叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数25000
标示量(mg)0.4供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.069867198544984989851998518985500.08
210.009862698704986650.06
单位质量响应值RSD%判断
9796.229866.500.51数据可信
供试品溶液-24050301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%
5min16341-634110.58813.1917.8210.5913.1917.83
28290-829013.84213.84
36211-621110.37110.37
49797-979716.35916.36
57914-791413.21513.21
68832-883214.74714.75
10min111617-1161719.39822.0814.2819.5222.2314.23
215763-1576326.32126.47
311260-1126018.80218.92
412061-1206120.13920.32
513552-1355222.62922.78
615083-1508325.18525.35
15min115129-1512925.26228.5312.6125.6028.9312.46
219292-1929232.21332.66
318158-1815830.32030.64
419569-1956932.67633.08
515150-1515025.29725.70
615232-1523225.43425.88
20min117664-1766429.49533.488.6730.1134.198.70
221950-2195036.65237.46
318553-1855330.97931.64
421752-2175236.32137.09
519643-1964332.79933.48
620749-2074934.64635.37
30min120554-2055434.32138.006.7435.2639.086.77
224869-2486941.52642.74
322271-2227137.18838.19
422425-2242537.44538.62
522302-2230237.23938.28
624122-2412240.27841.39
45min124987-2498741.72344.674.9643.0546.185.06
228324-2832447.29548.97
326212-2621243.76845.19
427977-2797746.71548.30
525713-2571342.93544.39
627312-2731245.60547.16
60min127340-2734045.65249.184.1447.4451.184.25
230472-3047250.88253.08
328971-2897148.37550.28
430069-3006950.20952.32
529278-2927848.88850.82
630572-3057251.04953.11
90min130693-3069351.25154.623.6453.5457.163.76
233793-3379356.42759.19
332734-3273454.65957.10
433216-3321655.46358.13
532052-3205253.52056.00
633777-3377756.40059.03
极限134165-3416557.04856.592.6159.9159.742.26
232489-3248954.24957.64
334779-3477958.07361.12
434300-3430057.27360.55
534472-3447257.56160.63
633140-3314055.33758.60
叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数25000
标示量(mg)0.4供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.069873698384988109865198644986450.17
210.009832798396983620.05
单位质量响应值RSD%判断
9805.679836.200.22数据可信
供试品溶液-24050302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%
5min18271-827113.82514.3211.0813.8314.3211.09
28232-823213.76013.76
310305-1030517.22517.23
48818-881814.74014.74
58292-829213.86013.86
67498-749812.53312.53
10min114471-1447124.18925.178.2524.3425.328.26
215129-1512925.28925.44
317142-1714228.65328.84
415707-1570726.25526.42
514181-1418123.70423.86
613708-1370822.91323.05
15min117879-1787929.88530.677.7730.3131.117.78
219164-1916432.03332.47
319938-1993833.32733.84
419508-1950832.60833.06
517345-1734528.99329.41
616253-1625327.16727.56
20min120424-2042434.13935.437.4734.8936.217.49
221521-2152135.97336.76
323645-2364539.52340.40
422236-2223637.16837.99
519918-1991833.29434.03
619432-1943232.48133.18
30min123466-2346639.22440.695.7240.3641.865.78
225213-2521342.14443.33
326240-2624043.86145.18
425200-2520042.12343.35
523160-2316038.71339.82
622783-2278338.08339.14
45min126906-2690644.97447.564.9946.5449.185.02
228356-2835647.39849.06
329946-2994650.05651.86
429771-2977149.76351.46
529087-2908748.62050.16
626635-2663544.52146.00
60min128881-2888148.27650.524.9950.3452.675.05
230517-3051751.01053.19
332741-3274154.72857.09
430978-3097851.78154.03
529271-2927148.92851.01
628936-2893648.36850.34
90min132869-3286954.94257.144.7657.5559.864.82
234429-3442957.54960.30
336622-3662261.21564.19
435482-3548259.30962.14
533224-3322455.53558.16
632491-3249154.31056.82
极限133936-3393656.72559.204.1459.9462.544.22
235562-3556259.44362.83
337306-3730662.35866.01
437019-3701961.87965.36
534342-3434257.40460.64
634321-3432157.36960.48
叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数25000
标示量(mg)0.4供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.069863798289987039866398801986190.20
210.009877498403985880.27
单位质量响应值RSD%判断
9803.089858.800.41数据可信
供试品溶液-24050303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%
5min18216-821613.71913.458.9913.7213.468.98
28905-890514.87014.87
36742-674211.25811.26
48379-837913.99213.99
58197-819713.68813.69
67905-790513.20013.20
10min114100-1410023.54523.924.4823.7024.074.49
215432-1543225.76925.93
313636-1363622.77022.90
414674-1467424.50324.66
513919-1391923.24323.39
614181-1418123.68023.83
15min117563-1756329.32730.104.3029.7430.514.31
219344-1934432.30132.75
317285-1728528.86329.24
418463-1846330.83031.26
517475-1747529.18129.59
618013-1801330.07930.49
20min120345-2034533.97334.764.9034.7135.524.87
222396-2239637.39838.21
321077-2107735.19535.89
421443-2144335.80636.58
519644-1964432.80233.54
620011-2001133.41534.16
30min123622-2362239.44540.384.3940.5641.514.35
225666-2566642.85844.08
324918-2491841.60942.70
424561-2456141.01342.18
522765-2276538.01439.11
623548-2354839.32140.44
45min126597-2659744.41345.904.0845.9747.494.06
228999-2899948.42450.13
328507-2850747.60249.15
427835-2783546.48048.10
526274-2627443.87345.39
626731-2673144.63746.19
60min129112-2911248.61250.243.4750.6652.333.48
231652-3165252.85455.09
330786-3078651.40853.49
430463-3046350.86853.01
529211-2921148.77850.79
629288-2928848.90650.95
90min131821-3182153.13656.504.4455.7359.164.36
234948-3494858.35861.19
335817-3581759.80962.46
434536-3453657.67060.38
532969-3296955.05357.60
632933-3293354.99357.58
极限133331-3333155.65858.753.8358.8462.033.78
236223-3622360.48763.96
336939-3693961.68265.00
435727-3572759.65863.00
534274-3427457.23260.39
634603-3460357.78260.98
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