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%
19.892407762408702407502407152407632407750.03
29.942405262405962405610.03
单位质量响应值RSD%判断
24345.3024201.310.42数据可信
供试品溶液-24071501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%
5min144716-4471630.24230.032.4330.2430.032.42
244020-4402029.77129.77
346240-4624031.27231.27
444669-4466930.21030.21
543562-4356229.46129.46
643228-4322829.23529.24
10min167957-6795745.96045.562.1746.3045.892.17
267172-6717245.42945.76
368992-6899246.66047.01
468700-6870046.46246.80
565578-6557844.35144.68
665758-6575844.47244.80
15min180311-8031154.31553.732.1855.1654.572.18
278686-7868653.21654.05
380452-8045254.41055.28
481765-8176555.29856.15
576906-7690652.01252.83
678551-7855153.12453.94
20min187434-8743459.13258.452.3660.5859.892.35
285958-8595858.13459.56
386845-8684558.73460.20
489411-8941160.46961.94
583303-8330356.33857.74
685600-8560057.89259.30
30min196091-9609164.98763.823.7967.0965.913.73
294334-9433463.79965.87
394465-9446563.88766.01
499694-9969467.42469.56
588900-8890060.12362.15
692731-9273162.71464.77
45min1101683-10168368.76967.714.4971.6070.514.40
2100946-10094668.27071.05
399077-9907767.00669.84
4107114-10711472.44275.33
593406-9340663.17165.86
698486-9848666.60769.36
60min1106029-10602971.70869.774.7875.3073.324.67
2105428-10542871.30174.84
3100700-10070068.10471.68
4109888-10988874.31878.01
595950-9595064.89168.29
6101004-10100468.30971.80
90min1111145-11114575.16872.205.9679.5676.525.79
2109150-10915073.81978.15
3103741-10374170.16174.49
4115340-11534078.00582.52
597588-9758865.99970.11
6103547-10354770.02974.28
极限1121495-12149582.16880.452.1187.3985.572.19
2118868-11886880.39185.54
3117728-11772879.62084.73
4122210-12221082.65188.04
5115525-11552578.13082.98
6117875-11787579.71984.75
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%
19.892405002404732405042403592404242404520.03
29.942403122403262403190.01
单位质量响应值RSD%判断
24312.6424176.960.40数据可信
供试品溶液-24071502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%
5min147515-4751532.17232.552.5432.1732.542.54
246320-4632031.36331.36
348039-4803932.52732.53
447635-4763532.25432.25
549249-4924933.34633.35
649641-4964133.61233.61
10min172593-7259349.15348.501.8449.5148.861.82
272805-7280549.29649.64
370268-7026847.57847.94
469936-6993647.35447.71
572847-7284749.32549.70
671293-7129348.27248.65
15min181238-8123855.00656.872.0055.9157.771.97
286485-8648558.55959.46
383766-8376656.71857.61
484402-8440257.14958.03
584064-8406456.92057.84
683978-8397856.86157.77
20min192024-9202462.30961.482.7063.8263.012.64
293306-9330663.17764.72
390714-9071461.42262.94
486453-8645358.53760.06
592369-9236962.54364.09
689956-8995660.90962.45
30min197204-9720465.81766.713.1668.0268.923.09
2103918-10391870.36372.61
398641-9864166.79068.99
494513-9451363.99566.16
599203-9920367.17069.42
697632-9763266.10768.32
45min1103491-10349170.07470.123.7773.0173.073.68
2110688-11068874.94777.98
3102598-10259869.46972.41
499022-9902267.04869.93
5103869-10386970.33073.32
6101647-10164768.82571.78
60min197501-9750166.01870.365.1669.7374.094.98
2113305-11330576.71980.58
3102442-10244269.36373.08
4100804-10080468.25471.88
5105345-10534571.32975.10
6104082-10408270.47474.19
90min1107562-10756272.83073.323.5277.2877.833.45
2115121-11512177.94882.66
3107320-10732072.66677.15
4104634-10463470.84875.23
5109729-10972974.29778.86
6105335-10533571.32275.82
极限1117754-11775479.73174.3016.7584.9979.6415.75
2121294-12129482.12887.71
3113804-11380477.05782.35
472606-7260649.16154.33
5117932-11793279.85285.24
6115049-11504977.90083.19
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%
19.892402772403542402812403032402222402870.02
29.942401482402822402150.04
单位质量响应值RSD%判断
24295.9624166.500.38数据可信
供试品溶液-24071503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%
5min142152-4215228.55727.762.1228.5627.762.13
241027-4102727.79527.79
341830-4183028.33928.34
440655-4065527.54327.54
540227-4022727.25327.25
639982-3998227.08727.09
10min161517-6151741.67640.862.8641.9941.172.85
261278-6127841.51441.82
362339-6233942.23342.55
460207-6020740.78941.09
558155-5815539.39939.70
658400-5840039.56539.87
15min172924-7292449.40448.252.3050.1849.012.31
271824-7182448.65949.43
372534-7253449.14049.92
471634-7163448.53049.29
568922-6892246.69347.43
669496-6949647.08247.82
20min179504-7950453.86252.742.5055.1954.032.49
278544-7854453.21254.52
379831-7983154.08455.41
478239-7823953.00554.30
575717-7571751.29752.56
675210-7521050.95352.22
30min187461-8746159.25357.652.7061.1859.542.68
286014-8601458.27360.17
386994-8699458.93660.87
485308-8530857.79459.68
583290-8329056.42758.26
681504-8150455.21757.05
45min190608-9060861.38561.171.7963.9763.701.80
290292-9029261.17163.72
392640-9264062.76265.35
491231-9123161.80764.34
588438-8843859.91562.37
688555-8855559.99462.44
60min195078-9507864.41362.951.9567.6866.161.96
292548-9254862.69965.93
394723-9472364.17367.46
493296-9329663.20666.42
590488-9048861.30464.43
691401-9140161.92265.03
90min198516-9851666.74265.133.0170.7369.042.96
296039-9603965.06468.99
398634-9863466.82270.82
497907-9790766.33070.25
591238-9123861.81265.61
694489-9448964.01467.81
极限1115316-11531678.12477.261.0282.8581.891.09
2114496-11449677.56882.22
3114909-11490977.84882.59
4114298-11429877.43482.09
5112713-11271376.36180.85
6112536-11253676.24180.75
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%
19.892400412399532398952398902398422399240.04
29.942394752394682394720.01
单位质量响应值RSD%判断
24259.2524091.750.49数据可信
供试品溶液-24071504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%
5min145400-4540030.82929.963.3130.8329.963.31
245463-4546330.87130.87
343034-4303429.22229.22
445334-4533430.78430.78
542151-4215128.62228.62
643315-4331529.41329.41
10min165388-6538844.40144.004.0144.7444.334.00
266556-6655645.19445.54
367474-6747445.81846.14
466136-6613644.90945.25
560917-6091741.36541.68
662303-6230342.30642.63
15min175232-7523251.08650.834.9251.9251.654.89
277290-7729052.48353.33
378864-7886453.55254.39
476948-7694852.25153.09
571181-7118148.33549.11
669594-6959447.25748.05
20min183266-8326656.54155.354.2157.9456.744.20
283744-8374456.86658.29
384510-8451057.38658.81
483269-8326956.54357.96
576589-7658952.00753.32
677723-7772352.77754.10
30min187853-8785359.65659.603.5261.6961.603.53
289659-8965960.88262.94
390995-9099561.78963.86
489914-8991461.05563.11
583089-8308956.42158.31
685102-8510257.78859.70
45min191618-9161862.21362.413.9264.9165.073.91
294487-9448764.16166.90
395977-9597765.17267.93
494011-9401163.83766.57
586994-8699459.07361.59
688341-8834159.98762.54
60min194051-9405163.86563.943.7967.2567.303.79
296738-9673865.68969.14
398040-9804066.57370.05
496286-9628665.38268.82
589022-8902260.45063.63
690868-9086861.70364.92
90min196023-9602365.20465.533.9769.3069.593.95
299243-9924367.39071.57
398444-9844466.84871.06
4101143-10114368.68072.84
591370-9137062.04465.89
692779-9277963.00166.90
极限1111186-11118675.50075.841.7380.3280.631.85
2113171-11317176.84881.78
3113082-11308276.78881.75
4113723-11372377.22382.15
5109274-10927474.20278.74
6109642-10964274.45279.05
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