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%
116.741791741780131769981752301745161767861.09
217.071840741837261839000.14
单位质量响应值RSD%判断
10560.6910773.291.41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%
5min1110160-110160104.336104.540.90104.34104.540.90
2109570-109570103.778103.78
3110200-110200104.374104.37
4112299-112299106.362106.36
5109667-109667103.869103.87
6110339-110339104.506104.51
10min1110600-110600104.753103.381.93105.91104.541.92
2107562-107562101.876103.03
3109361-109361103.580104.74
4111843-111843105.930107.11
5105989-105989100.386101.54
6109571-109571103.779104.94
15min1109651-109651103.854102.741.81106.18105.051.80
2106318-106318100.697102.98
3108386-108386102.656104.97
4111729-111729105.822108.18
5107102-107102101.440103.71
6107641-107641101.951104.26
20min1106669-106669101.030100.631.36104.51104.081.34
2104434-10443498.913102.32
3107897-107897102.193105.64
4107720-107720102.025105.56
5105872-105872100.275103.67
6104901-10490199.355102.80
30min1104915-10491599.36999.611.43103.97104.191.42
2103960-10396098.464102.97
3105380-10538099.809104.40
4107880-107880102.177106.85
5103658-10365898.178102.69
6105250-10525099.686104.24
45min1105559-10555999.97999.481.37105.68105.161.36
2102656-10265697.229102.83
3104979-10497999.429105.12
4107123-107123101.460107.26
5104827-10482799.285104.89
6105069-10506999.515105.17
60min1105758-105758100.16798.921.42106.98105.701.40
2102512-10251297.093103.77
3106047-106047100.441107.24
4105323-10532399.755106.69
5103078-10307897.629104.33
6103954-10395498.458105.22
90min1104622-10462299.09197.751.23107.02105.641.23
2101945-10194596.556104.31
3103039-10303997.592105.51
4104876-10487699.332107.37
5102010-10201096.617104.41
6102774-10277497.341105.20
极限1100592-10059295.27496.361.75104.30105.331.68
299151-9915193.909102.74
3101965-10196596.575105.58
4104438-10443898.917108.06
5102245-10224596.840105.70
6102063-10206396.667105.61
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%
116.291905231892761899571879981875531890610.67
216.301910431904311907370.23
单位质量响应值RSD%判断
11605.9511701.660.59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%
5min129889-2988926.31525.332.6826.3125.332.68
228826-2882625.37925.38
329008-2900825.53925.54
429028-2902825.55725.56
527639-2763924.33424.33
628211-2821124.83724.84
10min152853-5285346.53344.514.2046.8244.794.19
251238-5123845.11145.39
351259-5125945.12945.41
451504-5150445.34545.63
546728-4672841.14041.41
649728-4972843.78144.06
15min167086-6708659.06357.783.1459.8758.563.14
267096-6709659.07259.86
366384-6638458.44559.23
465926-6592658.04258.83
561603-6160354.23654.96
665694-6569457.83858.60
20min175373-7537366.35965.602.9367.8367.012.93
275451-7545166.42867.87
375987-7598766.90068.33
476408-7640867.27168.70
570736-7073662.27763.61
673075-7307564.33665.74
30min184243-8424374.16976.263.8376.3778.413.77
291416-9141680.48482.66
387154-8715476.73278.91
488039-8803977.51179.69
581762-8176271.98474.01
687099-8709976.68378.80
45min193946-9394682.71184.112.8285.7487.102.80
298618-9861886.82589.90
396936-9693685.34488.37
494208-9420882.94285.98
591636-9163680.67883.50
697840-9784086.14089.11
60min197618-9761885.94489.733.6389.8993.663.57
2104795-10479592.26396.30
3104410-10441091.92495.90
4104670-10467092.15396.12
596815-9681585.23788.96
6103220-10322090.87694.81
90min197134-9713485.51892.924.4090.4297.844.20
2109216-10921696.155101.22
3103569-10356991.18496.18
4109420-10942096.335101.32
5106511-10651193.77498.44
6107398-10739894.55599.49
极限1101515-10151589.37594.222.7395.23100.182.61
2107551-10755194.689100.82
3107356-10735694.518100.53
4110118-11011896.949103.01
5108483-10848395.510101.22
6107074-10707494.269100.26
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%
116.741805691799441793281792331792961796740.33
217.071841011837491839250.14
单位质量响应值RSD%判断
10733.2110774.750.28数据可信
供试品溶液-24052001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%
5min1107844-107844101.307102.220.99101.31102.220.99
2109896-109896103.234103.23
3110142-110142103.466103.47
4107852-107852101.314101.31
5107924-107924101.382101.38
6109235-109235102.614102.61
10min1105679-10567999.273100.940.87100.40102.070.87
2107542-107542101.023102.17
3108213-108213101.653102.80
4107274-107274100.771101.90
5108092-108092101.540102.67
6107894-107894101.354102.49
15min1104942-10494298.581100.191.00100.81102.450.99
2107091-107091100.600102.87
3108107-108107101.554103.83
4106147-10614799.713101.96
5106664-106664100.198102.45
6106998-106998100.512102.78
20min1104111-10411197.80098.680.92101.12102.050.90
2106277-10627799.835103.22
3104142-10414297.829101.24
4105691-10569199.284102.64
5104327-10432798.003101.37
6105735-10573599.326102.71
30min1102761-10276196.53297.230.68100.94101.700.68
2104301-10430197.979102.48
3104145-10414597.832102.33
4103276-10327697.016101.47
5102685-10268596.461100.92
6103874-10387497.578102.06
45min1100210-10021094.13695.611.1299.62101.161.09
2102440-10244096.230101.82
3102489-10248996.276101.86
4101702-10170295.537101.07
5100690-10069094.587100.12
6103122-10312296.871102.44
60min1101004-10100494.88195.351.02101.41101.960.96
2103082-10308296.834103.49
3101557-10155795.401102.05
4101977-10197795.796102.39
5101408-10140895.261101.84
699986-9998693.925100.57
90min199550-9955093.51694.361.13101.10102.031.08
2101063-10106394.937102.67
3102343-10234396.139103.85
4100631-10063194.531102.19
599488-9948893.457101.10
699607-9960793.569101.26
极限198355-9835592.39392.790.81101.02101.510.77
299319-9931993.299102.08
399847-9984793.795102.57
497694-9769491.772100.48
599163-9916393.152101.83
698303-9830392.344101.07
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%
116.291928901918971915861918621909451918360.37
216.301902161898941900550.12
单位质量响应值RSD%判断
11776.3011659.820.71数据可信
供试品溶液-24052001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%
5min127089-2708923.71922.916.7023.7222.916.70
225724-2572422.52422.52
326565-2656523.26023.26
426084-2608422.83922.84
528390-2839024.85824.86
623137-2313720.25920.26
10min146096-4609640.36138.957.4740.6239.207.46
243838-4383838.38438.63
345773-4577340.07940.34
442046-4204636.81537.07
549292-4929243.16043.44
639865-3986534.90635.13
15min159738-5973852.30650.827.0353.0251.507.03
256958-5695849.87250.55
360861-6086153.28953.99
455135-5513548.27648.94
563360-6336055.47856.23
652180-5218045.68846.30
20min169912-6991261.21457.776.5762.5159.026.58
265105-6510557.00558.24
367787-6778759.35460.65
461467-6146753.82055.02
570997-7099762.16463.54
660604-6060453.06454.19
30min181188-8118871.08866.935.6273.0668.835.63
275913-7591366.46968.33
378883-7888369.06971.02
471152-7115262.30064.10
579907-7990769.96672.03
671620-7162062.71064.42
45min189848-8984878.67075.325.0681.4377.965.02
291056-9105679.72882.33
386570-8657075.80078.52
479591-7959169.68972.18
586589-8658975.81778.66
682472-8247272.21274.62
60min196697-9669784.66781.385.9088.3084.855.77
2100174-10017487.71291.20
391043-9104379.71783.28
483982-8398273.53476.80
592894-9289481.33785.02
692863-9286381.31084.52
90min1104145-10414591.18986.746.7695.7791.126.56
2106972-10697293.66498.13
394570-9457082.80587.26
488659-8865977.62981.71
598357-9835786.12190.71
6101671-10167189.02293.14
极限1103580-10358090.69489.334.0396.2994.683.99
2106841-10684193.54999.05
3100128-10012887.67193.04
494976-9497683.16088.10
5102243-10224389.52395.07
6104384-10438491.39896.50
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%
116.741805191805961808331805681805141806060.08
217.071836661835191835920.06
单位质量响应值RSD%判断
10788.8910755.240.23数据可信
供试品溶液-24062101批-左氨氯地平-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108649-108649101.892102.851.05101.89102.841.06
2110000-110000103.159103.16
3109508-109508102.697102.70
4108277-108277101.543101.54
5111503-111503104.568104.57
6110058-110058103.213103.21
10min1108142-108142101.416102.301.72102.55103.441.71
2107144-107144100.480101.63
3108366-108366101.626102.77
4107966-107966101.251102.38
5111696-111696104.749105.91
6111163-111163104.249105.40
15min1107171-107171100.506101.621.70102.76103.901.69
2106377-10637799.761102.02
3109343-109343102.542104.81
4106683-106683100.048102.30
5110699-110699103.814106.14
6109891-109891103.056105.36
20min1104736-10473698.222100.031.33101.60103.431.33
2106282-10628299.672103.04
3106886-106886100.238103.65
4105651-10565199.080102.44
5108570-108570101.818105.30
6107831-107831101.124104.57
30min1105501-10550198.93982.7049.00103.4187.2246.48
2-0.0004.48
3105318-10531898.768103.29
4105461-10546198.902103.37
5106602-10660299.972104.58
6106222-10622299.616104.19
45min1101080-10108094.79397.792.06100.36103.232.16
2103116-10311696.703101.18
3103986-10398697.519103.14
4104186-10418697.706103.27
5106775-106775100.134105.86
6106508-10650899.884105.56
60min1102645-10264596.26196.251.10102.88102.771.45
2100824-10082494.553100.11
3103708-10370897.258103.96
4101779-10177995.449102.10
5103377-10337796.947103.78
6103443-10344397.009103.80
90min1101994-10199495.65196.491.31103.34104.081.62
2100874-10087494.600101.20
3102650-10265096.266104.05
4103439-10343997.006104.72
5103734-10373497.282105.19
6104651-10465198.142106.01
极限1100081-10008193.85695.481.55102.61104.141.79
299966-9996693.749101.40
3101970-10197095.628104.48
4101943-10194395.603104.39
5102934-10293496.532105.52
6103972-10397297.505106.46
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%
116.291920661922431923681920811921631921840.07
216.301897541899301898420.07
单位质量响应值RSD%判断
11797.6711646.750.92数据可信
供试品溶液-24062101批-叶酸-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126886-2688623.53322.901.5123.5322.901.51
225798-2579822.58122.58
326090-2609022.83722.84
426270-2627022.99422.99
525838-2583822.61622.62
626117-2611722.86022.86
10min139025-3902534.15933.014.1334.4233.264.10
235555-3555531.12131.37
338210-3821033.44533.70
438872-3887234.02534.28
538676-3867633.85334.10
635922-3592231.44231.70
15min145371-4537139.71337.797.3140.3538.417.19
242308-4230837.03237.63
344747-4474739.16739.79
437480-3748032.80633.44
546204-4620440.44241.07
642912-4291237.56138.16
20min145770-4577040.06240.736.0541.1441.775.92
242008-4200836.77037.78
345762-4576240.05541.12
448329-4832942.30243.30
550333-5033344.05645.13
646988-4698841.12942.15
30min150329-5032944.05337.9849.1545.5839.4847.39
2-0.0001.42
350979-5097944.62246.13
452066-5206645.57347.04
555230-5523048.34349.91
651763-5176345.30846.79
45min152293-5229345.77247.046.0347.7948.965.96
253058-5305846.44247.86
352352-5235245.82447.83
451750-5175045.29747.27
560294-6029452.77554.88
652727-5272746.15248.13
60min154359-5435947.58048.036.3550.1150.476.47
250228-5022843.96445.90
353865-5386547.14849.66
453819-5381947.10849.59
560771-6077153.19355.88
656220-5622049.20951.70
90min156261-5626149.24550.398.2752.3053.368.11
255033-5503348.17050.59
355393-5539348.48551.52
452315-5231545.79148.79
565345-6534557.19660.48
661059-6105953.44556.49
极限178809-7880968.98166.2911.1372.5869.8210.76
272512-7251263.47066.43
360450-6045052.91256.48
478345-7834568.57572.09
584651-8465174.09578.01
679643-7964369.71173.35
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