苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%) 96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.058443884578845088455184617845380.09
2 14.038487385053849630.15
单位质量响应值RSD%判断
6016.946055.810.46数据可信
供试品溶液-FX3469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%
5min157002-5700265.70265.973.7665.7065.973.76
255741-5574164.24964.25
359052-5905268.06568.07
453953-5395362.18862.19
559736-5973668.85468.85
657928-5792866.77066.77
10min164020-6402073.79278.254.1774.4578.914.16
268681-6868179.16479.81
367896-6789678.25978.94
465152-6515275.09675.72
570920-7092081.74582.43
670679-7067981.46782.13
15min166013-6601376.08982.505.0777.4883.945.03
274919-7491986.35487.79
371111-7111181.96583.43
468743-6874379.23580.61
574485-7448585.85487.36
674189-7418985.51387.00
20min167726-6772678.06384.325.0480.2286.595.01
276269-7626987.91090.21
373229-7322984.40686.69
469689-6968980.32682.49
575544-7554487.07489.44
676481-7648188.15490.49
30min170890-7089081.71086.263.4084.6589.383.42
276246-7624687.88491.06
375186-7518686.66289.79
472701-7270183.79886.77
577584-7758489.42692.66
676431-7643188.09791.32
45min171003-7100381.84086.613.2185.5990.593.22
275980-7598087.57791.63
374466-7446685.83289.83
474667-7466786.06489.87
577843-7784389.72493.85
676910-7691088.64992.75
60min176030-7603087.63588.802.2092.2193.642.20
277464-7746489.28894.22
375715-7571587.27292.12
476427-7642788.09292.76
580268-8026892.52097.55
676333-7633387.98492.97
极限179251-7925191.34792.301.3796.8098.021.35
280477-8047792.76098.58
379330-7933091.43897.16
481141-8114193.52699.07
581441-8144193.87299.82
678806-7880690.83496.70
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%) 96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.058452684474844678451884418844810.06
2 14.038449784564845300.06
单位质量响应值RSD%判断
6012.886024.950.15数据可信
供试品溶液-FX3469批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min149302-4930256.99151.076.9356.9951.076.93
240271-4027146.55246.55
344855-4485551.85151.85
442274-4227448.86748.87
544989-4498952.00652.01
643398-4339850.16750.17
10min160657-6065770.11770.765.0170.6971.275.00
256922-5692265.80066.27
364409-6440974.45574.97
462933-6293372.74873.24
563927-6392773.89774.42
658429-5842967.54268.04
15min169588-6958880.44178.704.3281.7179.924.31
262800-6280072.59573.72
370294-7029481.25782.52
470678-7067881.70182.92
568188-6818878.82380.08
666943-6694377.38478.56
20min174509-7450986.13083.564.8988.2185.574.86
266452-6645276.81678.67
375030-7503086.73288.81
475774-7577487.59289.63
570753-7075381.78883.84
671185-7118582.28784.24
30min179605-7960592.02191.982.7194.9694.822.64
280823-8082393.42996.05
379720-7972092.15495.10
482813-8281395.72998.64
577414-7741489.48892.35
677055-7705589.07391.85
45min183481-8348196.50193.183.74100.3696.943.72
275734-7573487.54691.10
381730-8173094.47798.34
483669-8366996.718100.58
579841-7984192.29396.05
679190-7919091.54195.21
60min181961-8196194.74494.273.1299.5798.963.10
277722-7772289.84494.27
380659-8065993.23998.05
485599-8559998.949103.78
582031-8203194.82599.51
681315-8131593.99798.58
极限183334-8333496.33195.151.62102.10100.791.66
281674-8167494.41299.74
381818-8181894.579100.32
484066-8406697.177103.00
582648-8264895.538101.17
680336-8033692.86698.39
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%) 96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.058505684981850708507484784849930.15
2 14.038544485820856320.32
单位质量响应值RSD%判断
6049.326103.490.64数据可信
供试品溶液-FX3469批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min122694-2269425.98627.336.4125.9927.336.40
224608-2460828.17728.18
324726-2472628.31228.31
424054-2405427.54327.54
525662-2566229.38429.38
621469-2146924.58324.58
10min133922-3392238.84242.438.2939.1042.718.28
236749-3674942.07942.36
338277-3827743.82944.11
439754-3975445.52045.80
540589-4058946.47646.77
633062-3306237.85838.10
15min141383-4138347.38649.657.7448.0350.347.74
242274-4227448.40649.11
344361-4436150.79651.52
446857-4685753.65454.38
546932-4693253.73954.50
638339-3833943.90044.52
20min145737-4573752.37153.327.6353.4954.527.53
246789-4678953.57654.76
349717-4971756.92858.16
451509-5150958.98060.25
542590-4259048.76850.06
643072-4307249.32050.38
30min153072-5307260.77061.666.2662.4263.396.25
252073-5207359.62661.35
355313-5531363.33665.13
457228-5722865.52967.39
556998-5699865.26667.05
648420-4842055.44357.00
45min157519-5751965.86269.605.7668.1271.955.76
259437-5943768.05870.38
364569-6456973.93576.37
463088-6308872.23974.75
563784-6378473.03675.47
656311-5631164.47966.59
60min164391-6439173.73174.944.2476.6477.984.30
263594-6359472.81875.82
367171-6717176.91480.09
467891-6789177.73980.97
568304-6830478.21181.38
661352-6135270.25173.01
极限179682-7968291.24093.311.9894.8997.101.87
280739-8073992.45096.18
381757-8175793.61697.56
482709-8270994.70698.72
580139-8013991.76395.71
683894-8389496.06399.52
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