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Standard

Standard Substance Protein assay reagent Titration standard Forensic and veterinary standards Analytical Standards Spectral Standards Chemistry Cosmetics Standard Volatile organic compounds (VOCs) Clinical Standards Veterinary drug and Pesticide residues Agricultural and environmental standards Chromatography Standards Life Science Standards Food and cosmetics standards Food and beverage standards Inorganic single element standard solution Pharmaceutical Impurity Reference Standards Water Testing Standards Organic Standard Solutions Organic Pollutant Standards Chinese medicine standards
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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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Chemical Name:
Tenofovir Impurity 103
Chemical Name:
Cabozantinib impurity 44
Chemical Name:
Cabozantinib impurity 40
Chemical Name:
Cabozantinib impurity 74
Chemical Name:
5-hydroxy-N,1,2-trimethyl-1H-indole-3-carboxamide
Chemical Name:
Doxofylline Impurity 25
Chemical Name:
Dapoxetine impurity 62
Chemical Name:
Dapoxetine impurity 56
Structure:
Chemical Name:
D(-)-AMETHOPTERIN
CAS:
51865-79-3
MF:
C20H22N8O5
Structure:
Chemical Name:
Glycine, N-(2-aminobenzoyl)-, ethyl ester
CAS:
5973-34-2
MF:
C11H14N2O3
Structure:
Chemical Name:
6-Chloro-3,4-dihydro-4-methyl-3-oxo-2H-1,4-benzoxanine-8-carboxylic acid
CAS:
123040-79-9
MF:
C10H8ClNO4
Structure:
Chemical Name:
3-Amino-3-azabicyclo[3.3.0]octane
CAS:
54528-00-6
MF:
C7H14N2
Structure:
Chemical Name:
(S)-Methyl 2-aminobutanoate
CAS:
15399-22-1
MF:
C5H11NO2
Chemical Name:
Bimatoprost Impurity 11
Chemical Name:
Bimatoprost Impurity 9
Chemical Name:
Dolutegravir Impurity 18
Structure:
Chemical Name:
PeraMpanel
CAS:
380918-53-6
MF:
C23H15N3O
Chemical Name:
Lenvatinib Impurity 33
Structure:
Chemical Name:
CHLORHEXIDENE DIACETATE IMPURITY A
CAS:
152504-08-0
MF:
C16H24ClN9
Chemical Name:
NA
Structure:
Chemical Name:
isopropyl 2-(2-oxopyrrolidin-1-yl)acetate
CAS:
1249080-59-8
MF:
C9H15NO3
Chemical Name:
Pitavastatin Impurity 71
Chemical Name:
Rosuvastatin EP Impurity M Sodium Salt
Chemical Name:
Furosemide impurity 8
Chemical Name:
Febuxostat Impurity 108
Chemical Name:
Flucloxacillin EP Impurity J
Structure:
Chemical Name:
Phosphonic acid, P-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]-, mono[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethyl] ester
CAS:
1878175-77-9
MF:
C17H23N10O4P
Structure:
Chemical Name:
Acetic acid, 2-[[(1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]amino]-2-oxo-, ethyl ester
CAS:
480450-85-9
MF:
C21H31N5O5S
Structure:
Chemical Name:
3H-Oxireno[3,4]pyrrolo[2,1-b][1,3]oxazine-3-butanoic acid, 1b-(4-fluorophenyl)hexahydro-β,7-dihydroxy-7-(1-methylethyl)-1a-phenyl-7a-[(phenylamino)carbonyl]-, (βR,3R)-
CAS:
1193817-52-5
MF:
C33H35FN2O7
Structure:
Chemical Name:
Hexanoic acid, 3-formyl-, ethyl ester
CAS:
54374-02-6
MF:
C9H16O3
Structure:
Chemical Name:
D-erythro-Hexonic acid, 2,4-dideoxy-3,5-O-(1-methylethylidene)-
CAS:
154877-92-6
MF:
C9H16O5
Structure:
Chemical Name:
INDEX NAME NOT YET ASSIGNED
CAS:
2463617-49-2
MF:
C51H56N16O4
Structure:
Chemical Name:
Benzoic acid, 4-[(1,3-dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy]-
CAS:
906673-43-6
MF:
C14H11BO5
Structure:
Chemical Name:
Benzenemethanamine, α,α'-sulfonylbis(methylene)bis[3-ethoxy-4-methoxy-
CAS:
2417213-71-7
MF:
C22H32N2O6S
Structure:
Chemical Name:
1H-Purine-2,6-dione, 8-(3-amino-1-piperidinyl)-7-(3-chloro-2-buten-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-
CAS:
2138805-26-0
MF:
C25H29ClN8O2
Structure:
Chemical Name:
1,3-Benzenedicarboxamide, 5-[acetyl(2,3-dihydroxypropyl)amino]-N1,N3-bis(2,3-dihydroxypropyl)-2,4-diiodo-
CAS:
1651211-78-7
MF:
C19H27I2N3O9
Chemical Name:
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxy-3-ethylbenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol
Chemical Name:
(E)-1-(4-(2-carboxyvinyl)benzyl)-1H-imidazole 3-oxide
Chemical Name:
Aprepitant impurity 2
Chemical Name:
Aprepitant impurity 4
Chemical Name:
Vonoprazan Impurity B-2
Structure:
Chemical Name:
2-(Cyanomethylthio)acetic acid
CAS:
55817-29-3
MF:
C4H5NO2S
Structure:
Chemical Name:
2(1H)-Pyridinone, 1-(3-aminophenyl)-5,6-dihydro-3-(4-morpholinyl)-
CAS:
2437650-75-2
MF:
C15H19N3O2
Structure:
Chemical Name:
4(1H)-Pyridinone, 1-(6-methoxy-1H-benzimidazol-2-yl)-2,3,5-trimethyl-
CAS:
2512216-37-2
MF:
C16H17N3O2
Chemical Name:
Budesonide Impurity 31
Chemical Name:
Budesonide Impurity 23
Structure:
Chemical Name:
Hexanoic acid, 3-(chloromethyl)-, (3R)-
CAS:
2101641-90-9
MF:
C7H13ClO2
Structure:
Chemical Name:
Bisoprolol Impurity
CAS:
2226263-68-7
MF:
C18H31NO4
Structure:
Chemical Name:
2(1H)-Quinolinone, 5-[(1R)-1,2-dihydroxyethyl]-8-(phenylmethoxy)-
CAS:
1261219-83-3
MF:
C18H17NO4
Structure:
Chemical Name:
Tofacitinib Impurity
CAS:
2504210-41-5
MF:
C29H38N10O2
Chemical Name:
tert-butyl 2-((4R,6S)-6-((E)-2-(4-(3-fluorophenyl)-6-isopropyl-2-(N- methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-2,2-dimethyl-1,3- dioxan-4-yl)acetate
Structure:
Chemical Name:
2-Pentenoic acid, 3-amino-2-cyano-5-[(3R,4R)-4-methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-1-piperidinyl]-5-oxo-, ethyl ester, (2E)-
CAS:
2459302-85-1
MF:
C21H27N7O3
Chemical Name:
Avatrombopag Impurity 38
Structure:
Chemical Name:
(1S,1'S,2S,2'S)-2,2'-((pentane-1,5-diylbis(oxy))bis(3-oxopropane-3,1-diyl))bis(1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin-2-ium)
CAS:
96946-55-3
MF:
C53H72N2O12+2
Chemical Name:
Fesoterodine Impurity 14
Chemical Name:
Dexamethasone EP impurities E
Structure:
Chemical Name:
(R)-N-((S)-2-aminobutanoyl)-3-(bromomethyl)hexanamide
MF:
C11H21BrN2O2
Chemical Name:
Empagliflozin Impurity 57(R,R)
Structure:
Chemical Name:
Azacitidine Impurity 37
CAS:
206269-46-7
MF:
C8H12N4O5
Chemical Name:
Aripiprazole peroxide degradation Impurity (MW:303Da)
Chemical Name:
2,2'-(4,10-bis((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,7-diyl)diacetic acid Gd3+
Structure:
Chemical Name:
3-[4-(acetyloxymethyl)phenyl]-2-propenoic acid methyl ester
CAS:
100688-45-7
MF:
C13H14O4
Structure:
Chemical Name:
Acetaminophen Impurity 14
CAS:
1991204-56-8
MF:
C16H18N2O2
Structure:
Chemical Name:
Ketoconazole Impurity 7
CAS:
172032-21-2
MF:
C11H12Cl2O3
Chemical Name:
Rosuvastatin Impurity 59
Chemical Name:
5-(5-(3-fluoro-4-(methylcarbamoyl)phenyl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-7-yl)-3-(trifluoromethyl)picolinamide
Chemical Name:
5-(5-(3-fluoro-4-(methylcarbamoyl)phenyl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-7-yl)-3-(trifluoromethyl)picolinamide
Structure:
Chemical Name:
Losartan Impurity 12
CAS:
727718-93-6
MF:
C22H22ClN9
Structure:
Chemical Name:
benzyl (2S)-2-amino-3-(4-methanesulfonylphenyl)propanoate hydrochloride
CAS:
1865726-28-8
MF:
C17H19NO4S
Structure:
Chemical Name:
Glycopyrrolate Impurity 12
CAS:
857353-41-4
MF:
C13H14O3
Structure:
Chemical Name:
(4S,4aR,5R,12aS)-4-(dimethylamino)-3,5,10,11,12a-pentahydroxy-6-methyl-1,12-dioxo-1,4,4a,5,12,12a-hexahydrotetracene-2-carboxamide
CAS:
4660-26-8
MF:
C22H22N2O8
Chemical Name:
Regorafenib Impurity 38
Chemical Name:
Cefazolin Impurity 28
Chemical Name:
NA
Structure:
Chemical Name:
Acarbose Impurity IV (JP)
MF:
C13H21NO7
Structure:
Chemical Name:
(2S)-Pinocembrin 7-O-[2''-O-(5'''-O-trans -cinnamoyl)-β-D-apiofuranosyl]-β-D-glucoside
CAS:
773899-29-9
MF:
C35H36O14
Structure:
Chemical Name:
Demethylagrimonolide 6-O-glucoside
CAS:
1257408-55-1
MF:
C23H26O10
Chemical Name:
Vonoprazan Impurity 57
Structure:
Chemical Name:
Tafluprost Impurity 9
CAS:
2099033-66-4
MF:
C27H41NO8
Chemical Name:
AZITHROMYCIN IMPURITY A
Structure:
Chemical Name:
2H-3-Benzazepin-2-one, 3-[3-[[[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-5-hydroxy-7,8-dimethoxy-
CAS:
2253977-80-7
MF:
C27H36N2O6
Structure:
Chemical Name:
Benzeneacetic acid, 3-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl-, methyl ester
CAS:
1187954-56-8
MF:
C33H41NO4
Structure:
Chemical Name:
D-Streptamine, O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)]-N1-[(2R)-4-amino-2-hydroxy-1-oxobutyl]-2-deoxy-
CAS:
50896-99-6
MF:
C22H43N5O13
Structure:
Chemical Name:
3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[[2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)ethoxy]methyl]-6-methyl-3,5-pyridinedicarboxylate
CAS:
331258-36-7
MF:
C28H25ClN2O7
Structure:
Chemical Name:
N-[2-(methylthio)ethyl]-2-[(3,3,3-trifluoropropyl)thio]-Adenosine 5''-(hydrogen P-1H-imidazol-1-ylphosphonate)
CAS:
1054332-15-8
MF:
C19H25F3N7O6PS2
Structure:
Chemical Name:
N-[5-(4-Bromophenyl)-6-[2-(2-pyrimidinyloxy)ethoxy]-4-pyrimidinyl]-N''-propyl-sulfamide
CAS:
2211059-00-4
MF:
C19H21BrN6O4S
Chemical Name:
Isomer 1 of Tazobactam Impurity 3
Chemical Name:
Ceftiofur USP Impurity I
Structure:
Chemical Name:
Aztreonam Open-Ring Impurity
CAS:
102579-58-8
MF:
C13H19N5O9S2
Chemical Name:
Cephalexin Degradation Impurity A
Chemical Name:
Azlocillin Impurity 8
Chemical Name:
Pregabalin-8687(mixture of 4 isomers)
Chemical Name:
7-(2-chloropropanoyl)-5H-chromeno[2,3-b]pyridin-5-one
Chemical Name:
1-(5H-chromeno[2,3-b]pyridin-7-yl)-2-methoxypropan-1-one
Chemical Name:
(E)-4-chloro-6-(3-(2,4-difluorophenyl)-4-(1H-1,2,4-triazol-1-yl)but-3-en-2-yl)-5-fluoropyrimidine
Structure:
Chemical Name:
Dolutegravir Impurity C
CAS:
1802141-49-6
MF:
C22H23F2N3O5
Structure:
Chemical Name:
Adefovir Dipivoxil Impurity 24
CAS:
116384-58-8
MF:
C14H23O7PS
Structure:
Chemical Name:
Dapoxetine Impurity 68
CAS:
119357-48-1
MF:
C19H18O
Structure:
Chemical Name:
Tobramycin Impurity
CAS:
74501-86-3
MF:
C18H35N5O8
Chemical Name:
Peramivir Impurity 24