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:7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9,10-difluoro-2,3-dihydro-2-methyl-7-oxo-, (S)- (9CI)
- CAS:129798-65-8
- MF:C13H9F2NO4
- Chemical Name:Sitagliptin EP Impurity 1
- CAS:
- MF:
- Structure:
- Chemical Name:4,6-Methano-1,3,2-benzodioxaborole-2-methanamine, hexahydro-3a,8,8-trimethyl-α-(2-methylpropyl)-, (αS,3aR,4R,6R,7aS)-, 2,2,2-trifluoroacetate (1:1)
- CAS:2363753-29-9
- MF:C17H29BF3NO4
- Chemical Name:Beprostatin impurity 3
- CAS:
- MF:
- Structure:
- Chemical Name:endo-(±)-8-aza-8-isopropylbicyclo[3.2.1]oct-3-yl (hydroxymethyl)phenylacetate
- CAS:22235-81-0
- MF:C19H27NO3
- Structure:
- Chemical Name:8,11-Dioxa-3,5-diazadodecanoic acid, 12-(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)-10-(hydroxymethyl)-2,6-bis(1-methylethyl)-7-oxo-, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, (2S,6S)-
- CAS:1654737-35-5
- MF:C29H44N12O10
- Structure:
- Chemical Name:(1R,3r,5S,8R)-8-butyl-3-(((S)-3-hydroxy-2-phenylpropanoyl)oxy)-8-methyl-8-azabicyclo[3.2.1]octan-8-ium
- CAS:99571-66-1
- MF:C21H32NO3+
- Structure:
- Chemical Name:1,3-dihydro-1-oxoisobenzofuran-5-carboxamide
- CAS:85118-25-8
- MF:C9H7NO3
- Chemical Name:Ceftazidime Impurity IMPA
- CAS:
- MF:
- Chemical Name:Pitavastatin Impurity 82
- CAS:
- MF:
- Chemical Name:Terbutaline EP Impurity B Complete Set
- CAS:
- MF:
- Chemical Name:Peramivir Intermediate impurity 2
- CAS:
- MF:
- Chemical Name:Cetrorelix Impurity 8 (+L-Pro)
- CAS:
- MF:
- Chemical Name:Peramivir Intermediate Impurity 44
- CAS:
- MF:
- Chemical Name:Peramivir Hydroxy Isomeric Impurity
- CAS:
- MF:
- Chemical Name:Nintedanib impurity F drops
- CAS:
- MF:
- Chemical Name:Favipiravir Impurities 1-19
- CAS:
- MF:
- Chemical Name:Ticagrelor Impurity 138X
- CAS:
- MF:
- Structure:
- Chemical Name:(R)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-2-((4-methylquinazolin-2-yl)methoxy)-3,7-dihydro-6H-purin-6-one
- CAS:2446799-72-8
- MF:C25H28N8O2
- Chemical Name:CETEARYL GLUCOSIDE
- CAS:
- MF:
- Chemical Name:Troxipide Impurity 8
- CAS:
- MF:
- Chemical Name:Peramivir Impurity 12/11
- CAS:
- MF:
- Chemical Name:Apremilast Impurity 999
- CAS:
- MF:
- Chemical Name:Pranoprofen Impurity C
- CAS:
- MF:
- Chemical Name:Abiolone Impurity 24
- CAS:
- MF:
- Chemical Name:Deerasirox Impurity II
- CAS:
- MF:
- Chemical Name:Brivaracetam Impurity 49
- CAS:
- MF:
- Chemical Name:Paroxetine EP Impurity J HCl
- CAS:
- MF:
- Chemical Name:Brivaracetam Impurity 99
- CAS:
- MF:
- Chemical Name:Bendamustine Impurity 39
- CAS:
- MF:
- Chemical Name:AvatrombopagImpurity42
- CAS:
- MF:
- Chemical Name:(R)-4-(((R)-1-carboxy-2-((3-hydroxypropyl)thio)ethyl)amino)-3-hydroxy-4-oxobutanoic acid
- CAS:
- MF:
- Structure:
- Chemical Name:Hydrazinecarboxamide, 2-(6-hydroxy-1-methyl-1H-indol-5-yl)-
- CAS:70063-07-9
- MF:C10H12N4O2
- Structure:
- Chemical Name:1H-Pyrrole-3-carboxaldehyde, 1-[(5-chloro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)-
- CAS:2514742-82-4
- MF:C16H10ClFN2O3S
- Chemical Name: Crisaborole Impurity 20
- CAS:
- MF:
- Chemical Name:Nicergoline EP Impurity IJ
- CAS:
- MF:
- Chemical Name:Fulvestrant impurityABCDEFGHJKL
- CAS:
- MF:
- Structure:
- Chemical Name:2-((6S,8S,9S,10S,11S,13S,14S,17R)-11,17-dihydroxy-6,10,13-trimethyl-3-oxohexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl acetate
- CAS:114696-04-7
- MF:C24H36O6
- Chemical Name:Isavuconazole Impurity 49
- CAS:
- MF:
- Chemical Name:Avatrombopag Impurity 51
- CAS:
- MF:
- Chemical Name:Tafluprost Impurity 18
- CAS:
- MF:
- Chemical Name:Meropenem Impurity MAP-B
- CAS:
- MF:
- Chemical Name:N-(3-chloro-4-fluorophenyl)-7-fluoro-6,8-dinitroquinazolin-4-amine
- CAS:
- MF:
- Structure:
- Chemical Name:3-Azabicyclo[3.1.0]hexane-2-carboxamide, N-[(1R)-1-cyano-2-[(3S)-2-oxo-3-pyrrolidinyl]ethyl]-3-[(2S)-3,3-dimethyl-1-oxo-2-[(2,2,2-trifluoroacetyl)amino]butyl]-6,6-dimethyl-, (1R,2S,5S)-
- CAS:2755812-41-8
- MF:C23H32F3N5O4
- Chemical Name:3-(4-cyanophenoxy)benzyl acetate
- CAS:2990481-66-6
- MF:
- Chemical Name:Bisoprolol Impurity 53
- CAS:
- MF:
- Structure:
- Chemical Name:2-Desisopropyl-2-phenyl Repaglinide
- CAS:107362-12-9
- MF:C30H34N2O4
- Structure:
- Chemical Name:2-(3-CHLOROPHENYL)-2-CYANO-1-(3-PYRIDINYL)-1-ETHANONE
- CAS:114444-10-9
- MF:C14H9ClN2O
- Chemical Name:Droxidopa Impurity M
- CAS:
- MF:
- Chemical Name:Vigabatrin Impurity 2
- CAS:
- MF:
- Chemical Name:Aripiprazole peroxide degradation Impurity (MW:464Da)
- CAS:
- MF:
- Chemical Name:Zileuton Impurity (MW = 279.31 Da)
- CAS:
- MF:
- Chemical Name:3'-chloro-3'-deoxythymidine (zidovudine impurity)
- CAS:
- MF:
- Chemical Name:Rivaroxaban Impurity 81
- CAS:
- MF:
- Chemical Name:Salbutamol Impurity 37
- CAS:
- MF:
- Chemical Name:Gadobutrol Impurity 21
- CAS:
- MF:
- Chemical Name:Flucloxacillin sodium EP Impurity E
- CAS:
- MF:
- Chemical Name:Pyrazole
- CAS:
- MF:
- Chemical Name:Cephalomannine (Paclitaxel Impurity I)
- CAS:
- MF:
- Structure:
- Chemical Name:Aristolactam IIIa N-β-glucoside
- CAS:80311-26-8
- MF:C22H19NO9
- Structure:
- Chemical Name:METOPROLOL IMPURITY D
- CAS:
- MF:C15H25NO3
- Chemical Name:NITRENDIPINE IMPURITY A
- CAS:
- MF:
- Structure:
- Chemical Name:TAMSULOSIN IMPURITY D
- CAS:
- MF:C20H28N2O5S
- Structure:
- Chemical Name:Macitentan Hydroxy amine Impurity
- CAS:2211059-05-9
- MF:C12H12BrN3O2
- Structure:
- Chemical Name:1,3-diethyl-1,3-dimethylurea
- CAS:31468-19-6
- MF:C7H16N2O
- Structure:
- Chemical Name:2,4(1H,3H)-Pyrimidinedione, 6-[(3R)-3-amino-1-piperidinyl]-3-methyl-
- CAS:2276323-24-9
- MF:C10H16N4O2
- Structure:
- Chemical Name:7H-Purine-7-acetic acid, 1,2,3,6-tetrahydro-1,3-dimethyl-2,6-dioxo-, ethyl ester
- CAS:7029-96-1
- MF:C11H14N4O4
- Chemical Name:N-(2-Amino-4,5,6,7-tetrahydro-benzothiazol-6-yl)-acrylamide
- CAS:
- MF:
- Chemical Name:Rifampin Impurity 6
- CAS:
- MF:
- Chemical Name:Cefuroxime Dioxide Impurity(Cefuroxime Sulfoxide)
- CAS:
- MF:
- Chemical Name:Amoxicillin Impurity N(EP)
- CAS:
- MF:
- Chemical Name:Ampicillin Impurity F(USP)
- CAS:
- MF:
- Chemical Name:Azlocillin Opern-Ring Acetylation Impurity
- CAS:
- MF:
- Structure:
- Chemical Name:Miconazole Impurity G(EP)
- CAS:1370335-40-2
- MF:C18H14Cl4N2O
- Chemical Name:2-chloro-1-(5-hydroxy-5H-chromeno[2,3-b]pyridin-7-yl)propan-1-one
- CAS:
- MF:
- Structure:
- Chemical Name:2-(5H-chromeno[2,3-b]pyridin-7-yl)acrylic acid
- CAS:52549-22-1
- MF:C15H11NO3
- Structure:
- Chemical Name:PANTOPRAZOLE N-OXIDE
- CAS:953787-60-5
- MF:C16H15F2N3O5S
- Structure:
- Chemical Name:DEHYDROARIPIPRAZOLE, HYDROCHLORIDE
- CAS:1008531-60-9
- MF:C23H26Cl3N3O2
- Structure:
- Chemical Name:N-(3-GUANIDINO-4-METHYLPHENYL)-4-(METHYLPIPERAZINE-1-YL-METHYL)BENZAMIDE
- CAS:581076-65-5
- MF:C21H28N6O
- Structure:
- Chemical Name:Tirofiban-d9 Hydrochloride
- CAS:1331911-68-2
- MF:C22H37ClN2O5S
- Structure:
- Chemical Name:2-[4-(3-CHLORO-2-HYDROXYPROPOXY)PHENYL]ACETAMIDE
- CAS:115538-83-5
- MF:C11H14ClNO3
- Structure:
- Chemical Name:Ibuprofen Alcohol
- CAS:36039-36-8
- MF:C13H20O
- Structure:
- Chemical Name:1,1-BIS-(4-ISOBUTYLPHENYL)ETHANE
- CAS:102120-87-6
- MF:C22H30
- Chemical Name:Rosuvastatin Impurity 161
- CAS:
- MF:
- Chemical Name:Rosuvastatin Impurity 155
- CAS:
- MF:
- Chemical Name:Rosuvastatin Impurity 146
- CAS:
- MF:
- Chemical Name:Rosuvastatin Impurity 126
- CAS:
- MF:
- Structure:
- Chemical Name:(1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2,2-di(thiophen -2-yl)acetate
- CAS:29461-90-3
- MF:C18H21NO3S2
- Chemical Name:Digoxin Impurity 2
- CAS:
- MF:
- Structure:
- Chemical Name:DUTP, 100MM SOLUTION
- CAS:94736-09-1
- MF:C9H16N2NaO14P3
- Chemical Name:Oxacillin USP Impurity D
- CAS:
- MF:
- Chemical Name:Oxacillin sodium EP impurity B
- CAS:
- MF: