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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
Lansoprazole IMpurity I Lansoprazole IMpurity I
Lapatinib IMpurity 10 Lapatinib IMpurity 10 1152131-73-1 C26H17ClFN3O4
Metronidazole IMpurity D Metronidazole IMpurity D
PraMipexole IMpurity V (PraMipexole IMpurity Z) PraMipexole IMpurity V (PraMipexole IMpurity Z)
Prasugrel Acetyl IMpurity Prasugrel Acetyl IMpurity 1443034-67-0 C18H18FNO3S
Propofol IMpurity G Propofol IMpurity G
SalMeterol IMpurity A SalMeterol IMpurity A C25H37NO4
Sitagliptin Defuoro IMpurity 3 Sitagliptin Defuoro IMpurity 3 851307-12-5 C15H19F2NO4
Sitagliptin N-Boc IMpurity Sitagliptin N-Boc IMpurity 486460-23-5 C21H23F6N5O3
SulbactaM IMpurity D SulbactaM IMpurity D
Valsartan N2-Trityl IMpurity Valsartan N2-Trityl IMpurity
Vardenafil IMpurity 3 Vardenafil IMpurity 3 1255919-01-7 C26H30N6O4S
Montelukast Cyclopropaneacetonitrile Montelukast Cyclopropaneacetonitrile 866923-62-8 C35H35ClN2OS
(3R,4R,5R,6S)-2-(acetoxyMethyl)-6-(4-chloro-3-(4-ethoxybenzyl)phenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate (3R,4R,5R,6S)-2-(acetoxyMethyl)-6-(4-chloro-3-(4-ethoxybenzyl)phenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate 461432-24-6 C22H27ClO7
Ezetimibe Impurity Ezetimibe Impurity 1510820-22-0 C24H23F2NO2
10,13-bissidechainpaclitaxel 10,13-bissidechainpaclitaxel
Istradefylline Impurity A Istradefylline Impurity A
(3R,4S)-1-benzyl-N,4-diMethylpiperidin-3-aMine dihydrochloride (3R,4S)-1-benzyl-N,4-diMethylpiperidin-3-aMine dihydrochloride C14H24Cl2N2
Tegoprazan Impurity 4 Tegoprazan Impurity 4
PIVALOYLOXYMETHYL 6-AMINOPENICILANATE PIVALOYLOXYMETHYL 6-AMINOPENICILANATE 25031-08-7 C14H22N2O5S
(Z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)-3-methylbutanoic acid (Z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)-3-methylbutanoic acid
1H-Benzimidazole, 6-chloro-7-methyl-2-[(2S)-2-methyl-2-pyrrolidinyl]- 1H-Benzimidazole, 6-chloro-7-methyl-2-[(2S)-2-methyl-2-pyrrolidinyl]- 1788946-71-3 C13H16ClN3
(9S)-9-Amino-9-deoxoerythromycin (9S)-9-Amino-9-deoxoerythromycin 26116-56-3 C37H70N2O12
Oseltamivir Impurity 124 Oseltamivir Impurity 124
Oseltamivir Impurity 114 Oseltamivir Impurity 114
Avatrombopag Impurity 69 Avatrombopag Impurity 69
NSC525120 NSC525120 10221-08-6 C8H7Cl3
3-(2-cyanoethyl-(2-hydroxyethyl)amino)propanenitrile 3-(2-cyanoethyl-(2-hydroxyethyl)amino)propanenitrile 6305-56-2 C8H13N3O
TRANS-4-[[(2-AMINOPHENYL)METHYL]AMINO]-CYCLOHEXANOL TRANS-4-[[(2-AMINOPHENYL)METHYL]AMINO]-CYCLOHEXANOL 46727-91-7 C13H20N2O
Citalopram Related Compound F Citalopram Related Compound F
(1R,3aS,4E,7aR)-4-[(2E)-2-[(3S,5R)-3,5-bis[[(1,1-dimethylethyl)dimethylsilyl]oxy]-2-methylenecyclohexylidene]ethylidene]octahydro-7a-methyl-1-[(1R,4S)-1,4,5-trimethylhexyl]-1H-Indene (1R,3aS,4E,7aR)-4-[(2E)-2-[(3S,5R)-3,5-bis[[(1,1-dimethylethyl)dimethylsilyl]oxy]-2-methylenecyclohexylidene]ethylidene]octahydro-7a-methyl-1-[(1R,4S)-1,4,5-trimethylhexyl]-1H-Indene 2229745-37-1 C40H74O2Si2
2-Pyrrolidinecarboxamide,1-(hydroxyacetyl)-,(S)-(9CI) 2-Pyrrolidinecarboxamide,1-(hydroxyacetyl)-,(S)-(9CI) 96166-39-1 C7H12N2O3
1H-Pyrazole,3-ethoxy-5-methyl-1-phenyl-(9CI) 1H-Pyrazole,3-ethoxy-5-methyl-1-phenyl-(9CI) 300543-31-1 C12H14N2O
apiopaeonoside apiopaeonoside 100291-86-9 C20H28O12
(2-PHENOXY)METHYLSULFONYLANILINE (2-PHENOXY)METHYLSULFONYLANILINE 51765-51-6 C13H13NO3S
O-phenyl N-[4-[7-[6-cyano-5-(trifluoromethyl)pyridin-3-yl]-8-oxo-6-sulfanylidene-5,7-diazaspiro[3.4]octan-5-yl]-2-fluorobenzoyl]-N-methylcarbamothioate O-phenyl N-[4-[7-[6-cyano-5-(trifluoromethyl)pyridin-3-yl]-8-oxo-6-sulfanylidene-5,7-diazaspiro[3.4]octan-5-yl]-2-fluorobenzoyl]-N-methylcarbamothioate 2894796-78-0 C28H19F4N5O3S2
5,9,13,17-Nonadecatetraen-2-one, 6,10,14,18-tetramethyl-, (Z,E,Z)- (8CI) 5,9,13,17-Nonadecatetraen-2-one, 6,10,14,18-tetramethyl-, (Z,E,Z)- (8CI) 3879-25-2 C23H38O
(S)-Cilastatin EP Impurity G (S)-Cilastatin EP Impurity G
4-methoxy-2,3,5-trimethylpyridine 4-methoxy-2,3,5-trimethylpyridine 109371-19-9 C9H13NO
Lexithromycin Lexithromycin 53066-26-5 C38H70N2O13
Imimidistine impurity B Imimidistine impurity B
methylprednisolone 17-hemisuccinate methylprednisolone 17-hemisuccinate 77074-42-1 C26H34O8
N-Nitroso Macitentan N-Nitroso Macitentan
8-hydroxymethylriboflavin 8-hydroxymethylriboflavin 52134-62-0 C17H20N4O7
(R)-2-(3-(((3-(4-methoxyphenoxy)propyl)amino)methyl)phenoxy)butanoic acid (R)-2-(3-(((3-(4-methoxyphenoxy)propyl)amino)methyl)phenoxy)butanoic acid
RS 42358-197 RS 42358-197 135729-55-4 C19H23ClN2O
acetylthiamine acetylthiamine 3419-28-1
2-(((3-Methyl-4-nitropyridin-2-yl)Methyl)sulfinyl)-1H- benzo[d]iMidazole 2-(((3-Methyl-4-nitropyridin-2-yl)Methyl)sulfinyl)-1H- benzo[d]iMidazole 142384-07-4 C14H12N4O3S
Valsartan Desvaleryl Impurity Valsartan Desvaleryl Impurity 676129-92-3 C19H21N5O2
Istradefylline iMpurity Istradefylline iMpurity
(E)-Olopatadine Hydrochloride (E)-Olopatadine Hydrochloride 949141-22-4 C21H24ClNO3
(3R,4R,5R)-3-(1-Ethylpropoxy)-4-hydroxy-5-[(Methylsulfonyl)oxy]-1-cyclohexene-1-carboxylic Acid Ethyl Ester (3R,4R,5R)-3-(1-Ethylpropoxy)-4-hydroxy-5-[(Methylsulfonyl)oxy]-1-cyclohexene-1-carboxylic Acid Ethyl Ester 204254-92-2 C15H26O7S
(R)-α-[(2,2-DiMethyl-1-oxopropyl)aMino]-4-hydroxybenzeneacetic Acid (R)-α-[(2,2-DiMethyl-1-oxopropyl)aMino]-4-hydroxybenzeneacetic Acid 205826-86-4 C13H17NO4
(R)-α-[(2,2-DiMethyl-1-oxopropyl)aMino]-4-hydroxybenzeneacetic Acid (R)-α-[(2,2-DiMethyl-1-oxopropyl)aMino]-4-hydroxybenzeneacetic Acid 205826-86-4 C13H17NO4
4-PYRIDIN-4-YL-BUTYRIC ACID 4-PYRIDIN-4-YL-BUTYRIC ACID 102878-73-9 C9H11NO2
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
(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
Apixaban Impurities 15 Complete Set Apixaban Impurities 15 Complete Set
Peramivir Intermediate impurity 1 Peramivir Intermediate impurity 1
Rosuvastatin EP Impurity G Rosuvastatin EP Impurity G
Peramivir Intermediate Impurity 43 Peramivir Intermediate Impurity 43
(+)-Tamsulosin (+)-Tamsulosin 106138-88-9 C20H28N2O5S
deacetylcephalosporin C deacetylcephalosporin C 1476-46-6 C14H19N3O7S
N-nitroso-N-methylcyclohexylamine N-nitroso-N-methylcyclohexylamine 5432-28-0 C7H14N2O
ETHYLVANILLINBETA-D-GLUCOPYRANOSIDE ETHYLVANILLINBETA-D-GLUCOPYRANOSIDE 122397-96-0 C15H20O8
4-(2-Cyanophenyl)benzyl alcohol 4-(2-Cyanophenyl)benzyl alcohol 154709-19-0 C14H11NO
1-Propanol, 3-[[2-[(1H-benzimidazol-2-ylsulfinyl)methyl]-3-methyl-4-pyridinyl]oxy]- 1-Propanol, 3-[[2-[(1H-benzimidazol-2-ylsulfinyl)methyl]-3-methyl-4-pyridinyl]oxy]- 117976-94-0 C17H19N3O3S
2',3'-O-isopropylidene cytidine 2',3'-O-isopropylidene cytidine 362-42-5 C12H17N3O5
4,4''-Dimethoxyazoxybenzene 4,4''-Dimethoxyazoxybenzene 501-58-6 C14H14N2O2
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
LEYBOLD VACUUM PUMP OIL LEYBOLD VACUUM PUMP OIL 64742-65-0
2,2-Dimethyl-4-isopropyl-1,3-benzodioxole (Propofol Impurity L) 2,2-Dimethyl-4-isopropyl-1,3-benzodioxole (Propofol Impurity L) 201166-22-5 C12H16O2
24Dichloro-5methoxyacetanilide 24Dichloro-5methoxyacetanilide 65182-98-1 C9H9Cl2NO2
4,4,4-trifluoro-1-(2-methylphenyl)butane-1,3-dione 4,4,4-trifluoro-1-(2-methylphenyl)butane-1,3-dione 163266-02-2 C11H9F3O2
5-chloro-N-(4-nitrophenyl)pentanamide 5-chloro-N-(4-nitrophenyl)pentanamide 1039914-85-6 C11H13ClN2O3
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
6-(4-{2-[3,5-Bis-(tert-butyl-dimethyl-silanyloxy)-2-methylene-cyclohexylidene]-ethylidene}-7a-methyl-octahydro-inden-1-yl)-2-methyl-heptan-2-ol 6-(4-{2-[3,5-Bis-(tert-butyl-dimethyl-silanyloxy)-2-methylene-cyclohexylidene]-ethylidene}-7a-methyl-octahydro-inden-1-yl)-2-methyl-heptan-2-ol 140710-96-9 C39H72O3Si2
epi-Doxycycline epi-Doxycycline 3219-99-6 C22H24N2O8
C-Desmethyl Metoprolol C-Desmethyl Metoprolol 109632-08-8 C14H23NO3
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