叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.431952891951221966851949081955751955160.36
217.491944951942941943940.08
单位质量响应值RSD%判断
11217.2111114.580.65数据可信
供试品溶液-24070801批-左氨氯地平-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%
5min1110939-110939100.372103.122.05100.37103.122.05
2116778-116778105.654105.65
3111854-111854101.199101.20
4116346-116346105.263105.26
5113997-113997103.138103.14
6113922-113922103.070103.07
10min1110604-110604100.068102.571.54101.18103.711.55
2114410-114410103.512104.69
3112931-112931102.174103.30
4115814-115814104.782105.95
5112857-112857102.107103.25
6113576-113576102.757103.90
15min1109514-10951499.082101.361.77101.31103.651.77
2112997-112997102.233104.56
3110067-11006799.583101.84
4114783-114783103.849106.18
5112965-112965102.205104.49
6111866-111866101.210103.50
20min1108922-10892298.547100.721.84101.87104.131.84
2113306-113306102.513105.97
3109362-10936298.945102.31
4114028-114028103.166106.65
5111221-111221100.627104.04
6111136-111136100.550103.96
30min1106137-10613796.02798.792.14100.45103.322.12
2110282-11028299.777104.38
3107625-10762597.373101.84
4112901-112901102.147106.78
5109528-10952899.095103.63
6108697-10869798.343102.87
45min1106111-10611196.00398.191.65101.49103.821.66
2109979-10997999.503105.21
3107219-10721997.006102.55
4111020-111020100.445106.21
5108164-10816497.861103.50
6108677-10867798.325103.95
60min1103991-10399194.08597.032.05100.64103.742.03
2108463-10846398.131104.94
3106306-10630696.180102.81
4110489-11048999.964106.85
5107561-10756197.315104.04
6106636-10663696.478103.19
90min1103368-10336893.52296.151.81101.12103.951.81
2107411-10741197.180105.08
3104981-10498194.981102.68
4108860-10886098.491106.49
5106222-10622296.104103.91
6106821-10682196.646104.43
极限1100424-10042490.85894.482.7199.50103.352.63
2105743-10574395.670104.65
3102786-10278692.995101.74
4108824-10882498.458107.55
5104231-10423194.302103.17
6104575-10457594.614103.47
叶酸左氨氯地平片项目信息
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20000
标示量(mg)0.8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%
116.001960031958271977521966271981181968650.53
215.991952921951391952160.06
单位质量响应值RSD%判断
12304.0612208.630.56数据可信
供试品溶液-24070801批-叶酸-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%
5min146608-4660839.01739.912.1339.0239.912.13
248048-4804840.22240.22
346366-4636638.81438.81
448287-4828740.42240.42
548996-4899641.01641.02
647750-4775039.97339.97
10min167281-6728156.32358.234.1556.7658.674.13
270364-7036458.90459.35
367692-6769256.66757.10
467375-6737556.40256.85
574792-7479262.61163.07
669821-6982158.44958.89
15min178639-7863965.83166.725.0466.8967.805.00
278830-7883065.99167.09
375199-7519962.95164.01
478875-7887566.02967.10
587278-8727873.06374.21
679367-7936766.44067.53
20min182276-8227668.87670.154.8370.6771.984.80
283749-8374970.10971.94
378642-7864265.83467.59
483127-8312769.58871.40
591031-9103176.20578.17
683992-8399270.31272.14
30min185420-8542071.50872.174.7074.0674.784.68
285025-8502571.17773.79
381480-8148068.20970.70
485654-8565471.70474.29
593772-9377278.49981.31
685885-8588571.89774.51
45min187733-8773373.44473.734.2976.7977.144.28
287411-8741173.17476.58
383311-8331169.74272.99
486338-8633872.27675.66
594730-9473079.30182.98
688905-8890574.42577.84
60min186877-8687772.72773.145.4676.8977.375.38
287475-8747573.22877.45
380732-8073267.58371.61
485408-8540871.49875.68
595398-9539879.86184.42
688311-8831173.92878.17
90min187404-8740473.16973.944.0778.1478.994.08
287564-8756473.30278.33
384123-8412370.42275.20
486909-8690972.75477.73
594853-9485379.40484.85
689124-8912474.60879.67
极限199099-9909982.95985.031.8388.7590.901.93
2102296-10229685.63591.48
399705-9970583.46689.02
4102757-10275786.02191.81
5103945-10394587.01593.35
6101666-10166685.10891.00
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.431937571938051945021944631944921942040.20
217.491940351946971943660.25
单位质量响应值RSD%判断
11141.9411112.980.19数据可信
供试品溶液-24070802批-左氨氯地平-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%
5min1111506-111506101.231102.311.66101.23102.311.66
2111228-111228100.979100.98
3115059-115059104.457104.46
4114412-114412103.869103.87
5110518-110518100.334100.33
6113448-113448102.994102.99
10min1110028-11002899.889101.882.54101.01103.022.53
2110123-11012399.975101.10
3117151-117151106.356107.52
4113107-113107102.684103.84
5109869-10986999.745100.86
6113040-113040102.624103.77
15min1110412-110412100.238101.311.20102.47103.581.21
2112430-112430102.070104.30
3112912-112912102.507104.85
4112219-112219101.878104.17
5109496-10949699.406101.63
6112080-112080101.752104.04
20min1108183-10818398.21499.541.48101.56102.931.49
2109186-10918699.125102.49
3112114-112114101.783105.26
4111055-111055100.822104.25
5108036-10803698.081101.41
6109271-10927199.202102.62
30min1107754-10775497.82598.691.19102.26103.191.20
2107068-10706897.202101.67
3110331-110331100.164104.78
4110031-11003199.892104.44
5108160-10816098.193102.61
6108892-10889298.858103.38
45min1105128-10512895.44197.191.34100.97102.781.34
2106690-10669096.859102.41
3108904-10890498.869104.59
4107813-10781397.878103.54
5105822-10582296.071101.58
6107939-10793997.993103.61
60min1103396-10339693.86895.871.33100.46102.541.33
2105269-10526995.569102.19
3107518-10751897.610104.43
4106550-10655096.732103.48
5105123-10512395.436102.01
6105742-10574295.998102.70
90min1102442-10244293.00294.961.61100.63102.711.60
2103930-10393094.353102.04
3106793-10679396.952104.86
4105442-10544295.726103.55
5103188-10318893.679101.32
6105829-10582996.077103.85
极限1102328-10232892.89994.571.89101.56103.361.84
2103353-10335393.829102.56
3105629-10562995.896104.88
4106975-10697597.118106.00
5101963-10196392.567101.24
6104760-10476095.107103.95
叶酸左氨氯地平片项目信息
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20000
标示量(mg)0.8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%
116.001943241947311949581951531949401948210.17
215.991948191952951950570.18
单位质量响应值RSD%判断
12176.3112198.690.13数据可信
供试品溶液-24070802批-叶酸-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%
5min124683-2468320.77919.1814.2020.7819.1814.20
216390-1639013.79813.80
325250-2525021.25721.26
423652-2365219.91119.91
522953-2295319.32319.32
623756-2375619.99920.00
10min140839-4083934.38031.8614.4434.6132.0714.44
227238-2723822.93023.08
342611-4261135.87236.11
438224-3822432.17932.40
538108-3810832.08132.30
640022-4002233.69233.91
15min150106-5010642.18238.8312.9742.7939.4012.99
234502-3450229.04529.45
350668-5066842.65543.29
446616-4661639.24439.82
546128-4612838.83339.40
648744-4874441.03541.63
20min154972-5497246.27842.3912.6447.3643.3912.66
238200-3820032.15932.89
355964-5596447.11348.22
451589-5158943.43044.44
550458-5045842.47843.48
650928-5092842.87443.93
30min160659-6065951.06647.3412.4552.6648.8112.47
242614-4261435.87436.96
361251-6125151.56453.20
456196-5619647.30848.81
556633-5663347.67649.15
660026-6002650.53352.06
45min163972-6397253.85549.8211.7956.0251.8111.82
246389-4638939.05240.54
364229-6422954.07156.28
456793-5679347.81149.83
559469-5946950.06452.07
664193-6419354.04156.13
60min164749-6474954.50951.5310.8757.2754.0810.96
248360-4836040.71242.63
366263-6626355.78358.59
461210-6121051.52954.08
561206-6120651.52654.09
665460-6546055.10757.80
90min166621-6662156.08553.0410.8859.4556.1610.95
250261-5026142.31244.69
368398-6839857.58161.01
461798-6179852.02455.15
562596-6259652.69655.83
668357-6835757.54660.85
极限176626-7662664.50761.849.4968.5065.559.63
259442-5944250.04152.88
378103-7810365.75169.82
475089-7508963.21366.92
574911-7491163.06466.78
676560-7656064.45268.39
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.431939551939001941651943661941701941110.10
217.491943731942511943120.05
单位质量响应值RSD%判断
11136.6011109.890.17数据可信
供试品溶液-1批-左氨氯地平-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%
5min1103049-10304993.58982.5249.1393.5982.5249.13
2110234-110234100.114100.11
3112555-112555102.222102.22
4-0.0000.00
5111411-111411101.183101.18
6107953-10795398.04298.04
10min1103144-10314493.675100.113.5594.71101.023.37
2109688-10968899.618100.73
3112605-112605102.267103.40
4113991-113991103.526103.53
5112574-112574102.239103.36
6109356-10935699.317100.41
15min1102890-10289093.44498.933.5795.53100.963.39
2108345-10834598.399100.62
3112436-112436102.114104.39
4112362-112362102.047103.20
5111442-111442101.211103.47
6106097-10609796.35798.55
20min1101705-10170592.36897.673.4795.49100.803.25
2107144-10714497.308100.62
3110268-110268100.145103.55
4111809-111809101.544103.83
5109354-10935499.315102.70
6104998-10499895.35998.62
30min199992-9999290.81296.843.9394.96101.063.66
2106155-10615596.410100.80
3110321-110321100.193104.71
4111602-111602101.356104.77
5107229-10722997.385101.87
6104505-10450594.91199.23
45min198013-9801389.01595.073.7294.17100.363.52
2104112-10411294.554100.02
3107468-10746897.602103.23
4108468-10846898.510103.05
5107105-10710597.272102.84
6102933-10293393.48398.86
60min197479-9747988.53093.813.2994.67100.153.10
2103715-10371594.194100.71
3105716-10571696.011102.73
4106757-10675796.956102.59
5104675-10467595.065101.72
6101385-10138592.07798.49
90min197072-9707288.16093.454.3595.29100.843.95
2101622-10162292.29399.85
3105202-10520295.544103.33
4109861-10986199.775106.49
5103837-10383794.304102.01
699764-9976490.60598.04
极限195410-9541086.65191.903.4094.76100.333.17
2101297-10129791.998100.59
3103106-10310693.640102.49
4105309-10530995.641103.46
5102565-10256593.149101.90
699455-9945590.32598.77
叶酸左氨氯地平片项目信息
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20000
标示量(mg)0.8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%
116.001947441948171947801949471952141949000.10
215.991947101947681947390.03
单位质量响应值RSD%判断
12181.2512178.800.02数据可信
供试品溶液-1批-叶酸-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%
5min123392-2339219.70515.2255.7919.7015.2255.79
225991-2599121.89421.89
325364-2536421.36621.37
4-0.0000.00
512703-1270310.70110.70
620927-2092717.62817.63
10min138569-3856932.48927.3935.0432.7127.5635.15
242213-4221335.55935.80
341346-4134634.82835.07
414764-1476412.43712.44
521972-2197218.50818.63
636250-3625030.53630.73
15min147312-4731239.85433.9332.2540.4334.4032.38
250880-5088042.85943.50
350580-5058042.60743.23
419564-1956416.48016.62
528908-2890824.35124.68
644435-4443537.43037.97
20min152398-5239844.13838.1829.8445.1639.0330.01
256703-5670347.76448.88
355428-5542846.69047.79
423719-2371919.98020.30
533437-3343728.16628.76
650248-5024842.32743.28
30min157839-5783948.72143.5125.8850.2344.7926.14
262851-6285152.94354.59
361588-6158851.87953.50
430064-3006425.32525.87
540170-4017033.83834.75
657404-5740448.35549.78
45min161249-6124951.59446.6721.7853.6548.4322.16
266422-6642255.95158.18
364495-6449554.32856.52
435450-3545029.86230.69
546356-4635639.04940.33
658481-5848149.26251.22
60min162970-6297053.04448.7621.1055.6751.0421.49
268087-6808757.35460.21
365728-6572855.36758.16
437064-3706431.22132.38
549050-4905041.31843.04
664393-6439354.24256.75
90min165056-6505654.80151.5815.7658.0254.4016.40
269315-6931558.38861.88
367979-6797957.26360.67
445574-4557438.39039.89
553026-5302644.66746.84
666435-6643555.96259.07
极限175395-7539563.51060.4917.3567.3463.8817.81
283709-8370970.51374.65
379743-7974367.17371.22
451453-5145343.34245.27
561929-6192952.16754.84
678616-7861666.22369.95
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.431941731938841938521939781938981939570.07
217.491937851935091936470.11
单位质量响应值RSD%判断
11127.7711071.870.36数据可信
供试品溶液-2批-左氨氯地平-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%
5min1112639-112639102.51585.9849.01102.5185.9849.01
2112313-112313102.218102.22
3115081-115081104.737104.74
4-0.0000.00
5114242-114242103.974103.97
6112571-112571102.453102.45
10min1111551-111551101.525102.811.46102.66103.771.39
2111452-111452101.434102.57
3115745-115745105.342106.51
4113980-113980103.735103.74
5112685-112685102.557103.71
6112380-112380102.279103.42
15min1111057-111057101.075101.771.51103.34103.861.50
2110675-110675100.727102.99
3115023-115023104.684107.02
4112379-112379102.278103.43
5110804-110804100.845103.14
6110957-110957100.984103.26
20min1109737-10973799.874100.681.42103.26103.911.36
2108418-10841898.673102.06
3113009-113009102.851106.35
4111578-111578101.549103.84
5110632-110632100.688104.10
6110372-110372100.451103.85
30min1109505-10950599.66299.991.21104.16104.341.04
2109213-10921399.397103.88
3111594-111594101.564106.20
4111293-111293101.290104.71
5108132-10813298.413102.95
6109449-10944999.611104.12
45min1107912-10791298.21398.331.23103.82103.790.99
2106925-10692597.314102.90
3109521-10952199.677105.45
4109809-10980999.939104.48
5106776-10677697.179102.81
6107319-10731997.673103.29
60min1107014-10701497.39597.561.51104.09104.111.37
2104996-10499695.559102.22
3109491-10949199.650106.53
4108568-10856898.810104.46
5106853-10685397.249103.96
6106241-10624196.692103.40
90min1104888-10488895.46095.851.30103.24103.481.13
2104052-10405294.700102.43
3106895-10689597.287105.27
4106657-10665797.070103.82
5103595-10359594.284102.07
6105779-10577996.271104.05
极限1105344-10534495.87595.400.91104.72104.100.79
2103668-10366894.350103.13
3105776-10577696.269105.33
4105796-10579696.287104.12
5103920-10392094.579103.41
6104404-10440495.020103.87
叶酸左氨氯地平片项目信息
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20000
标示量(mg)0.8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%
116.001948721949591947201944661946551947340.10
215.991948431948321948380.01
单位质量响应值RSD%判断
12170.8812184.990.09数据可信
供试品溶液-2批-叶酸-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%
5min122725-2272519.14615.7152.8319.1515.7152.82
224678-2467820.79120.79
324335-2433520.50220.50
4-0.0000.00
515182-1518212.79112.79
624990-2499021.05421.05
10min138194-3819432.17928.2831.0832.3928.4631.21
240357-4035734.00134.23
340136-4013633.81534.04
415564-1556413.11313.11
526198-2619822.07222.21
640978-4097834.52434.76
15min146792-4679239.42334.9428.5939.9935.4328.73
249176-4917641.43142.04
348955-4895541.24541.85
420659-2065917.40517.55
533704-3370428.39628.78
649566-4956641.76042.38
20min151606-5160643.47839.1326.2944.4940.0126.47
254215-5421545.67746.75
353481-5348145.05846.12
424502-2450220.64320.98
539525-3952533.30034.00
655364-5536446.64547.73
30min158122-5812248.96844.2223.0150.4645.5323.25
260966-6096651.36452.94
359121-5912149.81051.37
430521-3052125.71426.28
546107-4610738.84639.92
660097-6009750.63252.23
45min161197-6119751.55947.8019.9653.5949.6020.29
264250-6425054.13156.28
362593-6259352.73554.85
435779-3577930.14431.00
551730-5173043.58345.09
664864-6486454.64856.81
60min163427-6342753.43849.9717.5956.0552.3018.02
265745-6574555.39158.14
364875-6487554.65857.36
439802-3980233.53334.72
555151-5515146.46548.45
666848-6684856.32059.09
90min164689-6468954.50151.1715.0757.7054.0615.60
266545-6654556.06559.43
363234-6323453.27556.58
443753-4375336.86238.42
557481-5748148.42850.93
668733-6873357.90861.30
极限175647-7564763.73364.596.2667.5468.046.40
279610-7961067.07271.06
378264-7826465.93869.84
478229-7822965.90967.88
567499-6749956.86859.91
680714-8071468.00272.04
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