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%
19.982731182728232713612719562721262722770.26
210.032709822705692707760.11
单位质量响应值RSD%判断
27282.2626996.610.75数据可信
加速3月-供试品溶液-25020801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%
5min1110733-11073340.72140.633.4540.7240.623.45
2108178-10817839.78139.78
3107677-10767739.59739.60
4114759-11475942.20242.20
5115270-11527042.38942.39
6106225-10622539.06339.06
10min1137693-13769350.63550.183.7050.7650.303.70
2134197-13419749.35049.47
3131670-13167048.42048.54
4143059-14305952.60952.74
5141227-14122751.93552.06
6130897-13089748.13648.25
15min1152721-15272156.16255.543.9856.4455.813.98
2148273-14827354.52654.79
3145862-14586253.63953.90
4158495-15849558.28558.57
5156947-15694757.71658.00
6143826-14382652.89153.15
20min1162025-16202559.58359.114.0160.0359.554.01
2158353-15835358.23358.66
3155892-15589257.32857.75
4169134-16913462.19762.66
5166682-16668261.29661.75
6152329-15232956.01856.44
30min1173484-17348463.79763.313.9064.4263.923.90
2169745-16974562.42263.03
3168275-16827561.88262.48
4181563-18156366.76867.41
5177122-17712265.13565.77
6162710-16271059.83560.42
45min1183412-18341267.44867.512.9768.2668.322.96
2178886-17888665.78466.58
3176170-17617064.78565.57
4191370-19137070.37571.22
5186317-18631768.51669.35
6185342-18534268.15868.93
60min1189256-18925669.59770.015.7970.6171.025.75
2183789-18378967.58768.58
3183682-18368267.54768.52
4197335-19733572.56873.63
5208931-20893176.83277.87
6179213-17921365.90466.88
极限1224962-22496282.72882.561.7783.9583.781.80
2224324-22432482.49383.69
3220169-22016980.96582.14
4231151-23115185.00486.28
5225716-22571683.00584.28
6220760-22076081.18282.35
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%
19.982750002750072748372749532748482749290.03
210.032879842876792878320.08
单位质量响应值RSD%判断
27548.0028697.112.89数据不可信!(响应值差异过大,请重新称样测定!)
室温3月-供试品溶液-25020801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%
5min1160108-16010856.84255.892.1556.8455.892.15
2155877-15587755.34055.34
3155394-15539455.16955.17
4162082-16208257.54357.54
5158201-15820156.16556.17
6152842-15284254.26354.26
10min1183879-18387965.28164.721.6765.4564.891.67
2183118-18311865.01165.18
3181564-18156464.45964.62
4186247-18624766.12266.29
5181923-18192364.58764.76
6177118-17711862.88163.04
15min1200402-20040271.14770.111.7171.5170.471.71
2197458-19745870.10270.46
3195789-19578969.51069.87
4200707-20070771.25671.63
5198797-19879770.57870.94
6191741-19174168.07368.42
20min1208432-20843273.99873.371.7974.5873.941.79
2205123-20512372.82373.39
3205295-20529572.88573.45
4212340-21234075.38675.97
5207356-20735673.61674.19
6201391-20139171.49972.05
30min1218963-21896377.73776.991.7178.5477.781.71
2216913-21691377.00977.80
3214506-21450676.15576.94
4221699-22169978.70879.52
5218023-21802377.40378.20
6211058-21105874.93175.70
45min1225645-22564580.10978.991.5681.1480.021.56
2222437-22243778.97079.99
3220623-22062378.32679.34
4227389-22738980.72881.78
5220935-22093578.43779.46
6217987-21798777.39178.39
60min1228948-22894881.28279.731.8182.5680.991.80
2224774-22477479.80081.06
3220021-22002178.11379.36
4228731-22873181.20582.49
5225347-22534780.00381.27
6219675-21967577.99079.22
极限1252958-25295889.80688.511.0191.3390.011.02
2248178-24817888.10989.61
3248593-24859388.25689.74
4251373-25137389.24390.78
5248838-24883888.34389.85
6245842-24584287.28088.74
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%
19.982739882744942738402737232738802739850.11
210.032763162749072756120.37
单位质量响应值RSD%判断
27453.4127478.760.07数据可信
-供试品溶液-25061201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%
5min1150583-15058354.71551.345.3154.7251.345.31
2139136-13913650.55650.56
3129920-12992047.20747.21
4146987-14698753.40953.41
5144245-14424552.41252.41
6136874-13687449.73449.73
10min1175133-17513363.63660.324.4363.8060.484.43
2165326-16532660.07260.22
3155040-15504056.33556.48
4171470-17147062.30562.47
5168522-16852261.23461.39
6160555-16055558.33958.49
15min1192912-19291270.09666.654.0170.4566.984.02
2179953-17995365.38765.72
3173984-17398463.21863.53
4189624-18962468.90169.25
5186326-18632667.70368.04
6177754-17775464.58864.91
20min1202532-20253273.59170.823.6774.1671.363.68
2192236-19223669.85070.38
3184724-18472467.12167.62
4202600-20260073.61674.17
5197194-19719471.65272.20
6190179-19017969.10369.62
30min1215218-21521878.20175.722.9478.9976.472.96
2205218-20521874.56775.31
3199626-19962672.53673.24
4214991-21499178.11978.89
5209873-20987376.25977.02
6205496-20549674.66875.39
45min1222570-22257080.87279.192.9581.8980.162.95
2210199-21019976.37777.34
3211686-21168676.91877.84
4227176-22717682.54683.56
5218106-21810679.25080.24
6217881-21788179.16980.12
60min1225323-22532381.87380.572.0983.1481.782.11
2218648-21864879.44780.64
3215552-21555278.32279.47
4228471-22847183.01784.27
5221111-22111180.34281.57
6221325-22132580.42081.61
极限1250467-25046791.00989.781.3392.5291.241.35
2245559-24555989.22690.65
3241787-24178787.85589.24
4249052-24905290.49592.00
5246003-24600389.38790.85
6249664-24966490.71792.15
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