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:Topiroxostat Impurity 6
- CAS:2044704-63-2
- MF:C7H8N4O2
- Structure:
- Chemical Name:Dienogest Impurity I
- CAS:65928-65-6
- MF:C20H27NO2
- Structure:
- Chemical Name:Febuxostat Impurity 8
- CAS:144060-62-8
- MF:C16H17NO4S
- Structure:
- Chemical Name:Lornoxicam Impurity 9
- CAS:70374-36-6
- MF:C6H6ClNO4S2
- Structure:
- Chemical Name:Ticagrelor Related Compound 3
- CAS:88756-83-6
- MF:C8H15NO3
- Structure:
- Chemical Name:135270-10-9
- CAS:135270-10-9
- MF:C12H11F2N3O
- Structure:
- Chemical Name:Tadalafil EP Impurity
- CAS:479545-76-1
- MF:C21H16N2O5
- Chemical Name:Vonoprazan Impurity C
- CAS:
- MF:
- Structure:
- Chemical Name:(5RS)-5-Ethyl-2,6-diimino-5-phenyl-1,2,5,6-tetrahydropyrimidin-4(3H)-one
- CAS:69125-70-8
- MF:C12H14N4O
- Structure:
- Chemical Name:4-(benzyloxy)-2-methyl-1H-benzo[d]imidazole-6-carboxylic acid
- CAS:942195-83-7
- MF:C16H14N2O3
- Chemical Name:Tofacitinib Impurity G
- CAS:
- MF:
- Structure:
- Chemical Name:Ceftaroline Fosamil Impurity 6
- CAS:953037-71-3
- MF:C22H20N8O5S4
- Structure:
- Chemical Name:Zolmitriptan Related Compound F
- CAS:1350928-05-0
- MF:C38H53N7O4
- Structure:
- Chemical Name:4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butan-1-ol
- CAS:913614-15-0
- MF:C16H22N2OS
- Structure:
- Chemical Name:3-((methoxycarbonyl)methyl)-5-methylhexanoic acid
- CAS:181289-11-2
- MF:C10H18O4
- Structure:
- Chemical Name:Cyanocobalamin Impurity F
- CAS:23208-66-4
- MF:C63H85CoN13O15P
- Chemical Name:Acarbose Impurity D
- CAS:
- MF:
- Chemical Name:Acarbose Impurity D
- CAS:
- MF:
- Chemical Name:Acarbose Impurity C
- CAS:
- MF:
- Chemical Name:Acarbose Impurity C
- CAS:
- MF:
- Chemical Name:Nintedanib Impurity G (Intedanib Impurity G)
- CAS:
- MF:
- Chemical Name:Canagliflozin alpha-Isomer Impurity
- CAS:
- MF:
- Chemical Name:Dapagliflozin Impurity 4
- CAS:
- MF:
- Chemical Name:Isavuconazole Impurity 9
- CAS:
- MF:
- Chemical Name:Apremilast Impurity E
- CAS:
- MF:
- Structure:
- Chemical Name:Bisoprolol EP Impurity N
- CAS:1346601-75-9
- MF:C17H29NO4
- Chemical Name:Rosuvastatin EP Impurity J
- CAS:
- MF:
- Structure:
- Chemical Name:Bosutinib Impurity
- CAS:380843-12-9
- MF:C19H15Cl2N3O3
- Structure:
- Chemical Name:4-(4-Chloro-pyrimidin-2-ylamino)-benzamide
- CAS:1629023-90-0
- MF:C18H12N6
- Structure:
- Chemical Name:Methyl 4-(4-fluorophenyl)-6-isopropyl-2-oxo-1,2,3,4-tetrahydropyrimidine-5-carboxylate
- CAS:488798-36-3
- MF:C15H17FN2O3
- Structure:
- Chemical Name:Nateglinide Methyl Ester
- CAS:105746-47-2
- MF:C20H29NO3
- Structure:
- Chemical Name:(1S,2S,3R,5S)-3-(5-Amino-6-chloro-2-(propylthio)pyrimidin-4-ylamino)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
- CAS:1402150-32-6
- MF:C14H23ClN4O4S
- Structure:
- Chemical Name:Lamivudine impurity 6
- CAS:147126-64-5
- MF:C14H24O4S
- Chemical Name:Palbociclib Impurity G
- CAS:
- MF:
- Chemical Name:Trifluridine Impurity 1
- CAS:
- MF:
- Structure:
- Chemical Name:Tigecycline Impurity 1
- CAS:1138343-10-8
- MF:C29H38N5O10+
- Structure:
- Chemical Name:Cephalexin Impurity 3
- CAS:
- MF:C16H17N3O4S
- Chemical Name:Vonoprazan Impurity 2
- CAS:
- MF:
- Structure:
- Chemical Name:Sildenafil Impurity F
- CAS:263897-18-3
- MF:C21H28N6O4S
- Structure:
- Chemical Name:Cetirizine impurity 5
- CAS:
- MF:C21H25ClN2O3
- Structure:
- Chemical Name:Valsartan impurity 35
- CAS:1283097-98-2
- MF:C24H29N5O3
- Structure:
- Chemical Name:Valsartan Impurity 16
- CAS:2680532-87-8
- MF:C7H16N2O
- Chemical Name:Istradefylline Impurity 1
- CAS:
- MF:
- Chemical Name:Everolimus impurity 4
- CAS:
- MF:
- Structure:
- Chemical Name:Ambrisentan Impurity 3
- CAS:178306-49-5
- MF:C16H16O4
- Chemical Name:Avanafil Impurity 9
- CAS:
- MF:
- Chemical Name:Erlotinib Imp.15
- CAS:
- MF:
- Chemical Name:Erlotinib Imp.5
- CAS:
- MF:
- Chemical Name:Ticagrelor Imp.Q
- CAS:
- MF:
- Structure:
- Chemical Name:Avibactam Impurity 15
- CAS:1416134-60-5
- MF:C15H20N2O3
- Structure:
- Chemical Name:(1R,3R)-Solifenacin Succinate 2
- CAS:740780-79-4
- MF:C23H26N2O2
- Chemical Name:Daptomycin Impurity 3
- CAS:
- MF:
- Chemical Name:Duluvir impurity 1
- CAS:
- MF:
- Chemical Name:Lincomycin sulfoxide Impurity D
- CAS:
- MF:
- Chemical Name:Lornoxicam Impurity 4
- CAS:
- MF:
- Chemical Name:Netupitant Impurity 3
- CAS:
- MF:
- Chemical Name:nicergoline impurity B
- CAS:
- MF:
- Chemical Name:Tacrolimus Impurity B
- CAS:
- MF:
- Chemical Name:Oxytetracycline Impurity
- CAS:
- MF:
- Structure:
- Chemical Name:1H-Benz[de]isoquinolin-1-one,2,4,5,6-tetrahydro-2-[(3S)-1-oxido-1-azabicyclo[2.2.2]oct-3-yl]-
- CAS:1021456-82-5
- MF:C19H22N2O2
- Structure:
- Chemical Name:Erlotinib Impurity 20
- CAS:236750-62-2
- MF:C13H20N2O5
- Structure:
- Chemical Name:Afatinib Impurity 17
- CAS:1870880-09-3
- MF:C20H18Cl2FN5O
- Structure:
- Chemical Name:6-amino-1,5-dimethylpyrimidine-2,4(1H,3H)-dione
- CAS:63959-47-7
- MF:C6H9N3O2
- Chemical Name:Ciclosporin impurity
- CAS:
- MF:
- Structure:
- Chemical Name:Atomoxetine impurity
- CAS:42064-62-0
- MF:C18H24ClNO
- Structure:
- Chemical Name:Conivaptan impurity
- CAS:1129433-63-1
- MF:C32H26N4O2
- Structure:
- Chemical Name:Terazosin impurity
- CAS:1260939-66-9
- MF:C19H27N5O4
- Structure:
- Chemical Name:ent-Ivabradine Hydrochloride
- CAS:167072-91-5
- MF:C27H36N2O5
- Chemical Name:SofosBuvir Impurity 2
- CAS:
- MF:
- Structure:
- Chemical Name:isopropyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate
- CAS:1346238-10-5
- MF:C19H22N2O3S
- Structure:
- Chemical Name:1,3-diphenylpropan-1-ol
- CAS:14097-24-6
- MF:C15H16O
- Chemical Name:Canagliflozin Impurity 21
- CAS:
- MF:
- Chemical Name:Canagliflozin Impurity 7
- CAS:
- MF:
- Chemical Name:Dolutegravir Glucoside
- CAS:
- MF:
- Structure:
- Chemical Name:Fasudil Impurity 5
- CAS:2044702-91-0
- MF:C10H9NO3S
- Chemical Name:Ibrutinib Impurity 10
- CAS:
- MF:
- Structure:
- Chemical Name:Lesinurad Impurity 4
- CAS:1533519-97-9
- MF:C17H14BrN3O2S
- Structure:
- Chemical Name:1-(5-(2-fluorophenyl)-1H-pyrrol-3-yl)-N-methylmethanamine
- CAS:1610043-62-3
- MF:C12H13FN2
- Structure:
- Chemical Name:FeBuxostat Impurity 26
- CAS:1886961-39-2
- MF:C14H12N2O3S
- Chemical Name:Rivaroxaban degradation impurity 2
- CAS:
- MF:
- Structure:
- Chemical Name:(S)-methyl 2-(((S)-(perfluorophenoxy)(phenoxy)phosphoryl)amino)propanoate
- CAS:1911578-88-5
- MF:C16H13F5NO5P
- Structure:
- Chemical Name:(R)-3-((R)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium
- CAS:
- MF:C19H28NO3+
- Structure:
- Chemical Name:5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidine-2,4(1H,3H)-dione
- CAS:
- MF:C8H9FN2O4S
- Structure:
- Chemical Name:Amlodipine Impurity 13
- CAS:
- MF:C26H31ClN2O8S
- Chemical Name:Apixaban Impurity 13
- CAS:
- MF:
- Structure:
- Chemical Name:Aripiprazole-Impurity 17
- CAS:1424857-89-5
- MF:C16H17Cl4N3
- Structure:
- Chemical Name:Aripiprazole-Impurity 17
- CAS:1424857-89-5
- MF:C16H17Cl4N3
- Structure:
- Chemical Name:Cefathiamidine Impurity 3
- CAS:1417570-09-2
- MF:C17H26N4O4S2
- Chemical Name:Rivaroxaban Impurity 34
- CAS:
- MF:
- Structure:
- Chemical Name:Rivaroxaban Impurity 43
- CAS:2197189-38-9
- MF:C19H18ClN3O6S
- Structure:
- Chemical Name:(S)-thiazolidine-4-carboxylic acid (D)
- CAS:
- MF:C4H7NO2S
- Structure:
- Chemical Name:Clindamycin 2,4-Diphosphate
- CAS:1309048-48-3
- MF:C18H35ClN2O11P2S
- Structure:
- Chemical Name:1-(5,6,7,8-tetrahydronaphthalen-1-yl)ethan-1-amine hydrochloride
- CAS:154377-56-7
- MF:C12H17N
- Structure:
- Chemical Name:Abiraterone Impurity 4
- CAS:2118-32-3
- MF:C23H34O2
- Structure:
- Chemical Name:Brexpiprazole Impurity 20
- CAS:1420987-85-4
- MF:C20H20N2S2
- Chemical Name:Cabozantinib Impurity D
- CAS:
- MF:
- Structure:
- Chemical Name:4,9-diisobutyl-1,6-diazecane-2,7-dione
- CAS:1990538-03-8
- MF:C16H30N2O2
- Structure:
- Chemical Name:ethyl 7-chloro-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate
- CAS:75073-15-3
- MF:C12H9ClFNO3
- Structure:
- Chemical Name:5-phenyl-1H-pyrrole-3-carbonitrile
- CAS:122453-85-4
- MF:C11H8N2
- Structure:
- Chemical Name:Apixaban Impurity 42
- CAS:132577-23-2
- MF:C12H14N2O4