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10000
标示量(mg)1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%
110.391063521062831063351062181063671063110.06
210.381062951049751056350.89
单位质量响应值RSD%判断
10232.0510176.780.39数据可信
供试品溶液-24080502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%
5min118383-1838329.57330.744.0329.5730.744.04
218962-1896230.50530.50
320370-2037032.77032.77
418947-1894730.48130.48
518367-1836729.54729.55
619605-1960531.53931.54
10min130236-3023648.64149.841.6648.9750.191.66
230813-3081349.57049.91
331072-3107249.98650.35
431726-3172651.03851.38
530745-3074549.46049.79
631313-3131350.37450.72
15min138712-3871262.27762.050.5763.1562.940.57
238398-3839861.77262.66
338647-3864762.17263.09
438880-3888062.54763.45
538294-3829461.60562.48
638490-3849061.92062.83
20min143445-4344569.89169.420.6371.4571.000.61
242764-4276468.79670.37
342909-4290969.02970.64
443268-4326869.60671.21
543393-4339369.80771.37
643116-4311669.36270.96
30min147470-4747076.36677.371.1078.7079.721.06
248102-4810277.38379.72
347650-4765076.65679.03
448385-4838577.83880.21
548932-4893278.71881.06
648022-4802277.25479.62
45min150874-5087481.84282.761.1985.0385.981.14
251915-5191583.51786.72
350625-5062581.44284.67
451886-5188683.47086.71
552082-5208283.78687.00
651282-5128282.49985.73
60min152418-5241884.32684.610.8688.4288.740.82
253086-5308685.40189.53
352080-5208083.78387.92
452922-5292285.13789.30
552939-5293985.16489.31
652106-5210683.82487.97
90min153144-5314485.49485.980.8690.5391.060.83
253975-5397586.83191.91
352799-5279984.93990.00
453661-5366186.32691.44
553248-5324885.66190.75
653859-5385986.64491.72
极限152093-5209383.80384.493.5189.7990.523.28
254012-5401286.89192.93
353101-5310185.42591.43
453674-5367486.34792.42
553241-5324185.65091.69
649006-4900678.83784.88
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10000
标示量(mg)1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%
110.391049521048901048621049961048391049080.07
210.381047151047411047280.02
单位质量响应值RSD%判断
10097.0210089.400.06数据可信
供试品溶液-24080502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%
5min125637-2563741.69741.843.5941.7041.843.59
225764-2576441.90441.90
325833-2583342.01642.02
424947-2494740.57540.57
524780-2478040.30340.30
627375-2737544.52444.52
10min139603-3960364.41263.352.0864.8863.812.09
239526-3952664.28764.75
338982-3898263.40263.87
438201-3820162.13262.58
537736-3773661.37561.82
639643-3964364.47764.97
15min147107-4710776.61774.991.8877.8076.161.88
246750-4675076.03677.22
346004-4600474.82375.99
445546-4554674.07875.22
544746-4474672.77773.91
646491-4649175.61576.83
20min150212-5021281.66781.261.3083.7083.261.31
250646-5064682.37384.40
350298-5029881.80783.81
449129-4912979.90581.87
549177-4917779.98381.92
650317-5031781.83883.89
30min154482-5448288.61287.381.7791.5590.281.75
254957-5495789.38492.32
354205-5420588.16191.07
452871-5287185.99288.84
552669-5266985.66388.49
653148-5314886.44289.40
45min156576-5657692.01790.131.3595.9494.001.35
255932-5593290.97094.90
355425-5542590.14594.04
454957-5495789.38493.19
554482-5448288.61292.39
655119-5511989.64893.57
60min156139-5613991.30790.471.2896.2595.341.26
256704-5670492.22697.17
355294-5529489.93294.83
454715-5471588.99193.79
555622-5562290.46695.23
655260-5526089.87794.79
90min156349-5634991.64890.451.1497.6196.331.13
256274-5627491.52697.49
355793-5579390.74496.64
455312-5531289.96295.75
555159-5515989.71395.48
654791-5479189.11495.03
极限155908-5590890.93190.041.3797.9196.921.35
256514-5651491.91798.90
355496-5549690.26197.16
454681-5468188.93595.72
554944-5494489.36396.13
654611-5461188.82295.73
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10000
标示量(mg)1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%
110.391051531050861051661051581050511051230.05
210.381048971048091048530.06
单位质量响应值RSD%判断
10117.7110101.450.12数据可信
供试品溶液-24080502批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1116716-116716189.524192.311.40189.52192.311.40
2116526-116526189.216189.22
3119555-119555194.134194.13
4119157-119157193.488193.49
5117972-117972191.564191.56
6120665-120665195.937195.94
10min1116190-116190188.670192.311.68190.78194.451.67
2115891-115891188.185190.29
3119466-119466193.990196.15
4119393-119393193.871196.02
5118749-118749192.826194.95
6120898-120898196.315198.49
15min1115733-115733187.928191.721.73192.13195.991.72
2115466-115466187.495191.69
3119113-119113193.417197.73
4118904-118904193.077197.38
5118583-118583192.556196.83
6120602-120602195.834200.19
20min1115613-115613187.733191.291.79194.02197.701.78
2115010-115010186.754193.03
3118857-118857193.001199.46
4118631-118631192.634199.08
5118162-118162191.872198.28
6120558-120558195.763202.30
30min1114712-114712186.270190.271.79194.65198.801.78
2114543-114543185.996194.35
3118245-118245192.007200.61
4118001-118001191.611200.20
5117792-117792191.272199.81
6119755-119755194.459203.17
45min1114561-114561186.025189.601.89196.47200.241.87
2113644-113644184.536194.95
3117787-117787191.263202.00
4117523-117523190.835201.55
5117594-117594190.950201.62
6119451-119451193.965204.84
60min1114006-114006185.124188.771.88197.64201.521.87
2113287-113287183.956196.43
3116927-116927189.867202.73
4116988-116988189.966202.81
5117212-117212190.330203.12
6119073-119073193.352206.38
90min1-0.0000.00-14.5714.841.72
2-0.00014.51
3-0.00014.97
4-0.00014.95
5-0.00014.90
6-0.00015.17
极限1-0.0000.00-14.5714.841.72
2-0.00014.51
3-0.00014.97
4-0.00014.95
5-0.00014.90
6-0.00015.17
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10000
标示量(mg)1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%
110.392589172589112589372590392590872589780.04
210.382591842591742591790.01
单位质量响应值RSD%判断
24925.7024969.080.13数据可信
供试品溶液-24072204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%
5min162761-6276141.29841.603.6841.3041.603.68
260753-6075339.97739.98
365735-6573543.25543.26
460414-6041439.75439.75
563995-6399542.11042.11
665637-6563743.19143.19
10min187449-8744957.54458.752.1658.0059.222.17
288316-8831658.11458.56
391551-9155160.24360.72
487069-8706957.29457.74
590247-9024759.38559.85
691084-9108459.93660.42
15min1101167-10116766.57067.991.5867.6769.111.59
2102869-10286967.69068.78
3105013-10501369.10170.25
4102112-10211267.19268.27
5103490-10349068.09969.23
6105310-10531069.29770.44
20min1111140-11114073.13373.520.9474.9775.390.96
2110380-11038072.63374.47
3111831-11183173.58875.51
4111262-11126273.21375.04
5112393-11239373.95775.84
6113357-11335774.59276.51
30min1117895-11789577.57878.160.8180.2380.850.83
2117885-11788577.57180.22
3119543-11954378.66281.40
4118697-11869778.10680.74
5118373-11837377.89280.60
6120282-12028279.14981.89
45min1122075-12207580.32880.530.6283.8484.090.62
2122734-12273480.76284.27
3121632-12163280.03783.65
4122273-12227380.45983.96
5121865-12186580.19083.76
6123726-12372681.41585.04
60min1122594-12259480.67081.210.8785.0785.660.84
2124296-12429681.79086.20
3122098-12209880.34484.84
4123435-12343581.22385.62
5123073-12307380.98585.45
6124967-12496782.23186.76
90min1123028-12302880.95682.000.8286.2687.350.79
2125219-12521982.39787.71
3124942-12494282.21587.61
4125360-12536082.49087.79
5123674-12367481.38186.74
6125456-12545682.55388.00
极限1123871-12387181.51081.310.9687.7187.580.87
2123685-12368581.38887.62
3121266-12126679.79686.10
4124735-12473582.07988.30
5123945-12394581.55987.83
6123921-12392181.54387.90
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