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.
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- Chemical Name:
- α,α''-[(Methylimino)di-2,1-ethanediyl]bis-benzenemethanol
- CAS:
- 857786-66-4
- MF:
- C19H25NO2
- Chemical Name:
- sodium 5-methoxy-2-sulfinatobenzo[d]imidazol-1-id
- Structure:
- Chemical Name:
- 2-[(4-METHYLPIPERAZIN-1-YL)METHYL]BENZONITRILE
- CAS:
- 864069-00-1
- MF:
- C13H17N3
- Structure:
- Chemical Name:
- 1-METHYL-2-PHENOXYETHYLAMINE
- CAS:
- 35205-54-0
- MF:
- C9H13NO
- Chemical Name:
- Pramipexole 828 Impurity
- Chemical Name:
- E-Ceftazidime Oxide Impurity
- Chemical Name:
- Cefuroxime Impurity D Δ3-Isomer
- Chemical Name:
- Ampicillin Open-Ring Formylation Impurity
- Chemical Name:
- Faropenem Degradation Impurity A
- Structure:
- Chemical Name:
- 7-(4-BROMOBUTOXY)-QUINOLINE-2(1H)-ONE
- CAS:
- 203395-59-9
- MF:
- C13H14BrNO2
- Structure:
- Chemical Name:
- DESMETHYL ATOMOXETINE HYDROCHLORIDE
- CAS:
- 881995-46-6
- MF:
- C16H19NO.ClH
- Structure:
- Chemical Name:
- 2-HYDROXY-5-BENZYLOXYACETOPHENONE
- CAS:
- 30992-63-3
- MF:
- C15H14O3
- Chemical Name:
- SULPIRIDE IMPURITY B
- Structure:
- Chemical Name:
- (2R,4S)-Isopropyl 5-([1,1''-biphenyl]-4-yl)-4-(4-isopropoxy-4-oxobutanamido)-2-methylpentanoate
- CAS:
- 2216755-67-6
- MF:
- C28H37NO5
- Chemical Name:
- 1,2-Dihydro Diethyl Loteprednol Carbonate
- CAS:
- 82048-81-5
- MF:
- C26H36O9
- Structure:
- Chemical Name:
- Nilotinib 3-Imidazolyl N-oxide
- CAS:
- 2139382-75-3
- MF:
- C28H22F3N7O2
- Chemical Name:
- 2-(5-hydroxy-5H-chromeno[2,3-b]pyridin-7-yl)propanoic acid
- Chemical Name:
- Eribulin Impurity 2
- Chemical Name:
- (2S)-dimethyl 2-(4-(4-oxobutan-2-yl)benzamido)pentanedioate
- Chemical Name:
- (E)-1-(2,4-difluorostyryl)-1H-1,2,4-triazole
- Chemical Name:
- Peramivir Impurity 22
- Structure:
- Chemical Name:
- Olaparib Impurity 58
- CAS:
- 848136-41-4
- MF:
- C22H21FN4O3
- Structure:
- Chemical Name:
- Fluconazole Impurity 4
- CAS:
- 168479-96-7
- MF:
- C10H7F2N3O
- Structure:
- Chemical Name:
- Roxatidine Impurity 7
- CAS:
- 876497-65-3
- MF:
- C7H6N2O2
- Structure:
- Chemical Name:
- Sparfloxacin Impurity
- CAS:
- 126457-99-6
- MF:
- C19H21F2N3O3
- Chemical Name:
- Peramivir Impurity 39
- Chemical Name:
- Imatinib impurity 39
- Chemical Name:
- Gadobutrol Impurity 3
- Chemical Name:
- Empagliflozin Impurity 84
- Chemical Name:
- Octreotide (Dimer, Antiparallel)
- CAS:
- 1926163-78-1
- MF:
- C98H132N20O20S4
- Chemical Name:
- Iohexol Impurity O
- Chemical Name:
- Avibactam sodium Impurity CES
- Structure:
- Chemical Name:
- (2,5-dichlorophenyl)(4-ethoxyphenyl)methanone
- CAS:
- 1097076-93-1
- MF:
- C15H12Cl2O2
- Structure:
- Chemical Name:
- Lenvatinib impurity LFZZ-10
- MF:
- C11H8Cl2N2O2
- Chemical Name:
- (2S,5S)-(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl 5-(4-amino-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylate
- Chemical Name:
- Febuxostat Impurity 98
- Chemical Name:
- (2-(methyl((vinyloxy)carbonyl)amino)pyridin-3-yl)methyl 2-(methylamino)acetate hydrochloride
- Structure:
- Chemical Name:
- 1-(4-bromo-3,5-dimethoxyphenyl)ethanone
- CAS:
- 1333472-28-8
- MF:
- C10H11BrO3
- Chemical Name:
- Ticagrelor Impurity 117
- Chemical Name:
- Ticagrelor Impurity 136
- Structure:
- Chemical Name:
- Phenol, 2-(diphenylmethyl)-5-methyl-
- CAS:
- 411239-19-5
- MF:
- C20H18O
- Structure:
- Chemical Name:
- 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-(formylamino)-, ethyl ester, (3R,4R,5S)-
- CAS:
- 2148317-96-6
- MF:
- C17H28N2O5
- Structure:
- Chemical Name:
- Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-(5-chloro-2-ethoxyphenyl)-5-methyl-7-propyl-
- CAS:
- 2245167-80-8
- MF:
- C17H19ClN4O2
- Structure:
- Chemical Name:
- Posaconazole impurity 18
- CAS:
- 1819334-66-1
- MF:
- C44H49F2N8O4+
- Structure:
- Chemical Name:
- (4S,6R)-6-(2-(tert-butoxy)-2-oxoethyl)-2,2-dimethyl-1,3-dioxane-4-carboxylic acid
- CAS:
- 2095786-11-9
- MF:
- C13H22O6
- Structure:
- Chemical Name:
- Crisaborole intermediate
- CAS:
- 2354382-27-5
- MF:
- C14H8BCl2NO3
- Chemical Name:
- Ropivacaine Impurity 48
- Structure:
- Chemical Name:
- 2(1H)-Pyridinone, 1,1'-[(1E)-1,2-diazenediyldi-4,1-phenylene]bis[5,6-dihydro-3-(4-morpholinyl)-
- CAS:
- 1998079-15-4
- MF:
- C30H34N6O4
- Structure:
- Chemical Name:
- 2,4-Heptadienoic acid, 7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-, (2Z,4E)-
- CAS:
- 1148131-09-2
- MF:
- C33H31FN2O3
- Structure:
- Chemical Name:
- 2(3H)-Furanone, dihydro-4-(1-methylethyl)-, (4S)-
- CAS:
- 53657-15-1
- MF:
- C7H12O2
- Chemical Name:
- NA
- Structure:
- Chemical Name:
- Crisaborole Impurity 9 HCl
- CAS:
- 1187187-01-4
- MF:
- C14H15BClNO3
- Structure:
- Chemical Name:
- 2H-Indol-2-one, 3-[[3,5-dimethyl-4-(1-pyrrolidinylcarbonyl)-1H-pyrrol-2-yl]methylene]-5-fluoro-1,3-dihydro-
- CAS:
- 2135339-43-2
- MF:
- C20H20FN3O2
- Chemical Name:
- Nicergoline Impurity 02
- Structure:
- Chemical Name:
- N-Depiperidin-3-amine Linagliptin Dimer
- CAS:
- 2253964-98-4
- MF:
- C45H44N14O4
- Structure:
- Chemical Name:
- (1R,5R,6S)-5-Hydroxy-7-oxabicyclo[4.1.0]hept-2-ene-3-carboxylic Acid Ethyl Ester
- CAS:
- 1476028-68-8
- MF:
- C9H12O4
- Structure:
- Chemical Name:
- (8S,11S,Z)-5-(2-Aminothiazol-4-yl)-11-(3-guanidinopropyl)-2,2-dimethyl-6,9-dioxo-8-((S)-1-(sulfoamino)ethyl)-3-oxa-4,7,10-triazadodec-4-ene-1,12-dioic Acid
- MF:
- C19H31N9O10S2
- Chemical Name:
- Brepperazole impurity
- Structure:
- Chemical Name:
- Mupirocin iMpurity 4
- MF:
- C26H44O9
- Structure:
- Chemical Name:
- Tenofovirdisoproxil Impurity C
- CAS:
- 1878175-82-6
- MF:
- C11H17N5O2
- Structure:
- Chemical Name:
- Cytarabine Impurity 13
- CAS:
- 82855-62-7
- MF:
- C17H19N5O8
- Structure:
- Chemical Name:
- 2052297-80-8
- CAS:
- 2052297-80-8
- MF:
- C12H21NO3
- Chemical Name:
- Pramipexole Impurity L
- Structure:
- Chemical Name:
- 1020151-61-4
- CAS:
- 1020151-61-4
- MF:
- C14H23ClO3S
- Chemical Name:
- Nicergoline Impurity M
- Chemical Name:
- Apixaban Impurity 48
- Structure:
- Chemical Name:
- ethyl 2-(4-(tert-butoxy)-3-cyanophenyl)-4-methylthiazole-5- carboxylate
- MF:
- C18H20N2O3S
- Structure:
- Chemical Name:
- (trans)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4'-fluoro- [1,1'-biphenyl]-4-yl)piperidine-1-carboxylate
- MF:
- C32H28FNO5
- Chemical Name:
- Moxifloxacin Impurity 9
- Chemical Name:
- Ticagrelor Impurity 10
- Chemical Name:
- Tofacitinib Impurity O
- Structure:
- Chemical Name:
- Celecoxib Impurity 5
- MF:
- C17H14F3N3O2S
- Chemical Name:
- Prasugrel Impurity 10
- Structure:
- Chemical Name:
- Amlodipine N-Lactoside
- CAS:
- 749864-27-5
- MF:
- C32H45ClN2O15
- Chemical Name:
- Sugammadex Impurity 19
- CAS:
- 2379877-89-9
- Chemical Name:
- Apixaban Impurity 29
- Chemical Name:
- Alogliptin Impurity 22
- Structure:
- Chemical Name:
- Ritonavir Impurity
- CAS:
- 1414933-89-3
- MF:
- C23H32N2O3
- Chemical Name:
- Riociguat Impurity 7
- Structure:
- Chemical Name:
- Tacrolimus Impurity 5
- CAS:
- 161861-18-3
- MF:
- C44H67NO12
- Structure:
- Chemical Name:
- monocalciummono(4-(((2S,4R)-1-([1,1'-biphenyl]-4-yl)-5- methoxy-4-methyl-5-oxopentan-2-yl)amino)-4-oxobutanoate)
- MF:
- C23H26CaNO5
- Chemical Name:
- Aprepitant iMpurity 38
- Chemical Name:
- Aprepitant iMpurity 41
- Chemical Name:
- (E)-3'-(2-(1-(3,4-dimethylphenyl)
- Structure:
- Chemical Name:
- Tenofovir
- CAS:
- 34956-22-4
- MF:
- C14H23O6PS
- Chemical Name:
- Afatinib Impurity YHQ
- Structure:
- Chemical Name:
- Sorafenib impurity 24/N-Methyl-4-[4-[[2-[(methylamino)carbonyl]-4-pyridinyl]amino]phenoxy]-2-pyridinecarboxamide
- CAS:
- 2004659-83-8
- MF:
- C20H19N5O3
- Structure:
- Chemical Name:
- Cabozantinib Impurity 49
- CAS:
- 190728-26-8
- MF:
- C17H14N2O5
- Chemical Name:
- Landiolol impurity S
- Structure:
- Chemical Name:
- Mupirocin Calcium EP Impurity G
- MF:
- C26H44CaO9
- Structure:
- Chemical Name:
- Atorvastatin Impurity 40
- CAS:
- 1116118-82-1
- MF:
- C50H64FN3O8
- Chemical Name:
- Hyoscine Butylbromide EP Impurity F
- Chemical Name:
- Tocopherol EP Impurity D
- Chemical Name:
- Bromhexine ImpurityABCDEFGHJKL
- Structure:
- Chemical Name:
- 1-Butanone, 1-(4-fluorophenyl)-4-[(6bR,10aR)-2,3,6b,9,10,10a-hexahydro-3-methyl-1H-pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl]-
- CAS:
- 1576240-16-8
- MF:
- C24H28FN3O
- Chemical Name:
- impurity 37
- Chemical Name:
- Aprepitant impurity 3
- Structure:
- Chemical Name:
- 2(1H)-Pyridinone, 1-(4-aminophenyl)-3-chloro-5,6-dihydro-
- CAS:
- 1801881-15-1
- MF:
- C11H11ClN2O
- Structure:
- Chemical Name:
- 1,4,7,10-Tetraazacyclododecane-1,4-diacetic acid
- CAS:
- 229312-34-9
- MF:
- C12H24N4O4