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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
Febuxostat Impurity 109 Febuxostat Impurity 109
Brivaracetam Impurity 37 Brivaracetam Impurity 37
Ticagrelor Impurity 133 Ticagrelor Impurity 133
3-(Dimethylamino)-1-(2-thienyl)-1-propanol 3-(Dimethylamino)-1-(2-thienyl)-1-propanol 13636-02-7 C9H15NOS
2-PENTANOYLBENZOIC ACID 2-PENTANOYLBENZOIC ACID 550-37-8 C12H14O3
Benzamide, 2,5-dichloro-N-(3-methylbutyl)- Benzamide, 2,5-dichloro-N-(3-methylbutyl)- 349086-08-4 C12H15Cl2NO
BECLOTIAMINE BECLOTIAMINE 13471-78-8 C12H16Cl2N4S
methyl 5-sulpho-o-anisate methyl 5-sulpho-o-anisate 94134-07-3 C9H10O6S
2,4-dioxo-3-azaspiro[5.5]undecane-1,5-dicarbonitrile 2,4-dioxo-3-azaspiro[5.5]undecane-1,5-dicarbonitrile 4355-15-1 C12H13N3O2
Sugammadex Impurity 12 Monomer(Org198958-2(RRT0.45)) Sugammadex Impurity 12 Monomer(Org198958-2(RRT0.45)) 2412953-11-6 C72H112O49S8
Sulfamide, N-[5-phenyl-6-[2-(2-pyrimidinyloxy)ethoxy]-4-pyrimidinyl]-N'-propyl- Sulfamide, N-[5-phenyl-6-[2-(2-pyrimidinyloxy)ethoxy]-4-pyrimidinyl]-N'-propyl- 2300968-85-6 C19H22N6O4S
Acetamide, 2-chloro-N-(2-chloroacetyl)-N-(2,6-dimethylphenyl)- Acetamide, 2-chloro-N-(2-chloroacetyl)-N-(2,6-dimethylphenyl)- 112843-97-7 C12H13Cl2NO2
4-[(1,3-Dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy]-benzamide 4-[(1,3-Dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy]-benzamide 1187188-59-5 C14H12BNO4
2-Propenoic acid, 3-[4-(hydroxymethyl)phenyl]- 2-Propenoic acid, 3-[4-(hydroxymethyl)phenyl]- 219915-41-0 C10H10O3
L-Alanine, 3-[(R)-(carboxymethyl)sulfinyl]- L-Alanine, 3-[(R)-(carboxymethyl)sulfinyl]- 61475-35-2 C5H9NO5S
Phenol, 2-(2-phenyldiazenyl)- Phenol, 2-(2-phenyldiazenyl)- 2362-57-4 C12H10N2O
3-Quinolinecarboxylic acid, 1-cyclopropyl-7-fluoro-1,4-dihydro-6,8-dimethoxy-4-oxo- 3-Quinolinecarboxylic acid, 1-cyclopropyl-7-fluoro-1,4-dihydro-6,8-dimethoxy-4-oxo- 2410658-30-7 C15H14FNO5
Hexanoic acid, 3-(hydroxymethyl)- Hexanoic acid, 3-(hydroxymethyl)- 81381-87-5 C7H14O3
1-Pyrrolidinecarboxylic acid, 3,3'-dithiobis[5-[(dimethylamino)carbonyl]-, 1,1'-bis[(4-nitrophenyl)methyl] ester, (3S,3'S,5S,5'S)- 1-Pyrrolidinecarboxylic acid, 3,3'-dithiobis[5-[(dimethylamino)carbonyl]-, 1,1'-bis[(4-nitrophenyl)methyl] ester, (3S,3'S,5S,5'S)- 936226-36-7 C30H36N6O10S2
D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[[4-(1-methylethoxy)phenyl]methyl]phenyl]-, (1S)- D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[[4-(1-methylethoxy)phenyl]methyl]phenyl]-, (1S)- 946525-39-9 C22H27ClO6
Topiroxostat Impurity 42 Topiroxostat Impurity 42
Crisaborole intermediate Crisaborole intermediate 1187188-60-8 C14H13BO4
Regorafenib Impurity MHY Regorafenib Impurity MHY
2-Thiazolamine, 5-(4-cyclohexyl-1-piperazinyl)-4-(4,5-dichloro-2-thienyl)- 2-Thiazolamine, 5-(4-cyclohexyl-1-piperazinyl)-4-(4,5-dichloro-2-thienyl)- 570407-63-5 C17H22Cl2N4S2
N,N'-(2,2'-(sulfonylbis(1-(3-ethoxy-4-methoxyphenyl)ethane-2,1-diyl))bis(1,3-dioxoisoindoline-4,2-diyl))diacetamide N,N'-(2,2'-(sulfonylbis(1-(3-ethoxy-4-methoxyphenyl)ethane-2,1-diyl))bis(1,3-dioxoisoindoline-4,2-diyl))diacetamide 2417213-74-0 C42H42N4O12S
Lumateperone Impurity 6 Lumateperone Impurity 6 313368-82-0 C23H26FN3O
1H-?Indole-?5,?6-?diol, 1-?[3-?(4-?hydroxyphenyl)?-?1-?methylpropyl]?- 1H-?Indole-?5,?6-?diol, 1-?[3-?(4-?hydroxyphenyl)?-?1-?methylpropyl]?- 2514709-72-7 C18H19NO3
2,8-Chrysenedione, 10b-fluoro-1,3,4,4a,4b,5,6,10a,10b,11,12,12a-dodecahydro-1,11-dihydroxy-3,10a,12a-trimethyl-1-[(phosphonooxy)methyl]-, (1S,3S,4aS,4bS,10aS,10bR,11S,12aS)- 2,8-Chrysenedione, 10b-fluoro-1,3,4,4a,4b,5,6,10a,10b,11,12,12a-dodecahydro-1,11-dihydroxy-3,10a,12a-trimethyl-1-[(phosphonooxy)methyl]-, (1S,3S,4aS,4bS,10aS,10bR,11S,12aS)- 1202002-01-4 C22H30FO8P
6,6'-oxybis(3-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoic acid) 6,6'-oxybis(3-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoic acid)
4-Pyrimidineethanol, 6-bromo-α-(2,4-difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)- 4-Pyrimidineethanol, 6-bromo-α-(2,4-difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)- 1307315-04-3 C16H13BrF3N5O
Cycloocta[b]pyridine, 2-(4-ethyl-1,4-dioxido-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydro- Cycloocta[b]pyridine, 2-(4-ethyl-1,4-dioxido-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydro- 2247538-61-8 C23H30FN3O2
Apremilast Impurity 84 Apremilast Impurity 84 2096492-43-0 C22H24N2O8S
Vonoprazan Impurity B-3 Vonoprazan Impurity B-3
3-Azetidineacetamide, 1-(ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]- 3-Azetidineacetamide, 1-(ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]- 2271228-51-2 C16H19N7O3S
Budesonide Impurity 26 Budesonide Impurity 26
Peramivir Impurity 48 Peramivir Impurity 48
Tolvaptan dehydroxylated impurity Tolvaptan dehydroxylated impurity
3-Quinolinemethanol, 2-cyclopropyl-4-phenyl- 3-Quinolinemethanol, 2-cyclopropyl-4-phenyl- 2153433-73-7 C19H17NO
Avatrombopag Impurity 37 Avatrombopag Impurity 37
Piperacillin ImpurityABCDEFGHI Piperacillin ImpurityABCDEFGHI
5,6-DIMETHOXY-2-PYRIDIN-4-YLMETHYL-INDAN-1-ONE 5,6-DIMETHOXY-2-PYRIDIN-4-YLMETHYL-INDAN-1-ONE 4803-57-0 C17H17NO3
(R)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-2-((4-methylquinazolin-2-yl)methoxy)-3,7-dihydro-6H-purin-6-one (R)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-2-((4-methylquinazolin-2-yl)methoxy)-3,7-dihydro-6H-purin-6-one 2446799-72-8 C25H28N8O2
CETEARYL GLUCOSIDE CETEARYL GLUCOSIDE
Troxipide Impurity 8 Troxipide Impurity 8
Peramivir Impurity 12/11 Peramivir Impurity 12/11
(1S,2R,3R,4R)-3-((S)-1-acetamido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentane-1-carboxylic acid (1S,2R,3R,4R)-3-((S)-1-acetamido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentane-1-carboxylic acid
Ceftazidime Impurity IMPA Ceftazidime Impurity IMPA
Pitavastatin Impurity 82 Pitavastatin Impurity 82
Terbutaline EP Impurity B Complete Set Terbutaline EP Impurity B Complete Set
Peramivir Intermediate impurity 2 Peramivir Intermediate impurity 2
Cetrorelix Impurity 8 (+L-Pro) Cetrorelix Impurity 8 (+L-Pro)
Peramivir Intermediate Impurity 44 Peramivir Intermediate Impurity 44
Peramivir Hydroxy Isomeric Impurity Peramivir Hydroxy Isomeric Impurity
Nintedanib impurity F drops Nintedanib impurity F drops
1-[2-cyano-1-(cyanoimino)ethyl]piperidine 1-[2-cyano-1-(cyanoimino)ethyl]piperidine 56488-00-7 C9H12N4
Oseltamivir Impurity 99 Oseltamivir Impurity 99
Oseltamivir  Impurity 92 Oseltamivir Impurity 92
Oseltamivir  Impurity 76 Oseltamivir Impurity 76
Regorafenib Impurity ABCDEFGHJKL Regorafenib Impurity ABCDEFGHJKL
(S)-2-((1r,3R,5R,7S)-3-hydroxyadamantan-1-yl)-1-iminohexahydro pyrrolo[1,2-a]pyrazin-4(1H)-one hydrochloride (S)-2-((1r,3R,5R,7S)-3-hydroxyadamantan-1-yl)-1-iminohexahydro pyrrolo[1,2-a]pyrazin-4(1H)-one hydrochloride
Benzonitrile, 4-[2-[(1R,2S)-2-(2,5-difluorophenyl)-2-hydroxy-1-methyl-3-(1H-1,2,4-triazol-1-yl)propyl]-4-thiazolyl]-, rel- Benzonitrile, 4-[2-[(1R,2S)-2-(2,5-difluorophenyl)-2-hydroxy-1-methyl-3-(1H-1,2,4-triazol-1-yl)propyl]-4-thiazolyl]-, rel- 1797905-83-9 C22H17F2N5OS
3,4,5-Piperidinetriol, 1-(2-hydroxyethyl)-2-(hydroxymethyl)-, (2S,3S,4R,5S)- 3,4,5-Piperidinetriol, 1-(2-hydroxyethyl)-2-(hydroxymethyl)-, (2S,3S,4R,5S)- 1550201-56-3 C8H17NO5
1-(2,4-difluoro-6-hydroxyphenyl)prop-2-en-1-one 1-(2,4-difluoro-6-hydroxyphenyl)prop-2-en-1-one
1-(4-fluorophenyl)-1,3-dihydro-1-[3-(methylamino)propyl]isobenzofuran-5-carbonitrile 1-(4-fluorophenyl)-1,3-dihydro-1-[3-(methylamino)propyl]isobenzofuran-5-carbonitrile 62498-67-3 C19H19FN2O
17,21-Dihydroxy-16α-methylpregna-1,4,9(11)-triene-3,20-dione 21-Acetate 17,21-Dihydroxy-16α-methylpregna-1,4,9(11)-triene-3,20-dione 21-Acetate 10106-41-9 C24H30O5
2-chloro-N-(2,4-dimethylphenyl)acetamide 2-chloro-N-(2,4-dimethylphenyl)acetamide 39106-10-0 C10H12ClNO
sodium [2S-(2alpha,5alpha,6beta)]-6-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate sodium [2S-(2alpha,5alpha,6beta)]-6-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 73335-78-1 C8H9BrNNaO3S
8-chloro-3,7-dihydro-1,3,7-trimethyl-1H-purine-2,6-dione 8-chloro-3,7-dihydro-1,3,7-trimethyl-1H-purine-2,6-dione 4921-49-7 C8H9ClN4O2
2-amino-1-(3,4-dihydroxyphenyl)ethan-1-one 2-amino-1-(3,4-dihydroxyphenyl)ethan-1-one 499-61-6 C8H9NO3
Benzoic acid, 5-(aminosulfonyl)-2-[[[4-methoxy-3-(methoxycarbonyl)phenyl]sulfonyl]oxy]-, methyl ester Benzoic acid, 5-(aminosulfonyl)-2-[[[4-methoxy-3-(methoxycarbonyl)phenyl]sulfonyl]oxy]-, methyl ester 2267259-70-9 C17H17NO10S2
2(1H)-Quinolinone, 7-(4-chlorobutoxy)-1-(4-chlorobutyl)-3,4-dihydro- 2(1H)-Quinolinone, 7-(4-chlorobutoxy)-1-(4-chlorobutyl)-3,4-dihydro- 2295935-56-5 C17H23Cl2NO2
7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9,10-difluoro-2,3-dihydro-2-methyl-7-oxo-, (S)- (9CI) 7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9,10-difluoro-2,3-dihydro-2-methyl-7-oxo-, (S)- (9CI) 129798-65-8 C13H9F2NO4
Sitagliptin EP Impurity 1 Sitagliptin EP Impurity 1
4,6-Methano-1,3,2-benzodioxaborole-2-methanamine, hexahydro-3a,8,8-trimethyl-α-(2-methylpropyl)-, (αS,3aR,4R,6R,7aS)-, 2,2,2-trifluoroacetate (1:1) 4,6-Methano-1,3,2-benzodioxaborole-2-methanamine, hexahydro-3a,8,8-trimethyl-α-(2-methylpropyl)-, (αS,3aR,4R,6R,7aS)-, 2,2,2-trifluoroacetate (1:1) 2363753-29-9 C17H29BF3NO4
Beprostatin impurity 3 Beprostatin impurity 3
endo-(±)-8-aza-8-isopropylbicyclo[3.2.1]oct-3-yl (hydroxymethyl)phenylacetate endo-(±)-8-aza-8-isopropylbicyclo[3.2.1]oct-3-yl (hydroxymethyl)phenylacetate 22235-81-0 C19H27NO3
8,11-Dioxa-3,5-diazadodecanoic acid, 12-(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)-10-(hydroxymethyl)-2,6-bis(1-methylethyl)-7-oxo-, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, (2S,6S)- 8,11-Dioxa-3,5-diazadodecanoic acid, 12-(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)-10-(hydroxymethyl)-2,6-bis(1-methylethyl)-7-oxo-, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, (2S,6S)- 1654737-35-5 C29H44N12O10
(1R,3r,5S,8R)-8-butyl-3-(((S)-3-hydroxy-2-phenylpropanoyl)oxy)-8-methyl-8-azabicyclo[3.2.1]octan-8-ium (1R,3r,5S,8R)-8-butyl-3-(((S)-3-hydroxy-2-phenylpropanoyl)oxy)-8-methyl-8-azabicyclo[3.2.1]octan-8-ium 99571-66-1 C21H32NO3
1,3-dihydro-1-oxoisobenzofuran-5-carboxamide 1,3-dihydro-1-oxoisobenzofuran-5-carboxamide 85118-25-8 C9H7NO3
Favipiravir Impurities 1-19 Favipiravir Impurities 1-19
Ticagrelor Impurity 138X Ticagrelor Impurity 138X
Apremilast Impurity 999 Apremilast Impurity 999
Pranoprofen Impurity C Pranoprofen Impurity C
Abiolone Impurity 24 Abiolone Impurity 24
Deerasirox Impurity II Deerasirox Impurity II
Brivaracetam Impurity 49 Brivaracetam Impurity 49
Paroxetine EP Impurity J HCl Paroxetine EP Impurity J HCl
Brivaracetam Impurity 99 Brivaracetam Impurity 99
Bendamustine Impurity 39 Bendamustine Impurity 39
AvatrombopagImpurity42 AvatrombopagImpurity42
(R)-4-(((R)-1-carboxy-2-((3-hydroxypropyl)thio)ethyl)amino)-3-hydroxy-4-oxobutanoic acid (R)-4-(((R)-1-carboxy-2-((3-hydroxypropyl)thio)ethyl)amino)-3-hydroxy-4-oxobutanoic acid
Hydrazinecarboxamide, 2-(6-hydroxy-1-methyl-1H-indol-5-yl)- Hydrazinecarboxamide, 2-(6-hydroxy-1-methyl-1H-indol-5-yl)- 70063-07-9 C10H12N4O2
1H-Pyrrole-3-carboxaldehyde, 1-[(5-chloro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)- 1H-Pyrrole-3-carboxaldehyde, 1-[(5-chloro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)- 2514742-82-4 C16H10ClFN2O3S
3,5-Pyridinedicarboxylic acid, 2-[(2-chloroethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester 3,5-Pyridinedicarboxylic acid, 2-[(2-chloroethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester 221446-45-3 C20H23Cl2NO5
	Crisaborole Impurity 20 Crisaborole Impurity 20
(Z)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-methoxyquinazolin-6-yl)-4-(piperidin-1-yl)but-2-enamide (Z)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-methoxyquinazolin-6-yl)-4-(piperidin-1-yl)but-2-enamide
(1S,3R,5S,6R)-6-hydroxy-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2,2-di(thiophen-2-yl)acetate (1S,3R,5S,6R)-6-hydroxy-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2,2-di(thiophen-2-yl)acetate
Nicergoline EP Impurity IJ Nicergoline EP Impurity IJ
Fulvestrant impurityABCDEFGHJKL Fulvestrant impurityABCDEFGHJKL
2-((6S,8S,9S,10S,11S,13S,14S,17R)-11,17-dihydroxy-6,10,13-trimethyl-3-oxohexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl acetate 2-((6S,8S,9S,10S,11S,13S,14S,17R)-11,17-dihydroxy-6,10,13-trimethyl-3-oxohexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl acetate 114696-04-7 C24H36O6
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