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.
- Chemical Name:Cefradine Impurity F
- CAS:
- MF:
- Structure:
- Chemical Name:Mirabegron Impurity
- CAS:1684452-83-2
- MF:C26H28N6O3S2
- Structure:
- Chemical Name:1-methyl-1H-indol-6-ol
- CAS:130570-60-4
- MF:C9H9NO
- Structure:
- Chemical Name:2-(2-Hydroxyphenyl)-4-methyl-5-thiazolecarboxylic acid ethyl ester
- CAS:118485-48-6
- MF:C13H13NO3S
- Structure:
- Chemical Name:32-Carboxycyanocobalamin
- CAS:121483-62-3
- MF:C63H87CoN13O15P
- Chemical Name:Alvimopan Impurity 6
- CAS:
- MF:
- Chemical Name:Acarbose Impurity B
- CAS:
- MF:
- Chemical Name:Sofosbuvir Impurity28
- CAS:
- MF:
- Chemical Name:Rivaroxaban Impurity 10
- CAS:
- MF:
- Chemical Name:Ipragliflozin Impurity 1
- CAS:
- MF:
- Structure:
- Chemical Name:(17α)-4-Bromo-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile
- CAS:98149-13-4
- MF:C20H24BrNO2
- Structure:
- Chemical Name:316173-27-0
- CAS:316173-27-0
- MF:C17H28N2O5
- Structure:
- Chemical Name:Azilsartan Impurity
- CAS:1821386-21-3
- MF:C22H18N4O4
- Structure:
- Chemical Name:Irbesartan Impurity 7
- CAS:
- MF:C25H28N6O
- Chemical Name:Voriconazole Impurity 2
- CAS:
- MF:
- Chemical Name:Safinamide Impurity 1
- CAS:
- MF:
- Chemical Name:Caspofungin impurit 2
- CAS:
- MF:
- Chemical Name:Lamivudine impurity 1
- CAS:
- MF:
- Structure:
- Chemical Name:Raltitrexed Impurity 1
- CAS:1378372-01-0
- MF:C10H10N2O2
- Structure:
- Chemical Name:Loratadine Impurity 6
- CAS:
- MF:C22H23ClN2O2
- Chemical Name:Mirabegron Impurity 3
- CAS:
- MF:
- Chemical Name:Plerixafor Impurity C
- CAS:
- MF:
- Chemical Name:Vonoprazan Impuirty 8
- CAS:
- MF:
- Chemical Name:Sitagliptin IMpurity 4
- CAS:
- MF:
- Chemical Name:Brexpiprazole Impurity1
- CAS:
- MF:
- Chemical Name:Acarbose Impurity E
- CAS:
- MF:
- Structure:
- Chemical Name:Alvimopan Impurity 1
- CAS:2250243-53-7
- MF:C14H19NO
- Chemical Name:Febuxostat Impurity A
- CAS:
- MF:
- Structure:
- Chemical Name:Fingolimod Hexyl Impurity
- CAS:1201794-93-5
- MF:C17H29NO2
- Chemical Name:Palbociclib Impurity 1
- CAS:
- MF:
- Chemical Name:Trelagliptin Impurity 8
- CAS:
- MF:
- Structure:
- Chemical Name:Bromhexine Impurity H
- CAS:63471-27-2
- MF:C14H21BrN2
- Structure:
- Chemical Name:Apixaban Impurity 17
- CAS:1423803-24-0
- MF:C20H19N5O3
- Structure:
- Chemical Name:Rivaroxaban Impurity 11
- CAS:1411775-06-8
- MF:C14H17N3O4
- Structure:
- Chemical Name:(R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl propionate
- CAS:
- MF:C25H35NO3
- Chemical Name:Flomoxef Impurity 4
- CAS:
- MF:
- Chemical Name:Nicardipine Impurity 5
- CAS:
- MF:
- Structure:
- Chemical Name:11,11'-(PIPERAZINE-1,4-DIYL)-BIS-8-CHLORO-5H-DIBENZE[B,E][1,4]-DIAZEPINE
- CAS:263366-81-0
- MF:C30H24Cl2N6
- Structure:
- Chemical Name:Sacubitril Impurity 7
- CAS:149709-44-4
- MF:C22H25NO5
- Structure:
- Chemical Name:Valsartan Impurity 5
- CAS:1266616-11-8
- MF:C18H21N5
- Structure:
- Chemical Name:3-Hydroxy Agomelatine
- CAS:166526-99-4
- MF:C15H17NO3
- Structure:
- Chemical Name:Milnacipran Impurity 4
- CAS:1353644-49-1
- MF:C15H21NO2
- Structure:
- Chemical Name:(3S,5R)-Atorvastatin
- CAS:887324-52-9
- MF:C33H35FN2O5
- Structure:
- Chemical Name:Heptyl Deoctyl Fingolimod Hydrochloride
- CAS:745767-97-9
- MF:C18H31NO2
- Structure:
- Chemical Name:Tenofovir Fumarate
- CAS:1246812-23-6
- MF:C21H34N5O9P
- Structure:
- Chemical Name:Prucalopride Impurity C
- CAS:1599434-55-5
- MF:C17H24ClN3O3
- Structure:
- Chemical Name:1-cyclopropyl-7-fluoro-8-methoxy-6-((4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
- CAS:2205053-60-5
- MF:C21H24FN3O4
- Structure:
- Chemical Name:Brexpiprazole N-Oxide
- CAS:1191900-58-9
- MF:C25H27N3O3S
- Structure:
- Chemical Name:2,6-Dibenzyloxyacetophenone
- CAS:3886-19-9
- MF:C22H20O3
- Structure:
- Chemical Name:ethyl(4aS,9bR)-6-bromo-1,3,4,4a,5,9b-hexahydro-2H-pyrido[4,3-b]indole-2-carboxylate
- CAS:1059630-08-8
- MF:C14H17BrN2O2
- Structure:
- Chemical Name:diphenhydramine impurity
- CAS:
- MF:C17H21NO
- Structure:
- Chemical Name:Pyridine, 4-chloro-2-(chloromethyl)-3,5-dimethyl-, hydrochloride
- CAS:143016-68-6
- MF:C8H10Cl3N
- Structure:
- Chemical Name:1,1-dimethyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-ium iodide
- CAS:
- MF:C18H23IN4S
- Structure:
- Chemical Name:2-(4-butoxy-3-cyanophenyl)-4-methylthiazole-5-carboxylic acid
- CAS:1657014-33-9
- MF:C16H16N2O3S
- Structure:
- Chemical Name:vildagliptin Impurity O
- CAS:2253194-12-4
- MF:C12H18N4O2
- Structure:
- Chemical Name:methyl (41R,12S,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate
- CAS:38990-17-9
- MF:C21H26N2O3
- Structure:
- Chemical Name:1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethenamine
- CAS:1450657-31-4
- MF:C12H17NO4S
- Chemical Name:Apremilast Impurity D
- CAS:
- MF:
- Structure:
- Chemical Name:Canagliflozin Impurity 17
- CAS:1951467-28-9
- MF:C24H23FO6S
- Chemical Name:Canagliflozin Impurity 22
- CAS:
- MF:
- Chemical Name:Carfilzomib Impurity 3
- CAS:
- MF:
- Chemical Name:Dolutegravir Impurity 4
- CAS:
- MF:
- Chemical Name:Febuxostat Impurity 20
- CAS:
- MF:
- Chemical Name:Lenvatinib Impurity 1
- CAS:
- MF:
- Structure:
- Chemical Name:methyl (41S,12S,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate
- CAS:83508-82-1
- MF:C21H26N2O3
- Structure:
- Chemical Name:4-[6-[(8-cyclopentyl-6-ethenyl-7,8-dihydro-5-methyl-7-oxopyrido[2,3-d]pyrimidin-2-yl)amino]-3-pyridinyl]-1-piperazinecarboxylic acid tert-butyl ester
- CAS:1941177-45-2
- MF:C29H37N7O3
- Structure:
- Chemical Name:Cabozantinib impurity 1
- CAS:748707-58-6
- MF:C17H16N2O3
- Structure:
- Chemical Name:Amlodipine Impurity 19
- CAS:
- MF:C26H31ClN2O8S
- Structure:
- Chemical Name:Amlodipine Impurity 9
- CAS:90445-05-9
- MF:C26H31ClN2O8S
- Structure:
- Chemical Name:Clopidogrel Impurity 7
- CAS:444728-13-6
- MF:C15H15ClN2OS
- Structure:
- Chemical Name:Rivaroxaban Impurity 36
- CAS:1770812-39-9
- MF:C19H17Cl2N3O5S
- Structure:
- Chemical Name:(S)-methyl 2-((2'-(2H-tetrazol-5-yl)biphenyl-4-yl)methylamino)-3-methylbutanoate
- CAS:1111177-24-2
- MF:C20H23N5O2
- Structure:
- Chemical Name:Clopidogrel Impurity C
- CAS:1346605-15-9
- MF:C16H18ClNO2S
- Structure:
- Chemical Name:Nilotinib genotoxic impurity 2
- CAS:1157857-29-8
- MF:C19H15F3N4O3
- Structure:
- Chemical Name:NCFJJNFEEPMRAQ-XMMPIXPASA-N
- CAS:1453221-45-8
- MF:C35H41F6N3O6
- Chemical Name:Gliclazide Impurity E
- CAS:
- MF:
- Structure:
- Chemical Name:Ethyl 1-butanesulfonate
- CAS:2374-68-7
- MF:C6H14O3S
- Structure:
- Chemical Name:OLANEXIDINE intermediate
- CAS:60852-95-1
- MF:C10H20N4
- Structure:
- Chemical Name:1H-Isoindole, octahydro-, trans-
- CAS:10479-63-7
- MF:C8H15N
- Structure:
- Chemical Name:1H-Purine-2,6-dione,8-[2-(3,4-dihydroxyphenyl)ethenyl]-1,3-diethyl-3,7-dihydro-7-methyl-, (E)-(9CI)
- CAS:155272-03-0
- MF:C18H20N4O4
- Structure:
- Chemical Name:Hexanoicacid, 3-(2-amino-2-oxoethyl)-5-methyl-, (3S)-
- CAS:181289-34-9
- MF:C9H17NO3
- Structure:
- Chemical Name:Ethanedioic acid, monoethyl ester, 2-(4-methoxyphenyl)hydrazide
- CAS:2614-10-0
- MF:C11H14N2O4
- Structure:
- Chemical Name:4-Pyridinecarboxamide, N-[2-(nitrooxy)ethyl]-, mononitrate
- CAS:65141-48-2
- MF:C8H10N4O7
- Structure:
- Chemical Name:1-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-hydroxy-pyrimidine-2,4-dione
- CAS:69321-95-5
- MF:C9H12N2O7
- Structure:
- Chemical Name:2-(ACETOXYMETHYL)-4-METHOXY-3,5-DIMETHYLPYRIDINE
- CAS:91219-90-8
- MF:C11H15NO3
- Structure:
- Chemical Name:4,4'-(4H-1,2,4-TRIAZOL-4-YLMETHYLENE)BIS BENZONITRILE
- CAS:112809-52-6
- MF:C17H11N5
- Structure:
- Chemical Name:Pregna-1,4,9(11)-triene-3,20-dione,21-(acetyloxy)-17-hydroxy-6-methyl-, (6a)-
- CAS:93239-37-3
- MF:C24H30O5
- Chemical Name:Tadalafil EP impurity E
- CAS:
- MF:
- Structure:
- Chemical Name:4'-chloro-7H-4,7'-bipyrrolo[2,3-d]pyrimidine
- CAS:134965-85-8
- MF:C12H7ClN6
- Structure:
- Chemical Name:myricetin 3-O-β-D-xylopyranosyl(1-2)-β-D-glucopyranoside
- CAS:142449-93-2
- MF:C26H28O17
- Chemical Name:Atracurium Impurity 26
- CAS:
- MF:
- Chemical Name:Aztreonam Impurity 2
- CAS:
- MF:
- Structure:
- Chemical Name:Benazepril Impurity E
- CAS:
- MF:C24H28N2O5
- Chemical Name:Canagliflozin Impurity 44
- CAS:
- MF:
- Chemical Name:Clotrimazole Impurity 3
- CAS:
- MF:
- Structure:
- Chemical Name:Dithio-Desethyl Carbodenafil
- CAS:1610830-81-3
- MF:C22H28N6OS2
- Chemical Name:Erlotinib Impurity 57
- CAS:
- MF:
- Chemical Name:Esomeprazole Impurity 41
- CAS:
- MF:
- Chemical Name:Oseltamivir Impurity 29
- CAS:
- MF:
- Chemical Name:Pramipexole Impurity 36
- CAS:
- MF: