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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
rac Adrenaline IMpurity D rac Adrenaline IMpurity D 1095714-91-2 C16H19NO3
2-(1-Methylethenyl)-6-(1-Methylethyl)phenol 2-(1-Methylethenyl)-6-(1-Methylethyl)phenol 74926-89-9 C12H16O
Irinotecan IMpurity G Irinotecan IMpurity G 947687-02-7 C35H42N4O6
5-[Bis(2-hydroxyethyl)aMino]-1-Methyl-1H-benziMidazole-2-butanoic Acid 5-[Bis(2-hydroxyethyl)aMino]-1-Methyl-1H-benziMidazole-2-butanoic Acid 109882-30-6 C16H23N3O4
5-Chloro-6'-Methyl-3-[4-(Methylsulfonyl)phenyl]-2,3'-bipyridine 1'-Oxide 5-Chloro-6'-Methyl-3-[4-(Methylsulfonyl)phenyl]-2,3'-bipyridine 1'-Oxide 325855-74-1 C18H15ClN2O3S
Lafutidine IMpuritiy B Lafutidine IMpuritiy B 174583-84-7 C22H29N3O5S
N-(Methylsulfonyl)-N-(2-phenoxyphenyl)MethanesulfonaMide N-(Methylsulfonyl)-N-(2-phenoxyphenyl)MethanesulfonaMide 905858-63-1 C14H15NO5S2
4,5-Dihydro-α,3-diMethyl-5-oxo-1-phenyl-α-sulfo-1H-pyrazole-4-acetic Acid 4,5-Dihydro-α,3-diMethyl-5-oxo-1-phenyl-α-sulfo-1H-pyrazole-4-acetic Acid 1357477-99-6 C13H14N2O6S
tert-butyl 4-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)Methyl)benzoyl)piperazine-1-carboxylate tert-butyl 4-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)Methyl)benzoyl)piperazine-1-carboxylate 763114-04-1 C25H27FN4O4
1H-IMidazole, 4-Methyl-1-[3-nitro-5-(trifluoroMethyl)phenyl]- 1H-IMidazole, 4-Methyl-1-[3-nitro-5-(trifluoroMethyl)phenyl]- 916975-92-3 C11H8F3N3O2
Edaravone iMpurity P3 Edaravone iMpurity P3 1323485-71-7 C13H16N2O4S
5-(5-Chlorosulfonyl-2-ethoxyphenyl)-3-propyl-1,6-dihydro_x000b_-7H-pyrazolo[4,3-d]pyrimidin-7-one 5-(5-Chlorosulfonyl-2-ethoxyphenyl)-3-propyl-1,6-dihydro_x000b_-7H-pyrazolo[4,3-d]pyrimidin-7-one 139756-31-3 C16H17ClN4O4S
DU 6858 DU 6858 127199-06-8 C19H18ClF2N3O3
rac 4-[4-(Oxiranylmethoxy)-1,2,5-thiadiazol-3-yl]morpholine rac 4-[4-(Oxiranylmethoxy)-1,2,5-thiadiazol-3-yl]morpholine 58827-68-2 C9H13N3O3S
N-Formyl-L-leucine (3S,4S,6S)-3-Hexyltetrahydro-2-oxo-6-undecyl-2H-pyran-4-yl Ester N-Formyl-L-leucine (3S,4S,6S)-3-Hexyltetrahydro-2-oxo-6-undecyl-2H-pyran-4-yl Ester 130676-65-2 C29H53NO5
rac a-Hydroxy Ibuprofen rac a-Hydroxy Ibuprofen 60057-62-7 C13H18O3
3a,7a-dihydroxy-5-(1-methyl-1H-indole-3-carbonyl)-hexahydro-1H-benzo[d]imidazol-2(3H)-one 3a,7a-dihydroxy-5-(1-methyl-1H-indole-3-carbonyl)-hexahydro-1H-benzo[d]imidazol-2(3H)-one 171967-74-1 C17H19N3O4
N-nitrosamino Deucravacitinib 1 N-nitrosamino Deucravacitinib 1
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
3-Chloro-4-morpholino-1,2,5-thiadiazole 3-Chloro-4-morpholino-1,2,5-thiadiazole 30165-96-9 C6H8ClN3OS
2,6-DIMETHYL-4-(3-NITRO-PHENYL)-PYRIDINE-3,5-DICARBOXYLIC ACID DIMETHYL ESTER 2,6-DIMETHYL-4-(3-NITRO-PHENYL)-PYRIDINE-3,5-DICARBOXYLIC ACID DIMETHYL ESTER 76258-20-3 C17H16N2O6
monocalcium mono((3R,5S,E)-7-(4-(2-fluorophenyl)-6-isopropyl-2- (N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6- enoate) monocalcium mono((3R,5S,E)-7-(4-(2-fluorophenyl)-6-isopropyl-2- (N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6- enoate)
Benzenepropanoic acid, 4-(2-oxiranylmethoxy)- Benzenepropanoic acid, 4-(2-oxiranylmethoxy)- 2167848-51-1 C12H14O4
(S)-(+)-N,N-Dimethyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propanamine (S)-(+)-N,N-Dimethyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propanamine 132335-46-7 C19H21NOS
OEM Honey OEM Honey
D-Tryptophan, N-(trifluoroacetyl)- (9CI) D-Tryptophan, N-(trifluoroacetyl)- (9CI) 22220-03-7 C13H11F3N2O3
2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)-N-(5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)-1H-indazol-3-yl)benzamide 2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)-N-(5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)-1H-indazol-3-yl)benzamide
1H-benzo[d][1,2,3]triazol-1-yl 2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoate 1H-benzo[d][1,2,3]triazol-1-yl 2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoate
1-Ethyl-3(3-dimethylamino)urea 1-Ethyl-3(3-dimethylamino)urea 32897-26-0 C8H19N3O
Brivaracetam Impurity 29 Brivaracetam Impurity 29
L-erythro-Hexuronic acid, 3,5-dideoxy-, 1,1-dimethylethyl ester L-erythro-Hexuronic acid, 3,5-dideoxy-, 1,1-dimethylethyl ester 1501982-84-8 C10H18O5
(Gly8-OH)-Carbetocin (Impurity B) (Gly8-OH)-Carbetocin (Impurity B)
D-Asn4-Carbetocin (Impurity F) D-Asn4-Carbetocin (Impurity F)
Benzoic acid, 2-(1',6'-dihydro-6'-oxo-1'-phenyl[2,3'-bipyridin]-5'-yl)-, methyl ester Benzoic acid, 2-(1',6'-dihydro-6'-oxo-1'-phenyl[2,3'-bipyridin]-5'-yl)-, methyl ester 543699-60-1 C24H18N2O3
5,7-difluorochroman-4-one 5,7-difluorochroman-4-one 844648-22-2 C9H6F2O2
2-[(Azidoacetyl)amino]-2-deoxy-D-glucopyranose 1,3,4,6-tetraacetate 2-[(Azidoacetyl)amino]-2-deoxy-D-glucopyranose 1,3,4,6-tetraacetate 98924-81-3 C16H22N4O10
(3R,5R,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic acid (3R,5R,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic acid 769908-13-6 C25H24FNO4
(7a,17b)-7-7-[9-[(4,4,5,5,5-Pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol 17-acetate (7a,17b)-7-7-[9-[(4,4,5,5,5-Pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol 17-acetate 261506-24-5 C34H49F5O4S
Pirodavir Impurity 1 Pirodavir Impurity 1 124437-13-4 C23H31N3O3
1-(1H-benzo[d]imidazol-2-yl)-3-methyl-4-oxo-1,4-dihydropyridine-2-carboxylic acid 1-(1H-benzo[d]imidazol-2-yl)-3-methyl-4-oxo-1,4-dihydropyridine-2-carboxylic acid 1163685-30-0 C14H11N3O3
O-Desethyl Candesartan Cilexetil  O-Desethyl Candesartan Cilexetil 869631-11-8 C31H30N6O6
α-Desmethyl Anastrozole α-Desmethyl Anastrozole 1215780-15-6 C16H17N5
Epi Lovastatin Epi Lovastatin 79952-44-6 C24H36O5
Hydroxy Brimonidine Hydroxy Brimonidine 1216379-05-3 C11H12BrN5O
Vehicle exhaust detection standard gas Vehicle exhaust detection standard gas
Laser standard gas Laser standard gas
7-Methoxy-3,4-dihydro-1H-quinolin-2-one 7-Methoxy-3,4-dihydro-1H-quinolin-2-one 22246-17-9 C10H11NO2
4-Methoxy-alpha-methyl-N-(phenylmethyl)benzeneethanamine hydrochloride 4-Methoxy-alpha-methyl-N-(phenylmethyl)benzeneethanamine hydrochloride 1049695-95-5 C17H21NO.ClH
Montelukast Methyl Ketone Montelukast Methyl Ketone 937275-23-5 C34H32ClNO3S
Propyl Itraconazole Propyl Itraconazole 74855-91-7 C34H36Cl2N8O4
Olmesartan Methyl Ketone Olmesartan Methyl Ketone 1227626-45-0 C25H28N6O2
3-methyleneisobenzofuran-1(3H)-one 3-methyleneisobenzofuran-1(3H)-one 3453-63-2 C9H6O2
Irbesartan impurity A Irbesartan impurity A C25H28N6O
3-(2-TRIFLUOROMETHYL-PHENYL)-PROPAN-1-OL 3-(2-TRIFLUOROMETHYL-PHENYL)-PROPAN-1-OL 191155-81-4 C10H11F3O
1,2-bis(2-methoxyphenoxy)ethane 1,2-bis(2-methoxyphenoxy)ethane 553-45-7 C16H18O4
Dispiro[11H-benzo[5,6]cyclohepta[1,2-b]pyridine-11,2'-oxirane-3',4''-piperidine]-1''-carboxylic acid, 8-chloro-5,6-dihydro-, ethyl ester, 1-oxide Dispiro[11H-benzo[5,6]cyclohepta[1,2-b]pyridine-11,2'-oxirane-3',4''-piperidine]-1''-carboxylic acid, 8-chloro-5,6-dihydro-, ethyl ester, 1-oxide 1432057-93-6 C22H23ClN2O4
Oseltamivir Impurity 109 Oseltamivir Impurity 109
Oseltamivir  Impurity 81 Oseltamivir Impurity 81
Oseltamivir  Impurity 71 Oseltamivir Impurity 71
1-hydrazino-3-(methylthio)propan-2-ol 1-hydrazino-3-(methylthio)propan-2-ol 14359-97-8 C4H12N2OS
Benzenemethanol, 4-(3-chloro-2-hydroxypropoxy)- Benzenemethanol, 4-(3-chloro-2-hydroxypropoxy)- 293302-44-0 C10H13ClO3
N,N-bis((5-(2-fluorophenyl)-1H-pyrrol-3-yl)methyl)pyridine-3-sulfonamide N,N-bis((5-(2-fluorophenyl)-1H-pyrrol-3-yl)methyl)pyridine-3-sulfonamide 2514957-29-8 C27H22F2N4O2S
2,4(1H,3H)-Pyrimidinedione, 1-β-L-ribofuranosyl-, 4-oxime (9CI) 2,4(1H,3H)-Pyrimidinedione, 1-β-L-ribofuranosyl-, 4-oxime (9CI) 402725-23-9 C9H13N3O6
1H-Indole-2-sulfonic acid, 6-hydroxy-1-methyl- 1H-Indole-2-sulfonic acid, 6-hydroxy-1-methyl- 2271443-87-7 C9H9NO4S
5-[ethyl(2-hydroxyethyl)amino]pentan-2-one 5-[ethyl(2-hydroxyethyl)amino]pentan-2-one 74509-79-8 C9H19NO2
Sitagliptin EP Impurity 5 Sitagliptin EP Impurity 5
Simvastatin Impurity 6 Simvastatin Impurity 6
colocynthin colocynthin 1398-78-3 C38H54O13
(S)-Baclofen-d4 (S)-Baclofen-d4
Anastrozole Impurity 14 Anastrozole Impurity 14
Flomoxef oxidation impurities Flomoxef oxidation impurities
Toltrazuril Impurity 1 Toltrazuril Impurity 1
((2R,3R,5S)-5-(4-amino-2-oxopyrimidin-1(2H)-yl)-4,4-difluoro-3-hydroxytetrahydrofuran-2-yl)methyl benzoate ((2R,3R,5S)-5-(4-amino-2-oxopyrimidin-1(2H)-yl)-4,4-difluoro-3-hydroxytetrahydrofuran-2-yl)methyl benzoate
Aprepitant Impurity 53 Aprepitant Impurity 53
Cetrorelix Impurity 21 Cetrorelix Impurity 21
Brivaracetam Impurity 43 Brivaracetam Impurity 43
Canagliflozin Impurity 25 Complete Set Canagliflozin Impurity 25 Complete Set
Peramivir Intermediate Impurity 37 Peramivir Intermediate Impurity 37
Peramivir Diastereomer Impurity 1 Peramivir Diastereomer Impurity 1
Vinpocetine impurity 18 drops Vinpocetine impurity 18 drops
Canagliflozin Impurities 999 Canagliflozin Impurities 999
1,4,8,11-tetraazacyclotetradecane sodium chelation 1,4,8,11-tetraazacyclotetradecane sodium chelation
Apixaban Impurity D(BMS-719288)+ Apixaban Impurity D(BMS-719288)+
4-Methoxy-2,3,5-trimethylpyride-N-oxide 4-Methoxy-2,3,5-trimethylpyride-N-oxide 86604-80-0 C9H13NO2
4-nitro-1H-Imidazole-2-carboxaldehyde 4-nitro-1H-Imidazole-2-carboxaldehyde 33543-81-6 C4H3N3O3
1-CHLOROMETHYL-2,3,4-TRIMETHOXYBENZENE 1-CHLOROMETHYL-2,3,4-TRIMETHOXYBENZENE 1133-49-9 C10H13ClO3
Bumetanide Impurity 19 Bumetanide Impurity 19
Rocuronium Bromide Impurity 26 、27 Rocuronium Bromide Impurity 26 、27
Roxadustat Impurity 20 Roxadustat Impurity 20
Ruxolitinib Impurity Ruxolitinib Impurity
	Sitagliptin Impurity 82 Sitagliptin Impurity 82
(1S,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran- 2-yl)ethyl)-3,7-dimethyl-1,2,4a,5,6,7,8,8a-octahydronaphthalen-1-yl 2,2-dimethylbutanoate (1S,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran- 2-yl)ethyl)-3,7-dimethyl-1,2,4a,5,6,7,8,8a-octahydronaphthalen-1-yl 2,2-dimethylbutanoate
Perospirone Impurity 21 Perospirone Impurity 21
Perospirone Impurity 11 Perospirone Impurity 11
Dolutegravir Impurity 21 Dolutegravir Impurity 21
Related impurities of fluoxetine sodium 6 Related impurities of fluoxetine sodium 6
Fondaparinux sodium impurity 7 Fondaparinux sodium impurity 7
Fondaparinux sodium impurity 3 Fondaparinux sodium impurity 3
Oxacillin sodium  Impurity B Oxacillin sodium Impurity B
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