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)5供试品稀释倍数2.5系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.052502922501332501822502532501002501920.04
211.152510742534122522430.66
单位质量响应值RSD%判断
22641.8122622.690.06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%
5min1241028-24102890.73086.124.4990.7386.134.49
2232327-23232787.45587.46
3226325-22632585.19685.20
4236618-23661889.07089.07
5224284-22428484.42784.43
6212166-21216679.86679.87
10min1252385-25238595.00593.112.4796.0194.062.48
2247661-24766193.22794.20
3243827-24382791.78492.73
4249262-24926293.83094.82
5253721-25372195.50896.45
6237181-23718189.28290.17
15min1257070-25707096.76995.271.4698.8397.261.49
2253375-25337595.37897.39
3249686-24968693.98995.96
4254110-25411095.65597.69
5256469-25646996.54398.54
6247825-24782593.28995.17
20min1254582-25458295.83295.661.9298.9798.711.92
2254717-25471795.88398.95
3254487-25448795.79798.81
4257429-25742996.904100.00
5258627-25862797.355100.43
6244830-24483092.16295.08
30min1251017-25101794.49194.961.8998.6999.061.87
2254021-25402195.62199.75
3246204-24620492.67996.75
4256354-25635496.500100.67
5258127-25812797.167101.32
6247782-24778293.27397.21
45min1253184-25318495.30695.391.84100.56100.561.82
2250491-25049194.29299.49
3248197-24819793.42998.53
4260440-26044098.038103.28
5257426-25742696.903102.14
6250758-25075894.39399.37
60min1250925-25092594.45695.761.68100.77101.991.64
2255619-25561996.223102.47
3256219-25621996.449102.59
4261011-26101198.253104.59
5253595-25359595.461101.77
6248981-24898193.72499.75
极限1257157-25715796.80297.781.65104.16105.071.58
2264808-26480899.682106.99
3261042-26104298.264105.48
4264388-26438899.524106.95
5255021-25502195.998103.37
6256116-25611696.410103.48
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)5供试品稀释倍数2.5系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.052498202498302495752503652504252500030.15
211.152522382526732524560.13
单位质量响应值RSD%判断
22624.7122641.790.06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%
5min1199421-19942175.06576.426.1075.0676.426.10
2196979-19697974.14674.15
3207501-20750178.10678.11
4188785-18878571.06171.06
5200317-20031775.40275.40
6225063-22506384.71784.72
10min1231272-23127287.05488.614.9087.8989.464.91
2229715-22971586.46887.29
3246606-24660692.82693.69
4218539-21853982.26183.05
5236655-23665589.08089.92
6249693-24969393.98894.93
15min1231565-23156587.16490.105.4988.9791.935.49
2227219-22721985.52887.31
3248893-24889393.68795.59
4227950-22795085.80487.51
5240341-24034190.46892.30
6260172-26017297.93299.92
20min1236311-23631188.95190.164.6491.7292.994.66
2233067-23306787.73090.46
3243994-24399491.84394.78
4224580-22458084.53587.19
5241805-24180591.01993.85
6257325-25732596.86199.93
30min1238080-23808089.61790.603.5793.3794.433.63
2233939-23393988.05891.77
3243451-24345191.63895.60
4230874-23087486.90490.50
5242621-24262191.32695.17
6255110-25511096.027100.18
45min1235541-23554188.66189.623.9293.4194.463.96
2232586-23258687.54992.24
3246018-24601892.60597.58
4225296-22529684.80589.37
5237955-23795589.57094.43
6251153-25115394.53899.75
60min1227271-22727185.54889.384.6891.2995.224.66
2230118-23011886.62092.28
3248043-24804393.36799.37
4227551-22755185.65391.16
5238610-23861089.81695.67
6253159-25315995.293101.56
极限1245824-24582492.53294.732.8999.22101.562.97
2250036-25003694.117100.74
3260293-26029397.978105.02
4245590-24559092.44498.90
5246934-24693492.94999.80
6261295-26129598.355105.68
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