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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
Valsartan Impurity 13 Valsartan Impurity 13 C24H29N5O3
Valsartan Impurity 27 Valsartan Impurity 27 C24H29N5O3
Etoricoxib Impurity 6 Etoricoxib Impurity 6
Ezetimibe impurity 3 Ezetimibe impurity 3
Apremilast Impurity C Apremilast Impurity C
bis(1-benzylpiperidin-3-yl) 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate bis(1-benzylpiperidin-3-yl) 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate 166808-97-5 C16H16N2O6
Ticagrelor Imp.J Ticagrelor Imp.J 2248538-63-6 C14H20ClN5O4S
Vortioxetine Imp.E Vortioxetine Imp.E 508233-77-0 C18H22N2S
(3R,4S)-1-(4-fluorophenyl)-3-((S)-3-hydroxy-3-(p-tolyl)propyl)-4-(4-hydroxyphenyl)azetidin-2-one (3R,4S)-1-(4-fluorophenyl)-3-((S)-3-hydroxy-3-(p-tolyl)propyl)-4-(4-hydroxyphenyl)azetidin-2-one 1700622-07-6 C25H24FNO3
Topiroxostat Impurity 1 Topiroxostat Impurity 1
Oxcarbazepine Impurity3 Oxcarbazepine Impurity3
Mosapride  IMP Mosapride IMP
4-Ethoxy Paroxetine 4-Ethoxy Paroxetine 606968-04-1 C21H25NO4
Methylene-Bis Paroxetine Methylene-Bis Paroxetine 1292846-10-6 C39H40F2N2O6
Trelagliptin Impurity X Trelagliptin Impurity X 1938080-44-4 C18H22FN5O3
Afatinib Impurity 19 Afatinib Impurity 19 1245555-42-3 C21H21ClFN5O2
Cefoxitin Sodium impurity Cefoxitin Sodium impurity
(1S,2S,3S)-Aprepitant (1S,2S,3S)-Aprepitant 1242175-40-1 C23H21F7N4O3
Triamterene Related Compound B (50 mg) (2,7-diamino-4-hydroxy-6-phenylpteridine) Triamterene Related Compound B (50 mg) (2,7-diamino-4-hydroxy-6-phenylpteridine) 19375-89-4 C12H10N6O
IMp. B (EP): (2RS,4S)-2-[[[[3-(2-Chloro-6-fluorophenyl)-5-Methylisoxazol-4-yl]carbonyl]aMino]Methyl]-5,5-diMethyl- thiazolidine-4-carboxylic Acid (Penilloic Acids of Flucloxacillin) IMp. B (EP): (2RS,4S)-2-[[[[3-(2-Chloro-6-fluorophenyl)-5-Methylisoxazol-4-yl]carbonyl]aMino]Methyl]-5,5-diMethyl- thiazolidine-4-carboxylic Acid (Penilloic Acids of Flucloxacillin)
IMp. C (EP): (4-(DiphenylMethyl)-1,1-bis[(E)-3-phenylprop-2-enyl]piperaziniuM Chloride IMp. C (EP): (4-(DiphenylMethyl)-1,1-bis[(E)-3-phenylprop-2-enyl]piperaziniuM Chloride 95062-18-3 C35H35ClF2N2
IMp. E (EP): 4-AMino-5-(ethylsulphonyl)-2-Methoxybenzoic Acid IMp. E (EP): 4-AMino-5-(ethylsulphonyl)-2-Methoxybenzoic Acid
3,5-DiMethyl-1-nitroadaMantane 3,5-DiMethyl-1-nitroadaMantane 6588-68-7 C12H19NO2
2-Deschloro Aripiprazole 2-Deschloro Aripiprazole 203395-82-8 C23H28ClN3O2
6-O-Benzyl-4-dehydroxy-4-diMethylphenylsilyl Entecavir 6-O-Benzyl-4-dehydroxy-4-diMethylphenylsilyl Entecavir 649761-24-0 C27H31N5O2Si
Desisobutyl-n-butyl BortezoMib Desisobutyl-n-butyl BortezoMib 1104011-35-9 C19H25BN4O4
2-aMino-4-Methoxy-5-(3-Morpholinopropoxy)benzaMide 2-aMino-4-Methoxy-5-(3-Morpholinopropoxy)benzaMide 246512-44-7 C15H23N3O4
N-(4,6-dichloro-2-(propylthio)pyriMidin-5-yl)forMaMide N-(4,6-dichloro-2-(propylthio)pyriMidin-5-yl)forMaMide 1402150-28-0 C8H9Cl2N3OS
Ebastine IMpurity G Ebastine IMpurity G 1429071-65-7 C32H39NO3
edaravone iMpurity edaravone iMpurity
(2R,3R,4R,5S,6R)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)-6-(hydroxyMethyl)tetrahydro-2H-pyran-3,4,5-triol (2R,3R,4R,5S,6R)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)-6-(hydroxyMethyl)tetrahydro-2H-pyran-3,4,5-triol C24H25FO5S
Androst-16-en-3-ol, 17-(3-pyridinyl)-, acetate (ester),(3β,5α)- Androst-16-en-3-ol, 17-(3-pyridinyl)-, acetate (ester),(3β,5α)- 219843-76-2 C26H35NO2
5-(4-fluorophenyl)-1H-pyrrole-3-carbaldehyde 5-(4-fluorophenyl)-1H-pyrrole-3-carbaldehyde C11H8FNO
Ganciclovir EP Impurity H Ganciclovir EP Impurity H 84222-50-4 C9H13N5O4
2-[4-[(1E)-1,2-Diphenylethenyl]phenoxy]-N,N-dimethylethanamine 2-[4-[(1E)-1,2-Diphenylethenyl]phenoxy]-N,N-dimethylethanamine 97151-10-5 C24H25NO
[S-(R*,R*)]-3,3'-Dithiobis[2-methylpropanoic acid] [S-(R*,R*)]-3,3'-Dithiobis[2-methylpropanoic acid] 65134-74-9 C8H14O4S2
(E)-1-(4-(2-Methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-yl)ethanone (E)-1-(4-(2-Methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-yl)ethanone 935272-10-9 C18H20N4OS
2-(thiophen-3-yl)ethyl 4-methylbenzenesulfonate 2-(thiophen-3-yl)ethyl 4-methylbenzenesulfonate 40412-09-7 C13H14O3S2
4-Nitrophenyl 5-chlorothiophene-2-carboxylate 4-Nitrophenyl 5-chlorothiophene-2-carboxylate 1450877-56-1 C11H6ClNO4S
Olaparib iMpurity B Olaparib iMpurity B
Posaconazole iMpurity 6 Posaconazole iMpurity 6 2185472-85-7 C30H35N5O3
Everolimus Isomer C Everolimus Isomer C
3-Deschloro-4-Desfluoro-4-Chloro-3-Fluorogefitinib 3-Deschloro-4-Desfluoro-4-Chloro-3-Fluorogefitinib 1603814-04-5 C22H24ClFN4O3
Brivaracetam (Racemate) Brivaracetam (Racemate) 357335-87-6 C11H20N2O2
Donepezil Impurity 2 Donepezil Impurity 2 36517-91-6 C11H10O4
Fesoterodine Related Impurity 2 Fesoterodine Related Impurity 2 1254942-29-4 C30H39NO6
Prasugrel Impurity 13 HCl Prasugrel Impurity 13 HCl 1618108-01-2 C18H19ClFNOS
Ticagrelor Related Compound 5 Ticagrelor Related Compound 5 1414348-35-8 C9H9F2N
Vortioxetine Impurity 2 Vortioxetine Impurity 2 1293489-69-6 C17H20N2S
Chrysin 6-C-arabinoside 8-C-glucoside Chrysin 6-C-arabinoside 8-C-glucoside 185145-33-9 C26H28O13
Meloside A Meloside A 60767-80-8 C27H30O15
DONEPEZIL IMP DONEPEZIL IMP 923571-16-8 C24H22NO4.Cl
Parecoxib Impurity N Parecoxib Impurity N
2-{[(methoxycarbonylmethyl)(toluene-4-sulfonyl)amino]methyl}-4-phenoxybenzoic acid methyl ester 2-{[(methoxycarbonylmethyl)(toluene-4-sulfonyl)amino]methyl}-4-phenoxybenzoic acid methyl ester 1455091-06-1 C25H25NO7S
1-METHYL-4-PHENYL-3-(TRIFLUOROMETHYL)-1H-PYRAZOL-5-AMINE 1-METHYL-4-PHENYL-3-(TRIFLUOROMETHYL)-1H-PYRAZOL-5-AMINE 63156-74-1 C11H10F3N3
AURORA KA-7735 AURORA KA-7735 6487-86-1 C9H13NO2
Sugammadex sodium Impurity 45 Sugammadex sodium Impurity 45
Carboprost Trometamol 1 Carboprost Trometamol 1
Apremilast ImpurityTNN Apremilast ImpurityTNN
Tenofovir Impurity 113 Tenofovir Impurity 113 1335287-28-9 C11H13IN4O
Cefazolin USP Impurity L-δ3 Cefazolin USP Impurity L-δ3
Cabozantinib impurity 38 Cabozantinib impurity 38
Cabozantinib impurity 57 Cabozantinib impurity 57
(2R,3S)-3-(6-(1-(6-chloro-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol hydrochloride (2R,3S)-3-(6-(1-(6-chloro-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol hydrochloride
(R)-2-((2R,5R)-3,6-dioxo-5-phenylpiperazin-2-yl)-5-methyl-3,6-dihydro-2H-1,3-thiazine-4-carboxylic acid (R)-2-((2R,5R)-3,6-dioxo-5-phenylpiperazin-2-yl)-5-methyl-3,6-dihydro-2H-1,3-thiazine-4-carboxylic acid 860011-30-9 C16H17N3O4S
6-bromo-4-((dimethylamino)methyl)-5-hydroxy-N,1-dimethyl-2-((phenylthio)methyl)-1H-indole-3-carboxamide 6-bromo-4-((dimethylamino)methyl)-5-hydroxy-N,1-dimethyl-2-((phenylthio)methyl)-1H-indole-3-carboxamide
Dapoxetine impurity 54 Dapoxetine impurity 54
Doxofylline Impurity 21 Doxofylline Impurity 21
Dapoxetine impurity 60 Dapoxetine impurity 60
5-[bis-(2-Chloroethyl)amino]-1-methyl-1H-benzimidazole-2-butanoic acid ethyl ester 5-[bis-(2-Chloroethyl)amino]-1-methyl-1H-benzimidazole-2-butanoic acid ethyl ester 87475-54-5 C18H25Cl2N3O2
6-Hydroxykaempferol 3-Rutinoside -6-glucoside 6-Hydroxykaempferol 3-Rutinoside -6-glucoside 145134-63-0 C33H40O21
(R)-1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinoline (R)-1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinoline 85-63-2 C21H27NO4
Linagliptin Impurity P Linagliptin Impurity P
Linagliptin Impurity U Linagliptin Impurity U
(R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzoic acid (R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzoic acid 1917324-15-2 C18H21FN4O4
N1,N4-bis((R)-1-(3-(2-cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)piperidin-3-yl)succinamide N1,N4-bis((R)-1-(3-(2-cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)piperidin-3-yl)succinamide C40H42F2N10O6
ethyl ((1R,3aR,4aR,6S,8aR,9S,9aS)-9-((E)-2-(5-(3-fluorophenyl)pyridin-2-yl)vinyl)-1-methyl-3-oxododecahydronaphtho[2,3-c]furan-6-yl)carbamate ethyl ((1R,3aR,4aR,6S,8aR,9S,9aS)-9-((E)-2-(5-(3-fluorophenyl)pyridin-2-yl)vinyl)-1-methyl-3-oxododecahydronaphtho[2,3-c]furan-6-yl)carbamate 618385-10-7 C29H33FN2O4
(2R)-2-deoxy-2-fluoro-2-methyl-α/β-D-erythro-pentofuranosyl chloride-3,5-dibenzoate (2R)-2-deoxy-2-fluoro-2-methyl-α/β-D-erythro-pentofuranosyl chloride-3,5-dibenzoate 1621160-31-3 C20H18ClFO5
Apremilast Impurity F Apremilast Impurity F
Etoricoxib Impurity 17 Etoricoxib Impurity 17
Ibrutinib Impurity 3 Ibrutinib Impurity 3 1226872-27-0 C25H26N6O4
Imatinib Impurity 2 Imatinib Impurity 2 1384131-91-2 C7H11NO
Mirabegron M5 (YM-538852) Mirabegron M5 (YM-538852) 1365244-63-8 C18H22N2O2
Sofosbuvir Impurity 6 Sofosbuvir Impurity 6
Vonoprazan Impurity 2 Vonoprazan Impurity 2 881733-36-4 C17H16FN3O2S
Atomoxetine EP impurity A Atomoxetine EP impurity A 56161-70-7 C16H19NO
Cinacalcet Impurity 21 Cinacalcet Impurity 21
Dasatinib Impurity D Dasatinib Impurity D
Doxofylline Impurity 1 Doxofylline Impurity 1 1429636-74-7 C10H16N4O3
Isopropyl4-hydroxy-3,5-diisopropylbenzoate Isopropyl4-hydroxy-3,5-diisopropylbenzoate 2095678-97-8 C16H24O3
Sitagliptin EP Impurity B Sitagliptin EP Impurity B 1345822-87-8 C16H19F5N5O5P
Trospium Impurity Trospium Impurity
Vildagliptin Related Compound A Vildagliptin Related Compound A 741657-02-3 C17H25N3O
2-amino-9-((1R,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one hydrate 2-amino-9-((1R,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one hydrate 1367369-78-5 C12H15N5O3
Moxifloxacin Impurity 6 Moxifloxacin Impurity 6 849770-49-6 C25H29BFN3O8
beta-D-Hydroxymethoxymethylanthraquinonyl glucopyranoside beta-D-Hydroxymethoxymethylanthraquinonyl glucopyranoside 29013-18-1 C22H22O10
Sitafloxacin Impurity A Sitafloxacin Impurity A 500295-83-0 C16H16FN3O3
1-benzylpiperidin-4-yl [1,1'-biphenyl]-2-ylcarbamate 1-benzylpiperidin-4-yl [1,1'-biphenyl]-2-ylcarbamate 171723-80-1 C25H26N2O2
Merariveron impurity C Merariveron impurity C
4H-Inden-4-one, 1-[1,5-dimethyl-5-[(triethylsilyl)oxy]hexyl]octahydro-7a-methyl-, [1R-[1α(R*),3aβ,7aα]]- 4H-Inden-4-one, 1-[1,5-dimethyl-5-[(triethylsilyl)oxy]hexyl]octahydro-7a-methyl-, [1R-[1α(R*),3aβ,7aα]]- 144848-24-8 C24H46O2Si
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