左氨氯地平叶酸片项目信息
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%
116.741824471826551818811826781826751824670.19
217.071878691878051878370.03
单位质量响应值RSD%判断
10900.0611003.930.68数据可信
供试品溶液-24062101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%
5min1108814-108814100.372100.800.78100.37100.800.78
2108110-10811099.72299.72
3108660-108660100.230100.23
4109975-109975101.443101.44
5110022-110022101.486101.49
6110062-110062101.523101.52
10min1107100-10710098.791100.311.1799.91101.431.15
2110057-110057101.518102.63
3107483-10748399.144100.26
4108948-108948100.495101.62
5110129-110129101.585102.71
6108772-108772100.333101.46
15min1107520-10752099.178100.311.84101.39102.541.80
2112063-112063103.369105.60
3106799-10679998.513100.73
4107538-10753899.195101.44
5110153-110153101.607103.86
6108392-10839299.983102.23
20min1104693-10469396.57198.121.0599.89101.471.04
2106964-10696498.665102.05
3105616-10561697.422100.73
4106161-10616197.925101.27
5107707-10770799.351102.74
6107117-10711798.807102.16
30min1102351-10235194.41097.131.5298.80101.571.49
2106010-10601097.785102.27
3105313-10531397.142101.53
4104964-10496496.821101.25
5106411-10641198.155102.64
6106779-10677998.495102.95
45min1102767-10276794.79496.551.08100.23102.071.07
2104477-10447796.371101.94
3104842-10484296.708102.18
4104558-10455896.446101.96
5106216-10621697.975103.56
6105171-10517197.012102.56
60min1100900-10090093.07295.281.3599.56101.881.30
2104237-10423796.150102.79
3103109-10310995.109101.66
4104739-10473996.613103.19
5102755-10275594.783101.45
6104049-10404995.977102.60
90min198894-9889491.22193.871.7198.75101.521.65
2102366-10236694.424102.13
3100906-10090693.077100.68
4101581-10158193.700101.35
5103747-10374795.698103.42
6103073-10307395.076102.77
极限1100669-10066992.85992.840.57101.40101.540.57
2100544-10054492.743101.50
3100139-10013992.370101.01
4100143-10014392.374101.07
5101685-10168593.796102.58
6100726-10072692.911101.66
左氨氯地平叶酸片项目信息
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%
116.291997432002252010342012001999872004380.33
216.302015682008972012320.24
单位质量响应值RSD%判断
12304.3612345.520.24数据可信
供试品溶液-24062101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%
5min126754-2675422.27221.651.8622.2721.651.86
225328-2532821.08521.08
325735-2573521.42321.42
426044-2604421.68121.68
526255-2625521.85621.86
625943-2594321.59721.60
10min139820-3982033.14932.033.2933.4032.283.27
239153-3915332.59332.83
339673-3967333.02633.26
437239-3723931.00031.24
538166-3816631.77232.01
636841-3684130.66930.91
15min147295-4729539.37137.883.3739.9938.483.35
245222-4522237.64638.24
346870-4687039.01739.62
445333-4533337.73838.32
545368-4536837.76738.36
642948-4294835.75336.33
20min150508-5050842.04640.195.2143.1041.215.14
248535-4853540.40341.42
350275-5027541.85242.89
449999-4999941.62242.63
545643-4564337.99639.01
644715-4471537.22338.20
30min153652-5365244.66344.483.6046.1845.953.55
252884-5288444.02445.49
354326-5432645.22446.73
456422-5642246.96948.44
552693-5269343.86545.30
650641-5064142.15743.55
45min157065-5706547.50446.925.3649.5248.885.23
255486-5548646.19048.14
357076-5707647.51449.52
461529-6152951.22053.21
554085-5408545.02446.95
652918-5291844.05245.91
60min157696-5769648.03048.526.5150.5751.006.31
256881-5688147.35149.82
358529-5852948.72351.26
465492-6549254.52057.08
556652-5665247.16149.59
654430-5443045.31147.66
90min158277-5827748.51349.966.8651.5952.986.63
258645-5864548.82051.81
359681-5968149.68252.76
467938-6793856.55659.72
559583-5958349.60152.55
655942-5594246.57049.42
极限175737-7573763.04867.265.2566.6770.845.07
276080-7608063.33466.87
382167-8216768.40172.03
486916-8691672.35476.15
582210-8221068.43771.94
681687-8168768.00171.37
左氨氯地平叶酸片项目信息
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%
116.741822711814791815021817371816871817350.18
217.071878301878221878260.01
单位质量响应值RSD%判断
10856.3311003.280.96数据可信
供试品溶液-24062101批-左氨氯地平-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%
5min1110150-110150101.813103.602.03101.81103.602.03
2110361-110361102.008102.01
3110200-110200101.859101.86
4113014-113014104.460104.46
5115826-115826107.059107.06
6112934-112934104.386104.39
10min1109370-109370101.092102.621.72102.22103.771.72
2109193-109193100.928102.06
3109426-109426101.144102.28
4113469-113469104.881106.04
5112138-112138103.650104.84
6112513-112513103.997105.16
15min1105698-10569897.698101.422.0799.95103.712.06
2109555-109555101.263103.52
3109228-109228100.961103.22
4112277-112277103.779106.10
5111276-111276102.854105.19
6110333-110333101.982104.30
20min1104741-10474196.813100.072.52100.15103.492.49
2107331-10733199.207102.59
3105681-10568197.682101.06
4110894-110894102.500105.98
5110050-110050101.720105.20
6110908-110908102.513105.96
30min1107374-10737499.24799.901.39103.66104.431.38
2105475-10547597.492101.97
3108541-108541100.326104.79
4109827-109827101.514106.13
5108775-108775100.542105.16
6108468-108468100.258104.85
45min1103214-10321495.40297.811.87100.92103.451.85
2105654-10565497.657103.22
3104081-10408196.203101.78
4108682-108682100.456106.20
5106805-10680598.721104.45
6106510-10651098.448104.15
60min1101609-10160993.91896.902.48100.50103.632.42
2102591-10259194.826101.48
3103575-10357595.735102.38
4107091-10709198.985105.85
5106223-10622398.183105.01
6107923-10792399.754106.55
90min1100108-10010892.53195.712.38100.15103.522.34
2102356-10235694.609102.31
3101889-10188994.177101.89
4106224-10622498.184106.15
5104844-10484496.908104.83
6105884-10588497.870105.77
极限198614-9861491.15094.222.3399.80103.092.28
2100572-10057292.960101.72
3100808-10080893.178101.93
4104979-10497997.033106.09
5102707-10270794.933103.93
6103926-10392696.060105.05
左氨氯地平叶酸片项目信息
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%
116.292002141995351995721997571996111997380.14
216.302004092003112003600.04
单位质量响应值RSD%判断
12261.3912292.020.18数据可信
供试品溶液-24062101批-叶酸-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%
5min145956-4595638.40738.902.1738.4138.892.17
246347-4634738.73438.73
346564-4656438.91538.91
445088-4508837.68137.68
547940-4794040.06540.06
647347-4734739.56939.57
10min171537-7153759.78660.491.9760.2160.921.96
271735-7173559.95160.38
371061-7106159.38859.82
471599-7159959.83760.26
574389-7438962.16962.61
673982-7398261.82962.27
15min186280-8628072.10773.161.4373.2074.261.44
288606-8860674.05175.15
386981-8698172.69373.78
486094-8609471.95173.03
589009-8900974.38875.52
688257-8825773.75974.89
20min192737-9273777.50378.921.7879.4080.841.77
295183-9518379.54781.47
393187-9318777.87979.78
493124-9312477.82779.71
596931-9693181.00882.97
695464-9546479.78281.73
30min199696-9969683.31985.201.9686.0788.001.94
2101112-10111284.50287.31
3102938-10293886.02888.79
499978-9997883.55586.30
5103309-10330986.33889.20
6104681-10468187.48590.32
45min1100783-10078384.22788.422.6787.9192.162.60
2104172-10417287.06090.80
3107805-10780590.09693.82
4106612-10661289.09992.78
5107919-10791990.19194.01
6107475-10747589.82093.62
60min1102316-10231685.50989.853.2590.1294.583.14
2103939-10393986.86591.57
3110459-11045992.31497.04
4109383-10938391.41596.08
5110206-11020692.10396.93
6108779-10877990.91095.71
90min1102730-10273085.85590.873.3591.4296.593.25
2105947-10594788.54394.22
3110190-11019092.08997.84
4109973-10997391.90897.59
5111660-11166093.31899.17
6111890-11189093.51099.32
极限1105400-10540088.08690.892.0194.6197.632.00
2106920-10692089.35696.01
3108956-10895691.05897.83
4109739-10973991.71298.42
5110587-11058792.42199.31
6110951-11095192.72599.58
左氨氯地平叶酸片项目信息
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%
116.741819091821301816921819911819151819270.09
217.071891511893181892340.07
单位质量响应值RSD%判断
10867.8011085.761.41数据可信
供试品溶液-XYD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%
5min1110299-110299101.520102.020.68101.52102.020.68
2110916-110916102.087102.09
3111296-111296102.437102.44
4110175-110175101.405101.41
5110289-110289101.510101.51
6112080-112080103.159103.16
10min1109050-109050100.370101.731.18101.50102.871.17
2109088-109088100.405101.54
3111069-111069102.228103.37
4110376-110376101.590102.72
5111275-111275102.418103.55
6112326-112326103.385104.53
15min1108054-10805499.453100.921.26101.70103.181.25
2108464-10846499.831102.08
3111576-111576102.695104.97
4109393-109393100.686102.94
5109433-109433100.723102.99
6110939-110939102.109104.40
20min1108971-108971100.297100.241.00103.65103.630.99
2107232-10723298.697102.06
3109846-109846101.103104.52
4108319-10831999.697103.07
5108847-108847100.183103.57
6110258-110258101.482104.91
30min1106994-10699498.47898.701.48102.94103.201.45
2105982-10598297.546102.00
3107536-10753698.977103.52
4105892-10589297.463101.95
5106812-10681298.310102.81
6110191-110191101.420105.98
45min1105593-10559397.18898.281.60102.75103.881.56
2104596-10459696.271101.81
3108820-108820100.158105.80
4105799-10579997.378102.94
5108482-10848299.847105.44
6107383-10738398.836104.52
60min1106690-10669098.19898.173.24104.83104.863.08
2104909-10490996.559103.17
3105542-10554297.141103.89
4104406-10440696.096102.74
5104912-10491296.561103.26
6113525-113525104.489111.27
90min1102397-10239794.24795.541.28101.97103.311.27
2102616-10261694.448102.13
3105000-10500096.642104.47
4103655-10365595.404103.12
5103389-10338995.160102.93
6105730-10573097.314105.26
极限1102762-10276294.58393.970.73103.36102.810.74
2101059-10105993.015101.75
3102674-10267494.502103.41
4101460-10146093.384102.16
5101883-10188393.773102.60
6102732-10273294.555103.58
左氨氯地平叶酸片项目信息
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%
116.291996851999052005961997821999801999900.18
216.302011882013402012640.06
单位质量响应值RSD%判断
12276.8612347.480.41数据可信
供试品溶液-XYD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%
5min124561-2456120.46721.544.3020.4721.544.30
226426-2642622.02222.02
327141-2714122.61722.62
425989-2598921.65721.66
524426-2442620.35520.35
626520-2652022.10022.10
10min136665-3666530.55432.886.4130.7833.126.39
239182-3918232.65132.90
341441-4144134.53434.79
439782-3978233.15133.39
536709-3670930.59130.82
642995-4299535.82936.07
15min144054-4405436.71139.577.5637.2840.177.52
246640-4664038.86639.47
349795-4979541.49642.13
447684-4768439.73640.35
543611-4361136.34236.91
653100-5310044.25044.89
20min148561-4856140.46743.458.7441.4444.498.68
251577-5157742.98144.02
354119-5411945.09946.19
451149-5114942.62443.67
547352-4735239.46040.43
660060-6006050.05051.19
30min153857-5385744.88147.969.8646.3149.499.76
256085-5608546.73748.25
358843-5884349.03650.63
455999-5599946.66648.19
552325-5232543.60445.01
668214-6821456.84558.54
45min157265-5726547.72151.5810.0749.6453.649.97
259431-5943149.52651.56
364154-6415453.46155.60
459671-5967149.72651.77
557320-5732047.76649.66
673530-7353061.27563.60
60min159263-5926349.38652.9211.8851.8455.5611.69
260611-6061150.50953.10
364510-6451053.75856.49
461294-6129451.07853.67
557275-5727547.72950.15
678102-7810265.08568.09
90min159776-5977649.81353.5710.9152.8256.7910.77
262498-6249852.08155.23
364507-6450753.75657.09
462620-6262052.18355.35
558411-5841148.67651.63
677875-7787564.89568.62
极限181964-8196468.30369.573.8971.8673.394.15
282466-8246668.72172.45
384267-8426770.22274.15
482186-8218668.48872.23
580437-8043767.03070.53
689622-8962274.68579.13
左氨氯地平叶酸片项目信息
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%
116.741829301828171829341834751832161830740.15
217.071882401874041878220.32
单位质量响应值RSD%判断
10936.3211003.050.44数据可信
供试品溶液-DYD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%
5min1111231-111231102.435101.791.34102.43101.791.35
2109936-109936101.242101.24
3112101-112101103.236103.24
4110069-110069101.364101.36
5111745-111745102.908102.91
6108093-10809399.54599.54
10min1109126-109126100.496100.961.54101.63102.091.54
2109020-109020100.398101.52
3112419-112419103.529104.68
4108948-108948100.332101.46
5110681-110681101.928103.07
6107597-10759799.088100.19
15min1108552-10855299.967100.241.60102.22102.501.59
2109098-109098100.470102.71
3110352-110352101.625103.92
4107149-10714998.675100.92
5111182-111182102.389104.67
6106766-10676698.323100.53
20min1106843-10684398.39499.331.02101.76102.701.03
2107896-10789699.363102.72
3109214-109214100.577104.00
4106996-10699698.534101.87
5109169-109169100.536103.95
6107049-10704998.583101.88
30min1105050-10505096.74297.791.43101.20102.261.41
2106513-10651398.090102.55
3107009-10700998.546103.09
4107067-10706798.600103.03
5107754-10775499.232103.76
6103714-10371495.51299.91
45min1104300-10430096.05297.000.95101.59102.550.96
2105246-10524696.923102.47
3106726-10672698.286103.92
4105448-10544897.109102.64
5106083-10608397.694103.33
6104151-10415195.914101.37
60min1102304-10230494.21495.141.42100.81101.781.39
2103373-10337395.198101.83
3105947-10594797.568104.30
4101865-10186593.809100.42
5103771-10377195.564102.28
6102613-10261394.498101.02
90min1102475-10247594.37194.981.74102.02102.671.66
2102380-10238094.283101.97
3103334-10333495.162102.98
4101400-10140093.381101.03
5106550-10655098.124105.90
6102677-10267794.557102.13
极限1100647-10064792.68893.331.46101.38102.081.42
299490-9949091.622100.36
3103029-10302994.881103.75
4100680-10068092.718101.40
5103232-10323295.068103.94
6100986-10098693.000101.62
左氨氯地平叶酸片项目信息
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%
116.292004012004242004262002722001892003420.06
216.302004062003952004000.01
单位质量响应值RSD%判断
12298.4712294.480.03数据可信
供试品溶液-DYD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%
5min126264-2626421.91422.685.2121.9122.685.21
229832-2983224.89124.89
327044-2704422.56522.57
426149-2614921.81821.82
527590-2759023.02123.02
626237-2623721.89221.89
10min139078-3907832.60633.246.2632.8533.496.26
244500-4450037.13037.41
340291-4029133.61833.87
437846-3784631.57831.82
539575-3957533.02133.28
637716-3771631.47031.71
15min145512-4551237.97538.947.5638.5839.567.54
253160-5316044.35645.05
347352-4735239.51040.13
443817-4381736.56037.15
546662-4666238.93439.56
643484-4348436.28236.88
20min148207-4820740.22341.958.2841.2543.008.24
258047-5804748.43449.62
351335-5133542.83343.90
446968-4696839.18940.19
549899-4989941.63542.69
647180-4718039.36640.36
30min151091-5109142.63045.019.3144.1046.539.23
263089-6308952.64154.36
355510-5551046.31747.86
450420-5042042.07043.50
553981-5398145.04146.56
649563-4956341.35542.79
45min154357-5435745.35547.729.7447.3049.749.65
267348-6734856.19458.50
359534-5953449.67451.73
452639-5263943.92145.82
556083-5608346.79548.81
653157-5315744.35346.25
60min151353-5135342.84847.6311.5445.3050.1811.35
268432-6843257.09960.03
361031-6103150.92353.53
452756-5275644.01946.41
556322-5632246.99449.53
652591-5259143.88146.27
90min156398-5639847.05849.489.9249.9952.569.83
269894-6989458.31961.88
361706-6170651.48754.66
453769-5376944.86447.74
558661-5866148.94652.01
655390-5539046.21749.09
极限181839-8183968.28568.843.5871.7472.473.78
285856-8585671.63775.85
385887-8588771.66375.41
480174-8017466.89670.27
582621-8262168.93872.54
678651-7865165.62569.01
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