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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
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
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
Favipiravir Impurities 1-19 Favipiravir Impurities 1-19
Ticagrelor Impurity 138X Ticagrelor Impurity 138X
(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
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
	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
Isavuconazole Impurity 49 Isavuconazole Impurity 49
(R)-5-(2-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)amino)-1-methoxyethyl)-8-hydroxyquinolin-2(1H)-one (R)-5-(2-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)amino)-1-methoxyethyl)-8-hydroxyquinolin-2(1H)-one
Avatrombopag Impurity 51 Avatrombopag Impurity 51
Tafluprost Impurity 18 Tafluprost Impurity 18
Meropenem Impurity MAP-B Meropenem Impurity MAP-B
(S,E)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-hydroxybut-2-enamide (S,E)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-hydroxybut-2-enamide
isopropyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate isopropyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate
N-(3-chloro-4-fluorophenyl)-7-fluoro-6,8-dinitroquinazolin-4-amine N-(3-chloro-4-fluorophenyl)-7-fluoro-6,8-dinitroquinazolin-4-amine
(S)-4-(((2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-5,12-dihydroxy-7-methoxy-6,11-dioxo-3,4,6,11-tetrahydrotetracene-2-carboxylic acid (S)-4-(((2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-5,12-dihydroxy-7-methoxy-6,11-dioxo-3,4,6,11-tetrahydrotetracene-2-carboxylic acid
3-Azabicyclo[3.1.0]hexane-2-carboxamide, N-[(1R)-1-cyano-2-[(3S)-2-oxo-3-pyrrolidinyl]ethyl]-3-[(2S)-3,3-dimethyl-1-oxo-2-[(2,2,2-trifluoroacetyl)amino]butyl]-6,6-dimethyl-, (1R,2S,5S)- 3-Azabicyclo[3.1.0]hexane-2-carboxamide, N-[(1R)-1-cyano-2-[(3S)-2-oxo-3-pyrrolidinyl]ethyl]-3-[(2S)-3,3-dimethyl-1-oxo-2-[(2,2,2-trifluoroacetyl)amino]butyl]-6,6-dimethyl-, (1R,2S,5S)- 2755812-41-8 C23H32F3N5O4
3-(4-cyanophenoxy)benzyl acetate 3-(4-cyanophenoxy)benzyl acetate 2990481-66-6
5-chloro-N-(4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)-6-(4-((4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)carbamoyl)piperidin-1-yl)nicotinamide 5-chloro-N-(4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)-6-(4-((4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)carbamoyl)piperidin-1-yl)nicotinamide
Bisoprolol Impurity 53 Bisoprolol Impurity 53
2-Desisopropyl-2-phenyl Repaglinide 2-Desisopropyl-2-phenyl Repaglinide 107362-12-9 C30H34N2O4
2-(3-CHLOROPHENYL)-2-CYANO-1-(3-PYRIDINYL)-1-ETHANONE 2-(3-CHLOROPHENYL)-2-CYANO-1-(3-PYRIDINYL)-1-ETHANONE 114444-10-9 C14H9ClN2O
Droxidopa Impurity M Droxidopa Impurity M
Vigabatrin Impurity 2 Vigabatrin Impurity 2
Aripiprazole peroxide degradation Impurity (MW:464Da) Aripiprazole peroxide degradation Impurity (MW:464Da)
Zileuton Impurity (MW = 279.31 Da) Zileuton Impurity (MW = 279.31 Da)
3'-chloro-3'-deoxythymidine (zidovudine impurity) 3'-chloro-3'-deoxythymidine (zidovudine impurity)
Rivaroxaban Impurity 81 Rivaroxaban Impurity 81
Salbutamol Impurity 37 Salbutamol Impurity 37
Gadobutrol Impurity 21 Gadobutrol Impurity 21
Flucloxacillin sodium EP Impurity E Flucloxacillin sodium EP Impurity E
Pyrazole Pyrazole
Cephalomannine (Paclitaxel Impurity I) Cephalomannine (Paclitaxel Impurity I)
Aristolactam IIIa N-β-glucoside Aristolactam IIIa N-β-glucoside 80311-26-8 C22H19NO9
METOPROLOL IMPURITY D METOPROLOL IMPURITY D C15H25NO3
NITRENDIPINE IMPURITY A NITRENDIPINE IMPURITY A
TAMSULOSIN IMPURITY D TAMSULOSIN IMPURITY D C20H28N2O5S
Macitentan Hydroxy amine Impurity Macitentan Hydroxy amine Impurity 2211059-05-9 C12H12BrN3O2
1,3-diethyl-1,3-dimethylurea 1,3-diethyl-1,3-dimethylurea 31468-19-6 C7H16N2O
2,4(1H,3H)-Pyrimidinedione, 6-[(3R)-3-amino-1-piperidinyl]-3-methyl- 2,4(1H,3H)-Pyrimidinedione, 6-[(3R)-3-amino-1-piperidinyl]-3-methyl- 2276323-24-9 C10H16N4O2
7H-Purine-7-acetic acid, 1,2,3,6-tetrahydro-1,3-dimethyl-2,6-dioxo-, ethyl ester 7H-Purine-7-acetic acid, 1,2,3,6-tetrahydro-1,3-dimethyl-2,6-dioxo-, ethyl ester 7029-96-1 C11H14N4O4
N-(2-Amino-4,5,6,7-tetrahydro-benzothiazol-6-yl)-acrylamide N-(2-Amino-4,5,6,7-tetrahydro-benzothiazol-6-yl)-acrylamide
Rifampin Impurity 6 Rifampin Impurity 6
Cefuroxime Dioxide Impurity(Cefuroxime Sulfoxide) Cefuroxime Dioxide Impurity(Cefuroxime Sulfoxide)
Amoxicillin Impurity N(EP) Amoxicillin Impurity N(EP)
Ampicillin Impurity F(USP) Ampicillin Impurity F(USP)
Azlocillin Opern-Ring Acetylation Impurity Azlocillin Opern-Ring Acetylation Impurity
Miconazole Impurity G(EP) Miconazole Impurity G(EP) 1370335-40-2 C18H14Cl4N2O
2-chloro-1-(5-hydroxy-5H-chromeno[2,3-b]pyridin-7-yl)propan-1-one 2-chloro-1-(5-hydroxy-5H-chromeno[2,3-b]pyridin-7-yl)propan-1-one
2-(5H-chromeno[2,3-b]pyridin-7-yl)acrylic acid 2-(5H-chromeno[2,3-b]pyridin-7-yl)acrylic acid 52549-22-1 C15H11NO3
PANTOPRAZOLE N-OXIDE PANTOPRAZOLE N-OXIDE 953787-60-5 C16H15F2N3O5S
DEHYDROARIPIPRAZOLE, HYDROCHLORIDE DEHYDROARIPIPRAZOLE, HYDROCHLORIDE 1008531-60-9 C23H26Cl3N3O2
N-(3-GUANIDINO-4-METHYLPHENYL)-4-(METHYLPIPERAZINE-1-YL-METHYL)BENZAMIDE N-(3-GUANIDINO-4-METHYLPHENYL)-4-(METHYLPIPERAZINE-1-YL-METHYL)BENZAMIDE 581076-65-5 C21H28N6O
Tirofiban-d9 Hydrochloride Tirofiban-d9 Hydrochloride 1331911-68-2 C22H37ClN2O5S
2-[4-(3-CHLORO-2-HYDROXYPROPOXY)PHENYL]ACETAMIDE 2-[4-(3-CHLORO-2-HYDROXYPROPOXY)PHENYL]ACETAMIDE 115538-83-5 C11H14ClNO3
Ibuprofen Alcohol Ibuprofen Alcohol 36039-36-8 C13H20O
1,1-BIS-(4-ISOBUTYLPHENYL)ETHANE 1,1-BIS-(4-ISOBUTYLPHENYL)ETHANE 102120-87-6 C22H30
Rosuvastatin Impurity 161 Rosuvastatin Impurity 161
Rosuvastatin Impurity 155 Rosuvastatin Impurity 155
Rosuvastatin Impurity 146 Rosuvastatin Impurity 146
Rosuvastatin Impurity 126 Rosuvastatin Impurity 126
(1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2,2-di(thiophen -2-yl)acetate (1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2,2-di(thiophen -2-yl)acetate 29461-90-3 C18H21NO3S2
Digoxin Impurity 2 Digoxin Impurity 2
DUTP, 100MM SOLUTION DUTP, 100MM SOLUTION 94736-09-1 C9H16N2NaO14P3
Oxacillin USP Impurity D Oxacillin USP Impurity D
Oxacillin sodium EP impurity B Oxacillin sodium EP impurity B
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