达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354278609427834242779214275558427705742774970.03
210.376048611660820.80
单位质量响应值RSD%判断
413284.73586.50141.03数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2025081921批-二甲双胍-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%
5min1232056-2320561981.1211661.2010.381981.121661.2010.38
2197722-1977221688.0031688.00
3190826-1908261629.1301629.13
4187587-1875871601.4781601.48
5172025-1720251468.6211468.62
6187279-1872791598.8481598.85
10min1356481-3564813043.3693097.724.103053.273106.024.09
2381003-3810033252.7203261.16
3352829-3528293012.1913020.34
4368064-3680643142.2563150.26
5342284-3422842922.1662929.51
6376421-3764213213.6023221.60
15min1491559-4915594196.5644348.182.614221.694371.972.59
2509582-5095824350.4314375.13
3497842-4978424250.2044273.41
4510427-5104274357.6454381.36
5518484-5184844426.4304448.38
6528015-5280154507.7984531.86
20min1632251-6322515397.6885427.432.125443.795472.972.12
2638665-6386655452.4465498.90
3634303-6343035415.2065459.66
4650872-6508725556.6605602.17
5612312-6123125227.4635271.55
6646008-6460085515.1355561.74
30min1824161-8241617036.0727206.692.157109.177279.362.14
2849695-8496957254.0627327.78
3843818-8438187203.8897275.42
4851831-8518317272.2987345.59
5823949-8239497034.2627104.49
6871420-8714207439.5347513.71
45min11096601-10966019361.9629460.422.819470.249569.132.80
21114328-11143289513.3029623.29
31095931-10959319356.2429463.79
41130429-11304299650.7609760.41
51060994-10609949057.9769163.37
61150520-11505209822.2829933.66
60min11308000-130800011166.72911286.701.2411321.8111442.711.24
21325791-132579111318.61511476.17
31323580-132358011299.73911454.07
41313569-131356911214.27311372.18
51309510-130951011179.62011330.30
61351867-135186711541.23211701.72
120min11982283-198228316923.25417013.001.5917134.1717225.441.58
22005040-200504017117.53717331.68
32025814-202581417294.88917505.72
42006871-200687117133.16817347.15
51934943-193494316519.10116725.68
62001818-200181817090.03017308.22
180min12478004-247800421155.35121299.300.5821450.8821596.800.59
22488967-248896721248.94421548.68
32501844-250184421358.87921656.19
42508925-250892521419.33121718.97
52480268-248026821174.67921463.86
62511183-251118321438.60821742.25
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12830117-283011724161.42924493.721.7824562.7424897.731.77
22925546-292554624976.13025382.11
32911848-291184824859.18725263.29
42880742-288074224593.62725000.37
52790062-279006223819.46924214.52
62875924-287592424552.49524963.33
360min13471019-347101929632.97229500.140.9330155.0930026.620.93
23445360-344536029413.91529944.78
33489126-348912629787.55630315.95
43460128-346012829539.99330069.70
53397497-339749729005.29629519.45
63469631-346963129621.12330154.72
480min13842274-384227432802.47132205.521.5833472.7532879.491.56
23707293-370729331650.10332328.03
33782319-378231932290.62032967.96
43785449-378544932317.34132994.75
53695909-369590931552.91532212.09
63820863-382086332619.67933301.38
600min13953959-395395933755.95433713.641.1734590.2534548.641.17
23916201-391620133433.60434269.79
33982709-398270934001.40034840.19
43946577-394657733692.93234531.93
53882605-388260533146.78733963.73
64011966-401196634251.17435095.98
720min14067991-406799134729.47434598.071.3435732.5535601.641.33
24110415-411041535091.65936095.01
34062311-406231134680.98235689.78
44031940-403194034421.69735429.16
53955830-395583033771.92734754.60
64087106-408710634892.66435908.72
极限14042217-404221734509.43534180.880.9535686.1635357.440.95
24009080-400908034226.53635405.34
34002544-400254434170.73635352.94
43991338-399133834075.06835254.64
53938490-393849033623.89134775.42
64038725-403872534479.62335670.14
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数12500
标示量(mg)5供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.481591315960157371589515807158620.57
212.544324958432740043261790.04
单位质量响应值RSD%判断
1270.99344990.35140.39数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2025081921批-达格列净-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%
5min118573-1857347.16847.633.5947.1747.633.59
219510-1951049.54849.55
318788-1878847.71447.71
419136-1913648.59848.60
517545-1754544.55844.56
618984-1898448.21248.21
10min118758-1875847.63849.264.0647.8749.504.05
220372-2037251.73751.98
318978-1897848.19748.44
419910-1991050.56450.81
518407-1840746.74746.97
619959-1995950.68850.93
15min118550-1855047.11048.792.7247.5849.282.73
219829-1982950.35850.86
319054-1905448.39048.87
419403-1940349.27649.77
518731-1873147.57048.03
619712-1971250.06150.56
20min119310-1931049.04049.321.9549.7550.051.97
220019-2001950.84151.60
319260-1926048.91349.63
419536-1953649.61450.36
518879-1887947.94648.64
619527-1952749.59150.34
30min119254-1925448.89849.582.5249.8550.552.53
220029-2002950.86651.88
319255-1925548.90049.87
419803-1980350.29251.28
518805-1880547.75848.69
619984-1998450.75251.74
45min119395-1939549.25649.303.2350.4650.523.22
220133-2013351.13052.40
319169-1916948.68249.89
419689-1968950.00351.24
518325-1832546.53947.71
619760-1976050.18351.43
60min119264-1926448.92349.141.5050.3750.611.54
219707-1970750.04851.57
319197-1919748.75350.21
419400-1940049.26950.76
518914-1891448.03449.44
619613-1961349.81051.31
120min119116-1911648.54749.041.7950.2450.761.80
219733-1973350.11451.89
319598-1959849.77251.47
419125-1912548.57050.31
518822-1882247.80149.45
619468-1946849.44151.19
180min119287-1928748.98249.190.9650.9151.161.02
219579-1957949.72351.75
319439-1943949.36851.31
419430-1943049.34551.33
519044-1904448.36550.25
619446-1944649.38651.38
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min119594-1959449.76149.072.7551.9451.282.71
220146-2014651.16353.44
319296-1929649.00551.20
419082-1908248.46150.69
518551-1855147.11349.24
619267-1926748.93151.17
360min119522-1952249.57949.511.2952.0151.971.30
219745-1974550.14552.67
319682-1968249.98552.42
419261-1926148.91651.39
519125-1912548.57050.93
619646-1964649.89352.38
480min119883-1988350.49549.022.5253.1751.722.46
219403-1940349.27652.05
319271-1927148.94151.63
419211-1921148.78951.50
518446-1844646.84649.45
619595-1959549.76452.50
600min119018-1901848.29948.261.6151.2351.211.61
219298-1929849.01052.03
319214-1921448.79651.73
418840-1884047.84750.81
518479-1847946.93049.77
619176-1917648.70051.68
720min119074-1907448.44148.241.4251.6151.431.44
219370-1937049.19352.46
318947-1894748.11851.30
418785-1878547.70750.90
518627-1862747.30650.38
619172-1917248.69051.92
极限118916-1891648.04047.981.0751.4551.400.96
218898-1889847.99451.51
318916-1891648.04051.46
418511-1851147.01150.45
519092-1909248.48751.80
619016-1901648.29451.76
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354342929434485043420584342631434286943430670.03
210.374288839428619142875150.05
单位质量响应值RSD%判断
419620.00413453.711.05数据可信
供试品溶液-2025081921批-二甲双胍-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%
5min1228907-2289075.4964.6510.305.504.6410.36
2200008-2000084.8024.80
3190076-1900764.5634.56
4187438-1874384.5004.50
5169729-1697294.0754.07
6184967-1849674.4414.44
10min1355985-3559858.5478.713.998.578.733.98
2380714-3807149.1409.16
3351808-3518088.4468.47
4369045-3690458.8608.88
5343753-3437538.2538.27
6375212-3752129.0089.03
15min1490151-49015111.76812.202.5711.8412.272.54
2504791-50479112.11912.19
3500761-50076112.02312.09
4510015-51001512.24512.31
5516278-51627812.39512.46
6527871-52787112.67412.74
20min1629069-62906915.10315.312.2115.2315.442.21
2637036-63703615.29415.42
3640348-64034815.37415.50
4654790-65479015.72115.85
5615547-61554714.77914.90
6649025-64902515.58215.71
30min1826947-82694719.85420.341.7520.0620.541.75
2855159-85515920.53120.74
3850349-85034920.41620.62
4853422-85342220.49020.70
5831618-83161819.96620.16
6865329-86532920.77620.98
45min11102156-110215626.46126.682.7226.7726.992.71
21117099-111709926.82027.13
31098989-109898926.38526.69
41128065-112806527.08327.39
51066005-106600525.59325.89
61155628-115562827.74528.06
60min11316334-131633431.60431.841.7232.0432.281.72
21327170-132717031.86432.31
31332127-133212731.98332.42
41332712-133271231.99732.44
51289144-128914430.95131.38
61358431-135843132.61433.07
120min11986537-198653747.69447.961.3448.2948.561.34
22013637-201363748.34548.95
32024524-202452448.60649.20
42006993-200699348.18548.79
51949508-194950846.80547.39
62004419-200441948.12448.74
180min12483303-248330359.62159.970.6560.4560.810.65
22479126-247912659.52160.37
32496767-249676759.94460.78
42514817-251481760.37861.22
52495031-249503159.90360.72
62518602-251860260.46961.32
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12802398-280239867.28269.101.8668.4170.241.82
22877815-287781569.09370.24
32842173-284217368.23769.38
42923930-292393070.20071.35
52949074-294907470.80471.92
62872105-287210568.95670.11
360min13410243-341024381.87682.680.6883.3484.160.68
23449321-344932182.81484.30
33460243-346024383.07684.56
43441394-344139482.62484.12
53426331-342633182.26283.73
63474551-347455183.42084.92
480min13701527-370152788.86990.591.5790.7592.481.56
23797551-379755191.17593.08
33812023-381202391.52293.42
43775443-377544390.64492.56
53704146-370414688.93290.81
63847476-384747692.37394.29
600min13884472-388447293.26194.580.7995.5896.930.80
23953153-395315394.91097.27
33951167-395116794.86397.22
43943086-394308694.66997.03
53929240-392924094.33696.66
63975912-397591295.45797.84
720min13948599-394859994.80197.091.2897.5999.911.26
24031700-403170096.79699.63
34057551-405755197.417100.24
44057132-405713297.407100.24
54099343-409934398.420101.22
64069210-406921097.697100.56
极限13943818-394381894.68696.131.0197.9599.440.98
23985274-398527495.68299.00
33992223-399222395.84899.16
44018032-401803296.46899.79
54062428-406242897.534100.82
64021777-402177796.55899.90
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数12500
标示量(mg)5供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.481607616055161141603016228161010.49
212.541613216143161380.05
单位质量响应值RSD%判断
1290.141286.920.18数据可信
供试品溶液-2025081921批-达格列净-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%
5min118552-1855292.60793.993.5992.6193.993.59
219686-1968698.26798.27
318663-1866393.16193.16
419176-1917695.72195.72
517732-1773288.51388.51
619165-1916595.66795.67
10min118914-1891494.41496.153.3994.8896.623.39
220076-20076100.214100.71
318752-1875293.60594.07
419730-1973098.48798.97
518428-1842891.98892.43
619667-1966798.17298.65
15min118635-1863593.02195.892.3793.9696.842.37
219861-1986199.141100.13
319144-1914495.56296.50
419293-1929396.30597.28
518803-1880393.86094.76
619525-1952597.46498.43
20min119258-1925896.13197.272.0297.5398.702.04
220087-20087100.269101.76
319391-1939196.79598.21
419609-1960997.88399.34
518929-1892994.48895.86
619648-1964898.07899.53
30min118891-1889194.29997.822.9896.1899.742.97
220471-20471102.186104.18
319410-1941096.88998.79
419921-1992199.440101.38
519090-1909095.29297.14
619797-1979798.821100.77
45min119420-1942096.93997.052.4599.2999.462.45
219862-1986299.146101.65
319304-1930496.36098.74
419679-1967998.232100.67
518580-1858092.74695.07
619806-1980698.866101.31
60min119390-1939096.79097.192.1699.63100.082.16
219910-1991099.385102.38
319537-1953797.523100.39
419637-1963798.023100.95
518690-1869093.29596.08
619660-1966098.137101.07
120min119486-1948697.26997.161.78100.59100.541.77
219782-1978298.746102.24
319836-1983699.016102.37
419104-1910495.36298.78
519002-1900294.85398.10
619579-1957997.733101.16
180min119082-1908295.25297.221.8099.06101.081.76
219323-1932396.455100.44
319843-1984399.051102.90
419321-1932196.445100.34
519312-1931296.400100.13
619975-1997599.710103.62
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118589-1858992.79196.812.6797.07101.162.54
219377-1937796.725101.19
319198-1919895.831100.17
419613-1961397.903102.28
520172-20172100.693104.90
619416-1941696.919101.33
360min118996-1899694.82397.261.7299.57102.091.63
219137-1913795.527100.48
319765-1976598.662103.48
419754-1975498.607103.48
519683-1968398.252102.96
619568-1956897.678102.58
480min118720-1872093.44596.061.4598.67101.381.41
219222-1922295.951101.38
319394-1939496.810102.12
419228-1922895.981101.34
519391-1939196.795102.00
619505-1950597.364102.75
600min118652-1865293.10695.532.3998.79101.322.27
218843-1884394.05999.97
318930-1893094.493100.29
419102-1910295.352101.19
519371-1937196.695102.38
619923-1992399.450105.32
720min118630-1863092.99695.952.1299.15102.231.99
218930-1893094.493100.87
319315-1931596.415102.68
419412-1941296.899103.22
519810-1981098.886105.06
619239-1923996.036102.41
极限118265-1826591.17493.992.1397.79100.742.00
218550-1855092.59799.45
318795-1879593.820100.57
418927-1892794.478101.28
519436-1943697.019103.68
618999-1899994.838101.69
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354281431428591642898164283723428625042854270.08
210.374383532438145343824920.04
单位质量响应值RSD%判断
414050.92422612.541.45数据可信
供试品溶液-2025081922批-二甲双胍-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%
5min1159196-1591963.8064.3313.163.814.3313.12
2164831-1648313.9413.94
3183376-1833764.3844.38
4208664-2086644.9894.99
5160091-1600913.8273.83
6210911-2109115.0425.04
10min1339312-3393128.1128.808.478.138.828.48
2358843-3588438.5798.60
3340091-3400918.1318.15
4419667-41966710.03310.06
5389656-3896569.3159.33
6361615-3616158.6458.67
15min1499134-49913411.93312.072.8811.9912.132.90
2493541-49354111.79911.86
3485414-48541411.60511.67
4509270-50927012.17512.25
5522108-52210812.48212.55
6519008-51900812.40812.48
20min1606910-60691014.50914.942.1114.6315.072.10
2628023-62802315.01415.14
3624801-62480114.93715.06
4630729-63072915.07915.21
5614775-61477514.69714.83
6644680-64468015.41215.54
30min1820475-82047519.61520.152.6419.8120.352.62
2873291-87329120.87821.07
3837812-83781220.03020.22
4857761-85776120.50620.72
5816366-81636619.51719.72
6852094-85209420.37120.58
45min11080669-108066925.83626.102.0326.1326.402.04
21085796-108579625.95826.26
31081868-108186825.86426.16
41132790-113279027.08227.40
51070365-107036525.58925.89
61099258-109925826.28026.59
60min11359615-135961532.50431.342.4132.9231.782.35
21296890-129689031.00531.44
31338685-133868532.00432.43
41304798-130479831.19431.64
51287972-128797230.79231.22
61278127-127812730.55631.00
120min11980803-198080347.35546.481.4747.9447.071.46
21945580-194558046.51347.10
31961282-196128246.88847.47
41943408-194340846.46147.07
51894867-189486745.30145.88
61939933-193993346.37846.97
180min12483590-248359059.37558.462.8660.1959.282.82
22554728-255472861.07661.89
32440183-244018358.33759.16
42407723-240772357.56158.40
52347886-234788656.13156.94
62437254-243725458.26759.09
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12829712-282971267.65067.081.3168.7768.191.28
22844859-284485968.01269.14
32784825-278482566.57767.69
42782811-278281166.52967.65
52837256-283725667.83068.92
62754769-275476965.85866.97
360min13424500-342450081.86980.262.1783.3281.712.14
23407872-340787281.47282.94
33343380-334338079.93081.37
43353061-335306180.16281.62
53223399-322339977.06278.49
63390271-339027181.05182.50
480min13781427-378142790.40288.721.8692.2790.581.84
23762774-376277489.95791.83
33721252-372125288.96490.81
43749497-374949789.63991.50
53627934-362793486.73388.55
63624585-362458586.65388.50
600min13941312-394131294.22592.101.8496.5494.391.82
23870864-387086492.54194.86
33909128-390912893.45595.74
43828727-382872791.53393.84
53742347-374234789.46891.71
63821514-382151491.36193.65
720min14075432-407543297.43194.992.59100.2297.742.54
24046276-404627696.73499.52
34006935-400693595.79498.55
44019418-401941896.09298.86
53866186-386618692.42995.12
63824594-382459491.43494.18
极限14026005-402600596.25093.872.6299.5297.102.57
24021360-402136096.13999.41
33963984-396398494.76798.00
43937433-393743394.13297.38
53841088-384108891.82994.98
63768514-376851490.09493.29
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数12500
标示量(mg)5供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.481608516076161291603116069160780.22
212.541648916373164310.50
单位质量响应值RSD%判断
1288.301310.291.20数据可信
供试品溶液-2025081922批-达格列净-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%
5min117491-1749186.59389.753.8886.5989.753.88
219166-1916694.88694.89
318002-1800289.12389.12
418793-1879393.03993.04
517457-1745786.42586.42
617863-1786388.43588.43
10min118287-1828790.53491.772.0290.9792.222.02
219016-1901694.14394.62
318037-1803789.29689.74
418569-1856991.93092.40
518406-1840691.12391.56
618903-1890393.58494.03
15min118720-1872092.67892.432.5493.5693.332.53
219314-1931495.61896.56
317848-1784888.36189.25
418622-1862292.19393.12
518702-1870292.58993.48
618810-1881093.12394.03
20min118257-1825790.38692.052.2191.7393.422.21
219396-1939696.02497.45
318472-1847291.45092.78
418466-1846691.42092.81
518599-1859992.07993.43
618365-1836590.92092.30
30min118145-1814589.83192.502.3591.6394.322.34
219422-1942296.15398.06
318555-1855591.86193.65
418847-1884793.30695.15
518406-1840691.12392.93
618724-1872492.69894.53
45min118106-1810689.63892.902.8891.8995.202.86
219553-1955396.80299.19
318294-1829490.56992.82
419170-1917094.90697.22
518667-1866792.41594.68
618801-1880193.07995.37
60min118550-1855091.83692.731.2294.5395.481.24
219149-1914994.80297.67
318655-1865592.35695.06
418704-1870492.59995.38
518794-1879493.04495.77
618528-1852891.72794.49
120min118239-1823990.29692.092.1493.4595.322.13
219382-1938295.95599.30
318457-1845791.37694.54
418524-1852491.70794.95
518505-1850591.61394.81
618506-1850691.61894.84
180min118475-1847591.46593.224.1395.0796.904.04
220375-20375100.871104.69
318455-1845591.36694.99
418500-1850091.58995.29
518331-1833190.75294.40
618846-1884693.30296.98
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118282-1828290.50991.822.3494.5895.962.34
219372-1937295.906100.23
318127-1812789.74293.82
418502-1850291.59895.76
518552-1855291.84695.95
618443-1844391.30695.45
360min118299-1829990.59391.492.8095.1196.102.77
219530-1953096.688101.49
318216-1821690.18394.71
418347-1834790.83195.45
518198-1819890.09394.66
618291-1829190.55495.15
480min118279-1827990.49492.803.3195.4797.873.26
219953-1995398.782104.07
318401-1840191.09896.08
418764-1876492.89697.97
518681-1868192.48597.50
618393-1839391.05996.11
600min118209-1820990.14890.732.0695.5796.262.06
219078-1907894.450100.23
318314-1831490.66896.10
418077-1807789.49495.03
518167-1816789.94095.42
618120-1812089.70795.21
720min118148-1814889.84691.052.3595.7297.032.33
219190-1919095.005101.26
318363-1836390.91096.80
418468-1846891.43097.42
518239-1823990.29696.22
617941-1794188.82194.78
极限117887-1788788.55489.613.0094.8896.042.92
218990-1899094.014100.74
318118-1811889.69796.04
418188-1818890.04496.49
518104-1810489.62896.01
617312-1731285.70792.11
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