依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.101916171886711887301884941885381892100.72
211.061886181889461887820.13
单位质量响应值RSD%判断
17045.9517068.900.10数据可信
供试品溶液-Y012651批-依折麦布-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%
5min14911-49112.5852.1812.922.582.1812.87
23623-36231.9071.91
33522-35221.8541.85
44297-42972.2622.26
53972-39722.0912.09
64503-45032.3702.37
10min110001-100015.2645.3111.235.285.3211.24
29266-92664.8774.89
39470-94704.9844.99
49895-98955.2085.22
512338-123386.4946.51
69588-95885.0465.06
15min112069-120696.3526.264.596.406.304.58
211697-116976.1566.19
312803-128036.7386.78
412084-120846.3606.40
511403-114036.0026.05
611329-113295.9636.00
20min113229-132296.9636.901.187.046.971.21
212945-129456.8136.88
313106-131066.8986.97
413253-132536.9757.05
513203-132036.9497.03
612890-128906.7846.86
30min114478-144787.6207.523.427.747.643.35
215099-150997.9478.06
313800-138007.2637.38
414457-144577.6097.72
513983-139837.3597.48
613924-139247.3287.44
45min114851-148517.8167.821.747.987.981.70
214804-148047.7927.95
315306-153068.0568.21
414538-145387.6527.81
514917-149177.8518.01
614702-147027.7387.89
60min115454-154548.1348.051.318.348.251.28
215583-155838.2028.40
315043-150437.9178.12
415213-152138.0078.21
515271-152718.0378.24
615153-151537.9758.17
极限115273-152738.0388.181.028.298.420.95
215657-156578.2408.48
315544-155448.1818.42
415729-157298.2788.52
515518-155188.1678.42
615478-154788.1468.39
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906对照品来源工作对照品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2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.994134274165234169164159514162684158170.34
210.994111714103574107640.15
单位质量响应值RSD%判断
37835.9437376.160.87数据可信
供试品溶液-Y012651批-辛伐他汀-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%
5min14452-44521.0600.8717.621.060.8717.54
23054-30540.7270.73
32976-29760.7090.71
43265-32650.7780.78
53795-37950.9040.90
64311-43111.0271.03
10min119272-192724.5894.453.954.604.463.99
217552-175524.1804.18
318559-185594.4204.42
419687-196874.6884.69
518645-186454.4404.45
618405-184054.3834.39
15min126596-265966.3336.213.256.366.243.20
225906-259066.1696.20
326439-264396.2966.32
427248-272486.4896.52
525055-250555.9666.00
625220-252206.0066.04
20min131128-311287.4137.541.037.487.611.00
231536-315367.5107.57
331717-317177.5537.62
431832-318327.5807.65
532087-320877.6417.70
631777-317777.5677.63
30min138189-381899.0949.271.669.209.371.64
239130-391309.3189.42
338604-386049.1939.30
440076-400769.5449.65
538760-387609.2309.34
638756-387569.2299.33
45min144916-4491610.69610.763.5210.8510.923.46
245973-4597310.94811.10
346905-4690511.17011.33
444075-4407510.49610.66
546443-4644311.06011.22
642710-4271010.17110.33
60min152826-5282612.58012.332.0012.8012.541.99
251984-5198412.37912.60
352000-5200012.38312.60
451227-5122712.19912.42
552534-5253412.51012.73
649974-4997411.90112.11
极限154561-5456112.99313.271.4513.2813.551.42
255998-5599813.33513.62
356834-5683413.53413.82
456214-5621413.38713.67
555356-5535613.18213.47
655265-5526513.16113.44
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.101898321897731898931898381896351897940.06
211.061893801893511893660.02
单位质量响应值RSD%判断
17098.5617121.700.10数据可信
供试品溶液-Y012651批-依折麦布-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%
5min14723-47232.4781.9823.992.481.9824.00
24280-42802.2462.25
33356-33561.7611.76
42707-27071.4201.42
52877-28771.5101.51
64675-46752.4532.45
10min110159-101595.3305.044.085.345.054.11
29689-96895.0845.10
39481-94814.9754.98
49598-95985.0365.04
58963-89634.7034.71
69773-97735.1285.14
15min111377-113775.9696.073.356.016.103.35
211558-115586.0646.11
311351-113515.9565.99
411314-113145.9365.97
511439-114396.0026.04
612331-123316.4706.51
20min113550-135507.1106.723.887.196.803.92
212920-129206.7796.85
312483-124836.5506.62
412256-122566.4316.50
512473-124736.5446.61
613188-131886.9207.00
30min113874-138747.2807.155.057.407.264.99
214012-140127.3527.46
312245-122456.4256.53
413908-139087.2977.40
514024-140247.3587.46
613732-137327.2057.32
45min114902-149027.8197.711.857.987.861.84
214463-144637.5897.74
315105-151057.9258.07
414478-144787.5967.74
514469-144697.5927.74
614781-147817.7557.91
60min115724-157248.2507.933.168.458.123.18
215292-152928.0248.22
314472-144727.5937.78
414978-149787.8598.05
514726-147267.7277.91
615507-155078.1368.34
极限115808-158088.2948.191.938.548.421.93
215313-153138.0358.27
315512-155128.1398.37
415900-159008.3438.57
515214-152147.9838.21
615884-158848.3348.58
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906对照品来源工作对照品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2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.994293214300614293434295274291624294830.09
210.994278764284504281630.10
单位质量响应值RSD%判断
39079.4438959.330.22数据可信
供试品溶液-Y012651批-辛伐他汀-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%
5min15121-51211.1750.8536.281.180.8636.53
24481-44811.0281.03
32827-28270.6490.65
41932-19320.4430.44
52883-28830.6620.66
65094-50941.1691.17
10min121749-217494.9914.419.355.004.419.42
219294-192944.4284.43
318897-188974.3374.34
419061-190614.3754.38
516213-162133.7213.72
619959-199594.5814.59
15min126659-266596.1186.092.426.156.122.40
226339-263396.0456.08
326500-265006.0826.11
425813-258135.9245.95
526280-262806.0316.06
627724-277246.3636.39
20min134594-345947.9397.324.438.017.384.44
232199-321997.3907.45
331108-311087.1397.20
430754-307547.0587.12
531253-312537.1737.23
631376-313767.2017.27
30min140942-409429.3968.826.499.518.926.43
240182-401829.2229.33
333924-339247.7867.89
438718-387188.8868.98
539195-391958.9959.09
637598-375988.6298.74
45min147811-4781110.97310.782.1011.1410.942.08
246416-4641610.65310.81
348303-4830311.08611.23
446849-4684910.75210.90
545550-4555010.45410.60
646968-4696810.77910.93
60min155802-5580212.80711.935.7313.0312.145.67
253586-5358612.29812.51
347207-4720710.83411.04
450542-5054211.59911.81
551368-5136811.78911.99
653317-5331712.23612.45
极限158010-5801013.31313.192.0713.6113.472.04
256047-5604712.86313.15
356677-5667713.00713.27
458478-5847813.42113.69
556592-5659212.98813.26
658993-5899313.53913.82
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