氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661447149146476214649981466700146499614617210.56
210.611469754147096214703580.06
单位质量响应值RSD%判断
137122.05138582.280.75数据可信
长期24月-供试品溶液-2024041521批-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%
60min1127972-1279728.5758.214.688.578.214.66
2121021-1210218.1098.11
3113138-1131387.5817.58
4128067-1280678.5818.58
5125107-1251078.3838.38
6119989-1199898.0408.04
120min1246608-24660816.52416.294.2516.5416.304.26
2241596-24159616.18816.20
3225957-22595715.14115.15
4252711-25271116.93316.95
5253553-25355316.99017.00
6238245-23824515.96415.98
240min1468049-46804931.36231.056.7631.4031.096.75
2486783-48678332.61732.65
3408135-40813527.34827.38
4479115-47911532.10432.14
5491144-49114432.91032.95
6447421-44742129.98030.02
360min1690734-69073446.28345.458.1346.3745.548.12
2703126-70312647.11447.20
3573831-57383138.45038.53
4703850-70385047.16247.25
5730526-73052648.95049.04
6667865-66786544.75144.83
480min1925644-92564462.02459.189.1862.1859.349.17
2889608-88960859.60959.77
3728997-72899748.84748.98
4915925-91592561.37361.53
5961274-96127464.41164.57
6878169-87816958.84358.99
600min11119631-111963175.02271.788.7075.2772.028.70
21082397-108239772.52772.77
3887848-88784859.49159.70
41098266-109826673.59173.84
51150424-115042477.08677.34
61088670-108867072.94873.18
720min11272707-127270785.27982.437.5685.6482.777.56
21240384-124038483.11383.47
31046892-104689270.14870.44
41255905-125590584.15384.51
51310569-131056987.81688.19
61254334-125433484.04884.39
840min11433796-143379696.07393.457.0796.5693.927.07
21391877-139187793.26493.74
31206471-120647180.84181.24
41408616-140861694.38694.87
51494475-1494475100.139100.64
61432239-143223995.96996.44
960min11509332-1509332101.135100.731.49101.77101.341.52
21490755-149075599.890100.51
31471489-147148998.59999.12
41497979-1497979100.374101.00
51537731-1537731103.037103.69
61512675-1512675101.359101.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min11505762-1505762100.895101.171.27101.68101.931.26
21485278-148527899.523100.29
31525696-1525696102.231102.90
41495235-1495235100.190100.97
51537174-1537174103.000103.81
61509969-1509969101.177101.95
1200min11508003-1508003101.046101.221.19101.98102.131.17
21486764-148676499.622100.54
31526247-1526247102.268103.09
41495548-1495548100.211101.14
51533795-1533795102.774103.74
61512852-1512852101.370102.29
1320min11510190-1510190101.192101.311.19102.28102.371.17
21488400-148840099.732100.80
31528894-1528894102.445103.42
41496487-1496487100.274101.35
51534773-1534773102.839103.96
61512619-1512619101.355102.43
1440min11502368-1502368100.668100.731.21101.91101.951.19
21477905-147790599.029100.25
31522202-1522202101.997103.13
41488408-148840899.733100.96
51523909-1523909102.111103.38
61505292-1505292100.864102.09
极限11499817-1499817100.497100.621.23101.89101.991.22
21475069-147506998.839100.20
31519668-1519668101.827103.11
41488425-148842599.734101.11
51523858-1523858102.108103.53
61503042-1503042100.713102.09
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661467901146833814692991469521146851714687150.05
210.611467222146683514670280.02
单位质量响应值RSD%判断
137778.14138268.430.26数据可信
长期24月-供试品溶液-2024041521批-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%
60min1118040-1180407.8998.477.867.908.477.86
2126743-1267438.4828.48
3118677-1186777.9427.94
4121823-1218238.1538.15
5144695-1446959.6839.68
6129517-1295178.6678.67
120min1227155-22715515.20216.077.9415.2116.087.94
2247361-24736116.55416.57
3214386-21438614.34714.36
4230573-23057315.43015.44
5260130-26013017.40817.42
6261177-26117717.47817.49
240min1428349-42834928.66630.689.8828.7030.729.87
2487955-48795532.65532.69
3397386-39738626.59426.63
4431404-43140428.87028.91
5498061-49806133.33133.37
6507862-50786233.98734.03
360min1652283-65228343.65244.768.9243.7344.858.92
2719330-71933048.13948.23
3568669-56866938.05638.13
4643199-64319943.04443.12
5715887-71588747.90848.00
6713924-71392447.77747.87
480min1823883-82388355.13558.0810.0155.2858.2310.01
2934528-93452862.54062.70
3725261-72526148.53648.67
4845238-84523856.56556.71
5952569-95256963.74763.91
6925535-92553561.93862.10
600min1963133-96313364.45469.827.4064.6870.067.41
21114294-111429474.57074.82
3939327-93932762.86163.06
41044942-104494269.92970.16
51124153-112415375.23075.49
61074271-107427171.89272.15
720min11189362-118936279.59481.154.5579.9281.494.57
21272976-127297685.18985.55
31130674-113067475.66675.96
41191806-119180679.75780.09
51274749-127474985.30885.68
61216158-121615881.38781.75
840min11293189-129318986.54292.135.4586.9892.605.46
21449720-144972097.01797.51
31288211-128821186.20986.62
41379809-137980992.33992.79
51465785-146578598.09298.59
61383857-138385792.61093.09
960min11414532-141453294.66397.902.1095.2398.502.12
21478101-147810198.91799.55
31437479-143747996.19896.74
41478278-147827898.92999.52
51496960-1496960100.179100.82
61471912-147191298.50299.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min11428181-142818195.57698.301.5296.2999.051.54
21477562-147756298.88199.67
31466052-146605298.11098.79
41478498-147849898.94399.68
51494556-1494556100.018100.81
61468832-146883298.29699.07
1200min11417905-141790594.88898.161.7695.7599.061.78
21475084-147508498.71599.65
31466559-146655998.14498.98
41476635-147663598.81999.71
51494365-1494365100.005100.95
61470559-147055998.41299.33
1320min11441795-144179596.48798.361.0897.4999.401.10
21472523-147252398.54399.63
31466140-146614098.11699.10
41476616-147661698.81799.85
51489777-148977799.698100.79
61471499-147149998.47599.54
1440min11406312-140631294.11297.531.8295.2698.721.82
21464603-146460398.01399.24
31458854-145885497.62998.75
41468769-146876998.29299.48
51483098-148309899.251100.50
61462655-146265597.88399.10
极限11456161-145616197.44897.910.6298.7399.250.65
21461680-146168097.81899.20
31456758-145675897.48898.76
41463266-146326697.92499.26
51480563-148056399.081100.48
61460153-146015397.71699.08
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661455934145891814592601459452145942014585970.11
210.611455062145411114545860.05
单位质量响应值RSD%判断
136828.99137095.760.14数据可信
长期24月-供试品溶液-2024041721批-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%
60min1121269-1212698.1788.314.798.188.314.80
2129376-1293768.7258.73
3113247-1132477.6377.64
4121791-1217918.2148.21
5128501-1285018.6668.67
6124812-1248128.4178.42
120min1230609-23060915.55216.326.3615.5616.346.36
2264094-26409417.81017.82
3222045-22204514.97514.99
4239109-23910916.12516.14
5254674-25467417.17517.19
6241763-24176316.30416.32
240min1465921-46592131.42231.046.7231.4631.086.72
2494247-49424733.33233.37
3407519-40751927.48327.52
4447073-44707330.15030.19
5485480-48548032.74132.78
6461489-46148931.12331.16
360min1640004-64000443.16245.317.9243.2445.397.92
2717583-71758348.39448.48
3580767-58076739.16739.24
4677942-67794245.72045.80
5717124-71712448.36348.45
6697610-69761047.04747.13
480min1880811-88081159.40259.638.0159.5559.788.01
2934636-93463663.03263.19
3750754-75075450.63150.76
4879222-87922259.29459.44
5944804-94480463.71763.88
6915290-91529061.72761.88
600min11055724-105572471.19871.966.5071.4372.206.50
21114856-111485675.18675.44
3937270-93727063.20963.42
41068544-106854472.06272.30
51129153-112915376.15076.41
61096439-109643973.94374.19
720min11218893-121889382.20283.054.3382.5583.404.34
21268583-126858385.55385.92
31133961-113396176.47476.78
41230925-123092583.01383.36
51282430-128243086.48786.86
61254422-125442284.59884.96
840min11428189-142818996.31795.553.6896.7896.023.69
21472808-147280899.32699.82
31339970-133997090.36790.79
41379849-137984993.05793.53
51471332-147133299.22699.73
61408606-140860694.99695.48
960min11480744-148074499.861100.661.30100.47101.281.32
21498427-1498427101.053101.70
31478802-147880299.730100.28
41498171-1498171101.036101.65
51525983-1525983102.912103.56
61473422-147342299.36799.99
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min11479924-147992499.806100.611.28100.57101.381.28
21497916-1497916101.019101.82
31490084-1490084100.491101.20
41495398-1495398100.849101.61
51522116-1522116102.651103.45
61465663-146566398.84499.62
1200min11485549-1485549100.185100.521.22101.10101.431.22
21494799-1494799100.809101.76
31489008-1489008100.418101.27
41494992-1494992100.822101.74
51517145-1517145102.316103.27
61461155-146115598.54099.46
1320min11489779-1489779100.470100.541.41101.53101.601.41
21497644-1497644101.001102.10
31488989-1488989100.417101.42
41495329-1495329100.845101.91
51518785-1518785102.426103.54
61454041-145404198.06099.13
1440min11478642-147864299.71999.981.48100.93101.201.47
21487968-1487968100.348101.60
31484186-1484186100.093101.25
41490643-1490643100.528101.75
51510063-1510063101.838103.10
61443664-144366497.36098.58
极限11477012-147701299.60999.831.51100.97101.201.50
21488708-1488708100.398101.80
31481303-148130399.899101.21
41486883-1486883100.275101.64
51507478-1507478101.664103.08
61440241-144024197.12998.49
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661456860145756414569621456759145693514570160.03
210.611456212145655014563810.02
单位质量响应值RSD%判断
136680.68137264.940.31数据可信
长期24月-供试品溶液-2024041721批-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%
60min1107998-1079987.2838.3912.357.288.3912.34
2135071-1350719.1089.11
3104209-1042097.0277.03
4141989-1419899.5759.57
5133271-1332718.9878.99
6123754-1237548.3458.35
120min1215931-21593114.56116.409.6814.5716.419.69
2255478-25547817.22817.24
3213129-21312914.37214.38
4271088-27108818.28118.30
5256385-25638517.28917.30
6246962-24696216.65416.67
240min1410274-41027427.66730.347.7627.7030.387.76
2465163-46516331.36831.41
3402382-40238227.13527.17
4487351-48735132.86432.91
5470890-47089031.75431.79
6463418-46341831.25031.29
360min1591953-59195339.91844.107.3139.9944.187.31
2680267-68026745.87445.96
3597091-59709140.26540.34
4691454-69145446.62846.72
5700353-70035347.22847.32
6662629-66262944.68444.77
480min1783676-78367652.84758.266.1752.9858.406.18
2895445-89544560.38460.54
3811321-81132154.71154.84
4900995-90099560.75860.92
5912906-91290661.56261.72
6878967-87896759.27359.42
600min11005317-100531767.79371.114.6468.0171.344.65
21088724-108872473.41873.66
3981941-98194166.21766.43
41100149-110014974.18874.44
51083794-108379473.08573.34
61066772-106677271.93872.18
720min11181999-118199979.70882.083.2480.0282.423.26
21246006-124600684.02484.38
31158375-115837578.11578.43
41262152-126215285.11385.48
51228623-122862382.85283.21
61226173-122617382.68783.03
840min11338869-133886990.28692.872.9890.7293.342.99
21396803-139680394.19394.68
31329099-132909989.62790.06
41442070-144207097.24697.74
51374088-137408892.66193.15
61382549-138254993.23293.70
960min11499768-1499768101.137100.100.97101.71100.710.94
21471876-147187699.25699.88
31502640-1502640101.330101.90
41479599-147959999.776100.41
51467840-146784098.98399.61
61484966-1484966100.138100.75
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min11497881-1497881101.00999.821.21101.73100.571.18
21467569-146756998.96599.74
31498310-1498310101.038101.76
41476111-147611199.541100.33
51453471-145347198.01498.79
61487742-1487742100.326101.09
1200min11496048-1496048100.88699.711.35101.76100.621.32
21468651-146865199.03899.96
31502836-1502836101.343102.21
41476605-147660599.575100.51
51447403-144740397.60598.52
61480237-148023799.819100.73
1320min11490180-1490180100.49099.181.59101.51100.241.56
21462785-146278598.64399.71
31494718-1494718100.796101.82
41465769-146576998.84499.93
51430806-143080696.48697.55
61480282-148028299.822100.89
1440min11484553-1484553100.11182.3149.02101.2983.5148.31
21456971-145697198.25199.47
31485908-1485908100.202101.37
41467025-146702598.929100.16
51428854-142885496.35497.56
6-0.0001.21
极限1-0.0000.00-1.331.324.55
2-0.0001.36
3-0.0001.32
4-0.0001.38
5-0.0001.35
6-0.0001.21
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661460796146115414598501462218145807414604180.11
210.611460017145724114586290.14
单位质量响应值RSD%判断
136999.81137476.810.25数据可信
长期24月-供试品溶液-2024041821批-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%
60min1117457-1174577.9058.564.557.918.564.54
2132390-1323908.9108.91
3129644-1296448.7268.73
4124416-1244168.3748.37
5126201-1262018.4948.49
6132738-1327388.9348.93
120min1235808-23580815.87116.722.6815.8816.732.69
2252654-25265417.00517.02
3252524-25252416.99617.01
4246454-24645416.58716.60
5249735-24973516.80816.82
6253116-25311617.03617.05
240min1456872-45687230.74931.691.8430.7931.721.83
2469414-46941431.59431.63
3475729-47572932.01932.06
4478342-47834232.19432.23
5478956-47895632.23632.27
6465417-46541731.32531.36
360min1663818-66381844.67845.832.1944.7645.922.19
2702763-70276347.29947.39
3674764-67476445.41445.50
4693674-69367446.68746.77
5681679-68167945.88045.97
6669208-66920845.04145.13
480min1855211-85521157.55959.883.3757.7160.043.37
2928750-92875062.50962.67
3864718-86471858.19958.35
4906698-90669861.02561.18
5912090-91209061.38861.54
6870862-87086258.61358.77
600min11061305-106130571.43072.352.3571.6772.592.35
21109870-110987074.69974.95
31036807-103680769.78170.02
41085763-108576373.07673.32
51087243-108724373.17673.42
61068500-106850071.91572.16
720min11220460-122046082.14282.861.7882.4883.221.78
21262857-126285784.99685.36
31197584-119758480.60280.95
41234826-123482683.10983.47
51242316-124231683.61383.97
61229086-122908682.72383.07
840min11376303-137630392.63194.172.0293.1094.652.02
21450250-145025097.60898.10
31380160-138016092.89193.36
41409285-140928594.85195.33
51399666-139966694.20394.69
61379554-137955492.85093.32
960min11482686-148268699.791100.120.57100.40100.740.56
21492102-1492102100.425101.06
31496941-1496941100.750101.36
41489879-1489879100.275100.90
51473290-147329099.15999.78
61490442-1490442100.313100.93
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min11483621-148362199.85499.890.43100.61100.660.42
21486937-1486937100.077100.86
31491601-1491601100.391101.15
41486051-1486051100.017100.79
51472763-147276399.12399.90
61483915-148391599.874100.64
1200min11476882-147688299.40099.660.41100.30100.570.40
21483471-148347199.844100.78
31489011-1489011100.217101.13
41480709-148070999.658100.58
51471638-147163899.04799.97
61482359-148235999.769100.68
1320min11480935-148093599.67399.670.46100.73100.740.45
21483904-148390499.873100.96
31487556-1487556100.119101.18
41481620-148162099.719100.79
51468087-146808798.80899.88
61483315-148331599.833100.90
1440min11477308-147730899.42999.400.44100.63100.610.43
21480119-148011999.618100.86
31483972-148397299.878101.09
41475508-147550899.308100.53
51465137-146513798.61099.83
61478793-147879399.529100.74
极限11470357-147035798.96199.090.48100.31100.460.47
21477745-147774599.458100.85
31479889-147988999.603100.96
41471591-147159199.044100.42
51460131-146013198.27399.64
61473819-147381999.194100.56
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661452191145475314512071454300145270914530320.11
210.611451612145459314531020.15
单位质量响应值RSD%判断
136306.94136955.890.34数据可信
长期24月-供试品溶液-2024041821批-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%
60min1107173-1071737.2457.619.787.257.619.79
2106854-1068547.2247.22
3108852-1088527.3597.36
4119537-1195378.0818.08
5101672-1016726.8736.87
6131613-1316138.8978.90
120min1210066-21006614.20115.1610.2714.2115.1710.27
2215212-21521214.54914.56
3212073-21207314.33714.35
4240925-24092516.28716.30
5203795-20379513.77713.79
6263249-26324917.79717.81
240min1396554-39655426.80828.7511.2026.8428.7911.21
2412322-41232227.87427.91
3403665-40366527.28927.32
4460612-46061231.13931.18
5375155-37515525.36225.39
6503451-50345134.03534.08
360min1577056-57705639.01141.5310.7039.0841.6110.70
2601014-60101440.63140.71
3582746-58274639.39639.47
4676090-67609045.70645.79
5538129-53812936.37936.45
6711267-71126748.08448.18
480min1769050-76905051.99054.1310.6352.1254.2710.63
2790102-79010253.41453.55
3758016-75801651.24451.38
4889996-88999660.16760.32
5686184-68618446.38846.51
6910916-91091661.58161.74
600min1954725-95472564.54366.4110.2264.7566.6310.22
2997263-99726367.41867.63
3933351-93335163.09863.31
41070109-107010972.34372.59
5829733-82973356.09356.29
61108560-110856074.94275.20
720min11139314-113931477.02178.078.5377.3378.398.53
21180982-118098279.83880.16
31142531-114253177.23977.54
41218510-121851082.37582.73
5979888-97988866.24466.52
61267430-126743085.68386.05
840min11306599-130659988.33089.128.2388.7589.568.23
21337677-133767790.43190.87
31307124-130712488.36688.79
41363292-136329292.16392.64
51131139-113113976.46976.85
61463426-146342698.93299.43
960min11466439-146643999.13697.524.8099.6998.094.82
21480301-1480301100.073100.65
31446841-144684197.81198.36
41469987-146998799.37699.99
51304078-130407888.16088.65
61487522-1487522100.561101.21
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min11463225-146322598.919100.211.1599.62100.931.17
21486564-1486564100.497101.22
31495243-1495243101.083101.78
41468914-146891499.304100.06
51473019-147301999.581100.20
61507196-1507196101.891102.69
1200min11466180-146618099.119100.191.0999.97101.061.11
21483098-1483098100.262101.14
31491025-1491025100.798101.65
41465125-146512599.04799.96
51479047-147904799.989100.76
61508015-1508015101.947102.90
1320min11463471-146347198.936100.201.1199.94101.221.13
21485310-1485310100.412101.44
31493030-1493030100.934101.94
41471172-147117299.456100.52
51472362-147236299.537100.46
61507415-1507415101.906103.01
1440min11463368-146336898.92999.991.04100.08101.161.05
21478276-147827699.936101.11
31490545-1490545100.766101.92
41463038-146303898.906100.11
51476832-147683299.839100.91
61502289-1502289101.560102.81
极限11454266-145426698.31399.681.1299.61101.001.14
21476619-147661999.824101.15
31481570-1481570100.159101.46
41463911-146391198.965100.32
51469129-146912999.318100.54
61501697-1501697101.520102.93
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