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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
Cefuroxime impurity 1 Cefuroxime impurity 1 C16H16N4O8S
Vonoprazan Impurity 9 Vonoprazan Impurity 9
Sitagliptin IMpurity 5 Sitagliptin IMpurity 5
Brexpiprazole Impurity3 Brexpiprazole Impurity3
Levetiracetam impurity 5 Levetiracetam impurity 5 1543300-90-8 C9H17NO4
Febuxostat Impurity B Febuxostat Impurity B
Sorafenib Impurity F Sorafenib Impurity F
Trelagliptin Impurity 1 Trelagliptin Impurity 1 1821400-07-0 C21H13ClF2N4O2
Vortioxetine Imp.J Vortioxetine Imp.J 2137588-68-0 C18H22N2S
4-amino-N-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide 4-amino-N-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide 1608459-56-8 C18H27N3O3
4,5-dichloro Rivaroxaban 4,5-dichloro Rivaroxaban 2305917-61-5 C25H28ClN3O6S
Solifenacin EP Impurity B Solifenacin EP Impurity B 1534326-81-2 C31H28N2O
Vildagliptin Impurity 6 Vildagliptin Impurity 6 1846606-31-2 C17H23N3O2
Flucloxacillin Impurity A Flucloxacillin Impurity A
(1R,2R,4S)-2-[(tert-butoxycarbonyl)aMino]-4-[(diMethylaMino)carbonyl]cyclohexyl Methanesulfonate (1R,2R,4S)-2-[(tert-butoxycarbonyl)aMino]-4-[(diMethylaMino)carbonyl]cyclohexyl Methanesulfonate 929693-31-2 C15H28N2O6S
Palonosetron Impurity 7 Palonosetron Impurity 7 177932-92-2 C18H24N2O
4-(2,3-Dichlorophenyl)-2,6-diMethyl-1,4-dihydropyridine-3,5-dicarboxylic acid 4-(2,3-Dichlorophenyl)-2,6-diMethyl-1,4-dihydropyridine-3,5-dicarboxylic acid 138279-32-0 C15H13Cl2NO4
IMp. A (EP) as Hydrochloride: 3-[[[2-[(DiaMinoMethylene)aMino]thiazol-4-yl]- Methyl]sulphanyl]propaniMidaMide Hydrochloride IMp. A (EP) as Hydrochloride: 3-[[[2-[(DiaMinoMethylene)aMino]thiazol-4-yl]- Methyl]sulphanyl]propaniMidaMide Hydrochloride
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
6,7-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
7-Methoxy-4-oxo-1,4-dihydroquinoline-6-carboxaMide 7-Methoxy-4-oxo-1,4-dihydroquinoline-6-carboxaMide 417724-81-3 C11H10N2O3
Tegafur Impurity BCB Tegafur Impurity BCB
(R)-diethyl 2-(4-(3-chloro-4-fluorophenylaMino)-7-(tetrahydrofuran-3-yloxy)quinazolin-6-ylaMino)-2-oxo (R)-diethyl 2-(4-(3-chloro-4-fluorophenylaMino)-7-(tetrahydrofuran-3-yloxy)quinazolin-6-ylaMino)-2-oxo 618061-77-1 C24H27ClFN4O6P
((2R,3R,4R)-3-(benzoyloxy)-4-chloro-4-Methyl-5-oxotetrahydrofuran-2-yl)Methyl benzoate ((2R,3R,4R)-3-(benzoyloxy)-4-chloro-4-Methyl-5-oxotetrahydrofuran-2-yl)Methyl benzoate 1496551-65-5 C20H17ClO6
2-(4-fluorophenyl)-5-(2-Methylbenzyl)thiophene 2-(4-fluorophenyl)-5-(2-Methylbenzyl)thiophene 2005454-69-1 C18H15FS
AcetaMide, N-[[(5S)-2-oxo-3-[4-(3-oxo-4-Morpholinyl)phenyl]-5-oxazolidinyl]Methyl]- AcetaMide, N-[[(5S)-2-oxo-3-[4-(3-oxo-4-Morpholinyl)phenyl]-5-oxazolidinyl]Methyl]- 1429334-00-8 C16H19N3O5
PSI 7411 PSI 7411 1015073-43-4 C10H14FN2O8P
5-[[4-(Hydroxymethyl)phenoxy]methyl]-3-(1-methylethyl)-2-oxazolidinone 5-[[4-(Hydroxymethyl)phenoxy]methyl]-3-(1-methylethyl)-2-oxazolidinone 1071765-44-0 C14H19NO4
(1S)-1,5-Anhydro-1-C-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol 2,3,4,6-tetrakis(2,2-dimethylpropanoate) (1S)-1,5-Anhydro-1-C-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol 2,3,4,6-tetrakis(2,2-dimethylpropanoate) 1283129-18-9 C44H57FO9S
[1,4'-Bipiperidine]-1'-carboxylic acid [1,4'-Bipiperidine]-1'-carboxylic acid 1026078-50-1 C11H20N2O2
4-[[3-(1-Methylethyl)-2-oxo-5-oxazolidinyl]methoxy]benzaldehyde 4-[[3-(1-Methylethyl)-2-oxo-5-oxazolidinyl]methoxy]benzaldehyde 1173203-26-3 C14H17NO4
EMpagliflozin  iMpurity 9 EMpagliflozin iMpurity 9
EMpagliflozin  iMpurity 14 EMpagliflozin iMpurity 14 2137418-13-2 C23H27ClO8
Avatrapa impurity 12 Avatrapa impurity 12 570403-04-2 C23H24Cl3N5OS2
ibrutinib iMpurity A ibrutinib iMpurity A
Sunitinib iMpurity E Sunitinib iMpurity E
Rosuvastatin EP impurity H Rosuvastatin EP impurity H 1335110-44-5 C22H28FN3O6S
Saxagliptin Impurity 4 (Deoxy Saxagliptin) Saxagliptin Impurity 4 (Deoxy Saxagliptin)
Betamethasone EP Impurity D Betamethasone EP Impurity D 52619-05-3 C25H33FO7
Dihydropenicillin F Potassium Salt Dihydropenicillin F Potassium Salt 31447-86-6 C14H23KN2O4S
Etoricoxib Impurity 7 Etoricoxib Impurity 7 646459-39-4 C20H21N3O2S
Mupirocin Impurity D Mupirocin Impurity D C26H44O9
Pazopanib Related Compound 2 Pazopanib Related Compound 2 1226500-02-2 C26H23ClN10
Phenylephrine EP Impurity D Phenylephrine EP Impurity D 1367567-95-0 C16H19NO2
Verapamil Impurity O Verapamil Impurity O 959011-16-6 C27H38N2O4
1,1′-[(1-Methylethyl)imino]bis[3-[4-(2-methoxyethyl)phenoxy]-2-propanol hydrochloride 1,1′-[(1-Methylethyl)imino]bis[3-[4-(2-methoxyethyl)phenoxy]-2-propanol hydrochloride 1486464-40-7 C27H42ClNO6
4'-FLUOROCYCLOPROPANECARBOXANILIDE 4'-FLUOROCYCLOPROPANECARBOXANILIDE 2354-89-4 C10H10FNO
(Z)-2-(2-Aminothiazol-4-yl)-2-(1-carboxy-1-methyl)ethoxyiminoacetic acid (Z)-2-(2-Aminothiazol-4-yl)-2-(1-carboxy-1-methyl)ethoxyiminoacetic acid 102507-85-7 C9H11N3O5S
Cefaclor EP IMpurity Cefaclor EP IMpurity
Alogliptin Impurity B Alogliptin Impurity B 865758-98-1 C17H19N5O2
Alogliptin Impurity B Alogliptin Impurity B 865758-98-1 C17H19N5O2
Linagliptin Impurity F Linagliptin Impurity F 1673546-62-7 C27H27F3N8O3
Parecoxib Impurity D Parecoxib Impurity D
Parecoxib Impurity I Parecoxib Impurity I
1-Hydroxymethyl-beta-carboline glucoside 1-Hydroxymethyl-beta-carboline glucoside 1408311-12-5 C18H20N2O6
Axitinib Impurity D Axitinib Impurity D 1443118-72-6 C29H25N5OS
Lenvatinib Impurity d Lenvatinib Impurity d 417717-04-5 C20H17ClN4O4
4-bromo-3-(hydroxymethyl)phenol 4-bromo-3-(hydroxymethyl)phenol 2737-20-4 C7H7BrO2
4-(4-Bromo-3-formyl-phenoxy)-benzonitrile 4-(4-Bromo-3-formyl-phenoxy)-benzonitrile 906673-54-9 C14H8BrNO2
Atracurium Impurity E Atracurium Impurity E
Linagliptin Impurity I Linagliptin Impurity I
1H-Pyrrole-3-carbonitrile,5-(2-fluorophenyl)-1-(3-pyridinylsulfonyl)- 1H-Pyrrole-3-carbonitrile,5-(2-fluorophenyl)-1-(3-pyridinylsulfonyl)- 1807642-39-2 C16H10FN3O2S
4-amino-1-[(2RS)-2-(2,4-difluorophenyl)-2-hydroxy-3(1H-
1,2,4-triazol-1-yl)propyl]-4H-1,2,4-triazolium 4-amino-1-[(2RS)-2-(2,4-difluorophenyl)-2-hydroxy-3(1H- 1,2,4-triazol-1-yl)propyl]-4H-1,2,4-triazolium 749821-19-0 C13H14F2N7O+
Canagliflozin Defluoro Impurity Canagliflozin Defluoro Impurity
Dapagliflozin Impurity 6 Dapagliflozin Impurity 6
1-(4-(2-methyl-6-oxopiperidin-1-yl)phenyl)-3-morpholino-5,6-dihydropyridin-2(1H)-one 1-(4-(2-methyl-6-oxopiperidin-1-yl)phenyl)-3-morpholino-5,6-dihydropyridin-2(1H)-one 2098457-93-1 C21H27N3O3
5-ethyl 3-isopropyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate 5-ethyl 3-isopropyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate 2170716-02-4 C22H29ClN2O5
Acetamide,N-(2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl)- Acetamide,N-(2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl)- 6118-65-6 C10H8N2O3
Ibrutinib impurity D Ibrutinib impurity D
Mupirocin impurity A Mupirocin impurity A C26H44O9
Aurantio-obtusin-6-O-β-D-glucoside Aurantio-obtusin-6-O-β-D-glucoside 129025-96-3 C23H24O12
FG-4592 intermediate7 FG-4592 intermediate7 1509958-19-3 C20H20N2O4
Milnacipran Impurity 13 Milnacipran Impurity 13 710339-49-4 C12H16NO+
Ofloxacin/Levofloxacin Impurity A Ofloxacin/Levofloxacin Impurity A
Urapidil Impurity A Urapidil Impurity A
Tofacitinib Impurity I Tofacitinib Impurity I
N-(3-chloro-4-fluorophenyl)-6 ,7-dimethoxyquinazolin-4-amine N-(3-chloro-4-fluorophenyl)-6 ,7-dimethoxyquinazolin-4-amine 153437-78-6 C16H13ClFN3O2
Itopride Impurity C Itopride Impurity C 141996-97-6 C19H24N2O4
Mirabegron Impurity Mirabegron Impurity 1796931-48-0 C21H24N4O2S
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