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%
110.372206612206532205002206132205872206030.03
210.372198432196032197230.08
单位质量响应值RSD%判断
21273.1921188.330.29数据可信
供试品溶液-AM221354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%
5min127901-2790121.57421.859.8821.5721.859.88
226410-2641020.42120.42
327232-2723221.05621.06
427571-2757121.31821.32
526591-2659120.56120.56
633835-3383526.16226.16
10min154180-5418041.89339.674.6242.1339.914.61
253040-5304041.01241.24
348679-4867937.64037.87
450389-5038938.96239.20
548702-4870237.65737.89
652804-5280440.82941.12
15min171194-7119455.04955.293.7255.7555.973.72
275371-7537158.27858.96
368328-6832852.83353.48
471715-7171555.45256.12
568976-6897653.33453.98
673437-7343756.78357.53
20min186891-8689167.18666.292.9568.5067.592.96
289092-8909268.88870.22
382739-8273963.97665.21
486744-8674467.07268.36
582726-8272663.96565.20
686213-8621366.66268.04
30min1102408-10240879.18478.762.3281.2580.792.34
2105233-10523381.36883.46
399594-9959477.00878.96
4101409-10140978.41280.44
599005-9900576.55378.50
6103483-10348380.01582.13
45min1112373-11237386.88986.341.6889.8389.251.69
2114446-11444688.49291.49
3111050-11105085.86688.67
4112340-11234086.86489.77
5108853-10885384.16786.97
6110942-11094285.78388.79
60min1116897-11689790.38789.911.4494.3093.781.48
2118589-11858991.69595.68
3115234-11523489.10192.86
4116866-11686690.36394.23
5113678-11367887.89891.63
6116435-11643590.03093.99
90min1123943-12394395.83593.641.72100.7598.511.71
2121734-12173494.12799.13
3121475-12147593.92798.68
4119278-11927892.22897.10
5118139-11813991.34896.06
6122032-12203294.35899.32
极限1124233-12423396.06093.981.72102.0499.891.73
2122813-12281394.962101.01
3121241-12124193.74699.54
4120054-12005492.82898.72
5118430-11843091.57397.30
6122503-12250394.722100.73
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%
110.372194082192862190722188882188032190910.12
210.372182342182142182240.01
单位质量响应值RSD%判断
21127.3921043.780.29数据可信
供试品溶液-AM221354批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min111809-118099.1948.983.639.198.983.62
211337-113378.8268.83
311203-112038.7228.72
411626-116269.0519.05
512178-121789.4819.48
611059-110598.6108.61
10min121089-2108916.41915.713.4516.5215.813.45
219456-1945615.14715.25
319993-1999315.56515.66
420463-2046315.93116.03
520699-2069916.11516.22
619353-1935315.06715.16
15min129920-2992023.29422.382.6623.5822.652.67
228016-2801621.81222.08
328123-2812321.89522.16
429431-2943122.91323.19
528604-2860422.26922.55
628380-2838022.09522.36
20min137331-3733129.06428.102.0729.6128.622.08
235354-3535427.52528.03
336146-3614628.14128.65
436457-3645728.38328.92
535875-3587527.93028.46
635382-3538227.54628.06
30min147585-4758537.04736.081.6537.9136.921.66
245857-4585735.70236.52
345553-4555335.46536.29
446847-4684736.47237.32
546377-4637736.10736.95
645847-4584735.69436.51
45min158303-5830345.39144.600.9646.6745.840.98
256691-5669144.13645.35
356995-5699544.37345.59
457163-5716344.50445.76
557265-5726544.58345.83
657295-5729544.60745.82
60min165850-6585051.26750.740.5553.0552.480.58
265034-6503450.63252.33
365309-6530950.84652.56
464985-6498550.59452.34
564957-6495750.57252.31
664932-6493250.55252.26
90min175745-7574558.97158.810.9361.3261.110.90
274283-7428357.83360.10
376212-7621259.33461.61
475607-7560758.86361.17
575319-7531958.63960.94
676091-7609159.24061.51
极限180154-8015462.40361.391.1965.4164.341.15
279417-7941761.83064.74
378306-7830660.96563.90
477462-7746260.30863.27
578637-7863761.22264.17
679156-7915661.62664.55
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%
110.372194412194522194962193582190982193690.08
210.372200102200952200520.03
单位质量响应值RSD%判断
21154.1921220.060.22数据可信
供试品溶液-AM221354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%
5min135518-3551827.52027.172.9227.5227.172.92
236483-3648328.26728.27
334145-3414526.45626.46
435415-3541527.44027.44
535194-3519427.26927.27
633645-3364526.06926.07
10min159183-5918345.85645.223.1946.1645.523.19
260585-6058546.94247.26
356057-5605743.43443.73
459704-5970446.25946.56
558374-5837445.22945.53
656233-5623343.57043.86
15min179860-7986061.87661.822.7062.6962.622.70
282069-8206963.58864.42
377186-7718659.80560.58
482273-8227363.74664.56
579737-7973761.78162.59
677573-7757360.10460.88
20min194072-9407272.88872.672.1274.3974.162.13
294726-9472673.39574.94
390999-9099970.50771.95
496708-9670874.93176.46
593990-9399072.82574.32
692266-9226671.48972.93
30min1107286-10728683.12683.541.2285.4485.841.24
2108309-10830983.91986.28
3105832-10583282.00084.22
4109029-10902984.47786.84
5109284-10928484.67586.98
6107167-10716783.03485.27
45min1116233-11623390.05990.421.0893.3093.651.09
2116440-11644090.21993.51
3115286-11528689.32592.46
4117840-11784091.30494.60
5118564-11856491.86595.11
6115820-11582089.73992.90
60min1118441-11844191.77092.891.2996.0197.121.30
2121385-12138594.05198.34
3117841-11784191.30595.43
4121217-12121793.92098.23
5121054-12105493.79498.06
6119401-11940192.51396.67
90min1121021-12102193.76994.411.1799.0399.681.18
2123031-12303195.326100.66
3119922-11992292.91798.06
4122227-12222794.703100.06
5123771-12377195.899101.20
6121130-12113093.85399.04
极限1119890-11989092.89293.921.1399.19100.231.13
2123074-12307495.359101.76
3119498-11949892.58898.76
4121222-12122293.924100.33
5122257-12225794.726101.10
6121325-12132594.004100.23
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