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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
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
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
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
Avatrombopag Impurity 58 Avatrombopag Impurity 58
4-methylsulfinylbenzoate 4-methylsulfinylbenzoate 33963-58-5 C8H8O3S
Capecitabine Related Compound C Capecitabine Related Compound C
4-Methoxyglucobrassicin 4-Methoxyglucobrassicin 83327-21-3 C17H22N2O10S2
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
((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
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
PseudoMonic Acid D SodiuM PseudoMonic Acid D SodiuM 85178-60-5 C26H41NaO9
N-DesMethyl SuMatriptan N-DesMethyl SuMatriptan 88919-51-1 C13H19N3O2S
2-epi-(-)-EMtricitabine 2-epi-(-)-EMtricitabine 145416-34-8 C8H10FN3O3S
Parent nucleus of cefotiaM hydrochloride Parent nucleus of cefotiaM hydrochloride 372092-19-8 C13H21N7O3S2
Bisacodyl Related Compound E (20 mg) (2-[(4-Acetoxyphenyl)(pyridin-2-yl)methyl]phenyl acetate) Bisacodyl Related Compound E (20 mg) (2-[(4-Acetoxyphenyl)(pyridin-2-yl)methyl]phenyl acetate) 111664-35-8 C22H19NO4
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
6-(2,5-dichlorophenyl)-1,3,5-Triazine-2,4(1H,3H)-dione 6-(2,5-dichlorophenyl)-1,3,5-Triazine-2,4(1H,3H)-dione 30222-00-5 C9H5Cl2N3O2
(2'R)-2'-Deoxy-2'-fluoro-2'-Methyl-uridine 3',5'-dibenzoate (2'R)-2'-Deoxy-2'-fluoro-2'-Methyl-uridine 3',5'-dibenzoate 863329-65-1 C24H21FN2O7
Anastrozole iMpurityC Anastrozole iMpurityC
Celecoxib iMpurity-A Celecoxib iMpurity-A
EMtricitabine iMpurity A EMtricitabine iMpurity A
RocuroniuMbroMide iMpurity D RocuroniuMbroMide iMpurity D
Ondansetron Impurity B Ondansetron Impurity B
LeflunoMide EP IMpurity F LeflunoMide EP IMpurity F 1403564-06-6 C12H9F3N2O2
4'-((1,7'-dimethyl-2'-propyl-1H,1'H-2,5'-bibenzo[d]imidazol-1'-yl)methyl)biphenyl-2-carboxylic acid 4'-((1,7'-dimethyl-2'-propyl-1H,1'H-2,5'-bibenzo[d]imidazol-1'-yl)methyl)biphenyl-2-carboxylic acid
Itraconazole iMpurity D Itraconazole iMpurity D
3-amino-2-chloroacrolein 3-amino-2-chloroacrolein 221615-73-2 C3H4ClNO
3-Amino-4-pyrazolecarbonitrile 3-Amino-4-pyrazolecarbonitrile 16617-46-2 C4H4N4
BenzaMide, 3,4-bis(cyclopropylMethoxy)-N-(3,5-dichloro-4-pyridinyl)- BenzaMide, 3,4-bis(cyclopropylMethoxy)-N-(3,5-dichloro-4-pyridinyl)- 1391052-24-6 C20H20Cl2N2O3
4-ISOBUTYRYLACETOPHENONE 4-ISOBUTYRYLACETOPHENONE 103931-20-0 C12H14O2
ButanaMide, 4-hydroxy-N-(1-Methylethyl)- ButanaMide, 4-hydroxy-N-(1-Methylethyl)- 42042-66-0 C7H15NO2
5H-chroMeno[2,3-b]pyridin-7-ylacetic acid 5H-chroMeno[2,3-b]pyridin-7-ylacetic acid 52549-07-2 C14H11NO3
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
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
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