坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.676765467602675226769167695676330.11
213.766764067458675490.20
单位质量响应值RSD%判断
4947.554909.080.56数据可信
供试品溶液-6041401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%
5min123662-2366231.12939.5519.3431.1339.5519.34
223742-2374231.23431.23
329106-2910638.29138.29
435618-3561846.85846.86
537529-3752949.37249.37
630709-3070940.40040.40
10min149383-4938364.96668.477.5465.0268.547.55
246097-4609760.64360.70
351739-5173968.06668.13
456015-5601573.69173.77
556308-5630874.07774.16
652737-5273769.37969.45
15min155060-5506072.43575.895.2572.6076.075.27
254880-5488072.19872.35
355300-5530072.75172.93
459990-5999078.92179.12
561996-6199681.56081.77
658897-5889777.48377.67
20min158886-5888677.46879.974.7177.7580.284.73
257032-5703275.02975.30
359880-5988078.77679.07
464026-6402684.23084.56
564241-6424184.51384.85
660665-6066579.80980.12
30min162263-6226381.91180.743.9682.3281.183.94
260245-6024579.25679.65
359806-5980678.67979.11
458081-5808176.40976.88
564656-6465685.05985.54
663181-6318183.11983.56
45min162309-6230981.97182.732.9282.5283.312.94
260223-6022379.22779.76
362428-6242882.12882.69
463160-6316083.09183.69
565864-6586486.64887.27
663338-6333883.32583.91
60min161758-6175881.24784.162.9481.9384.872.96
262586-6258682.33683.00
362905-6290582.75583.45
465455-6545586.11086.85
566674-6667487.71488.48
664441-6444184.77685.50
极限164980-6498085.48586.532.7886.3087.392.78
263741-6374183.85584.66
367894-6789489.31990.15
467557-6755788.87589.76
566606-6660687.62488.54
663886-6388684.04684.91
坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.676763467718676476796967889677710.23
213.766813167997680640.14
单位质量响应值RSD%判断
4957.644946.510.16数据可信
供试品溶液-6041501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%
5min128442-2844237.23729.8514.8137.2429.8514.81
224838-2483832.51932.52
321094-2109427.61727.62
419417-1941725.42125.42
522782-2278229.82729.83
620222-2022226.47526.48
10min156200-5620073.57964.767.9273.6464.817.92
247296-4729661.92161.98
346271-4627160.57960.63
445829-4582960.00160.04
550066-5006665.54865.60
651119-5111966.92766.97
15min161376-6137680.35574.664.7080.5474.824.71
253896-5389670.56270.72
355334-5533472.44572.59
456500-5650073.97274.11
556197-5619773.57573.73
658846-5884677.04377.20
20min162739-6273982.14077.653.8482.4677.933.85
256657-5665774.17774.45
356988-5698874.61174.88
459331-5933177.67877.94
559546-5954677.96078.24
660606-6060679.34779.63
30min163713-6371383.41581.583.4483.8782.003.45
259765-5976578.24678.64
360437-6043779.12679.52
461942-6194281.09681.49
562422-6242281.72582.14
665605-6560585.89286.31
45min160782-6078279.57883.393.3880.1783.943.35
263477-6347783.10683.64
362365-6236581.65082.17
464394-6439484.30784.84
563972-6397283.75484.30
667186-6718687.96288.52
60min167513-6751388.39085.682.7689.1286.372.77
265160-6516085.31085.98
363214-6321482.76283.42
464129-6412983.96084.63
564988-6498885.08485.77
667674-6767488.60189.31
极限166925-6692587.62088.112.3388.4988.942.32
267997-6799789.02489.83
364304-6430484.18984.99
468594-6859489.80590.62
568043-6804389.08489.91
667944-6794488.95489.81
坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.676849867960679046824668270681760.36
213.766779467568676810.24
单位质量响应值RSD%判断
4987.274918.680.98数据可信
供试品溶液-6041502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%
5min122038-2203828.84931.4516.0528.8531.4516.05
222690-2269029.70229.70
320483-2048326.81326.81
423774-2377431.12131.12
523676-2367630.99330.99
631499-3149941.23441.23
10min149842-4984265.24665.698.3265.2965.748.32
245241-4524159.22359.27
346551-4655160.93860.98
453908-5390870.56970.62
549466-4946664.75464.81
656090-5609073.42573.49
15min159132-5913277.40776.725.8177.5676.885.82
254723-5472371.63571.78
354824-5482471.76871.91
460722-6072279.48979.66
558776-5877676.94177.10
663483-6348383.10383.29
20min160037-6003778.59280.463.9078.8880.753.91
260177-6017778.77579.04
358508-5850876.59076.86
463149-6314982.66682.97
561821-6182180.92781.21
665110-6511085.23385.56
30min163380-6338082.96883.032.3483.3883.462.35
263996-6399683.77484.17
362344-6234481.61282.01
461506-6150680.51580.95
563526-6352683.15983.58
665834-6583486.18086.65
45min165494-6549485.73585.483.1986.2986.043.20
264457-6445784.37884.92
362177-6217781.39381.92
467499-6749988.36088.93
564484-6448484.41384.97
667660-6766088.57189.19
60min166193-6619386.65086.512.1987.3587.222.21
265086-6508685.20185.88
364954-6495485.02885.69
466265-6626586.74587.47
565235-6523585.39686.10
668797-6879790.05990.82
极限168301-6830189.41088.631.8590.2589.481.85
265453-6545385.68286.50
367441-6744188.28489.09
469164-6916490.54091.41
567762-6776288.70489.55
668098-6809889.14490.06
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