1262288-26228877.44479.763.6178.5480.863.62
2269606-26960679.60580.69
3274642-27464281.09282.17
4264594-26459478.12579.16
5287462-28746284.87786.09
6262292-26229277.44578.54
30min1271844-27184480.26681.023.2081.7982.563.23
2276516-27651681.64583.18
3271347-27134780.11981.65
4264591-26459178.12479.60
5290519-29051985.78087.47
6271516-27151680.16981.69
45min1277034-27703481.79881.933.4983.7783.933.48
2279943-27994382.65784.64
3271188-27118880.07282.05
4262369-26236977.46879.37
5288370-28837085.14587.31
6286070-28607084.46686.43
60min1302454-30245489.30486.594.9991.7389.044.91
2302649-30264989.36191.80
3289457-28945785.46687.88
4265270-26527078.32580.66
5297723-29772387.90790.54
6302077-30207789.19291.63
极限1338351-33835199.90399.771.27102.82102.701.28
2340393-340393100.506103.45
3340863-340863100.644103.54
4329829-32982997.387100.16
5337039-33703999.515102.64
6341013-341013100.689103.62
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%
110.031694461695611694371696961696211695520.07
210.091670821672801671810.09
单位质量响应值RSD%判断
16904.4916568.981.42数据可信
供试品溶液-2023121621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%
5min111176-111765.9916.144.405.996.144.38
211484-114846.1566.16
311773-117736.3116.31
411568-115686.2016.20
512059-120596.4646.46
610615-106155.6905.69
10min116660-166608.9309.212.068.969.242.07
217713-177139.4949.53
317107-171079.1709.20
417404-174049.3299.36
517110-171109.1719.21
617091-170919.1619.19
15min117604-176049.4369.261.659.529.351.65
217465-174659.3629.45
317117-171179.1759.26
416881-168819.0499.13
517112-171129.1729.26
617505-175059.3839.47
20min117158-171589.1979.041.819.339.181.78
217086-170869.1589.30
316642-166428.9209.06
416427-164278.8058.94
516758-167588.9839.12
617136-171369.1859.32
30min116382-163828.7818.812.478.978.992.42
216025-160258.5908.78
316112-161128.6368.82
417153-171539.1949.38
516318-163188.7478.93
616575-165758.8859.07
45min116324-163248.7508.652.578.998.892.51
215918-159188.5328.77
315560-155608.3408.57
416229-162298.6998.94
516036-160368.5968.83
616786-167868.9989.23
60min116151-161518.6578.542.328.948.832.25
215595-155958.3598.64
315470-154708.2928.57
415920-159208.5338.82
516475-164758.8319.11
616034-160348.5958.88
极限115981-159818.5668.572.648.908.902.58
215652-156528.3908.72
315568-155688.3458.67
416016-160168.5858.92
516758-167588.9839.32
615937-159378.5438.88
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%
110.733019833024303026053024223022813023440.08
210.782992232988662990440.09
单位质量响应值RSD%判断
28177.4527740.631.11数据可信
供试品溶液-2023121621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%
5min1180834-18083453.42750.8413.5753.4350.8413.56
2154270-15427045.57945.58
3182741-18274153.99153.99
4175681-17568151.90551.90
5202601-20260159.85959.86
6136430-13643040.30840.31
10min1232243-23224368.61673.184.0168.9173.464.00
2254479-25447975.18675.44
3246029-24602972.68972.99
4244514-24451472.24272.53
5261625-26162577.29777.63
6247293-24729373.06373.29
15min1242139-24213971.54076.064.3772.2276.754.35
2263881-26388177.96478.63
3253756-25375674.97275.68
4248365-24836573.38074.07
5271925-27192580.34081.10
6264584-26458478.17178.80
20min1243026-24302671.80277.074.7872.8878.184.75
2271725-27172580.28181.39
3255115-25511575.37476.49
4252787-25278774.68675.78
5274862-27486281.20882.42
6267571-26757179.05480.12
30min1239450-23945070.74676.605.1072.2278.145.06
2263289-26328977.78979.34
3252594-25259474.62976.17
4254587-25458775.21876.73
5276651-27665181.73783.40
6268928-26892879.45580.96
45min1254142-25414275.08678.254.1876.9580.214.14
2272659-27265980.55782.54
3254637-25463775.23377.19
4255840-25584075.58877.52
5274196-27419681.01183.12
6277600-27760082.01783.96
60min1256542-25654275.79580.005.9478.0882.405.84
2276143-27614381.58784.02
3253233-25323374.81877.19
4261984-26198477.40379.75
5283086-28308683.63886.20
6293640-29364086.75689.16
极限1326378-32637896.42897.781.1699.13100.621.16
2330138-33013897.539100.42
3329514-32951497.355100.14
4333021-33302198.391101.17
5329263-32926397.281100.31
6337455-33745599.701102.58
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%
110.031685721696471705311708491711451701490.62
210.091676411684221680320.33
单位质量响应值RSD%判断
16964.0116653.321.31数据可信
供试品溶液-2023121621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%
5min111202-112025.9795.624.805.985.624.79
29898-98985.2835.28
310074-100745.3775.38
410988-109885.8645.86
510476-104765.5915.59
610506-105065.6075.61
10min116796-167968.9649.142.249.009.172.23
216607-166078.8638.89
317220-172209.1919.22
417380-173809.2769.31
517126-171269.1409.17
617657-176579.4249.45
15min116995-169959.0719.131.049.159.211.01
217264-172649.2149.29
316928-169289.0359.12
417141-171419.1489.23
516971-169719.0589.14
617371-173719.2719.35
20min116405-164058.7568.982.018.899.121.99
217077-170779.1149.24
317006-170069.0769.21
416661-166618.8929.03
516563-165638.8408.97
617276-172769.2209.36
30min116328-163288.7158.771.468.908.951.44
216500-165008.8068.99
316299-162998.6998.88
416746-167468.9389.12
516076-160768.5808.76
616592-165928.8559.04
45min116113-161138.6008.651.618.838.881.61
216195-161958.6448.87
316087-160878.5868.82
416101-161018.5938.83
515989-159898.5348.76
616713-167138.9209.16
60min115834-158348.4518.461.048.738.741.04
215635-156358.3458.62
315887-158878.4798.76
416019-160198.5508.83
515692-156928.3758.65
616034-160348.5588.84
极限115569-155698.3098.441.878.638.771.81
215569-155698.3098.63
316338-163388.7209.04
415868-158688.4698.80
515664-156648.3608.68
615926-159268.5008.83
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%
110.732996973016133027223033363036183021970.53
210.783001483006473003980.12
单位质量响应值RSD%判断
28163.7527866.230.76数据可信
供试品溶液-2023121621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%
5min1183965-18396554.24245.4522.8154.2445.4522.81
2102518-10251830.22730.23
3121922-12192235.94935.95
4190322-19032256.11756.12
5170733-17073350.34150.34
6155417-15541745.82545.82
10min1248033-24803373.13373.215.9273.4373.465.96
2238500-23850070.32270.49
3231022-23102268.11768.32
4262420-26242077.37577.69
5268994-26899479.31379.59
6240753-24075370.98671.24
15min1259338-25933876.46676.276.0377.1776.936.06
2258116-25811676.10676.66
3237666-23766670.07670.65
4272329-27232980.29681.04
5279056-27905682.28083.00
6245541-24554172.39873.05
20min1259165-25916576.41577.265.9977.5578.356.01
2259797-25979776.60177.58
3244484-24448472.08673.05
4275318-27531881.17882.37
5285274-28527484.11385.29
6248235-24823573.19274.24
30min1263351-26335177.64977.305.7779.2178.815.80
2257310-25731075.86877.27
3244523-24452372.09873.47
4277381-27738181.78683.42
5281879-28187983.11284.76
6248471-24847173.26274.72
45min1270353-27035379.71478.444.8781.7080.384.92
2260627-26062776.84678.67
3246173-24617372.58474.35
4276428-27642881.50583.60
5282016-28201683.15385.26
6260517-26051776.81478.68
60min1280083-28008382.58379.905.6585.0182.285.69
2259811-25981176.60578.86
3249820-24982073.66075.83
4284587-28458783.91186.46
5287720-28772084.83487.40
6263866-26386677.80180.09
极限1326060-32606096.13996.780.4699.0399.600.48
2327324-32732496.51299.19
3329919-32991997.27799.86
4329920-32992097.277100.29
5328343-32834396.81299.85
6327927-32792796.68999.41
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%
110.031684331686901687891685371685631686020.09
210.091693361697351695360.17
单位质量响应值RSD%判断
16809.7716802.380.04数据可信
供试品溶液-2023121421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%
5min110127-101275.4055.489.075.415.489.04
210653-106535.6865.69
39344-93444.9874.99
411178-111785.9665.97
511229-112295.9945.99
69022-90224.8164.82
10min117361-173619.2669.281.139.309.321.15
217672-176729.4329.46
317193-171939.1779.20
417361-173619.2669.30
517579-175799.3839.42
617198-171989.1799.21
15min117573-175739.3809.261.689.469.341.63
217706-177069.4519.53
317430-174309.3039.38
416948-169489.0469.13
517072-170729.1129.20
617355-173559.2639.34
20min117623-176239.4069.172.199.549.312.15
217491-174919.3369.47
317235-172359.1999.33
416794-167948.9649.10
516684-166848.9059.04
617308-173089.2389.37
30min116745-167458.9388.841.339.129.021.31
216885-168859.0129.20
316602-166028.8619.04
416374-163748.7408.92
516320-163208.7118.90
616465-164658.7888.97
45min116511-165118.8138.762.109.058.992.08
216933-169339.0389.28
316502-165028.8089.04
415956-159568.5178.75
516104-161048.5968.83
616442-164428.7769.01
60min116557-165578.8378.601.949.128.891.88
215909-159098.4918.78
316354-163548.7299.01
415953-159538.5158.80
515723-157238.3928.67
616219-162198.6578.94
极限116306-163068.7038.631.249.048.961.20
216226-162268.6619.00
316242-162428.6699.00
415828-158288.4488.78
516036-160368.5598.89
616361-163618.7339.06
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%
110.732985542991562990112986362991672989050.10
210.783013243013633013440.01
单位质量响应值RSD%判断
27856.9427953.990.25数据可信
供试品溶液-2023121421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%
5min1150172-15017244.45140.0723.1944.4540.0723.19
2127475-12747537.73337.73
3125693-12569337.20537.21
4164422-16442248.66948.67
5163228-16322848.31648.32
681255-8125524.05224.05
10min1246626-24662673.00172.242.6273.2572.462.65
2233913-23391369.23869.45
3246986-24698673.10873.31
4252203-25220374.65274.92
5244849-24484972.47572.74
6239749-23974970.96671.10
15min1262146-26214677.59575.832.5078.2576.462.50
2244901-24490172.49173.09
3256854-25685476.02976.64
4261639-26163977.44578.13
5253404-25340475.00875.68
6258188-25818876.42476.95
20min1264369-26436978.25376.912.4979.3477.962.48
2248558-24855873.57374.57
3260830-26083077.20678.24
4265733-26573378.65779.77
5256231-25623175.84476.93
6263267-26326777.92778.88
30min1265447-26544778.57277.112.1680.0978.582.17
2251112-25111274.32975.73
3261367-26136777.36578.83
4266195-26619578.79480.35
5257330-25733076.17077.68
6261606-26160677.43578.82
45min1264109-26410978.17678.210.8880.1380.110.88
2260832-26083277.20679.03
3263769-26376978.07679.97
4266264-26626478.81480.80
5263020-26302077.85479.79
6267288-26728879.11780.93
60min1267804-26780479.27079.812.7781.6682.152.72
2258029-25802976.37778.62
3265094-26509478.46880.80
4272838-27283880.76083.19
5277323-27732382.08884.45
6276701-27670181.90484.16
极限1328196-32819697.14697.070.4199.9899.840.40
2328630-32863097.27599.95
3325905-32590596.46899.23
4328902-32890297.355100.23
5326644-32664496.68799.51
6329260-32926097.461100.17
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%
110.031685421692761694941696721698901693750.31
210.091690811696151693480.23
单位质量响应值RSD%判断
16886.8416783.750.44数据可信
供试品溶液-2023121421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%
5min110267-102675.4715.425.805.475.425.82
29943-99435.2985.30
310604-106045.6505.65
49257-92574.9324.93
59991-99915.3245.32
610957-109575.8385.84
10min116880-168808.9949.141.299.029.171.33
217073-170739.0979.13
317223-172239.1779.21
417053-170539.0869.11
517201-172019.1659.19
617535-175359.3439.38
15min117268-172689.2019.110.659.289.190.64
217095-170959.1099.19
316963-169639.0389.12
417010-170109.0639.14
517114-171149.1199.20
617169-171699.1489.23
20min116756-167568.9289.001.459.069.131.44
216867-168678.9879.12
316588-165888.8398.97
417150-171509.1389.27
516769-167698.9359.07
617214-172149.1729.31
30min116156-161568.6088.761.328.798.941.31
216460-164608.7708.95
316693-166938.8959.08
416627-166278.8599.04
516216-162168.6408.82
616501-165018.7928.98
45min115971-159718.5108.571.188.748.801.17
216077-160778.5668.80
315980-159808.5158.75
416297-162978.6848.91
515828-158288.4348.66
616294-162948.6828.92
60min115538-155388.2798.451.838.568.721.78
215927-159278.4868.76
315636-156368.3318.61
416328-163288.7008.98
515694-156948.3628.64
615980-159808.5158.80
极限116262-162628.6658.461.348.998.791.31
215785-157858.4118.73
315686-156868.3588.68
415970-159708.5098.83
515719-157198.3768.70
615893-158938.4688.80
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%
110.732991233003243011733013053014073006660.33
210.783018143019493018820.04
单位质量响应值RSD%判断
28021.0628003.900.05数据可信
供试品溶液-2023121421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%
5min1146131-14613143.08940.1719.1543.0940.1719.14
2106743-10674331.47531.48
3136636-13663640.29040.29
4133165-13316539.26639.27
5114392-11439233.73133.73
6180344-18034453.17853.18
10min1242520-24252071.51273.042.5271.7573.262.55
2241416-24141671.18671.36
3253674-25367474.80175.02
4251709-25170974.22174.44
5242333-24233371.45671.64
6254534-25453475.05475.35
15min1261507-26150777.11076.611.2977.7577.241.32
2254838-25483875.14475.71
3264356-26435677.95078.59
4260231-26023176.73477.36
5257280-25728075.86476.45
6260696-26069676.87177.58
20min1265181-26518178.19478.531.5679.2679.581.59
2261615-26161577.14278.13
3268838-26883879.27280.34
4271629-27162980.09581.15
5261721-26172177.17378.18
6268958-26895879.30780.45
30min1263439-26343977.68079.022.5679.1880.502.58
2259833-25983376.61778.03
3276491-27649181.52983.04
4271382-27138280.02281.52
5262694-26269477.46078.89
6273982-27398280.78982.37
45min1283740-28374083.66682.155.5485.6084.085.47
2259487-25948776.51578.36
3304174-30417489.69191.66
4276052-27605281.39983.35
5267166-26716678.77980.64
6280917-28091782.83484.86
60min1296225-29622587.34784.587.3789.7486.977.23
2268328-26832879.12281.39
3324648-32464895.72998.19
4276998-27699881.67884.08
5270490-27049079.75982.06
6284422-28442283.86786.36
极限1335717-33571798.99297.930.84101.87100.780.86
2331793-33179397.835100.54
3334851-33485198.737101.73
4328209-32820996.77999.63
5331212-33121297.664100.41
6330811-33081197.546100.50
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