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%
111.242566832560192540952553602543302552970.44
211.312529702523012526360.19
单位质量响应值RSD%判断
22713.2622337.401.18数据可信
供试品溶液-WK0055批-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%
5min1107651-10765140.71836.6617.5440.7236.6617.54
2112273-11227342.46742.47
3113774-11377443.03443.03
474585-7458528.21128.21
579625-7962530.11830.12
693592-9359235.40135.40
10min1200367-20036775.78865.0111.0776.2465.4211.10
2183655-18365569.46669.94
3177954-17795467.31067.79
4149129-14912956.40756.72
5156554-15655459.21659.55
6163595-16359561.87962.27
15min1219591-21959183.05972.0711.3684.3573.2011.38
2199385-19938575.41676.66
3207648-20764878.54279.77
4164316-16431662.15263.09
5172820-17282065.36866.36
6179479-17947967.88768.97
20min1217211-21721182.15972.347.7284.3874.287.78
2187465-18746570.90772.99
3193394-19339473.15075.25
4174781-17478166.11067.74
5180492-18049268.27069.99
6194241-19424173.47075.31
30min1229455-22945586.79075.689.3689.9278.429.38
2196352-19635274.26977.14
3213318-21331880.68683.60
4175873-17587366.52368.89
5190775-19077572.15974.64
6194756-19475673.66576.32
45min1231371-23137187.51577.108.6691.6180.688.71
2203175-20317576.85080.54
3212664-21266480.43984.25
4178143-17814367.38170.49
5196633-19663374.37577.65
6201090-20109076.06179.53
60min1223991-22399184.72378.534.6389.7982.964.77
2202791-20279176.70481.25
3212300-21230080.30185.00
4208116-20811678.71982.57
5197136-19713674.56578.67
6201437-20143776.19280.51
极限1229426-22942686.77986.832.1692.7992.142.13
2234864-23486488.83694.24
3225520-22552085.30290.90
4223418-22341884.50689.23
5235779-23577989.18294.12
6228430-22843086.40291.56
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%
111.242575252569922569632564972567192569390.15
211.312575842572872574360.09
单位质量响应值RSD%判断
22859.3422761.800.31数据可信
供试品溶液-WK0055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%
5min1163819-16381961.18563.162.8261.1863.162.83
2173392-17339264.76064.76
3168672-16867262.99763.00
4165282-16528261.73161.73
5167295-16729562.48362.48
6176110-17611065.77565.78
10min1199664-19966474.57274.423.9875.2575.123.96
2202166-20216675.50776.23
3189278-18927870.69371.39
4191061-19106171.35972.05
5202923-20292375.79076.48
6210453-21045378.60279.33
15min1204373-20437376.33177.903.5077.8479.423.49
2211156-21115678.86580.42
3200715-20071574.96576.45
4205119-20511976.61078.09
5208485-20848577.86779.40
6221530-22153082.73984.34
20min1208776-20877677.97678.643.6880.3381.043.66
2211565-21156579.01781.45
3199640-19964074.56376.88
4205993-20599376.93679.27
5215330-21533080.42482.83
6222042-22204282.93085.45
30min1211204-21120478.88279.763.7982.1183.033.76
2214447-21444780.09483.41
3207424-20742477.47180.62
4204407-20440776.34479.53
5216441-21644180.83884.13
6227349-22734984.91288.36
45min1220409-22040982.32081.673.7186.4285.823.66
2213404-21340479.70483.91
3213979-21397979.91983.93
4208736-20873677.96181.99
5225213-22521384.11588.31
6230219-23021985.98490.37
60min1218246-21824681.51380.662.3286.5385.732.36
2213851-21385179.87184.96
3211011-21101178.81083.71
4210684-21068478.68883.59
5218581-21858181.63886.77
6223451-22345183.45788.80
极限1255624-25562495.47393.211.32101.3999.171.29
2250050-25005093.39199.37
3247941-24794192.60398.37
4245939-24593991.85697.63
5248668-24866892.87598.91
6249244-24924493.09099.36
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%
111.242557372564892571762572882570712567520.26
211.312613232622882618060.27
单位质量响应值RSD%判断
22842.7023148.190.94数据可信
供试品溶液-WK0055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%
5min1181281-18128167.16570.577.1167.1670.567.11
2188678-18867869.90569.91
3201374-20137474.60974.61
4174560-17456064.67564.67
5211253-21125378.27078.27
6185618-18561868.77268.77
10min1194102-19410271.91577.538.0672.6678.318.04
2215362-21536279.79280.57
3221232-22123281.96782.80
4184305-18430568.28569.00
5228749-22874984.75285.62
6211778-21177878.46479.23
15min1197253-19725373.08379.297.5174.6380.937.50
2215202-21520279.73381.40
3222918-22291882.59184.33
4194898-19489872.21073.69
5237659-23765988.05389.86
6216081-21608180.05881.69
20min1198292-19829273.46778.076.9475.8280.596.95
2211568-21156878.38680.94
3220144-22014481.56484.22
4188484-18848469.83472.11
5227038-22703884.11886.91
6218715-21871581.03483.56
30min1205561-20556176.16180.865.9079.3384.255.96
2220341-22034181.63785.06
3224337-22433783.11786.68
4200801-20080174.39777.45
5235612-23561287.29591.02
6222738-22273882.52585.95
45min1213058-21305878.93884.715.7782.9689.005.81
2231259-23125985.68290.01
3231180-23118085.65390.14
4213681-21368179.16983.05
5247147-24714791.56896.26
6235503-23550387.25491.60
60min1215352-21535279.78885.605.4484.6990.845.49
2234510-23451086.88692.17
3235968-23596887.42792.87
4215573-21557379.87084.63
5244331-24433190.52596.24
6240510-24051089.10994.42
极限1251542-25154293.19794.953.6898.98101.133.78
2249483-24948392.43498.68
3259072-25907295.987102.40
4249358-24935892.38898.04
5274031-274031101.529108.25
6254084-25408494.139100.44
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