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%
19.851664081657681660591661271660951660910.14
29.911655781660581658180.21
单位质量响应值RSD%判断
16862.0316732.390.55数据可信
供试品溶液-2022091801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%
5min111517-115176.1515.1915.306.155.1915.27
28836-88364.7194.72
38366-83664.4684.47
410939-109395.8425.84
58035-80354.2914.29
610663-106635.6955.69
10min116975-169759.0658.863.629.108.893.59
216350-163508.7328.76
317506-175069.3499.37
416638-166388.8858.92
515774-157748.4248.45
616299-162998.7048.74
15min116997-169979.0779.120.689.169.190.67
217270-172709.2239.30
317050-170509.1059.18
417133-171339.1509.23
517009-170099.0849.15
616959-169599.0579.14
20min117017-170179.0889.061.079.229.181.05
217205-172059.1889.31
317129-171299.1489.27
416761-167618.9519.08
516799-167998.9719.09
616880-168809.0159.14
30min117401-174019.2938.932.479.489.112.47
216965-169659.0609.24
316610-166108.8709.05
416553-165538.8409.02
516220-162208.6628.83
616544-165448.8359.02
45min116738-167388.9398.721.259.188.961.29
216315-163158.7138.94
316205-162058.6548.88
416317-163178.7148.95
516198-161988.6508.87
616250-162508.6788.91
60min116440-164408.7808.710.639.078.990.70
216329-163298.7209.00
316307-163078.7098.98
416282-162828.6958.98
516136-161368.6178.88
616362-163628.7389.02
极限116382-163828.7498.700.519.089.020.51
216358-163588.7369.06
316150-161508.6258.95
416260-162608.6849.01
516285-162858.6979.01
616260-162608.6849.01
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%
111.003198943186143191833190833191463191840.15
211.053186373191283188820.11
单位质量响应值RSD%判断
29016.7328858.100.39数据可信
供试品溶液-2022091801批-阿托伐他汀钙-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%
5min142434-4243412.11311.565.5912.1111.565.60
241079-4107911.72611.73
337853-3785310.80510.80
440166-4016611.46511.47
538023-3802310.85410.85
643362-4336212.37812.38
10min176752-7675221.90923.356.5221.9823.426.49
289678-8967825.59825.66
385122-8512224.29824.36
475229-7522921.47421.54
582223-8222323.47023.53
681846-8184623.36323.43
15min199290-9929028.34230.225.3728.5330.425.36
2115186-11518632.87933.09
3108046-10804630.84131.04
4100751-10075128.75928.94
5106130-10613030.29430.49
6105898-10589830.22830.43
20min1114187-11418732.59434.064.1632.9434.424.17
2127228-12722836.31736.71
3119772-11977234.18834.55
4114482-11448232.67833.02
5117955-11795533.67034.03
6122277-12227734.90335.27
30min1133637-13363738.14637.864.0738.6738.414.04
2137829-13782939.34339.93
3128492-12849236.67837.23
4128849-12884936.77937.30
5127062-12706236.26936.82
6140038-14003839.97340.53
45min1133499-13349938.10737.404.4738.8538.164.41
2131813-13181337.62538.44
3126508-12650836.11136.87
4127976-12797636.53037.26
5125290-12529035.76436.51
6141101-14110140.27741.06
60min1139223-13922339.74139.024.8340.6939.994.76
2139201-13920139.73440.75
3131353-13135337.49438.45
4134371-13437138.35639.29
5128891-12889136.79137.74
6147168-14716842.00843.01
极限1152223-15222343.45143.042.7544.6244.232.76
2153380-15338043.78245.02
3146941-14694141.94443.11
4149660-14966042.72043.86
5145785-14578541.61442.76
6156761-15676144.74745.99
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%
19.851652541651411655791658501658981655440.21
29.911662421673751668080.49
单位质量响应值RSD%判断
16806.5016832.290.11数据可信
供试品溶液-2022091801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%
5min19529-95295.0825.135.725.085.135.76
29490-94905.0615.06
310071-100715.3715.37
410178-101785.4285.43
59809-98095.2315.23
68653-86534.6154.61
10min115007-150078.0048.483.388.038.513.37
216155-161558.6168.64
316347-163478.7188.75
415852-158528.4548.48
516435-164358.7658.79
615600-156008.3208.35
15min116404-164048.7498.932.288.829.012.26
217491-174919.3289.40
316576-165768.8408.92
416637-166378.8738.95
516776-167768.9479.02
616616-166168.8628.93
20min116379-163798.7358.932.158.869.052.12
217386-173869.2729.40
316706-167068.9109.04
416485-164858.7928.92
516850-168508.9879.11
616608-166088.8588.98
30min116039-160398.5548.821.828.729.001.84
216924-169249.0269.21
316694-166948.9039.08
416408-164088.7518.93
516531-165318.8168.99
616654-166548.8829.05
45min116136-161368.6068.691.718.828.921.72
216680-166808.8969.13
316620-166208.8649.09
416165-161658.6218.85
516154-161548.6158.84
616034-160348.5518.77
60min115844-158448.4508.551.798.728.821.79
216534-165348.8189.10
316020-160208.5448.82
415694-156948.3708.64
516089-160898.5818.85
615970-159708.5178.78
极限115829-158298.4428.551.748.758.871.72
216451-164518.7749.10
316024-160248.5468.87
415694-156948.3708.69
516260-162608.6728.99
615962-159628.5138.83
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%
111.003185323179163188723192553191653187480.18
211.053196073216483206280.46
单位质量响应值RSD%判断
28977.0929016.110.10数据可信
供试品溶液-2022091801批-阿托伐他汀钙-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%
5min139761-3976111.32610.7618.8411.3310.7618.82
242967-4296712.24012.24
325264-252647.1977.20
437551-3755110.69710.70
545540-4554012.97312.97
635515-3551510.11710.12
10min178266-7826622.29522.2214.3122.3622.2814.32
286949-8694924.76824.84
360168-6016817.14017.18
474251-7425121.15121.21
592353-9235326.30826.38
675990-7599021.64721.70
15min1100139-10013928.52628.7911.6928.7128.9811.71
2112438-11243832.02932.23
382991-8299123.64123.78
497166-9716627.67927.86
5115735-11573532.96833.19
697958-9795827.90428.08
20min1111824-11182431.85432.5110.1432.2032.8610.17
2124426-12442635.44435.83
399099-9909928.22928.50
4107826-10782630.71531.05
5130868-13086837.27937.68
6110734-11073431.54431.88
30min1122097-12209734.78136.019.2935.3036.549.33
2133115-13311537.91938.50
3113024-11302432.19632.62
4119339-11933933.99534.50
5146244-14624441.65942.27
6124682-12468235.51736.02
45min1124177-12417735.37336.068.7636.0936.788.79
2129768-12976836.96637.76
3115549-11554932.91533.52
4121243-12124334.53735.23
5147136-14713641.91342.75
6121591-12159134.63735.34
60min1128727-12872736.66937.139.0637.5838.069.08
2132279-13227937.68138.68
3117744-11774433.54134.33
4124835-12483535.56136.44
5152324-15232443.39144.46
6126172-12617235.94236.84
极限1145125-14512541.34041.955.6842.4643.085.80
2149297-14929742.52943.73
3138841-13884139.55040.52
4144279-14427941.09942.18
5162898-16289846.40347.72
6143191-14319140.79041.89
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