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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
TenoxicaM IMpurity E (2-Methylthieno[2,3-d]isothiazol-3(2H)-one-1,1-dioxide ) TenoxicaM IMpurity E (2-Methylthieno[2,3-d]isothiazol-3(2H)-one-1,1-dioxide ) 94040-09-2 C6H5NO3S2
(+)-(14β)-Dihydrovinpocetine (+)-(14β)-Dihydrovinpocetine 57517-54-1 C22H28N2O2
D,L-Venlafaxine-d10 Hydrochloride D,L-Venlafaxine-d10 Hydrochloride 1216539-56-8 C17H28ClNO2
Ceritinib IMpurity Ceritinib IMpurity
Melphalan IMpurity Melphalan IMpurity
1-[2-[(5-chloro-2,4-diMethylphenyl)thio]phenyl]- Piperazine 1-[2-[(5-chloro-2,4-diMethylphenyl)thio]phenyl]- Piperazine 1240670-87-4 C18H21ClN2S
4'-(Difluoromethoxy)acetanilide 4'-(Difluoromethoxy)acetanilide 22236-11-9 C9H9F2NO2
EthanediaMide, N1-(5-chloro-2-pyridinyl)-N2-[(1S,2S,4R)-4-[(diMethylaMino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-Methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]aMino]cyclohexyl]- EthanediaMide, N1-(5-chloro-2-pyridinyl)-N2-[(1S,2S,4R)-4-[(diMethylaMino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-Methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]aMino]cyclohexyl]- 1255529-28-2 C24H30ClN7O4S
N-carbaMoyl-2-Methyl benzene sulfonaMide N-carbaMoyl-2-Methyl benzene sulfonaMide 39051-77-9 C8H10N2O3S
Capecitabin iMpurity Capecitabin iMpurity 71609-08-0 C9H12FN3O4
4-[[(2RS)-2-Hydroxy-3-(isopropylaMino)propyl]oxy]benzaldehydeHydrochloride (4-[(2RS)-2-Hydroxy-3-[(1-Methylethyl)aMino]propoxy]benzaldehydeHydrochloride) 4-[[(2RS)-2-Hydroxy-3-(isopropylaMino)propyl]oxy]benzaldehydeHydrochloride (4-[(2RS)-2-Hydroxy-3-[(1-Methylethyl)aMino]propoxy]benzaldehydeHydrochloride)
4-(4-(4-(4-(((3S,5S)-5-((1H-1,2,4-triazol-1-yl)Methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)Methoxy)phenyl)piperazin-1-yl)phenyl)-1-((2R,3R)-2-hydroxypentan-3-yl)-1H-1,2,4-triazol-5(4H)-one 4-(4-(4-(4-(((3S,5S)-5-((1H-1,2,4-triazol-1-yl)Methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)Methoxy)phenyl)piperazin-1-yl)phenyl)-1-((2R,3R)-2-hydroxypentan-3-yl)-1H-1,2,4-triazol-5(4H)-one 2243785-97-7 C37H42F2N8O4
4-(4-broMo-3-(hydroxyMethyl)phenoxy)benzonitrile 4-(4-broMo-3-(hydroxyMethyl)phenoxy)benzonitrile 906673-45-8 C14H10BrNO2
ACT 080803 ACT 080803 1433875-21-8 C16H13Br2N5O2
L-Alanine, N-[(S)-hydroxyphenoxyphosphinyl]-, 1-Methylethyl ester, (P→3'),(P'→5')-diester with (2'R)-2'-deoxy-2'-fluoro-2'-Methyluridine L-Alanine, N-[(S)-hydroxyphenoxyphosphinyl]-, 1-Methylethyl ester, (P→3'),(P'→5')-diester with (2'R)-2'-deoxy-2'-fluoro-2'-Methyluridine 1337482-17-3 C34H45FN4O13P2
Pyrido[2,3-d]pyriMidin-7(8H)-one, 2,6-dibroMo-8-cyclopentyl-5-Methyl- Pyrido[2,3-d]pyriMidin-7(8H)-one, 2,6-dibroMo-8-cyclopentyl-5-Methyl- 1415560-29-0 C13H13Br2N3O
1-Dimethylamino-2-phenylbutan-2-yl 3,4,5-trimethoxybenzoate 1-Dimethylamino-2-phenylbutan-2-yl 3,4,5-trimethoxybenzoate 92414-09-0 C22H29NO5
Celecoxib 2-Methyl Analog Celecoxib 2-Methyl Analog 170569-99-0 C17H14F3N3O2S
Ibuprofen IMp. I (EP): 1-(2-Methylpropyl)-4-[(3RS)-3-[4-(2-Methylpropyl)phenyl]butyl]benzene Ibuprofen IMp. I (EP): 1-(2-Methylpropyl)-4-[(3RS)-3-[4-(2-Methylpropyl)phenyl]butyl]benzene
3-Quinolinecarboxylic acid, 7-[(7S)-7-aMino-5-azaspiro[2.4]hept-5-yl]-8-chloro-6-fluoro-1-[(1R,2S)-2-fluorocyclopropyl]-1,4-dihydro-4-oxo-, hydrate 3-Quinolinecarboxylic acid, 7-[(7S)-7-aMino-5-azaspiro[2.4]hept-5-yl]-8-chloro-6-fluoro-1-[(1R,2S)-2-fluorocyclopropyl]-1,4-dihydro-4-oxo-, hydrate 163253-37-0 C19H20ClF2N3O4
3-oxo-1,3-dihydroisobenzofuran-1-ylphosphonic acid 3-oxo-1,3-dihydroisobenzofuran-1-ylphosphonic acid 61260-15-9 C10H11O5P
1-(4,8-bis-(2,2,2-trifluoroacetyl)-11-{4-[4,8,11-tris-(2,2,2-trifluoroacetyl)-1,4,8,11-tetraazacyclotetradec-1-ylMethyl]-benzyl}-1,4,8,11-tetraazacyclotetradec-1-yl)-2,2,2-trifluoroethanone 1-(4,8-bis-(2,2,2-trifluoroacetyl)-11-{4-[4,8,11-tris-(2,2,2-trifluoroacetyl)-1,4,8,11-tetraazacyclotetradec-1-ylMethyl]-benzyl}-1,4,8,11-tetraazacyclotetradec-1-yl)-2,2,2-trifluoroethanone 406939-93-3 C40H48F18N8O6
Anastrozole iMpurity A Anastrozole iMpurity A
Anastrozole iMpurity A Anastrozole iMpurity A
EMtricitabine iMpurity C EMtricitabine iMpurity C
IMp. F (EP) IMp. F (EP)
RocuroniuMbroMide iMpurity F RocuroniuMbroMide iMpurity F
(Z)-2-ethoxy-3-((2'-(N'-hydroxycarbaMiMidoyl)biphenyl-4-yl)Methyl)-3H-benzo[d]iMidazole-4-carboxylic acid (Z)-2-ethoxy-3-((2'-(N'-hydroxycarbaMiMidoyl)biphenyl-4-yl)Methyl)-3H-benzo[d]iMidazole-4-carboxylic acid 1397836-49-5 C24H22N4O4
Ribavirin IMpurity E Ribavirin IMpurity E 58151-90-9 C15H16N4O6
TetrahydrogalantaMine TetrahydrogalantaMine 664995-65-7 C17H19NO2
EMpagliflozin  iMpurity 6 EMpagliflozin iMpurity 6 1620758-21-5 C32H37ClO12
EMpagliflozin  iMpurity 11 EMpagliflozin iMpurity 11
1,4,7,10-Tetraazacyclododecane-1,4,7-triacetic acid,10-[2,3-dihydroxy-1-(hydroxymethyl)propyl]- 1,4,7,10-Tetraazacyclododecane-1,4,7-triacetic acid,10-[2,3-dihydroxy-1-(hydroxymethyl)propyl]- 138168-36-2 C18H34N4O9
Di-Norbudesonide (Mixture of DiastereoMers) Di-Norbudesonide (Mixture of DiastereoMers) 1040085-98-0 C23H30O6
Linagliptin MethyldiMer Linagliptin MethyldiMer 1418133-47-7 C50H56N16O4
Trelagliptin Impurity isomer Trelagliptin Impurity isomer 2206135-35-3 C18H20FN5O2
(2R,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxyMethyl)tetrahydro-2H-pyran-3,4,5-triol (2R,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxyMethyl)tetrahydro-2H-pyran-3,4,5-triol C21H25ClO6
3,6-Dichloropyrazine-2-carboxaMide 3,6-Dichloropyrazine-2-carboxaMide 1023813-21-9 C5H3Cl2N3O
N-acetic acid-1-aMino-3-adaMantanol N-acetic acid-1-aMino-3-adaMantanol 1032564-18-3 C12H19NO3
9(10H)-Acridinone, 2-ethoxy-6-nitro- 9(10H)-Acridinone, 2-ethoxy-6-nitro- 451460-48-3 C15H12N2O4
Olaparib iMpurity D Olaparib iMpurity D
(5-broMo-2-chlorophenyl)(4-hydroxyphenyl)Methanone (5-broMo-2-chlorophenyl)(4-hydroxyphenyl)Methanone 1360568-68-8 C13H8BrClO2
(2-broMo-4,5-diMethylphenyl)Methanol (2-broMo-4,5-diMethylphenyl)Methanol 1126385-20-3 C9H11BrO
Posaconazole iMpurity 8 Posaconazole iMpurity 8
Dehydro Benidipine Dehydro Benidipine 118935-44-7 C28H29N3O6
Etoposide Impurity B Etoposide Impurity B 100007-56-5 C29H32O13
Istradefylline Impurity 2 Istradefylline Impurity 2 606080-73-3 C20H24N4O4
Oxonic Acid Impurity 1 Oxonic Acid Impurity 1 60301-55-5 C3H3N3O2
Vortioxetine Impurity 4 Vortioxetine Impurity 4 1293489-77-6 C18H22N2S
Zidovudine USP Impurity G Zidovudine USP Impurity G 148665-49-0 C20H25N7O8
Quinoline, 6,7-dimethoxy-4-(4-nitrophenoxy)- Quinoline, 6,7-dimethoxy-4-(4-nitrophenoxy)- 190728-24-6 C17H14N2O5
Itopride Impurity A Itopride Impurity A 943518-63-6 C16H17NO4
Aripiprazole N1-Oxide Aripiprazole N1-Oxide
Aripiprazole N1-Oxide Aripiprazole N1-Oxide
Diethyl-carbaMic Acid ChloroMethyl Ester Diethyl-carbaMic Acid ChloroMethyl Ester 133217-92-2 C6H12ClNO2
ClarithroMycin IMpurity G ClarithroMycin IMpurity G 127182-44-9 C39H72N2O13
1-(3-Hydroxypropyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]aMino]propyl]-1H-indole-7-carboxaMide 1-(3-Hydroxypropyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]aMino]propyl]-1H-indole-7-carboxaMide 175870-21-0 C25H30F3N3O4
5-[(4,5-Dihydro-1H-iMidazol-2-yl)aMino]-6-hydroxy-2-Methyl-4(3H)-pyriMidinone 5-[(4,5-Dihydro-1H-iMidazol-2-yl)aMino]-6-hydroxy-2-Methyl-4(3H)-pyriMidinone 352457-32-0 C8H11N5O2
1,4-Bis(2,3,4-triMethoxybenzyl)piperazine 1,4-Bis(2,3,4-triMethoxybenzyl)piperazine 1257-19-8 C24H34N2O6
N-ForMyl-L-leucine [S-(E)]-1-(2-Nonenyl)dodecyl Ester N-ForMyl-L-leucine [S-(E)]-1-(2-Nonenyl)dodecyl Ester 130676-63-0 C28H53NO3
3-(1,4-Dihydro-5-Methyl-4-oxo-7-propyliMidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxybenzoic Acid 3-(1,4-Dihydro-5-Methyl-4-oxo-7-propyliMidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxybenzoic Acid 358390-39-3 C18H20N4O4
β-(BenzoylaMino)-α-hydroxybenzenepropanoic Acid (αR,βS)-(1S,3S,4S,4aR,5S,6S,8S,11R,12aS)-3,11-Bis(acetyloxy)-4-[(benzoyloxy)Methyl]-1,2,3,4,4a,5,6,7,8,11,12,12a-dodecahydro-1,4,5,6-tetrahydroxy-9,12a,13,13-tetraMethyl-12-oxo-6,10-Methanobenzocyclodecen-8- β-(BenzoylaMino)-α-hydroxybenzenepropanoic Acid (αR,βS)-(1S,3S,4S,4aR,5S,6S,8S,11R,12aS)-3,11-Bis(acetyloxy)-4-[(benzoyloxy)Methyl]-1,2,3,4,4a,5,6,7,8,11,12,12a-dodecahydro-1,4,5,6-tetrahydroxy-9,12a,13,13-tetraMethyl-12-oxo-6,10-Methanobenzocyclodecen-8- 932042-85-8 C47H53NO15
(S)-Sitagliptin Phosphate (S)-Sitagliptin Phosphate 823817-58-9 C16H16F6N5O5P
4-[(2,3,4-TriMethoxyphenyl)Methyl]-1-piperazinecarboxylic Acid Ethyl Ester 4-[(2,3,4-TriMethoxyphenyl)Methyl]-1-piperazinecarboxylic Acid Ethyl Ester 53531-01-4 C17H26N2O5
(S)-2-(3-chloro-2-hydroxypropyl)isoindoline-1,3-dione (S)-2-(3-chloro-2-hydroxypropyl)isoindoline-1,3-dione 148857-42-5 C11H10ClNO3
Loratadine IMpurity C Loratadine IMpurity C C22H23ClN2O2
Metoprolol IMpurity C Metoprolol IMpurity C C15H25NO3
Metoprolol IMpurity I Metoprolol IMpurity I C15H25NO3
Telmisartan impurity D Telmisartan impurity D
itraconazole impurity f itraconazole impurity f
Ethanediamide, N1-(5-chloro-2-pyridinyl)-N2-[(1S,2S,4S)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]- Ethanediamide, N1-(5-chloro-2-pyridinyl)-N2-[(1S,2S,4S)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]- 1255529-27-1 C24H30ClN7O4S
1-(p-Toluenesulfonyl)hoMopiperazine, 95% 1-(p-Toluenesulfonyl)hoMopiperazine, 95% 872103-28-1 C12H18N2O2S
1-NaphthaleneethanaMine, 1,2,3,4-tetrahydro-7-Methoxy- 1-NaphthaleneethanaMine, 1,2,3,4-tetrahydro-7-Methoxy- 59081-66-2 C13H19NO
1-NaphthaleneethanaMine, 1,2,3,4-tetrahydro-7-Methoxy- 1-NaphthaleneethanaMine, 1,2,3,4-tetrahydro-7-Methoxy- 59081-66-2 C13H19NO
1H-Indazole, 4,5-dichloro- 1H-Indazole, 4,5-dichloro- 1020243-02-0 C7H4Cl2N2
1H-Indazole, 4,5-dichloro- 1H-Indazole, 4,5-dichloro- 1020243-02-0 C7H4Cl2N2
1,4-ditosyl-1,4-diazepane 1,4-ditosyl-1,4-diazepane 5769-35-7 C19H24N2O4S2
Flurbiprofen Impurity Flurbiprofen Impurity 64858-90-8 C17H17FO2
IMp. A (EP) as DisodiuM Salt: (4S)-2-[Carboxy[[[3-(2-chloro-6-fluorophenyl)-5-Methylisoxazol-4-yl]carbonyl]aMino]Methyl]-5,5-diMethylthiazolidine-4-carboxylic Acid DisodiuM Salt(Penicilloic Acids of Flucloxacillin DisodiuM Salt) IMp. A (EP) as DisodiuM Salt: (4S)-2-[Carboxy[[[3-(2-chloro-6-fluorophenyl)-5-Methylisoxazol-4-yl]carbonyl]aMino]Methyl]-5,5-diMethylthiazolidine-4-carboxylic Acid DisodiuM Salt(Penicilloic Acids of Flucloxacillin DisodiuM Salt)
the Metabolite of Ivabradine the Metabolite of Ivabradine 215935-23-2 C26H34N2O5
Acarbose 1,1-α,α-Glycoside IMpurity Acarbose 1,1-α,α-Glycoside IMpurity 610271-07-3 C25H43NO18
Acarbose 1,1-α,α-Glycoside IMpurity Acarbose 1,1-α,α-Glycoside IMpurity 610271-07-3 C25H43NO18
Des-6-[4-(2-hydroxyethyl)-1-piperazinyl]-6-chloro Dasatinib Des-6-[4-(2-hydroxyethyl)-1-piperazinyl]-6-chloro Dasatinib 910297-71-1 C16H13Cl2N5O2S
Hydroxythiovardenafil Hydroxythiovardenafil 912576-30-8 C23H32N6O4S2
(((((1-(6-aMino-9H-purin-9-yl)propan-2-yl)oxy)Methyl)phosphoryl)bis(oxy))bis(Methylene) isopropyl Methyl dicarbonate (((((1-(6-aMino-9H-purin-9-yl)propan-2-yl)oxy)Methyl)phosphoryl)bis(oxy))bis(Methylene) isopropyl Methyl dicarbonate 1246812-43-0 C17H26N5O10P
9(10H)-Acridinone, 6-aMino-2-ethoxy- 9(10H)-Acridinone, 6-aMino-2-ethoxy- 144335-20-6 C15H14N2O2
parecoxib impurity L parecoxib impurity L
Rupatadine iMpurity Rupatadine iMpurity 169253-15-0 C19H19ClN2
ceftazidiMe iMpurity C ceftazidiMe iMpurity C
pidotiMod iMpurity E pidotiMod iMpurity E 162148-16-5 C9H12N2O4S
1H-Pyrazole-1-propanenitrile, β-cyclopentyl-4-[7-(hydroxyMethyl)-7H-pyrrolo[2,3-d]pyriMidin-4-yl]-,(βR)- 1H-Pyrazole-1-propanenitrile, β-cyclopentyl-4-[7-(hydroxyMethyl)-7H-pyrrolo[2,3-d]pyriMidin-4-yl]-,(βR)- 1236033-03-6 C18H20N6O
Cyclopropanecarboxylic acid, 1-[(phenylaMino)carbonyl]- Cyclopropanecarboxylic acid, 1-[(phenylaMino)carbonyl]- 145591-80-6 C11H11NO3
3-PiperidinaMine, 1-acetyl-N,4-diMethyl-N-1H-pyrrolo[2,3-d]pyriMidin-4-yl-, (3R,4R)- (9CI) 3-PiperidinaMine, 1-acetyl-N,4-diMethyl-N-1H-pyrrolo[2,3-d]pyriMidin-4-yl-, (3R,4R)- (9CI) 477600-76-3 C15H21N5O
AzithroMycin iMpurity AzithroMycin iMpurity 194809-66-0 C37H69BN2O13
MeropeneM iMpurity MeropeneM iMpurity 96035-23-3 C15H19N3O5S
Ciprofloxacin EP IMpurity B Ciprofloxacin EP IMpurity B 93107-11-0 C17H19N3O3
Valdecoxib IMpurity-E Valdecoxib IMpurity-E 1373038-63-1 C16H11Cl2NO5S2
Sunitinib N-Oxide Sunitinib N-Oxide 356068-99-0 C22H27FN4O3
Abiraterone Sulfate Abiraterone Sulfate
AtracuriuM IMpurity G (R-Laudanosine) AtracuriuM IMpurity G (R-Laudanosine)
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