培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5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%
19.802041720422205322047020446204570.23
29.862055920581205700.08
单位质量响应值RSD%判断
2087.452086.210.05数据可信
供试品溶液-25102201批-培哚普利-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%
5min123482-2348296.00689.787.1396.0189.787.13
221772-2177289.01589.01
322013-2201390.00090.00
423973-2397398.01498.01
520172-2017282.47382.47
620339-2033983.15683.16
10min124579-24579100.49196.144.11101.5697.144.13
223534-2353496.21997.21
323067-2306794.30995.31
424750-24750101.190102.28
522720-2272092.89193.81
622437-2243791.73492.66
15min124207-2420798.97096.553.18101.1598.623.23
223790-2379097.26599.32
323228-2322894.96897.02
424680-24680100.904103.12
523138-2313894.60096.55
622653-2265392.61794.56
20min124367-2436799.62596.623.46102.9199.753.49
223428-2342895.78598.92
323377-2337795.57798.68
424796-24796101.379104.71
523291-2329195.22598.22
622528-2252892.10695.08
30min124148-2414898.72996.093.06103.12100.303.11
223411-2341195.71699.92
323594-2359496.464100.63
424386-2438699.702104.16
523051-2305194.24498.30
622426-2242691.68995.68
45min123637-2363796.64095.192.44102.13100.482.52
223427-2342795.781101.05
323045-2304594.22099.46
424089-2408998.488104.06
523057-2305794.26999.37
622444-2244491.76296.78
极限123647-2364796.68194.732.71103.24101.072.76
222852-2285293.43099.76
323158-2315894.682100.97
424151-2415198.741105.40
522744-2274492.98999.14
622472-2247291.87797.91
培哚普利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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.958312982935829548317483296830980.19
214.188336083395833780.03
单位质量响应值RSD%判断
5956.855879.970.92数据可信
供试品溶液-25102201批-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%
5min169548-6954876.18069.809.1276.1869.809.12
264531-6453170.68570.68
364622-6462270.78470.78
469877-6987776.54076.54
555870-5587061.19861.20
657920-5792063.44363.44
10min189424-8942497.95192.855.2798.8093.625.29
287012-8701295.30996.09
380935-8093588.65389.44
489719-8971998.27599.12
580007-8000787.63688.32
681480-8148089.25089.95
15min189406-8940697.93294.154.1099.8795.964.14
288244-8824496.65998.50
382708-8270890.59592.37
489761-8976198.321100.26
582786-8278690.68092.33
682824-8282490.72292.42
20min189498-8949898.03294.253.76101.0697.113.81
286607-8660794.86697.78
383007-8300790.92293.70
490227-9022798.831101.87
583247-8324791.18593.85
683692-8369291.67394.38
30min188479-8847996.91694.243.35101.0398.143.41
286819-8681995.09899.07
383850-8385091.84695.63
490091-9009198.682102.81
583965-8396591.97295.65
682985-8298590.89894.62
45min187169-8716995.48193.862.49100.6798.802.58
286369-8636994.60599.63
383068-8306890.98995.80
488766-8876697.231102.46
584647-8464792.71997.42
684088-8408892.10796.84
极限187712-8771296.07694.672.03102.33100.662.13
285418-8541893.56399.64
385169-8516993.29199.11
489428-8942897.956104.27
585366-8536693.50699.23
685468-8546893.61899.37
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5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%
19.802049420626205582045620613205490.36
29.862046420635205500.59
单位质量响应值RSD%判断
2096.842084.180.43数据可信
供试品溶液-25102301批-培哚普利-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%
5min121787-2178788.92086.623.7988.9286.623.78
220953-2095385.51685.52
321859-2185989.21489.21
421906-2190689.40689.41
519843-1984380.98680.99
620993-2099385.68085.68
10min123296-2329695.07996.131.3796.0797.091.37
223677-2367796.63497.58
323639-2363996.47997.47
423629-2362996.43897.43
523080-2308094.19795.10
624000-2400097.95298.90
15min123694-2369496.70397.041.2198.7599.071.21
223542-2354296.08398.11
323849-2384997.33699.40
423832-2383297.26799.33
523467-2346795.77797.72
624274-2427499.071101.11
20min123698-2369896.72096.991.0799.84100.101.07
223452-2345295.71698.81
323904-2390497.560100.71
423770-2377097.014100.16
523585-2358596.25899.27
624172-2417298.654101.80
30min124119-2411998.43896.611.06102.63100.791.04
223687-2368796.675100.83
323528-2352896.026100.25
423527-2352796.022100.25
523415-2341595.56599.64
623746-2374696.916101.15
45min123744-2374496.90795.361.03102.19100.620.99
223005-2300593.89199.12
323336-2333695.242100.54
423273-2327394.985100.28
523407-2340795.532100.67
623429-2342995.622100.94
极限123706-2370696.75295.141.20103.12101.461.15
222924-2292493.56199.83
323238-2323894.842101.20
423118-2311894.352100.70
523391-2339195.467101.67
623487-2348795.858102.24
培哚普利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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.958332083344835928338883484834260.14
214.188354983458835040.08
单位质量响应值RSD%判断
5980.365888.861.10数据可信
供试品溶液-25102301批-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%
5min156988-5698862.25361.874.8162.2561.874.81
255805-5580560.96160.96
355521-5552160.65060.65
461806-6180667.51667.52
555824-5582460.98160.98
653893-5389358.87258.87
10min178558-7855885.81690.533.4586.5191.223.43
284768-8476892.60093.28
382614-8261490.24790.92
485480-8548093.37794.13
580503-8050387.94188.62
685315-8531593.19793.85
15min181173-8117388.67292.883.1490.3294.583.11
286295-8629594.26895.97
384523-8452392.33294.01
486441-8644194.42796.21
583093-8309390.77092.42
688637-8863796.82698.52
20min180740-8074088.19993.253.2990.8395.983.26
285926-8592693.86596.62
386527-8652794.52197.22
487050-8705095.09297.93
583461-8346191.17293.84
688489-8848996.66499.43
30min182811-8281190.46293.602.0394.0797.362.06
286763-8676394.77998.58
385690-8569093.60797.36
486987-8698795.02498.92
584539-8453992.34996.03
687320-8732095.38799.23
45min183203-8320390.89093.111.7495.5197.911.78
285174-8517493.04397.89
385316-8531693.19897.99
486839-8683994.86299.81
584005-8400591.76696.47
686870-8687094.89699.80
极限186233-8623394.20094.340.6399.83100.180.66
285516-8551693.41799.30
386570-8657094.568100.40
486624-8662494.627100.63
586139-8613994.09799.82
687099-8709995.146101.10
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5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%
19.802057120603204412061720483205430.38
29.862065320594206240.21
单位质量响应值RSD%判断
2096.222091.680.16数据可信
供试品溶液-25102302批-培哚普利-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%
5min122049-2204989.84183.847.4089.8483.847.40
219573-1957379.75279.75
322518-2251891.75291.75
418977-1897777.32477.32
521104-2110485.99085.99
619239-1923978.39178.39
10min123569-2356996.03490.964.1197.0391.894.13
221595-2159587.99188.88
322809-2280992.93793.96
421426-2142687.30288.16
522998-2299893.70794.66
621538-2153887.75988.63
15min123641-2364196.32792.733.6398.3994.683.67
222170-2217090.33492.20
323485-2348595.69297.74
421993-2199389.61391.44
523388-2338895.29797.29
621878-2187889.14490.99
20min123192-2319294.49892.283.2497.6395.253.28
222094-2209490.02492.89
323076-2307694.02597.14
421930-2193089.35692.18
523618-2361896.23499.29
621979-2197989.55592.39
30min123116-2311694.18892.932.2698.3796.932.32
222261-2226190.70594.57
322938-2293893.46397.62
422666-2266692.35596.17
523592-2359296.128100.25
622277-2227790.77094.60
45min123132-2313294.25393.151.8999.4998.181.93
222568-2256891.95596.83
322720-2272092.57597.77
422920-2292093.39098.23
523524-2352495.851101.04
622310-2231090.90495.74
极限122643-2264392.26193.932.1198.5499.992.07
222545-2254591.86297.76
323142-2314294.294100.52
423192-2319294.498100.38
523889-2388997.338103.60
622899-2289993.30499.15
培哚普利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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.958313982868834168299883012830870.25
214.188322083560833900.29
单位质量响应值RSD%判断
5956.065880.820.90数据可信
供试品溶液-25102302批-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%
5min167668-6766874.12067.2410.8574.1267.2410.85
256501-5650161.88861.89
369982-6998276.65576.65
458988-5898864.61364.61
562579-6257968.54668.55
652591-5259157.60657.61
10min184916-8491693.01383.417.0293.8484.167.05
271324-7132478.12578.81
379478-7947887.05687.91
474455-7445581.55482.27
575938-7593883.17983.94
670808-7080877.56078.20
15min185624-8562493.78885.506.3395.6587.176.37
273219-7321980.20181.76
381889-8188989.69791.52
476274-7627483.54785.17
578091-7809185.53787.22
673220-7322080.20281.70
20min185158-8515893.27885.955.4496.1888.575.50
274945-7494582.09184.54
380929-8092988.64691.46
476188-7618883.45386.01
579687-7968787.28589.92
673879-7387980.92483.32
30min185180-8518093.30287.094.8397.2490.674.91
275603-7560382.81286.17
381985-8198589.80293.60
477501-7750184.89188.37
580993-8099388.71692.32
675791-7579183.01886.31
45min185817-8581794.00088.744.1798.9793.294.29
278376-7837685.84990.13
384103-8410392.12296.92
479420-7942086.99391.42
581242-8124288.98993.58
677158-7715884.51588.73
极限185763-8576393.94193.591.4999.9699.121.67
284143-8414392.16697.40
386584-8658494.840100.66
485332-8533293.46998.86
586988-8698895.282100.86
683851-8385191.84697.00
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