精氨酸培哚普利片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)5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%
110.273230103217523219053222073220283221800.16
210.263227503221993224740.13
单位质量响应值RSD%判断
31370.9831430.210.14数据可信
长期24月-供试品溶液-2023092121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%
5min1276504-276504150.260151.5626.24150.26151.5626.24
2160623-16062387.28787.29
3232361-232361126.272126.27
4358536-358536194.839194.84
5337412-337412183.360183.36
6307899-307899167.321167.32
10min1380188-380188206.605195.564.96206.86195.814.97
2329101-329101178.843178.99
3372531-372531202.444202.65
4365901-365901198.841199.17
5355070-355070192.956193.26
6356349-356349193.651193.93
15min1383385-383385208.343198.343.73208.94198.923.73
2348152-348152189.196189.64
3378777-378777205.839206.39
4364573-364573198.120198.78
5356990-356990193.999194.63
6358009-358009194.553195.15
20min1379556-379556206.262198.842.96207.20199.752.96
2355617-355617193.253194.01
3379175-379175206.055206.95
4363451-363451197.510198.50
5356717-356717193.851194.80
6360885-360885196.116197.04
30min1378818-378818205.861199.012.74207.15200.262.73
2361261-361261196.320197.40
3378193-378193205.521206.76
4365057-365057198.383199.70
5355687-355687193.291194.56
6358294-358294194.708195.96
极限1381655-381655207.403199.782.80209.03201.352.78
2366448-366448199.139200.55
3378677-378677205.784207.36
4362596-362596197.045198.69
5357117-357117194.068195.66
6359236-359236195.219196.80
精氨酸培哚普利片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)5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%
110.273224703225953230813232113209893224690.28
210.263194053197833195940.09
单位质量响应值RSD%判断
31399.1231149.510.57数据可信
长期24月-供试品溶液-2023092221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%
5min1251118-251118137.018139.1124.86137.02139.1124.86
2315341-315341172.060172.06
3160811-16081187.74487.74
4209020-209020114.048114.05
5327960-327960178.946178.95
6265487-265487144.858144.86
10min1345235-345235188.371196.202.33188.60196.442.35
2368674-368674201.160201.45
3358694-358694195.715195.86
4357745-357745195.197195.39
5367169-367169200.339200.64
6360031-360031196.444196.69
15min1353602-353602192.937198.951.54193.48199.511.54
2368384-368384201.002201.62
3364336-364336198.793199.27
4366901-366901200.193200.71
5368074-368074200.833201.47
6366406-366406199.923200.49
20min1356074-356074194.285199.251.29195.15200.141.30
2369339-369339201.523202.48
3364946-364946199.126199.93
4366515-366515199.982200.83
5366360-366360199.898200.86
6367754-367754200.658201.56
30min1357624-357624195.131199.401.27196.32200.631.28
2368902-368902201.285202.58
3363999-363999198.610199.75
4364427-364427198.843200.03
5367077-367077200.289201.59
6370711-370711202.272203.51
极限1361894-361894197.461199.860.80198.97201.410.81
2368445-368445201.035202.66
3365922-365922199.659201.13
4365845-365845199.617201.13
5365173-365173199.250200.88
6370443-370443202.126203.70
精氨酸培哚普利片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)5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%
110.273220803230843210843203963229513219190.37
210.263224143225293224720.03
单位质量响应值RSD%判断
31345.5731430.020.20数据可信
长期24月-供试品溶液-2023092321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%
5min1276081-276081150.092172.808.62150.09172.808.62
2322273-322273175.204175.20
3346358-346358188.298188.30
4331143-331143180.026180.03
5293465-293465159.543159.54
6337835-337835183.665183.66
10min1370683-370683201.522200.111.12201.77200.401.12
2371560-371560201.999202.29
3363960-363960197.868198.18
4361824-361824196.706197.01
5369862-369862201.076201.34
6370651-370651201.505201.81
15min1373691-373691203.158201.331.06203.74201.951.05
2372529-372529202.526203.15
3368083-368083200.109200.75
4363588-363588197.665198.29
5370768-370768201.569202.17
6373365-373365202.981203.62
20min1374140-374140203.402201.101.17204.33202.061.17
2370203-370203201.262202.23
3369646-369646200.959201.94
4361742-361742196.662197.62
5372668-372668202.602203.54
6370986-370986201.687202.67
30min1373323-373323202.958200.761.35204.22202.051.34
2371371-371371201.897203.20
3365127-365127198.502199.81
4361172-361172196.352197.64
5373116-373116202.845204.12
6371593-371593202.017203.33
极限1372618-372618202.574200.551.23204.18202.181.22
2372412-372412202.462204.10
3364818-364818198.334199.98
4361821-361821196.705198.32
5370273-370273201.300202.91
6371456-371456201.943203.60
精氨酸培哚普利片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)5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%
110.273201613190753202973208933213063203460.27
210.263192503209183200840.37
单位质量响应值RSD%判断
31192.4131197.270.02数据可信
长期24月-供试品溶液-715967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%
5min1133231-13323172.87970.4611.7772.8870.4611.77
2126341-12634169.11069.11
3142000-14200077.67677.68
4117119-11711964.06664.07
5147135-14713580.48580.48
6106997-10699758.52958.53
10min1262739-262739143.722150.568.15143.84150.688.15
2272315-272315148.960149.08
3301770-301770165.072165.20
4269705-269705147.532147.64
5300716-300716164.496164.63
6244224-244224133.594133.69
15min1339393-339393185.653190.163.30186.01190.523.31
2342462-342462187.331187.69
3362910-362910198.517198.92
4354227-354227193.767194.12
5354522-354522193.928194.34
6332260-332260181.751182.07
20min1365597-365597199.987199.530.89200.66200.220.87
2365073-365073199.700200.38
3365620-365620199.999200.73
4359515-359515196.660197.34
5363489-363489198.833199.56
6369333-369333202.030202.65
30min1365522-365522199.945200.381.06200.95201.401.05
2368498-368498201.573202.58
3364891-364891199.600200.67
4360997-360997197.470198.47
5365488-365488199.927200.99
6372515-372515203.771204.73
极限1364267-364267199.259199.400.95200.60200.760.94
2366832-366832200.662202.01
3365901-365901200.153201.55
4359027-359027196.393197.73
5362424-362424198.251199.65
6368731-368731201.701203.00
精氨酸培哚普利片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)5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%
110.273204223205173208813205413214493207620.14
210.263211423208203209810.08
单位质量响应值RSD%判断
31232.9131284.700.12数据可信
长期24月-供试品溶液-2023091921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%
5min1135526-13552673.98382.8111.1573.9882.8111.15
2149992-14999281.88081.88
3129164-12916470.51070.51
4156596-15659685.48585.48
5170552-17055293.10393.10
6168330-16833091.89091.89
10min1177991-17799197.16498.231.3597.2998.371.35
2181576-18157699.12199.26
3178521-17852197.45497.57
4179547-17954798.01498.16
5178002-17800297.17097.33
6184026-184026100.459100.61
15min1179515-17951597.99698.811.2498.2899.111.24
2183208-183208100.012100.31
3180139-18013998.33798.62
4179945-17994598.23198.54
5178834-17883497.62597.94
6184382-184382100.653100.97
20min1178728-17872897.56798.701.1098.0299.161.10
2182318-18231899.52699.99
3180694-18069498.64099.08
4179707-17970798.10198.57
5179397-17939797.93298.41
6183935-183935100.409100.90
30min1178807-17880797.61098.631.2198.2299.261.22
2182751-18275199.763100.40
3179607-17960798.04698.65
4179202-17920297.82598.46
5179609-17960998.04898.69
6184063-184063100.479101.13
极限1178262-17826297.31298.591.2798.0999.391.27
2182811-18281199.796100.60
3179827-17982798.16798.94
4179265-17926597.86098.66
5179446-17944697.95998.77
6184055-184055100.475101.30
精氨酸培哚普利片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)5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%
110.273212753210823209323209483223393213150.19
210.263215453215413215430.01
单位质量响应值RSD%判断
31286.7631339.470.12数据可信
长期24月-供试品溶液-2023092021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%
5min1129268-12926870.44488.0611.2370.4488.0611.23
2171261-17126193.32893.33
3166724-16672490.85690.86
4151996-15199682.83082.83
5178175-17817597.09697.10
6172175-17217593.82693.83
10min1169197-16919792.20496.834.4392.3296.984.44
2184215-184215100.388100.54
3181956-18195699.15799.31
4166417-16641790.68990.83
5184303-184303100.436100.60
6180014-18001498.09898.25
15min1176214-17621496.02798.142.9996.3098.443.00
2184807-184807100.710101.03
3183996-183996100.268100.58
4171279-17127993.33893.63
5183851-183851100.189100.52
6180351-18035198.28298.60
20min1179191-17919197.65098.442.3998.0898.912.40
2184957-184957100.792101.28
3183476-18347699.985100.47
4173139-17313994.35294.80
5183334-18333499.907100.40
6179773-17977397.96798.45
30min1181496-18149698.90698.651.8399.5099.291.84
2183705-183705100.110100.77
3184121-184121100.336100.99
4175490-17549095.63396.23
5182519-18251999.463100.13
6178868-17886897.47498.12
极限1185034-185034100.83499.351.49101.59100.141.48
2183992-183992100.266101.09
3184429-184429100.504101.32
4179101-17910197.60198.36
5182330-18233099.360100.19
6178930-17893097.50898.32
精氨酸培哚普利片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)5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%
110.273211453213913214383211813216433213600.07
210.263212393214503213440.05
单位质量响应值RSD%判断
31291.1431320.080.07数据可信
长期24月-供试品溶液-2023092022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%
5min1144924-14492478.99590.129.3778.9990.129.37
2166079-16607990.52690.53
3179413-17941397.79497.79
4149993-14999381.75881.76
5167714-16771491.41791.42
6183870-183870100.224100.22
10min1183901-183901100.24099.742.14100.3799.892.14
2175699-17569995.77095.92
3185459-185459101.090101.25
4184555-184555100.597100.73
5181775-18177599.08299.23
6186506-186506101.660101.83
15min1185443-185443101.081100.591.55101.38100.901.55
2179430-17943097.80398.11
3186273-186273101.533101.86
4186293-186293101.544101.85
5182971-18297199.733100.05
6186809-186809101.826102.16
20min1184624-184624100.635100.451.03101.10100.941.03
2181223-18122398.78199.25
3184841-184841100.753101.25
4186115-186115101.447101.92
5182931-18293199.712100.20
6185997-185997101.383101.89
30min1184900-184900100.785100.990.73101.42101.640.73
2183807-183807100.189100.83
3185554-185554101.141101.81
4186583-186583101.702102.34
5183818-183818100.195100.85
6186963-186963101.909102.58
极限1185221-185221100.960101.070.56101.76101.890.55
2186108-186108101.443102.25
3184856-184856100.761101.60
4186471-186471101.641102.45
5183736-183736100.150100.97
6186141-186141101.461102.31
精氨酸培哚普利片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)5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%
110.273209303211643211503205893214413210550.10
210.263202393203193202790.02
单位质量响应值RSD%判断
31261.4431216.280.11数据可信
长期24月-供试品溶液-716277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%
5min197502-9750253.26048.4713.0453.2648.4713.04
299893-9989354.56654.57
389130-8913048.68748.69
489839-8983949.07449.07
588836-8883648.52648.53
667149-6714936.68036.68
10min1163148-16314889.11886.203.1889.2186.283.19
2164624-16462489.92590.02
3157289-15728985.91886.00
4152177-15217783.12683.21
5155520-15552084.95285.03
6154106-15410684.17984.24
15min1185363-185363101.253100.201.85101.49100.421.85
2187424-187424102.379102.62
3183408-183408100.185100.41
4177797-17779797.12097.34
5181581-18158199.18799.41
6185023-185023101.068101.27
20min1186133-186133101.674100.961.35102.08101.351.35
2187749-187749102.557102.97
3185508-185508101.332101.72
4180956-18095698.84699.23
5182790-18279099.848100.24
6185792-185792101.488101.86
30min1185859-185859101.524100.761.49102.10101.321.49
2187411-187411102.372102.95
3185508-185508101.332101.89
4180546-18054698.62299.17
5181573-18157399.18399.74
6185873-185873101.532102.07
极限1185386-185386101.266100.611.40102.01101.341.40
2186663-186663101.963102.72
3185324-185324101.232101.96
4180275-18027598.47499.19
5181718-18171899.26299.98
6185784-185784101.483102.19
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