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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
(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
Moxifloxacin Methyl Ester Moxifloxacin Methyl Ester 721970-35-0 C22H26FN3O4
Atomoxetine Related Compound C (10 mg) (N-methyl-3-phenyl-3-(p-tolyloxy)propan-1-amine hydrochloride) Atomoxetine Related Compound C (10 mg) (N-methyl-3-phenyl-3-(p-tolyloxy)propan-1-amine hydrochloride) 873310-31-7 C17H22ClNO
Dofetilide Related Compound A (25 mg) (N-[4-(2-(2-[4-(methanesulfonamido)phenoxy]ethyl)amino)phenyl]methanesulfonamide) Dofetilide Related Compound A (25 mg) (N-[4-(2-(2-[4-(methanesulfonamido)phenoxy]ethyl)amino)phenyl]methanesulfonamide) 176447-94-2 C18H25N3O5S2
5-Methyl-2-(1H-1,2,3-triazol-1-yl)benzoic acid 5-Methyl-2-(1H-1,2,3-triazol-1-yl)benzoic acid 1149352-55-5 C10H9N3O2
9-ethyl-8-iodo-6,6-diMethyl-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile 9-ethyl-8-iodo-6,6-diMethyl-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile 1256584-80-1 C21H17IN2O
9-ethyl-8-iodo-6,6-diMethyl-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile 9-ethyl-8-iodo-6,6-diMethyl-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile 1256584-80-1 C21H17IN2O
ForMaMide, N-[5-(2R)-oxiranyl-2-(phenylMethoxy)phenyl]- ForMaMide, N-[5-(2R)-oxiranyl-2-(phenylMethoxy)phenyl]- 201677-57-8 C16H15NO3
2-(MethylcarbaMoyl)benzoic acid 2-(MethylcarbaMoyl)benzoic acid 6843-36-3 C9H9NO3
1-(4-(2-Methoxyethyl)phenoxy)-3-(oxiran-2-ylMethoxy)propan-2-ol 1-(4-(2-Methoxyethyl)phenoxy)-3-(oxiran-2-ylMethoxy)propan-2-ol 1416440-64-6 C15H22O5
(3S,4S)-1-benzyl-N,4-diMethylpiperidin-3-aMine (3S,4S)-1-benzyl-N,4-diMethylpiperidin-3-aMine 1354621-59-2 C14H22N2
1H-BenziMidazole-7-carboxylic acid, 1-[[2'-(2,5-dihydro-5-oxo-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]Methyl] -2-ethoxy-, ethyl ester 1H-BenziMidazole-7-carboxylic acid, 1-[[2'-(2,5-dihydro-5-oxo-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]Methyl] -2-ethoxy-, ethyl ester 1403474-70-3 C27H24N4O5
6-acetyl-2-aMino-8-cyclopentyl-5-Methylpyrido[2,3-d]pyriMidin-7(8H)-one 6-acetyl-2-aMino-8-cyclopentyl-5-Methylpyrido[2,3-d]pyriMidin-7(8H)-one 571189-64-5 C15H18N4O2
Apixaban-13C-D3 Apixaban-13C-D3 1261393-15-0 C2413CH22D3N5O4
IMp. C (EP): Ethyl [(4-Methylphenyl)sulphonyl]-CarbaMate IMp. C (EP): Ethyl [(4-Methylphenyl)sulphonyl]-CarbaMate
IMp. C (EP): Methyl-2-[4-[2-[(4-Chlorobenzoyl)aMino]ethyl]phenoxy]-2-Methylpropanoate IMp. C (EP): Methyl-2-[4-[2-[(4-Chlorobenzoyl)aMino]ethyl]phenoxy]-2-Methylpropanoate
5-PyriMidinecarboxylic acid, 4-(4-fluorophenyl)-1,2-dihydro-6-(1-Methylethyl)-2-oxo-, Methyl ester 5-PyriMidinecarboxylic acid, 4-(4-fluorophenyl)-1,2-dihydro-6-(1-Methylethyl)-2-oxo-, Methyl ester 488798-37-4 C15H15FN2O3
Milrinone IMpurity 4 Milrinone IMpurity 4
Nebivolol O-Beta-D-Glucuronide Nebivolol O-Beta-D-Glucuronide 1698091-61-0 C22H27NO4
Nicergoline IMp. C (EP) Nicergoline IMp. C (EP)
Perindopril IMpurity E Perindopril IMpurity E
Pitavastatin 3-Oxo SodiuM Pitavastatin 3-Oxo SodiuM 2245811-12-3 C25H22FNO4
PraMipexole IMp.BI-II828BS PraMipexole IMp.BI-II828BS C20H32N6S2
Propofol IMpurity F Propofol IMpurity F
Rosuvastatin IMpurity SodiuM Salt (5-Oxo Rosuvastatin SodiuM Salt) Rosuvastatin IMpurity SodiuM Salt (5-Oxo Rosuvastatin SodiuM Salt) 1422619-13-3 C22H26FN3O6S
Sertraline IMpurity (SRTRC-3) Sertraline IMpurity (SRTRC-3) 91797-76-1 C17H17Cl2N
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 C10H14ClN3O2
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
4-[5-({2-[(4-{5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazol-2-yl}butanoyl)oxy]ethyl}(2-chloroethyl)amino)-1-methyl-1H benzimidazol-2-yl]butanoic acid 4-[5-({2-[(4-{5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazol-2-yl}butanoyl)oxy]ethyl}(2-chloroethyl)amino)-1-methyl-1H benzimidazol-2-yl]butanoic acid 1926162-37-9 C32H42Cl4N6O4
N-Deshydroxyethyl Dasatinib N-Deshydroxyethyl Dasatinib 910297-51-7 C20H22ClN7OS
N-Desethyl Sunitinib N-Desethyl Sunitinib 356068-97-8 C20H23FN4O2
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
2-chloro-N-(3-chloro-2-methylphenyl)nicotinamide 2-chloro-N-(3-chloro-2-methylphenyl)nicotinamide 57841-61-9 C13H10Cl2N2O
(R)-3-Amino-3-phenylpropionic acid (R)-3-Amino-3-phenylpropionic acid 13921-90-9 C9H11NO2
4-(2-Ethoxy benzamido)-1-methyl-3-n-propyl pyrazole-5-carboxamide. 4-(2-Ethoxy benzamido)-1-methyl-3-n-propyl pyrazole-5-carboxamide. 139756-03-9 C17H22N4O3
N-Hydroxy Riluzole N-Hydroxy Riluzole 179070-90-7 C8H5F3N2O2S
2-piperazine-4-amino-6,7-dimethoxyquinazoline Hydrochloride 2-piperazine-4-amino-6,7-dimethoxyquinazoline Hydrochloride 70843-11-7 C14H20ClN5O2
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
(1α,2β,4β,5α)-9-Methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7α-ol (1α,2β,4β,5α)-9-Methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7α-ol 498-46-4 C8H13NO2
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
(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
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
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