瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101028-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.002498822499302498542500012498792499090.03
211.152553372520422536900.92
单位质量响应值RSD%判断
22719.0022752.470.11数据可信
供试品溶液-506264批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1228329-22832985.55983.733.6885.5683.733.68
2215683-21568380.82080.82
3226452-22645284.85684.86
4235947-23594788.41388.41
5215111-21511180.60680.61
6219124-21912482.11082.11
10min1252144-25214494.48391.472.3995.4392.402.39
2237837-23783789.12290.02
3241083-24108390.33891.28
4250179-25017993.74694.73
5243664-24366491.30592.20
6239782-23978289.85190.76
15min1248871-24887193.25692.731.6495.2694.671.66
2243130-24313091.10592.99
3249604-24960493.53195.48
4252959-25295994.78896.81
5247853-24785392.87594.78
6242348-24234890.81292.72
20min1249169-24916993.36893.101.6996.4096.071.69
2246341-24634192.30895.21
3248080-24808092.96095.95
4253916-25391695.14798.22
5251336-25133694.18097.12
6241822-24182290.61593.53
30min1241018-24101890.31490.561.4394.3994.571.44
2238949-23894989.53893.46
3242109-24210990.72294.74
4248300-24830093.04297.18
5239865-23986589.88293.87
6239742-23974289.83693.76
45min1246361-24636192.31690.291.8997.3995.301.87
2238841-23884189.49894.42
3241930-24193090.65595.68
4244135-24413591.48296.65
5241130-24113090.35695.34
6233287-23328787.41792.34
60min1244014-24401491.43689.841.9997.5495.861.98
2236337-23633788.56094.48
3236866-23686688.75894.79
4246965-24696592.54298.73
5239389-23938989.70395.69
6234932-23493288.03393.93
极限1248720-24872093.20092.391.62100.3299.411.60
2243990-24399091.42798.33
3243677-24367791.31098.33
4250982-25098294.047101.26
5250393-25039393.827100.81
6241549-24154990.51397.39
瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101028-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.002517582521892518642514252516792517830.12
211.152557162553952555560.09
单位质量响应值RSD%判断
22889.3622919.820.10数据可信
供试品溶液-506264批-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1230341-23034185.67682.823.5685.6882.823.56
2232398-23239886.44286.44
3224507-22450783.50683.51
4212428-21242879.01479.01
5220414-22041481.98481.98
6215847-21584780.28580.29
10min1241351-24135189.77288.633.7090.7289.553.70
2252131-25213193.78194.74
3243080-24308090.41591.34
4228920-22892085.14886.03
5232454-23245486.46287.37
6231753-23175386.20287.09
15min1248993-24899392.61492.114.4394.5694.024.41
2266179-26617999.007101.01
3253270-25327094.20596.14
4237152-23715288.21090.03
5239456-23945689.06790.94
6240770-24077089.55691.41
20min1249244-24924492.70892.883.1595.6995.813.16
2262421-26242197.609100.71
3254826-25482694.78497.76
4245539-24553991.32994.13
5240235-24023589.35792.22
6245946-24594691.48194.33
30min1248469-24846992.41992.453.3796.4396.413.37
2262010-26201097.456101.64
3253884-25388494.43398.47
4240667-24066789.51793.34
5240129-24012989.31793.17
6246101-24610191.53895.40
45min1252316-25231693.85094.062.5598.8999.052.59
2261584-26158497.297102.57
3259402-25940296.486101.57
4245527-24552791.32596.14
5247283-24728391.97896.82
6251148-25114893.41698.29
60min1252177-25217793.79894.851.9799.88100.882.03
2262343-26234397.580103.93
3259386-25938696.480102.63
4249238-24923892.70598.53
5251711-25171193.62599.49
6255111-25511194.890100.81
极限1255800-25580095.14695.461.67102.27102.541.69
2259317-25931796.454103.89
3261407-26140797.232104.46
4250812-25081293.291100.15
5259840-25984096.649103.56
6252606-25260693.958100.93
瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101028-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.002499702466232459642467172491932476930.72
211.152543852542662543260.04
单位质量响应值RSD%判断
22517.5522809.510.92数据可信
供试品溶液-24121701批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min197863-9786336.78948.4615.8036.7948.4615.80
2131072-13107249.27349.27
3141115-14111553.04953.05
4136609-13660951.35551.35
5154075-15407557.92157.92
6112721-11272142.37542.37
10min1152964-15296457.50368.6912.3157.9169.2312.34
2184207-18420769.24869.80
3195850-19585073.62574.21
4187006-18700670.30170.87
5214542-21454280.65281.30
6161823-16182360.83461.30
15min1182086-18208668.45178.609.4769.5079.909.54
2206021-20602177.44978.77
3216471-21647181.37782.78
4219067-21906782.35383.70
5237655-23765589.34190.88
6193229-19322972.64073.79
20min1203436-20343676.47783.028.6478.2985.208.71
2215988-21598881.19683.37
3228240-22824085.80288.11
4224058-22405884.22986.50
5252744-25274495.01397.55
6200594-20059475.40977.36
30min1205594-20559477.28885.147.7179.9588.247.76
2216555-21655581.40984.49
3229009-22900986.09189.36
4224259-22425984.30587.51
5257701-25770196.877100.46
6225828-22582884.89587.69
45min1210291-21029179.05486.396.4882.5790.436.56
2218909-21890982.29486.28
3240933-24093390.57394.79
4224608-22460884.43688.58
5250931-25093194.33299.00
6233098-23309887.62891.36
60min1212656-21265679.94386.966.1384.3491.966.17
2217716-21771681.84586.74
3239859-23985990.16995.40
4228369-22836985.85090.93
5248670-24867093.48299.19
6240671-24067190.47595.18
极限1230349-23034986.59489.894.2191.8895.864.40
2225727-22572784.85790.66
3244866-24486692.05298.28
4242579-24257991.19297.22
5253357-25335795.244101.99
6237767-23776789.38395.10
瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101028-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.002545342545382548332548362543512546180.09
211.152561432549022555220.35
单位质量响应值RSD%判断
23147.0922916.770.71数据可信
供试品溶液-24121702批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100058-10005837.01245.5713.3237.0145.5713.32
2137463-13746350.84950.85
3125609-12560946.46446.46
4105618-10561839.06939.07
5133940-13394049.54549.55
6136464-13646450.47950.48
10min1156534-15653457.90368.4010.6758.3168.9110.68
2210857-21085777.99878.56
3182060-18206067.34567.86
4170625-17062563.11563.55
5189175-18917569.97770.53
6200224-20022474.06474.63
15min1195409-19540972.28378.857.8373.3480.117.86
2234099-23409986.59588.03
3197512-19751273.06174.33
4207539-20753976.77077.91
5212196-21219678.49379.82
6232136-23213685.86987.25
20min1219098-21909881.04683.596.2482.9085.736.27
2242106-24210689.55791.95
3208554-20855477.14679.22
4222482-22248282.29884.29
5219458-21945881.17983.38
6244080-24408090.28792.62
30min1222405-22240582.26985.724.6685.0388.794.74
2240943-24094389.12792.52
3221946-22194682.09985.03
4232160-23216085.87888.78
5224852-22485283.17486.28
6248057-24805791.75895.10
45min1231977-23197785.81086.034.1389.4890.054.17
2242914-24291489.85694.23
3221048-22104881.76785.61
4232565-23256586.02889.88
5223059-22305982.51186.54
6243906-24390690.22394.58
60min1228434-22843484.49986.444.0689.1391.424.13
2241050-24105089.16694.54
3221604-22160481.97386.73
4236463-23646387.46992.28
5227556-22755684.17589.12
6246946-24694691.34796.71
极限1243303-24330390.00090.581.5595.5696.521.77
2249252-24925292.20098.57
3238519-23851988.23093.90
4244483-24448390.43696.22
5245702-24570290.88796.77
6247897-24789791.69998.08
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