培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.431632661631861626221630831632111630740.17
216.441639261638871639060.02
单位质量响应值RSD%判断
9925.389969.950.32数据可信
长期18月-供试品溶液-2023110721批-培哚普利-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156363-5636335.34241.1620.1735.3441.1620.17
261735-6173538.71038.71
362300-6230039.06439.06
469765-6976543.74543.75
553535-5353533.56833.57
690134-9013456.51756.52
10min1154400-15440096.81493.734.5796.9693.894.56
2135847-13584785.18185.34
3151090-15109094.73994.89
4152221-15222195.44895.62
5150468-15046894.34994.48
6152827-15282795.82896.05
15min1155654-15565497.60096.410.8098.1396.950.79
2154282-15428296.74097.24
3153337-15333796.14896.68
4154269-15426996.73297.29
5152431-15243195.58096.09
6152554-15255495.65796.27
20min1155488-15548897.49696.791.1098.4297.721.06
2156968-15696898.42499.31
3154132-15413296.64697.57
4153954-15395496.53497.48
5153633-15363396.33397.23
6152038-15203895.33396.33
30min1154866-15486697.10696.681.0198.4298.000.98
2156899-15689998.38199.66
3153907-15390796.50597.81
4153918-15391896.51297.84
5153018-15301895.94897.23
6152521-15252195.63697.01
45min1154726-15472697.01996.581.3798.7298.281.33
2157151-15715198.539100.21
3153857-15385796.47498.17
4154375-15437596.79898.51
5153451-15345196.21997.88
6150641-15064194.45796.21
60min1154316-15431696.76196.241.2998.8598.321.25
2156327-15632798.022100.09
3154049-15404996.59498.67
4152963-15296395.91398.02
5152880-15288095.86197.91
6150346-15034694.27296.41
极限1154077-15407796.61295.940.9999.0898.410.95
2155035-15503597.21299.67
3152781-15278195.79998.26
4152926-15292695.89098.38
5152630-15263095.70498.14
6150562-15056294.40896.92
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.592931022934532932182936682942942935470.17
212.542951392957112954250.14
单位质量响应值RSD%判断
23315.8923558.610.74数据可信
长期18月-供试品溶液-2023110721批-吲达帕胺-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142533-4253314.25714.9016.1714.2614.9016.18
241294-4129413.84213.84
341643-4164313.95913.96
448185-4818516.15216.15
536196-3619612.13312.13
656883-5688319.06719.07
10min1131954-13195444.23145.009.0944.2945.069.09
2121173-12117340.61740.67
3133264-13326444.67044.73
4144681-14468148.49748.56
5122362-12236241.01641.06
6152020-15202050.95751.03
15min1186667-18666762.57161.834.1062.8162.074.12
2177893-17789359.63059.85
3182535-18253561.18661.42
4190437-19043763.83564.09
5174684-17468458.55458.77
6194565-19456565.21965.50
20min1216031-21603172.41471.422.8372.9071.912.85
2210419-21041970.53370.99
3210848-21084870.67771.16
4217646-21764672.95573.47
5203493-20349368.21168.66
6219948-21994873.72774.27
30min1247815-24781583.06881.572.2383.8482.342.24
2244398-24439881.92382.66
3239543-23954380.29581.06
4247391-24739182.92683.73
5234242-23424278.51879.24
6246742-24674282.70883.54
45min1269854-26985490.45688.681.9791.5689.771.98
2267008-26700889.50290.57
3261328-26132887.59888.68
4267251-26725189.58390.72
5255579-25557985.67186.70
6266235-26623589.24290.41
60min1279264-27926493.61091.941.7595.0893.401.76
2277557-27755793.03894.46
3270371-27037190.62992.06
4276979-27697992.84494.34
5266774-26677489.42390.80
6274838-27483892.12693.65
极限1284909-28490995.50294.371.2197.3496.201.22
2284649-28464995.41597.21
3280719-28071994.09895.89
4282930-28293094.83996.71
5275843-27584392.46394.20
6280199-28019993.92395.82
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.431642421642991649761649141643271645520.22
216.441640431637841639140.12
单位质量响应值RSD%判断
10015.349970.440.32数据可信
长期18月-供试品溶液-2023110821批-培哚普利-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149742-4974231.04932.8320.3131.0532.8320.31
261361-6136138.30138.30
352019-5201932.47032.47
468537-6853742.78142.78
543438-4343827.11427.11
640482-4048225.26925.27
10min1152578-15257895.23985.959.7195.3686.089.71
2143074-14307489.30689.46
3138446-13844686.41886.55
4148171-14817192.48892.66
5126280-12628078.82478.93
6117664-11766473.44673.55
15min1156281-15628197.55094.002.7598.0694.482.78
2151085-15108594.30794.82
3152354-15235495.09995.57
4151801-15180194.75495.29
5147814-14781492.26592.69
6144240-14424090.03490.43
20min1155628-15562897.14395.711.2198.0496.561.20
2152992-15299295.49796.38
3155090-15509096.80797.66
4151085-15108594.30795.23
5151492-15149294.56195.35
6153738-15373895.96396.72
30min1156410-15641097.63196.291.0798.9197.521.05
2154585-15458596.49297.76
3154632-15463296.52197.76
4151574-15157494.61295.91
5153308-15330895.69496.87
6155040-15504096.77697.91
45min1155796-15579697.24795.981.0798.9297.601.03
2152056-15205694.91396.57
3154703-15470396.56598.19
4151615-15161594.63896.31
5153743-15374395.96697.52
6154682-15468296.55298.08
60min1156672-15667297.79495.861.2899.8697.861.28
2152793-15279395.37397.41
3155013-15501396.75998.77
4151503-15150394.56896.62
5153443-15344395.77997.72
6151989-15198994.87196.78
极限1156272-15627297.54595.581.62100.0097.961.58
2151246-15124694.40796.82
3154928-15492896.70699.11
4149603-14960393.38295.81
5152578-15257895.23997.56
6154123-15412396.20398.49
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.592971472972982985362975272969202974860.22
212.542957492952202954840.13
单位质量响应值RSD%判断
23628.7523563.320.20数据可信
长期18月-供试品溶液-2023110821批-吲达帕胺-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132407-3240710.79011.2423.8110.7911.2423.82
239867-3986713.27313.27
333934-3393411.29811.30
445341-4534115.09615.10
528292-282929.4199.42
622808-228087.5947.59
10min1118089-11808939.31637.6513.7139.3637.6913.73
2122133-12213340.66340.72
3112705-11270537.52437.57
4133897-13389744.57944.64
5101537-10153733.80633.84
690116-9011630.00330.03
15min1173751-17375157.84855.825.8858.0556.025.91
2171665-17166557.15457.37
3166328-16632855.37755.57
4180378-18037860.05560.29
5161366-16136653.72553.90
6152538-15253850.78650.94
20min1204125-20412567.96166.702.4668.3967.122.51
2202324-20232467.36167.81
3199778-19977866.51466.93
4206472-20647268.74269.22
5194850-19485064.87365.26
6194421-19442164.73065.08
30min1234195-23419577.97277.821.1078.6878.501.11
2232066-23206677.26477.98
3233573-23357377.76578.45
4237192-23719278.97079.72
5229884-22988476.53777.18
6235482-23548278.40179.01
45min1255017-25501784.90585.591.3385.9286.591.29
2255624-25562485.10786.13
3255812-25581285.17086.16
4258263-25826385.98687.06
5254307-25430784.66885.62
6263467-26346787.71888.64
60min1264808-26480888.16588.652.2789.5289.992.19
2266523-26652388.73690.10
3266408-26640888.69790.03
4257582-25758285.75987.17
5265776-26577688.48789.78
6276460-27646092.04493.32
极限1272314-27231490.66492.341.6392.3794.031.58
2275214-27521491.62993.35
3274383-27438391.35393.04
4277924-27792492.53194.29
5279234-27923492.96894.61
6285019-28501994.89496.54
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.431648931653271654541654581647421651750.21
216.441645211647151646180.09
单位质量响应值RSD%判断
10053.2610013.260.29数据可信
长期18月-供试品溶液-2023110822批-培哚普利-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151725-5172532.15735.6713.3832.1635.6713.38
263633-6363339.56039.56
359379-5937936.91536.92
451653-5165332.11232.11
568464-6846442.56342.56
649387-4938730.70330.70
10min1156931-15693197.56292.983.7997.6993.123.80
2152501-15250194.80894.97
3149416-14941692.89093.04
4146347-14634790.98291.11
5151671-15167194.29294.46
6140461-14046187.32287.45
15min1158545-15854598.56595.261.7499.0895.781.73
2153145-15314595.20895.75
3152229-15222994.63895.16
4151447-15144794.15294.64
5152005-15200594.49995.05
6152051-15205194.52895.00
20min1158707-15870798.66695.411.7299.5896.301.71
2151965-15196594.47495.39
3152393-15239394.74095.64
4151617-15161794.25895.13
5152811-15281195.00095.93
6153310-15331095.31196.16
30min1158294-15829498.40995.141.7599.7296.421.74
2152120-15212094.57195.87
3150616-15061693.63694.91
4152348-15234894.71295.96
5152361-15236194.72196.03
6152460-15246094.78296.01
45min1158289-15828998.40695.151.80100.1196.811.79
2151003-15100393.87695.55
3151294-15129494.05795.71
4153054-15305495.15196.78
5153338-15333895.32897.01
6151359-15135994.09895.71
60min1158066-15806698.26794.991.73100.3697.031.73
2151347-15134794.09096.14
3151813-15181394.38096.41
4152542-15254294.83396.84
5152088-15208894.55196.62
6150930-15093093.83195.82
极限1156896-15689697.54094.431.65100.0396.851.65
2150048-15004893.28395.71
3151339-15133994.08596.49
4151468-15146894.16596.55
5150958-15095893.84896.29
6150666-15066693.66796.03
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.592997603001592999043001183002193000320.07
212.542982332972842977580.23
单位质量响应值RSD%判断
23830.9823744.660.26数据可信
长期18月-供试品溶液-2023110822批-吲达帕胺-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133878-3387811.18813.2213.7411.1913.2213.73
245491-4549115.02415.02
341554-4155413.72313.72
438631-3863112.75812.76
546563-4656315.37815.38
633998-3399811.22811.23
10min1125614-12561441.48543.078.4441.5343.128.45
2142348-14234847.01147.07
3132876-13287643.88343.94
4126289-12628941.70741.76
5141809-14180946.83346.89
6113466-11346637.47337.52
15min1183351-18335160.55260.032.7760.7660.262.79
2187570-18757061.94662.19
3182072-18207260.13060.36
4177192-17719258.51858.74
5185894-18589461.39261.64
6174548-17454857.64557.84
20min1211905-21190569.98369.301.4170.4469.761.43
2212467-21246770.16870.66
3207878-20787868.65369.12
4205298-20529867.80168.25
5212514-21251470.18470.68
6208920-20892068.99769.42
30min1247036-24703681.58579.811.2482.3280.551.22
2240746-24074679.50780.28
3238419-23841978.73979.48
4240279-24027979.35380.08
5240704-24070479.49480.27
6242770-24277080.17680.88
45min1270597-27059789.36687.231.4290.4288.291.39
2260140-26014085.91287.01
3261924-26192486.50187.56
4263386-26338686.98488.02
5262496-26249686.69087.78
6266244-26624487.92888.95
60min1282943-28294393.44390.791.6694.8692.201.62
2269570-26957089.02790.46
3273711-27371190.39491.80
4274449-27444990.63892.03
5272407-27240789.96491.40
6276433-27643391.29392.67
极限1292544-29254496.61493.392.3198.4095.162.26
2274340-27434090.60292.40
3280820-28082092.74294.51
4282324-28232493.23994.99
5278797-27879792.07493.87
6287876-28787695.07296.81
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