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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
N-Ethoxycarbonyl 7-ADCA N-Ethoxycarbonyl 7-ADCA 72820-16-7 C11H14N2O5S
3R,4S-4-(4-methoxyphenyl)-1-methylpiperi
dinyl] methanol 3R,4S-4-(4-methoxyphenyl)-1-methylpiperi dinyl] methanol 127017-78-1 C14H21NO2
6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(1R,3S,4R)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]- 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(1R,3S,4R)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]- 188399-46-4 C12H15N5O3
4,4'-(2-HYDROXY-1,3-PROPANDIYLDIOXY)BIS(2-PHENYLACETAMIDE) 4,4'-(2-HYDROXY-1,3-PROPANDIYLDIOXY)BIS(2-PHENYLACETAMIDE) 141650-31-9 C19H22N2O5
Valsartan cyano analog methyl ester Valsartan cyano analog methyl ester 137863-90-2 C25H30N2O3
(8S)-2-BroMo α-Ergocryptine (8S)-2-BroMo α-Ergocryptine 65700-36-9 C32H40BrN5O5
2'-Nor ThiaMine 2'-Nor ThiaMine 7770-93-6 C11H15ClN4OS
6α-Methyl Hydrocortisone 21-Acetate 6α-Methyl Hydrocortisone 21-Acetate 1625-11-2 C24H34O6
piperacillinylaMpicillin piperacillinylaMpicillin
Celecoxib iMpurity-B Celecoxib iMpurity-B
EMtricitabine iMpurity B EMtricitabine iMpurity B
(S,S)-1,7-diazatricyclo[7.3.0.07,11]dodecane-2,6,8,12-tetrone (S,S)-1,7-diazatricyclo[7.3.0.07,11]dodecane-2,6,8,12-tetrone 14842-41-2 C10H10N2O4
1-Hydroxy-7-Methoxy-1,2,3,4-tetrahydronaphthalene 1-Hydroxy-7-Methoxy-1,2,3,4-tetrahydronaphthalene 32820-10-3 C11H14O2
BroMhexine Hydrochloride iMpurity DN-(2-AMino-5-broMobenzyl)-N-MethylcyclohexanaMine Dihydrochloride BroMhexine Hydrochloride iMpurity DN-(2-AMino-5-broMobenzyl)-N-MethylcyclohexanaMine Dihydrochloride 132004-28-5 C14H21BrN2
2-(DiMethylcarbaMoyl)benzoic acid, 97% 2-(DiMethylcarbaMoyl)benzoic acid, 97% 20320-37-0 C10H11NO3
RAC DESMETHYL CITALOPRAM HYDROCHLORIDE RAC DESMETHYL CITALOPRAM HYDROCHLORIDE 97743-99-2 C19H19FN2O
rac-3-Oxo Atorvastatin SodiuM Salt rac-3-Oxo Atorvastatin SodiuM Salt 1391052-00-8 C33H34FN2NaO5
2-Demethoxy-4-methoxy urapidil 2-Demethoxy-4-methoxy urapidil 34661-79-5 C20H29N5O3
Ribavirin IMpurity F Ribavirin IMpurity F 58151-87-4 C10H14N4O6
4-[-((-((4-(5-(Bis(2-hydroxyethyl)aMino)-1-Methyl-1H-benzo[d]iMidazol-2-yl)butanoyl)oxy)ethyl)(2-hydroxyethyl)aMino)-1-Methyl-1H-benzo[d]iMidazol-2-yl)butanic Acid 4-[-((-((4-(5-(Bis(2-hydroxyethyl)aMino)-1-Methyl-1H-benzo[d]iMidazol-2-yl)butanoyl)oxy)ethyl)(2-hydroxyethyl)aMino)-1-Methyl-1H-benzo[d]iMidazol-2-yl)butanic Acid 1228551-91-4 C32H41Cl3N6O4
3-(6,7-Dihydro-2-Methyl-7-oxo-3-propyl-2H-pyrazolo[4,3-d]pyriMidin-5-yl)-4-ethoxy-benzenesulfonyl Chloride 3-(6,7-Dihydro-2-Methyl-7-oxo-3-propyl-2H-pyrazolo[4,3-d]pyriMidin-5-yl)-4-ethoxy-benzenesulfonyl Chloride 501120-42-9 C17H19ClN4O4S
(3R,4S)-rel-3-[(1,3-Benzodioxol-5-yloxy)Methyl]-4-(4'-fluoro[1,1'-biphenyl]-4-yl)-piperidine Hydrochloride (3R,4S)-rel-3-[(1,3-Benzodioxol-5-yloxy)Methyl]-4-(4'-fluoro[1,1'-biphenyl]-4-yl)-piperidine Hydrochloride 1217655-87-2 C25H25ClFNO3
(16α)-16,17-[Butylidenebis(oxy)]-21-hydroxypregna-1,4-diene-3,11,20-trione (16α)-16,17-[Butylidenebis(oxy)]-21-hydroxypregna-1,4-diene-3,11,20-trione 216453-74-6 C25H32O6
6(S)-Hydroperoxy Simvastatin 6(S)-Hydroperoxy Simvastatin 149949-01-9 C25H38O7
Russupteridine IV Russupteridine IV 2535-20-8 C13H18N4O6
2-[(1-Benzylpiperidin-4-yl)hydroxyMethyl]-5,6-diMethoxyindan-1-one 2-[(1-Benzylpiperidin-4-yl)hydroxyMethyl]-5,6-diMethoxyindan-1-one 197010-20-1 C24H29NO4
5,6-trans-Ergocalciferol 5,6-trans-Ergocalciferol 51744-66-2 C28H44O
2-isonicotinoyl-5,6-diMethoxy-2,3-dihydro-1H-inden-1-one 2-isonicotinoyl-5,6-diMethoxy-2,3-dihydro-1H-inden-1-one 923571-15-7 C17H15NO4
4-(2-nitrophenyl)Morpholin-3-one 4-(2-nitrophenyl)Morpholin-3-one 845729-41-1 C10H10N2O4
2-Naphthalenecarboxylic acid, 4-hydroxy-8-Methyl- 2-Naphthalenecarboxylic acid, 4-hydroxy-8-Methyl- 16036-18-3 C12H10O3
(1R)-2-chloro-1-(3,4-difluorophenyl)-1-ethanol (1R)-2-chloro-1-(3,4-difluorophenyl)-1-ethanol 1212376-05-0 C8H7ClF2O
2-[[(3aR,4S,6R,6aS)-6-[7-Chloro-5-(propylthio)-3H-1,2,3-triazolo[4,5-d]pyrimidin-3-yl]tetrahydro-2,2-dimethyl-4H-cyclopenta-1,3-dioxol-4-yl]oxy]-ethanol 2-[[(3aR,4S,6R,6aS)-6-[7-Chloro-5-(propylthio)-3H-1,2,3-triazolo[4,5-d]pyrimidin-3-yl]tetrahydro-2,2-dimethyl-4H-cyclopenta-1,3-dioxol-4-yl]oxy]-ethanol 376608-75-2 C17H24ClN5O4S
Fluconazole IMpurity F Fluconazole IMpurity F C13H12F2N6O
Erlotinib IMpurity A Erlotinib IMpurity A 1058132-82-3 C22H25N3O4
Apixaban iMpurity 5 Apixaban iMpurity 5
cefaclor iMpurity C cefaclor iMpurity C 143059-69-2 C15H14ClN3O4S
ceftazidiMe iMpurity B ceftazidiMe iMpurity B 1236700-64-3
pidotiMod iMpurity D pidotiMod iMpurity D 162148-15-4 C9H12N2O4S
Irinotecan Hydroxyl Acid Irinotecan Hydroxyl Acid 142677-15-4 C22H22N2O6
CyclopropanaMine, 2-(4-fluorophenyl)-(hydrochloride)(1:1),(1R,2S)- CyclopropanaMine, 2-(4-fluorophenyl)-(hydrochloride)(1:1),(1R,2S)- 1314324-00-9 C9H11ClFN
(1S,2S,3R,5S)-3-(7-(((1R,2S)-2-(3,4-difluorophenyl)cyclopropyl)aMino)-5-(propylsulfinyl)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol (1S,2S,3R,5S)-3-(7-(((1R,2S)-2-(3,4-difluorophenyl)cyclopropyl)aMino)-5-(propylsulfinyl)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol 1644461-85-7 C23H28F2N6O5S
AtracuriuM IMpurity C (Mixture of DiastereoMers) AtracuriuM IMpurity C (Mixture of DiastereoMers) 86293-35-8
AtracuriuM IMpurity E (cis-Quaternary Acid) AtracuriuM IMpurity E (cis-Quaternary Acid)
AztreonaM IMpurity B AztreonaM IMpurity B
Ceftriaxone IMpurit E Ceftriaxone IMpurit E
Cetirizine IMpurity-6 Cetirizine IMpurity-6 C21H25ClN2O3
Cinacalcet IMpurity 10 Cinacalcet IMpurity 10 1809324-40-0 C29H28F3NO2S
Dasatinib IMpurity 5 Dasatinib IMpurity 5
Diacerein IMpurity F Diacerein IMpurity F 13928-72-8 C35H36O16
D-Valganciclovir Hydrochloride D-Valganciclovir Hydrochloride 1393911-57-3 C14H23ClN6O5
Entecavir IMpurity E Entecavir IMpurity E
EzetiMibe IMpurity 1 EzetiMibe IMpurity 1 190595-66-5 C24H22FNO3
Flurbiprofen IMpurity B Flurbiprofen IMpurity B 1797883-74-9 C18H17FO4
IMatinib DiPiperidine IMpurity IMatinib DiPiperidine IMpurity
Lasmiditan Impurity 9 Lasmiditan Impurity 9
2,4'-Diamino[sulfonylbisbenzene] 2,4'-Diamino[sulfonylbisbenzene] 27147-69-9 C12H12N2O2S
2-P-TOLYLOXYMETHYL-OXIRANE 2-P-TOLYLOXYMETHYL-OXIRANE 2186-24-5 C10H12O2
3-Hydroxyazobenzene 3-Hydroxyazobenzene 2437-11-8
Astragalin 7-O-β-D-glucopyranoside Astragalin 7-O-β-D-glucopyranoside 25615-14-9 C27H30O16
4-(5-CHLORO-2-THIENYL)-1,3-THIAZOL-2-AMINE 4-(5-CHLORO-2-THIENYL)-1,3-THIAZOL-2-AMINE 123971-45-9 C7H5ClN2S2
α,α-Dibromo-o-tolunitrile α,α-Dibromo-o-tolunitrile 655-63-0 C8H5Br2N
7-CHLORO-1-ETHYL-6-FLUORO-4-OXO-1,4-DIHYDRO-[1,8]NAPHTHYRIDINE-3-CARBOXYLIC ACID 7-CHLORO-1-ETHYL-6-FLUORO-4-OXO-1,4-DIHYDRO-[1,8]NAPHTHYRIDINE-3-CARBOXYLIC ACID 79286-73-0 C11H8ClFN2O3
HYDRIDE-L HYDRIDE-L 41639-74-1 C18H22O4
2-Amino-4-trifluoromethoxybenzothiazole 2-Amino-4-trifluoromethoxybenzothiazole 235101-36-7 C8H5F3N2OS
7-[(4S)-4-Amino-6-azaspiro[2.4]heptan-6-yl]-8-chloro-6-fluoro-1-[(1R,2S)-2-fluorocyclopropyl]-4-oxoquinoline-3-carboxylic acid 7-[(4S)-4-Amino-6-azaspiro[2.4]heptan-6-yl]-8-chloro-6-fluoro-1-[(1R,2S)-2-fluorocyclopropyl]-4-oxoquinoline-3-carboxylic acid 127254-10-8 C19H18ClF2N3O3
Sitagliptin Carbamoyl -D-Glucuronide Sitagliptin Carbamoyl -D-Glucuronide 940002-59-5 C23H23F6N5O9
5-Hydroxy Desloratadine 5-Hydroxy Desloratadine 117811-12-8 C19H19ClN2O
D-Streptamine, o-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-6)-o-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1-4))-N(sup 3)-(4-amino-2-hydroxybutyryl)-2-deoxy- D-Streptamine, o-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-6)-o-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1-4))-N(sup 3)-(4-amino-2-hydroxybutyryl)-2-deoxy- 50725-24-1 C22H43N5O13
O-Benzyl Posaconazole O-Benzyl Posaconazole 170985-86-1 C44H48F2N8O4
10-trans-Atorvastatin Acetonide tert-Butyl Ester 10-trans-Atorvastatin Acetonide tert-Butyl Ester 1105067-90-0 C40H47FN2O5
3-Bromo Carbidopa 3-Bromo Carbidopa 1246819-09-9 C10H13BrN2O4
(4S,6R)-6-(Cyanomethyl)-2,2-dimethyl-1,3-dioxane-4-acetic Acid tert-Butyl Ester (4S,6R)-6-(Cyanomethyl)-2,2-dimethyl-1,3-dioxane-4-acetic Acid tert-Butyl Ester 186508-95-2 C14H23NO4
(5R)-6-Cyano-5-hydroxy-3-oxo-hexanoic Acid tert-Butyl Ester (5R)-6-Cyano-5-hydroxy-3-oxo-hexanoic Acid tert-Butyl Ester 125988-01-4 C11H17NO4
(4-Carboxy-3-ethoxy)phenyl Acetic Acid (Repaglinide Impurity) (4-Carboxy-3-ethoxy)phenyl Acetic Acid (Repaglinide Impurity) 220438-80-2 C11H12O5
2-Chloromethyl-3,5-dimethylpyridin-4-ol 2-Chloromethyl-3,5-dimethylpyridin-4-ol 220771-03-9 C8H10ClNO
(3S,5R)-6-Cyano-3,5-dihydroxy-hexanoic Acid tert-Butyl Ester (3S,5R)-6-Cyano-3,5-dihydroxy-hexanoic Acid tert-Butyl Ester 186508-94-1 C11H19NO4
2-Methyl-6-[(4-methylphenyl)sulfonyl]-1,4,5,6-tetrahydroimidazo[4,5-d][1]benzazepine 2-Methyl-6-[(4-methylphenyl)sulfonyl]-1,4,5,6-tetrahydroimidazo[4,5-d][1]benzazepine 717917-14-1 C19H19N3O2S
(1R-4S)-4-[[(1,1-dimethylethoxy)carbonyl]amino]- 2-Cyclopentene-1-carboxylic acid methyl ester (1R-4S)-4-[[(1,1-dimethylethoxy)carbonyl]amino]- 2-Cyclopentene-1-carboxylic acid methyl ester 251326-99-5 C12H19NO4
O-Isobutyryl (R)-Fesoterodine O-Isobutyryl (R)-Fesoterodine 1208313-13-6 C30H43NO4
Isopropyl Itraconazole Isopropyl Itraconazole 89848-49-7 C34H36Cl2N8O4
(R)-(-)-Ibuprofen-d3 (R)-(-)-Ibuprofen-d3 121702-86-1 C13H18O2
(S,R,S,S)-Orlistat (S,R,S,S)-Orlistat 111466-63-8 C29H53NO5
N-Trityl Candesartan Ethyl Ester N-Trityl Candesartan Ethyl Ester 856414-35-2 C45H38N6O3
3-[4-(4-Chlorobenzoyl)phenoxy]-2-butanone (Fenofibrate IMpurity) 3-[4-(4-Chlorobenzoyl)phenoxy]-2-butanone (Fenofibrate IMpurity) 217636-47-0 C17H15ClO3
5-(2-Chlorobenzyl)-thieno[3,2-c]pyridiniuM Chloride 5-(2-Chlorobenzyl)-thieno[3,2-c]pyridiniuM Chloride 53885-64-6 C14H11Cl2NS
ClarithroMycin 9-OxiMe ClarithroMycin 9-OxiMe 103450-87-9 C38H70N2O13
Desloratadine N-Hydroxypiperidine Desloratadine N-Hydroxypiperidine 1193725-73-3 C19H19ClN2O
O-DesMethyl Venlafaxine Cyclic IMpurity O-DesMethyl Venlafaxine Cyclic IMpurity 1346601-55-5 C16H23NO2
rac-cis-2,3-Dichloro Sertraline Hydrochloride rac-cis-2,3-Dichloro Sertraline Hydrochloride 1198084-29-5 C17H18Cl3N
11β-Hydroperoxy Dienogest 11β-Hydroperoxy Dienogest 106111-43-7 C20H25NO4
levocetirizine IMpurity levocetirizine IMpurity
N-Ethyl Tadalafil N-Ethyl Tadalafil 1609405-34-6 C23H21N3O4
OseltaMivir IMpurity F OseltaMivir IMpurity F
RocuroniuM BroMide IMpurity 19 RocuroniuM BroMide IMpurity 19
S-(+)-O-DesMethyl-Venlafaxine-d6 S-(+)-O-DesMethyl-Venlafaxine-d6 1062609-99-7 C16H25NO2
SalMeterol IMpurity F SalMeterol IMpurity F C25H37NO4
Sitagliptin Defuoro IMpurity 4 Sitagliptin Defuoro IMpurity 4 486459-98-7 C15H19F2NO4
Sulpiride IMpurity F Sulpiride IMpurity F
trans-Ibuprofen IMpurity G trans-Ibuprofen IMpurity G 1391054-15-1 C26H32O4
EthanediaMide  iMpurity F EthanediaMide iMpurity F 480452-37-7 C16H22ClN5O3
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