辅酶Q10片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号140611-202107对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
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%
110.332720562721312706252720722715202716810.24
210.302725072726422725740.04
单位质量响应值RSD%判断
26300.1926463.500.44数据可信
加速6月-供试品溶液-2025071821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%
5min1178231-17823167.42470.505.7967.4270.505.79
2196204-19620474.22374.22
3183745-18374569.51069.51
4178319-17831967.45767.46
5178404-17840467.48967.49
6203198-20319876.86976.87
10min1207205-20720578.38478.751.1178.5978.961.12
2208496-20849678.87379.10
3209818-20981879.37379.58
4207451-20745178.47778.68
5204682-20468277.43077.63
6211320-21132079.94180.17
15min1217976-21797682.45982.170.7782.9082.620.77
2216894-21689482.05082.51
3218364-21836482.60683.05
4216733-21673381.98982.43
5214316-21431681.07481.51
6218960-21896082.83183.30
20min1222864-22286484.30883.660.6884.9984.360.68
2219955-21995583.20883.91
3221683-22168383.86184.56
4220944-22094483.58284.27
5219016-21901682.85283.53
6222492-22249284.16784.89
30min1226168-22616885.55884.530.8286.5085.470.82
2222120-22212084.02784.98
3223738-22373884.63985.58
4222956-22295684.34385.28
5221039-22103983.61884.54
6224659-22465984.98785.96
45min1228839-22883986.56885.530.9787.7686.730.97
2223060-22306084.38285.59
3227264-22726485.97387.17
4225933-22593385.46986.66
5224042-22404284.75485.93
6227392-22739286.02187.25
60min1229490-22949086.81585.620.9588.2787.070.95
2224748-22474885.02186.48
3227241-22724185.96487.42
4225507-22550785.30886.75
5223542-22354284.56586.00
6227398-22739886.02387.51
极限1261643-26164398.97898.030.81100.6999.740.79
2255681-25568196.72398.44
3258468-25846897.77799.49
4258897-25889797.93999.64
5260905-26090598.699100.38
6259269-25926998.08099.82
辅酶Q10片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号140611-202107对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
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%
110.332727112737622746822738972726282735360.32
210.302735422728762732090.18
单位质量响应值RSD%判断
26479.7726525.150.13数据可信
加速6月-供试品溶液-2025071821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%
5min1178592-17859267.25265.685.9867.2565.685.98
2181172-18117268.22468.22
3153730-15373057.89057.89
4180381-18038167.92667.93
5174177-17417765.59065.59
6178406-17840667.18267.18
10min1207581-20758178.16978.901.4278.3779.101.41
2213835-21383580.52480.73
3209960-20996079.06479.24
4208970-20897078.69278.90
5211455-21145579.62779.82
6205383-20538377.34177.54
15min1217476-21747681.89582.331.4682.3382.771.46
2222497-22249783.78684.23
3217717-21771781.98682.40
4219113-21911382.51182.95
5221434-22143483.38583.82
6213593-21359380.43380.87
20min1220982-22098283.21584.001.6883.9084.691.67
2226653-22665385.35186.05
3219822-21982282.77883.44
4223741-22374184.25484.94
5228145-22814585.91286.60
6219111-21911182.51083.19
30min1221762-22176283.50984.571.5284.4485.501.52
2228255-22825585.95486.91
3222247-22224783.69184.60
4224486-22448684.53585.47
5229231-22923186.32187.26
6221516-22151683.41684.34
45min1226764-22676485.39285.981.3186.5787.161.31
2231172-23117287.05288.26
3227040-22704085.49686.65
4230105-23010586.65087.84
5231164-23116487.04988.25
6223727-22372784.24985.42
60min1225234-22523484.81685.911.5186.2587.361.51
2230923-23092386.95888.43
3225561-22556184.93986.35
4230061-23006186.63488.09
5232571-23257187.57989.04
6224562-22456284.56385.99
极限1256041-25604196.41797.601.1098.1199.301.11
2262505-26250598.851100.58
3256552-25655296.61098.28
4260349-26034998.03999.75
5262111-26211198.703100.43
6257488-25748896.96298.64
辅酶Q10片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号140611-202107对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
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%
110.332738312738052743152739412735972738980.10
210.302723962719962721960.11
单位质量响应值RSD%判断
26514.8126426.800.24数据可信
中间条件6月-供试品溶液-2025071821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%
5min1195099-19509973.55673.123.2873.5673.123.27
2199676-19967675.28275.28
3184788-18478869.66969.67
4191356-19135672.14572.15
5190677-19067771.88971.89
6202063-20206376.18276.18
10min1221243-22124383.41383.442.1683.6383.662.17
2227682-22768285.84186.07
3213209-21320980.38480.59
4222151-22215183.75583.97
5219941-21994182.92283.14
6223614-22361484.30784.54
15min1230203-23020386.79186.261.7187.2686.731.71
2233754-23375488.13088.61
3221890-22189083.65784.11
4230029-23002986.72687.19
5228654-22865486.20786.67
6228272-22827286.06386.54
20min1230901-23090187.05487.771.2687.7988.501.26
2236237-23623789.06689.81
3228031-22803185.97286.67
4234514-23451488.41789.14
5233635-23363588.08588.81
6233532-23353288.04688.79
30min1233748-23374888.12888.481.0489.1289.471.05
2238509-23850989.92390.94
3231265-23126587.19288.15
4236106-23610689.01790.01
5234237-23423788.31289.30
6234203-23420388.29989.30
45min1237950-23795089.71289.361.5090.9790.621.50
2242308-24230891.35592.64
3231622-23162287.32688.55
4238529-23852989.93091.19
5235780-23578088.89490.15
6235928-23592888.95090.22
60min1235788-23578888.89789.151.4590.4290.671.45
2241486-24148691.04592.60
3231965-23196587.45588.94
4239319-23931990.22891.76
5234619-23461988.45689.98
6235548-23554888.80690.34
极限1267279-267279100.77098.701.28102.56100.501.27
2263908-26390899.499101.33
3258245-25824597.36499.11
4261480-26148098.583100.38
5259060-25906097.67199.46
6260843-26084398.343100.15
辅酶Q10片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号140611-202107对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
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%
110.332743642735322744412746092729972739890.26
210.302746012737122741560.23
单位质量响应值RSD%判断
26523.6226617.090.25数据可信
中间条件6月-供试品溶液-2025071821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%
5min1192053-19205372.13772.082.9972.1472.082.99
2200812-20081275.42775.43
3186152-18615269.92069.92
4189407-18940771.14371.14
5196171-19617173.68373.68
6186740-18674070.14170.14
10min1221145-22114583.06483.322.9383.2883.542.92
2229031-22903186.02686.25
3217819-21781981.81582.02
4226106-22610684.92785.14
5225508-22550884.70384.92
6211361-21136179.38979.60
15min1233879-23387987.84787.363.1588.3187.823.15
2241180-24118090.58991.07
3227437-22743785.42785.88
4236746-23674688.92489.39
5235430-23543088.42988.90
6220745-22074582.91483.36
20min1234544-23454488.09788.343.4388.8389.063.42
2246122-24612292.44593.20
3229767-22976786.30287.01
4240633-24063390.38491.12
5236780-23678088.93689.68
6223246-22324683.85384.55
30min1236503-23650388.83289.143.0389.8390.133.03
2245633-24563392.26293.30
3233051-23305187.53688.51
4243067-24306791.29892.30
5239752-23975290.05391.06
6225900-22590084.85085.80
45min1239979-23997990.13890.533.1791.4091.793.16
2250708-25070894.16895.48
3236139-23613988.69689.93
4246717-24671792.66993.95
5243179-24317991.34092.62
6229421-22942186.17287.38
60min1240809-24080990.45089.913.0991.9891.443.09
2248737-24873793.42895.02
3236485-23648588.82690.32
4242558-24255891.10792.66
5241029-24102990.53292.08
6226672-22667285.14086.60
极限1262476-26247698.58898.671.57100.39100.481.59
2270538-270538101.616103.49
3260112-26011297.70099.47
4263049-26304998.803100.63
5261060-26106098.05699.88
6258981-25898197.27598.99
辅酶Q10片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号140611-202107对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
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%
110.332744862737402744542722332730802735990.36
210.302739612731612735610.21
单位质量响应值RSD%判断
26485.8726559.320.20数据可信
长期6月-供试品溶液-2025071821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%
5min1197420-19742074.28673.490.8074.2973.490.80
2193975-19397572.99072.99
3196986-19698674.12374.12
4194089-19408973.03373.03
5195329-19532973.49973.50
6194053-19405373.01973.02
10min1219153-21915382.46483.191.2982.6983.411.29
2220291-22029182.89283.11
3224477-22447784.46784.69
4224729-22472984.56284.78
5217969-21796982.01882.24
6219829-21982982.71882.94
15min1231804-23180487.22488.011.4787.6988.481.47
2232012-23201287.30287.77
3236334-23633488.92989.40
4239362-23936290.06890.54
5229997-22999786.54487.01
6233822-23382287.98388.45
20min1237654-23765489.42589.691.0490.1690.421.04
2238457-23845789.72790.46
3239260-23926090.03090.77
4242446-24244691.22891.97
5234962-23496288.41289.14
6237367-23736789.31790.05
30min1241196-24119690.75891.921.8591.7692.931.84
2246046-24604692.58393.58
3250099-25009994.10895.12
4247903-24790393.28294.30
5238075-23807589.58490.58
6242445-24244591.22892.23
45min1248538-24853893.52191.841.5194.7993.121.50
2242464-24246491.23592.51
3242231-24223191.14892.44
4248593-24859393.54194.84
5239592-23959290.15591.41
6243032-24303291.44992.72
60min1242429-24242991.22291.220.9792.7892.780.97
2244407-24440791.96693.52
3243695-24369591.69893.27
4244554-24455492.02293.60
5238569-23856989.77091.30
6240916-24091690.65392.20
极限1256198-25619896.40397.621.1098.2399.441.08
2256127-25612796.37698.20
3258642-25864297.32399.17
4262429-26242998.748100.60
5261693-26169398.471100.27
6261444-26144498.377100.20
辅酶Q10片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号140611-202107对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
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%
110.332747262751022747922776892769262758470.50
210.302758652758052758350.02
单位质量响应值RSD%判断
26703.4826780.100.21数据可信
长期6月-供试品溶液-2025071821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%
5min1194844-19484472.71672.934.1072.7272.934.10
2208946-20894677.97977.98
3195807-19580773.07573.08
4195782-19578273.06673.07
5183964-18396468.65568.66
6193158-19315872.08672.09
10min1217347-21734781.11481.672.9281.3381.882.92
2226637-22663784.58184.81
3221520-22152082.67182.89
4221658-22165882.72382.94
5207662-20766277.49977.71
6218160-21816081.41781.63
15min1226136-22613684.39485.682.1284.8686.142.13
2235534-23553487.90188.39
3232197-23219786.65687.12
4232021-23202186.59087.06
5221952-22195282.83283.27
6229628-22962885.69786.16
20min1233816-23381687.26087.721.7887.9788.441.79
2238961-23896189.18089.93
3237166-23716688.51089.24
4238558-23855889.03089.76
5227817-22781785.02185.71
6233919-23391987.29888.02
30min1236170-23617088.13989.051.8189.1190.041.81
2242447-24244790.48191.50
3240626-24062689.80190.79
4241489-24148990.12491.12
5231020-23102086.21787.16
6239944-23994489.54790.53
45min1236595-23659588.29789.181.1389.5490.431.15
2241395-24139590.08891.38
3239149-23914989.25090.51
4241819-24181990.24791.51
5234963-23496387.68888.89
6239820-23982089.50190.75
60min1237107-23710788.48889.691.7489.9991.211.73
2239252-23925289.28990.85
3242739-24273990.59092.12
4247419-24741992.33793.87
5236019-23601988.08289.55
6239399-23939989.34490.86
极限1261360-26136097.53998.180.8299.3199.970.82
2264185-26418598.594100.42
3261058-26105897.42799.23
4266720-26672099.540101.35
5263234-26323498.23999.97
6261890-26189097.73799.52
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