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DSMF-387-240606对照品来源自制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%
19.771652291663651665721663991659561661040.33
29.811654221648851651540.23
单位质量响应值RSD%判断
17001.4316835.270.70数据可信
供试品溶液-SC24092711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%
5min16385-63853.3883.8212.013.393.8212.00
27718-77184.0964.10
38512-85124.5174.52
47575-75754.0204.02
56476-64763.4363.44
66554-65543.4783.48
10min116181-161818.5868.411.608.618.431.62
215748-157488.3578.38
316115-161158.5518.58
415697-156978.3308.35
515522-155228.2378.26
615813-158138.3918.41
15min116584-165848.8008.751.338.878.821.31
216129-161298.5598.63
316415-164158.7118.78
416611-166118.8158.88
516761-167618.8948.96
616403-164038.7048.77
20min116608-166088.8138.750.678.938.870.66
216415-164158.7118.83
316621-166218.8208.94
416488-164888.7498.87
516453-164538.7318.85
616341-163418.6718.79
30min114854-148547.8828.363.898.058.533.79
215536-155368.2448.41
315324-153248.1328.30
416310-163108.6558.82
516251-162518.6248.79
616281-162818.6408.80
45min116777-167778.9038.442.969.118.652.88
216005-160058.4938.70
315878-158788.4268.64
415582-155828.2698.48
515743-157438.3548.56
615456-154568.2028.41
60min115801-158018.3858.334.108.648.583.95
214656-146567.7778.04
315622-156228.2908.55
416459-164598.7348.99
516230-162308.6128.87
615380-153808.1618.42
极限116834-168348.9338.613.899.248.923.76
216062-160628.5238.82
317155-171559.1039.41
415528-155288.2408.55
515767-157678.3678.67
616054-160548.5198.82
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100590-202406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(%)95.1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%
110.993091383078103078443088413088373084940.21
210.983076733063863070300.30
单位质量响应值RSD%判断
28070.4327962.660.28数据可信
供试品溶液-SC24092711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%
5min157838-5783817.08816.364.3017.0916.364.29
255364-5536416.35716.36
352585-5258515.53615.54
455536-5553616.40816.41
558096-5809617.16417.16
652741-5274115.58215.58
10min1109588-10958832.37831.664.6832.4731.754.67
2105841-10584131.27131.36
3103074-10307430.45330.54
4112878-11287833.35033.44
5111524-11152432.95033.04
6100142-10014229.58729.67
15min1136186-13618640.23639.215.1240.5139.475.12
2128990-12899038.11038.37
3131048-13104838.71838.97
4141095-14109541.68641.96
5136880-13688040.44140.72
6122015-12201536.04936.30
20min1144023-14402342.55142.424.4643.0542.904.46
2139549-13954941.23041.71
3141819-14181941.90042.37
4150850-15085044.56845.08
5150686-15068644.52045.02
6134531-13453139.74740.20
30min1139858-13985841.32140.725.7742.0641.445.74
2131195-13119538.76139.47
3131323-13132338.79939.50
4148042-14804243.73944.49
5146057-14605743.15243.90
6130548-13054838.57039.24
45min1147346-14734643.53341.835.8644.5042.785.83
2135500-13550040.03340.95
3137652-13765240.66941.59
4148883-14888343.98744.99
5150080-15008044.34145.33
6130086-13008638.43439.32
60min1145402-14540242.95941.445.7244.1642.625.69
2132361-13236139.10640.25
3136155-13615540.22741.37
4148678-14867843.92745.17
5147932-14793243.70644.94
6130981-13098138.69839.80
极限1158039-15803946.69246.412.9248.1447.822.91
2153904-15390445.47146.83
3163851-16385148.40949.78
4158707-15870746.89048.38
5157708-15770846.59548.07
6150361-15036144.42445.74
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DSMF-387-240606对照品来源自制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%
19.771659531661391655731655691671581660780.40
29.811669331677351673340.34
单位质量响应值RSD%判断
16998.7717057.490.25数据可信
供试品溶液-SC24092711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%
5min111974-119746.3135.1617.436.315.1617.38
28577-85774.5224.52
39348-93484.9284.93
48644-86444.5574.56
58265-82654.3574.36
611900-119006.2746.27
10min117077-170779.0038.681.979.048.712.00
216455-164558.6758.70
316263-162638.5748.60
416303-163038.5958.62
516550-165508.7258.75
616186-161868.5348.57
15min116991-169918.9588.722.899.048.802.85
216864-168648.8918.96
315879-158798.3728.45
416119-161198.4988.57
516998-169988.9629.03
616441-164418.6688.75
20min115769-157698.3148.461.888.458.581.83
215725-157258.2908.41
315897-158978.3818.50
416408-164088.6518.77
516388-163888.6408.76
616100-161008.4888.62
30min115469-154698.1568.142.868.348.322.84
215383-153838.1108.28
314766-147667.7857.95
415408-154088.1238.29
516154-161548.5178.69
615501-155018.1728.35
45min114812-148127.8097.851.718.048.061.64
215326-153268.0808.29
314883-148837.8478.06
414568-145687.6817.89
514955-149557.8858.10
614750-147507.7768.00
60min114460-144607.6247.652.627.897.922.52
214821-148217.8148.07
314485-144857.6377.89
414494-144947.6417.90
514972-149727.8938.16
613873-138737.3147.58
极限115408-154088.1237.802.468.448.112.44
214514-145147.6527.95
314354-143547.5687.87
414885-148857.8488.15
514869-148697.8398.14
614774-147747.7898.10
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100590-202406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(%)95.1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%
110.993068763083173077143078603071873075910.19
210.983107303091583099440.36
单位质量响应值RSD%判断
27988.2628228.050.61数据可信
供试品溶液-SC24092711批-阿托伐他汀钙-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%
5min1146016-14601643.00035.3815.1243.0035.3815.12
2111960-11196032.97132.97
3126642-12664237.29537.29
491499-9149926.94626.95
5117903-11790334.72134.72
6126814-12681437.34537.35
10min1240298-24029870.76567.933.3871.0068.133.40
2225488-22548866.40466.59
3238669-23866970.28670.49
4219828-21982864.73764.89
5229760-22976067.66267.85
6230018-23001867.73867.95
15min1272040-27204080.11377.882.5780.7478.462.60
2261125-26112576.89977.45
3272604-27260480.27980.88
4254889-25488975.06275.57
5263306-26330677.54178.11
6262828-26282877.40077.98
20min1281191-28119182.80880.262.4983.8881.272.51
2267440-26744078.75879.74
3277705-27770581.78182.82
4263503-26350377.59978.53
5275921-27592181.25682.26
6269562-26956279.38380.40
30min1291730-29173085.91183.492.0487.4584.952.04
2275534-27553481.14282.56
3284532-28453283.79285.29
4287578-28757884.68986.05
5282358-28235883.15184.60
6279381-27938182.27583.73
45min1300806-30080688.58485.443.4690.6087.363.41
2283046-28304683.35485.22
3297706-29770687.67189.63
4298857-29885788.01089.84
5282229-28222983.11485.03
6278210-27821081.93083.84
60min1296640-29664087.35784.582.8389.8686.972.81
2278242-27824281.93984.27
3294110-29411086.61289.06
4292172-29217286.04288.36
5278701-27870182.07584.45
6283313-28331383.43385.80
极限1307871-30787190.66588.581.8993.6691.441.88
2295842-29584287.12289.91
3301350-30135088.74491.68
4307190-30719090.46493.26
5294865-29486586.83589.67
6297645-29764587.65390.48
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DSMF-387-240606对照品来源自制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%
19.771670071675941672041677531680721675260.26
29.811664001671171667580.31
单位质量响应值RSD%判断
17146.9816998.780.62数据可信
供试品溶液-SC24092711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%
5min110540-105405.5424.4323.085.544.4323.05
26615-66153.4783.48
36005-60053.1583.16
410592-105925.5705.57
57850-78504.1284.13
68941-89414.7024.70
10min115357-153578.0757.874.038.117.894.07
214530-145307.6417.66
314719-147197.7407.76
415101-151017.9417.97
515868-158688.3448.37
614201-142017.4687.49
15min115480-154808.1407.972.308.228.042.30
215302-153028.0468.11
315488-154888.1448.20
415186-151867.9858.06
514671-146717.7157.78
614789-147897.7777.84
20min114409-144097.5777.701.317.707.821.25
214700-147007.7307.84
314865-148657.8177.92
414810-148107.7887.91
514429-144297.5877.70
614661-146617.7097.82
30min113815-138157.2657.452.337.437.602.27
214392-143927.5687.72
314406-144067.5757.72
414522-145227.6367.80
514088-140887.4087.56
613746-137467.2287.38
45min113833-138337.2747.313.447.487.513.38
213559-135597.1307.32
314017-140177.3717.56
413873-138737.2957.50
514758-147587.7607.96
613381-133817.0367.23
60min113123-131236.9017.073.827.147.313.67
214061-140617.3947.62
313921-139217.3207.55
413655-136557.1807.43
512728-127286.6936.93
613216-132166.9507.18
极限114081-140817.4047.302.507.697.582.42
214017-140177.3717.64
314101-141017.4157.69
413847-138477.2817.57
514087-140877.4087.68
613210-132106.9467.22
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100590-202406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(%)95.1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%
110.993096393106923113033111203106853106880.21
210.983085133104293094710.44
单位质量响应值RSD%判断
28270.0628184.970.22数据可信
供试品溶液-SC24092711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%
5min1203746-20374659.74653.3524.7259.7553.3524.73
2210436-21043661.70861.71
3172049-17204950.45250.45
4216101-21610163.36963.37
595774-9577428.08528.08
6193460-19346056.73056.73
10min1238375-23837569.90175.9910.8670.2376.2910.87
2267588-26758878.46778.81
3281668-28166882.59682.88
4299368-29936887.78788.14
5228595-22859567.03367.19
6239321-23932170.17870.49
15min1238867-23886770.04578.1711.7970.7778.8911.78
2273308-27330880.14580.92
3288023-28802384.46085.20
4315186-31518692.42593.26
5235061-23506168.92969.46
6249061-24906173.03573.74
20min1238910-23891070.05877.9611.4871.1779.1111.48
2271112-27111279.50180.72
3290119-29011985.07486.28
4311188-31118891.25392.61
5234682-23468268.81869.73
6249114-24911473.05074.16
30min1237833-23783369.74278.5511.1771.2480.1411.17
2280661-28066182.30183.97
3287761-28776184.38386.06
4311770-31177091.42393.28
5242663-24266371.15872.45
6246619-24661972.31873.84
45min1245799-24579972.07881.849.0173.9683.869.03
2289298-28929884.83486.96
3294478-29447886.35388.50
4314902-31490292.34294.71
5268791-26879178.82080.51
6261286-26128676.61978.54
60min1246754-24675472.35880.889.2074.6483.369.23
2281221-28122182.46585.06
3293964-29396486.20288.83
4314152-31415292.12295.00
5260953-26095376.52278.65
6257864-25786475.61677.96
极限1315451-31545192.50395.345.4795.1998.265.44
2317826-31782693.19996.25
3360699-360699105.771108.88
4323191-32319194.77298.17
5320030-32003093.84596.40
6313465-31346591.92094.68
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