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%
110.251022591022721021271021681021151021880.08
210.161019411019281019340.01
单位质量响应值RSD%判断
9969.5610032.870.45数据可信
供试品溶液-24070102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%
5min1125742-125742206.395204.541.81206.40204.541.81
2121345-121345199.178199.18
3122377-122377200.872200.87
4124981-124981205.146205.15
5126373-126373207.431207.43
6126853-126853208.219208.22
10min1125977-125977206.781205.111.80209.07207.381.80
2121845-121845199.998202.21
3122523-122523201.111203.34
4125477-125477205.960208.24
5126657-126657207.897210.20
6127279-127279208.918211.23
15min1125698-125698206.323204.851.81210.91209.401.81
2121744-121744199.833204.27
3122320-122320200.778205.24
4125242-125242205.574210.14
5126641-126641207.871212.49
6127170-127170208.739213.37
20min1125434-125434205.889204.341.81212.77211.161.81
2121352-121352199.189205.84
3122055-122055200.343207.04
4125020-125020205.210212.06
5126384-126384207.449214.37
6126685-126685207.943214.90
30min1125014-125014205.200203.991.75214.37213.091.75
2121229-121229198.987207.86
3122028-122028200.299209.22
4124769-124769204.798213.93
5126182-126182207.117216.35
6126435-126435207.533216.80
45min1124887-124887204.992203.621.81216.44214.991.81
2120919-120919198.478209.56
3121740-121740199.826210.97
4124399-124399204.191215.60
5126040-126040206.884218.41
6126334-126334207.367218.94
60min1124787-124787204.827203.321.83218.56216.951.83
2120724-120724198.158211.44
3121473-121473199.388212.76
4124271-124271203.980217.66
5125759-125759206.423220.25
6126204-126204207.153221.03
90min1-0.0000.00-16.0015.881.80
2-0.00015.49
3-0.00015.58
4-0.00015.94
5-0.00016.12
6-0.00016.18
极限1-0.0000.00-16.0015.881.80
2-0.00015.49
3-0.00015.58
4-0.00015.94
5-0.00016.12
6-0.00016.18
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%
110.251268649126844512686311268673126857612685950.01
210.161268476126830112683880.01
单位质量响应值RSD%判断
123765.37124841.340.62数据可信
供试品溶液-24070101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%
5min11474919-1474919194.787196.691.11194.79196.691.11
21465801-1465801193.583193.58
31498545-1498545197.908197.91
41488444-1488444196.574196.57
51510115-1510115199.436199.44
61498175-1498175197.859197.86
10min11507711-1507711199.118198.770.97201.28200.950.97
21478612-1478612195.275197.43
31510297-1510297199.460201.66
41502129-1502129198.381200.57
51522297-1522297201.044203.26
61509246-1509246199.321201.52
15min11510553-1510553199.493198.950.96203.87203.340.96
21479512-1479512195.394199.71
31509335-1509335199.333203.75
41507181-1507181199.048203.44
51522771-1522771201.107205.56
61509206-1509206199.316203.73
20min11512938-1512938199.808198.740.98206.40205.340.98
21476720-1476720195.025201.52
31508441-1508441199.215205.84
41504622-1504622198.710205.31
51519036-1519036200.614207.30
61507278-1507278199.061205.69
30min11506623-1506623198.974198.350.93207.79207.160.93
21474597-1474597194.745203.40
31507308-1507308199.065207.91
41504264-1504264198.663207.47
51514713-1514713200.043208.96
61503750-1503750198.595207.43
45min11503280-1503280198.533197.780.94209.56208.800.94
21471030-1471030194.274205.10
31501372-1501372198.281209.34
41499459-1499459198.028209.04
51512436-1512436199.742210.88
61498002-1498002197.836208.88
60min11501438-1501438198.290197.300.95211.52210.520.94
21466620-1466620193.691206.67
31497535-1497535197.774211.03
41497014-1497014197.705210.92
51506684-1506684198.982212.34
61494562-1494562197.382210.63
90min1-0.0000.00-15.4315.410.96
2-0.00015.13
3-0.00015.46
4-0.00015.41
5-0.00015.57
6-0.00015.44
极限1-0.0000.00-15.4315.410.96
2-0.00015.13
3-0.00015.46
4-0.00015.41
5-0.00015.57
6-0.00015.44
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%
110.252504272503442503212503472504522503780.03
210.162499712499602499660.01
单位质量响应值RSD%判断
24427.1224602.950.51数据可信
供试品溶液-24070103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%
5min143833-4383329.35230.832.8329.3530.842.84
245794-4579430.66530.67
347064-4706431.51631.52
446321-4632131.01831.02
547560-4756031.84831.85
645701-4570130.60330.60
10min159855-5985540.08142.813.8740.4143.153.86
263994-6399442.85343.19
365024-6502443.54343.89
465525-6552543.87844.22
566740-6674044.69245.05
662444-6244441.81542.15
15min170205-7020547.01250.133.8847.7850.953.88
274901-7490150.15750.97
376917-7691751.50752.34
476471-7647151.20852.04
577917-7791752.17653.03
672789-7278948.74249.55
20min176494-7649451.22355.004.1952.5256.374.17
281694-8169454.70556.08
382952-8295255.54856.95
484413-8441356.52657.93
586510-8651057.93059.36
680708-8070854.04555.39
30min183731-8373156.06959.653.7657.9361.643.76
288510-8851059.27061.25
391754-9175461.44263.47
491969-9196961.58663.62
591651-9165161.37363.45
686878-8687858.17760.12
45min187794-8779458.79062.753.9061.2865.403.89
293713-9371362.75465.39
396274-9627464.46967.17
497299-9729965.15567.87
596051-9605164.31967.08
691098-9109861.00363.60
60min190593-9059360.66564.443.9363.8067.793.92
296064-9606464.32867.67
398253-9825365.79469.22
4100531-10053167.31970.76
598894-9889466.22369.69
693067-9306762.32165.59
90min191635-9163561.36265.964.3965.1870.024.35
298534-9853465.98270.03
3100477-10047767.28371.44
4102847-10284768.87073.06
5102160-10216068.41072.62
695354-9535463.85367.82
极限1110314-11031473.87076.652.2778.3781.452.34
2116067-11606777.72382.51
3115112-11511277.08381.98
4114923-11492376.95781.91
5117645-11764578.78083.75
6112723-11272375.48480.16
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