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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
Olaparib iMpurity B Olaparib iMpurity B
Posaconazole iMpurity 6 Posaconazole iMpurity 6 2185472-85-7 C30H35N5O3
Everolimus Isomer C Everolimus Isomer C
(S)-2-(2-(5-chloro-N-(4-(5-((5-chlorothiophene-2-carboxamido)methyl)-2-oxooxazolidin-3-yl)phenyl)thiophene-2-carboxamido)ethoxy)acetic acid (S)-2-(2-(5-chloro-N-(4-(5-((5-chlorothiophene-2-carboxamido)methyl)-2-oxooxazolidin-3-yl)phenyl)thiophene-2-carboxamido)ethoxy)acetic acid 1151893-81-0 C24H21Cl2N3O7S2
Cilastatin ammonium salt Cilastatin ammonium salt 877674-82-3 C16H29N3O5S
DONEPEZIL IMP DONEPEZIL IMP 923571-16-8 C24H22NO4.Cl
Parecoxib Impurity N Parecoxib Impurity N
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
Dinitrogen oxide-15N Dinitrogen oxide-15N 20509-24-4 N15NO
(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
Benzonitrile, 2-[(4-chloro-3,6-dihydro-2,6-dioxo-1(2H)-pyrimidinyl)methyl]- Benzonitrile, 2-[(4-chloro-3,6-dihydro-2,6-dioxo-1(2H)-pyrimidinyl)methyl]- 2749357-07-9 C12H8ClN3O2
Odaterol Impurity 36 Odaterol Impurity 36
3,3',5,5'-TETRAIODOTHYRO-ACETIC ACID 3,3',5,5'-TETRAIODOTHYRO-ACETIC ACID 67-30-1 C14H8I4O4
2-Cyclopentene-1-methanol, 4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-, (1R-cis)- 2-Cyclopentene-1-methanol, 4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-, (1R-cis)- 136470-79-6 C14H18N6O
Glycopyrrolate Erythro Isomer Glycopyrrolate Erythro Isomer 201667-20-1
1,2-Benzenedicarboxylicacid,3-(hydroxyamino)-(9CI) 1,2-Benzenedicarboxylicacid,3-(hydroxyamino)-(9CI) 202262-76-8 C8H7NO5
Oprinone Impurity 1 Oprinone Impurity 1
Benzamide, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-[3-fluoro-4-[(methylamino)carbonyl]phenyl]-N-methyl- Benzamide, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-[3-fluoro-4-[(methylamino)carbonyl]phenyl]-N-methyl- 2894796-76-8 C29H21F5N6O3S
5-chloro-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine 5-chloro-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine 91147-46-5 C11H10ClN5
(S)-(+)-3-HYDROXYTETRAHYDROFURAN (S)-(+)-3-HYDROXYTETRAHYDROFURAN 79107-75-8 C4H8OS
TRIBENZYLPHOSPHITE TRIBENZYLPHOSPHITE 15205-57-9 C21H21O3P
4-Chlor-3-nitro-5-sulfobenzoesure 4-Chlor-3-nitro-5-sulfobenzoesure 130262-91-8 C7H4ClNO7S
4-(4-Methylpiperazin-1-ylmethyl)benzoic acid 4-(4-Methylpiperazin-1-ylmethyl)benzoic acid 106261-48-7 C13H18N2O2
Benzoic acid, 4-[(2S,4S)-4-hydroxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]-2-piperidinyl]- Benzoic acid, 4-[(2S,4S)-4-hydroxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]-2-piperidinyl]- 1644670-02-9 C23H26N2O4
Diphenylpiperidin-4-ylmethanol hydrochloride Diphenylpiperidin-4-ylmethanol hydrochloride 1798-50-1 C18H22ClNO
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
Avatrombopag Impurity 58 Avatrombopag Impurity 58
4-Methoxyglucobrassicin 4-Methoxyglucobrassicin 83327-21-3 C17H22N2O10S2
4-methylsulfinylbenzoate 4-methylsulfinylbenzoate 33963-58-5 C8H8O3S
Capecitabine Related Compound C Capecitabine Related Compound C
(D-LYS16)-ACTH (1-24) (HUMAN, BOVINE, MOUSE, OVINE, PORCINE, RABBIT, RAT) (D-LYS16)-ACTH (1-24) (HUMAN, BOVINE, MOUSE, OVINE, PORCINE, RABBIT, RAT) 494750-52-6 C136H210N40O31S
1-(diaminomethylidene)-3-[(2R,3R,4R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]urea 1-(diaminomethylidene)-3-[(2R,3R,4R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]urea 2508-80-7 C7H14N4O5
3-(2-amino-1-hydroxyethyl)benzene-1,2-diol 3-(2-amino-1-hydroxyethyl)benzene-1,2-diol 73660-93-2 C8H11NO3
3-(4-Methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)benzonitrile 3-(4-Methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)benzonitrile 641571-12-2 C12H8F3N3
17-BETA-ESTRADIOL 3-METHYL ETHER 17-BETA-ESTRADIOL 3-METHYL ETHER 1474-53-9 C19H26O3
7-Epi-10-oxo-docetaxel (Docetaxel Impurity D) 7-Epi-10-oxo-docetaxel (Docetaxel Impurity D) 162784-72-7 C43H51NO14
(3-CHLORO-3-PHENYL-PROPYL)-DIMETHYL-AMINE HYDROCHLORIDE (3-CHLORO-3-PHENYL-PROPYL)-DIMETHYL-AMINE HYDROCHLORIDE 79130-51-1 C11H16ClN
(Dimethylamino)acetaldehyde Dimethyl Acetal (Dimethylamino)acetaldehyde Dimethyl Acetal 38711-20-5 C6H15NO2
Dasatinib N-Oxide Dasatinib N-Oxide 910297-52-8 C22H26ClN7O3S
1H-Indole-2-carboxylic acid, 1-[(1S,2S)-1-(2,5-dihydro-5-oxo-1,2,4-oxadiazol-3-yl)-2-methylcyclopropyl]-5-[(4R)-tetrahydro-2,2-dimethyl-2H-pyran-4-yl]- 1H-Indole-2-carboxylic acid, 1-[(1S,2S)-1-(2,5-dihydro-5-oxo-1,2,4-oxadiazol-3-yl)-2-methylcyclopropyl]-5-[(4R)-tetrahydro-2,2-dimethyl-2H-pyran-4-yl]- 3067284-94-7 C22H25N3O5
[1,1′-Biphenyl]-2-sulfonamide, 4′-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-N-(4,5-dimethyl-3-isoxazolyl)-2′-(hydroxymethyl)- [1,1′-Biphenyl]-2-sulfonamide, 4′-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-N-(4,5-dimethyl-3-isoxazolyl)-2′-(hydroxymethyl)- 254740-63-1 C30H36N4O5S
(R)-9-[2-(DIETHYLPHOSPHONOMETHOXY)PROPYL] ADENINE (R)-9-[2-(DIETHYLPHOSPHONOMETHOXY)PROPYL] ADENINE 180587-75-1 C13H22N5O4P
P-TOLYL-PROPYNOIC ACID ETHYL ESTER P-TOLYL-PROPYNOIC ACID ETHYL ESTER 52188-06-4 C12H12O2
cis-N-Methyl-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-naphthalenamine hydrochloride cis-N-Methyl-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-naphthalenamine hydrochloride 79617-89-3 C17H17Cl2N.HCl
2,4-DIMETHYLDIPHENYLSULFIDE 2,4-DIMETHYLDIPHENYLSULFIDE 16704-47-5 C14H14S
Dibenz[b,e]oxepin-11(6H)-one Dibenz[b,e]oxepin-11(6H)-one 4504-87-4 C14H10O2
2-CHLORO-1-(4,5-DICHLORO-2-THIENYL)ETHAN-1-ONE 2-CHLORO-1-(4,5-DICHLORO-2-THIENYL)ETHAN-1-ONE 64218-50-4 C6H3Cl3OS
(5Z,7E)-9,10-Seco-26,27-cyclo-1α,3β-dihydroxycholesta-5,7,10(19)-trien-24-one (5Z,7E)-9,10-Seco-26,27-cyclo-1α,3β-dihydroxycholesta-5,7,10(19)-trien-24-one 126860-84-2 C27H40O3
(-)-3-Demethylcolchicine (-)-3-Demethylcolchicine 7336-33-6 C21H23NO6
Benzoic acid, 4-[(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]-2-piperidinyl]-, ethyl ester Benzoic acid, 4-[(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]-2-piperidinyl]-, ethyl ester 1644670-76-7 C27H34N2O4
4,4'-((2S,2'S,4S,4'S)-((methylenebis(5-methoxy-7-methyl-1H-indole-3,4-diyl))bis(methylene))bis(4-ethoxypiperidine-1,2-diyl))dibenzoic acid 4,4'-((2S,2'S,4S,4'S)-((methylenebis(5-methoxy-7-methyl-1H-indole-3,4-diyl))bis(methylene))bis(4-ethoxypiperidine-1,2-diyl))dibenzoic acid
(2R,3S)-2-(4-(cyclopentylamino)phenyl)-1-(2-fluoro-6-methylbenzoyl)-N-(4-((2R,3S)-1-(2-fluoro-6-methylbenzoyl)-3-((4-methyl-3-(trifluoromethyl)phenyl)carbamoyl)piperidin-2-yl)phenyl)piperidine-3-carboxamide (2R,3S)-2-(4-(cyclopentylamino)phenyl)-1-(2-fluoro-6-methylbenzoyl)-N-(4-((2R,3S)-1-(2-fluoro-6-methylbenzoyl)-3-((4-methyl-3-(trifluoromethyl)phenyl)carbamoyl)piperidin-2-yl)phenyl)piperidine-3-carboxamide
3',5'-Dimethoxytricetin 7-O-β-D-glucopypranoside 3',5'-Dimethoxytricetin 7-O-β-D-glucopypranoside 32769-01-0 C23H24O12
2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropionic acid methyl ester 2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropionic acid methyl ester 42019-07-8 C18H17ClO4
1,3-Dimethyl-5,5-diallylhexahydropyrimidine-2,4,6-trione 1,3-Dimethyl-5,5-diallylhexahydropyrimidine-2,4,6-trione 722-97-4 C12H16N2O3
Pseudomonic acid C Pseudomonic acid C 71980-98-8 C26H44O8
Cytarabine Impurity 12 Cytarabine Impurity 12 14057-18-2 C15H18N2O9
D,L-O-DesMethyl Venlafaxine-d6 D,L-O-DesMethyl Venlafaxine-d6 1062605-69-9 C16H19D6NO2
(E)-3-[p-Bromomethylphenyl]acrylic acid ethyl ester (E)-3-[p-Bromomethylphenyl]acrylic acid ethyl ester 78712-67-1 C12H13BrO2
3-Amino-2-butenoic acid 3-Amino-2-butenoic acid 21112-45-8 C4H7NO2
((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
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