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
N-(2,6-dimethylphenyl)piperidine-4-carboxamide N-(2,6-dimethylphenyl)piperidine-4-carboxamide 109403-19-2 C14H20N2O
5-{2-[1-(5-Hydroxy-1,5-dimethyl-hexyl)-7a-methyl-octahydro-inden-4-ylidene]-ethylidene}-4-methylene-cyclohexane-1,3-diol 5-{2-[1-(5-Hydroxy-1,5-dimethyl-hexyl)-7a-methyl-octahydro-inden-4-ylidene]-ethylidene}-4-methylene-cyclohexane-1,3-diol 73837-24-8 C27H44O3
3,5-Dibenzyloxy terbutalline 3,5-Dibenzyloxy terbutalline 28924-25-6 C26H31NO3
1H-BENZIMIDAZOLE,2-CHLORO-1-(2-ETHOXYETHYL) 1H-BENZIMIDAZOLE,2-CHLORO-1-(2-ETHOXYETHYL) 87233-54-3 C11H13ClN2O
2',3'-O-isopropylidene cytidine 2',3'-O-isopropylidene cytidine 362-42-5 C12H17N3O5
4,4''-Dimethoxyazoxybenzene 4,4''-Dimethoxyazoxybenzene 501-58-6 C14H14N2O2
(+)-Tamsulosin (+)-Tamsulosin 106138-88-9 C20H28N2O5S
Crisaborole Impurity 16 Crisaborole Impurity 16 2268785-42-6 C14H10BNO3
guanidine guanidine 113-00-8 CH5N3
tert-Butyl (E)-3,5-Dihydroxy-7-[3'-(4 tert-Butyl (E)-3,5-Dihydroxy-7-[3'-(4"-fluorophenyl)-1'-methylethylindol-2'-yl)hept-6-enoate 194934-96-8 C28H34FNO4
ethyl (R)-thiazolidine-4-carboxylate ethyl (R)-thiazolidine-4-carboxylate 60664-15-5 C6H11NO2S
3-((3R,4R)-3-(7H-[4,7'-bipyrrolo[2,3-d]pyrimidin]-4'-yl(methyl) amino)-4-methylpiperidin-1-yl)-3-oxopropanenitrile		3-((3R,4R)-3-(7H-[4,7'-bipyrrolo[2,3-d]pyrimidin]-4'-yl(methyl) amino)-4-methylpiperidin-1-yl)-3-oxopropanenitrile 2504210-48-2 C22H23N9O
Faropenem Impurity D Faropenem Impurity D
[2S-(2alpha,5alpha,6alpha)]-6-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid [2S-(2alpha,5alpha,6alpha)]-6-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 24138-28-1 C8H10BrNO3S
5-nitro-2-furaldehyde (5-nitrofurfurylene)hydrazone 5-nitro-2-furaldehyde (5-nitrofurfurylene)hydrazone 736-53-8 C10H6N4O6
4-(benzo[b]thiophen-4-yl)-1,1-bis(4-((2-oxo-1,2-dihydroquinolin-7-yl)oxy)butyl)piperazin-1-ium chloride 4-(benzo[b]thiophen-4-yl)-1,1-bis(4-((2-oxo-1,2-dihydroquinolin-7-yl)oxy)butyl)piperazin-1-ium chloride 2454317-16-7 C38H41N4O4S+
methyl (R)-thiazolidine-4-carboxylate methyl (R)-thiazolidine-4-carboxylate 42258-90-2 C5H9NO2S
Revefenacin Impurity 7 Revefenacin Impurity 7 1158777-54-8 C14H19ClN2O3
Glycine, N-[(4,7-dihydroxy-1-methyl-3-isoquinolinyl)carbonyl]- Glycine, N-[(4,7-dihydroxy-1-methyl-3-isoquinolinyl)carbonyl]- 2173338-12-8 C13H12N2O5
5-Thiazolecarboxylic acid, 2-[3,5-diformyl-4-(2-methylpropoxy)phenyl]-4-methyl-, ethyl ester 5-Thiazolecarboxylic acid, 2-[3,5-diformyl-4-(2-methylpropoxy)phenyl]-4-methyl-, ethyl ester 2375033-26-2 C19H21NO5S
Furosemide Impurity 6 Furosemide Impurity 6 74793-12-7 C12H10ClNO3
Lumateperone Impurity 3 Lumateperone Impurity 3 313544-76-2 C17H21N3O3
Butanoic acid, L-2-aminobutanoyl-L-2-amino-, methyl ester (9CI) Butanoic acid, L-2-aminobutanoyl-L-2-amino-, methyl ester (9CI) 772292-30-5 C9H18N2O3
Hexanoic acid, 3-(hydroxymethyl)-, (3R)- Hexanoic acid, 3-(hydroxymethyl)-, (3R)- 2096999-79-8 C7H14O3
2-(((Z)-(1-(2-aminothiazol-4-yl)-2-(((2S,3S)-1-(ethoxysulfonyl)-2-methyl-4-oxoazetidin-3-yl)amino)-2-oxoethylidene)amino)oxy)-2-methylpropanoic acid 2-(((Z)-(1-(2-aminothiazol-4-yl)-2-(((2S,3S)-1-(ethoxysulfonyl)-2-methyl-4-oxoazetidin-3-yl)amino)-2-oxoethylidene)amino)oxy)-2-methylpropanoic acid
3-Thiophenecarboxylic acid, 4-formyl-2,5-dihydro-2-(4-hydroxybutylidene)-5-methyl-, (2Z)- 3-Thiophenecarboxylic acid, 4-formyl-2,5-dihydro-2-(4-hydroxybutylidene)-5-methyl-, (2Z)- 1025974-23-5 C11H14O4S
1H-Pyrrole-3-methanamine, 1-[(1,4-dihydro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)-N-methyl- 1H-Pyrrole-3-methanamine, 1-[(1,4-dihydro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)-N-methyl- 2416241-98-8 C17H18FN3O2S
impurity 44 impurity 44
3-((2-acetamido-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy)propane- 1,2-diyl diacetate 3-((2-acetamido-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy)propane- 1,2-diyl diacetate 96429-68-4
L-erythro-Pentonic acid, 2-deoxy-2-fluoro-2-methyl-, γ-lactone, 3,5-dibenzoate, (2S)- L-erythro-Pentonic acid, 2-deoxy-2-fluoro-2-methyl-, γ-lactone, 3,5-dibenzoate, (2S)- 1946820-91-2 C20H17FO6
5,5'-Bi-1H-benzimidazole, 6,6'-bis(difluoromethoxy)-2,2'-bis[[(3,4-dimethoxy-2-pyridinyl)methyl]thio]- 5,5'-Bi-1H-benzimidazole, 6,6'-bis(difluoromethoxy)-2,2'-bis[[(3,4-dimethoxy-2-pyridinyl)methyl]thio]- 2251784-93-5 C32H28F4N6O6S2
1,4,7,10-Tetraazacyclododecane-1,7-diacetic acid, 4,10-bis[2,3-dihydroxy-1-(hydroxymethyl)propyl]- 1,4,7,10-Tetraazacyclododecane-1,7-diacetic acid, 4,10-bis[2,3-dihydroxy-1-(hydroxymethyl)propyl]- 2514736-58-2 C20H40N4O10
Valsartan Methyl Ester N2-Trityl Analog Valsartan Methyl Ester N2-Trityl Analog 883223-10-7 C44H45N5O3
Ampicillin Impurity G Ampicillin Impurity G
N-(5-((diphenylphosphoryl)methyl)-4-(3-fluorophenyl)-6-isopropylpyrimidin-2-yl)-N-methylmethanesulfonamide N-(5-((diphenylphosphoryl)methyl)-4-(3-fluorophenyl)-6-isopropylpyrimidin-2-yl)-N-methylmethanesulfonamide
(R)-8-(3-aminopiperidin-1-yl)-3-methyl-1,7-bis((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione (R)-8-(3-aminopiperidin-1-yl)-3-methyl-1,7-bis((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione
Oxytocin Impurity 8 Trifluoroacetate Oxytocin Impurity 8 Trifluoroacetate
Peramivir Dehydrated Impurity Peramivir Dehydrated Impurity
Apixaban Impurity 78 Apixaban Impurity 78
Formoterol Impurity 32 Formoterol Impurity 32
(1S,2S,3R,4R)-2-((R)-1-acetamido-2-ethylbutyl)-4-guanidino-3-hydroxycyclopentane-1-carboxylic acid (1S,2S,3R,4R)-2-((R)-1-acetamido-2-ethylbutyl)-4-guanidino-3-hydroxycyclopentane-1-carboxylic acid
Desloratadine EP impurity A hcl Desloratadine EP impurity A hcl 2250242-44-3 C19H21Cl2FN2
(R)-6-(2-((1S,2S)-2,6-dimethyl-1,2,3,4-tetrahydronaphthalen-1-yl) ethyl)-5,6-dihydro-2H-pyran-2-one and (R)-6-(2-((R)-2,6-dimethyl- 5,6,7,8-tetrahydronaphthalen-1-yl)ethyl)-5,6-dihydro-2H-pyran-2-one (R)-6-(2-((1S,2S)-2,6-dimethyl-1,2,3,4-tetrahydronaphthalen-1-yl) ethyl)-5,6-dihydro-2H-pyran-2-one and (R)-6-(2-((R)-2,6-dimethyl- 5,6,7,8-tetrahydronaphthalen-1-yl)ethyl)-5,6-dihydro-2H-pyran-2-one
(3S,4S)-Tofacitinib (3S,4S)-Tofacitinib 1092578-47-6 C16H20N6O
Rosuvastatin Impurity 145 Rosuvastatin Impurity 145
NA NA
Peramivir Intermediate impurity 1 Peramivir Intermediate impurity 1
NA NA
Peramivir Intermediate Impurity 43 Peramivir Intermediate Impurity 43
Peramivir Deacetylated Impurity Peramivir Deacetylated Impurity
NA NA
Loxoprofen Sodium Impurity 35 Loxoprofen Sodium Impurity 35
Dashatinib impurity 46 Dashatinib impurity 46
(R,S)-N-Acetyl-3,4-dimethoxy phenylalanine (R,S)-N-Acetyl-3,4-dimethoxy phenylalanine 27313-65-1 C13H17NO5
Sugammadex sodium Org199129-1 Impurity Sugammadex sodium Org199129-1 Impurity
Sugammadex sodium Impurity 41 Sugammadex sodium Impurity 41
Apixaban Impurity 51 Apixaban Impurity 51 1620494-29-2 C33H32N4O5
4-(5-methyl-2-phenyloxazol-4-yl)benzenesulfonamide 4-(5-methyl-2-phenyloxazol-4-yl)benzenesulfonamide 2242749-01-3 C16H14N2O3S
Cefazolin Impurity EP-I Cefazolin Impurity EP-I
Cabozantinib impurity 42 Cabozantinib impurity 42
Cabozantinib impurity 55 Cabozantinib impurity 55
Canagliflozin Impurity 68 Canagliflozin Impurity 68
4-PYRIDIN-4-YL-BUTYRIC ACID 4-PYRIDIN-4-YL-BUTYRIC ACID 102878-73-9 C9H11NO2
Azacitidine Impurity EJ Azacitidine Impurity EJ
Budesonide Impurity 28 Budesonide Impurity 28
Ethanol, 2-[2-(2-methyl-4-nitro-1H-imidazol-1-yl)ethoxy]- Ethanol, 2-[2-(2-methyl-4-nitro-1H-imidazol-1-yl)ethoxy]- 19765-12-9 C8H13N3O4
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2452301-30-1 C23H27ClO7
(5R,6S)-6-((R)-1-hydroxyethyl)-7-oxo-3-((S)-tetrahydrofuran-2-yl)-4-thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid 4,4-dioxide (5R,6S)-6-((R)-1-hydroxyethyl)-7-oxo-3-((S)-tetrahydrofuran-2-yl)-4-thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid 4,4-dioxide
(3S,5R,6E) Rosuvastatin Calcium Salt (2:1) (3S,5R,6E) Rosuvastatin Calcium Salt (2:1) 2414245-11-5 C22H30CaFN3O6S
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2452301-42-5 C23H27ClO7
Avatrombopag Impurity 35 Avatrombopag Impurity 35
2-AMINO-2'-FLUOROBENZOPHENONE 2-AMINO-2'-FLUOROBENZOPHENONE 1581-13-1 C13H10FNO
(R)-1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2,2-dimethyl-1,2,3,4-tetrahydroisoquinolin-2-ium (R)-1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2,2-dimethyl-1,2,3,4-tetrahydroisoquinolin-2-ium 2480467-84-1 C28H35NO7S
5-METHOXY-2-(METHYLTHIO)BENZIMIDAZOLE 5-METHOXY-2-(METHYLTHIO)BENZIMIDAZOLE 91168-31-9 C9H10N2OS
4-METHYL-6-PYRIDIN-3-YLPYRIMIDIN-2-AMINE 4-METHYL-6-PYRIDIN-3-YLPYRIMIDIN-2-AMINE 90916-52-2 C10H10N4
1-Benzyl-4-(5,6-dimethoxy-1-oxoindan-2-ylindenemethyl)piperidine 1-Benzyl-4-(5,6-dimethoxy-1-oxoindan-2-ylindenemethyl)piperidine 120014-07-5 C24H27NO3
Brivaracetam Impurity 55 Brivaracetam Impurity 55
alpha-(4-chlorophenyl)-alpha-[2-(dimethylamino)ethyl]pyridine-2-acetonitrile alpha-(4-chlorophenyl)-alpha-[2-(dimethylamino)ethyl]pyridine-2-acetonitrile 65676-21-3 C17H18ClN3
Baloxavir Impurity ABCDEFGHJKL Baloxavir Impurity ABCDEFGHJKL
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2514724-36-6 C22H19F2N3
scopoline scopoline 487-27-4 C8H13NO2
N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide 1474-02-8 C21H26N2O
Oseltamivir Impurity 106 Oseltamivir Impurity 106
Oseltamivir  Impurity 85 Oseltamivir Impurity 85
Oseltamivir  Impurity 83 Oseltamivir Impurity 83
Oseltamivir  Impurity 75 Oseltamivir Impurity 75
[1,1'-bicyclohexyl]-1-carboxylic acid [1,1'-bicyclohexyl]-1-carboxylic acid 60263-54-9 C13H22O2
3-Pyridinecarboxamide, 5-chloro-N-[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]-6-(dimethylamino)- 3-Pyridinecarboxamide, 5-chloro-N-[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]-6-(dimethylamino)- 2626934-45-8 C25H30Cl2N6OS2
Dapagliflozin Impurity 49 Dapagliflozin Impurity 49
11-[3-(dimethylamino)propyl]-6,11-dihydrodibenz[b,e]oxepin-11-ol 11-[3-(dimethylamino)propyl]-6,11-dihydrodibenz[b,e]oxepin-11-ol 4504-88-5 C19H23NO2
Avatrombopag Impurity ABCDEFGHJKL Avatrombopag Impurity ABCDEFGHJKL
1-(2-chloroethyl)-3-(dicyclopropylmethyl)urea 1-(2-chloroethyl)-3-(dicyclopropylmethyl)urea 54187-03-0 C10H17ClN2O
1,3-Dioxane-4-acetic acid, 6-[2-[3-[[[2-[(4R,6R)-6-[2-(1,1-dimethylethoxy)-2-oxoethyl]-2,2-dimethyl-1,3-dioxan-4-yl]ethyl]amino]carbonyl]-5-(4-fluorophenyl)-2-(1-methylethyl)-4-phenyl-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-, 1,1-dimethylethyl ester, (4R,6R)- 1,3-Dioxane-4-acetic acid, 6-[2-[3-[[[2-[(4R,6R)-6-[2-(1,1-dimethylethoxy)-2-oxoethyl]-2,2-dimethyl-1,3-dioxan-4-yl]ethyl]amino]carbonyl]-5-(4-fluorophenyl)-2-(1-methylethyl)-4-phenyl-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-, 1,1-dimethylethyl ester, (4R,6R)- 1229658-18-7 C48H67FN2O9
1H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-, 1,1-dimethylethyl ester, (βS,δR)- 1H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-, 1,1-dimethylethyl ester, (βS,δR)- 2588261-38-3 C37H43FN2O5
3-hydroxy-2,4-dimethoxybenzaldehyde 3-hydroxy-2,4-dimethoxybenzaldehyde 32246-34-7 C9H10O4
butyl 3-aminosulphonyl-5-butylamino-4-phenoxybenzoate butyl 3-aminosulphonyl-5-butylamino-4-phenoxybenzoate 32643-00-8 C21H28N2O5S
11beta,16alpha,17,21-tetrahydroxypregn-4-ene-3,20-dione 11beta,16alpha,17,21-tetrahydroxypregn-4-ene-3,20-dione 1171-81-9 C21H30O6
trans-2-amino-N-(4-hydroxycyclohexyl)benzamide trans-2-amino-N-(4-hydroxycyclohexyl)benzamide 15942-11-7 C13H18N2O2
4-O-(Carboxymethyl)rifamycin 4-O-(Carboxymethyl)rifamycin 13929-35-6 C39H49NO14
ethyl 3,5-bis(benzyloxy)benzoate ethyl 3,5-bis(benzyloxy)benzoate 50841-46-8 C23H22O4
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