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2306201对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.5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%
110.242652612634122622612652012641632640600.48
210.282662092659002660540.09
单位质量响应值RSD%判断
25787.1125880.740.26数据可信
供试品溶液-24123001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%
5min1147943-14794356.98156.772.1956.9856.772.19
2144861-14486155.79455.79
3147020-14702056.62556.63
4153544-15354459.13859.14
5145194-14519455.92255.92
6145874-14587456.18456.18
10min1178117-17811768.60271.425.5868.7771.595.57
2173675-17367566.89267.06
3188108-18810872.45172.62
4187328-18732872.15072.33
5203346-20334678.31978.49
6182009-18200970.10170.27
15min1203254-20325478.28476.623.3478.6677.013.32
2192048-19204873.96874.34
3194549-19454974.93175.32
4206303-20630379.45879.85
5192411-19241174.10874.51
6205106-20510678.99779.38
20min1197556-19755676.08976.141.8376.7076.751.83
2193391-19339174.48575.08
3199222-19922276.73177.34
4203565-20356578.40479.04
5194562-19456274.93675.56
6197812-19781276.18876.80
30min1203116-20311678.23179.061.9279.0779.901.92
2201520-20152077.61678.43
3207624-20762479.96780.81
4211861-21186181.59982.47
5202211-20221177.88278.73
6205264-20526479.05879.90
45min1209245-20924580.59181.211.8881.6782.291.88
2206626-20662679.58380.63
3213137-21313782.09183.17
4216945-21694583.55784.67
5207141-20714179.78180.86
6212074-21207481.68182.76
60min1211869-21186981.60282.261.7582.9283.581.74
2209345-20934580.63081.92
3215773-21577383.10684.43
4219296-21929684.46385.83
5210490-21049081.07182.39
6214654-21465482.67584.00
极限1244389-24438994.12793.531.3895.6995.101.38
2239345-23934592.18593.71
3244596-24459694.20795.78
4245715-24571594.63896.25
5237877-23787791.61993.19
6245122-24512294.41095.98
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2306201对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.5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%
110.242658382660442657992654012650022656170.16
210.282661382667392664380.16
单位质量响应值RSD%判断
25939.1625918.090.06数据可信
供试品溶液-24123002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%
5min1140249-14024953.82051.963.7353.8251.963.73
2140110-14011053.76753.77
3138322-13832253.08053.08
4127921-12792149.08949.09
5134482-13448251.60751.61
6131366-13136650.41150.41
10min1161471-16147161.96460.803.3362.1360.963.33
2166357-16635763.83964.00
3159826-15982661.33361.49
4151584-15158458.17058.32
5156910-15691060.21460.37
6154523-15452359.29859.45
15min1176498-17649867.73067.552.8568.0867.892.85
2184828-18482870.92771.28
3177410-17741068.08068.42
4170179-17017965.30565.63
5173733-17373366.66967.00
6173509-17350966.58366.91
20min1188124-18812472.19272.372.4072.7472.922.40
2197454-19745475.77276.34
3187893-18789372.10372.65
4184699-18469970.87771.40
5187091-18709171.79572.33
6186334-18633471.50572.03
30min1199813-19981376.67777.482.4677.4478.242.46
2210296-21029680.70081.49
3202789-20278977.81978.58
4195173-19517374.89775.63
5200692-20069277.01577.77
6202738-20273877.80078.54
45min1208026-20802679.82981.482.3880.8382.472.37
2221566-22156685.02586.06
3213207-21320781.81782.81
4207813-20781379.74780.70
5210987-21098780.96581.95
6212417-21241781.51482.49
60min1212113-21211381.39783.522.1882.6384.752.18
2225948-22594886.70788.00
3217490-21749083.46184.70
4215857-21585782.83484.03
5215063-21506382.53083.75
6219376-21937684.18585.41
极限1243923-24392393.60494.051.5295.0995.541.53
2251229-25122996.40897.96
3246596-24659694.63096.12
4240040-24004092.11493.56
5243726-24372693.52995.00
6245006-24500694.02095.49
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2306201对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.5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%
110.242689112689692694342685472686582689040.13
210.282651722653652652680.06
单位质量响应值RSD%判断
26260.1625804.281.24数据可信
供试品溶液-24123003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%
5min1116185-11618544.41144.212.4044.4144.202.40
2114981-11498143.95143.95
3111610-11161042.66342.66
4118967-11896745.47545.47
5113839-11383943.51543.51
6118303-11830345.22145.22
10min1131807-13180750.38350.532.4150.5250.672.41
2133777-13377751.13651.27
3129701-12970149.57849.71
4136234-13623452.07552.21
5127531-12753148.74848.88
6134142-13414251.27651.41
15min1148293-14829356.68556.622.2756.9756.902.27
2149337-14933757.08457.37
3146755-14675556.09756.37
4151007-15100757.72258.01
5142150-14215054.33754.61
6151118-15111857.76558.05
20min1162350-16235062.05861.583.3062.5162.033.29
2165750-16575063.35863.81
3156520-15652059.82960.27
4166484-16648463.63864.10
5152989-15298958.48058.92
6162525-16252562.12562.59
30min1175529-17552967.09667.232.8667.7467.872.85
2178538-17853868.24668.89
3174290-17429066.62267.25
4180505-18050568.99869.65
5166856-16685663.78064.40
6179538-17953868.62869.28
45min1191199-19119973.08572.612.7873.9373.452.77
2193706-19370674.04474.90
3183126-18312670.00070.82
4193984-19398474.15075.01
5183506-18350670.14570.95
6194261-19426174.25675.11
60min1199266-19926676.16975.892.5177.2376.952.50
2202042-20204277.23078.30
3195094-19509474.57475.61
4201137-20113776.88477.97
5190270-19027072.73073.75
6203388-20338877.74578.82
极限1225543-22554386.21385.262.5087.5086.542.50
2227115-22711586.81488.12
3218046-21804683.34884.61
4225526-22552686.20787.52
5214197-21419781.87683.11
6227858-22785887.09888.41
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