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DSMF-387-240606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(%)99.75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%
110.181697011694891699011698621698351697580.10
210.201696831704391700610.32
单位质量响应值RSD%判断
16675.6416672.650.02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%
5min117941-179419.6605.2042.179.665.2042.19
28236-82364.4344.43
37615-76154.1004.10
48290-82904.4634.46
57864-78644.2344.23
67959-79594.2854.29
10min115419-154198.3028.752.838.368.782.69
216644-166448.9618.99
316021-160218.6268.65
416497-164978.8828.91
516342-163428.7998.82
616539-165398.9058.93
15min116920-169209.1109.141.879.219.221.83
216812-168129.0529.13
316559-165598.9168.99
417032-170329.1709.24
517514-175149.4309.50
617044-170449.1779.25
20min116884-168849.0909.091.169.249.221.20
217109-171099.2129.34
316613-166138.9459.06
416866-168669.0819.21
517074-170749.1939.32
616706-167068.9959.12
30min117502-175029.4238.903.409.629.083.43
216123-161238.6818.86
315921-159218.5728.74
416337-163378.7968.97
516558-165588.9159.09
616769-167699.0299.20
45min117049-170499.1798.792.869.439.022.90
216309-163098.7819.01
315649-156498.4268.64
416072-160728.6538.88
516492-164928.8799.10
616439-164398.8519.08
60min116204-162048.7248.661.869.038.941.83
215825-158258.5208.79
316324-163248.7899.05
415813-158138.5148.79
516494-164948.8819.16
615835-158358.5268.80
极限116987-169879.1468.673.529.509.003.52
216299-162998.7769.10
315663-156638.4338.75
415504-155048.3478.67
516443-164438.8539.18
615770-157708.4918.81
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%
111.513172533172623171593171583170603171780.03
211.533179753175213177480.11
单位质量响应值RSD%判断
27556.7327558.370.01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%
5min1-0.0007.2152.770.007.2152.77
226570-265707.9647.96
323216-232166.9596.96
428242-282428.4658.47
528787-287878.6298.63
637437-3743711.22111.22
10min197002-9700229.07533.8115.2329.0833.8515.26
2116262-11626234.84834.89
393489-9348928.02228.06
4122891-12289136.83536.88
5107640-10764032.26432.31
6139470-13947041.80441.87
15min1161443-16144348.39054.3012.3948.5554.5312.41
2171558-17155851.42251.66
3169502-16950250.80651.00
4182125-18212554.58954.84
5177781-17778153.28753.51
6224598-22459867.32067.61
20min1185534-18553455.61162.0610.9556.0462.5910.98
2192599-19259957.72958.25
3201474-20147460.38960.87
4205537-20553761.60762.16
5206889-20688962.01262.54
6250209-25020974.99775.67
30min1207248-20724862.12066.5410.6862.8667.4110.69
2199109-19910959.68060.52
3217053-21705365.05965.87
4216347-21634764.84765.74
5225535-22553567.60168.47
6266663-26666379.92981.01
45min1234869-23486970.39972.269.2071.4873.519.23
2217268-21726865.12366.30
3231733-23173369.45970.63
4233423-23342369.96571.22
5247373-24737374.14775.39
6281872-28187284.48786.02
60min1235952-23595270.72373.989.8072.2075.629.80
2217829-21782965.29166.83
3244813-24481373.37974.94
4236763-23676370.96672.61
5256745-25674576.95678.61
6288740-28874086.54688.54
极限1251521-25152175.39078.377.2077.2680.437.27
2240727-24072772.15574.05
3260382-26038278.04680.01
4251107-25110775.26677.31
5271541-27154181.39183.47
6293553-29355387.98990.47
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DSMF-387-240606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(%)99.75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%
110.181696051696871697971698321697701697380.06
210.201702251705231703740.13
单位质量响应值RSD%判断
16673.6716703.330.13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%
5min110068-100685.4165.594.175.425.594.17
210456-104565.6255.62
39921-99215.3375.34
410968-109685.9005.90
510810-108105.8155.82
610076-100765.4205.42
10min116548-165488.9029.021.608.939.051.57
216935-169359.1109.14
316818-168189.0479.08
416821-168219.0499.08
516367-163678.8058.84
617106-171069.2029.23
15min117368-173689.3439.272.039.429.352.00
217040-170409.1679.25
317598-175989.4679.55
417103-171039.2009.28
516703-167038.9859.07
617585-175859.4609.54
20min117265-172659.2889.251.729.429.381.70
217265-172659.2889.42
317147-171479.2249.36
417328-173289.3229.46
516653-166538.9589.09
617524-175249.4279.56
30min117479-174799.4038.973.919.599.153.85
216262-162628.7488.93
316817-168179.0479.23
416246-162468.7398.93
515870-158708.5378.72
617342-173429.3299.52
45min116779-167799.0268.891.969.269.121.93
216443-164438.8459.08
316878-168789.0799.31
416629-166298.9459.18
515971-159718.5928.82
616420-164208.8339.07
60min116264-162648.7498.731.769.039.021.73
216224-162248.7289.01
316514-165148.8849.17
416302-163028.7709.05
515692-156928.4418.72
616393-163938.8199.11
极限116601-166018.9308.752.149.269.082.09
216381-163818.8129.14
316503-165038.8789.21
416058-160588.6388.97
515664-156648.4268.75
616379-163798.8119.15
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%
111.513163393163413164163164633164383163990.02
211.533166313163393164850.07
单位质量响应值RSD%判断
27489.0527448.830.11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%
5min129244-292448.7947.9313.368.797.9313.33
228733-287338.6408.64
324013-240137.2217.22
427158-271588.1678.17
528744-287448.6438.64
620342-203426.1176.12
10min1111744-11174433.60234.189.4033.6534.229.40
2128741-12874138.71338.76
3100300-10030030.16130.20
4121004-12100436.38636.43
5116494-11649435.03035.08
6103711-10371131.18631.22
15min1178021-17802153.53250.124.2353.7750.364.24
2169764-16976451.04951.31
3164047-16404749.32949.54
4168328-16832850.61750.86
5162246-16224648.78849.03
6157678-15767847.41447.62
20min1195919-19591958.91456.173.3459.4556.693.36
2189090-18909056.86057.41
3185481-18548155.77556.26
4189204-18920456.89457.42
5183845-18384555.28355.80
6177314-17731453.31953.79
30min1209748-20974863.07259.273.4063.9360.093.39
2194778-19477858.57059.43
3197724-19772459.45660.25
4196549-19654959.10359.95
5193052-19305258.05158.87
6190690-19069057.34158.11
45min1228806-22880668.80364.614.0770.0165.774.05
2214755-21475564.57865.77
3215948-21594864.93666.06
4217041-21704165.26566.44
5210533-21053363.30864.45
6202142-20214260.78561.87
60min1230653-23065369.35866.673.1570.9568.193.15
2220695-22069566.36467.91
3223540-22354067.21968.70
4226972-22697268.25169.79
5217346-21734665.35766.85
6211146-21114663.49264.92
极限1253245-25324576.15272.722.7978.1374.602.80
2239935-23993572.14974.06
3241793-24179372.70874.56
4244204-24420473.43375.35
5238687-23868771.77473.63
6233077-23307770.08771.86
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DSMF-387-240606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(%)99.75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%
110.181707171702891703921704951705141704810.10
210.201706911705801706360.05
单位质量响应值RSD%判断
16746.6616729.020.08数据可信
供试品溶液-X027066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%
5min110127-101275.4325.038.775.435.038.76
210200-102005.4715.47
38626-86264.6274.63
410034-100345.3825.38
58540-85404.5814.58
68716-87164.6754.67
10min116199-161998.6888.403.608.728.433.63
216001-160018.5828.61
315688-156888.4148.44
416140-161408.6578.69
514850-148507.9657.99
615116-151168.1088.13
15min117124-171249.1859.021.779.269.091.78
216938-169389.0859.16
317013-170139.1259.20
416905-169059.0679.15
516457-164578.8278.90
616422-164228.8088.88
20min117320-173209.2908.0628.209.428.1927.77
26402-64023.4343.56
316489-164898.8448.97
416744-167448.9819.11
516646-166468.9289.05
616612-166128.9109.03
30min116508-165088.8548.881.639.049.051.56
216833-168339.0299.18
316109-161098.6408.81
416822-168229.0239.20
516563-165638.8849.05
616460-164608.8289.00
45min116959-169599.0968.913.409.339.133.38
216587-165878.8979.09
316727-167278.9729.19
417230-172309.2419.47
515578-155788.3558.57
616593-165938.9009.12
60min116621-166218.9158.731.919.209.001.89
216378-163788.7849.03
315998-159988.5818.85
416547-165478.8759.15
516313-163138.7509.01
615829-158298.4908.76
极限116878-168789.0538.861.849.389.181.76
216706-167068.9609.26
316029-160298.5978.92
416415-164158.8049.13
516675-166758.9449.26
616373-163738.7829.10
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%
111.513167833165663163723164653164063165180.06
211.533171453167143169300.10
单位质量响应值RSD%判断
27499.3927487.420.04数据可信
供试品溶液-X027066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%
5min127518-275188.2677.0114.358.277.0114.36
226216-262167.8767.88
320637-206376.2006.20
425209-252097.5747.57
520369-203696.1206.12
620070-200706.0306.03
10min192542-9254227.80322.9813.9827.8523.0213.98
275816-7581622.77822.82
376587-7658723.00923.04
482829-8282924.88524.93
561431-6143118.45618.49
669696-6969620.93920.97
15min1162804-16280448.91246.595.6049.1146.765.62
2153546-15354646.13146.30
3160550-16055048.23548.40
4162653-16265348.86749.05
5140880-14088042.32542.46
6150077-15007745.08845.24
20min1191196-19119657.44247.9043.2457.9148.3242.86
219027-190275.7166.14
3184318-18431855.37655.81
4193410-19341058.10758.56
5181400-18140054.49954.87
6187181-18718156.23656.64
30min1201984-20198460.68362.314.8461.4763.004.89
2195190-19519058.64259.10
3201247-20124760.46261.20
4218187-21818765.55166.33
5207431-20743162.32062.99
6220416-22041666.22166.93
45min1227953-22795368.48569.326.9469.6170.366.99
2203347-20334761.09361.88
3232296-23229669.79070.86
4242100-24210072.73573.87
5228411-22841168.62369.64
6250358-25035875.21676.30
60min1230143-23014369.14371.216.6370.6572.636.66
2212549-21254963.85764.98
3233075-23307570.02471.49
4245356-24535673.71475.26
5242213-24221372.76974.17
6258798-25879877.75279.25
极限1250510-25051075.26277.185.5477.1679.005.58
2236846-23684671.15772.64
3250619-25061975.29577.15
4261123-26112378.45180.40
5263856-26385679.27281.08
6278439-27843983.65385.58
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DSMF-387-240606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(%)99.75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%
110.181703911699001701921700941700861701330.11
210.201699681706191702940.28
单位质量响应值RSD%判断
16712.4816695.490.08数据可信
供试品溶液-X027066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%
5min19694-96945.2104.6115.965.214.6215.95
27213-72133.8773.88
38606-86064.6254.63
46937-69373.7283.73
58570-85704.6064.61
610468-104685.6265.63
10min115364-153648.2577.815.638.297.835.67
214578-145787.8357.86
314275-142757.6727.70
413118-131187.0507.07
514518-145187.8037.83
615291-152918.2188.25
15min115993-159938.5958.743.178.678.813.11
217299-172999.2979.36
315991-159918.5948.66
416179-161798.6958.76
515965-159658.5808.65
616186-161868.6998.78
20min115740-157408.4598.572.118.588.682.05
216568-165688.9049.02
315961-159618.5788.69
415900-159008.5458.65
515863-158638.5268.64
615593-155938.3808.51
30min115898-158988.5448.422.178.718.592.13
215837-158378.5128.68
315030-150308.0788.24
415912-159128.5528.71
515806-158068.4958.66
615571-155718.3698.54
45min116015-160158.6078.641.788.828.861.69
215964-159648.5808.79
316420-164208.8259.03
416100-161008.6538.86
516368-163688.7979.01
615645-156458.4088.63
60min115397-153978.2758.351.428.548.601.32
215800-158008.4928.75
315729-157298.4548.71
415617-156178.3938.64
515383-153838.2688.53
615246-152468.1948.46
极限115620-156208.3958.482.938.718.792.80
216639-166398.9439.25
315669-156698.4218.73
415799-157998.4918.79
515684-156848.4298.74
615251-152518.1978.51
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%
111.513159223158123157433156713156913157680.04
211.533158533156293157410.06
单位质量响应值RSD%判断
27434.2327384.300.13数据可信
供试品溶液-X027066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%
5min127156-271568.1846.8617.548.186.8617.56
219485-194855.8725.87
322275-222756.7136.71
417994-179945.4235.42
521799-217996.5696.57
627830-278308.3878.39
10min190045-9004527.13622.0314.7227.1822.0714.69
281830-8183024.66024.69
363683-6368319.19119.23
462602-6260218.86618.90
570248-7024821.17021.21
670264-7026421.17521.22
15min1167701-16770150.53845.816.8650.7345.976.87
2161790-16179048.75748.93
3142541-14254142.95643.10
4147109-14710944.33344.47
5150122-15012245.24045.39
6142827-14282743.04243.21
20min1197397-19739759.48756.503.9659.9656.913.98
2189787-18978757.19457.63
3181348-18134854.65155.03
4184445-18444555.58455.97
5193707-19370758.37558.78
6178202-17820253.70354.11
30min1219790-21979066.23663.744.4467.0464.474.43
2204802-20480261.71962.48
3200945-20094560.55661.24
4213781-21378164.42565.11
5224587-22458767.68168.41
6205223-20522361.84662.55
45min1245497-24549773.98372.393.8675.1673.473.83
2226669-22666968.30969.41
3242623-24262373.11674.14
4239904-23990472.29773.34
5253085-25308576.26977.37
6233406-23340670.33971.38
60min1246650-24665074.33074.093.2775.9275.583.22
2232438-23243870.04771.53
3249162-24916275.08776.52
4251026-25102675.64977.10
5254791-25479176.78378.31
6241032-24103272.63774.07
极限1267774-26777480.69680.381.8782.7082.281.86
2261199-26119978.71480.58
3269452-26945281.20283.05
4269133-26913381.10582.98
5272657-27265782.16784.12
6260155-26015578.40080.24
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