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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
3,3',5-TRIIODOTHYROPROPIONIC ACID 3,3',5-TRIIODOTHYROPROPIONIC ACID 51-26-3 C15H11I3O4
Cytidine,N-benzoyl-2^-C-Methyl-,3^,5^-dibenzoate(9CI) Cytidine,N-benzoyl-2^-C-Methyl-,3^,5^-dibenzoate(9CI) 863329-64-0 C31H27N3O8
(R)-2-((6-(3-((3-(2-cyanobenzyl)-1-Methyl-2,6-dioxo-1,2,3,6-tetrahydropyriMidin-4-yl)aMino)piperidin-1-yl)-3-Methyl-2,4-dioxo-3,4-dihydropyriMidin-1(2H)-yl)Methyl)benzonitrile (R)-2-((6-(3-((3-(2-cyanobenzyl)-1-Methyl-2,6-dioxo-1,2,3,6-tetrahydropyriMidin-4-yl)aMino)piperidin-1-yl)-3-Methyl-2,4-dioxo-3,4-dihydropyriMidin-1(2H)-yl)Methyl)benzonitrile 1268836-55-0 C31H30N8O4
(R)-2-((6-(3-((3-(2-cyanobenzyl)-1-Methyl-2,6-dioxo-1,2,3,6-tetrahydropyriMidin-4-yl)aMino)piperidin-1-yl)-3-Methyl-2,4-dioxo-3,4-dihydropyriMidin-1(2H)-yl)Methyl)benzonitrile (R)-2-((6-(3-((3-(2-cyanobenzyl)-1-Methyl-2,6-dioxo-1,2,3,6-tetrahydropyriMidin-4-yl)aMino)piperidin-1-yl)-3-Methyl-2,4-dioxo-3,4-dihydropyriMidin-1(2H)-yl)Methyl)benzonitrile 1268836-55-0 C31H30N8O4
1-Pyrrolidinecarboxylic acid, 4-oxo-2-(3-thiazolidinylcarbonyl)-, 1,1-diMethylethyl ester, (2R)- 1-Pyrrolidinecarboxylic acid, 4-oxo-2-(3-thiazolidinylcarbonyl)-, 1,1-diMethylethyl ester, (2R)- 1415908-67-6 C13H20N2O4S
(2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoroMethyl)phenyl]ethoxy]-3-(phenyl)Morpholine hydrochloride (2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoroMethyl)phenyl]ethoxy]-3-(phenyl)Morpholine hydrochloride 874460-46-5 C20H20ClF6NO2
AlMotriptan iMpurity AlMotriptan iMpurity
AlMotriptan iMpurity AlMotriptan iMpurity
FaMotidine iMpurity FaMotidine iMpurity 130463-35-3 C5H8N4S2.Na
Nitrendipine iMpurity Nitrendipine iMpurity
TraMadol EP IMpurity-C TraMadol EP IMpurity-C 66170-31-8 C16H24ClNO
tert-Butyl [(1R,2S,5S)-2-amino-5-[(dimethylamino)carbonyl]cyclohexyl]carbamate oxalate tert-Butyl [(1R,2S,5S)-2-amino-5-[(dimethylamino)carbonyl]cyclohexyl]carbamate oxalate 1210348-34-7 C16H29N3O7
Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetic acid) Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetic acid) 1338800-82-0 C17H20N4O2
Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetic acid) Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetic acid) 1338800-82-0 C17H20N4O2
AtracuriuM IMpurity K (Mixture of cis, trans, cis, cis(K1 & K2), tans, trans IsoMer) AtracuriuM IMpurity K (Mixture of cis, trans, cis, cis(K1 & K2), tans, trans IsoMer)
ChlorphenaMine IMpurity B ChlorphenaMine IMpurity B
Clozapine EP IMpurity D Clozapine EP IMpurity D 65514-71-8 C18H21ClN4O
Febuxostat IMpurity (2-(3-carboxy-4-isobutyloxyphenyl)-4-Methylthiazole-5-carboxylic acid) Febuxostat IMpurity (2-(3-carboxy-4-isobutyloxyphenyl)-4-Methylthiazole-5-carboxylic acid)
Fluconazole IMpurity I Fluconazole IMpurity I C13H12F2N6O
IMidafenacin Related CoMpound 1 (4-(1H-IMidzol-1-yl)-2,2-DiphenylbutanaMide) IMidafenacin Related CoMpound 1 (4-(1H-IMidzol-1-yl)-2,2-DiphenylbutanaMide) 170105-20-1 C19H19N3O
IMidafenacin Related CoMpound 6 (4-AcetiMidoylaMino-2,2-DiphenylbutanaMide) IMidafenacin Related CoMpound 6 (4-AcetiMidoylaMino-2,2-DiphenylbutanaMide) 503598-33-2 C18H21N3O
Lansoprazole IMpurity H Lansoprazole IMpurity H 1346598-28-4 C23H16F3N5OS
LevetiracetaM IMurity (L-2-AMinobutanaMide HCl,S-2-AMinobutanaMide HCl) LevetiracetaM IMurity (L-2-AMinobutanaMide HCl,S-2-AMinobutanaMide HCl) 1933471-30-7 C8H14N2O3
Milrinone IMpurity 4 Milrinone IMpurity 4
Terbutaline IMpurity B Terbutaline IMpurity B 94120-05-5 C13H19NO3
Benzoic acid, 4-[(4-Methyl-1-piperazinyl)Methyl]-3-(trifluoroMethyl)- Benzoic acid, 4-[(4-Methyl-1-piperazinyl)Methyl]-3-(trifluoroMethyl)- 859282-11-4 C14H17F3N2O2
N-(5-Chloropyridin-2-yl)oxalaMic acid ethyl ester N-(5-Chloropyridin-2-yl)oxalaMic acid ethyl ester 349125-08-2 C9H9ClN2O3
5-chloro-2,3-diphenylpyrazine 5-chloro-2,3-diphenylpyrazine 41270-66-0 C16H11ClN2
Canagliflozin iMpurity Canagliflozin iMpurity 2648347-42-4
Vortioxetine iMpurity Vortioxetine iMpurity 853745-55-8 C10H14BrClN2
PD 312236 PD 312236 501666-24-6 C20H35NO11
(17α)-3,3-[1,2-Ethanediylbis(oxy)]-17-hydroxy-19-norpregna-5(10),9(11)-diene-21-nitrile (17α)-3,3-[1,2-Ethanediylbis(oxy)]-17-hydroxy-19-norpregna-5(10),9(11)-diene-21-nitrile 190662-30-7 C22H29NO3
(S)-4-(4-Hydrazinobenzyl)-2-oxazolidinone Hydrochloride (S)-4-(4-Hydrazinobenzyl)-2-oxazolidinone Hydrochloride 139264-57-6 C10H13N3O2.ClH
1-[4-(4-AMino-6,7-diMethoxy-2-quinazolinyl)-1-piperazinyl]-5-hydroxy-1-pentanone 1-[4-(4-AMino-6,7-diMethoxy-2-quinazolinyl)-1-piperazinyl]-5-hydroxy-1-pentanone 109678-71-9 C19H27N5O4
4-[2-(2-AMino-4,5,6,7-tetrahydro-4,6-dioxo-3H-pyrrolo[2,3-d]pyriMidin-5-yl)ethyl]benzoic Acid 4-[2-(2-AMino-4,5,6,7-tetrahydro-4,6-dioxo-3H-pyrrolo[2,3-d]pyriMidin-5-yl)ethyl]benzoic Acid 193265-47-3 C15H14N4O4
9-(1,3-Dioxolan-2-ylMethyl)-3,9-dihydro-1,3-diMethyl-1H-purine-2,6-dione 9-(1,3-Dioxolan-2-ylMethyl)-3,9-dihydro-1,3-diMethyl-1H-purine-2,6-dione 1174289-18-9 C11H14N4O4
DesMethyl AMisulpride DesMethyl AMisulpride 148516-54-5 C16H25N3O4S
DiMethoxy Dienogest DiMethoxy Dienogest 102193-41-9 C22H31NO3
Desfluoro Rosuvastatin Sodium Salt Desfluoro Rosuvastatin Sodium Salt 847849-66-5 C22H29N3O6S
N-Benzoyl-N-[2-(phenyl)ethyl]-N-carbamic Acid R-Quinuclidinol Ester Succinic Acid Salt N-Benzoyl-N-[2-(phenyl)ethyl]-N-carbamic Acid R-Quinuclidinol Ester Succinic Acid Salt 1798817-92-1 C27H32N2O7
Tadalafil EP IMpurity A Tadalafil EP IMpurity A
(1R,3R,4R)-3-AMino-4-hydroxy-cyclohexanecarboxylic acid ethyl ester (1R,3R,4R)-3-AMino-4-hydroxy-cyclohexanecarboxylic acid ethyl ester 1392745-70-8 C14H25NO5
(S)-3-Hydroxypiperidine (S)-3-Hydroxypiperidine 24211-55-0 C5H11NO
Aprepitant iMpurity B Aprepitant iMpurity B
Aripiprazole iMpurity 4 Aripiprazole iMpurity 4 1424857-63-5 C36H42Cl2N4O4
Aripiprazole iMpurity 4 Aripiprazole iMpurity 4 1424857-63-5 C36H42Cl2N4O4
Avanafil IMpurity 8 (R-Avanafil) Avanafil IMpurity 8 (R-Avanafil)
EzetiMibe ring-opening dehydrate iMpurity EzetiMibe ring-opening dehydrate iMpurity 1292292-63-7 C24H21F2NO3
Fondaparinux sodiuM iMpurity 1 Fondaparinux sodiuM iMpurity 1 348625-84-3 C13H21NO19S3
Pitavastatin IMpurity 4 (PP-4) Pitavastatin IMpurity 4 (PP-4) 1422058-54-5 C25H22FNO3
Pregabalin IMpurity Pregabalin IMpurity 159029-27-3 C7H18N2
Valdecoxib 3'-SulfonaMide IMpurity Valdecoxib 3'-SulfonaMide IMpurity 1373038-56-2 C16H14N2O3S
4'-O-2,6-Dideoxy-3-O-Methyl-α-L-arabino-hexopyranosyl SelaMectin 4'-O-2,6-Dideoxy-3-O-Methyl-α-L-arabino-hexopyranosyl SelaMectin 301849-46-7 C50H75NO14
(3R,4R)-4-(2,5-Difluorophenyl)-3-Methyl-4-(1H-1,2,4-triazol-1-ylMethyl)-2-oxetanone (3R,4R)-4-(2,5-Difluorophenyl)-3-Methyl-4-(1H-1,2,4-triazol-1-ylMethyl)-2-oxetanone 483340-20-1 C13H11F2N3O2
6-(4-{2-[5-(tert-Butyl-dimethyl-silanyloxy)-2-methylene-cyclohexylidene]-ethylidene}-7a-methyl-octahydro-inden-1-yl)-2-methyl-heptan-2-ol 6-(4-{2-[5-(tert-Butyl-dimethyl-silanyloxy)-2-methylene-cyclohexylidene]-ethylidene}-7a-methyl-octahydro-inden-1-yl)-2-methyl-heptan-2-ol 140710-90-3 C33H58O2Si
3-Hydroxy loratadine 3-Hydroxy loratadine 183483-15-0 C22H23ClN2O3
Dehydro Lacidipine Dehydro Lacidipine 130996-24-6 C26H31NO6
Granisetron Impurity F Granisetron Impurity F 1364914-39-5 C18H24N4O
Solifenacin N-Oxide Solifenacin N-Oxide 180272-28-0 C23H26N2O3
2-chloro-N-(4-ethoxyphenyl)-4-nitrobenzamide 2-chloro-N-(4-ethoxyphenyl)-4-nitrobenzamide 328258-90-8 C15H13ClN2O4
ACETAMINOPHEN IMPURITY B ACETAMINOPHEN IMPURITY B 1693-37-4 C9H11NO2
Lenacapavir impurity Lenacapavir impurity 3025145-48-3 C41H36ClF10N7O5S2
3-[(E)-Ethylidene]-2-pyrrolidone 3-[(E)-Ethylidene]-2-pyrrolidone 930-94-9
1-(3-Aminopropyl)aziridine 1-(3-Aminopropyl)aziridine 1072-65-7 C5H12N2
3,5-Di(4-pyridinyl)-1H-1,2,4-triazol-1-amine 3,5-Di(4-pyridinyl)-1H-1,2,4-triazol-1-amine 4923-06-2 C12H10N6
Ambroxol EP Impurity B Ambroxol EP Impurity B 18683-95-9 C14H18Br2N2O
4'-((2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl)-N-(4,5-dimethylisoxazol-3-yl)-2'-(ethoxymethyl)-[1,1'-biphenyl]-3-sulfonamide 4'-((2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl)-N-(4,5-dimethylisoxazol-3-yl)-2'-(ethoxymethyl)-[1,1'-biphenyl]-3-sulfonamide
Aminoarteether Maleate Impurity 1 Aminoarteether Maleate Impurity 1 139716-77-1 C21H36N2O5
16-Hydroxyerythromycin 16-Hydroxyerythromycin 82230-93-1 C37H67NO14
BUPROPION MORPHOLINOL BUPROPION MORPHOLINOL 357399-43-0 C13H18ClNO2
4-[1-(4-Chlorophenyl)-1-phenylethoxy]-1-methylhexahydro-1H-azepine 4-[1-(4-Chlorophenyl)-1-phenylethoxy]-1-methylhexahydro-1H-azepine 61771-18-4 C21H26ClNO
1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylic acid 3-isopropyl 5-(2-hydroxyethyl) ester 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylic acid 3-isopropyl 5-(2-hydroxyethyl) ester 82219-47-4 C20H24N2O7
3-[(3-TRIFLUOROMETHYL)PHENYL]-1-PROPENE 3-[(3-TRIFLUOROMETHYL)PHENYL]-1-PROPENE 1813-96-3 C10H9F3
(AS)-A-(2-CHLOROPHENYL)-2,3,6,7-TETRAHYDRO-2-OXO-THIENO[3,2-C]PYRIDINE-5(4H)-ACETIC ACID METHYL ESTER (AS)-A-(2-CHLOROPHENYL)-2,3,6,7-TETRAHYDRO-2-OXO-THIENO[3,2-C]PYRIDINE-5(4H)-ACETIC ACID METHYL ESTER 527687-26-9 C16H16ClNO3S
1-(P-METHOXYPHENYL)-1-BUTEN-3-ONE 1-(P-METHOXYPHENYL)-1-BUTEN-3-ONE 943-88-4 C11H12O2
ANAGRELIDE IMPURITY 5 ANAGRELIDE IMPURITY 5 444904-63-6 C8H7Cl2N3
ANAGRELIDE IMPURITY 5 ANAGRELIDE IMPURITY 5 444904-63-6 C8H7Cl2N3
2-[2-(2-AMINO-9H-PURIN-9-YL)ETHYL]-1,3-PROPANEDIOL 2-[2-(2-AMINO-9H-PURIN-9-YL)ETHYL]-1,3-PROPANEDIOL 104227-86-3 C10H15N5O2
1,4,8,11-Tetrakis[(4-methylphenyl)sulfonyl]-1,4,8,11-tetraazacyclotetradecane 1,4,8,11-Tetrakis[(4-methylphenyl)sulfonyl]-1,4,8,11-tetraazacyclotetradecane 71089-74-2 C38H48N4O8S4
3-Cyano-4-isobutoxybenzoic acid 3-Cyano-4-isobutoxybenzoic acid 528607-60-5 C12H13NO3
REF DUPL: trans-2-Hydroxymethyl-5-(cytosin-1-yl)-1,3-oxathiolane REF DUPL: trans-2-Hydroxymethyl-5-(cytosin-1-yl)-1,3-oxathiolane 139757-68-9 C8H11N3O3S
(R)-4-(4-(5-chloropyrimidin-2-yl)piperidin-1-yl)-2-((1-( hydroxymethyl)cyclobutyl)amino)-6,7-dihydrothieno[3,2-d] pyrimidine 5-oxide (R)-4-(4-(5-chloropyrimidin-2-yl)piperidin-1-yl)-2-((1-( hydroxymethyl)cyclobutyl)amino)-6,7-dihydrothieno[3,2-d] pyrimidine 5-oxide
Nemonoxacin Nemonoxacin 378746-64-6 C20H25N3O4
1-Propanol,3-[(1,1-dimethylethyl)amino]-2-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]-oxy]- 1-Propanol,3-[(1,1-dimethylethyl)amino]-2-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]-oxy]- 59697-06-2 C13H24N4O3S
Tretinoin-d6 (Retinoic Acid-d6, Isotretinoin EP Impurity A-d6) Tretinoin-d6 (Retinoic Acid-d6, Isotretinoin EP Impurity A-d6)
2-(hydroxy(phenyl)methyl)-N-(2-hydroxyethyl)benzamide 2-(hydroxy(phenyl)methyl)-N-(2-hydroxyethyl)benzamide
N-(4-methoxy-2-(4-(3-methoxyazetidin-1-yl)piperidin-1-yl)-5-((6-(1-methyl-1H-indazol-5-yl)pyrimidin-4-yl)amino)phenyl)-N-(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)acrylamide N-(4-methoxy-2-(4-(3-methoxyazetidin-1-yl)piperidin-1-yl)-5-((6-(1-methyl-1H-indazol-5-yl)pyrimidin-4-yl)amino)phenyl)-N-(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)acrylamide
Anagrelide impurity 4 Anagrelide impurity 4 1092352-99-2 C10H6Cl3N3O
Anagrelide impurity 4 Anagrelide impurity 4 1092352-99-2 C10H6Cl3N3O
rac Cetirizine N-Oxide > 70% by HPLC
(Mixture of Diastereomers) rac Cetirizine N-Oxide > 70% by HPLC (Mixture of Diastereomers) 1076199-80-8 C21H25ClN2O4
Hydroxy Flunarizine Hydroxy Flunarizine 87166-81-2 C26H26F2N2O
1-METHYL-4-NITRO-3-PROPYL-1H-PYRAZOLE-5-CARBOXYLIC ACID 1-METHYL-4-NITRO-3-PROPYL-1H-PYRAZOLE-5-CARBOXYLIC ACID 139756-00-6 C8H11N3O4
Mixed gas of propane and carbon monoxide Mixed gas of propane and carbon monoxide
6,7-DiMethoxy-2-(4-(tetrahydrofuran-2-carbonyl)piperazin-1-yl)quinazolin-4(1H)-one 6,7-DiMethoxy-2-(4-(tetrahydrofuran-2-carbonyl)piperazin-1-yl)quinazolin-4(1H)-one 1177261-73-2 C19H24N4O5
2-Hydroxy Atorvastatin Calcium Salt 2-Hydroxy Atorvastatin Calcium Salt 265989-46-6 C33H37CaFN2O6
13-oxo-1,4,7,10-Tetraazabicyclo[8.2.1]tridecane-4,7-diacetic Acid 13-oxo-1,4,7,10-Tetraazabicyclo[8.2.1]tridecane-4,7-diacetic Acid 229312-33-8 C13H22N4O5
rac-Clopidogrel Carboxylic Acid Hydrochloride rac-Clopidogrel Carboxylic Acid Hydrochloride 1015247-88-7 C15H15Cl2NO2S
Milnacipran IMpurity Milnacipran IMpurity 810696-16-3 C11H11NO
Terbutaline IMpurity 8 Terbutaline IMpurity 8 28924-20-1 C26H30BrNO3
Etoricoxib IMpurity Etoricoxib IMpurity 1350206-14-2 C18H16N2O2S
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