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2000
标示量(mg)5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%
110.09 1225535122561512255411225165122519212254100.02
210.041226333122423512252840.13
单位质量响应值RSD%判断
121447.97122040.240.35数据可信
供试品溶液-24101101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%
5min176544-7654410.32110.424.2910.3210.424.28
281715-8171511.01911.02
378698-7869810.61210.61
476090-7609010.26010.26
571932-719329.6999.70
678868-7886810.63510.63
10min1137295-13729518.51318.603.1118.6318.723.11
2144796-14479619.52419.65
3140024-14002418.88119.00
4138520-13852018.67818.79
5132931-13293117.92518.03
6134143-13414318.08818.21
15min1186867-18686725.19724.822.3225.5225.152.32
2191491-19149125.82126.16
3182370-18237024.59124.92
4182014-18201424.54324.86
5180255-18025524.30624.61
6181608-18160824.48824.81
20min1218338-21833829.44129.072.5830.0429.662.56
2223734-22373430.16930.79
3211645-21164528.53829.14
4215767-21576729.09429.69
5216224-21622429.15629.73
6207603-20760327.99328.58
30min1276184-27618437.24135.604.3938.1736.524.31
2272672-27267236.76737.73
3258856-25885634.90435.82
4256569-25656934.59635.51
5272795-27279536.78437.68
6247033-24703333.31034.21
45min1334727-33472745.13542.684.9246.4844.004.82
2320338-32033843.19544.56
3304459-30445941.05442.36
4311085-31108541.94743.25
5332635-33263544.85346.16
6295825-29582539.88941.16
60min1381602-38160251.45647.287.5053.3049.077.31
2354159-35415947.75549.61
3335693-33569345.26547.03
4343051-34305146.25748.03
5377309-37730950.87752.68
6312066-31206642.07943.79
90min1436755-43675558.89253.598.1061.3155.907.92
2400380-40038053.98856.37
3375020-37502050.56852.83
4382714-38271451.60653.89
5432820-43282058.36260.74
6356761-35676148.10650.29
极限1469243-46924363.27360.834.0866.3463.744.09
2453173-45317361.10664.09
3436362-43636258.83961.67
4440874-44087459.44862.30
5476169-47616964.20767.23
6430989-43098958.11560.83
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2000
标示量(mg)5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%
110.09 1224153122461512243841224616122439112244320.02
210.041223683122354512236140.01
单位质量响应值RSD%判断
121351.04121873.900.31数据可信
供试品溶液-24101101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%
5min1106739-10673914.40814.273.7114.4114.273.73
2106718-10671814.40614.41
3112422-11242215.17515.18
4104371-10437114.08914.09
5102110-10211013.78313.78
6101866-10186613.75113.75
10min1197127-19712726.61025.183.4526.7725.343.45
2189026-18902625.51625.68
3188745-18874525.47825.65
4182431-18243124.62624.78
5182103-18210324.58124.73
6179695-17969524.25624.41
15min1254385-25438534.33933.192.5534.7933.622.55
2252632-25263234.10234.55
3245328-24532833.11633.57
4241942-24194232.65933.09
5241419-24141932.58833.01
6239387-23938732.31432.74
20min1294271-29427139.72338.692.8040.5639.502.79
2299281-29928140.39941.22
3281868-28186838.04838.87
4280918-28091837.92038.71
5281233-28123337.96338.75
6282265-28226538.10238.88
30min1353623-35362347.73446.702.4449.0147.942.43
2358638-35863848.41149.68
3338946-33894645.75347.00
4344631-34463146.52147.74
5337369-33736945.54046.75
6342546-34254646.23947.44
45min1403102-40310254.41354.532.7856.2256.292.73
2422089-42208956.97658.79
3395738-39573853.41955.17
4410481-41048155.41057.14
5390412-39041252.70054.42
6402171-40217154.28856.01
60min1444413-44441359.99059.592.9862.4061.952.95
2463520-46352062.56965.01
3433497-43349758.51660.86
4443975-44397559.93162.28
5424426-42442657.29259.59
6438740-43874059.22461.55
90min1488956-48895666.00366.163.2169.0869.193.15
2517263-51726369.82472.96
3474471-47447164.04767.04
4493577-49357766.62669.64
5474770-47477064.08867.03
6491851-49185166.39369.37
极限1548234-54823474.00473.561.9677.8277.321.97
2563047-56304776.00479.92
3531515-53151571.74775.45
4539175-53917572.78176.53
5541178-54117873.05276.70
6546506-54650673.77177.49
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2000
标示量(mg)5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%
110.09 1222626122309812232121222746122296312229290.02
210.041222606122069012216480.12
单位质量响应值RSD%判断
121202.08121678.090.28数据可信
供试品溶液-01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%
5min1110177-11017714.89414.752.9014.8914.742.90
2112833-11283315.25315.25
3107275-10727514.50114.50
4111786-11178615.11115.11
5104268-10426814.09514.09
6108241-10824114.63214.63
10min1191552-19155225.89425.861.8826.0626.021.88
2197056-19705626.63826.81
3192851-19285126.06926.23
4186230-18623025.17425.34
5189948-18994825.67725.83
6190131-19013125.70225.86
15min1252423-25242334.12234.382.3334.5834.832.32
2262717-26271735.51435.98
3259693-25969335.10535.56
4248004-24800433.52533.97
5248671-24867133.61534.06
6254283-25428334.37434.82
20min1297627-29762740.23340.542.0841.0741.372.06
2303130-30313040.97741.84
3309352-30935241.81842.66
4291506-29150639.40540.23
5296032-29603240.01740.83
6301665-30166540.77941.61
30min1354787-35478747.96048.962.7449.2450.242.71
2365073-36507349.35050.67
3374194-37419450.58351.89
4352264-35226447.61848.88
5353814-35381447.82849.09
6372933-37293350.41251.70
45min1417230-41723056.40056.902.1358.2158.722.11
2421060-42106056.91858.78
3429336-42933658.03759.90
4409255-40925555.32257.11
5415364-41536456.14857.94
6433135-43313558.55060.39
60min1454836-45483661.48461.852.4263.9264.312.39
2459758-45975862.14964.65
3460718-46071862.27964.79
4445647-44564760.24262.64
5447992-44799260.55962.97
6476393-47639364.39866.89
90min1496552-49655267.12367.662.0170.2570.811.99
2499214-49921467.48370.67
3503488-50348868.06171.27
4495052-49505266.92069.99
5490065-49006566.24669.33
6518903-51890370.14473.35
极限1545299-54529973.71373.820.9477.5877.710.97
2545139-54513973.69177.63
3554761-55476174.99278.95
4541771-54177173.23677.05
5540736-54073673.09676.92
6548628-54862874.16378.15
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