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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- Chemical Name:
- Erlotinib hydrochloride Impurity C
- Chemical Name:
- Linagliptin Impurity B
- Chemical Name:
- Parecoxib Impurity A
- Chemical Name:
- Parecoxib Impurity F
- Structure:
- Chemical Name:
- 2-(4-Benzhydrylpiperazino)ethyl acetoacetate
- CAS:
- 89226-49-3
- MF:
- C23H28N2O3
- Structure:
- Chemical Name:
- Axitinib Impurity a
- CAS:
- 1347304-18-0
- MF:
- C22H18N4O2S
- Structure:
- Chemical Name:
- Cycloocta[b]pyridine, 4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydro-2-(1-piperazinyl)-
- CAS:
- 132811-84-8
- MF:
- C21H26FN3
- Chemical Name:
- Linagliptin Impurity W
- Structure:
- Chemical Name:
- (R)-4-fluoro-2-((3-methyl-2,4-dioxo-6-(piperidin-3-ylamino)-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile
- MF:
- C18H20FN5O2
- Structure:
- Chemical Name:
- 1-cyclopropyl-6-fluoro-8-methoxy-7-((4aS,7aS)-octahydro-1H-pyrrolo[3,4-b]pyridin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
- MF:
- C21H24FN3O4
- Structure:
- Chemical Name:
- ethyl 1-cyclopropyl-7-fluoro-6,8-dimethoxy-4-oxo-1,4-dihydroquinoline-3-carboxylate
- MF:
- C17H18FNO5
- Chemical Name:
- Dapagliflozin Impurity 1
- Chemical Name:
- Ibrutinib Impurity 5
- Structure:
- Chemical Name:
- Imatinib Impurity 4
- CAS:
- 942514-62-7
- MF:
- C30H33N7O
- Structure:
- Chemical Name:
- Macitentan Impurity 2
- CAS:
- 2211054-90-7
- MF:
- C10H8Br2N4O2
- Structure:
- Chemical Name:
- (R)-2-amino-4-(2-((4-(2-((2-hydroxy-2-phenylethyl)amino)ethyl) phenyl)amino)-2-oxoethyl)thiazole 3-oxide
- CAS:
- 1884646-38-1
- MF:
- C21H24N4O3S
- Structure:
- Chemical Name:
- Nilotinib Impurity 7
- CAS:
- 2119583-26-3
- MF:
- C27H20F3N7O
- Chemical Name:
- Regorafenib Impurity 1
- Structure:
- Chemical Name:
- Regorafenib Impurity 6
- CAS:
- 1187945-05-6
- MF:
- C20H12ClF4N3O4
- Chemical Name:
- Sofosbuvir Impurity 9
- Structure:
- Chemical Name:
- Venlafaxine N-Oxide Impurity
- CAS:
- 1021933-95-8
- MF:
- C16H25NO3
- Chemical Name:
- Vonoprazan Impurity 4
- Structure:
- Chemical Name:
- Vortioxetine Impurity 25
- CAS:
- 1639263-80-1
- MF:
- C18H22N2O2S
- Structure:
- Chemical Name:
- Cinacalcet Impurity B
- CAS:
- 66469-40-7
- MF:
- C19H19N
- Structure:
- Chemical Name:
- Dapagliflozin Impurity D
- CAS:
- 2133407-75-5
- MF:
- C21H25ClO6
- Structure:
- Chemical Name:
- Escitalopram Impurity
- CAS:
- 91283-87-3
- MF:
- C18H14FNO3
- Chemical Name:
- Furosemide Imp.(EP)
- Structure:
- Chemical Name:
- Nifuratel Impurity
- CAS:
- 167103-07-3
- MF:
- C6H5N3O4
- Structure:
- Chemical Name:
- Vinpocetine Impurity
- CAS:
- 102341-40-2
- MF:
- C19H23N3O
- Structure:
- Chemical Name:
- 2-amino-9-((1R,3S,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one
- CAS:
- 1367369-81-0
- MF:
- C12H15N5O3
- Structure:
- Chemical Name:
- N-(3,4-dichlorophenyl)-7-methoxy-6-(3-morpholinopropoxy)quinazolin-4-amine
- CAS:
- 2089650-13-3
- MF:
- C22H24Cl2N4O3
- Chemical Name:
- Moxifloxacin Impurity 8
- Structure:
- Chemical Name:
- (3R,5S)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid
- MF:
- C33H35FN2O5
- Chemical Name:
- Olaparib Imp.2
- Structure:
- Chemical Name:
- Ciprofloxacin impurity I
- MF:
- C17H18FN3O3
- Structure:
- Chemical Name:
- 5-(4'-((2-butyl-4-chloro-5-(isopropoxymethyl)-1H-imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-1H-tetrazole
- CAS:
- 1332713-64-0
- MF:
- C25H29ClN6O
- Chemical Name:
- Afatinib Impurity L (Afatinib N-Oxide)
- Structure:
- Chemical Name:
- Mirabegron Deshydroxy
- CAS:
- 1581284-82-3
- MF:
- C21H24N4OS
- Structure:
- Chemical Name:
- 4-Thiazoleacetyl chloride, 2-amino-, monohydrochloride
- CAS:
- 66313-72-2
- MF:
- C5H6Cl2N2OS
- Structure:
- Chemical Name:
- 1,2-bis(bromomethyl)-4,5-dimethoxybenzene
- CAS:
- 26726-81-8
- MF:
- C10H12Br2O2
- Chemical Name:
- Alvimopan Impurity 2
- Chemical Name:
- Alvimopan Impurity 4
- Chemical Name:
- Isavuconazole Impurity 13
- Structure:
- Chemical Name:
- Sofosbuvir Impurity13
- CAS:
- 220503-64-0
- MF:
- C38H31N3O9
- Structure:
- Chemical Name:
- 21-Acetyl-6β-fluorotriamcinolone Acetonide
- CAS:
- 67438-37-3
- MF:
- C26H32F2O7
- Structure:
- Chemical Name:
- Quetiapine EP Impurity W
- CAS:
- 1800608-95-0
- MF:
- C34H32N4O2S2
- Structure:
- Chemical Name:
- (2R,3R)-1,1,4,4-tetraphenylbutane-1,2,3,4-tetrol
- CAS:
- 117780-08-2
- MF:
- C28H26O4
- Structure:
- Chemical Name:
- (11β,16α)-21-(Acetyloxy)-11,16,17-trihydroxypregna-1,4,14-triene-3,20-dione
- CAS:
- 131918-72-4
- MF:
- C23H28O7
- Structure:
- Chemical Name:
- (S)-Alogliptin Benzoate Salt
- CAS:
- 1638544-64-5
- MF:
- C25H27N5O4
- Structure:
- Chemical Name:
- O-Acetyl Silodosin
- CAS:
- 160970-86-5
- MF:
- C27H34F3N3O5
- Structure:
- Chemical Name:
- Azilsartan Impurity
- CAS:
- 1675221-59-6
- MF:
- C25H22N2O5
- Chemical Name:
- Agomelatine Impurity 1
- Chemical Name:
- Olaparib Impurity I
- Chemical Name:
- Brexpiprazole Impurity C
- Structure:
- Chemical Name:
- Myricetin 3-β-D-glucopyranoside
- CAS:
- 19833-12-6
- MF:
- C21H20O13
- Structure:
- Chemical Name:
- 2,4,5-Trifluoro-3-methoxybenzoyl chloride
- CAS:
- 112811-66-2
- MF:
- C8H4ClF3O2
- Structure:
- Chemical Name:
- 1-(Dimethoxymethyl)-2-methoxybenzene
- CAS:
- 58378-33-9
- MF:
- C10H14O3
- Structure:
- Chemical Name:
- 2,3,5,4'-TETRAHYDROXYSTILBENE-2-O-BETA-D-GLUCOSIDE
- MF:
- C20H22O9
- Structure:
- Chemical Name:
- N-(2-BENZOYL-4-CHLOROPHENYL)FORMAMIDE
- CAS:
- 10352-28-0
- MF:
- C14H10ClNO2
- Structure:
- Chemical Name:
- Benzylpenicillin EP Impurity
- CAS:
- 5985-13-7
- MF:
- C16H19N2NaO5S
- Structure:
- Chemical Name:
- 4,4,4-TRIFLUORO-1-(3-METHYLPHENYL)-1,3-BUTANEDIONE
- CAS:
- 53764-99-1
- MF:
- C11H9F3O2
- Structure:
- Chemical Name:
- DU 6856
- CAS:
- 127254-11-9
- MF:
- C19H18ClF2N3O3
- Structure:
- Chemical Name:
- Nsc249004
- CAS:
- 7428-39-9
- MF:
- C9H13N3O5
- Structure:
- Chemical Name:
- (3S,5R,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic acid
- CAS:
- 254452-86-3
- MF:
- C25H24FNO4
- Structure:
- Chemical Name:
- (E)-4-Acetoxy Tamoxifen
- CAS:
- 76117-70-9
- MF:
- C28H31NO3
- Structure:
- Chemical Name:
- Atorvastatin Cyclic Isopropyl Impurity
- CAS:
- 873950-17-5
- MF:
- C33H35FN2O7
- Structure:
- Chemical Name:
- O-Acetyl Losartan
- CAS:
- 1006062-27-6
- MF:
- C24H25ClN6O2
- Structure:
- Chemical Name:
- (2-Chloro-5-iodophenyl)(4-ethoxyphenyl)methanone
- CAS:
- 1103738-26-6
- MF:
- C15H12ClIO2
- Structure:
- Chemical Name:
- 3-Dechloro-4-chloro Lamotrigine
- CAS:
- 38943-76-9
- MF:
- C9H7Cl2N5
- Structure:
- Chemical Name:
- D-2’-Deoxyribofuranosyl-3-guanylurea (α/β-Mixture)
- CAS:
- 570410-72-9
- MF:
- C7H14N4O4
- Structure:
- Chemical Name:
- Difluoro Atorvastatin
- CAS:
- 693794-20-6
- MF:
- C66H66CaF4N4O10
- Structure:
- Chemical Name:
- (4S,trans)-1,1-Dimethylethyl-6-aminoethyl-2,2-dimethyl-1,3-dioxane-4-acetate
- CAS:
- 1105067-89-7
- MF:
- C14H27NO4
- Structure:
- Chemical Name:
- rac 5-Keto Fluvastatin
- CAS:
- 1160169-39-0
- MF:
- C24H24FNO4
- Structure:
- Chemical Name:
- 9-Piperazino Ofloxacin
- CAS:
- 197291-75-1
- MF:
- C18H20FN3O4
- Structure:
- Chemical Name:
- Thyroxine-4-hydroxy-3,5-diiodophenyl Ether DISCONTINUED
- CAS:
- 911661-90-0
- MF:
- C21H13I6NO5
- Structure:
- Chemical Name:
- (S)-Ethyl 2-((3S,5aS,9aS,10aS)-3-methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl)pentanoate ,95%
- CAS:
- 129970-98-5
- MF:
- C19H30N2O4
- Chemical Name:
- Exemestane Impurity A
- Chemical Name:
- Dapoxetine Impurity 7
- Structure:
- Chemical Name:
- Irbesartan Impurity 5
- CAS:
- 1213252-81-3
- MF:
- C25H28N6O
- Chemical Name:
- Cabozantinib impurity C
- Structure:
- Chemical Name:
- Loratadine Impurity 4
- MF:
- C22H23ClN2O2
- Structure:
- Chemical Name:
- Metoprolol IMpurity 4
- MF:
- C15H25NO3
- Chemical Name:
- Mirabegron Impurity 10
- Structure:
- Chemical Name:
- 8-cyclopentyl-6-(1-hydroxyethyl)-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)pyrido[2,3-d]pyrimidin-7(8H)-one
- CAS:
- 1376615-91-6
- MF:
- C24H31N7O2
- Chemical Name:
- Plerixafor Impurity A
- Structure:
- Chemical Name:
- Ceftazidime Impurity G
- CAS:
- 138829-73-9
- MF:
- C11H14N4O5S
- Chemical Name:
- Vonoprazan Impurity 6
- Structure:
- Chemical Name:
- Umeclidinium Bromide Impurity 4
- CAS:
- 869112-31-2
- MF:
- C22H28BrNO2
- Chemical Name:
- Deschloro Etoricoxib
- Structure:
- Chemical Name:
- Cefazolin impurity B
- CAS:
- 1798004-55-3
- MF:
- C16H20N4O4S3.Na
- Structure:
- Chemical Name:
- 5-chloro-N-(4-((S)-5-((5-chlorothiophene-2-carboxamido)methyl)-2-oxooxazolidin-3-yl)phenyl)-N-(2-(2-oxo-2-((((S)-2-oxo-3-(4-(3-oxomorpholino)phenyl)oxazolidin-5-yl)methyl)amino)ethoxy)ethyl)thiophene-2-carboxamide
- CAS:
- 1632463-24-1
- MF:
- C38H36Cl2N6O10S2
- Structure:
- Chemical Name:
- Apremilast Impurity 4
- CAS:
- 1831833-38-5
- MF:
- C12H16O4S
- Chemical Name:
- Rivaroxaban Impurity 16
- Chemical Name:
- Topiroxostat Impurity 3
- Chemical Name:
- Diroxide Impurity 4
- Structure:
- Chemical Name:
- (R,E)-4-((3-(3-(diisopropylamino)-1-phenylpropyl)-4-hydroxybenzyl)oxy)-4-oxobut-2-enoic acid
- MF:
- C26H33NO5
- Structure:
- Chemical Name:
- Flomoxef Impurity 2
- CAS:
- 1208982-59-5
- MF:
- C32H30N6O7S
- Chemical Name:
- Lincomycin impurity B
- Structure:
- Chemical Name:
- Valsartan Impurity 1
- CAS:
- 914465-68-2
- MF:
- C19H21N5O
- Structure:
- Chemical Name:
- Axitinib Impurity 2
- CAS:
- 1428728-83-9
- MF:
- C44H36N8O2S2