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%
110.422720772722672719542720842721442721050.05
210.302728752730492729620.05
单位质量响应值RSD%判断
26113.7226501.171.05数据可信
加速6月-供试品溶液-249A29S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%
5min1217841-21784182.64582.461.1182.6482.461.11
2218185-21818582.77582.78
3218933-21893383.05983.06
4213844-21384481.12881.13
5220233-22023383.55283.55
6215115-21511581.61181.61
10min1231085-23108587.66986.781.1487.9287.031.14
2229902-22990287.22087.47
3229154-22915486.93787.19
4224064-22406485.00685.25
5230610-23061087.48987.74
6227598-22759886.34686.59
15min1234418-23441888.93487.781.2389.4488.291.23
2231644-23164487.88188.39
3231365-23136587.77588.29
4226401-22640185.89286.39
5233712-23371288.66689.18
6230716-23071687.52988.03
20min1234368-23436888.91588.041.0789.6988.811.07
2232585-23258588.23889.01
3232073-23207388.04488.82
4227542-22754286.32587.08
5234086-23408688.80889.59
6231686-23168687.89788.66
30min1235423-23542389.31588.201.1890.3689.241.18
2232789-23278988.31689.35
3232423-23242388.17789.21
4227596-22759686.34687.36
5234678-23467889.03290.08
6232070-23207088.04389.07
45min1235407-23540789.30988.421.1090.6289.721.10
2233281-23328188.50289.81
3232451-23245188.18789.49
4228390-22839086.64787.92
5235201-23520189.23190.54
6233644-23364488.64089.93
60min1234708-23470889.04488.631.1190.6290.191.10
2234491-23449188.96190.53
3233606-23360688.62690.19
4228624-22862486.73688.27
5236035-23603589.54791.13
6234179-23417988.84390.40
极限1250285-25028594.95394.271.5296.8096.101.51
2249609-24960994.69796.53
3248592-24859294.31196.14
4241138-24113891.48393.28
5249342-24934294.59696.44
6251918-25191895.57397.40
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%
110.422722622724102727342725862725082725000.07
210.302731732729482730600.06
单位质量响应值RSD%判断
26151.6326510.680.97数据可信
加速6月-供试品溶液-249A29S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%
5min1216853-21685382.19582.791.5382.2082.801.53
2222217-22221784.22884.23
3215271-21527181.59681.60
4220471-22047183.56783.57
5221327-22132783.89183.89
6214448-21444881.28481.28
10min1227207-22720786.12086.741.5486.3786.981.53
2230526-23052687.37887.63
3224719-22471985.17785.42
4232412-23241288.09388.34
5232661-23266188.18788.44
6225457-22545785.45685.70
15min1229160-22916086.86087.651.6287.3688.161.62
2233156-23315688.37588.89
3226955-22695586.02486.52
4235471-23547189.25289.77
5234914-23491489.04189.56
6227816-22781686.35186.85
20min1230415-23041587.33687.651.6588.1088.431.65
2232828-23282888.25089.03
3226234-22623485.75186.51
4235091-23509189.10889.89
5235289-23528989.18389.97
6227682-22768286.30087.06
30min1231229-23122987.64487.841.5988.6788.871.59
2233890-23389088.65389.70
3227528-22752886.24187.26
4235536-23553689.27790.33
5234984-23498489.06790.12
6227266-22726686.14287.16
45min1230820-23082087.48987.951.8588.7889.261.85
2233612-23361288.54789.86
3228013-22801386.42587.70
4237121-23712189.87791.20
5236094-23609489.48890.81
6226632-22663285.90287.18
60min1231600-23160087.78588.231.7589.3489.791.74
2233676-23367688.57290.15
3227965-22796586.40787.94
4237501-23750190.02291.61
5237066-23706689.85791.44
6228779-22877986.71688.25
极限1247074-24707493.65094.041.3895.4795.871.38
2249695-24969594.64396.49
3243636-24363692.34794.14
4252493-25249395.70497.56
5250613-25061394.99196.85
6245082-24508292.89594.69
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%
110.422728782726042727442725002727182726890.06
210.302724692724342724520.01
单位质量响应值RSD%判断
26169.7726451.650.76数据可信
中间条件6月-供试品溶液-249A29S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%
5min1224584-22458485.19087.471.4785.1987.471.47
2233243-23324388.47588.47
3234194-23419488.83588.84
4231023-23102387.63387.63
5229981-22998187.23787.24
6230479-23047987.42687.43
10min1236114-23611489.56491.361.2989.8291.621.28
2242996-24299692.17492.44
3242610-24261092.02892.29
4242620-24262092.03292.29
5237727-23772790.17690.44
6242973-24297392.16692.43
15min1236491-23649189.70792.041.5290.2392.581.52
2245110-24511092.97693.52
3244974-24497492.92593.47
4244264-24426492.65593.19
5239739-23973990.93991.47
6245316-24531693.05493.59
20min1237860-23786090.22692.231.3791.0293.041.36
2244795-24479592.85793.68
3246862-24686293.64194.46
4244399-24439992.70693.52
5240483-24048391.22192.03
6244410-24441092.71193.53
30min1236915-23691589.86892.051.5190.9393.141.51
2245178-24517893.00294.10
3244589-24458992.77993.88
4245365-24536593.07394.17
5239178-23917890.72691.80
6244784-24478492.85293.95
45min1238244-23824490.37292.331.6591.7193.701.64
2247514-24751493.88895.27
3244829-24482992.87094.25
4245677-24567793.19194.57
5238527-23852790.47991.83
6245712-24571293.20494.58
60min1237550-23755090.10892.161.4891.7193.811.48
2246989-24698993.68995.35
3243563-24356392.38994.05
4244526-24452692.75594.41
5239803-23980390.96392.59
6245399-24539993.08694.74
极限1249223-24922394.53696.421.2996.4198.341.29
2258110-25811097.90799.85
3253573-25357396.18698.12
4255264-25526496.82898.76
5252103-25210395.62997.52
6256902-25690297.44999.38
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%
110.422714942714772715932711372712792713960.07
210.302686372689262687820.08
单位质量响应值RSD%判断
26045.6826095.340.14数据可信
中间条件6月-供试品溶液-249A29S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%
5min1232510-23251089.00788.391.0689.0188.401.06
2227815-22781587.20987.21
3234707-23470789.84889.85
4231020-23102088.43688.44
5229815-22981587.97587.98
6229575-22957587.88387.88
10min1242343-24234392.77191.731.0793.0492.001.07
2237217-23721790.80991.07
3243020-24302093.03093.30
4237232-23723290.81491.08
5239720-23972091.76792.03
6238207-23820791.18891.45
15min1243667-24366793.27892.631.2793.8293.171.27
2239772-23977291.78792.32
3246961-24696194.53995.09
4238485-23848591.29491.83
5242335-24233592.76893.31
6240563-24056392.09092.63
20min1244421-24442193.56692.741.1594.3993.561.15
2238434-23843491.27592.08
3245877-24587794.12494.96
4241253-24125392.35493.17
5243339-24333993.15293.97
6240233-24023391.96392.78
30min1245303-24530393.90492.581.3095.0193.681.30
2237476-23747690.90891.99
3244971-24497193.77794.89
4239430-23943091.65692.74
5243043-24304393.03994.14
6240877-24087792.21093.30
45min1244726-24472693.68392.411.1895.0793.781.18
2237317-23731790.84792.20
3243978-24397893.39794.79
4239736-23973691.77393.14
5242523-24252392.84094.22
6240110-24011091.91693.28
60min1251486-25148696.27193.362.0797.9495.012.05
2240697-24069792.14193.77
3243511-24351193.21894.89
4238872-23887291.44293.08
5248441-24844195.10596.76
6240236-24023691.96493.61
极限1257518-25751898.58096.571.17100.5498.511.17
2249589-24958995.54597.45
3252463-25246396.64598.60
4249718-24971895.59497.51
5253186-25318696.92298.86
6251194-25119496.15998.08
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%
110.422733912727242730622731842735142731750.12
210.302710732710562710640.01
单位质量响应值RSD%判断
26216.4126316.890.28数据可信
长期6月-供试品溶液-249A29S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%
5min1239532-23953291.01089.471.9591.0189.471.96
2231603-23160387.99888.00
3231722-23172288.04388.04
4232238-23223888.23988.24
5235310-23531089.40689.41
6242502-24250292.13992.14
10min1243847-24384792.65091.921.2892.9292.191.29
2237277-23727790.15490.42
3241579-24157991.78892.05
4241479-24147991.75092.01
5240915-24091591.53691.80
6246538-24653893.67293.95
15min1246345-24634593.59992.191.5594.1592.731.55
2238893-23889390.76891.30
3238637-23863790.67091.21
4240789-24078991.48892.03
5243927-24392792.68093.22
6247217-24721793.93094.49
20min1245720-24572093.36292.461.5294.1993.281.52
2239709-23970991.07891.88
3238348-23834890.56191.37
4243157-24315792.38893.20
5245313-24531393.20794.03
6247867-24786794.17795.02
30min1246807-24680793.77592.521.4394.8993.621.42
2242217-24221792.03193.11
3237833-23783390.36591.45
4244426-24442692.87093.96
5242552-24255292.15893.26
6247154-24715493.90695.03
45min1250477-25047795.16992.671.6096.5694.051.59
2241101-24110191.60792.96
3240268-24026891.29092.64
4242957-24295792.31293.68
5242113-24211391.99193.37
6246530-24653093.66995.07
60min1244195-24419592.78291.791.3694.4693.441.35
2239098-23909890.84592.48
3237561-23756190.26291.89
4241437-24143791.73493.38
5240783-24078391.48693.14
6246419-24641993.62795.31
极限1254568-25456896.72396.071.6198.6898.001.59
2257133-25713397.69899.60
3247035-24703593.86195.76
4249593-24959394.83396.76
5251961-25196195.73397.66
6256873-25687397.59999.56
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%
110.422835142825532841322853932842522839690.37
210.302756812744202750500.33
单位质量响应值RSD%判断
27252.3026703.881.44数据可信
长期6月-供试品溶液-249A29S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%
5min1246878-24687891.33788.722.4891.3488.722.48
2247238-24723891.47091.47
3232663-23266386.07886.08
4238011-23801188.05688.06
5237829-23782987.98987.99
6236160-23616087.37287.37
10min1251961-25196193.21890.072.0593.4990.332.05
2241918-24191889.50289.78
3240102-24010288.83089.09
4245766-24576690.92691.19
5243212-24321289.98190.24
6237701-23770187.94288.20
15min1252405-25240593.38291.032.6593.9491.572.65
2252200-25220093.30693.85
3237198-23719887.75688.28
4250527-25052792.68793.22
5242952-24295289.88490.42
6240995-24099589.16089.69
20min1251143-25114392.91591.332.6893.7592.142.67
2254566-25456694.18195.00
3240128-24012888.84089.63
4252430-25243093.39194.21
5243013-24301389.90790.71
6239882-23988288.74989.54
30min1255264-25526494.44090.762.6595.5591.852.65
2247832-24783291.69092.80
3238346-23834688.18089.23
4248922-24892292.09393.19
5242056-24205689.55390.63
6239524-23952488.61689.68
45min1261794-26179496.85591.183.3098.2592.543.28
2245885-24588590.97092.35
3241262-24126289.25990.58
4247179-24717991.44892.82
5243879-24387990.22791.57
6238729-23872988.32289.65
60min1261535-26153596.76092.343.2898.4593.983.26
2246632-24663291.24692.90
3250491-25049192.67494.26
4255677-25567794.59296.24
5244707-24470790.53492.15
6238549-23854988.25589.85
极限1260083-26008396.22293.831.9798.2095.741.98
2255823-25582394.64696.57
3248397-24839791.89993.76
4257966-25796695.43997.37
5250449-25044992.65894.54
6249015-24901592.12893.98
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