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: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: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:OCTAKIS-6-BROMO-6-DEOXY-GAMMA-CYCLODEXTRIN
- CAS:53784-84-2
- MF:C48H72Br8O32
- Chemical Name:Recombinant N-Acetyl Alpha-D-Glucosaminidase (NAGLU)
- CAS:
- MF:
- Structure:
- Chemical Name:(2R,3R,4R,5R)-2-(4-amino-2-oxo
- CAS:1415316-72-1
- MF:C12H16N4O7
- Structure:
- Chemical Name:(R)-2-(3-(diisopropylamino)-1-phenylpropyl)phenol
- CAS:
- MF:C21H29NO
- Chemical Name:Dexamethasone EP impurities F
- CAS:
- MF:
- Structure:
- Chemical Name:D-Ribofuranose, 1-C-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-2,3,5-tris-O-(phenylmethyl)-
- CAS:1355049-94-3
- MF:C32H32N4O5
- Chemical Name:Delamanid Impurity 1
- CAS:
- MF:
- Structure:
- Chemical Name:2-Ethynylaniline
- CAS:52670-38-9
- MF:C8H7N
- Structure:
- Chemical Name:N-[4-[(6,7-Dimethoxy-4-quinolinyl)oxy]phenyl]-N'-(4-fluoro-3-hydroxyphenyl)-1,1-cyclopropanedicarboxamide
- CAS:1628530-41-5
- MF:C28H24FN3O6
- Chemical Name:Oseltamivir Impurity Mixture (MW:486 Da)
- CAS:
- MF:
- Structure:
- Chemical Name:(R)-Ethyl 3-(bromomethyl)hexanoate
- CAS:1956435-91-8
- MF:C9H17BrO2
- Chemical Name:Flucloxacillin Sodium EP Impurity B
- CAS:
- MF:
- Chemical Name:Acyclovir Impurity 15
- CAS:
- MF:
- Structure:
- Chemical Name:Brivaracetam Impurity 5
- CAS:1942054-60-5
- MF:C7H13BrO2
- Structure:
- Chemical Name:(S,E)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-5-hydroxyhept-2-enoic acid calcium(II)
- CAS:1659317-57-3
- MF:C33H35CaFN2O4
- Structure:
- Chemical Name:Epalrestat Impurity 4
- CAS:130786-32-2
- MF:C8H9NO3S2
- Structure:
- Chemical Name:Olmesartan Impurity 58
- CAS:2190488-06-1
- MF:C12H22N2O2
- Chemical Name:Apixaban Impurity 73
- CAS:1998079-13-2
- MF:C44H40N8O8
- Structure:
- Chemical Name:Alectinib Impurity 10
- CAS:1256584-81-2
- MF:C28H29N3O3
- Structure:
- Chemical Name:Alectinib Impurity 10
- CAS:1256584-81-2
- MF:C28H29N3O3
- Chemical Name:Acemetacin Impurity C
- CAS:
- MF:
- Chemical Name:Propofol Impurity II (2,6-Diisopropyl-1,4-benzoquinone)
- CAS:
- MF:
- Chemical Name:Vonoprazan Impurity 58
- CAS:
- MF:
- Chemical Name:Tafluprost Impurity 12
- CAS:
- MF:
- Structure:
- Chemical Name:METOPROLOL IMPURITY A
- CAS:
- MF:C15H25NO3
- Chemical Name:NICERGOLINE IMPURITY A
- CAS:
- MF:
- Structure:
- Chemical Name:AZITHROMYCIN IMPURITY B
- CAS:307974-61-4
- MF:C38H72N2O11
- Structure:
- Chemical Name:1026009-77-7
- CAS:1026009-77-7
- MF:C20H22N2O
- Structure:
- Chemical Name:α,α,α'',5-Tetramethyl-1,3-benzenediacetonitrile
- CAS:120512-38-1
- MF:C14H16N2
- Structure:
- Chemical Name:α,α,α'',5-Tetramethyl-1,3-benzenediacetonitrile
- CAS:120512-38-1
- MF:C14H16N2
- Chemical Name:Regorafenib Impurity MJ
- CAS:
- MF:
- Chemical Name:Aztreonam Open-Ring Desulfurization Impurity
- CAS:
- MF:
- Chemical Name:L-Cefadroxil Oxide Impurity
- CAS:
- MF:
- Chemical Name:Azlocillin dioxide Impurity
- CAS:
- MF:
- Chemical Name:Azlocillin dioxide Impurity
- CAS:
- MF:
- Structure:
- Chemical Name:Ibrutinib Impurity 42
- CAS:2031255-24-8
- MF:C25H23N5O3
- Chemical Name:Pramipexole Impurity N
- CAS:
- MF:
- Structure:
- Chemical Name:Hydroxychloroquine Impurity 12 Hydrochloride
- CAS:2411340-31-1
- MF:C18H26ClN3O
- Structure:
- Chemical Name:Verteporfin impurity
- CAS:121310-58-5
- MF:C40H40N4O8
- Chemical Name:Peramivir Impurity 25
- CAS:
- MF:
- Structure:
- Chemical Name:Peramivir Impurity 33
- CAS:2758048-78-9
- MF:C18H34N2O5
- Chemical Name:Imatinib impurity XT
- CAS:
- MF:
- Chemical Name:Alogliptin Impurity 7
- CAS:
- MF:
- Chemical Name:Alogliptin Impurity 7
- CAS:
- MF:
- Structure:
- Chemical Name:diethyl 2-(2-bromoethyl)-malonate
- CAS:18721-64-7
- MF:C9H15BrO4
- Structure:
- Chemical Name:methyl 2,5-dihydroxybenzenesulfonate
- CAS:
- MF:C7H8O5S
- Chemical Name:Pinocembroside,Pinocembrin41-O-beta-D-glucoside
- CAS:
- MF:
- Structure:
- Chemical Name:4-(1-(dimethylamino)ethyl)phenyl ethyl(methyl)carbamate 2,3- dihydroxysuccinate
- CAS:123441-05-4
- MF:C14H22N2O2
- Structure:
- Chemical Name:Dapagliflozin mono acetyl impurity
- CAS:1632287-34-3
- MF:C23H27ClO7
- Chemical Name:Piperacillin Impurity 3
- CAS:
- MF:
- Structure:
- Chemical Name:Varenicline Impurity 5
- CAS:950781-87-0
- MF:C11H13N3O2
- Structure:
- Chemical Name:4-MORPHOLIN-4-YL-1,2,5-THIADIAZOL-3-OL
- CAS:30165-97-0
- MF:C6H9N3O2S
- Structure:
- Chemical Name:Amlodipine Impurity 29
- CAS:93848-82-9
- MF:C22H27ClN2O6
- Structure:
- Chemical Name:Amlodipine Impurity 34
- CAS:
- MF:C26H31ClN2O8S
- Structure:
- Chemical Name:1-benzyl-4-(piperidin-1-yl)-1,2,3,6-tetrahydropyridine
- CAS:53877-76-2
- MF:C17H24N2
- Structure:
- Chemical Name:propan-2-yl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate
- CAS:1112262-71-1
- MF:C39H45FN2O5
- Structure:
- Chemical Name:Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-9,11-epoxy-16,17-dihydroxy-, (9β,11β,16α)-
- CAS:58404-37-8
- MF:C23H28O7
- Structure:
- Chemical Name:TYRPHOSTIN AG 1290
- CAS:160391-70-8
- MF:C10H6N2O6
- 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:4-[[2-(2-Amino-4-thiazolyl)acetyl]amino]-benzeneacetic Acid
- CAS:1365244-64-9
- MF:C13H13N3O3S
- Structure:
- Chemical Name:PEONIN CHLORIDE(SH)
- CAS:132-37-6
- MF:C28H33ClO16
- Structure:
- Chemical Name:Palbociclib Impurity 91
- CAS:571191-15-6
- MF:C22H27N7O2
- Structure:
- Chemical Name:Ibrutinib Impurity 28
- CAS:2213398-75-3
- MF:C18H15N5O
- Structure:
- Chemical Name:Clopidogrel Impurity 60
- CAS:1430373-12-8
- MF:C25H26ClNO6S
- Chemical Name:Ozagrel Impurity F
- CAS:
- MF:
- Structure:
- Chemical Name:Ceftriaxone Sodium impurity 1
- CAS:1214622-93-1
- MF:C10H12N2O5S
- Chemical Name:Lasoprazole impurity
- CAS:
- MF:
- Structure:
- Chemical Name:2-bromo-1-(4-chlorothiophen-2-yl)ethanone
- CAS:677007-73-7
- MF:C6H4BrClOS
- Structure:
- Chemical Name:Fluticasone Impurity 14
- CAS:
- MF:C25H31F3O5S
- Chemical Name:Ritonavir EP Impurity U
- CAS:
- MF:
- Structure:
- Chemical Name:((3R,5S)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenyl carbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate)calcium(II)
- CAS:
- MF:C66H68CaF2N4O10
- Chemical Name:DexMedetoMidine IMpurity O
- CAS:
- MF:
- Structure:
- Chemical Name:Rivaroxaban Impurity 48
- CAS:1414932-72-1
- MF:C21H20ClN3O4
- Chemical Name:Imatinib Impurity A
- CAS:
- MF:
- Chemical Name:Vonoprazan Impurity 19
- CAS:
- MF:
- Structure:
- Chemical Name:Pregabalin Diacid
- CAS:1788341-42-3
- MF:C16H26N2O
- Chemical Name:Dexamethasone Impurity A
- CAS:
- MF:
- Chemical Name:Olaparib Impurity 24
- CAS:
- MF:
- Chemical Name:Topiroxostat Impurity 6
- CAS:
- MF:
- Chemical Name:Irinotecan EP Impurity H
- CAS:
- MF:
- Chemical Name:Teneligliptin Impurity 4
- CAS:
- MF:
- Chemical Name:7-(2-methoxypropanoyl)-5H-chromeno[2,3-b]pyridin-5-one
- CAS:
- MF:
- Structure:
- Chemical Name:N-(4-AMINO-6,7-DIMETHOXYQUINAZOL-2-YL)-N-METHYL-PROPYLENEDIAMINE, HYDROCHLORIDE
- CAS:81403-69-2
- MF:C14H22ClN5O2
- Structure:
- Chemical Name:N-(4-AMINO-6,7-DIMETHOXYQUINAZOL-2-YL)-N-METHYL-PROPYLENEDIAMINE, HYDROCHLORIDE
- CAS:81403-69-2
- MF:C14H22ClN5O2
- Structure:
- Chemical Name:FAMOTIDINE RELATED COMPOUND B
- CAS:89268-62-2
- MF:C16H23N11O2S5
- Structure:
- Chemical Name:TIZOXANIDE GLUCURONIDE, SODIUM SALT
- CAS:221287-83-8
- MF:C16H14N3NaO10S