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%
110.221724861729411728431729501730081728460.13
210.151738501756331747420.73
单位质量响应值RSD%判断
16912.5217215.961.26数据可信
供试品溶液-2023121621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%
5min16345-63453.3363.7926.383.343.7926.34
29596-95965.0455.04
38066-80664.2404.24
45867-58673.0843.08
54616-46162.4272.43
68742-87424.5964.60
10min115199-151997.9908.1313.088.018.1613.08
216418-164188.6318.66
318252-182529.5959.62
415352-153528.0718.09
512047-120476.3336.35
615553-155538.1778.20
15min116414-164148.6298.982.418.699.042.42
216797-167978.8318.91
317363-173639.1289.20
417431-174319.1649.23
517052-170528.9659.01
617418-174189.1579.23
20min116131-161318.4808.712.658.598.822.71
216590-165908.7228.85
316694-166948.7768.90
417108-171088.9949.11
515968-159688.3958.49
616891-168918.8809.00
30min116317-163178.5788.601.478.748.761.53
216446-164468.6468.82
316463-164638.6558.83
416646-166468.7518.91
515931-159318.3758.52
616364-163648.6038.77
45min115529-155298.1648.392.258.378.602.25
215931-159318.3758.60
315784-157848.2988.52
416287-162878.5628.77
515762-157628.2868.48
616488-164888.6688.89
60min115560-155608.1808.292.048.438.542.04
215695-156958.2518.52
315590-155908.1968.47
416207-162078.5208.78
515409-154098.1018.34
616105-161058.4678.73
极限114976-149767.8738.172.468.178.482.42
215620-156208.2128.53
315269-152698.0278.34
416044-160448.4358.74
515524-155248.1618.44
615816-158168.3158.63
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%
110.403109653112993111433113933115613112720.08
210.403135793164603150200.65
单位质量响应值RSD%判断
29930.0030290.380.85数据可信
供试品溶液-2023121621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%
5min188546-8854624.29137.7036.5724.2937.7036.57
2216249-21624959.32559.32
3167465-16746545.94245.94
497709-9770926.80526.81
5101425-10142527.82427.82
6153113-15311342.00442.00
10min1186007-18600751.02861.9619.2651.1662.1719.32
2278342-27834276.35976.69
3255234-25523470.02070.27
4189579-18957952.00852.16
5184772-18477250.69050.84
6261202-26120271.65771.89
15min1210486-21048657.74469.3214.7858.1669.8714.85
2286585-28658578.62079.37
3286309-28630978.54579.19
4221885-22188560.87161.31
5224182-22418261.50161.94
6286547-28654778.61079.24
20min1224757-22475761.65972.1112.2962.4073.0512.39
2294579-29457980.81382.00
3291229-29122979.89480.98
4231570-23157063.52864.30
5245979-24597967.48168.26
6289077-28907779.30480.37
30min1244015-24401566.94275.499.8668.0276.8310.00
2297721-29772181.67583.32
3302175-30217582.89784.42
4245775-24577567.42568.55
5264209-26420972.48273.63
6297192-29719281.53083.04
45min1252873-25287369.37277.498.1670.8379.258.31
2297909-29790981.72783.82
3302993-30299383.12285.11
4257983-25798370.77472.28
5278157-27815776.30877.86
6304794-30479483.61685.58
60min1256473-25647370.36078.157.4572.2080.347.63
2300597-30059782.46485.01
3303063-30306383.14185.59
4264724-26472472.62374.52
5278916-27891676.51778.50
6305481-30548183.80486.23
极限1348631-34863195.64295.411.6297.8798.031.33
2338913-33891392.97695.98
3348297-34829795.55098.46
4355539-35553997.53799.84
5350633-35063396.19198.60
6344598-34459894.53597.43
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%
110.221743751750811750491752331746361748750.21
210.151733141745971739560.53
单位质量响应值RSD%判断
17111.0617138.520.12数据可信
供试品溶液-2023121621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%
5min16678-66783.4984.7418.923.504.7418.88
29288-92884.8654.87
311787-117876.1746.17
49760-97605.1125.11
58172-81724.2814.28
68603-86034.5064.51
10min112658-126586.6317.847.986.657.877.99
214798-147987.7517.78
315388-153888.0618.09
415552-155528.1468.17
515511-155118.1258.15
615949-159498.3548.38
15min116109-161098.4388.772.098.498.842.14
216881-168818.8438.91
316590-165908.6908.77
416795-167958.7988.87
517056-170568.9349.00
616998-169988.9048.98
20min116023-160238.3938.582.338.508.702.30
216445-164458.6148.73
315981-159818.3718.50
416349-163498.5648.69
516489-164898.6378.76
617031-170318.9219.04
30min117130-171308.9738.642.489.128.802.36
216713-167138.7558.92
315994-159948.3788.55
416624-166248.7088.88
516222-162228.4978.66
616290-162908.5338.70
45min116617-166178.7048.531.848.908.751.77
216326-163268.5528.77
316313-163138.5458.77
416240-162408.5078.73
515747-157478.2498.46
616491-164918.6388.86
60min115905-159058.3318.271.728.588.531.69
215999-159998.3818.64
315495-154958.1178.38
416100-161008.4348.70
515434-154348.0858.34
615837-158378.2968.56
极限115777-157778.2648.222.868.568.532.77
216322-163228.5508.86
315980-159808.3718.68
415591-155918.1678.48
514999-149997.8578.16
615533-155338.1368.45
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%
110.403139173149803149443152013140673146220.19
210.403121243140993131120.45
单位质量响应值RSD%判断
30252.1230106.920.35数据可信
供试品溶液-2023121621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%
5min1109526-10952629.97744.0923.7529.9844.0923.74
2119836-11983632.79932.80
3162299-16229944.42144.42
4183539-18353950.23450.23
5200805-20080554.96054.96
6190591-19059152.16452.16
10min1232346-23234663.59267.625.9763.7667.876.00
2244747-24474766.98767.17
3240140-24014065.72665.97
4236248-23624864.66064.94
5257782-25778270.55470.86
6271202-27120274.22774.52
15min1269721-26972173.82273.774.2874.3474.394.26
2275115-27511575.29875.85
3268855-26885573.58574.20
4247765-24776567.81368.45
5274594-27459475.15675.85
6281088-28108876.93377.64
20min1271688-27168874.36075.164.4075.2976.194.40
2275551-27555175.41876.39
3274958-27495875.25576.28
4254671-25467169.70370.72
5278784-27878476.30277.42
6292042-29204279.93181.06
30min1283520-28352077.59978.322.5678.9479.762.56
2290063-29006379.38980.78
3293288-29328880.27281.71
4272875-27287574.68576.09
5286796-28679678.49580.03
6290345-29034579.46781.04
45min1293031-29303180.20281.245.5481.9883.135.44
2297063-29706381.30583.14
3325729-32572989.15191.04
4276490-27649075.67577.49
5288218-28821878.88480.86
6300507-30050782.24884.26
60min1296789-29678981.23081.875.2483.4584.215.13
2297430-29743081.40683.69
3329416-32941690.16092.54
4283880-28388077.69779.93
5291826-29182679.87282.29
6295478-29547880.87183.34
极限1336975-33697592.22994.232.0294.9097.021.96
2349621-34962195.69098.43
3353566-35356696.77099.65
4347863-34786395.20997.88
5338382-33838292.61495.47
6339356-33935692.88195.80
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%
110.221728401741461748701752591753411744910.60
210.151718931738271728600.80
单位质量响应值RSD%判断
17073.4817030.540.18数据可信
供试品溶液-X013993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%
5min19321-93214.9035.568.644.905.568.69
210648-106485.6015.60
311209-112095.8975.90
411895-118956.2576.26
510407-104075.4755.47
69932-99325.2255.22
10min114020-140207.3758.005.437.408.045.46
216021-160218.4288.46
315139-151397.9648.00
415610-156108.2128.25
516016-160168.4258.46
614490-144907.6237.65
15min115324-153248.0618.503.228.138.583.23
216368-163688.6108.69
316503-165038.6828.76
416271-162718.5598.64
516718-167188.7958.87
615751-157518.2868.36
20min116117-161178.4788.662.548.598.782.57
216898-168988.8899.02
316849-168498.8648.99
416344-163448.5988.73
516646-166468.7578.88
615862-158628.3448.46
30min115779-157798.3018.472.108.468.642.14
216122-161228.4818.66
316208-162088.5268.70
416262-162628.5558.73
516581-165818.7238.90
615656-156568.2368.40
45min116174-161748.5088.442.388.718.662.37
216204-162048.5248.75
316197-161978.5218.74
415814-158148.3198.54
516508-165088.6848.91
615414-154148.1098.32
60min115411-154118.1078.181.408.368.451.43
215386-153868.0948.36
315749-157498.2858.55
415614-156148.2148.48
515862-158628.3448.62
615329-153298.0648.32
极限116218-162188.5328.322.298.838.632.19
215784-157848.3038.62
316128-161288.4848.80
415325-153258.0628.38
515960-159608.3968.71
615453-154538.1298.43
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%
110.403107693129993141913144953145523134010.52
210.403095053125203110120.69
单位质量响应值RSD%判断
30134.7129905.000.55数据可信
供试品溶液-X013993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%
5min160773-6077316.72228.4533.1916.7228.4533.19
2156921-15692143.17843.18
3118269-11826932.54232.54
4108598-10859829.88129.88
5103395-10339528.45028.45
672467-7246719.94019.94
10min1157019-15701943.20554.5916.5943.3054.7516.58
2215469-21546959.28759.53
3179242-17924249.31949.50
4179960-17996049.51749.68
5249220-24922068.57468.73
6209507-20950757.64757.76
15min1227017-22701762.46569.4614.3762.8069.9214.32
2237334-23733465.30465.87
3220941-22094160.79361.25
4235023-23502364.66865.11
5311373-31137385.67686.21
6282943-28294377.85378.28
20min1256765-25676570.65075.4111.2571.3376.2611.23
2265002-26500272.91773.85
3239829-23982965.99066.78
4258464-25846471.11871.92
5317101-31710187.25288.27
6307212-30721284.53185.39
30min1293098-29309880.64782.646.4281.7283.906.46
2293100-29310080.64881.99
3275338-27533875.76176.92
4293416-29341680.73581.93
5322054-32205488.61590.11
6324998-32499889.42590.76
45min1327732-32773290.17787.204.7191.7088.924.70
2303602-30360283.53885.32
3295673-29567381.35682.94
4314164-31416486.44488.09
5327876-32787690.21792.21
6332364-33236491.45293.28
60min1333179-33317991.67689.884.2993.7092.104.26
2325451-32545189.55091.80
3300206-30020682.60384.64
4333753-33375391.83493.96
5327146-32714690.01692.51
6340248-34024893.62195.96
极限1361380-36138099.43696.651.72101.9799.361.52
2345822-34582295.15597.90
3355347-35534797.776100.27
4349986-34998696.30098.93
5346395-34639595.31298.31
6348636-34863695.92998.79
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%
110.221745461757871766491772591775731763630.70
210.151723151733941728540.45
单位质量响应值RSD%判断
17256.6517029.950.94数据可信
供试品溶液-X013993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%
5min19646-96465.0485.7612.605.055.7612.62
212167-121676.3676.37
311117-111175.8175.82
48979-89794.6994.70
512128-121286.3466.35
612030-120306.2956.30
10min114153-141537.4068.076.997.438.107.03
216822-168228.8038.84
314947-149477.8217.85
414559-145597.6187.64
515498-154988.1108.14
616544-165448.6578.69
15min115224-152247.9668.434.218.048.514.24
216753-167538.7668.85
315929-159298.3358.41
415906-159068.3238.39
515792-157928.2648.34
617070-170708.9329.02
20min115958-159588.3508.602.548.468.722.57
216961-169618.8759.01
316404-164048.5848.71
416648-166488.7128.83
515925-159258.3338.46
616677-166778.7278.86
30min115927-159278.3348.492.348.498.662.34
215972-159728.3588.54
316365-163658.5638.73
416373-163738.5688.73
515858-158588.2988.47
616848-168488.8169.00
45min115826-158268.2818.350.578.498.570.56
215886-158868.3138.54
316020-160208.3838.60
416068-160688.4088.62
516007-160078.3768.59
615950-159508.3468.58
60min115329-153298.0218.202.208.278.472.15
215465-154658.0928.37
315745-157458.2398.50
416227-162278.4918.75
515412-154128.0658.33
615904-159048.3228.60
极限115522-155228.1228.131.298.428.441.24
215673-156738.2018.52
315608-156088.1678.48
415820-158208.2788.58
515276-152767.9948.30
615365-153658.0408.36
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%
110.403139433159233170383181203186603167370.60
210.403095043109253102140.33
单位质量响应值RSD%判断
30455.4829828.271.48数据可信
供试品溶液-X013993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%
5min187691-8769124.03327.9230.5124.0327.9230.51
2150258-15025841.18141.18
389220-8922024.45224.45
462911-6291117.24217.24
5125677-12567734.44434.44
695485-9548526.16926.17
10min1217095-21709559.49955.4820.6659.6355.6320.67
2249540-24954068.39168.62
3199648-19964854.71754.85
4128558-12855835.23435.33
5228932-22893262.74362.93
6190759-19075952.28152.43
15min1268429-26842973.56869.9417.9174.0370.4117.93
2314310-31431086.14286.75
3257260-25726070.50670.95
4173918-17391847.66547.96
5266839-26683973.13273.67
6250466-25046668.64469.08
20min1294768-29476880.78675.7513.6781.6676.6013.74
2321281-32128188.05389.14
3276935-27693575.89976.73
4208394-20839457.11457.67
5286999-28699978.65779.60
6270045-27004574.01074.83
30min1327986-32798689.89084.405.9591.2185.676.07
2312677-31267785.69487.27
3307071-30707184.15885.41
4279806-27980676.68677.56
5325013-32501389.07590.46
6295061-29506180.86782.09
45min1328744-32874490.09890.073.5491.9291.813.48
2318831-31883187.38189.43
3333961-33396191.52893.25
4329804-32980490.38891.69
5346709-34670995.02296.90
6313767-31376785.99387.67
60min1336790-33679092.30392.083.8894.6294.323.57
2313763-31376385.99288.53
3340447-34044793.30595.53
4353482-35348296.87898.68
5339235-33923592.97395.38
6332132-33213291.02693.18
极限1337999-33799992.63496.002.5795.4798.762.34
2349139-34913995.68898.70
3352761-35276196.68099.43
4365510-365510100.174102.51
5349748-34974895.85498.78
6346625-34662594.99897.66
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