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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
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
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
Anastrozole Impurity 14 Anastrozole Impurity 14
1-BOC-4-(5-NITRO-2-PYRIDYL)PIPERAZINE 1-BOC-4-(5-NITRO-2-PYRIDYL)PIPERAZINE 193902-78-2 C14H20N4O4
(1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-phenylacetate (1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-phenylacetate
Relugolix Impurity 25 Relugolix Impurity 25
Lumateperone Impurity 5 Lumateperone Impurity 5
Sugammadex Sodium Impurity ORG139131-1 Sugammadex Sodium Impurity ORG139131-1
2-[4-(Azidomethyl)phenyl]benzoic acid 2-[4-(Azidomethyl)phenyl]benzoic acid
2-[(2-AZIDOETHOXY)METHYL]-4-(2-CHLOROPHENYL)-3-ETHOXYCARBONYL-5-METHOXYCARBONYL)-6-METHYL-1,4-DIHYDROPYRIDINE 2-[(2-AZIDOETHOXY)METHYL]-4-(2-CHLOROPHENYL)-3-ETHOXYCARBONYL-5-METHOXYCARBONYL)-6-METHYL-1,4-DIHYDROPYRIDINE 88150-46-3 C20H23ClN4O5
((6aR,9R,10aR)-7-methyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinolin-9-yl)methanol acetic acid salt ((6aR,9R,10aR)-7-methyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinolin-9-yl)methanol acetic acid salt
Brivaracetam Impurity 56 Brivaracetam Impurity 56
Oxytocin Impurity 3 Oxytocin Impurity 3
Rosuvastatin Impurity 158 Rosuvastatin Impurity 158
Rosuvastatin Impurity 139 Rosuvastatin Impurity 139
Rosuvastatin Impurity 124 Rosuvastatin Impurity 124
((R)-3-Methyl-1-((R)-3-phenyl-2-(pyrazine-2-carboxaMido)propanaMido)butyl)boronic acid ((R)-3-Methyl-1-((R)-3-phenyl-2-(pyrazine-2-carboxaMido)propanaMido)butyl)boronic acid 1132709-15-9 C19H25BN4O4
(S)-N-(1-AMino-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide (S)-N-(1-AMino-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide 289472-80-6 C14H14N4O2
(3aS,4R,6S,6aR)-6-AMinotetrahydro-2,2-diMethyl-4H-cyclopenta-1,3-dioxol-4-ol (3aS,4R,6S,6aR)-6-AMinotetrahydro-2,2-diMethyl-4H-cyclopenta-1,3-dioxol-4-ol 592533-90-9 C8H15NO3
(4R,6S)-tert-Butyl-6-cyanoMethyl-2,2-diMethyl-1,3-dioxane-4-acetate (4R,6S)-tert-Butyl-6-cyanoMethyl-2,2-diMethyl-1,3-dioxane-4-acetate 196085-84-4 C14H23NO4
(1R,2R,3S,5R)-3-(7-((1S,2R)-2-(3,4-difluorophenyl)cyclopropylaMino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol (1R,2R,3S,5R)-3-(7-((1S,2R)-2-(3,4-difluorophenyl)cyclopropylaMino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol 2096989-55-6 C23H28F2N6O4S
Rivaroxaban iMpurity Rivaroxaban iMpurity 1616563-62-2 C15H17N3O5
AMoxicillin iMpurity K AMoxicillin iMpurity K C16H19N3O5S
cefoxitin iMpurity D cefoxitin iMpurity D
3-Morpholinone, 4-(2,4-diaMinophenyl)- 3-Morpholinone, 4-(2,4-diaMinophenyl)- 482308-13-4 C10H13N3O2
BenzenesulfonaMide, N-[1,6-dihydro-5-(2-Methoxyphenoxy)-6-oxo[2,2'-bipyriMidin]-4-yl]-4-(1,1-diMethylethyl)- BenzenesulfonaMide, N-[1,6-dihydro-5-(2-Methoxyphenoxy)-6-oxo[2,2'-bipyriMidin]-4-yl]-4-(1,1-diMethylethyl)- 174227-14-6 C25H25N5O5S
BenzaMide, N-[1-(3,5-di-O-benzoyl-2-C-Methyl-β-D-arabinofuranosyl)-1,2-dihydro-2-oxo-4-pyriMidinyl]- BenzaMide, N-[1-(3,5-di-O-benzoyl-2-C-Methyl-β-D-arabinofuranosyl)-1,2-dihydro-2-oxo-4-pyriMidinyl]- 863329-62-8 C31H27N3O8
Fosfluconazole iMpurity Fosfluconazole iMpurity
Cinacalcet Impurity D Cinacalcet Impurity D 1271930-15-4 C32H31F6N
AtracuriuM IMpurity D2 (cis-Quaternary Alcohol) AtracuriuM IMpurity D2 (cis-Quaternary Alcohol) 1100676-16-1 C35H47NO10S
AzithroMycin IMpurity O AzithroMycin IMpurity O
BendaMustine Dihydroxy IMpurity BendaMustine Dihydroxy IMpurity 109882-29-3 C16H24ClN3O4
BroMocriptine IMpurity G BroMocriptine IMpurity G C32H40BrN5O5
Captopril IMpurity H Captopril IMpurity H 205521-07-9 C15H23NO5S2
Cefdinir IMpurity 3 (Cefdinir Decarboxy Open Ring Lactone (Mixture of A and B)) Cefdinir IMpurity 3 (Cefdinir Decarboxy Open Ring Lactone (Mixture of A and B)) 178949-04-7 C13H15N5O4S2
Ceftriaxone IMpurit D Ceftriaxone IMpurit D
Ciprofloxacin Related CoMpound Ciprofloxacin Related CoMpound 528851-30-1 C15H17Cl2N3O3
Dasatinib IMpurity 4 Dasatinib IMpurity 4
Deferasirox Methyl Ester Deferasirox Methyl Ester 1266741-05-2 C22H17N3O4
Deltacortinene Acetate (Predisolone Acetate IMpurity) Deltacortinene Acetate (Predisolone Acetate IMpurity) 4380-55-6 C23H28O5
Entecavir IMpurity A Entecavir IMpurity A
Fasudil IMpurity 1 Fasudil IMpurity 1 1423155-03-6 C14H17N3O2S
Irbesartan IMpurity Irbesartan IMpurity 1079997-01-5 C26H30N6O2
Montelukast EP IMpurity I Montelukast EP IMpurity I
RaceMic Fudosteine HCl RaceMic Fudosteine HCl 1023971-15-4 C6H13NO3S
RocuroniuM BroMide IMpurity 18 RocuroniuM BroMide IMpurity 18
SalMeterol IMpurity E SalMeterol IMpurity E C25H37NO4
SulbactaM IMpurity C SulbactaM IMpurity C
Terazosin IMpurity J Terazosin IMpurity J 152551-75-2 C19H27N5O4
Ticarcillin SodiuM IMpurity A Ticarcillin SodiuM IMpurity A 36041-93-7 C14H16N2O4S2
R-afatinib R-afatinib 945553-91-3 C24H25ClFN5O3
EthanediaMide  iMpurity E EthanediaMide iMpurity E C2H4N2O2
Methyl (1-benzyl-4-Methylpiperidin-3-yl)carbaMate Methyl (1-benzyl-4-Methylpiperidin-3-yl)carbaMate 1206875-41-3 C15H22N2O2
S-(-)-[1-(3-Methoxyphenyl)ethyl]-N,N-diMethylaMine S-(-)-[1-(3-Methoxyphenyl)ethyl]-N,N-diMethylaMine 889443-69-0 C11H17NO
N-(4-aMinophenyl)-2-chloro-N-MethylacetaMide N-(4-aMinophenyl)-2-chloro-N-MethylacetaMide 855860-75-2 C9H11ClN2O
Ibrutinib iMpurity Ibrutinib iMpurity 936351-48-3 C12H13ClN2O
1-Phenyl-5-(pyridin-2-yl)-1,2-dihydropyridin-2-one 1-Phenyl-5-(pyridin-2-yl)-1,2-dihydropyridin-2-one 381725-50-4 C16H12N2O
Abacavir Impurity E Abacavir Impurity E 208762-35-0 C14H20N6O
(1R,5S,6R)-rel-5-(1-Ethylpropoxy)-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic Acid Ethyl Ester (1R,5S,6R)-rel-5-(1-Ethylpropoxy)-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic Acid Ethyl Ester 347378-74-9 C14H22O4
(3R,5R,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic Acid CalciuM Salt (3R,5R,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic Acid CalciuM Salt 254452-96-5 C25H24FNO4
(αZ)-α-(MethoxyiMino)-N-[(5aR,6R)-1,4,5a,6-tetrahydro-1,7-dioxo-3H,7H-azeto[2,1-b]furo[3,4-d][1,3]thiazin-6-yl]-2-furanacetaMide (αZ)-α-(MethoxyiMino)-N-[(5aR,6R)-1,4,5a,6-tetrahydro-1,7-dioxo-3H,7H-azeto[2,1-b]furo[3,4-d][1,3]thiazin-6-yl]-2-furanacetaMide 947723-87-7 C15H13N3O6S
1-[[2-[(2-AMinophenyl)aMino]-5-Methyl-3-thienyl]carbonyl]-4-Methyl-piperazine 1-[[2-[(2-AMinophenyl)aMino]-5-Methyl-3-thienyl]carbonyl]-4-Methyl-piperazine 138564-61-1 C17H22N4OS
1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-hydroxy-4-oxo-3-quinolinecarboxylic Acid Ethyl Ester 1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-hydroxy-4-oxo-3-quinolinecarboxylic Acid Ethyl Ester 452092-31-8 C15H13F2NO4
2-(IsopropylaMino)-2',6'-acetoxylidide Hydrochloride 2-(IsopropylaMino)-2',6'-acetoxylidide Hydrochloride 35891-87-3 C13H21ClN2O
2,2'-IMinobis(N-(2,6-DiMethylphenyl)acetiaMide Hydrochloride 2,2'-IMinobis(N-(2,6-DiMethylphenyl)acetiaMide Hydrochloride 1135231-62-7 C20H26ClN3O2
3,4-O-(DiethylMethylidene) ShikiMic Acid Ethyl Ester 3,4-O-(DiethylMethylidene) ShikiMic Acid Ethyl Ester 943515-58-0 C14H22O5
4-Hydroxy-α1-[[[6-(2-phenylethoxy)hexyl]aMino]Methyl]-1,3-benzenediMethanol 4-Hydroxy-α1-[[[6-(2-phenylethoxy)hexyl]aMino]Methyl]-1,3-benzenediMethanol 94749-02-7 C23H33NO4
5-[2-Ethoxy-5-[(4-Methyl-1-piperazinyl)thioxoMethyl]phenyl]-1,6-dihydro-1-Methyl-3-propyl-7H-pyrazolo[4,3-d]pyriMidine-7-thione 5-[2-Ethoxy-5-[(4-Methyl-1-piperazinyl)thioxoMethyl]phenyl]-1,6-dihydro-1-Methyl-3-propyl-7H-pyrazolo[4,3-d]pyriMidine-7-thione 1333233-46-7 C23H30N6OS2
BIRG 613 BS BIRG 613 BS 287980-85-2 C15H16N4O
Deferasirox Salicyloyl Ester Deferasirox Salicyloyl Ester 1395346-28-7 C28H19N3O6
N-2-Hydroxy-3-[[2-(Methoxyphenoxy)ethyl]aMine Carvedilol N-2-Hydroxy-3-[[2-(Methoxyphenoxy)ethyl]aMine Carvedilol 1198090-73-1 C36H43N3O7
N-[2-[1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide N-[2-[1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide 253168-86-4 C22H24N2O7S
Ticagrelor IMpurity B Ticagrelor IMpurity B
AtracuriuM IMpurity V AtracuriuM IMpurity V 1075726-86-1 C25H34INO6
Avanafil iMpurity 3 Avanafil iMpurity 3
CitalopraM carboxylic acid iMpurity CitalopraM carboxylic acid iMpurity 440121-09-5 C20H22FNO3
Decitabine iMpurity 6 Decitabine iMpurity 6 178671-74-4 C7H14N4O4
DiazepaM IMpurity E DiazepaM IMpurity E 20927-53-1 C15H11ClN2O
ErtapeneM Side Chain EnantioMer 2 HCl ErtapeneM Side Chain EnantioMer 2 HCl 503607-49-6 C12H15ClN2O3S
Ribavirin IMpurity G Ribavirin IMpurity G
Ethanone, 1-(2,5-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)- 1-(2,5-Difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanone,1-(2,5-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanone Ethanone, 1-(2,5-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)- 1-(2,5-Difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanone,1-(2,5-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanone 1157938-97-0 C10H7F2N3O
3-Fluoro-4-phenylphenol 3-Fluoro-4-phenylphenol 477860-13-2 C12H9FO
Heptyl Deoctyl FingoliMod Hydrochloride Heptyl Deoctyl FingoliMod Hydrochloride 162361-44-6 C18H32ClNO2
4-Methoxy-3,5-diMethylpyridine 1-Oxide 4-Methoxy-3,5-diMethylpyridine 1-Oxide 91219-89-5 C8H11NO2
N-Ethyl-3-buteno-o-toluidide N-Ethyl-3-buteno-o-toluidide 13936-71-5 C13H17NO
Pramipexole Impurity 21 Pramipexole Impurity 21 104617-86-9 C10H17N3S
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