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:
- 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:
- IRAS vials are low alkaline and meet the pharmacopoeia standards of various countries
- 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
- 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
- Structure:
- Chemical Name:
- Pentanoic acid, 3-(bromomethyl)-4-methyl-, ethyl ester, (3S)-
- CAS:
- 2432911-38-9
- MF:
- C9H17BrO2
- Structure:
- Chemical Name:
- 2-Pyrrolidinone, 3-ethylidene-, (Z)- (8CI)
- CAS:
- 930-93-8
- MF:
- C6H9NO
- Structure:
- Chemical Name:
- Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-[5-[(4-ethyl-1-piperazinyl)sulfonyl]-2-hydroxyphenyl]-5-methyl-7-propyl-
- CAS:
- 2411340-39-9
- MF:
- C21H28N6O4S
- Structure:
- Chemical Name:
- 3-Azetidineacetonitrile, 1-(ethylsulfonyl)-3-[4-[7-(hydroxymethyl)-7H-pyrrolo[2,3-d]pyrimidin-4-yl]-1H-pyrazol-1-yl]-
- CAS:
- 1187595-89-6
- MF:
- C17H19N7O3S
- Structure:
- Chemical Name:
- 4-methyl-N-(2-(methylamino)phenyl)-2-propyl-1H-benzo[d]imidazole-6-carboxamide
- CAS:
- 884330-18-1
- MF:
- C19H22N4O
- Structure:
- Chemical Name:
- Benzeneacetic acid, 3-(2-amino-1,1-dimethyl-2-oxoethyl)-α,α-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-
- CAS:
- 2469244-33-3
- MF:
- C17H22N4O3
- Structure:
- Chemical Name:
- 2,4(1H,3H)-Pyrimidinedione, 5-(2-fluoro-3-methoxyphenyl)-1-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3-[(2R)-2-(hydroxyamino)-2-phenylethyl]-6-methyl-
- CAS:
- 2486454-64-0
- MF:
- C28H24F5N3O4
- Structure:
- Chemical Name:
- 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-hydroxyphenyl)amino]-6-hydroxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-
- CAS:
- 2468737-94-0
- MF:
- C24H25Cl2N5O3
- Structure:
- Chemical Name:
- 1H-Pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxaline, 2,3,6b,7,8,9,10,10a-octahydro-, (6bR,10aS)-
- CAS:
- 313368-81-9
- MF:
- C13H17N3
- Structure:
- Chemical Name:
- Ergoline-8-methanol, 1,6-dimethyl-, (8β)- (9CI)
- CAS:
- 40170-12-5
- MF:
- C17H22N2O
- Chemical Name:
- Avatrombopag Impurity 22
- Chemical Name:
- Avatrombopag Impurity 33
- Chemical Name:
- Cisatracurium besylate impurity 16
- Structure:
- Chemical Name:
- 1-ACETYL-2-METHYLBENZIMIDAZOLE
- CAS:
- 14678-81-0
- MF:
- C10H10N2O
- Structure:
- Chemical Name:
- (E)-3-(2-Formylphenyl)-2-propenoic acid 1,1-dimethyl ethyl ester
- CAS:
- 103890-69-3
- MF:
- C14H16O3
- Structure:
- Chemical Name:
- 1H-Dibenz[e,g]indole-1-heptanoic acid, 9-fluoro-2,3-dihydro-β,δ-dihydroxy-3-(1-methylethyl)-2-oxo-3-[(phenylamino)carbonyl]-, (βR,δR)-
- CAS:
- 1046533-62-3
- MF:
- C33H33FN2O6
- Chemical Name:
- Bimatoprost Impurity 22
- Chemical Name:
- Bumetanide Impurity 9
- Chemical Name:
- Crisaborole Impurity 14
- Structure:
- Chemical Name:
- Benzonitrile, 4-[(1E)-4-(dimethylamino)-1-(4-fluorophenyl)-1-buten-1-yl]-3-(hydroxymethyl)-
- CAS:
- 1370643-23-4
- MF:
- C20H21FN2O
- Chemical Name:
- Latamoxef impurity B
- Structure:
- Chemical Name:
- (9alpha,13alpha,14alpha)-3-methoxymorphinan-17-carbaldehyde
- CAS:
- 28973-48-0
- MF:
- C18H23NO2
- Structure:
- Chemical Name:
- 3-(7,8-dimethoxy-2-oxo-1,2,4,5-tetrahydro-3H-benzo[d]azepin-3-yl)-N-(((S)-3,4-dimethoxybicyclo[4.2.0]octa-1(6),2,4-trien-7-yl)methyl)-N-methylpropan-1-amine oxide
- CAS:
- 2511244-97-4
- MF:
- C27H36N2O6
- Structure:
- Chemical Name:
- 2,4,6,3',5'-pentamethoxybiphenyl
- CAS:
- 84212-55-5
- MF:
- C17H20O5
- Structure:
- Chemical Name:
- 2-benzoyl-N-(2-hydroxyethyl)-N-methylbenzamide
- CAS:
- 24833-47-4
- MF:
- C17H17NO3
- Chemical Name:
- Labetalol EP Impurity I
- Chemical Name:
- (Asp4)-Carbetocin (Impurity G)
- Structure:
- Chemical Name:
- Sulfamide, N-[5-(4-bromophenyl)-6-[2-[(5-chloro-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propyl-
- CAS:
- 2443747-63-3
- MF:
- C19H20BrClN6O4S
- Structure:
- Chemical Name:
- methyl 3-oxo1,2-benzisothiazole-2(3H)-acetate 1,1-dioxide
- CAS:
- 6639-62-9
- MF:
- C10H9NO5S
- Structure:
- Chemical Name:
- (6R-cis)-3-(hydroxymethyl)-7-methoxy-8-oxo-7-(2-thienylacetamido)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- CAS:
- 54333-94-7
- MF:
- C15H16N2O6S2
- Structure:
- Chemical Name:
- 5-acetyl-1,3-phenylene bis(dimethylcarbamate)
- CAS:
- 81732-48-1
- MF:
- C14H18N2O5
- Chemical Name:
- Oseltamivir Impurity L
- Structure:
- Chemical Name:
- 1-METHYL-2-PHENOXYETHYLAMINE
- CAS:
- 35205-54-0
- MF:
- C9H13NO
- Structure:
- Chemical Name:
- Brexpiprazole Impurity 76
- CAS:
- 433303-94-7
- MF:
- C12H14N2S
- Structure:
- Chemical Name:
- Phenacetin Impurity 3
- CAS:
- 24176-84-9
- MF:
- C14H13ClN2O2
- Structure:
- Chemical Name:
- 2-(isopropylamino)-3-(4-(2-methoxyethyl)phenoxy)propan-1-ol
- CAS:
- 109632-11-3
- MF:
- C15H25NO3
- 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:
- 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
- Chemical Name:
- Pramipexole 828 Impurity
- Chemical Name:
- E-Ceftazidime Oxide Impurity
- Chemical Name:
- Cefuroxime Impurity D Δ3-Isomer
- 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
- 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
- Structure:
- Chemical Name:
- 2-[(4-METHOXY-3-METHYL-2-PYRIDINYL)-METHYLTHIO]-BENZIMIDAZOLE
- CAS:
- 102804-82-0
- MF:
- C15H15N3OS
- Structure:
- Chemical Name:
- 2-[(4-METHYLPIPERAZIN-1-YL)METHYL]BENZONITRILE
- CAS:
- 864069-00-1
- MF:
- C13H17N3
- Chemical Name:
- Afatinib impurity 84
- Chemical Name:
- Sugammadex sodium Impurity 40
- Chemical Name:
- Sugammadex sodium Impurity 44
- Chemical Name:
- Sugammadex sodium Impurity 49
- Chemical Name:
- Cefazolin Impurity EP-E
- Chemical Name:
- Canagliflozin Impurity 70
- Chemical Name:
- Dapoxetine impurity 66
- Chemical Name:
- EP Impurity Catalog
- Structure:
- Chemical Name:
- 2-[(5-CARBOXY-4-METHOXY-3-METHYLPYRID-2-YL)-METHYLSULFO]-5-METHOXYBENZIMIDAZOLE
- CAS:
- 120003-72-7
- MF:
- C17H17N3O5S
- Structure:
- Chemical Name:
- 1,4-Naphthalenediol, 2-methyl-, 4-acetate
- CAS:
- 110327-29-2
- MF:
- C13H12O3
- Chemical Name:
- Oseltamivir Impurity 105
- Chemical Name:
- Oseltamivir Impurity 77
- Chemical Name:
- Imidapril Impurity 2
- Structure:
- Chemical Name:
- Betamethasone EP Impurity G
- CAS:
- 85700-75-0
- MF:
- C22H30O5
- Chemical Name:
- Crisaborole Impurity ABCDEFGHJKL
- Structure:
- Chemical Name:
- 3-Azetidinecarboxylic acid, 1-[(4-acetyl-2-ethylphenyl)methyl]-
- CAS:
- 2474774-17-7
- MF:
- C15H19NO3
- Structure:
- Chemical Name:
- 1-chloro-3-(chlorophenylmethyl)benzene
- CAS:
- 13391-39-4
- MF:
- C13H10Cl2