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:3-(1,4-Dihydro-5-Methyl-4-oxo-7-propyliMidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxybenzoic Acid
- CAS:358390-39-3
- MF:C18H20N4O4
- Structure:
- Chemical Name:β-(BenzoylaMino)-α-hydroxybenzenepropanoic Acid (αR,βS)-(1S,3S,4S,4aR,5S,6S,8S,11R,12aS)-3,11-Bis(acetyloxy)-4-[(benzoyloxy)Methyl]-1,2,3,4,4a,5,6,7,8,11,12,12a-dodecahydro-1,4,5,6-tetrahydroxy-9,12a,13,13-tetraMethyl-12-oxo-6,10-Methanobenzocyclodecen-8-
- CAS:932042-85-8
- MF:C47H53NO15
- Structure:
- Chemical Name:(S)-Sitagliptin Phosphate
- CAS:823817-58-9
- MF:C16H16F6N5O5P
- Structure:
- Chemical Name:4-[(2,3,4-TriMethoxyphenyl)Methyl]-1-piperazinecarboxylic Acid Ethyl Ester
- CAS:53531-01-4
- MF:C17H26N2O5
- Structure:
- Chemical Name:(S)-2-(3-chloro-2-hydroxypropyl)isoindoline-1,3-dione
- CAS:148857-42-5
- MF:C11H10ClNO3
- Structure:
- Chemical Name:Loratadine IMpurity C
- CAS:
- MF:C22H23ClN2O2
- Structure:
- Chemical Name:Metoprolol IMpurity C
- CAS:
- MF:C15H25NO3
- Structure:
- Chemical Name:Metoprolol IMpurity I
- CAS:
- MF:C15H25NO3
- Chemical Name:Telmisartan impurity D
- CAS:
- MF:
- Chemical Name:itraconazole impurity f
- CAS:
- MF:
- Structure:
- Chemical Name:Ethanediamide, N1-(5-chloro-2-pyridinyl)-N2-[(1S,2S,4S)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]-
- CAS:1255529-27-1
- MF:C24H30ClN7O4S
- Structure:
- Chemical Name:1-(p-Toluenesulfonyl)hoMopiperazine, 95%
- CAS:872103-28-1
- MF:C12H18N2O2S
- Structure:
- Chemical Name:1-NaphthaleneethanaMine, 1,2,3,4-tetrahydro-7-Methoxy-
- CAS:59081-66-2
- MF:C13H19NO
- Structure:
- Chemical Name:1-NaphthaleneethanaMine, 1,2,3,4-tetrahydro-7-Methoxy-
- CAS:59081-66-2
- MF:C13H19NO
- Structure:
- Chemical Name:1H-Indazole, 4,5-dichloro-
- CAS:1020243-02-0
- MF:C7H4Cl2N2
- Structure:
- Chemical Name:1H-Indazole, 4,5-dichloro-
- CAS:1020243-02-0
- MF:C7H4Cl2N2
- Structure:
- Chemical Name:1,4-ditosyl-1,4-diazepane
- CAS:5769-35-7
- MF:C19H24N2O4S2
- Structure:
- Chemical Name:4-FORMYLCINNAMIC ACID
- CAS:66885-68-5
- MF:C10H8O3
- Structure:
- Chemical Name:1,1'-[1,3-Propanediylbis(oxy)]bis[2,5-dimethylbenzene]
- CAS:415724-02-6
- MF:C19H24O2
- Structure:
- Chemical Name:1-Dimethylamino-2-phenylbutan-2-yl 3,4,5-trimethoxybenzoate
- CAS:92414-09-0
- MF:C22H29NO5
- Structure:
- Chemical Name:LCZ Impurity
- CAS:753421-85-1
- MF:C20H25NO2
- Structure:
- Chemical Name:Dehydro Benidipine
- CAS:118935-44-7
- MF:C28H29N3O6
- Structure:
- Chemical Name:Etoposide Impurity B
- CAS:100007-56-5
- MF:C29H32O13
- Structure:
- Chemical Name:Istradefylline Impurity 2
- CAS:606080-73-3
- MF:C20H24N4O4
- Structure:
- Chemical Name:Oxonic Acid Impurity 1
- CAS:60301-55-5
- MF:C3H3N3O2
- Structure:
- Chemical Name:Vortioxetine Impurity 4
- CAS:1293489-77-6
- MF:C18H22N2S
- Structure:
- Chemical Name:Zidovudine USP Impurity G
- CAS:148665-49-0
- MF:C20H25N7O8
- Structure:
- Chemical Name:Quinoline, 6,7-dimethoxy-4-(4-nitrophenoxy)-
- CAS:190728-24-6
- MF:C17H14N2O5
- Structure:
- Chemical Name:Itopride Impurity A
- CAS:943518-63-6
- MF:C16H17NO4
- Structure:
- Chemical Name:2-(((3aS,4R,6S,6aR)-6-((5-amino-6-chloro-2-(propylthio)pyrimidin-4-yl)amino)-2,2-dimethyltetrahydro-4H-cyclopenta[d][1,3]dioxol-4-yl)oxy)ethan-1-ol
- CAS:
- MF:C17H27ClN4O4S
- Structure:
- Chemical Name:Clindamycin impurity
- CAS:198080-64-7
- MF:C18H32N2O5S
- Chemical Name:Digoxin impurity
- CAS:
- MF:
- Chemical Name:Lamivudine impurity
- CAS:
- MF:
- Structure:
- Chemical Name:Levothyroxine Sodium impurity
- CAS:27566-09-2
- MF:C14H21NO4
- Structure:
- Chemical Name:Dexchlorpheniramine impurity
- CAS:73775-50-5
- MF:C12H15ClN2
- Structure:
- Chemical Name:(S)-N-(2-(1-(3-ethoxy-4-hydroxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide
- CAS:1384441-38-6
- MF:C21H22N2O7S
- Structure:
- Chemical Name:(1R,2S,3S)-Aprepitant
- CAS:172822-28-5
- MF:C23H21F7N4O3
- Structure:
- Chemical Name:6-benzyloxy-8-((R)-2-chloro-1-hydroxy-ethyl)-4H-benzo[1,4]-oxazin-3-one
- CAS:869478-11-5
- MF:C17H16ClNO4
- Structure:
- Chemical Name:ethyl (41R,13aS)-13a-ethyl-2,3,41,5,6,13a-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate
- CAS:77549-94-1
- MF:C22H26N2O2
- Chemical Name:Dolutegravir Impurity 2
- CAS:
- MF:
- Structure:
- Chemical Name:Lesinurad Impurity J
- CAS:1210330-64-5
- MF:C14H10BrN3O2S
- Structure:
- Chemical Name:Neratinib Impurity 4
- CAS:1144516-18-6
- MF:C31H32ClN6O3+
- Structure:
- Chemical Name:Avibactam Impurity 3(2R,5S)
- CAS:1383814-68-3
- MF:C7H12N3NaO6S
- Structure:
- Chemical Name:Linagliptin Impurity C
- CAS:1791405-13-4
- MF:C15H20N6O2
- Structure:
- Chemical Name:1,1-Cyclopropanedicarboxamide,N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-N'-phenyl-
- CAS:849221-94-9
- MF:C28H25N3O5
- Structure:
- Chemical Name:methyl (41S,12S,13aS)-13a-ethyl-12-hydroxy-8-methoxy-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:57430-34-9
- MF:C22H28N2O4
- Structure:
- Chemical Name:(R)-1-[3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]ethanone
- CAS:1288338-95-3
- MF:C24H24N6O2
- Structure:
- Chemical Name:Amlodipine Impurity 17
- CAS:
- MF:C26H31ClN2O8S
- Chemical Name:Edoxaban Impurity 12 (1R,2R,4S)
- CAS:
- MF:
- Structure:
- Chemical Name:Rivaroxaban Impurity 26
- CAS:1838133-00-8
- MF:C23H21Cl2N3O5S2
- Structure:
- Chemical Name:Erlotinib
- CAS:938185-06-9
- MF:C16H11N3O2
- Structure:
- Chemical Name:methyl (41R,12S,13aS)-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:18374-18-0
- MF:C21H26N2O3
- Structure:
- Chemical Name:Brexpiprazole sulfoxide impurity
- CAS:1191900-51-2
- MF:C25H27N3O3S
- Structure:
- Chemical Name:4-(4-(4-(4-(((3S,5S)-5-((1H-1,2,4-triazol-1-yl)Methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)Methoxy)phenyl)piperazin-1-yl)phenyl)-1-((2R,3R)-2-hydroxypentan-3-yl)-1H-1,2,4-triazol-5(4H)-one
- CAS:2243785-97-7
- MF:C37H42F2N8O4
- Structure:
- Chemical Name:4-(4-broMo-3-(hydroxyMethyl)phenoxy)benzonitrile
- CAS:906673-45-8
- MF:C14H10BrNO2
- Structure:
- Chemical Name:ACT 080803
- CAS:1433875-21-8
- MF:C16H13Br2N5O2
- Structure:
- Chemical Name:L-Alanine, N-[(S)-hydroxyphenoxyphosphinyl]-, 1-Methylethyl ester, (P→3'),(P'→5')-diester with (2'R)-2'-deoxy-2'-fluoro-2'-Methyluridine
- CAS:1337482-17-3
- MF:C34H45FN4O13P2
- Structure:
- Chemical Name:Pyrido[2,3-d]pyriMidin-7(8H)-one, 2,6-dibroMo-8-cyclopentyl-5-Methyl-
- CAS:1415560-29-0
- MF:C13H13Br2N3O
- Structure:
- Chemical Name:Celecoxib 2-Methyl Analog
- CAS:170569-99-0
- MF:C17H14F3N3O2S
- Structure:
- Chemical Name:EMpagliflozin iMpurity 6
- CAS:1620758-21-5
- MF:C32H37ClO12
- Chemical Name:EMpagliflozin iMpurity 11
- CAS:
- MF:
- Structure:
- Chemical Name:1,4,7,10-Tetraazacyclododecane-1,4,7-triacetic acid,10-[2,3-dihydroxy-1-(hydroxymethyl)propyl]-
- CAS:138168-36-2
- MF:C18H34N4O9
- Structure:
- Chemical Name:Di-Norbudesonide (Mixture of DiastereoMers)
- CAS:1040085-98-0
- MF:C23H30O6
- Structure:
- Chemical Name:Linagliptin MethyldiMer
- CAS:1418133-47-7
- MF:C50H56N16O4
- Structure:
- Chemical Name:Trelagliptin Impurity isomer
- CAS:2206135-35-3
- MF:C18H20FN5O2
- Structure:
- Chemical Name:(2R,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxyMethyl)tetrahydro-2H-pyran-3,4,5-triol
- CAS:
- MF:C21H25ClO6
- Structure:
- Chemical Name:3,6-Dichloropyrazine-2-carboxaMide
- CAS:1023813-21-9
- MF:C5H3Cl2N3O
- Structure:
- Chemical Name:N-acetic acid-1-aMino-3-adaMantanol
- CAS:1032564-18-3
- MF:C12H19NO3
- Structure:
- Chemical Name:9(10H)-Acridinone, 2-ethoxy-6-nitro-
- CAS:451460-48-3
- MF:C15H12N2O4
- Chemical Name:Olaparib iMpurity D
- CAS:
- MF:
- Structure:
- Chemical Name:(5-broMo-2-chlorophenyl)(4-hydroxyphenyl)Methanone
- CAS:1360568-68-8
- MF:C13H8BrClO2
- Structure:
- Chemical Name:(2-broMo-4,5-diMethylphenyl)Methanol
- CAS:1126385-20-3
- MF:C9H11BrO
- Chemical Name:Posaconazole iMpurity 8
- CAS:
- MF:
- Chemical Name:Aripiprazole N1-Oxide
- CAS:
- MF:
- Chemical Name:Aripiprazole N1-Oxide
- CAS:
- MF:
- Structure:
- Chemical Name:Ticagrelor Impurity N
- CAS:1643378-47-5
- MF:C23H29FN6O4S
- Structure:
- Chemical Name:carbamic acid, n-[(1r,2r,5s)-5-[(dimethylamino)carbonyl]-2-hydroxycyclohexyl]-, 1,1-dimethylethyl ester
- CAS:929693-30-1
- MF:C14H26N2O4
- Chemical Name:Valaciclovir iMpurity
- CAS:
- MF:
- Chemical Name:Erlotinib hydrochloride Impurity C
- CAS:
- MF:
- Chemical Name:Linagliptin Impurity B
- CAS:
- MF:
- Chemical Name:Parecoxib Impurity A
- CAS:
- MF:
- Chemical Name:Parecoxib Impurity F
- CAS:
- MF:
- Structure:
- Chemical Name:2-(4-Benzhydrylpiperazino)ethyl acetoacetate
- CAS:89226-49-3
- MF:C23H28N2O3
- Structure:
- Chemical Name:Axitinib Impurity a
- CAS:1347304-18-0
- MF:C22H18N4O2S
- Structure:
- Chemical Name:Cycloocta[b]pyridine, 4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydro-2-(1-piperazinyl)-
- CAS:132811-84-8
- MF:C21H26FN3
- Chemical Name:Linagliptin Impurity W
- CAS:
- MF:
- Structure:
- Chemical Name:(R)-4-fluoro-2-((3-methyl-2,4-dioxo-6-(piperidin-3-ylamino)-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile
- CAS:
- MF:C18H20FN5O2
- Structure:
- Chemical Name:1-cyclopropyl-6-fluoro-8-methoxy-7-((4aS,7aS)-octahydro-1H-pyrrolo[3,4-b]pyridin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
- CAS:
- MF:C21H24FN3O4
- Structure:
- Chemical Name:ethyl 1-cyclopropyl-7-fluoro-6,8-dimethoxy-4-oxo-1,4-dihydroquinoline-3-carboxylate
- CAS:
- MF:C17H18FNO5
- Chemical Name:Dapagliflozin Impurity 1
- CAS:
- MF:
- Chemical Name:Ibrutinib Impurity 5
- CAS:
- MF:
- Structure:
- Chemical Name:Imatinib Impurity 4
- CAS:942514-62-7
- MF:C30H33N7O
- Structure:
- Chemical Name:Macitentan Impurity 2
- CAS:2211054-90-7
- MF:C10H8Br2N4O2
- Structure:
- Chemical Name:(R)-2-amino-4-(2-((4-(2-((2-hydroxy-2-phenylethyl)amino)ethyl) phenyl)amino)-2-oxoethyl)thiazole 3-oxide
- CAS:1884646-38-1
- MF:C21H24N4O3S
- Structure:
- Chemical Name:Nilotinib Impurity 7
- CAS:2119583-26-3
- MF:C27H20F3N7O
- Chemical Name:Regorafenib Impurity 1
- CAS:
- MF:
- Structure:
- Chemical Name:Regorafenib Impurity 6
- CAS:1187945-05-6
- MF:C20H12ClF4N3O4
- Chemical Name:Sofosbuvir Impurity 9
- CAS:
- MF:
- Structure:
- Chemical Name:Venlafaxine N-Oxide Impurity
- CAS:1021933-95-8
- MF:C16H25NO3