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Standard

In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.

According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.

In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.

International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.

Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.

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Structure Chemical Name CAS MF
Canagliflozin Impurity 23 Canagliflozin Impurity 23
Carfilzomib Impurity 4 Carfilzomib Impurity 4
Lenvatinib Impurity 2 Lenvatinib Impurity 2 2380197-90-8 C28H22ClN5O5
FeBuxostat Impurity 33 FeBuxostat Impurity 33 100118-38-5 C12H14O5
(S)-3-(4-phenoxyphenyl)-1-(piperidin-3-yl) (S)-3-(4-phenoxyphenyl)-1-(piperidin-3-yl) 1642630-12-3 C22H22N6O
Latamoxef Impurity 1 Latamoxef Impurity 1 75007-70-4 C19H20N6O7S
Amlodipine iMpurity K Amlodipine iMpurity K 1809326-44-0 C18H21ClN2O5
Cabozantinib impurity 4 Cabozantinib impurity 4 95932-39-1 C11H15NO3
Rosuvastatin EP Impurity C Rosuvastatin EP Impurity C 1620823-61-1 C22H27FN3NaO6S
6,7-bis(2-methoxyethoxy)-N-phenylquinazolin-4-amine 6,7-bis(2-methoxyethoxy)-N-phenylquinazolin-4-amine 1145671-52-8 C20H23N3O4
(3R,4R,5S)-ethyl 4-acetamido-5-amino-3-isopropoxycyclohex-1-enecarboxylate (3R,4R,5S)-ethyl 4-acetamido-5-amino-3-isopropoxycyclohex-1-enecarboxylate 1052063-36-1 C14H24N2O4
4-(N-(tert-butyl)acetamido)-5-(diallylamino)-3-(pentan-3-yloxy)cyclohex-1-enecarboxylate 4-(N-(tert-butyl)acetamido)-5-(diallylamino)-3-(pentan-3-yloxy)cyclohex-1-enecarboxylate 941296-96-4 C16H28N2O4
(2R,5S)-5-(4-amino-5-fluoro-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylic acid (2R,5S)-5-(4-amino-5-fluoro-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylic acid C8H8FN3O4S
Amlodipine Impurity 10 Amlodipine Impurity 10 2170104-51-3 C26H31ClN2O8S
Apixaban Impurity 15 Apixaban Impurity 15 1466571-07-2 C21H20N4O4
Clopidogrel Impurity 8 Clopidogrel Impurity 8 C15H14ClNO2S
Acyclovir Impurity I: 7,9'-[Ethylene-bis(oxymethylene)] Bis (2-amino-1-9-dihydro-6H-purin-6-one) Acyclovir Impurity I: 7,9'-[Ethylene-bis(oxymethylene)] Bis (2-amino-1-9-dihydro-6H-purin-6-one) 1797832-75-7 C14H16N10O4
Nilotinib genotoxic impurity 3 Nilotinib genotoxic impurity 3 915711-42-1 C19H17F3N4O
34-Methylcyanocobalamin 34-Methylcyanocobalamin 38218-51-8 C64H90CoN14O14P
Empagliflozin Impurity D Empagliflozin Impurity D
Ipragliflozin Impurity 2 Ipragliflozin Impurity 2
Nicergoline EP impurity F Nicergoline EP impurity F
Mirabegron Impurity 4 Mirabegron Impurity 4
Bisoprolol EP Impurity D Bisoprolol EP Impurity D 1225195-71-0 C26H40N2O5
Febuxostat Descyano Impurity Febuxostat Descyano Impurity 1206550-99-3 C15H17NO3S
(5S,8R,9S,10S,13S,14S)-10,13-dimethyl-1,5,6,7,8,9,10,11,12,13,15,16-dodecahydro-4H-cyclopenta[a]phenanthren-17(14H)-one (5S,8R,9S,10S,13S,14S)-10,13-dimethyl-1,5,6,7,8,9,10,11,12,13,15,16-dodecahydro-4H-cyclopenta[a]phenanthren-17(14H)-one 14639-79-3 C19H28O
Cefuroxime Sodium Impurity Cefuroxime Sodium Impurity C16H16N4NaO8S
5-chloro-6-[4-(ethoxycarbonyl)piperidino]nicotinic acid 5-chloro-6-[4-(ethoxycarbonyl)piperidino]nicotinic acid 931395-73-2 C14H17ClN2O4
2-Bromo (S)-Carbidopa 2-Bromo (S)-Carbidopa 43197-33-7 C10H13BrN2O4
Eliglustat intermediate 3 Eliglustat intermediate 3 491833-26-2 C23H28N2O5
Aztreonam Impurity B Aztreonam Impurity B 102586-36-7 C13H19N5O6S
Atorvastatin Impurity 30 Atorvastatin Impurity 30 666714-64-3 C26H23FN2O
Olopatadine  impurity Olopatadine impurity 3112735-87-9 C20H20N2O4
Azilsartan Impurity Azilsartan Impurity 1863930-34-0 C23H23N3O3
Voriconazole Impurity 8 Voriconazole Impurity 8 239807-03-5 C16H14F3N5O
Caspofungin impurity 3 Caspofungin impurity 3
Dapagliflozin Open Ring Dapagliflozin Open Ring 2100872-88-4 C21H27ClO7
Rortezide impurity Rortezide impurity
Aprepitant Impurity 2 Aprepitant Impurity 2
Cabozantinib Impurity A Cabozantinib Impurity A
Loxoprofen Impurity E Loxoprofen Impurity E
(R)-4-Propylpyrrolidin-2-one (R)-4-Propylpyrrolidin-2-one 930123-37-8 C7H13NO
Rocuronium Bromide Intermediate B Impurity E-1 Rocuronium Bromide Intermediate B Impurity E-1 1190105-60-2 C29H48N2O3
4-Chloro-2-propylsulfanyl-pyrimidine 4-Chloro-2-propylsulfanyl-pyrimidine 1351990-36-7 C7H9ClN2S
benzyl (S)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoate benzyl (S)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoate 1194550-67-8 C36H30Cl2N2O7S
D-Proline, 1-[(2S)-3-mercapto-2-methyl-1-oxopropyl]- D-Proline, 1-[(2S)-3-mercapto-2-methyl-1-oxopropyl]- 119238-52-7 C9H15NO3S
2,4(1H,3H)-Pyrimidinedione,5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-, (2S-cis)- (9CI) 2,4(1H,3H)-Pyrimidinedione,5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-, (2S-cis)- (9CI) 145281-92-1 C8H9FN2O4S
Cyclopentanecarboxylic acid, 1-[(1-oxopentyl)amino]- Cyclopentanecarboxylic acid, 1-[(1-oxopentyl)amino]- 15026-80-9 C11H19NO3
L-Phenylalanine, N-L-leucyl-, methyl ester L-Phenylalanine, N-L-leucyl-, methyl ester 38155-18-9 C16H24N2O3
Ethanol, 2-[(2-chloroethyl)amino]- Ethanol, 2-[(2-chloroethyl)amino]- 3890-98-0 C4H10ClNO
5-Methylarabinosylcytosine 5-Methylarabinosylcytosine 6829-31-8 C10H15N3O5
Anthranilic acid, N-furfuryl-5-sulfamoyl- Anthranilic acid, N-furfuryl-5-sulfamoyl- 4818-85-3 C12H12N2O5S
1,3-Benzodioxol-4-ol 1,3-Benzodioxol-4-ol 69393-72-2 C7H6O3
1H-Benzimidazole, 6-bromo-2-methyl-4-(phenylmethoxy)- 1H-Benzimidazole, 6-bromo-2-methyl-4-(phenylmethoxy)- 774582-60-4 C15H13BrN2O
Palonosetron Impurity 7 Palonosetron Impurity 7 177932-92-2 C18H24N2O
4-(2,3-Dichlorophenyl)-2,6-diMethyl-1,4-dihydropyridine-3,5-dicarboxylic acid 4-(2,3-Dichlorophenyl)-2,6-diMethyl-1,4-dihydropyridine-3,5-dicarboxylic acid 138279-32-0 C15H13Cl2NO4
IMp. A (EP) as Hydrochloride: 3-[[[2-[(DiaMinoMethylene)aMino]thiazol-4-yl]- Methyl]sulphanyl]propaniMidaMide Hydrochloride IMp. A (EP) as Hydrochloride: 3-[[[2-[(DiaMinoMethylene)aMino]thiazol-4-yl]- Methyl]sulphanyl]propaniMidaMide Hydrochloride
Desfluoro Rosuvastatin Sodium Salt Desfluoro Rosuvastatin Sodium Salt 847849-66-5 C22H29N3O6S
N-Benzoyl-N-[2-(phenyl)ethyl]-N-carbamic Acid R-Quinuclidinol Ester Succinic Acid Salt N-Benzoyl-N-[2-(phenyl)ethyl]-N-carbamic Acid R-Quinuclidinol Ester Succinic Acid Salt 1798817-92-1 C27H32N2O7
Tadalafil EP IMpurity A Tadalafil EP IMpurity A
(1R,3R,4R)-3-AMino-4-hydroxy-cyclohexanecarboxylic acid ethyl ester (1R,3R,4R)-3-AMino-4-hydroxy-cyclohexanecarboxylic acid ethyl ester 1392745-70-8 C14H25NO5
(S)-3-Hydroxypiperidine (S)-3-Hydroxypiperidine 24211-55-0 C5H11NO
Aprepitant iMpurity B Aprepitant iMpurity B
Aripiprazole iMpurity 4 Aripiprazole iMpurity 4 1424857-63-5 C36H42Cl2N4O4
Aripiprazole iMpurity 4 Aripiprazole iMpurity 4 1424857-63-5 C36H42Cl2N4O4
Avanafil IMpurity 8 (R-Avanafil) Avanafil IMpurity 8 (R-Avanafil)
EzetiMibe ring-opening dehydrate iMpurity EzetiMibe ring-opening dehydrate iMpurity 1292292-63-7 C24H21F2NO3
Fondaparinux sodiuM iMpurity 1 Fondaparinux sodiuM iMpurity 1 348625-84-3 C13H21NO19S3
Pitavastatin IMpurity 4 (PP-4) Pitavastatin IMpurity 4 (PP-4) 1422058-54-5 C25H22FNO3
Pregabalin IMpurity Pregabalin IMpurity 159029-27-3 C7H18N2
Valdecoxib 3'-SulfonaMide IMpurity Valdecoxib 3'-SulfonaMide IMpurity 1373038-56-2 C16H14N2O3S
4'-O-2,6-Dideoxy-3-O-Methyl-α-L-arabino-hexopyranosyl SelaMectin 4'-O-2,6-Dideoxy-3-O-Methyl-α-L-arabino-hexopyranosyl SelaMectin 301849-46-7 C50H75NO14
(3R,4R)-4-(2,5-Difluorophenyl)-3-Methyl-4-(1H-1,2,4-triazol-1-ylMethyl)-2-oxetanone (3R,4R)-4-(2,5-Difluorophenyl)-3-Methyl-4-(1H-1,2,4-triazol-1-ylMethyl)-2-oxetanone 483340-20-1 C13H11F2N3O2
6,7-DiMethoxy-2-(4-(tetrahydrofuran-2-carbonyl)piperazin-1-yl)quinazolin-4(1H)-one 6,7-DiMethoxy-2-(4-(tetrahydrofuran-2-carbonyl)piperazin-1-yl)quinazolin-4(1H)-one 1177261-73-2 C19H24N4O5
2-Hydroxy Atorvastatin Calcium Salt 2-Hydroxy Atorvastatin Calcium Salt 265989-46-6 C33H37CaFN2O6
13-oxo-1,4,7,10-Tetraazabicyclo[8.2.1]tridecane-4,7-diacetic Acid 13-oxo-1,4,7,10-Tetraazabicyclo[8.2.1]tridecane-4,7-diacetic Acid 229312-33-8 C13H22N4O5
rac-Clopidogrel Carboxylic Acid Hydrochloride rac-Clopidogrel Carboxylic Acid Hydrochloride 1015247-88-7 C15H15Cl2NO2S
(1R,2R,4S)-2-[(tert-butoxycarbonyl)aMino]-4-[(diMethylaMino)carbonyl]cyclohexyl Methanesulfonate (1R,2R,4S)-2-[(tert-butoxycarbonyl)aMino]-4-[(diMethylaMino)carbonyl]cyclohexyl Methanesulfonate 929693-31-2 C15H28N2O6S
Tegafur Impurity BCB Tegafur Impurity BCB
(R)-diethyl 2-(4-(3-chloro-4-fluorophenylaMino)-7-(tetrahydrofuran-3-yloxy)quinazolin-6-ylaMino)-2-oxo (R)-diethyl 2-(4-(3-chloro-4-fluorophenylaMino)-7-(tetrahydrofuran-3-yloxy)quinazolin-6-ylaMino)-2-oxo 618061-77-1 C24H27ClFN4O6P
((2R,3R,4R)-3-(benzoyloxy)-4-chloro-4-Methyl-5-oxotetrahydrofuran-2-yl)Methyl benzoate ((2R,3R,4R)-3-(benzoyloxy)-4-chloro-4-Methyl-5-oxotetrahydrofuran-2-yl)Methyl benzoate 1496551-65-5 C20H17ClO6
2-(4-fluorophenyl)-5-(2-Methylbenzyl)thiophene 2-(4-fluorophenyl)-5-(2-Methylbenzyl)thiophene 2005454-69-1 C18H15FS
AcetaMide, N-[[(5S)-2-oxo-3-[4-(3-oxo-4-Morpholinyl)phenyl]-5-oxazolidinyl]Methyl]- AcetaMide, N-[[(5S)-2-oxo-3-[4-(3-oxo-4-Morpholinyl)phenyl]-5-oxazolidinyl]Methyl]- 1429334-00-8 C16H19N3O5
PSI 7411 PSI 7411 1015073-43-4 C10H14FN2O8P
5-[[4-(Hydroxymethyl)phenoxy]methyl]-3-(1-methylethyl)-2-oxazolidinone 5-[[4-(Hydroxymethyl)phenoxy]methyl]-3-(1-methylethyl)-2-oxazolidinone 1071765-44-0 C14H19NO4
Plerixafor Impurity D Plerixafor Impurity D
Cefuroxime impurity 1 Cefuroxime impurity 1 C16H16N4O8S
Vonoprazan Impurity 9 Vonoprazan Impurity 9
Sitagliptin IMpurity 5 Sitagliptin IMpurity 5
Brexpiprazole Impurity3 Brexpiprazole Impurity3
Levetiracetam impurity 5 Levetiracetam impurity 5 1543300-90-8 C9H17NO4
Febuxostat Impurity B Febuxostat Impurity B
Sorafenib Impurity F Sorafenib Impurity F
Trelagliptin Impurity 1 Trelagliptin Impurity 1 1821400-07-0 C21H13ClF2N4O2
Vortioxetine Imp.J Vortioxetine Imp.J 2137588-68-0 C18H22N2S
4-amino-N-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide 4-amino-N-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide 1608459-56-8 C18H27N3O3
4,5-dichloro Rivaroxaban 4,5-dichloro Rivaroxaban 2305917-61-5 C25H28ClN3O6S
Solifenacin EP Impurity B Solifenacin EP Impurity B 1534326-81-2 C31H28N2O
Vildagliptin Impurity 6 Vildagliptin Impurity 6 1846606-31-2 C17H23N3O2
Flucloxacillin Impurity A Flucloxacillin Impurity A
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