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%
110.221734261724961724061724141723711726230.27
210.151746991754731750860.32
单位质量响应值RSD%判断
16890.7017249.851.49数据可信
供试品溶液-2023120823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%
5min111735-117356.1675.728.666.175.728.69
210733-107335.6415.64
311831-118316.2186.22
411269-112695.9225.92
59327-93274.9024.90
610415-104155.4745.47
10min116220-162208.5248.412.928.568.442.93
216129-161298.4778.51
316479-164798.6618.70
416119-161198.4718.50
515912-159128.3638.39
615121-151217.9477.98
15min116727-167278.7918.682.198.878.762.19
216360-163608.5988.68
316684-166848.7688.85
416498-164988.6718.75
515903-159038.3588.43
616942-169428.9048.98
20min115202-152027.9898.283.008.128.402.93
215158-151587.9668.09
316173-161738.5008.63
415958-159588.3878.51
516233-162338.5318.65
615786-157868.2968.42
30min115140-151407.9578.073.948.138.243.86
215470-154708.1308.30
315954-159548.3858.56
415904-159048.3588.53
515392-153928.0898.26
614304-143047.5177.69
45min114216-142167.4717.993.457.698.213.38
215190-151907.9838.20
315718-157188.2618.49
415408-154088.0988.32
515178-151787.9778.19
615499-154998.1468.36
60min115212-152127.9958.083.348.268.353.30
215363-153638.0748.33
316395-163958.6168.89
415239-152398.0098.28
515067-150677.9188.18
615008-150087.8878.14
极限114393-143937.5647.792.387.878.092.32
214399-143997.5677.87
315166-151667.9708.29
414787-147877.7718.08
515009-150097.8888.19
615138-151387.9568.26
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%
110.401573391569411576051574391569231572490.20
210.401584681593311589000.39
单位质量响应值RSD%判断
15120.1015278.850.74数据可信
供试品溶液-2023120823批-瑞舒伐他汀钙-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%
5min1132579-13257972.05150.7335.5672.0550.7335.55
2104825-10482556.96856.97
3111796-11179660.75660.76
498738-9873853.66053.66
537548-3754820.40620.41
674572-7457240.52740.53
10min1136323-13632374.08565.6426.0474.4965.9226.07
2138622-13862275.33575.65
3138300-13830075.16075.50
4132915-13291572.23372.53
558091-5809131.57031.68
6120407-12040765.43665.66
15min1159161-15916186.49773.5824.5987.3174.2324.63
2151519-15151982.34483.08
3149369-14936981.17581.93
4145414-14541479.02679.73
568960-6896037.47737.77
6137942-13794274.96575.55
20min1155294-15529484.39574.7320.7985.6975.7820.88
2149487-14948781.23982.43
3151153-15115382.14583.35
4145792-14579279.23180.37
579764-7976443.34843.85
6143562-14356278.01979.02
30min1155594-15559484.55877.5418.1186.3279.0118.24
2159931-15993186.91588.56
3153854-15385483.61385.28
4151014-15101482.06983.65
590986-9098649.44750.18
6144656-14465678.61480.05
45min1158063-15806385.90079.1616.1288.1381.0616.29
2161662-16166287.85689.98
3154357-15435783.88686.01
4153696-15369683.52785.56
598750-9875053.66654.68
6147396-14739680.10381.98
60min1161874-16187487.97180.4815.2590.6882.8215.45
2162047-16204788.06590.68
3159314-15931486.58089.17
4152551-15255182.90585.40
5103180-10318056.07457.38
6149517-14951781.25683.58
极限1171752-17175293.33995.011.5396.5497.801.43
2179058-17905897.310100.41
3172352-17235293.66696.74
4174921-17492195.06298.02
5176305-17630595.81497.44
6174607-17460794.89197.66
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%
110.221740111732231737741727221734381734340.29
210.151744681764101754390.79
单位质量响应值RSD%判断
16970.0617284.631.30数据可信
供试品溶液-X007293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%
5min18955-89554.6913.5027.184.693.5027.12
23829-38292.0062.01
37657-76574.0114.01
47475-74753.9153.92
56770-67703.5463.55
65414-54142.8362.84
10min116325-163258.5518.227.518.588.247.53
214291-142917.4857.50
317104-171048.9598.98
416763-167638.7808.80
515004-150047.8597.88
614708-147087.7047.72
15min116459-164598.6218.662.378.698.732.43
216009-160098.3858.44
316982-169828.8958.97
416739-167398.7688.84
516863-168638.8338.90
616171-161718.4708.53
20min117226-172269.0239.031.619.149.141.62
217342-173429.0839.18
317568-175689.2029.32
417098-170988.9569.07
517440-174409.1359.25
616789-167898.7948.90
30min115934-159348.3468.692.148.528.852.04
216782-167828.7908.94
316660-166608.7268.90
416508-165088.6478.82
516968-169688.8889.05
616676-166768.7358.89
45min116530-165308.6588.741.908.888.951.84
216767-167678.7828.98
316873-168738.8389.06
416196-161968.4838.70
517120-171208.9679.18
616623-166238.7078.91
60min115414-154148.0748.523.358.348.783.19
216328-163288.5528.80
316198-161988.4848.75
416031-160318.3978.66
516710-167108.7529.01
616975-169758.8919.14
极限116002-160028.3828.602.618.698.902.46
216884-168848.8449.14
316536-165368.6618.98
415817-158178.2858.60
516426-164268.6048.91
616804-168048.8029.10
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%
110.401564491564961565781566751564851565370.06
210.401601921591101596510.48
单位质量响应值RSD%判断
15051.6315351.061.40数据可信
供试品溶液-X007293批-瑞舒伐他汀钙-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%
5min191083-9108349.49738.0223.3049.5038.0223.30
241014-4101422.28822.29
370501-7050138.31238.31
473388-7338839.88139.88
575429-7542940.99040.99
668389-6838937.16437.16
10min1142916-14291677.66459.2627.0777.9459.4727.06
256289-5628930.58930.71
3100026-10002654.35754.57
4121884-12188466.23566.46
5122336-12233666.48166.71
6110828-11082860.22760.43
15min1153555-15355583.44668.5325.7684.1569.0725.75
263014-6301434.24334.54
3131388-13138871.40071.91
4146529-14652979.62880.22
5135814-13581473.80574.40
6126348-12634868.66169.20
20min1159352-15935286.59673.0922.6487.7774.0222.67
275702-7570241.13841.62
3145783-14578379.22280.13
4154748-15474884.09485.13
5138880-13888075.47176.48
6132569-13256972.04172.96
30min1161088-16108887.53976.4318.6589.1977.7618.74
289922-8992248.86649.58
3147463-14746380.13581.49
4160192-16019287.05288.55
5144826-14482678.70280.13
6140375-14037576.28377.61
45min1165727-16572790.06078.4316.5692.2080.1816.69
298020-9802053.26754.25
3151821-15182182.50384.30
4158039-15803985.88287.87
5145558-14555879.10080.96
6146735-14673579.74081.49
60min1161451-16145187.73777.8215.1990.3780.0115.33
2103526-10352656.25957.54
3135301-13530173.52675.78
4160497-16049787.21889.68
5145881-14588179.27581.58
6152552-15255282.90185.09
极限1173030-17303094.02993.301.8097.1595.921.56
2175679-17567995.46897.06
3173152-17315294.09596.76
4171934-17193493.43396.38
5166981-16698190.74293.49
6169353-16935392.03194.68
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