依折麦布瑞舒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%
110.261703441711471720131727561732281718980.69
210.261728621744411736520.65
单位质量响应值RSD%判断
16754.1916925.150.72数据可信
供试品溶液-X013993批-依折麦布-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min112302-123026.5536.107.466.556.107.48
210384-103845.5325.53
310741-107415.7225.72
411291-112916.0156.01
512572-125726.6976.70
611410-114106.0786.08
10min117320-173209.2269.152.599.269.182.59
217631-176319.3929.42
316837-168378.9699.00
416447-164478.7618.79
517316-173169.2249.26
617472-174729.3079.34
15min117854-178549.5119.541.369.609.621.34
218207-182079.6999.78
318003-180039.5909.67
417829-178299.4989.58
517504-175049.3249.41
618060-180609.6219.71
20min117989-179899.5839.641.709.729.781.67
218421-184219.8139.95
318406-184069.8059.94
418063-180639.6229.76
517595-175959.3739.51
618161-181619.6749.81
30min117758-177589.4609.542.259.659.732.21
217957-179579.5669.76
318104-181049.6449.83
417746-177469.4539.64
517327-173279.2309.42
618527-185279.86910.06
45min117373-173739.2559.412.209.509.652.17
217502-175029.3239.57
318140-181409.6639.91
417732-177329.4469.69
517158-171589.1409.38
618056-180569.6189.87
60min117459-174599.3009.332.039.609.621.99
217818-178189.4929.79
317755-177559.4589.75
417396-173969.2679.56
516873-168738.9889.28
617734-177349.4479.75
极限117503-175039.3249.361.919.679.711.87
217592-175929.3719.72
317814-178149.4909.84
417527-175279.3379.68
516992-169929.0529.40
617968-179689.5729.93
依折麦布瑞舒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%
110.823044493054753068483080063086993066950.58
210.863085923111513098720.59
单位质量响应值RSD%判断
28345.1928533.330.47数据可信
供试品溶液-X013993批-瑞舒伐他汀钙-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min124441-244417.0997.1613.517.107.1613.52
229823-298238.6628.66
320742-207426.0246.02
425508-255087.4097.41
526079-260797.5757.57
621393-213936.2146.21
10min1116184-11618433.74529.6421.6333.7829.6821.60
276756-7675622.29422.34
3117085-11708534.00734.04
472450-7245021.04321.08
5123929-12392935.99536.04
6105926-10592630.76630.80
15min1174429-17442950.66247.1216.9250.8947.3216.92
2139374-13937440.48140.65
3194540-19454056.50456.73
4120925-12092535.12235.28
5180764-18076452.50252.74
6163270-16327047.42147.63
20min1210241-21024161.06459.0411.5061.5759.5011.54
2192274-19227455.84556.24
3234207-23420768.02568.56
4166294-16629448.30048.65
5217950-21795063.30363.84
6198628-19862857.69158.16
30min1238069-23806969.14669.207.6069.9970.007.67
2232759-23275967.60468.31
3261455-26145575.93976.85
4207424-20742460.24660.87
5248828-24882872.27173.16
6241067-24106770.01770.81
45min1256954-25695474.63175.105.3875.8676.285.47
2254323-25432373.86774.95
3277372-27737280.56281.90
4235525-23552568.40769.36
5265647-26564777.15678.44
6261575-26157575.97477.15
60min1275057-27505779.88979.133.9681.5480.734.06
2272010-27201079.00480.50
3282919-28291982.17383.96
4251717-25171773.11074.45
5275837-27583780.11681.83
6277118-27711880.48882.09
极限1291952-29195284.79784.011.7186.8986.041.82
2286688-28668883.26885.20
3293495-29349585.24587.48
4281652-28165281.80583.55
5287203-28720383.41785.58
6294461-29446185.52587.57
依折麦布瑞舒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%
110.261739511750131757871762401764801754940.59
210.261728091743141735620.62
单位质量响应值RSD%判断
17104.6816916.370.79数据可信
供试品溶液-X013993批-依折麦布-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min113077-130776.8966.3311.976.906.3411.98
210246-102465.4035.40
312076-120766.3686.37
410278-102785.4205.42
513543-135437.1427.14
612855-128556.7796.78
10min117523-175239.2419.132.129.289.162.16
216597-165978.7528.78
317356-173569.1539.19
417360-173609.1559.18
517367-173679.1599.20
617640-176409.3039.34
15min117669-176699.3189.441.819.419.531.81
217460-174609.2089.29
317868-178689.4239.51
417960-179609.4719.55
518105-181059.5489.64
618380-183809.6939.78
20min117827-178279.4019.351.249.549.491.23
217782-177829.3779.51
317847-178479.4129.55
417420-174209.1879.32
517510-175109.2349.38
617996-179969.4909.63
30min116425-164258.6629.192.918.869.382.81
217669-176699.3189.50
317752-177529.3629.55
417751-177519.3619.55
517447-174479.2019.40
617517-175179.2389.43
45min116849-168498.8859.211.929.139.451.85
217519-175199.2399.47
317771-177719.3729.61
417638-176389.3019.54
517313-173139.1309.38
617643-176439.3049.55
60min117248-172489.0969.110.859.399.400.79
217437-174379.1959.48
317168-171689.0549.35
417367-173679.1599.45
517049-170498.9919.29
617374-173749.1629.46
极限117594-175949.2789.111.189.629.461.13
217201-172019.0719.41
317430-174309.1929.54
417275-172759.1109.45
517036-170368.9849.33
617144-171449.0419.39
依折麦布瑞舒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%
110.823103783120593132593139653142753127870.51
210.863100993123923112460.53
单位质量响应值RSD%判断
28908.2328659.850.62数据可信
供试品溶液-X013993批-瑞舒伐他汀钙-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min127935-279358.0177.8228.498.027.8228.50
220262-202625.8155.81
321487-214876.1666.17
441110-4111011.79711.80
529962-299628.5988.60
622824-228246.5506.55
10min1100206-10020628.75630.7711.0128.8030.8111.03
293165-9316526.73626.77
3100457-10045728.82828.86
4112766-11276632.36032.43
5126282-12628236.23936.29
6110391-11039131.67931.72
15min1160661-16066146.10551.686.8446.3151.896.85
2170447-17044748.91349.09
3185145-18514553.13153.33
4184111-18411152.83453.08
5194962-19496255.94856.20
6185102-18510253.11953.33
20min1200709-20070957.59762.183.9658.0662.683.96
2214701-21470161.61362.07
3222196-22219663.76464.25
4216748-21674862.20062.74
5221787-22178763.64664.21
6223825-22382564.23164.74
30min1229314-22931465.80671.453.9566.5972.303.95
2249922-24992271.72072.51
3254711-25471173.09473.94
4254156-25415672.93573.82
5254297-25429772.97673.89
6251550-25155072.18773.05
45min1261956-26195675.17477.471.4676.3278.711.51
2270871-27087177.73278.93
3271572-27157277.93379.18
4271427-27142777.89179.18
5271736-27173677.98079.30
6272130-27213078.09379.36
60min1281237-28123780.70780.891.2282.2782.561.21
2284943-28494381.77083.40
3275528-27552879.06880.75
4281562-28156280.80082.52
5283873-28387381.46383.22
6284044-28404481.51283.21
极限1299460-29946085.93683.821.7987.9585.941.70
2293800-29380084.31286.39
3283271-28327181.29083.41
4292220-29222083.85886.03
5291514-29151483.65685.86
6292269-29226983.87286.02
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