叶酸左氨氯地平片项目信息
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)5供试品稀释倍数4系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.291817521816531815631821811821251818550.16
216.351822321821921822120.02
单位质量响应值RSD%判断
11163.6011144.460.13数据可信
供试品溶液-8153342批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1219436-219436198.741197.881.86198.74197.881.86
2223217-223217202.165202.17
3219554-219554198.848198.85
4220096-220096199.339199.34
5217474-217474196.964196.96
6211110-211110191.200191.20
10min1218341-218341197.749199.311.89199.96201.511.89
2223268-223268202.211204.46
3221476-221476200.588202.80
4223730-223730202.630204.84
5221023-221023200.178202.37
6212539-212539192.494194.62
15min1215539-215539195.211196.842.11199.62201.262.11
2222448-222448201.469205.96
3219186-219186198.514202.95
4219312-219312198.628203.09
5218414-218414197.815202.23
6209144-209144189.419193.68
20min1214699-214699194.451195.551.59201.02202.151.59
2220781-220781199.959206.69
3216393-216393195.985202.63
4217573-217573197.053203.73
5215609-215609195.275201.89
6210436-210436190.590196.96
30min1212811-212811192.741192.381.97201.48201.161.96
2217560-217560197.042206.00
3213016-213016192.926201.75
4214416-214416194.194203.06
5211722-211722191.754200.53
6204955-204955185.625194.11
45min1209186-209186189.457190.402.13200.33201.302.12
2215806-215806195.453206.60
3210544-210544190.687201.65
4213433-213433193.304204.32
5209701-209701189.924200.83
6202660-202660183.547194.10
60min1207689-207689188.102188.851.78201.08201.881.79
2213346-213346193.225206.54
3210023-210023190.216203.30
4209562-209562189.798202.97
5208373-208373188.721201.74
6202098-202098183.038195.63
90min1-0.0000.00-15.0715.121.87
2-0.00015.46
3-0.00015.20
4-0.00015.28
5-0.00015.12
6-0.00014.62
极限1-0.0000.00-15.0715.121.87
2-0.00015.46
3-0.00015.20
4-0.00015.28
5-0.00015.12
6-0.00014.62
叶酸左氨氯地平片项目信息
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)5供试品稀释倍数4系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.291822741822201821611822341822611822300.03
216.351820801820381820590.02
单位质量响应值RSD%判断
11186.6211135.110.33数据可信
供试品溶液-8153342批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1110539-110539100.053100.631.54100.05100.631.54
2109787-10978799.37299.37
3109940-10994099.51199.51
4110099-11009999.65599.65
5113306-113306102.558102.56
6113415-113415102.656102.66
10min1111983-111983101.360102.191.77102.47103.311.76
2114424-114424103.570104.67
3110969-110969100.442101.55
4110722-110722100.219101.33
5115666-115666104.694105.83
6113628-113628102.849103.99
15min1111520-111520100.941100.251.62103.18102.511.61
2110370-11037099.900102.16
3109523-10952399.134101.36
4108072-10807297.820100.04
5112292-112292101.640103.94
6112794-112794102.094104.38
20min1109528-10952899.13899.411.11102.50102.781.12
2110669-110669100.171103.54
3108515-10851598.221101.54
4108473-10847398.183101.49
5110324-11032499.859103.29
6111489-111489100.913104.33
30min1108529-10852998.23498.181.46102.69102.651.46
2109007-10900798.666103.14
3106989-10698996.840101.25
4106218-10621896.142100.54
5110005-11000599.570104.11
6110082-11008299.639104.18
45min1106249-10624996.17096.421.61101.72101.981.59
2106374-10637496.283101.86
3105826-10582695.787101.28
4103898-10389894.04299.51
5108508-10850898.215103.86
6108309-10830998.035103.68
60min1105534-10553495.52395.141.41102.14101.781.40
2104583-10458394.662101.31
3104276-10427694.384100.94
4102932-10293293.16899.68
5106617-10661796.503103.24
6106751-10675196.624103.36
90min1104368-10436894.46894.451.25102.15102.141.25
2104299-10429994.405102.10
3103393-10339393.585101.19
4102583-10258392.852100.40
5106272-10627296.191104.00
6105160-10516095.184102.99
极限1102973-10297393.20592.811.42101.94101.561.42
2102620-10262092.885101.63
3101174-10117491.577100.22
4100487-10048790.95599.53
5103794-10379493.948102.83
6104196-10419694.312103.18
叶酸左氨氯地平片项目信息
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)5供试品稀释倍数4系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.291820701818831820761819801818051819630.07
216.351815341815911815620.03
单位质量响应值RSD%判断
11170.2311104.710.42数据可信
供试品溶液-8153342批-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%
5min1109297-10929799.13799.661.4399.1499.661.43
2112232-112232101.799101.80
3108565-10856598.47398.47
4109606-10960699.41799.42
5108278-10827898.21398.21
6111278-111278100.934100.93
10min1109490-10949099.31299.931.38100.41101.041.37
2111088-111088100.762101.89
3108464-10846498.38299.48
4110447-110447100.180101.28
5108987-10898798.85699.95
6112561-112561102.098103.22
15min1106052-10605296.19498.571.3198.40100.791.30
2109555-10955599.371101.62
3108290-10829098.224100.41
4109312-10931299.151101.37
5108844-10884498.726100.92
6110006-11000699.780102.04
20min1109961-10996199.73998.451.06103.01101.761.04
2109119-10911998.976102.33
3107098-10709897.142100.42
4108594-10859498.499101.82
5107266-10726697.295100.58
6109219-10921999.066102.43
30min1107476-10747697.48596.721.44101.87101.131.41
2106784-10678496.858101.31
3104569-10456994.84999.21
4106184-10618496.313100.73
5105764-10576495.932100.30
6109023-10902398.889103.35
45min1104436-10443694.72895.311.63100.19100.791.59
2107656-10765697.649103.18
3103912-10391294.25399.66
4105228-10522895.446100.93
5102940-10294093.37198.80
6106304-10630496.422101.99
60min1103881-10388194.22594.141.12100.74100.681.12
2104602-10460294.879101.49
3102082-10208292.59399.05
4103851-10385194.197100.74
5102961-10296193.39099.86
6105354-10535495.561102.20
90min1102448-10244892.92593.380.91100.49100.960.92
2103841-10384194.188101.86
3101737-10173792.28099.77
4103597-10359793.967101.56
5102186-10218692.687100.20
6103861-10386194.206101.90
极限1101283-10128391.86892.051.42100.47100.681.38
2102629-10262993.089101.81
3100439-10043991.10299.62
4100493-10049391.15199.79
5100263-10026390.94399.48
6103807-10380794.157102.90
叶酸左氨氯地平片项目信息
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)5供试品稀释倍数4系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.291821071819941819321818351818031819340.07
216.351814451815041814740.03
单位质量响应值RSD%判断
11168.4511099.330.44数据可信
供试品溶液-8153342批-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%
5min1111012-111012100.725100.711.14100.73100.711.14
2111196-111196100.892100.89
3109437-10943799.29699.30
4111141-111141100.842100.84
5113141-113141102.657102.66
6110050-11005099.85299.85
10min1111263-111263100.953101.020.85102.07102.140.85
2110638-110638100.386101.51
3111171-111171100.869101.97
4110878-110878100.604101.72
5113204-113204102.714103.85
6110900-110900100.624101.73
15min1108026-10802698.01698.590.61100.26100.830.61
2108552-10855298.493100.73
3108265-10826598.233100.46
4109130-10913099.018101.26
5109737-10973799.568101.85
6108225-10822598.196100.42
20min1108509-10850998.45498.020.94101.78101.360.93
2107105-10710597.180100.51
3108026-10802698.016101.33
4107813-10781397.823101.16
5109731-10973199.563102.95
6106999-10699997.084100.40
30min1107306-10730697.36397.300.73101.79101.720.72
2106615-10661596.736101.15
3106854-10685496.952101.36
4107915-10791597.915102.34
5108345-10834598.305102.80
6106365-10636596.509100.91
45min1103973-10397394.33895.590.8699.84101.100.84
2105711-10571195.915101.40
3105052-10505295.317100.80
4105543-10554395.763101.28
5106699-10669996.812102.40
6105141-10514195.398100.87
60min1103722-10372294.11194.421.15100.66100.991.12
2104094-10409494.448101.00
3103370-10337093.791100.33
4103864-10386494.240100.82
5106365-10636596.509103.17
6102983-10298393.44099.97
90min1103286-10328693.71594.562.26101.31102.172.14
2103810-10381094.191101.79
3103564-10356493.967101.55
4103142-10314293.584101.21
5108922-10892298.829106.56
6102554-10255493.051100.62
极限1102859-10285993.32893.191.09101.97101.861.06
2103461-10346193.874102.52
3101251-10125191.869100.50
4102412-10241292.922101.59
5104360-10436094.690103.52
6101908-10190892.465101.07
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