非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.282113284211558821109752105664210799121107000.19
210.652093750209261920931840.04
单位质量响应值RSD%判断
205321.01196543.103.09数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-250601批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1514870-51487023.05024.5411.0723.0524.5411.07
2491593-49159322.00822.01
3568242-56824225.43925.44
4564798-56479825.28525.28
5652347-65234729.20429.20
6497544-49754422.27422.27
10min11082802-108280248.47545.745.1848.5345.805.18
2990457-99045744.34144.39
31010503-101050345.23845.29
4966305-96630543.25943.32
51092267-109226748.89848.96
6988361-98836144.24744.30
15min11359165-135916560.84759.911.2361.0160.061.24
21331681-133168159.61659.76
31339545-133954559.96960.13
41318561-131856159.02959.18
51355401-135540160.67860.85
61324604-132460459.30059.45
20min11529349-152934968.46667.591.5668.7667.881.55
21513761-151376167.76868.05
31515357-151535767.83968.13
41465934-146593465.62765.91
51505487-150548767.39767.71
61529332-152933268.46568.74
30min11727135-172713577.32075.871.7277.7776.311.72
21705672-170567276.35976.79
31691556-169155675.72776.17
41644715-164471573.63074.06
51715754-171575476.81177.27
61683972-168397275.38875.82
45min11844335-184433582.56782.821.8483.1983.431.83
21873026-187302683.85184.45
31837883-183788382.27882.89
41790554-179055480.15980.75
51871276-187127683.77384.40
61882746-188274684.28684.89
60min11913353-191335385.65786.451.5786.4687.251.56
21953874-195387487.47188.26
31927718-192771886.30087.09
41881457-188145784.22985.00
51949835-194983587.29088.10
61960748-196074887.77888.57
极限11959296-195929687.71388.931.3288.7189.921.32
22006728-200672889.83790.82
31985888-198588888.90489.89
41950421-195042187.31688.27
52005874-200587489.79990.81
62011029-201102990.02991.01
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.282102597210060721045672101246210264621023330.08
210.652119366212054421199550.04
单位质量响应值RSD%判断
204507.10199056.811.91数据可信
供试品溶液-250601批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1680930-68093030.34621.7921.8130.3521.7821.82
2499300-49930022.25222.25
3360175-36017516.05216.05
4482716-48271621.51321.51
5476707-47670721.24521.24
6433287-43328719.31019.31
10min11239125-123912555.22346.3010.3255.2946.3510.33
2954534-95453442.54042.59
3979392-97939243.64843.68
41068695-106869547.62847.68
51028320-102832045.82845.88
6963503-96350342.94042.98
15min11452039-145203964.71259.795.1264.9059.945.13
21283081-128308157.18257.33
31314427-131442758.57958.71
41390768-139076861.98162.13
51336505-133650559.56359.71
61272926-127292656.72956.87
20min11574110-157411070.15267.563.2770.4967.843.29
21467091-146709165.38365.65
31525335-152533567.97868.24
41567305-156730569.84970.14
51505722-150572267.10467.39
61455628-145562864.87265.14
30min11646271-164627173.36874.972.4773.8675.402.45
21657801-165780173.88274.30
31724770-172477076.86677.28
41741253-174125377.60178.05
51678050-167805074.78475.21
61644860-164486073.30573.71
45min11808933-180893380.61781.912.4981.2782.512.47
21796628-179662880.06980.65
31904657-190465784.88385.47
41885173-188517384.01584.63
51827325-182732581.43782.03
61805356-180535680.45881.03
60min11897177-189717784.55085.462.1185.3886.252.11
21882945-188294583.91684.67
31969026-196902687.75288.53
41966085-196608587.62188.43
51912518-191251885.23486.01
61878450-187845083.71584.47
极限11908233-190823385.04387.912.6186.0688.882.58
21933421-193342186.16587.11
32023925-202392590.19891.17
42035408-203540890.71091.71
51987633-198763388.58189.55
61946429-194642986.74587.68
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.282048208204626820482932044409204802220470400.09
210.652157677215455021561140.11
单位质量响应值RSD%判断
199128.40202452.021.18数据可信
供试品溶液-250602批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1555923-55592324.89530.4914.1924.8930.4914.19
2764452-76445234.23334.23
3794915-79491535.59735.60
4733003-73300332.82532.82
5601838-60183826.95126.95
6635291-63529128.44928.45
10min11087786-108778648.71252.166.0148.7752.236.02
21214962-121496254.40754.48
31237431-123743155.41455.49
41231025-123102555.12755.20
51102762-110276249.38349.44
61114888-111488849.92649.99
15min11365327-136532761.14163.242.4061.3063.422.42
21439334-143933464.45564.65
31445486-144548664.73164.93
41437319-143731964.36564.56
51405257-140525762.92963.10
61380380-138038061.81561.99
20min11520850-152085068.10569.061.4568.4069.381.47
21567212-156721270.18270.52
31565081-156508170.08670.43
41553759-155375969.57969.92
51521021-152102168.11368.42
61525053-152505368.29468.61
30min11683273-168327375.37976.200.9975.8376.681.01
21722931-172293177.15577.65
31716994-171699476.88977.39
41708259-170825976.49876.99
51685701-168570175.48875.95
61692795-169279575.80576.27
45min11834746-183474682.16282.730.7782.7883.380.80
21848594-184859482.78283.45
31869442-186944283.71684.39
41858446-185844683.22383.89
51833936-183393682.12682.75
61839794-183979482.38883.02
60min11904196-190419685.27285.920.5286.0786.760.55
21927545-192754586.31887.17
31928406-192840686.35687.21
41925371-192537186.22087.07
51911003-191100385.57786.39
61916147-191614785.80786.62
极限11971529-197152988.28788.990.5689.2890.010.57
21988510-198851089.04890.09
31995090-199509089.34290.39
42002560-200256089.67790.72
51985457-198545788.91189.91
61980116-198011688.67289.68
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.282171416216587721680002164138215921021657280.21
210.652151855214834121500980.12
单位质量响应值RSD%判断
210673.93201887.143.02数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-250602批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1463215-46321520.19929.4517.6320.2029.4517.62
2758939-75893933.09433.09
3655896-65589628.60128.60
4780505-78050534.03534.03
5754046-75404632.88132.88
6640088-64008827.91227.91
10min11005890-100589043.86352.197.9543.9152.267.96
21228535-122853553.57253.65
31208029-120802952.67752.74
41258048-125804854.85954.93
51247949-124794954.41854.49
61233116-123311653.77153.83
15min11331569-133156958.06462.383.4958.2162.573.51
21444834-144483463.00463.20
31448400-144840063.15963.34
41466521-146652163.94964.15
51458370-145837063.59463.79
61434004-143400462.53162.71
20min11507472-150747265.73568.001.6766.0168.321.70
21566965-156696568.32968.66
31569680-156968068.44868.77
41579509-157950968.87669.22
51569955-156995568.46068.79
61562574-156257468.13868.46
30min11675470-167547073.06174.921.3473.4875.401.37
21728105-172810575.35675.84
31729318-172931875.40975.88
41741734-174173475.95076.44
51721268-172126875.05875.55
61713353-171335374.71375.18
45min11834163-183416379.98181.011.0780.5681.651.08
21855169-185516980.89781.55
31861463-186146381.17181.81
41854682-185468280.87581.54
51893535-189353582.57083.22
61848250-184825080.59581.23
60min11901206-190120682.90484.080.7983.6684.900.82
21930212-193021284.16985.00
31930185-193018584.16884.99
41946264-194626484.86985.71
51936978-193697884.46485.30
61923851-192385183.89284.71
极限11963099-196309985.60387.681.5186.5488.681.52
22054472-205447289.58790.61
32001680-200168087.28588.29
42008091-200809187.56588.59
52008769-200876987.59488.62
62028533-202853388.45689.46
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