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%
110.422706152719442704582715302702082709510.28
210.302722442726922724680.12
单位质量响应值RSD%判断
26002.9826453.201.22数据可信
加速6月-供试品溶液-2025071721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%
5min1181205-18120568.95570.431.7568.9670.431.74
2189665-18966572.17472.17
3186720-18672071.05471.05
4184431-18443170.18370.18
5186660-18666071.03171.03
6181844-18184469.19869.20
10min1210920-21092080.26380.831.2980.4781.041.29
2215789-21578982.11682.33
3213201-21320181.13181.34
4213492-21349281.24181.45
5213205-21320581.13281.35
6207801-20780179.07679.28
15min1223054-22305484.88085.060.9985.3385.520.99
2225971-22597185.99086.45
3224183-22418385.31085.77
4224149-22414985.29785.75
5224338-22433885.36985.83
6219459-21945983.51283.96
20min1225910-22591085.96786.540.8686.6787.240.87
2230234-23023487.61288.33
3227732-22773286.66087.37
4228847-22884787.08587.79
5226815-22681586.31187.02
6224891-22489185.57986.27
30min1232499-23249988.47487.930.8589.4388.900.84
2233773-23377388.95989.94
3230140-23014087.57788.55
4231467-23146788.08289.05
5230295-23029587.63688.61
6228243-22824386.85587.81
45min1230701-23070187.79087.980.4889.0289.210.49
2232708-23270888.55489.80
3230655-23065587.77389.01
4232296-23229688.39789.63
5231089-23108987.93889.17
6229755-22975587.43088.64
60min1231371-23137188.04588.320.6089.5389.810.60
2234434-23443489.21190.73
3231742-23174288.18689.68
4232791-23279188.58590.09
5230408-23040887.67989.18
6231738-23173888.18589.66
极限1258152-25815298.23698.311.3499.99100.071.31
2261954-26195499.683101.47
3255748-25574897.32199.08
4256394-25639497.56799.33
5254716-25471696.92998.69
6263076-263076100.110101.85
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%
110.422715582714442722542712992712762715660.15
210.302727962721832724900.16
单位质量响应值RSD%判断
26062.0026455.341.06数据可信
加速6月-供试品溶液-2025071721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%
5min1188634-18863471.69772.091.5371.7072.091.53
2188089-18808971.49071.49
3190386-19038672.36372.36
4190488-19048872.40272.40
5194491-19449173.92373.92
6185940-18594070.67370.67
10min1217071-21707182.50681.752.2282.7281.962.21
2216277-21627782.20482.42
3213820-21382081.27081.49
4218252-21825282.95583.17
5218966-21896683.22683.45
6206078-20607878.32778.54
15min1226678-22667886.15785.432.6286.6285.892.62
2228023-22802386.66887.13
3223416-22341684.91785.38
4228527-22852786.86087.33
5228482-22848286.84387.31
6213411-21341181.11581.56
20min1232877-23287788.51386.832.6389.2387.552.62
2230961-23096187.78588.51
3225519-22551985.71786.43
4231992-23199288.17788.90
5231914-23191488.14788.88
6217487-21748782.66483.35
30min1232791-23279188.48187.672.5689.4788.652.55
2234443-23444389.10990.09
3228637-22863786.90287.87
4234270-23427089.04390.03
5234341-23434189.07090.07
6219532-21953283.44184.38
45min1234668-23466889.19487.922.3390.4589.162.33
2234969-23496989.30890.56
3228241-22824186.75187.98
4234294-23429489.05290.31
5234095-23409588.97690.24
6221601-22160184.22885.42
60min1236942-23694290.05888.462.5291.5889.962.51
2236108-23610889.74191.26
3230008-23000887.42388.92
4235477-23547789.50291.03
5235912-23591289.66791.20
6221930-22193084.35385.79
极限1258738-25873898.34397.521.03100.1399.291.05
2259166-25916698.505100.29
3255558-25555897.13498.89
4256261-25626197.40199.20
5257722-25772297.95799.76
6252001-25200195.78297.48
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%
110.422716882716472710972721122725402718170.20
210.302710342702312706320.21
单位质量响应值RSD%判断
26086.0826274.950.52数据可信
中间条件6月-供试品溶液-2025071721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%
5min1182493-18249369.56770.521.5569.5770.521.55
2184686-18468670.40370.40
3184025-18402570.15170.15
4181934-18193469.35469.35
5189207-18920772.12772.13
6187531-18753171.48871.49
10min1210688-21068880.31581.221.6480.5281.431.64
2216298-21629882.45482.66
3214697-21469781.84382.05
4212079-21207980.84581.05
5216785-21678582.63982.86
6207863-20786379.23879.45
15min1222113-22211384.67085.271.5285.1285.731.52
2228432-22843287.07987.54
3223443-22344385.17785.63
4222020-22202084.63585.09
5226839-22683986.47286.94
6219267-21926783.58684.04
20min1225776-22577686.06787.041.8486.7787.751.83
2233106-23310688.86189.58
3230635-23063587.91988.63
4225118-22511885.81686.52
5232240-23224088.53189.25
6223112-22311285.05185.75
30min1225909-22590986.11887.831.8587.0888.801.85
2236224-23622490.05091.04
3231965-23196588.42689.40
4228833-22883387.23288.19
5233646-23364689.06790.06
6225836-22583686.09087.05
45min1229571-22957187.51388.682.0988.7389.912.08
2238184-23818490.79792.05
3233599-23359989.04990.29
4231840-23184088.37889.60
5237291-23729190.45691.71
6225244-22524485.86487.08
60min1227401-22740186.68688.331.9088.1789.831.89
2237205-23720590.42491.95
3233173-23317388.88790.39
4230986-23098688.05389.54
5235376-23537689.72691.25
6226136-22613686.20487.68
极限1256689-25668997.85198.811.6999.59100.571.69
2263704-263704100.525102.33
3261162-26116299.556101.33
4257602-25760298.19999.95
5263474-263474100.437102.23
6252561-25256196.27798.01
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%
110.422725702721052716532707642710432716270.28
210.302705342703642704490.05
单位质量响应值RSD%判断
26067.8526257.180.52数据可信
中间条件6月-供试品溶液-2025071721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%
5min1188124-18812471.76371.732.5871.7671.732.58
2189389-18938972.24672.25
3189776-18977672.39372.39
4188047-18804771.73471.73
5179099-17909968.32068.32
6193742-19374273.90673.91
10min1217715-21771583.05181.751.8183.2781.971.81
2212484-21248481.05681.27
3218175-21817583.22783.44
4211849-21184980.81381.03
5208656-20865679.59579.80
6217012-21701282.78383.00
15min1229254-22925487.45385.601.6387.9286.061.64
2221595-22159584.53184.99
3227252-22725286.68987.16
4220666-22066684.17784.63
5221279-22127984.41184.85
6226258-22625886.31086.78
20min1231286-23128688.22887.321.5188.9588.041.51
2229022-22902287.36488.08
3231905-23190588.46489.19
4223970-22397085.43786.15
5225454-22545486.00386.70
6231853-23185388.44489.17
30min1234858-23485889.59187.841.5290.5888.821.51
2228342-22834287.10588.08
3231489-23148988.30589.30
4224894-22489485.79086.76
5229522-22952287.55588.51
6232505-23250588.69389.69
45min1235417-23541789.80488.141.6291.0689.381.61
2228348-22834887.10788.34
3232900-23290088.84490.10
4226891-22689186.55187.78
5228098-22809887.01288.23
6234737-23473789.54490.80
60min1236325-23632590.15088.421.4691.6889.931.46
2228432-22843287.13988.64
3234347-23434789.39690.92
4227643-22764386.83888.32
5231235-23123588.20889.69
6232791-23279188.80290.33
极限1258237-25823798.50999.191.61100.31100.961.60
2255904-25590497.61999.38
3267469-267469102.031103.82
4260032-26003299.194100.94
5256934-25693498.01299.76
6261568-26156899.779101.57
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%
110.422742192732702731852735312731832734780.17
210.302715732723302719520.20
单位质量响应值RSD%判断
26245.4926403.110.43数据可信
长期6月-供试品溶液-2025071721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%
5min1184053-18405369.77869.840.6969.7869.840.69
2185261-18526170.23670.24
3185494-18549470.32570.32
4184444-18444469.92769.93
5181933-18193368.97568.97
6184119-18411969.80369.80
10min1217287-21728782.37882.081.1082.5982.291.10
2213593-21359380.97881.19
3219653-21965383.27583.49
4217615-21761582.50282.71
5217045-21704582.28682.49
6213756-21375681.03981.25
15min1227001-22700186.06186.280.7086.5286.740.70
2228582-22858286.66087.11
3229579-22957987.03887.50
4226892-22689286.01986.48
5228401-22840186.59287.05
6225093-22509385.33785.79
20min1231986-23198687.95187.471.1988.6788.191.19
2225682-22568285.56186.27
3232463-23246388.13288.85
4231179-23117987.64588.36
5233264-23326488.43589.15
6229780-22978087.11487.82
30min1233963-23396388.70088.361.2089.6889.341.19
2227614-22761486.29387.26
3233837-23383788.65289.64
4235098-23509889.13190.11
5234956-23495689.07790.06
6232898-23289888.29689.27
45min1233973-23397388.70488.971.2689.9590.211.25
2229404-22940486.97288.20
3235961-23596189.45890.71
4238096-23809690.26791.51
5236028-23602889.48390.73
6234528-23452888.91490.15
60min1234597-23459788.94188.901.2990.4590.401.27
2228555-22855586.65088.14
3234918-23491889.06290.58
4236161-23616189.53491.05
5235996-23599689.47190.99
6236650-23665089.71991.22
极限1257115-25711597.47899.241.6399.26101.021.61
2257078-25707897.46499.21
3265224-265224100.552102.34
4263617-26361799.943101.73
5267173-267173101.291103.07
6260362-26036298.709100.48
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%
110.422732492740122732062732052732132733770.14
210.302734572731432733000.09
单位质量响应值RSD%判断
26235.8026533.980.80数据可信
长期6月-供试品溶液-2025071721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%
5min1188157-18815771.17272.492.7271.1772.492.72
2198170-19817074.96074.96
3193593-19359373.22873.23
4183416-18341669.37969.38
5194625-19462573.61973.62
6191915-19191572.59472.59
10min1217532-21753282.28384.132.8082.5084.352.80
2223076-22307684.38084.61
3221011-22101183.59983.82
4216212-21621281.78481.99
5233748-23374888.41788.64
6222938-22293884.32884.55
15min1226741-22674185.76788.062.8386.2388.542.82
2230444-23044487.16787.65
3234003-23400388.51488.98
4227418-22741886.02386.48
5244731-24473192.57293.06
6233531-23353188.33588.81
20min1231659-23165987.62789.223.1088.3489.953.09
2232352-23235287.88988.63
3234883-23488388.84789.58
4229676-22967686.87787.59
5249871-24987194.51695.28
6236765-23676589.55890.29
30min1235315-23531589.01090.202.6089.9991.202.59
2234818-23481888.82289.83
3236534-23653489.47190.47
4234413-23441388.66989.64
5250609-25060994.79595.84
6239071-23907190.43191.44
45min1235633-23563389.13090.892.5590.3892.162.55
2237240-23724089.73891.01
3239871-23987190.73392.00
4236208-23620889.34890.59
5252072-25207295.34896.68
6240652-24065291.02992.30
60min1236318-23631889.38990.832.6490.9092.372.63
2236687-23668789.52991.07
3239915-23991590.75092.29
4235506-23550689.08290.59
5252449-25244995.49197.11
6239843-23984390.72392.27
极限1267849-267849101.316100.250.86103.10102.070.86
2264407-264407100.014101.82
3264185-26418599.930101.75
4264499-264499100.049101.82
5267466-267466101.171103.08
6261823-26182399.037100.86
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