坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903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2000
标示量(mg)8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%
1 15.977439274477744227494975134746750.46
2 15.947531874442748800.83
单位质量响应值RSD%判断
4675.954697.620.33数据可信
供试品溶液-2025022821批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118403-1840322.04320.2815.4622.0420.2815.47
214624-1462417.51617.52
315870-1587019.00919.01
417085-1708520.46420.46
514336-1433617.17217.17
621277-2127725.48525.49
10min142063-4206350.38350.268.9250.4250.308.93
238588-3858846.22046.25
339150-3915046.89346.93
446562-4656255.77155.81
538933-3893346.63446.66
646477-4647755.67055.71
15min158668-5866870.27271.854.9770.3971.964.97
258646-5864670.24670.35
356804-5680468.03968.15
463713-6371376.31576.44
558347-5834769.88769.99
663732-6373276.33776.47
20min167884-6788481.31183.212.4181.5583.452.42
270304-7030484.20984.43
367582-6758280.94981.17
471177-7117785.25585.51
568561-6856182.12282.34
671322-7132285.42985.69
30min174131-7413188.79389.721.4389.1790.101.42
276750-7675091.93092.29
373865-7386588.47588.83
475444-7544490.36690.76
574371-7437189.08189.44
674879-7487989.68990.09
45min176197-7619791.26890.821.1791.7991.351.16
277165-7716592.42792.94
376078-7607891.12591.63
475815-7581590.81091.36
574794-7479489.58790.10
674899-7489989.71390.27
60min175549-7554990.49290.221.4391.1790.901.42
276739-7673991.91792.59
375835-7583590.83491.49
475652-7565290.61591.31
573753-7375388.34189.00
674393-7439389.10789.81
极限175317-7531790.21489.551.4591.0490.381.43
275887-7588790.89791.72
375357-7535790.26291.07
475202-7520290.07690.93
573585-7358588.13988.94
673247-7324787.73488.59
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903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2000
标示量(mg)8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%
1 15.977450074761746847495874917747640.25
2 15.947496075224750920.25
单位质量响应值RSD%判断
4681.534710.920.45数据可信
供试品溶液-2025022821批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124286-2428629.03122.7616.6429.0322.7616.65
217351-1735120.74120.74
321169-2116925.30525.31
417970-1797021.48121.48
518048-1804821.57421.57
615413-1541318.42518.42
10min154146-5414664.72554.4012.4364.7754.4412.43
243006-4300651.40951.44
350288-5028860.11460.16
441438-4143849.53449.57
544913-4491353.68853.72
639252-3925246.92146.95
15min168411-6841181.77875.615.7081.9375.745.71
262227-6222774.38574.51
366351-6635179.31579.46
460184-6018471.94372.06
563375-6337575.75875.88
658983-5898370.50870.62
20min173470-7347087.82585.441.8688.1285.691.88
271481-7148185.44785.69
372038-7203886.11386.39
470532-7053284.31384.55
571712-7171285.72485.98
669592-6959283.18983.42
30min175425-7542590.16290.460.4990.6090.850.47
275547-7554790.30890.69
375313-7531390.02890.45
476230-7623091.12491.50
576013-7601390.86591.26
675496-7549690.24790.61
45min175620-7562090.39591.090.6090.9891.640.57
276174-7617491.05791.59
375740-7574090.53991.11
476792-7679291.79692.33
576395-7639591.32291.87
676498-7649891.44591.96
60min174918-7491889.55690.360.7190.3091.060.67
275553-7555390.31591.00
375259-7525989.96490.68
476384-7638491.30891.99
575422-7542290.15990.86
676021-7602190.87591.54
极限174079-7407988.55389.811.0489.4490.661.00
275208-7520889.90390.74
374586-7458689.15990.03
476300-7630091.20892.04
575025-7502589.68490.53
675607-7560790.38091.20
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903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2000
标示量(mg)8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%
1 15.977506774325746737462975383748150.56
2 15.947525975132751960.12
单位质量响应值RSD%判断
4684.724717.440.50数据可信
供试品溶液-2025030121批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114454-1445417.26020.4014.3117.2620.4014.33
216626-1662619.85419.85
315831-1583118.90518.90
420221-2022124.14724.15
515368-1536818.35218.35
619978-1997823.85723.86
10min141976-4197650.12648.4912.3450.1548.5212.34
237370-3737044.62644.66
336402-3640243.47043.50
444956-4495653.68453.72
535346-3534642.20942.24
647596-4759656.83756.88
15min160701-6070172.48669.889.3672.6070.009.37
255098-5509865.79665.90
353947-5394764.42164.53
462082-6208274.13674.27
552675-5267562.90263.00
666625-6662579.56179.70
20min169381-6938182.85281.424.8083.0881.654.82
266683-6668379.63079.85
365090-6509077.72877.94
470769-7076984.50984.76
564500-6450077.02377.23
672656-7265686.76387.03
30min174387-7438788.83088.062.5289.2088.422.54
273085-7308587.27587.62
373076-7307687.26487.60
475108-7510889.69190.08
570767-7076784.50784.84
676022-7602290.78291.19
45min175436-7543690.08289.362.3190.6089.882.33
274505-7450588.97089.47
374977-7497789.53490.02
475766-7576690.47691.02
571648-7164885.55986.03
676660-7666091.54492.11
60min174540-7454089.01288.631.9389.6889.301.95
273829-7382988.16388.81
374413-7441388.86189.50
475160-7516089.75390.45
571641-7164185.55086.17
675745-7574590.45191.17
极限174306-7430688.73388.401.8689.5589.211.88
273876-7387688.21989.01
374306-7430688.73389.52
474956-7495689.50990.35
571420-7142085.28786.05
675300-7530089.92090.79
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903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2000
标示量(mg)8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%
1 15.977430974546749737482274353746010.39
2 15.947488575376751300.47
单位质量响应值RSD%判断
4671.324713.300.64数据可信
供试品溶液-2025030121批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121155-2115525.31021.5310.5525.3121.5310.54
218998-1899822.72922.73
317585-1758521.03921.04
415663-1566318.73918.74
516848-1684820.15720.16
617723-1772321.20421.20
10min148385-4838557.88850.4610.9657.9350.4910.95
246360-4636055.46555.50
341863-4186350.08550.12
435535-3553542.51442.55
540929-4092948.96749.00
639976-3997647.82747.86
15min165779-6577978.69872.237.7878.8472.357.78
263968-6396876.53176.66
360416-6041672.28172.40
452662-5266263.00563.11
561654-6165473.76373.88
657738-5773869.07869.19
20min171892-7189286.01182.424.5486.2882.664.55
270312-7031284.12184.38
369135-6913582.71382.95
463686-6368676.19476.40
571449-7144985.48185.72
666890-6689080.02780.26
30min175530-7553090.36488.782.2290.7889.162.23
273971-7397188.49988.90
374640-7464089.29989.68
471775-7177585.87186.21
576261-7626191.23891.62
673046-7304687.39287.76
45min175467-7546790.28889.041.5790.8589.561.58
273649-7364988.11388.66
374998-7499889.72790.25
473142-7314287.50787.98
575869-7586990.76991.30
673409-7340987.82688.34
60min175066-7506689.80988.431.8190.5289.101.81
272981-7298187.31488.01
373664-7366488.13188.81
472795-7279587.09287.71
576015-7601590.94491.63
672947-7294787.27487.93
极限174253-7425388.83687.971.5489.7088.791.54
272332-7233286.53887.38
372985-7298587.31988.14
473060-7306087.40988.18
575454-7545490.27391.11
673094-7309487.44988.25
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