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(%)97.3对照品水分(%)0对照品稀释倍数2500
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%
117.833925053929873928203927603928563927860.05
217.893919393919943919660.01
单位质量响应值RSD%判断
22029.5021909.780.39数据可信
供试品溶液-24073101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%
5min1118144-118144108.651106.541.66108.65106.541.66
2114870-114870105.640105.64
3115906-115906106.593106.59
4113292-113292104.189104.19
5114896-114896105.664105.66
6117998-117998108.516108.52
10min1117439-117439108.002105.761.26109.21106.941.26
2113964-113964104.807105.98
3115925-115925106.610107.79
4113505-113505104.384105.54
5114624-114624105.414106.59
6114517-114517105.315106.52
15min1114020-114020104.858103.311.43107.27105.671.42
2111538-111538102.576104.91
3112294-112294103.271105.64
4110714-110714101.818104.14
5110925-110925102.012104.36
6114506-114506105.305107.68
20min1111968-111968102.971102.020.89106.54105.520.90
2110592-110592101.706105.18
3110754-110754101.855105.37
4109464-109464100.668104.12
5110705-110705101.809105.29
6112098-112098103.091106.64
30min1110259-110259101.399100.281.55106.12104.921.53
2109020-109020100.260104.87
3109800-109800100.977105.63
4106619-10661998.052102.62
5107514-10751498.875103.48
6111031-111031102.109106.80
45min1108643-10864399.91399.391.12105.76105.141.12
2108252-10825299.554105.28
3108927-108927100.174105.94
4106074-10607497.551103.21
5107244-10724498.627104.34
6109295-109295100.513106.34
60min1105803-10580397.30197.641.37104.25104.501.34
2106051-10605197.529104.36
3106539-10653997.978104.86
4104182-10418295.811102.55
5105814-10581497.311104.12
6108649-10864999.919106.86
90min1107569-10756998.92597.111.33106.96105.051.31
2104900-10490096.471104.38
3105756-10575697.258105.23
4104184-10418495.812103.62
5104281-10428195.902103.79
6106876-10687698.288106.34
极限1106356-10635697.81095.842.16106.94104.862.05
2100856-10085692.752101.74
3104928-10492896.497105.55
4103013-10301394.736103.61
5103340-10334095.036103.99
6106776-10677698.196107.34
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10000
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%
116.193913233913903914173915253913703914050.02
216.17 3905763909293907520.07
单位质量响应值RSD%判断
24175.7324165.240.04数据可信
供试品溶液-24073101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%
5min146266-4626639.27837.043.8539.2837.043.85
244175-4417537.50337.50
344292-4429237.60337.60
443277-4327736.74136.74
542130-4213035.76735.77
641628-4162835.34135.34
10min168964-6896458.54857.112.5458.9857.522.52
266766-6676656.68257.10
366049-6604956.07456.49
466035-6603556.06256.47
569857-6985759.30659.70
665965-6596556.00256.39
15min173466-7346662.37063.083.8163.4664.123.76
275875-7587564.41665.46
372764-7276461.77462.82
472200-7220061.29662.33
579337-7933767.35568.41
672157-7215761.25962.27
20min179020-7902067.08666.784.4768.8768.534.40
278294-7829466.46968.23
377451-7745165.75467.48
474483-7448363.23464.95
585092-8509272.24074.05
677633-7763365.90867.60
30min182118-8211869.71669.893.6372.2472.373.60
283638-8363871.00673.51
380658-8065868.47670.93
478331-7833166.50168.92
587219-8721974.04676.65
681942-8194269.56671.99
45min183638-8363871.00670.614.1174.3173.884.06
284820-8482072.01075.30
381597-8159769.27372.49
479609-7960967.58670.74
588906-8890675.47878.91
680451-8045168.30071.50
60min183060-8306070.51570.533.3374.6074.583.32
283449-8344970.84674.94
380933-8093368.71072.70
480520-8052068.35972.26
588207-8820774.88579.15
682296-8229669.86773.83
90min185233-8523372.36071.783.5377.2376.613.51
285339-8533972.45077.33
382991-8299170.45775.21
480792-8079268.59073.25
589578-8957876.04981.15
683351-8335170.76275.50
极限196672-9667282.07280.211.8487.7585.841.86
292721-9272178.71784.40
393610-9361079.47285.01
492776-9277678.76484.19
596298-9629881.75487.70
694792-9479280.47686.00
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(%)97.3对照品水分(%)0对照品稀释倍数2500
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%
117.833920753923943924123923203921883922780.04
217.893923173924523923840.03
单位质量响应值RSD%判断
22001.0121933.150.22数据可信
供试品溶液-24073101批-叶酸-pH1.2(内含%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113193-113193104.109103.801.58104.11103.801.58
2111736-111736102.769102.77
3115625-115625106.346106.35
4113550-113550104.438104.44
5112663-112663103.622103.62
6110347-110347101.492101.49
10min1110739-110739101.852103.391.96103.01104.541.96
2112376-112376103.358104.50
3115531-115531106.260107.44
4113227-113227104.140105.30
5113357-113357104.260105.41
6109232-109232100.466101.59
15min1109356-109356100.580102.161.37102.87104.461.37
2109979-109979101.153103.44
3113591-113591104.475106.84
4111263-111263102.334104.65
5111809-111809102.836105.15
6110422-110422101.561103.80
20min1107182-10718298.581101.131.72101.99104.571.71
2110312-110312101.459104.87
3112729-112729103.682107.21
4110393-110393101.534104.99
5110491-110491101.624105.08
6108600-10860099.885103.26
30min1107043-10704398.45399.661.45102.95104.221.45
2107901-10790199.242103.78
3111047-111047102.135106.81
4109065-109065100.312104.90
5108325-10832599.632104.21
6106747-10674798.180102.66
45min1105265-10526596.81798.831.96102.41104.501.93
2107054-10705498.463104.11
3110882-110882101.984107.79
4107955-10795599.292104.99
5108211-10821199.527105.22
6105328-10532896.875102.45
60min1103860-10386095.52597.811.83102.20104.571.81
2106832-10683298.259105.00
3108939-108939100.197107.14
4107647-10764799.008105.81
5106415-10641597.875104.67
6104349-10434995.975102.62
90min1102432-10243294.21296.361.85101.94104.211.83
2103933-10393395.592103.42
3107570-10757098.937106.99
4105887-10588797.389105.29
5105659-10565997.180105.06
6103116-10311694.841102.56
极限1102417-10241794.19894.811.12102.98103.741.14
2103056-10305694.786103.68
3104654-10465496.255105.41
4104316-10431695.945104.93
5101954-10195493.772102.73
6102121-10212193.926102.70
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10000
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%
116.193908463911163906773908043906593908200.05
216.17 3907773903113905440.09
单位质量响应值RSD%判断
24139.5924152.380.04数据可信
供试品溶液-24073101批-左氨氯地平-pH1.2(内含%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139366-3936633.45432.573.5133.4532.573.50
236463-3646330.98730.99
340209-4020934.17134.17
438237-3823732.49532.49
538275-3827532.52732.53
637382-3738231.76831.77
10min159440-5944050.51450.322.2350.8950.682.23
257641-5764148.98549.33
361002-6100251.84152.22
457721-5772149.05349.41
560022-6002251.00951.37
659439-5943950.51350.87
15min167516-6751657.37758.052.9358.3158.972.90
266638-6663856.63157.52
369653-6965359.19360.15
465624-6562455.76956.68
569814-6981459.33060.26
670598-7059859.99660.91
20min172287-7228761.43262.212.5863.0063.772.56
272419-7241961.54463.06
375035-7503563.76765.38
470291-7029159.73561.26
574012-7401262.89864.49
675148-7514863.86365.44
30min177754-7775466.07865.862.5368.3368.112.52
276539-7653965.04567.25
379126-7912667.24469.57
474103-7410362.97565.16
578021-7802166.30568.59
679411-7941167.48669.78
45min179817-7981767.83168.252.6970.8271.242.67
279519-7951967.57870.50
382704-8270470.28473.35
476686-7668665.17068.06
581164-8116468.97672.00
681980-8198069.66972.71
60min180418-8041868.34268.932.3172.0872.682.31
280881-8088168.73572.41
383424-8342470.89674.75
478022-7802266.30569.92
581370-8137069.15172.94
682538-8253870.14373.96
90min181539-8153969.29469.542.6173.7974.052.60
280409-8040968.33472.77
384349-8434971.68276.32
478492-7849266.70571.05
582943-8294370.48875.05
683221-8322170.72475.32
极限190376-9037676.80477.781.5282.0783.071.54
290854-9085477.21182.41
394204-9420480.05785.49
490744-9074477.11782.21
591738-9173877.96283.30
691250-9125077.54782.93
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(%)97.3对照品水分(%)0对照品稀释倍数2500
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%
117.833927333927793927333924763924753926390.04
217.893916833916993916910.01
单位质量响应值RSD%判断
22021.2621894.410.41数据可信
供试品溶液-24073101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%
5min1112767-112767103.762105.352.91103.76105.352.91
2117917-117917108.500108.50
3109418-109418100.680100.68
4117297-117297107.930107.93
5112930-112930103.912103.91
6116617-116617107.304107.30
10min1112782-112782103.775104.792.03104.93105.962.04
2117334-117334107.964109.17
3110575-110575101.745102.86
4114636-114636105.481106.68
5113005-113005103.981105.14
6114964-114964105.783106.98
15min1111947-111947103.007103.462.17105.31105.802.17
2115302-115302106.094108.50
3108684-108684100.005102.25
4113314-113314104.265106.64
5110958-110958102.097104.41
6114439-114439105.300107.67
20min1108617-10861799.943102.192.29103.39105.682.28
2114456-114456105.316108.90
3108329-10832999.678103.04
4112015-112015103.070106.60
5109772-109772101.006104.45
6113193-113193104.154107.69
30min1109007-109007100.302101.191.92104.86105.811.94
2112604-112604103.612108.37
3107028-10702898.481102.95
4111773-111773102.847107.52
5108633-10863399.958104.52
6110768-110768101.922106.62
45min1106881-10688198.34699.972.09104.02105.712.09
2111540-111540102.633108.54
3105380-10538096.965102.53
4110100-110100101.308107.13
5108239-10823999.595105.27
6109707-109707100.946106.77
60min1106597-10659798.08498.742.64104.85105.602.61
2111219-111219102.337109.38
3102931-10293194.711101.35
4108820-108820100.130107.07
5105998-10599897.533104.32
6108313-10831399.663106.61
90min1104624-10462496.26997.702.33104.13105.662.32
2109081-109081100.370108.55
3102962-10296294.740102.43
4107544-10754498.956107.01
5104522-10452296.175104.04
6108368-10836899.714107.77
极限1104176-10417695.85796.822.09104.78105.862.07
2108616-10861699.942109.24
3102526-10252694.338103.08
4106895-10689598.359107.51
5105028-10502896.641105.58
6104104-10410495.790104.95
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10000
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%
116.193909923910463910043908313908033909350.03
216.17 3900413902553901480.04
单位质量响应值RSD%判断
24146.7024127.890.06数据可信
供试品溶液-24073101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%
5min144675-4467537.98038.171.9837.9838.171.99
245056-4505638.30438.30
343834-4383437.26537.26
446108-4610839.19839.20
544063-4406337.46037.46
645650-4565038.80938.81
10min164504-6450454.83757.602.9855.2658.022.96
268434-6843458.17858.60
368875-6887558.55358.97
469466-6946659.05659.49
566037-6603756.14056.56
669205-6920558.83459.26
15min178442-7844266.68667.081.9767.7268.141.97
279417-7941767.51568.59
379095-7909567.24268.31
479850-7985067.88368.98
576073-7607364.67265.71
680527-8052768.45969.54
20min181737-8173769.48871.372.7071.2673.182.67
285777-8577772.92274.74
384773-8477372.06973.88
485089-8508972.33774.18
580521-8052168.45470.21
685831-8583172.96874.81
30min188339-8833975.10076.022.4277.6478.622.41
290854-9085477.23879.87
390063-9006376.56679.18
490703-9070377.11079.76
585517-8551772.70175.22
691077-9107777.42880.08
45min191173-9117377.51079.631.6280.8983.071.63
295031-9503180.78984.28
393451-9345179.44682.91
494602-9460280.42583.93
592763-9276378.86182.19
694955-9495580.72584.24
60min195965-9596581.58382.560.9885.8286.890.99
298440-9844083.68788.08
396056-9605681.66186.01
497561-9756182.94087.34
597286-9728682.70686.91
697374-9737482.78187.19
90min1102549-10254987.18187.762.0292.3393.011.95
2100283-10028385.25490.57
3103651-10365188.11893.37
4106277-10627790.35095.67
5102078-10207886.78091.90
6104540-10454088.87394.21
极限1106195-10619590.28090.431.1096.4096.661.07
2104711-10471189.01995.28
3106344-10634490.40796.64
4108345-10834592.10898.43
5106110-10611090.20896.29
6106534-10653490.56896.89
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