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%
117.821941021952011943201945851946581945730.22
217.841941431944881943160.13
单位质量响应值RSD%判断
10918.8010892.150.18数据可信
供试品溶液-23FA175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%
5min130775-3077528.50827.426.5928.5127.426.59
226608-2660824.64824.65
330877-3087728.60228.60
431200-3120028.90228.90
527672-2767225.63325.63
630484-3048428.23828.24
10min153740-5374049.78150.313.7450.1050.623.75
251100-5110047.33647.61
355967-5596751.84452.16
456903-5690352.71153.03
553672-5367249.71850.00
654498-5449850.48350.80
15min169451-6945164.33564.292.5765.2065.152.57
267003-6700362.06762.87
370358-7035865.17566.07
471849-7184966.55667.46
569999-6999964.84265.68
667735-6773562.74563.62
20min177925-7792572.18471.881.8573.7773.461.86
276533-7653370.89572.38
378561-7856172.77474.39
479205-7920573.37075.02
578078-7807872.32673.88
675292-7529269.74571.32
30min186865-8686580.46679.461.5082.8581.831.50
285629-8562979.32181.60
386094-8609479.75282.18
486879-8687980.47982.94
585801-8580179.48081.84
683388-8338877.24579.59
45min192004-9200485.22684.021.6588.5187.281.63
290915-9091584.21787.38
391392-9139284.65987.97
491693-9169384.93888.29
590298-9029883.64686.89
687925-8792581.44884.65
60min194979-9497987.98286.321.7892.2190.511.77
292810-9281085.97390.07
393766-9376686.85891.11
494632-9463287.66191.96
592435-9243585.62589.80
690488-9048883.82287.93
90min196876-9687689.73988.141.8694.9493.291.84
294594-9459487.62592.67
395634-9563488.58993.81
496788-9678889.65894.93
594876-9487687.88793.01
692102-9210285.31790.36
极限197370-9737090.19789.051.8696.4095.181.84
295817-9581788.75894.78
396696-9669689.57395.78
498484-9848491.22997.50
594923-9492387.93094.03
693509-9350986.62092.61
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%
116.191992771989041980751990521989411988500.23
216.171967891962861965380.19
单位质量响应值RSD%判断
12282.2712154.480.74数据可信
供试品溶液-23FA175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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
90min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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%
117.821948981947941940591940641942791944190.21
217.841942121943841942980.07
单位质量响应值RSD%判断
10910.1610891.140.13数据可信
供试品溶液-24081201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%
5min1111799-111799103.609103.632.12103.61103.632.12
2114087-114087105.729105.73
3108766-108766100.798100.80
4109502-109502101.480101.48
5114640-114640106.242106.24
6112124-112124103.910103.91
10min1111220-111220103.072103.322.01104.22104.482.01
2113884-113884105.541106.72
3108679-108679100.717101.84
4109112-109112101.119102.25
5113661-113661105.334106.51
6112389-112389104.156105.31
15min1109886-109886101.836102.291.81104.13104.591.82
2112189-112189103.970106.32
3107538-10753899.660101.90
4109026-109026101.039103.29
5112911-112911104.639106.99
6110719-110719102.608104.92
20min1109879-109879101.829101.282.04105.26104.722.03
2110658-110658102.551106.05
3105870-10587098.114101.46
4107359-10735999.494102.87
5111773-111773103.585107.10
6110211-110211102.137105.59
30min1108168-108168100.244100.022.08104.80104.582.08
2110299-110299102.219106.86
3104795-10479597.118101.55
4105664-10566497.923102.40
5109905-109905101.854106.52
6108741-108741100.775105.36
45min1106253-10625398.46998.442.31104.14104.112.29
2108824-108824100.852106.63
3102941-10294195.400100.92
4103933-10393396.319101.89
5108912-108912100.933106.73
6106441-10644198.643104.35
60min1105086-10508697.38897.572.25104.15104.342.20
2108195-108195100.269107.17
3103654-10365496.060102.64
4103760-10376096.159102.80
5108193-108193100.267107.18
6102840-10284095.306102.11
90min1103857-10385796.24997.102.16104.10104.952.14
2106679-10667998.864106.88
3103014-10301495.467103.11
4102125-10212594.643102.35
5108072-108072100.155108.19
6104903-10490397.218105.08
极限1102743-10274395.21696.191.75104.14105.121.76
2105653-10565397.913107.02
3101733-10173394.280102.98
4102210-10221094.722103.48
5105913-10591398.154107.30
6104536-10453696.878105.82
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%
116.191960561955171951861954421953571955120.17
216.171941361939171940260.08
单位质量响应值RSD%判断
12076.1011999.130.46数据可信
供试品溶液-24081201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%
5min127153-2715323.14422.154.9323.1422.154.93
226069-2606922.22022.22
324608-2460820.97420.97
424389-2438920.78820.79
527512-2751223.44923.45
626191-2619122.32422.32
10min148734-4873441.53838.994.6641.7939.244.65
247217-4721740.24540.49
344427-4442737.86738.10
443160-4316036.78737.02
546708-4670839.81140.07
644248-4424837.71437.96
15min160681-6068151.72147.674.8452.4448.364.82
256564-5656448.21248.91
354982-5498246.86347.52
453451-5345145.55846.20
556475-5647548.13648.84
653444-5344445.55246.22
20min168143-6814358.08153.265.1559.3754.475.13
263339-6333953.98655.22
362028-6202852.86954.04
458740-5874050.06651.21
562377-6237753.16654.40
660316-6031651.41052.58
30min177097-7709765.71360.375.0167.6562.175.00
271598-7159861.02662.86
370875-7087560.40962.17
466817-6681756.95158.65
570305-7030559.92461.75
668256-6825658.17759.92
45min186666-8666673.86966.996.0976.5469.476.04
280264-8026468.41270.92
377993-7799366.47668.91
473027-7302762.24464.58
578938-7893867.28269.78
674712-7471263.68066.07
60min192983-9298379.25371.116.8282.7474.326.74
285324-8532472.72575.99
383531-8353171.19774.37
478283-7828366.72369.75
583373-8337371.06274.30
677077-7707765.69668.79
90min199666-9966684.94976.486.3189.3280.496.26
290567-9056777.19481.27
388992-8899275.85179.81
483226-8322670.93774.70
590366-9036677.02281.05
685588-8558872.95076.78
极限1104104-10410488.73283.723.6294.0588.583.73
298723-9872384.14589.08
398499-9849983.95488.76
493527-9352779.71784.27
598716-9871684.13989.03
695779-9577981.63686.27
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%
117.821950051953801952801954531951641952560.10
217.841951601947481949540.15
单位质量响应值RSD%判断
10957.1310927.910.19数据可信
供试品溶液-24081202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%
5min1111915-111915103.319106.461.57103.32106.461.57
2116256-116256107.327107.33
3116510-116510107.562107.56
4116212-116212107.286107.29
5116404-116404107.464107.46
6114612-114612105.809105.81
10min1111758-111758103.175106.471.83104.32107.661.82
2115217-115217106.368107.56
3115049-115049106.213107.41
4117910-117910108.854110.05
5116913-116913107.934109.13
6115136-115136106.293107.47
15min1110014-110014101.565105.361.97103.86107.721.96
2114821-114821106.002108.38
3114356-114356105.573107.95
4116193-116193107.269109.67
5113452-113452104.738107.13
6115886-115886106.986109.34
20min1109824-109824101.389103.931.37104.81107.461.38
2113064-113064104.380107.93
3112018-112018103.415106.96
4114322-114322105.542109.14
5113319-113319104.616108.17
6112908-112908104.236107.78
30min1107481-10748199.226102.521.65103.78107.211.64
2111380-111380102.826107.54
3110943-110943102.422107.12
4112197-112197103.580108.35
5112372-112372103.741108.46
6111927-111927103.331108.03
45min1106835-10683598.630101.631.77104.28107.461.76
2110790-110790102.281108.14
3109876-109876101.437107.27
4112163-112163103.548109.47
5111710-111710103.130109.00
6109130-109130100.748106.60
60min1105818-10581897.691100.271.39104.44107.231.40
2109291-109291100.897107.89
3108696-108696100.348107.31
4110063-110063101.610108.68
5109506-109506101.096108.11
6108278-10827899.962106.93
90min1105165-10516597.08898.871.18104.92106.941.19
2106488-10648898.309106.42
3106822-10682298.618106.70
4108500-108500100.167108.36
5108413-108413100.086108.23
6107167-10716798.936107.02
极限1103974-10397495.98897.821.16104.90107.001.18
2107054-10705498.832108.04
3105880-10588097.748106.92
4107080-10708098.856108.17
5106632-10663298.442107.70
6105142-10514297.067106.25
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%
116.191931661934061932781932941929911932270.09
216.171918011923661920840.21
单位质量响应值RSD%判断
11934.9611879.040.34数据可信
供试品溶液-24081202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%
5min148568-4856841.85042.783.2641.8542.783.26
250929-5092943.88543.88
350076-5007643.15043.15
448776-4877642.02942.03
551937-5193744.75344.75
647625-4762541.03841.04
10min170400-7040060.66262.662.6361.1363.142.63
273380-7338063.23063.72
373707-7370763.51263.99
473193-7319363.06963.54
575195-7519564.79465.29
670462-7046260.71661.17
15min180327-8032769.21671.852.0170.3673.032.01
283495-8349571.94673.14
383994-8399472.37673.56
483449-8344971.90773.07
585435-8543573.61874.84
683628-8362872.06173.19
20min185374-8537473.56575.902.0775.4777.872.07
288159-8815975.96577.95
387923-8792375.76277.75
487878-8787875.72377.69
591107-9110778.50580.54
688091-8809175.90777.84
30min189219-8921976.87879.882.9079.6082.702.87
292248-9224879.48982.32
392693-9269379.87282.70
491631-9163178.95781.76
597452-9745283.97386.88
692996-9299680.13382.91
45min192117-9211779.37683.304.1582.9687.004.06
295481-9548182.27485.99
395745-9574582.50286.22
495001-9500181.86185.55
5103970-10397089.58993.43
697738-9773884.21987.88
60min193153-9315380.26884.864.4384.7389.494.33
297497-9749784.01288.64
397376-9737683.90788.54
495942-9594282.67287.27
5105508-10550890.91495.75
6101442-10144287.41192.01
90min194881-9488181.75786.625.5287.1192.195.34
297184-9718483.74289.31
3101291-10129187.28192.85
496203-9620382.89688.41
5109340-10934094.216100.06
6104236-10423689.81895.39
极限1101896-10189687.80291.312.9594.0697.842.97
2105339-10533990.76997.26
3106880-10688092.09798.63
4104075-10407589.68096.11
5111174-11117495.797102.69
6106450-10645091.72698.30
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%
117.821949391948001946941950811945951948220.10
217.841946471943901945180.10
单位质量响应值RSD%判断
10932.7710903.480.19数据可信
供试品溶液-24050801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%
5min1114457-114457105.902105.100.81105.90105.100.81
2113983-113983105.464105.46
3113781-113781105.277105.28
4114410-114410105.859105.86
5112394-112394103.994103.99
6112525-112525104.115104.11
10min1113214-113214104.752104.570.91105.93105.740.91
2113621-113621105.129106.30
3112906-112906104.467105.64
4114533-114533105.973107.15
5111675-111675103.328104.48
6112146-112146103.764104.92
15min1110716-110716102.441103.041.21104.78105.371.19
2112522-112522104.112106.45
3110698-110698102.424104.75
4113255-113255104.790107.14
5111413-111413103.086105.39
6109573-109573101.383103.69
20min1110037-110037101.813102.280.68105.29105.750.66
2110918-110918102.628106.12
3110098-110098101.869105.34
4110975-110975102.681106.20
5109617-109617101.424104.87
6111598-111598103.257106.69
30min1108658-108658100.53799.791.10105.15104.411.07
2107957-10795799.888104.53
3108139-108139100.057104.66
4108413-108413100.310104.97
5108466-108466100.359104.94
6105494-10549497.609102.19
45min1106899-10689998.90999.941.12104.64105.661.08
2109088-109088100.935106.68
3106982-10698298.986104.70
4109829-109829101.620107.39
5107288-10728899.269104.96
6108019-10801999.946105.61
60min1104037-10403796.26198.031.08103.09104.861.03
2106471-10647198.513105.38
3106117-10611798.186105.00
4107440-10744099.410106.31
5106192-10619298.255105.05
6105462-10546297.580104.36
90min1106128-10612898.19697.911.00106.09105.830.97
2106390-10639098.438106.40
3105545-10554597.656105.56
4107427-10742799.398107.40
5104670-10467096.847104.73
6104764-10476496.934104.80
极限1103274-10327495.55595.161.65104.54104.171.51
299676-9967692.226101.28
3103854-10385496.092105.08
4104539-10453996.726105.84
5102601-10260194.933103.89
6103158-10315895.448104.39
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%
116.191921321921991918681920161917561919940.10
216.171913271912381912820.04
单位质量响应值RSD%判断
11858.8011829.440.18数据可信
供试品溶液-24050801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%
5min138756-3875633.57332.484.0233.5732.484.02
239781-3978134.46034.46
337000-3700032.05132.05
435591-3559130.83130.83
536974-3697432.02932.03
636862-3686231.93231.93
10min159728-5972851.74051.063.7152.1151.423.71
262918-6291854.50354.89
358742-5874250.88551.24
457848-5784850.11150.45
557019-5701949.39349.75
657372-5737249.69950.05
15min169912-6991260.56260.623.5461.5161.553.53
274657-7465764.67265.66
369856-6985660.51361.43
469586-6958660.27961.18
568300-6830059.16560.07
667588-6758858.54859.46
20min175363-7536365.28366.152.7766.9067.752.78
280537-8053769.76571.47
375971-7597165.81067.40
475300-7530065.22966.80
574734-7473464.73966.30
676275-7627566.07467.63
30min182646-8264671.59272.143.0673.9474.483.05
288159-8815976.36878.85
381844-8184470.89873.22
482693-8269371.63373.93
583444-8344472.28474.57
680905-8090570.08472.38
45min192238-9223879.90279.823.4183.0482.963.40
298355-9835585.20088.53
390983-9098378.81481.93
489802-8980277.79180.88
590745-9074578.60881.69
690745-9074578.60881.68
60min197304-9730484.29083.643.6688.3287.673.63
2102701-10270188.96593.24
397529-9752984.48588.47
492732-9273280.32984.28
594985-9498582.28186.24
694104-9410481.51885.46
90min1106821-10682192.53489.903.7497.5094.863.70
2109964-10996495.257100.52
3103551-10355189.70194.63
4100825-10082587.34092.19
5100199-10019986.79891.67
6101340-10134087.78692.64
极限1106645-10664592.38290.161.8798.3896.121.88
2105397-10539791.30197.62
3104880-10488090.85396.78
4103046-10304689.26495.08
5101219-10121987.68193.52
6103319-10331989.50095.33
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