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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
Rosuvastatin Impurity 75 Rosuvastatin Impurity 75
Acyclovir Impurity 11 Acyclovir Impurity 11
Selexipag Impurity 6 Selexipag Impurity 6
Cabozantinib impurity N Cabozantinib impurity N
Barcitinib impurity-09 Barcitinib impurity-09 1187594-16-6 C14H13N7
Rotigotine Impurity 6 Rotigotine Impurity 6
Olprinone Impurity 7 Olprinone Impurity 7 2236020-10-1 C9H10N2
Cilastatin Impurity 2 Cilastatin Impurity 2
Cilastatin Impurity 7 Cilastatin Impurity 7
Dabrafenib Impurity 1 Dabrafenib Impurity 1 1907654-22-1 C24H21F3N4O3S2
Trelagliptin Impurity SJ Trelagliptin Impurity SJ 2087874-94-8 C40H42F2N10O6
8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one 8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one 31251-41-9 C14H10ClNO
(R)-Ornidazole (R)-Ornidazole 166734-80-1 C7H10ClN3O3
(E)-4-BROMO-N,N-DIMETHYLBUT-2-ENAMIDE (E)-4-BROMO-N,N-DIMETHYLBUT-2-ENAMIDE 137131-09-0 C6H10BrNO
(E)-4-BROMO-N,N-DIMETHYLBUT-2-ENAMIDE (E)-4-BROMO-N,N-DIMETHYLBUT-2-ENAMIDE 137131-09-0 C6H10BrNO
Almotriptan Impurity 1 Almotriptan Impurity 1 334981-13-4 C17H25N3O3S
Almotriptan Impurity 1 Almotriptan Impurity 1 334981-13-4 C17H25N3O3S
Amlodipine Impurity 33 Amlodipine Impurity 33 C26H31ClN2O8S
6-HYDROXY ONDANSETRON 6-HYDROXY ONDANSETRON 110708-17-3 C18H19N3O2
Apixaban Impurity 22 Apixaban Impurity 22 1449510-64-8 C25H26ClN5O4
Cefdinir impurity TU mixture Cefdinir impurity TU mixture
Fotagliptin Impurity 1 Fotagliptin Impurity 1
Rocuronium bromide Impurity 7 Rocuronium bromide Impurity 7
Tofacitinib Impurity 69 Tofacitinib Impurity 69
Benzenamine, 3-(2-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)- Benzenamine, 3-(2-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)- 641571-06-4 C11H10F3N3
Ciprofloxacin EP Impurity E Ciprofloxacin EP Impurity E 879005-96-6 C16H20FN3O
ethyl 2-(3-cyano-4-propoxyphenyl)-4-methylthiazole-5-
carboxylate ethyl 2-(3-cyano-4-propoxyphenyl)-4-methylthiazole-5- carboxylate C17H18N2O3S
(2S,5R,6S)-6-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Diphenylmethyl Ester (2S,5R,6S)-6-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Diphenylmethyl Ester 74189-25-6 C21H20BrNO3S
Trelagliptin Impurity 5 Trelagliptin Impurity 5 2087874-92-6 C22H24FN5O5
9H-Purin-6-amine, 9-beta-D-arabinofuranosyl-2-methoxy- 9H-Purin-6-amine, 9-beta-D-arabinofuranosyl-2-methoxy- 51742-84-8 C11H15N5O5
2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid 1-oxide 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid 1-oxide 2418591-42-9 C16H16N2O4S
Ropivacaine impurity Ropivacaine impurity 1786841-18-6 C12H14N2O3
Erlotinib Impurity 36 HCl Erlotinib Impurity 36 HCl
Rasagiline Impurity 6 HCl Rasagiline Impurity 6 HCl 138911-07-6 C9H11NO
Eliglustat Impurity 2(Eliglustat SR-Isomer) Eliglustat Impurity 2(Eliglustat SR-Isomer) 1092472-66-6 C23H36N2O4
Tamsulosin impurity C Tamsulosin impurity C C20H28N2O5S
Umeclidinium Bromide Impurity 9 DiHCl Umeclidinium Bromide Impurity 9 DiHCl 494778-36-8 C18H32N2O4
Flucloxacillin Impurity 4 Flucloxacillin Impurity 4
Ipratropium bromide Impurity 4 Ipratropium bromide Impurity 4 C20H29Br2NO3
Cefminox Impurity 6 Cefminox Impurity 6
Afatinib Impurity 55 Afatinib Impurity 55
Apremilast Impurity 30 Apremilast Impurity 30
Aprepitant Impurity 33 Aprepitant Impurity 33 502537-39-5 C20H20F7NO3
Brivaracetam Impurity 9 Brivaracetam Impurity 9
Esomeprazole Impurity 43 Esomeprazole Impurity 43
Etoricoxib Impurity 40 Etoricoxib Impurity 40
Lenvatinib Impurity 31 Lenvatinib Impurity 31
Oseltamivir Impurity 35 Oseltamivir Impurity 35 757965-01-8 C14H22O4
Palbociclib Impurity 39 Palbociclib Impurity 39
Posaconazole Impurity 75 Posaconazole Impurity 75
Rabeprazole Impurity 22 Rabeprazole Impurity 22
Sunitinib Impurity 12 Sunitinib Impurity 12
Ticagrelor Impurity 113 Ticagrelor Impurity 113
Ticagrelor Impurity 97 Ticagrelor Impurity 97
Tofacitinib Impurity 117 Tofacitinib Impurity 117
Trelagliptin Impurity 22 Trelagliptin Impurity 22
Trelagliptin Impurity 29 Trelagliptin Impurity 29
Vildagliptin Impurity 43 Vildagliptin Impurity 43
Dexchlorpheniramine impurity F Dexchlorpheniramine impurity F
Irbesartan IMpurity F Irbesartan IMpurity F C25H28N6O
Itraconazole iMpurity 2 Itraconazole iMpurity 2
Palbociclib Impurity 6 Palbociclib Impurity 6
Azacitidine Impurity 1 Azacitidine Impurity 1
Saxagliptin Impurity 5 Saxagliptin Impurity 5
Cinacalcet Impurity 18 Cinacalcet Impurity 18
Erlotinib Impurity 23 Erlotinib Impurity 23 2021249-11-4 C23H18F6N6O
Erlotinib Impurity 36 Erlotinib Impurity 36
Fasudil Impurity 17 Fasudil Impurity 17
Febuxostat Impurity 50 Febuxostat Impurity 50
Varenicline Impurity 8 Varenicline Impurity 8
Ticagrelor Impurity 53 Ticagrelor Impurity 53 2750247-77-7
Edoxaban Impurity 5 Edoxaban Impurity 5
Edoxaban Impurity 11 Edoxaban Impurity 11
Empagliflozin Impurity 5 Empagliflozin Impurity 5 1800196-46-6 C17H16ClIO3
Carfilzomib Impurity 2 Carfilzomib Impurity 2
Oseltamivir Impurity 20 Oseltamivir Impurity 20 212504-90-0 C12H22N2O3
Febuxostat Impurity 61 Febuxostat Impurity 61
Atosiban Impurity G Atosiban Impurity G
1-cyclopropyl-6,8-dimethoxy-7-((4aS,7aS)-octahydro-6H-pyrrolo [3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic 1-cyclopropyl-6,8-dimethoxy-7-((4aS,7aS)-octahydro-6H-pyrrolo [3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic 2252446-68-5 C22H28ClN3O5
CINACALCET-001-R CINACALCET-001-R 1630761-22-6 C11H11BF4N4O
Cefotiam Impurity D Cefotiam Impurity D
Atorvastatin Calcium Hydrate impurity 39 Atorvastatin Calcium Hydrate impurity 39 2243639-97-4 C33H35FN2O5
Peramivir Impurity B Peramivir Impurity B
AztreonaM IMpurity C AztreonaM IMpurity C
Pramipexole Related Impurity 3 Pramipexole Related Impurity 3 2166216-34-6 C10H17N3OS
Lincomycin sulfoxide Impurity 5 Lincomycin sulfoxide Impurity 5
Sulpiride Impurity 4 Sulpiride Impurity 4
Tacrolimus Impurity E Tacrolimus Impurity E
Bumetanide iMpurity E Bumetanide iMpurity E
CLOTRIMAZOLE IMP. A (PHARMEUROPA): (2-CHLOROPHENYL)DIPHENYLMETHANOL CLOTRIMAZOLE IMP. A (PHARMEUROPA): (2-CHLOROPHENYL)DIPHENYLMETHANOL 66774-02-5 C19H15ClO
PREDNICARBATE RELATED COMPOUND A (20 MG) (1,2-DIHYDROPREDNICARBATE) PREDNICARBATE RELATED COMPOUND A (20 MG) (1,2-DIHYDROPREDNICARBATE) 671225-26-6 C27H38O8
OPEN RING AZTREONAM OPEN RING AZTREONAM 87500-74-1 C13H19N5O9S2
CLONIDINE RELATED COMPOUND A (25 MG) (ACET-YLCLONIDINE) CLONIDINE RELATED COMPOUND A (25 MG) (ACET-YLCLONIDINE) 54707-71-0 C11H11Cl2N3O
Triphenylmethanol (Zidovudine impurity) Triphenylmethanol (Zidovudine impurity) C19H16O
Benzenesulfonamide, 2-(5-methyl-3-phenyl-4-isoxazolyl)- Benzenesulfonamide, 2-(5-methyl-3-phenyl-4-isoxazolyl)- 2304623-35-4 C16H14N2O3S
Amylmetacresol EP impurity A Amylmetacresol EP impurity A 876473-73-3 C12H18O
5-methyl-2-(2-methylbutyl)phenol 5-methyl-2-(2-methylbutyl)phenol C12H18O
N-(4-methyl-3-((5-(pyridin-3-yl) N-(4-methyl-3-((5-(pyridin-3-yl)
7-methyl-3,4-dihydropyrimido 7-methyl-3,4-dihydropyrimido
4'-hydroxy-3'-nitro-[1,1'-biphenyl]-3-carboxylic acid 4'-hydroxy-3'-nitro-[1,1'-biphenyl]-3-carboxylic acid 1097777-60-0 C13H9NO5
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