依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 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(%)100.00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%
110.971844721845071840761840451837841841770.17
211.031871501880701876100.35
单位质量响应值RSD%判断
16789.1517009.070.93数据可信
中间条件3月-供试品溶液-2024030121批-依折麦布-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min179103-7910342.13045.1820.7942.1345.1820.80
257931-5793130.85430.85
3107541-10754157.27657.28
4100771-10077153.67053.67
584064-8406444.77244.77
679546-7954642.36642.37
10min1147430-14743078.52077.7910.7378.7578.0410.75
2115878-11587861.71661.89
3156364-15636483.27983.60
4159458-15945884.92785.22
5145831-14583177.66977.92
6151386-15138680.62780.86
15min1166434-16643488.64288.395.8189.3189.085.86
2147523-14752378.57079.08
3168525-16852589.75690.54
4174888-17488893.14493.91
5166369-16636988.60789.29
6172064-17206491.64092.32
20min1177009-17700994.27492.932.4495.4494.112.51
2166677-16667788.77189.72
3172576-17257691.91393.19
4177892-17789294.74496.03
5176162-17616293.82395.00
6176612-17661294.06395.26
30min1179247-17924795.46695.961.1297.1597.641.14
2178720-17872095.18596.63
3182225-18222597.05298.84
4177565-17756594.57096.38
5180602-18060296.18897.88
6182646-18264697.27698.99
45min1182253-18225397.06796.980.8499.2899.200.82
2182018-18201896.94298.91
3180351-18035196.05498.38
4181967-18196796.91599.25
5181132-18113296.47098.70
6184826-18482698.437100.69
60min1183014-18301497.47297.161.19100.2399.921.08
2184560-18456098.296100.81
3180723-18072396.25299.12
4180018-18001895.87798.75
5181047-18104796.42599.19
6185224-18522498.649101.45
极限1184135-18413598.06997.590.93101.37100.900.88
2183106-18310697.521100.58
3182971-18297197.449100.85
4180451-18045196.10799.52
5185650-18565098.876102.18
6183094-18309497.515100.87
依折麦布辛伐他汀片项目信息
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对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.844314874322134323034315184314744317990.10
210.914392064414234403140.36
单位质量响应值RSD%判断
39833.8640358.750.93数据可信
中间条件3月-供试品溶液-2024030121批-辛伐他汀-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1206751-20675146.17748.9120.6046.1848.9120.60
2149853-14985333.46933.47
3279701-27970162.47062.47
4255824-25582457.13757.14
5216615-21661548.38048.38
6205101-20510145.80945.81
10min1356355-35635579.59178.4810.3779.8578.7510.39
2280552-28055262.66062.85
3373637-37363783.45183.80
4382567-38256785.44585.76
5352854-35285478.80979.08
6362345-36234580.92981.18
15min1389760-38976087.05286.545.5087.7587.255.56
2346938-34693877.48878.02
3389481-38948186.98987.80
4409298-40929891.41592.21
5390396-39039687.19487.90
6399010-39901089.11889.82
20min1403861-40386190.20189.422.2291.3890.602.29
2385276-38527686.05087.01
3395215-39521588.27089.56
4409500-40950091.46192.76
5406840-40684090.86692.06
6401458-40145889.66490.86
30min12372-23720.53076.1148.672.2177.8047.62
2405900-40590090.65692.10
3412524-41252492.13693.92
4401900-40190089.76391.57
5411144-41114491.82893.52
6410835-41083591.75993.46
45min1409185-40918591.39091.370.5893.0893.480.60
2408822-40882291.30993.26
3405875-40587590.65192.95
4409186-40918691.39093.70
5408295-40829591.19193.40
6413124-41312492.27094.48
60min1410879-41087991.76991.140.9193.9693.760.70
2412673-41267392.16994.62
3403992-40399290.23093.03
4404229-40422990.28393.10
5406442-40644290.77893.49
6410189-41018991.61494.33
极限1413876-41387692.43876.2848.7295.1479.4046.89
22060-20600.4603.43
3408160-40816091.16194.46
4403449-40344990.10993.43
5414654-41465492.61295.83
6406906-40690690.88194.11
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 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(%)100.00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%
110.971884261889581896041890751888561889840.23
211.031934361939221936790.18
单位质量响应值RSD%判断
17227.3517559.291.35数据可信
中间条件3月-供试品溶液-2024030221批-依折麦布-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1102137-10213752.85545.8819.4952.8545.8819.49
268184-6818435.28435.28
387946-8794645.51145.51
497331-9733150.36850.37
567986-6798635.18235.18
6108349-10834956.06956.07
10min1163039-16303984.37175.2812.4284.6675.5412.45
2125757-12575765.07865.27
3147016-14701676.07976.33
4149722-14972277.47977.76
5122366-12236663.32363.52
6164959-16495985.36485.68
15min1176501-17650191.33787.165.9092.1087.835.96
2155330-15533080.38180.94
3164604-16460485.18085.86
4168048-16804886.96387.67
5163040-16304084.37184.92
6182995-18299594.69895.48
20min1181539-18153993.94492.742.5895.2193.902.64
2171240-17124088.61489.62
3179168-17916892.71793.87
4177342-17734291.77292.97
5181288-18128893.81494.83
6184684-18468495.57296.88
30min1185176-18517695.82696.451.3397.6298.121.38
2186038-18603896.27297.77
3183445-18344594.93096.59
4187006-18700696.77398.48
5185824-18582496.16297.70
6190829-19082998.752100.59
45min1183577-18357794.99997.181.4397.3299.391.31
2188539-18853997.56799.60
3189720-18972098.178100.37
4186084-18608496.29698.54
5191075-19107598.879100.95
6187727-18772797.14699.54
60min1181495-18149593.92196.641.8596.7799.381.82
2184180-18418095.31197.88
3191339-19133999.015101.75
4187796-18779697.18299.96
5187188-18718896.86799.49
6188474-18847497.533100.46
极限1185579-18557996.03597.751.0499.41101.031.01
2188420-18842097.505100.61
3190557-19055798.611101.90
4187990-18799097.282100.60
5190301-19030198.478101.64
6190465-19046598.563102.04
依折麦布辛伐他汀片项目信息
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对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.844409144424894434854442324424664427170.29
210.914526644536954531800.17
单位质量响应值RSD%判断
40841.0541538.041.20数据可信
中间条件3月-供试品溶液-2024030221批-辛伐他汀-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1269731-26973158.64650.4619.0658.6550.4619.06
2182286-18228639.63439.63
3229087-22908749.80949.81
4253069-25306955.02455.02
5177145-17714538.51638.52
6281225-28122561.14561.15
10min12436-24360.53062.6550.150.8662.9349.91
2307472-30747266.85267.07
3356050-35605077.41477.69
4364607-36460779.27579.58
5301884-30188465.63765.85
6396525-39652586.21486.55
15min12385-23850.51971.2549.010.8571.8848.80
2365501-36550179.46980.06
3384485-38448583.59784.30
4397525-39752586.43287.18
5390049-39004984.80685.39
6426251-42625192.67893.50
20min1414746-41474690.17690.072.6390.5191.092.69
2395103-39510385.90586.94
3411820-41182089.54090.71
4414663-41466390.15891.38
5423158-42315892.00593.05
6426048-42604892.63493.97
30min1417646-41764690.80776.3948.7091.6477.9247.55
2421844-42184491.71993.23
3415874-41587490.42192.09
4429076-42907693.29295.02
5421374-42137491.61793.18
62244-22440.4882.34
45min1408693-40869388.86061.0776.9290.2063.0274.54
2423963-42396392.18094.20
3427302-42730292.90695.08
4421126-42112691.56393.81
52193-21930.4772.55
62019-20190.4392.29
60min1401561-40156187.30944.77108.3989.1447.06103.34
2408448-40844888.80791.34
32180-21800.4743.16
4418649-41864991.02593.78
52215-22150.4822.55
62311-23110.5022.36
极限13101-31010.67445.71108.262.9948.25103.13
2415915-41591590.43093.46
32056-20560.4473.14
4417078-41707890.68393.94
5421021-42102191.54193.62
62311-23110.5022.36
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 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(%)100.00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%
110.971878701885271889961891621889091886930.28
211.031914901921641918270.25
单位质量响应值RSD%判断
17200.8217391.390.78数据可信
中间条件3月-供试品溶液-2024030321批-依折麦布-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181791-8179142.56140.0511.1842.5640.0511.19
284936-8493644.19844.20
365230-6523033.94333.94
484371-8437143.90443.90
567496-6749635.12335.12
677998-7799840.58740.59
10min1128720-12872066.98169.685.9667.2269.905.97
2142320-14232074.05874.30
3126784-12678465.97466.16
4145652-14565275.79276.04
5129273-12927367.26967.46
6130665-13066567.99368.22
15min1167100-16710086.95386.864.3787.5687.474.37
2168458-16845887.66088.32
3166906-16690686.85287.41
4178875-17887593.08093.75
5163757-16375785.21385.78
6156438-15643881.40582.01
20min1179363-17936393.33493.162.2194.4394.262.23
2181595-18159594.49695.64
3181644-18164494.52195.56
4183081-18308195.26996.45
5175459-17545991.30392.34
6173081-17308190.06591.12
30min1176940-17694092.07395.612.3093.6897.222.28
2184269-18426995.88797.56
3182539-18253994.98796.55
4188401-18840198.03799.75
5182414-18241494.92296.47
6187895-18789597.77499.33
45min1186376-18637696.98396.200.9299.1198.340.89
2186480-18648097.03899.24
3182922-18292295.18697.28
4182950-18295095.20197.46
5184359-18435995.93498.01
6186129-18612996.85598.95
60min1180847-18084794.10695.912.4996.7798.582.43
2182265-18226594.84497.58
3178012-17801292.63195.25
4187116-18711697.368100.15
5189425-18942598.570101.18
6188175-18817597.920100.56
极限1184248-18424895.87696.681.0999.0699.891.03
2184686-18468696.10499.37
3185938-18593896.75599.89
4184670-18467096.09699.42
5189731-18973198.729101.89
6185508-18550896.53299.71
依折麦布辛伐他汀片项目信息
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对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.844408464419064429824433834432244424680.25
210.914475204494834485020.31
单位质量响应值RSD%判断
40818.0841109.260.51数据可信
中间条件3月-供试品溶液-2024030321批-辛伐他汀-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1209489-20948945.79743.2011.0245.8043.2011.02
2216245-21624547.27447.27
3167610-16761036.64136.64
4217549-21754947.55947.56
5173734-17373437.98037.98
6200929-20092943.92543.93
10min1307960-30796067.32370.346.0767.5870.586.07
2341244-34124474.60074.86
3305374-30537466.75866.96
4351387-35138776.81777.08
5310267-31026767.82868.04
6314347-31434768.72068.96
15min1393458-39345886.01485.324.4286.6485.954.42
2389684-38968485.18985.87
3390263-39026385.31685.89
4419306-41930691.66592.36
5382786-38278683.68184.27
6366261-36626180.06980.69
20min1413877-41387790.47844.53108.4891.5845.64105.79
22012-20120.4401.59
32030-20300.4441.49
42056-20560.4491.65
5402630-40263088.01989.07
6399622-39962287.36288.43
30min1403454-40345488.20015.09237.4289.8116.44218.67
22171-21710.4751.63
32023-20230.4421.49
42202-22020.4811.68
52138-21380.4672.01
62086-20860.4562.01
45min12089-20890.45715.26237.442.5616.70215.88
22151-21510.4701.63
3408055-40805589.20590.26
42014-20140.4401.65
52377-23770.5202.06
62075-20750.4542.01
60min1406260-40626088.81330.44152.4990.9131.97145.95
22111-21110.4611.62
32183-21830.4772.03
42246-22460.4911.70
5420431-42043191.91193.46
62356-23560.5152.08
极限12206-22060.4820.557.153.082.2423.16
22717-27170.5941.75
32634-26340.5762.13
42546-25460.5571.77
52552-25520.5582.62
62429-24290.5312.09
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