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%
117.821959951957011954831957271955881956990.10
217.841948111953081950600.19
单位质量响应值RSD%判断
10981.9910933.860.32数据可信
供试品溶液-24041202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%
5min1113964-113964105.064103.801.61105.06103.801.61
2114170-114170105.253105.25
3111247-111247102.559102.56
4110144-110144101.542101.54
5114402-114402105.467105.47
6111612-111612102.895102.90
10min1115517-115517106.495104.091.42107.66105.241.42
2114091-114091105.181106.35
3111661-111661102.940104.08
4111312-111312102.619103.75
5112581-112581103.789104.96
6112298-112298103.528104.67
15min1113781-113781104.895103.331.35107.25105.641.35
2113654-113654104.778107.12
3110235-110235101.626103.91
4110617-110617101.978104.25
5112613-112613103.818106.14
6111614-111614102.897105.19
20min1111779-111779103.049101.791.32106.57105.251.32
2112130-112130103.373106.88
3110221-110221101.613105.03
4108138-10813899.693103.09
5110472-110472101.844105.32
6109747-109747101.176104.61
30min1109245-109245100.713100.420.94105.37105.000.94
2109662-109662101.098105.75
3109483-109483100.933105.47
4107651-10765199.244103.75
5109881-109881101.299105.91
6107629-10762999.223103.78
45min1106866-10686698.52099.051.08104.30104.761.07
2108557-108557100.079105.85
3107444-10744499.053104.72
4106085-10608597.800103.41
5109069-109069100.551106.29
6106625-10662598.298103.96
60min1108243-10824399.78997.911.42106.66104.721.39
2106681-10668198.349105.24
3105296-10529697.073103.84
4104140-10414096.007102.71
5107357-10735798.973105.83
6105524-10552497.283104.04
90min1107147-10714798.77996.751.98106.76104.641.91
2107495-10749599.100107.08
3104413-10441396.258104.10
4102798-10279894.770102.53
5105161-10516196.948104.90
6102672-10267294.653102.49
极限1105449-10544997.21495.651.67106.29104.621.62
2106006-10600697.727106.81
3101850-10185093.896102.81
4102164-10216494.185103.00
5104106-10410695.975105.01
6102951-10295194.911103.80
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%
116.19 1979041979791977781972181975811976920.16
216.17 1959991961881960940.07
单位质量响应值RSD%判断
12210.7512127.030.49数据可信
供试品溶液-24041202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%
5min122310-2231018.81118.742.8318.8118.742.82
223014-2301419.40419.40
321605-2160518.21618.22
421962-2196218.51718.52
522894-2289419.30319.30
621563-2156318.18118.18
10min139254-3925433.09732.762.5433.3132.962.55
239756-3975633.52033.74
338262-3826232.26032.46
438309-3830932.30032.51
540026-4002633.74833.96
637487-3748731.60731.81
15min149913-4991342.08441.952.8742.6642.522.86
250190-5019042.31742.91
348101-4810140.55641.12
449160-4916041.44942.01
552231-5223144.03844.63
648920-4892041.24741.80
20min155998-5599847.21447.593.3048.2648.633.28
256474-5647447.61648.67
355172-5517246.51847.53
455435-5543546.74047.76
560119-6011950.68951.77
655452-5545246.75447.77
30min164119-6411954.06254.514.4855.6356.074.43
264108-6410854.05255.64
362721-6272152.88354.41
463546-6354653.57855.12
570441-7044159.39261.03
662955-6295553.08054.61
45min168694-6869457.91960.336.0060.0962.505.89
272855-7285561.42763.62
368748-6874857.96460.08
469911-6991158.94561.08
579720-7972067.21569.52
669378-6937858.49660.62
60min176256-7625664.29563.785.9167.1166.625.82
277745-7774565.55068.42
370420-7042059.37462.13
473294-7329461.79764.59
583092-8309270.05973.11
673038-7303861.58264.35
90min181546-8154668.75569.334.5772.2872.884.48
285088-8508871.74175.34
383327-8332770.25773.68
481727-8172768.90872.39
586166-8616672.65076.48
675528-7552863.68167.14
极限184836-8483671.52970.855.1875.8275.175.08
286580-8658072.99977.40
377596-7759665.42569.62
485241-8524171.87076.12
589593-8959375.54080.17
680330-8033067.73071.89
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%
117.821951791951741951531949691954041951760.08
217.841946191948861947520.10
单位质量响应值RSD%判断
10952.6410916.590.24数据可信
供试品溶液-24050801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%
5min1116767-116767107.877106.301.49107.88106.301.49
2116781-116781107.890107.89
3116168-116168107.323107.32
4113596-113596104.947104.95
5114096-114096105.409105.41
6112947-112947104.348104.35
10min1114546-114546105.825105.811.25107.02106.991.24
2116750-116750107.861109.06
3115647-115647106.842108.03
4113102-113102104.491105.66
5113670-113670105.016106.19
6113465-113465104.826105.99
15min1114839-114839106.096105.111.29108.47107.471.29
2115283-115283106.506108.90
3115151-115151106.384108.76
4112522-112522103.955106.28
5112740-112740104.156106.49
6112126-112126103.589105.91
20min1111859-111859103.343103.451.03106.90106.971.03
2113590-113590104.942108.52
3113168-113168104.552108.11
4111211-111211102.744106.23
5111201-111201102.735106.23
6110808-110808102.372105.85
30min1111645-111645103.145102.250.86107.85106.920.86
2111820-111820103.307108.05
3110645-110645102.221106.94
4110360-110360101.958106.58
5110310-110310101.911106.55
6109272-109272100.953105.57
45min1109067-109067100.763101.031.17106.61106.841.16
2111312-111312102.837108.73
3110400-110400101.995107.85
4107905-10790599.690105.45
5108981-108981100.684106.45
6108439-108439100.183105.92
60min1108875-108875100.58699.941.36107.55106.871.35
2110221-110221101.829108.87
3109253-109253100.935107.93
4106937-10693798.795105.66
5106850-10685098.715105.60
6106892-10689298.754105.60
90min1106426-10642698.32398.550.85106.41106.600.86
2107751-10775199.547107.72
3107642-10764299.447107.56
4105358-10535897.337105.30
5106297-10629798.204106.19
6106574-10657498.460106.40
极限1105296-10529697.27997.351.37106.46106.491.34
2107320-10732099.149108.42
3106830-10683098.696107.92
4104703-10470396.731105.77
5103538-10353895.655104.73
6104563-10456396.602105.64
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%
116.19 1952131950221948971950921949011950250.07
216.17 1940651940081940360.03
单位质量响应值RSD%判断
12046.0211999.750.28数据可信
供试品溶液-24050801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%
5min130162-3016225.74025.941.5825.7425.941.58
230529-3052926.05326.05
330475-3047526.00726.01
430604-3060426.11726.12
530997-3099726.45226.45
629581-2958125.24425.24
10min149937-4993742.61542.790.7242.9043.080.72
250645-5064543.21943.51
350155-5015542.80143.09
449805-4980542.50242.79
550505-5050543.10043.39
649826-4982642.52042.80
15min160711-6071151.80951.780.3852.5752.550.39
260754-6075451.84652.62
360879-6087951.95352.72
460603-6060351.71752.48
560873-6087351.94852.72
660263-6026351.42752.18
20min165424-6542455.83156.570.8357.1757.910.82
266349-6634956.62157.97
366736-6673656.95158.29
466455-6645556.71158.05
566900-6690057.09158.44
665900-6590056.23757.56
30min172932-7293262.23862.150.7964.1964.120.78
272435-7243561.81463.79
372475-7247561.84863.82
472869-7286962.18564.15
573902-7390263.06665.05
672383-7238361.77063.72
45min180190-8019068.43266.671.7371.0869.331.67
277233-7723365.90968.57
377548-7754866.17868.84
476839-7683965.57368.23
579412-7941267.76870.45
677524-7752466.15768.79
60min186031-8603173.41769.033.2876.8272.423.14
278904-7890467.33570.73
379890-7989068.17671.57
479607-7960767.93571.32
581342-8134269.41572.85
679542-7954267.87971.25
90min187974-8797475.07571.432.9679.3075.592.84
280919-8091969.05473.20
382567-8256770.46174.62
482670-8267070.54974.69
585045-8504572.57576.78
683021-8302170.84874.97
极限192295-9229578.76275.842.0183.8280.801.96
287670-8767074.81579.72
388126-8812675.20580.14
487862-8786274.97979.90
589328-8932876.23081.25
687933-8793375.04079.95
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%
117.821950281952651948961948411951011950260.09
217.841949411945921947660.13
单位质量响应值RSD%判断
10944.2210917.380.18数据可信
供试品溶液-24081202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%
5min1116793-116793107.938107.081.17107.94107.081.17
2116987-116987108.118108.12
3114781-114781106.079106.08
4116081-116081107.280107.28
5116859-116859107.999108.00
6113669-113669105.051105.05
10min1116524-116524107.690106.910.91108.89108.100.91
2116523-116523107.689108.89
3115381-115381106.634107.81
4115583-115583106.820108.01
5116260-116260107.446108.65
6113785-113785105.159106.33
15min1116292-116292107.475106.131.09109.87108.501.09
2115475-115475106.720109.12
3114768-114768106.067108.43
4114333-114333105.665108.04
5115439-115439106.687109.08
6112686-112686104.143106.48
20min1114262-114262105.599105.160.82109.19108.720.82
2115424-115424106.673110.26
3113449-113449104.848108.39
4112841-112841104.286107.84
5113608-113608104.995108.57
6113162-113162104.583108.08
30min1113020-113020104.451103.410.85109.21108.130.84
2111601-111601103.140107.91
3112791-112791104.240108.95
4111604-111604103.143107.85
5111913-111913103.428108.17
6110405-110405102.035106.69
45min1111821-111821103.343102.861.26109.27108.731.23
2113140-113140104.562110.48
3110763-110763102.366108.23
4110758-110758102.361108.22
5112171-112171103.667109.56
6109129-109129100.855106.64
60min1109425-109425101.129101.130.91108.20108.140.90
2109932-109932101.598108.67
3109886-109886101.555108.56
4109386-109386101.093108.09
5110367-110367102.000109.05
6107533-10753399.380106.29
90min1108281-108281100.072100.060.79108.27108.200.78
2108756-108756100.511108.72
3109224-109224100.943109.07
4108204-108204100.001108.12
5108405-108405100.186108.37
6106720-10672098.629106.64
极限1108454-108454100.23299.111.31109.54108.361.26
2108716-108716100.474109.80
3106212-10621298.160107.41
4107220-10722099.091108.32
5107777-10777799.606108.90
6105067-10506797.101106.21
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%
116.19 1935921937811936381936841936141936620.04
216.17 1927561927371927460.01
单位质量响应值RSD%判断
11961.8311919.980.25数据可信
供试品溶液-24081202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%
5min133818-3381829.05828.883.0129.0628.883.01
233742-3374228.99228.99
332665-3266528.06728.07
433290-3329028.60428.60
535425-3542530.43830.44
632735-3273528.12728.13
10min155989-5598948.10847.693.0448.4348.013.04
256077-5607748.18348.51
353609-5360946.06346.37
455383-5538347.58747.90
558175-5817549.98650.32
653817-5381746.24146.55
15min169911-6991160.07059.003.3660.9359.853.36
269508-6950859.72460.58
366171-6617156.85657.68
468808-6880859.12259.97
571794-7179461.68862.58
665786-6578656.52657.35
20min177345-7734566.45765.293.1167.9866.803.11
276995-7699566.15767.68
373278-7327862.96364.42
476049-7604965.34466.85
579100-7910067.96569.54
673164-7316462.86564.32
30min186707-8670774.50272.364.0676.7674.594.03
285969-8596973.86876.12
381114-8111469.69671.85
483453-8345371.70673.94
588432-8843275.98478.32
679622-7962268.41470.57
45min193819-9381980.61278.885.0183.7081.924.93
296312-9631282.75585.83
390762-9076277.98680.92
488899-8889976.38579.41
596362-9636282.79885.98
684671-8467172.75275.67
60min195730-9573082.25480.875.3086.2484.795.20
298284-9828484.44988.45
394866-9486681.51285.31
490878-9087878.08581.96
599119-9911985.16689.26
685871-8587173.78377.50
90min198887-9888784.96783.225.4089.8788.035.30
2101710-10171087.39392.33
397482-9748283.76088.46
492872-9287279.79984.54
5101668-10166887.35792.40
688522-8852276.06180.60
极限1101079-10107986.85185.203.6792.7090.943.69
2102965-10296588.47194.38
397807-9780784.03989.67
496888-9688883.24988.88
5102508-10250888.07894.09
693709-9370980.51885.90
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