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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
Vortioxetine impurity S Vortioxetine impurity S 1815608-51-5 C18H22N2S
Baloxavir marboxil Baloxavir marboxil 1985606-14-1 C27H23F2N3O7S
Linagliptin N-Acetyl Impurity Linagliptin N-Acetyl Impurity 1803079-49-3 C27H30N8O3
(1R,3R)-1-(benzo[d][1,3]dioxol-5-yl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylic acid (1R,3R)-1-(benzo[d][1,3]dioxol-5-yl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylic acid 474668-76-3 C19H16N2O4
Lidocaine  Impurity Lidocaine Impurity 70336-49-1 C20H22N2O2
(E)-2-cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2-enamide (E)-2-cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2-enamide 214782-56-6 C12H9F3N2O2
Amoxicillin Impurity  O Amoxicillin Impurity O C16H19N3O5S
Ampicillin Impurity R Ampicillin Impurity R
Spectinomycin Impurity C Spectinomycin Impurity C
Amifostine Impurity 2 Amifostine Impurity 2
Brexpiprazole Impurity Brexpiprazole Impurity 2138169-93-2 C41H47N5O2S2
Cefoxitin impurity EF Cefoxitin impurity EF
Tenofovir Impurity 38 Tenofovir Impurity 38 161760-09-4 C8H11O6PS
N-(4-methyl-3-(3-(4-((4-methylpiperazin-1-yl)methyl)benzoyl)guanidino)phenyl)-4-(4-methylpiperazin-1-yl)benzamide N-(4-methyl-3-(3-(4-((4-methylpiperazin-1-yl)methyl)benzoyl)guanidino)phenyl)-4-(4-methylpiperazin-1-yl)benzamide C33H42N8O2
Apremilast Apremilast 1384440-16-7 C19H20N2O6S
XMUJPIDSOJTMMS-VTBMCCKRSA-N XMUJPIDSOJTMMS-VTBMCCKRSA-N 212505-49-2 C21H30O3
XLMHAABXFLIUNQ-UHFFFAOYSA-N XLMHAABXFLIUNQ-UHFFFAOYSA-N 368451-15-4 C24H26O3
2-propyl-1H-indene-1,3(2H)-dione 2-propyl-1H-indene-1,3(2H)-dione 14570-43-5 C12H12O2
ACETIC ACID 2-METHOXY-4-(5-OXO-2-PHENYL-OXAZOL-4-YLIDENEMETHYL)-PHENYL ESTER ACETIC ACID 2-METHOXY-4-(5-OXO-2-PHENYL-OXAZOL-4-YLIDENEMETHYL)-PHENYL ESTER 18692-68-7 C19H15NO5
4-Methylpiperazine-1-carbonyl chloride 4-Methylpiperazine-1-carbonyl chloride 39539-66-7 C6H11ClN2O
Epoxy Exemestane (6-Beta Isomer) Epoxy Exemestane (6-Beta Isomer) 152764-31-3 C20H24O3
AFTMPFJWAIDLME-QWHCGFSZSA-N AFTMPFJWAIDLME-QWHCGFSZSA-N 1808087-53-7 C15H19N3O3S
6-Cyclopropyl-10-fluorobenzo[k]phenanthridine 6-Cyclopropyl-10-fluorobenzo[k]phenanthridine 1187966-95-5 C20H14FN
4-[2-fluoro-4-[2-(methylcarbamoyl)pyridin-4-yl]oxyanilino]-N-methylpyridine-2-carboxamide 4-[2-fluoro-4-[2-(methylcarbamoyl)pyridin-4-yl]oxyanilino]-N-methylpyridine-2-carboxamide 1855006-12-0 C20H18FN5O3
2,2'-((piperazine-1,4-disulfonyl)bis(2-ethoxy-5,1-phenylene))bis(5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(3H)-one) 2,2'-((piperazine-1,4-disulfonyl)bis(2-ethoxy-5,1-phenylene))bis(5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(3H)-one) 1255919-03-9 C38H46N10O8S2
Bortezomib Impurity P Bortezomib Impurity P
Esmolol impurity A Esmolol impurity A
(5-(4-fluorophenyl)thiophen-2-yl)(5-iodo-2-methylphenyl)methanol (5-(4-fluorophenyl)thiophen-2-yl)(5-iodo-2-methylphenyl)methanol 1818268-45-9 C18H14FIOS
GLORIOSINE GLORIOSINE 7411-12-3 C21H23NO6
N-METHYL-3-CHLORO-3-PHENYL PROPYLAMINE HCL N-METHYL-3-CHLORO-3-PHENYL PROPYLAMINE HCL 128036-32-8 C10H15Cl2N
2,4,5-TRIFLUORO-3-METHOXYBENZOIC ACID 2,4,5-TRIFLUORO-3-METHOXYBENZOIC ACID 11281-65-5 C8H5F3O3
Labetalone hydrochloride Labetalone hydrochloride 96441-14-4 C19H22N2O3.ClH
6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-
7,9-dimethyl-7,9-dihydro-8H-purin-8-one 6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)- 7,9-dimethyl-7,9-dihydro-8H-purin-8-one 1361569-23-4 C20H17FN8O
5-(1-amino-2-(methylsulfonyl)ethyl)-2-methoxyphenol 5-(1-amino-2-(methylsulfonyl)ethyl)-2-methoxyphenol 2169153-70-0 C10H15NO4S
Bendamustine Impurity 14 Bendamustine Impurity 14
Canagliflozin Impurity 28 Canagliflozin Impurity 28
Edoxaban Impurity 24 (1S,2S,4R) Edoxaban Impurity 24 (1S,2S,4R) 2024614-21-7 C21H30ClN5O5
Edoxaban Impurity 39 Edoxaban Impurity 39 2081883-55-6 C14H27N3O3
Ezetimibe Impurity 34 Ezetimibe Impurity 34 2280081-69-6 C20H21NO4
Linagliptin Impurity 33 Linagliptin Impurity 33 2443735-53-1 C38H42N10O4
Milrinone Impurity 15 Milrinone Impurity 15 156033-07-7 C12H9N3O2
Milrinone Impurity 6 Milrinone Impurity 6
Pantoprazole Impurity 2 Pantoprazole Impurity 2
rac-Valsartan EP Impurity B rac-Valsartan EP Impurity B 1894176-44-3 C31H35N5O3
Sitafloxacin Dechloro Impurity Sitafloxacin Dechloro Impurity
Ticagrelor Related Compound 85 Ticagrelor Related Compound 85 1628340-74-8 C28H34F2N6O5S
Valsartan Impurity 12 Valsartan Impurity 12 1189547-11-2 C11H21NO3
Vonoprazan Impurity 17 Vonoprazan Impurity 17
Avibactam Impurity B Avibactam Impurity B
Brexpiprazole Impurity L Brexpiprazole Impurity L
Cefaclor Impurity 4 Cefaclor Impurity 4
Nintedanib Impurity 26 Nintedanib Impurity 26
N-Formyl impurity N-Formyl impurity
(3R,4R)-N,1,4-trimethyl-N-{7H-pyrrolo[2,3-d]pyrimidin-4-yl}piperidin-3-amine (3R,4R)-N,1,4-trimethyl-N-{7H-pyrrolo[2,3-d]pyrimidin-4-yl}piperidin-3-amine 2227197-38-6 C14H21N5
4-Methoxyglucobrassicin 4-Methoxyglucobrassicin 83327-21-3 C17H22N2O10S2
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
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
Diphenylpiperidin-4-ylmethanol hydrochloride Diphenylpiperidin-4-ylmethanol hydrochloride 1798-50-1 C18H22ClNO
(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
(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
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
Linagliptin Impurity 38 Linagliptin Impurity 38 1979144-52-9 C20H17ClN6O2
Pidotimod Impurity N Pidotimod Impurity N
Pitavastatin (3S,5S)-Isomer Ethyl Ester Pitavastatin (3S,5S)-Isomer Ethyl Ester
Pramipexole Impurity 3 Pramipexole Impurity 3
Rupatadine Impurity A Rupatadine Impurity A
Sulpiride Impurity 2 Sulpiride Impurity 2
Tenofovir Impurity 55 Tenofovir Impurity 55
Voriconazole Impurity F Voriconazole Impurity F
MEDICARPIN-3-O-GLUCOSIDE MEDICARPIN-3-O-GLUCOSIDE 52766-70-8 C22H24O9
Atorvastatin Impurity F Atorvastatin Impurity F 1371615-56-3 C66H68CaF2N4O10
Ambroxol  Impurity 8(Ambroxol  Impurity M) Ambroxol Impurity 8(Ambroxol Impurity M) 1445719-53-8 C13H16Br2N2O
Cefdinir impurity PQ mixture Cefdinir impurity PQ mixture
Loratadine Impurity 16 Loratadine Impurity 16 C22H23ClN2O2
Meptazinol BP Impurity D Meptazinol BP Impurity D 1883577-02-3 C30H44N2O
Prasugrel Impurity 12 Prasugrel Impurity 12
Pregabalin Impurity 16 Pregabalin Impurity 16
PSI-7977-13C-d3 PSI-7977-13C-d3 2070009-25-3 C2113CH26D3FN3O9P
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