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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
Abiraterone Impurity 4 Abiraterone Impurity 4 2118-32-3 C23H34O2
Brexpiprazole Impurity 20 Brexpiprazole Impurity 20 1420987-85-4 C20H20N2S2
Cabozantinib Impurity D Cabozantinib Impurity D
4,9-diisobutyl-1,6-diazecane-2,7-dione 4,9-diisobutyl-1,6-diazecane-2,7-dione 1990538-03-8 C16H30N2O2
ethyl 7-chloro-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate ethyl 7-chloro-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate 75073-15-3 C12H9ClFNO3
5-phenyl-1H-pyrrole-3-carbonitrile 5-phenyl-1H-pyrrole-3-carbonitrile 122453-85-4 C11H8N2
Apixaban Impurity 42 Apixaban Impurity 42 132577-23-2 C12H14N2O4
Apixaban Impurity 42 Apixaban Impurity 42 132577-23-2 C12H14N2O4
2-METHYL-4,5-DINITRO-1H-IMIDAZOLE 2-METHYL-4,5-DINITRO-1H-IMIDAZOLE 19183-16-5 C4H4N4O4
1-Piperazineethanol, a-[(2-methoxyphenoxy)methyl]- 1-Piperazineethanol, a-[(2-methoxyphenoxy)methyl]- 162712-35-8 C14H22N2O3
2-(2-Ethoxyphenoxy)ethyl Methanesulfonate 2-(2-Ethoxyphenoxy)ethyl Methanesulfonate 169506-15-4 C11H16O5S
1-(5-(benzyloxy)-2-hydroxy-3-nitrophenyl)ethanone 1-(5-(benzyloxy)-2-hydroxy-3-nitrophenyl)ethanone 861841-94-3 C15H13NO5
acetylated penicilloic acids of piperacillin acetylated penicilloic acids of piperacillin
Atorvastatin Dehydro Lactone Atorvastatin Dehydro Lactone 442851-50-5 C33H31FN2O3
penicilloic acids of piperacillin penicilloic acids of piperacillin
Bisacodyl Related Compound B (20 mg) (2,4'-(Pyridin-2-ylmethylene)diphenol) Bisacodyl Related Compound B (20 mg) (2,4'-(Pyridin-2-ylmethylene)diphenol) 16985-05-0 C18H15NO2
Doxepin Related Compound C (25 mg) ((E-3-(dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-1-amine hydrochloride) Doxepin Related Compound C (25 mg) ((E-3-(dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-1-amine hydrochloride) 4504-96-5 C18H20ClNO
Imiquimod Related Compound B (25 mg) (1-Isobutyl-1H-imidazo[4,5-c]quinoline 5-oxide) Imiquimod Related Compound B (25 mg) (1-Isobutyl-1H-imidazo[4,5-c]quinoline 5-oxide) 99010-63-6 C14H15N3O
Iohexol related Compound I Iohexol related Compound I
1-(2,3-dichlorophenyl)-4-(4-hydroxybutyl)piperazine 1-(2,3-dichlorophenyl)-4-(4-hydroxybutyl)piperazine 870765-38-1 C14H20Cl2N2O
2,2'-Methylene Bis[Ranitidine] 2,2'-Methylene Bis[Ranitidine] 207592-21-0 C27H44N8O6S2
ChloroMethyl Propyl Carbonate ChloroMethyl Propyl Carbonate 35273-90-6 C5H9ClO3
2-AMino-5-(trifluoroMethoxy)phenyl Thiocyanate 2-AMino-5-(trifluoroMethoxy)phenyl Thiocyanate 1391054-04-8 C8H5F3N2OS
Ioversol Related Compound B (50 mg) (N,N'-bis(2,3-dihydroxypropyl)-5-[(N-(2-hydroxyethyl)-carbamoyl)methoxy]-2,4,6-triiodoisophthalamide) Ioversol Related Compound B (50 mg) (N,N'-bis(2,3-dihydroxypropyl)-5-[(N-(2-hydroxyethyl)-carbamoyl)methoxy]-2,4,6-triiodoisophthalamide) 104517-96-6 C18H24I3N3O9
Edoxaban Impurity 12 (1R,2R,4S) Edoxaban Impurity 12 (1R,2R,4S) 500572-10-1 C24H30ClN7O4S
paroxetine Mesylate paroxetine Mesylate 217797-14-3 C20H24FNO6S
RocuroniuMbroMide iMpurity B RocuroniuMbroMide iMpurity B
TetrazepaM IMp. C (EP): 7-Chloro-5-cyclohexyl-1-Methyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one TetrazepaM IMp. C (EP): 7-Chloro-5-cyclohexyl-1-Methyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one
bis(2-(7-Methoxynaphthalen-1-yl)ethyl)aMine bis(2-(7-Methoxynaphthalen-1-yl)ethyl)aMine 1623104-92-6 C26H28ClNO2
bis(2-(7-Methoxynaphthalen-1-yl)ethyl)aMine bis(2-(7-Methoxynaphthalen-1-yl)ethyl)aMine 1623104-92-6 C26H28ClNO2
Methyl 2-oxo-3-((2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl)Methyl)-2,3-dihydro-1H-benzo[d]iMidazole-4-carboxylate Methyl 2-oxo-3-((2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl)Methyl)-2,3-dihydro-1H-benzo[d]iMidazole-4-carboxylate 1403474-78-1 C24H18N4O5
Thiazolylacetyl glycine oxiMe Thiazolylacetyl glycine oxiMe 178949-03-6 C7H8N4O4S
3-O-Decladinosyl-6-O-Methylerythronolide A 3-O-Decladinosyl-6-O-Methylerythronolide A 118058-74-5 C30H55NO10
Desmethyl Ranolazine Desmethyl Ranolazine 755711-09-2 C23H31N3O3
P-[[(1S)-2-(6-AMino-9H-purin-9-yl)-1-Methylethoxy]Methyl]-phosphonic Acid Monoethyl Ester P-[[(1S)-2-(6-AMino-9H-purin-9-yl)-1-Methylethoxy]Methyl]-phosphonic Acid Monoethyl Ester 1255525-18-8 C11H18N5O4P
3-cyclopropyl-1-(2-fluoro-4-iodophenyl)-6,8-diMethyl-2,4,7-trioxo-1,2,3,4,7,8-hexahydropyrido[2,3-d]pyriMidin-5-yl 4-Methylbenzenesulfonate 3-cyclopropyl-1-(2-fluoro-4-iodophenyl)-6,8-diMethyl-2,4,7-trioxo-1,2,3,4,7,8-hexahydropyrido[2,3-d]pyriMidin-5-yl 4-Methylbenzenesulfonate 871700-32-2 C25H21FIN3O6S
4-(4-fluoro-3-(piperazine-1-carbonyl)benzyl)phthalazin-1(2H)-one 4-(4-fluoro-3-(piperazine-1-carbonyl)benzyl)phthalazin-1(2H)-one 763111-47-3 C20H19FN4O2
16α,17-[(1RS)-Butylidenebis(oxy)]-11β-hydroxy-17-(hydroxyMethyl)-D-hoMoandrosta-1,4-diene-3,17a-dione  (Mixture of DiastereoMers) 16α,17-[(1RS)-Butylidenebis(oxy)]-11β-hydroxy-17-(hydroxyMethyl)-D-hoMoandrosta-1,4-diene-3,17a-dione (Mixture of DiastereoMers) 1040085-99-1 C25H34O6
2-BroMo-1-cyclopropyl-2-(3-fluorophenyl)ethanone 2-BroMo-1-cyclopropyl-2-(3-fluorophenyl)ethanone 1359829-72-3 C11H10BrFO
N-((4-(5-Methyl-3-phenylisoxazol-4-yl)phenyl)sulfonyl)acetaMide N-((4-(5-Methyl-3-phenylisoxazol-4-yl)phenyl)sulfonyl)acetaMide 198471-06-6 C18H16N2O4S
N-((S)-1-(((S)-1-Hydroxy-3-Methylbutyl)aMino)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide N-((S)-1-(((S)-1-Hydroxy-3-Methylbutyl)aMino)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide 289472-81-7 C19H24N4O3
(Z)-N-(2-nitrovinyl)acetaMide (Z)-N-(2-nitrovinyl)acetaMide 1238305-24-2 C4H6N2O3
Azilsartan iMpurity Azilsartan iMpurity 1604812-35-2 C35H28N4O11
Azilsartan iMpurity N Azilsartan iMpurity N 2244031-86-3 C22H17N3O4
cefoxitin iMpurity B cefoxitin iMpurity B
pidotiMod iMpurity A pidotiMod iMpurity A
Rivaroxaban iMpurity A Rivaroxaban iMpurity A 931204-39-6 C19H20ClN3O6S
R-7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9-fluoro-2,3-dihydro-3-Methyl-10-(4-Methyl-1-piperazinyl)-7-oxo- Methyl ester R-7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9-fluoro-2,3-dihydro-3-Methyl-10-(4-Methyl-1-piperazinyl)-7-oxo- Methyl ester 1268719-66-9 C19H22FN3O4
Ticagrelor Sulfone Ticagrelor Sulfone 274693-39-9 C23H28F2N6O6S
2-(((3aR,4S,6R,6aS)-6-(7-aMino-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-2,2-diMethyltetrahydro-3aH-cyclopenta[d][1,3]dioxol-4-yl)oxy)ethanol 2-(((3aR,4S,6R,6aS)-6-(7-aMino-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-2,2-diMethyltetrahydro-3aH-cyclopenta[d][1,3]dioxol-4-yl)oxy)ethanol 1858267-99-8 C17H26N6O4S
(2R,3R)-2-[(1R)-1-[3,5-Bis(trifluoroMethyl)phenyl]ethoxy]-3-(4-fluorophenyl)Morpholine (2R,3R)-2-[(1R)-1-[3,5-Bis(trifluoroMethyl)phenyl]ethoxy]-3-(4-fluorophenyl)Morpholine 380499-06-9 C20H18F7NO2
Adefovir  iMpurity Adefovir iMpurity 1875153-79-9 C15H24N5O6P
Anastrozole iMpurity Anastrozole iMpurity
Anastrozole iMpurity Anastrozole iMpurity
N-DESMETHYLGALANTHAMINE N-DESMETHYLGALANTHAMINE 41303-74-6 C16H19NO3
(3S,5S)-Fluvastatin Sodium Salt (3S,5S)-Fluvastatin Sodium Salt 194935-01-8 C24H27FNNaO4
1H-Indeno[5,4-f]quinoline-7-carboxamide, N-[2,5-bis(trifluoromethyl)phenyl]-2,4a,4b,5,6,6a,7,8,9,9a,9b,10-dodecahydro-4a,6a-dimethyl-2-oxo-, (4aR,4bS,6aS,7R,9aS,9bS)- 1H-Indeno[5,4-f]quinoline-7-carboxamide, N-[2,5-bis(trifluoromethyl)phenyl]-2,4a,4b,5,6,6a,7,8,9,9a,9b,10-dodecahydro-4a,6a-dimethyl-2-oxo-, (4aR,4bS,6aS,7R,9aS,9bS)- 3088800-46-5 C27H28F6N2O2
Betaxolol EP Impurity A Betaxolol EP Impurity A 67193-95-7 C14H23NO2
4,6-diamino-2-(5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-5-((methoxycarbonyl)amino)pyrimidine 1-oxide 4,6-diamino-2-(5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-5-((methoxycarbonyl)amino)pyrimidine 1-oxide
3,5-Bis(benzyloxy)benzoic acid benzyl ester 3,5-Bis(benzyloxy)benzoic acid benzyl ester 50513-72-9 C28H24O4
[(2,3-Dihydro-1,5-dimethyl-3-oxo-2-phenyl-1H-pyrazol-4-yl)amino]methanesulfonic acid [(2,3-Dihydro-1,5-dimethyl-3-oxo-2-phenyl-1H-pyrazol-4-yl)amino]methanesulfonic acid 117-38-4 C12H15N3O4S
(4S,4aR,5S,5aR,6R,12aS)-3,5,10,12,12a-pentahydroxy-6-methyl-4-(methyl(nitroso)amino)-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide (4S,4aR,5S,5aR,6R,12aS)-3,5,10,12,12a-pentahydroxy-6-methyl-4-(methyl(nitroso)amino)-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide
p-Methylcinnamic acid ethyl ester p-Methylcinnamic acid ethyl ester 24393-49-5 C12H14O2
3-[(2-Hydroxyethyl)amino]propiononitrile 3-[(2-Hydroxyethyl)amino]propiononitrile 33759-44-3 C5H10N2O
2-Amino-5-bromobenzaldehyde 2-Amino-5-bromobenzaldehyde 29124-57-0 C7H6BrNO
(R)-(+)-3-(N-METHYLAMINO)-1-(2-THIENYL)-1-PROPANOL (R)-(+)-3-(N-METHYLAMINO)-1-(2-THIENYL)-1-PROPANOL 116539-57-2 C8H13NOS
3-OXO-3,4-DIHYDROPYRAZINE-2-CARBONITRILE 3-OXO-3,4-DIHYDROPYRAZINE-2-CARBONITRILE 81411-78-1 C5H3N3O
RP 48497 (Eszopiclone Impurity C) RP 48497 (Eszopiclone Impurity C) 148891-53-6 C11H7ClN4O
3-(1-methyl-1H-indole-3-carbonyl)hexanedioic acid 3-(1-methyl-1H-indole-3-carbonyl)hexanedioic acid 1352491-75-8 C16H17NO5
Decladinose Roxithromycin (Roxithromycin Impurity B) Decladinose Roxithromycin (Roxithromycin Impurity B) 214902-82-6 C33H62N2O12
3-chloro-5-((1-((4-methyl-1-((4-methyl-5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)methyl)-5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)methyl)-2-oxo-4-(trifluoromethyl)-1,2-dihydropyridin-3-yl)oxy)benzonitrile 3-chloro-5-((1-((4-methyl-1-((4-methyl-5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)methyl)-5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)methyl)-2-oxo-4-(trifluoromethyl)-1,2-dihydropyridin-3-yl)oxy)benzonitrile 2054541-33-0 C21H16ClF3N8O4
Unii-o0p4I5851i Unii-o0p4I5851i 139563-29-4 C28H37ClN4O2S
Amoxicillin Diketopiperazine (Mixture of Diastereomers) Amoxicillin Diketopiperazine (Mixture of Diastereomers) 94659-47-9 C16H19N3O5S
Amoxicillin Diketopiperazine (Mixture of Diastereomers) Amoxicillin Diketopiperazine (Mixture of Diastereomers) 94659-47-9 C16H19N3O5S
N-(4-methoxy-5-((3-((4-methoxy-2-(4-(3-methoxyazetidin-1-yl)piperidin-1-yl)-5-((6-(1-methyl-1H-indazol-5-yl)pyrimidin-4-yl)amino)phenyl)amino)-3-oxopropyl)amino)-2-(4-(3-methoxyazetidin-1-yl)piperidin-1-yl)phenyl)acrylamide N-(4-methoxy-5-((3-((4-methoxy-2-(4-(3-methoxyazetidin-1-yl)piperidin-1-yl)-5-((6-(1-methyl-1H-indazol-5-yl)pyrimidin-4-yl)amino)phenyl)amino)-3-oxopropyl)amino)-2-(4-(3-methoxyazetidin-1-yl)piperidin-1-yl)phenyl)acrylamide
tert-butyl (2-methoxy-6-nitro-4-(4-oxopiperidin-1-yl)phenyl)carbamate tert-butyl (2-methoxy-6-nitro-4-(4-oxopiperidin-1-yl)phenyl)carbamate
(R)-(2-(6-chloro-7-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone (R)-(2-(6-chloro-7-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone
Ferrous tartrate solution c(FeSO4)=1 g/L,c(C4H4O6KNa)=5 g/L Ferrous tartrate solution c(FeSO4)=1 g/L,c(C4H4O6KNa)=5 g/L
Atorvastatin Oxirane Impurity Atorvastatin Oxirane Impurity 1246818-88-1 C26H24FNO3
Dehydro Lovastatin Dehydro Lovastatin 109273-98-5 C24H34O4
LevosiMendan iMpurity LevosiMendan iMpurity 139052-02-1
(Z)-3-((2'-(N'-hydroxycarbaMiMidoyl)biphenyl-4-yl)Methyl)-2-oxo-2,3-dihydro-1H-benzo[d]iMidazole-4-carboxylic acid (Z)-3-((2'-(N'-hydroxycarbaMiMidoyl)biphenyl-4-yl)Methyl)-2-oxo-2,3-dihydro-1H-benzo[d]iMidazole-4-carboxylic acid 1174733-90-4 C10H14N4O6
rac Cinacalcet HCl rac Cinacalcet HCl 1025064-33-8 C22H22F3N
Acyclovir IMpurity I Acyclovir IMpurity I
AtracuriuM Besylate IMpurity D Iodide (Mixture of DiastereoMers) AtracuriuM Besylate IMpurity D Iodide (Mixture of DiastereoMers)
AzithroMycin IMpurity D AzithroMycin IMpurity D
AztreonaM IMpurity E AztreonaM IMpurity E
Dasatinib IMpurity 1 Dasatinib IMpurity 1
Deferasirox IMpurity 1 Deferasirox IMpurity 1
Doxycycline Hyclate IMpurity F Doxycycline Hyclate IMpurity F 122861-53-4 C23H25NO8
IpratropiuM BroMide IMpurity E IpratropiuM BroMide IMpurity E 183626-76-8 C19H27NO3
Minoxidil IMpurity D Minoxidil IMpurity D 75105-16-7 C11H12N4O4S
N-[2-(acetyloxy)propyl]-N-[3-[4-(1,1-diMethylpropyl)phenyl]-2-Methylpropyl]-forMaMide N-[2-(acetyloxy)propyl]-N-[3-[4-(1,1-diMethylpropyl)phenyl]-2-Methylpropyl]-forMaMide 142347-84-0 C21H33NO3
Ribavirin IMp. D (EP) Ribavirin IMp. D (EP)
SalMeterol IMpurity C SalMeterol IMpurity C C25H37NO4
SulbactaM IMpurity F SulbactaM IMpurity F
5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carbaldehyde 5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carbaldehyde 881677-11-8 C16H11FN2O3S
N-(4-(2-Methyl-1,4,5,6-tetrahydrobenzo[b]iMidazo[4,5-d]azepine-1-carbonyl)phenyl)-[1,1'-biphenyl]-2-carboxaMide N-(4-(2-Methyl-1,4,5,6-tetrahydrobenzo[b]iMidazo[4,5-d]azepine-1-carbonyl)phenyl)-[1,1'-biphenyl]-2-carboxaMide C32H26N4O2
1-(4-Methoxyphenyl)-6-(4-(2-Methyl-6-oxopiperidin-1-yl)phenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxaMide 1-(4-Methoxyphenyl)-6-(4-(2-Methyl-6-oxopiperidin-1-yl)phenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxaMide 2098457-92-0 C26H27N5O4
1-(4-Methoxyphenyl)-6-(4-(2-Methyl-6-oxopiperidin-1-yl)phenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxaMide 1-(4-Methoxyphenyl)-6-(4-(2-Methyl-6-oxopiperidin-1-yl)phenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxaMide 2098457-92-0 C26H27N5O4
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