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.
- Structure:

- Chemical Name:5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-, 5-oxide, (6R,7R)- (9CI)
- CAS:97466-28-9
- MF:C18H18N8O8S3
- Structure:

- Chemical Name:1,3-Benzenediamine, 4-methyl-N3-[4-methyl-6-(3-pyridinyl)-2-pyrimidinyl]-
- CAS:1032314-73-0
- MF:C17H17N5
- Chemical Name:5-methoxy-1-methyl-1H-benzo[d]imidazole-2-sulfonic acid
- CAS:
- MF:
- Chemical Name:Teneligliptin Impurity 17
- CAS:
- MF:
- Structure:

- Chemical Name:Ethanone, 2-bromo-1-(5-bromo-4-chloro-2-thienyl)-
- CAS:1519427-10-1
- MF:C6H3Br2ClOS
- Structure:

- Chemical Name:1(3H)-Isobenzofuranone, 3-(1-methylpropyl)-
- CAS:261783-87-3
- MF:C12H14O2
- Chemical Name:(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl methyl sulfate
- CAS:
- MF:
- Structure:

- Chemical Name:Carbamic acid, N-[(1R)-2-[5-(2-fluoro-3-hydroxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3,6-dihydro-4-methyl-2,6-dioxo-1(2H)-pyrimidinyl]-1-phenylethyl]-, 1,1-dimethylethyl ester
- CAS:1062642-68-5
- MF:C32H30F5N3O5
- Structure:

- Chemical Name:2-Oxazolidinone, 5-(2,2-dimethyl-4H-1,3-benzodioxin-6-yl)-, (5S)-
- CAS:2514942-86-8
- MF:C13H15NO4
- Structure:

- Chemical Name:Heptanoic acid, 7-[[(3R,5R)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-3,5-dihydroxy-1-oxoheptyl]amino]-3,5-dihydroxy-, 1,1-dimethylethyl ester, (3R,5R)-
- CAS:2409556-65-4
- MF:C44H56FN3O8
- Structure:

- Chemical Name:6-Heptenoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-5-hydroxy-3-oxo-, (5S,6E)-
- CAS:1803023-43-9
- MF:C22H26FN3O6S
- Chemical Name:Drug impurity detection and analysis
- CAS:
- MF:
- Structure:

- Chemical Name:1-Pyrrolidinecarboxamide, N-[5-[(2S)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl]-3-hydroxy-, (3R)-
- CAS:2409590-08-3
- MF:C21H22F2N6O2
- Structure:

- Chemical Name:Sertraline Impurity 20
- CAS:1498236-91-1
- MF:C16H14Cl2O
- Chemical Name:Budesonide Impurity 21
- CAS:
- MF:
- Structure:

- Chemical Name:2H-3-Benzazepin-2-one, 3-(3-bromopropyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-
- CAS:1192174-72-3
- MF:C15H20BrNO3
- Structure:

- Chemical Name:Benzamide, 2-[(1-acetyl-3-iodo-1H-indazol-6-yl)thio]-N-methyl-
- CAS:1639138-00-3
- MF:C17H14IN3O2S
- Structure:

- Chemical Name:2-Pyrrolidinone, 3-ethylidene-
- CAS:27428-45-1
- MF:C6H9NO
- Structure:

- Chemical Name:2-[4-(2,3-EPOXYPROPOXY)PHENYL]ACETAMIDE
- CAS:29122-69-8
- MF:C11H13NO3
- Structure:

- Chemical Name:1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-nitro-, ethyl ester, (3R,4R,5S)-
- CAS:949164-64-1
- MF:C16H26N2O6
- Chemical Name:Peramivir Impurity 55
- CAS:
- MF:
- Chemical Name:Peramivir Impurity 60
- CAS:
- MF:
- Structure:

- Chemical Name:Hexanoic acid, 3-(hydroxymethyl)-, methyl ester, (3R)-
- CAS:2408196-94-9
- MF:C8H16O3
- Chemical Name:Loratadine EP Impurity L
- CAS:
- MF:
- Structure:

- Chemical Name:Pregna-1,4-dien-3-one, 21-(acetyloxy)-11,17,20-trihydroxy-6-methyl-, (6α,11β)- (9CI)
- CAS:151003-82-6
- MF:C24H34O6
- Structure:

- Chemical Name:3-Pyridinecarboxamide, 5-chloro-N-[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]-1,6-dihydro-6-oxo-
- CAS:762237-66-1
- MF:C23H25Cl2N5O2S2
- Structure:

- Chemical Name:3-(4-TRIFLUOROMETHYL-PHENYL)-PROPAN-1-OL
- CAS:180635-74-9
- MF:C10H11F3O
- Chemical Name:Avatrombopag Impurity 39
- CAS:
- MF:
- Structure:

- Chemical Name:(E)-2-CYANO-5-METHYL-HEX-2-ENOIC ACID METHYL ESTER
- CAS:96914-67-9
- MF:C9H13NO2
- Chemical Name:Nicergoline Impurity 7
- CAS:
- MF:
- Structure:

- Chemical Name:N,N'-Bis(2-Hydroxyethyl)propane-1,3-diamine
- CAS:10563-27-6
- MF:C7H18N2O2
- Chemical Name:4-((3-hydroxy-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one
- CAS:
- MF:
- Structure:

- Chemical Name:Tirofiban Impurity 79
- CAS:158808-85-6
- MF:C21H34N2O5S
- Chemical Name:Brivaracetam Impurity 47
- CAS:2755924-55-9
- MF:
- Chemical Name:(Glu3)-Carbetocin (Impurity D)
- CAS:
- MF:
- Structure:

- Chemical Name:(Z)-[cyano(2,3-dichlorophenyl)methylene]carbazamidine
- CAS:94213-23-7
- MF:C9H7Cl2N5
- Chemical Name:Perampanel Impurity ABCDEFGHJKL
- CAS:
- MF:
- Structure:

- Chemical Name:4(1H)-Quinazolinone, 6,8-dibromo-3-cyclohexyl-2,3-dihydro-
- CAS:2512203-87-9
- MF:C14H16Br2N2O
- Structure:

- Chemical Name:Linagliptin impurity KH-3
- CAS:2279114-27-9
- MF:C30H37N7O6
- Structure:

- Chemical Name:4-Imidazolidinone, 2,5-dimethyl-3-(2-methylphenyl)-1-propyl-
- CAS:780037-66-3
- MF:C15H22N2O
- Structure:

- Chemical Name:3-Azetidineacetic acid, 1-(ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]-, methyl ester
- CAS:2402776-80-9
- MF:C17H20N6O4S
- Structure:

- Chemical Name:11beta,21-dihydroxypregna-1,4,16-triene-3,20-dione 21-acetate
- CAS:3044-42-6
- MF:C23H28O5
- Chemical Name:Ampicillin Impurity U
- CAS:
- MF:
- Chemical Name:Canagliflozin Hydroperoxide Impurity
- CAS:
- MF:
- Structure:

- Chemical Name:(E)-2-hydroxy-4-(phenyldiazenyl)benzoic acid
- CAS:40038-46-8
- MF:C13H10N2O3
- Chemical Name:Sitagliptin EP Impurity 6
- CAS:
- MF:
- Structure:

- Chemical Name:Vonoprazan-005
- CAS:2514735-09-0
- MF:C33H27F3N4
- Structure:

- Chemical Name:D-erythro-Hexonic acid, 6-S-2-benzothiazolyl-2,4-dideoxy-6-thio-, 1,1-dimethylethyl ester
- CAS:1469771-46-7
- MF:C17H23NO4S2
- Structure:

- Chemical Name:1-Demethyl Hydroxy Daunomycinone
- CAS:58199-98-7
- MF:C20H16O9
- Structure:

- Chemical Name:(S)-2-(butylsulfonamido)-3-(4-(4-(1-methylpiperidin-4-yl)butoxy)phenyl)propanoic acid
- CAS:1631053-75-2
- MF:C23H38N2O5S
- Chemical Name:Metronidazole Impurity 2
- CAS:
- MF:
- Structure:

- Chemical Name:ethyl 2-(3-cyano-4-isopropoxyphenyl)-4-methylthiazole-5- carboxylate
- CAS:144060-84-4
- MF:C17H18N2O3S
- Structure:

- Chemical Name:4-Desmethyl 3-Methyl Vortioxetine Hydrochloride
- CAS:1293343-01-7
- MF:
- Structure:

- Chemical Name:OFLOXACIN N-OXIDE (MIXTURE OF DIASTEREOMERS)
- CAS:104721-52-0
- MF:C18H20FN3O5
- Structure:

- Chemical Name:ethyl 3-acetoxy-2-butenoate
- CAS:29214-62-8
- MF:C8H12O4
- Structure:

- Chemical Name:2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-methanol
- CAS:68751-57-5
- MF:C11H11BrCl2O3
- Structure:

- Chemical Name:2H-3-Benzazepin-2-one, 3-[3-[[[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-1-hydroxy-7,8-dimethoxy-
- CAS:2511244-96-3
- MF:C27H36N2O6
- Chemical Name:Oseltamivir Impurity 91
- CAS:
- MF:
- Chemical Name:Oseltamivir Impurity 80
- CAS:
- MF:
- Chemical Name:Oseltamivir Impurity 72
- CAS:
- MF:
- Structure:

- Chemical Name:3-[3-(tert-butylamino)-2-hydroxypropoxy]-4-morpholino-1,2,5-thiadiazole monomaleate
- CAS:57073-55-9
- MF:C17H28N4O7S
- Structure:

- Chemical Name:FEXOFENADINE EP IMPURITY A - HCl
- CAS:153439-43-1
- MF:C32H38ClNO4
- Structure:

- Chemical Name:2-[(4-Chloro-3-Methyl-2-Pyridinyl-methyl)thio]-1H-Benzimidazole
- CAS:103312-62-5
- MF:C14H12ClN3S
- Structure:

- Chemical Name:Pazufloxacin
- CAS:127046-18-8
- MF:C18H19FN2O4
- Structure:

- Chemical Name:Vinpocetine
- CAS:80038-06-8
- MF:C22H26N2O2
- Chemical Name:7-(but-2-yn-1-yl)-8-(3-(hydroxyimino)piperidin-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione
- CAS:1297273-94-9
- MF:
- Chemical Name:Isavuconazole Impurity 35
- CAS:
- MF:
- Chemical Name:Brivaracetam Impurity 26 HCl
- CAS:
- MF:
- Chemical Name:Brivaracet amoxidation Impurity 1
- CAS:
- MF:
- Chemical Name:Rosuvastatin EP Impurity G Complete Set
- CAS:
- MF:
- Chemical Name:Bortezomib Impurity G Complete Set
- CAS:
- MF:
- Chemical Name:Peramivir Diacetyl Impurity
- CAS:
- MF:
- Chemical Name:Peramivir Chlorisomeric Impurity
- CAS:
- MF:
- Chemical Name:Canagliflozin impurities 15 drops
- CAS:
- MF:
- Chemical Name:Pemetrexed Impurities 41-45
- CAS:
- MF:
- Chemical Name:Pemetrexed Disodium EP Impurity 999
- CAS:
- MF:
- Chemical Name:Bumetanide Impurity 999
- CAS:
- MF:
- Chemical Name:Canagliflozin Impurity 998
- CAS:
- MF:
- Chemical Name:N,N-dimethyl-1,4,8,11-tetraazacyclotetradecane-1-sulfonamide
- CAS:
- MF:
- Chemical Name:Tamsulosin EP Impurity C (Desethoxy Tamsulosin)
- CAS:
- MF:
- Chemical Name:Itropopa Impurity 17
- CAS:
- MF:
- Chemical Name:Cefazolin Epimer Cefazolin Impuirty M (USP), Cefazolin Impurity L (EP)
- CAS:
- MF:
- Structure:

- Chemical Name:Relugolix Impurity 66
- CAS:2591260-06-7
- MF:C25H24F2N2O6S
- Chemical Name:methyl 3-(4-(2-hydroxy-3-(isopropylamino)propoxy)phenyl)-3- oxopropanoate
- CAS:
- MF:
- Chemical Name:Δ3-7-ACT
- CAS:
- MF:
- Structure:

- Chemical Name:methyl 5-methyl-3'-nitro-3-oxo-1,2,3,6-tetrahydro-[1,1'-biphenyl]-2-carboxylate
- CAS:2469735-68-8
- MF:C15H15NO5
- Structure:

- Chemical Name:Pregn-4-ene-3,20-dione, 9-fluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α)-
- CAS:3093-36-5
- MF:C24H33FO5
- Structure:

- Chemical Name:2-(3-(4-(1-(3-(cyanomethyl)-1-(ethylsulfonyl)azetidin-3-yl)-1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile
- CAS:2402776-84-3
- MF:C23H27N9O4S2
- Structure:

- Chemical Name:Cyclopentanecarboxylic acid, 3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-[(aminocarbonyl)amino]-2-hydroxy-, (1S,2S,3R,4R)-
- CAS:2597901-48-7
- MF:C15H27N3O5
- Structure:

- Chemical Name:3-Isoquinolinecarboxylic acid, 7-(4-chlorophenoxy)-4-hydroxy-, methyl ester
- CAS:2711953-58-9
- MF:C17H12ClNO4
- Structure:

- Chemical Name:Benzoic acid, 3-(aminosulfonyl)-2,4-dichloro-
- CAS:1870323-25-3
- MF:C7H5Cl2NO4S
- Structure:

- Chemical Name:Benzeneacetamide, N,α,α-trimethyl-N-[6-(4-methyl-1,4-dioxido-1-piperazinyl)-4-(2-methylphenyl)-3-pyridinyl]-3,5-bis(trifluoromethyl)-
- CAS:1431216-61-3
- MF:C30H32F6N4O3
- Structure:

- Chemical Name:1,3-Dioxane-4-acetic acid, 6-[2-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-, sodium salt (1:1), (4R,6R)-
- CAS:862260-38-6
- MF:C36H40FN2NaO5
- Chemical Name:Avatrombopag Impurity 54
- CAS:
- MF:
- Chemical Name:Atorvastatin Impurity 45 (Sodium Salt)
- CAS:
- MF: