依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.851323461322941322461319951317051321170.21
210.88 1315541316571316060.06
单位质量响应值RSD%判断
12176.6812096.140.47数据可信
供试品溶液-24021801批-匹伐他汀钙-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%
5min1118836-11883684.86683.544.4284.8783.544.42
2113698-11369881.19681.20
3110595-11059578.98078.98
4119582-11958285.39885.40
5124974-12497489.24989.25
6114228-11422881.57581.57
10min1129255-12925592.30691.171.3592.4591.311.35
2125359-12535989.52489.66
3127289-12728990.90291.03
4126408-12640890.27390.42
5127755-12775591.23591.38
6129934-12993492.79192.93
15min1129600-12960092.55391.241.4092.8591.531.40
2125786-12578689.82990.11
3127323-12732390.92691.21
4126069-12606990.03190.32
5127681-12768191.18291.48
6130121-13012192.92593.22
20min1125631-12563189.71891.162.0890.1791.602.07
2125344-12534489.51389.95
3127020-12702090.71091.14
4125980-12598089.96790.41
5131552-13155293.94794.40
6130339-13033993.08093.53
30min1129037-12903792.15091.491.9292.7592.081.92
2125442-12544289.58390.17
3126803-12680390.55591.14
4125771-12577189.81890.41
5131362-13136293.81194.42
6130231-13023193.00393.60
45min1128994-12899492.12091.701.5992.8792.441.59
2127988-12798891.40192.13
3126935-12693590.64991.39
4125436-12543689.57990.32
5130954-13095493.51994.29
6130091-13009192.90393.66
60min1128529-12852991.78890.991.8992.6991.881.88
2124694-12469489.04989.93
3126422-12642290.28391.17
4124971-12497189.24790.14
5130486-13048693.18594.11
6129334-12933492.36393.27
极限1128381-12838191.68291.011.9792.7492.071.97
2124874-12487489.17890.21
3126406-12640690.27291.31
4124723-12472389.07090.11
5130813-13081393.41994.50
6129479-12947992.46693.53
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.933822803821913818683812693807303816680.18
211.003798213809333803770.21
单位质量响应值RSD%判断
34919.3034579.730.70数据可信
供试品溶液-24021801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%
5min119799-197995.1285.087.125.135.087.11
220098-200985.2055.21
318573-185734.8104.81
421591-215915.5925.59
520140-201405.2165.22
617558-175584.5484.55
10min133189-331898.5968.333.168.608.343.14
232420-324208.3978.41
332448-324488.4048.41
433100-331008.5738.58
530803-308037.9787.99
631060-310608.0458.05
15min134646-346468.9738.852.469.008.882.46
235073-350739.0849.11
333953-339538.7948.82
434945-349459.0519.07
533112-331128.5768.60
633327-333278.6328.65
20min132417-324178.3968.823.668.438.853.65
232560-325608.4338.47
334745-347458.9999.04
435385-353859.1659.20
534347-343478.8968.93
634767-347679.0059.04
30min135035-350359.0748.932.199.138.992.18
235246-352469.1299.18
333373-333738.6448.70
435115-351159.0959.15
533999-339998.8068.86
634176-341768.8528.90
45min135344-353449.1548.991.009.229.060.99
234595-345958.9609.03
334575-345758.9559.02
434413-344138.9138.98
534836-348369.0239.09
634461-344618.9258.99
60min133348-333488.6378.781.518.728.861.52
234096-340968.8318.91
333330-333308.6338.71
434682-346828.9839.07
533919-339198.7858.87
634065-340658.8238.90
极限134847-348479.0258.932.909.129.022.88
234975-349759.0599.16
334580-345808.9569.05
432598-325988.4438.54
535498-354989.1949.29
634314-343148.8878.98
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.851322661323361322971323621322441323010.04
210.88 1325341324391324860.06
单位质量响应值RSD%判断
12193.6412177.020.10数据可信
供试品溶液-24021801批-匹伐他汀钙-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%
5min1122753-12275387.31083.393.1687.3183.393.16
2116141-11614182.60782.61
3112790-11279080.22480.22
4119191-11919184.77684.78
5118642-11864284.38684.39
6113897-11389781.01181.01
10min1128260-12826091.22789.831.5791.3789.961.56
2123976-12397688.18088.32
3128282-12828291.24391.38
4123970-12397088.17688.32
5126042-12604289.64989.79
6127204-12720490.47690.61
15min1128382-12838291.31490.061.3591.6190.351.35
2124742-12474288.72589.01
3128517-12851791.41091.70
4124548-12454888.58788.87
5126670-12667090.09690.39
6126835-12683590.21390.50
20min1127855-12785590.93989.801.4991.3990.241.49
2123918-12391888.13988.57
3128039-12803991.07091.51
4123944-12394488.15788.59
5126560-12656090.01890.46
6127178-12717890.45790.89
30min1127314-12731490.55489.551.4791.1690.141.47
2123752-12375288.02188.60
3127739-12773990.85691.45
4123455-12345587.80988.39
5126519-12651989.98990.58
6126647-12664790.08090.67
45min1127373-12737390.59689.391.4991.3590.121.49
2123251-12325187.66488.39
3127503-12750390.68891.43
4123510-12351087.84888.58
5126017-12601789.63290.37
6126379-12637989.88990.63
60min1127258-12725890.51489.191.5891.4290.071.57
2123147-12314787.59088.46
3127381-12738190.60291.49
4122848-12284887.37888.25
5125783-12578389.46590.35
6125934-12593489.57290.46
极限1127365-12736590.59088.991.6491.6490.031.63
2122869-12286987.39288.41
3126825-12682590.20691.25
4122409-12240987.06588.09
5125469-12546989.24290.28
6125778-12577889.46290.50
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.933810493816093817303817983812723814920.09
211.003846963850073848520.06
单位质量响应值RSD%判断
34903.2034986.550.17数据可信
供试品溶液-24021801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%
5min121930-219305.6485.167.125.655.167.11
221218-212185.4655.46
317892-178924.6084.61
419724-197245.0805.08
520150-201505.1905.19
619343-193434.9824.98
10min133002-330028.5008.273.008.518.283.01
232072-320728.2608.27
332120-321208.2728.28
432059-320598.2578.27
530420-304207.8357.84
633099-330998.5258.53
15min134499-344998.8858.830.468.918.860.47
234392-343928.8588.88
334299-342998.8348.86
434171-341718.8018.82
534073-340738.7758.80
634378-343788.8548.88
20min134772-347728.9558.890.438.998.930.41
234527-345278.8928.93
334485-344858.8828.92
434321-343218.8398.88
534444-344448.8718.91
634545-345458.8978.93
30min133159-331598.5408.801.508.598.861.50
234364-343648.8508.90
334556-345568.9008.95
434313-343138.8378.89
534283-342838.8308.88
634420-344208.8658.92
45min134804-348048.9648.860.729.038.930.70
234283-342838.8308.90
334092-340928.7808.85
434348-343488.8468.91
534566-345668.9028.97
634421-344218.8658.93
60min134676-346768.9318.870.539.018.950.50
234601-346018.9118.99
334192-341928.8068.89
434303-343038.8358.92
534385-343858.8568.94
634403-344038.8608.94
极限135475-354759.1378.921.939.239.011.92
235236-352369.0759.17
333662-336628.6708.76
434692-346928.9359.03
534533-345338.8948.99
634194-341948.8078.90
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