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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- Structure:
- Chemical Name:
- Lenvatinib impurity LFZZ-18
- MF:
- C11H8Cl2N2O2
- Structure:
- Chemical Name:
- Rosuvastatin Impurity 121
- CAS:
- 140164-51-8
- MF:
- C10H18O5
- Chemical Name:
- Brivaracetam Impurity 38
- Chemical Name:
- Isavuconazole Impurities 04
- Chemical Name:
- Ticagrelor Impurity 119
- Chemical Name:
- Ticagrelor Impurity 118
- Structure:
- Chemical Name:
- D-erythro-Hexonic acid, 2,4-dideoxy-3,5-O-(1-methylethylidene)-, acetate (9CI)
- CAS:
- 402508-35-4
- MF:
- C11H18O6
- Structure:
- Chemical Name:
- L-Alanine, 3-[(S)-(carboxymethyl)sulfinyl]-
- CAS:
- 112246-66-9
- MF:
- C5H9NO5S
- Structure:
- Chemical Name:
- 2-Propanone, 1-[4,5-dihydro-2-(4-methyl-1-piperazinyl)-4-thioxo-3H-1,5-benzodiazepin-3-ylidene]-
- CAS:
- 1902955-67-2
- MF:
- C17H20N4OS
- Structure:
- Chemical Name:
- 3(2H)-Pyridazinone, 6-[4-(ethylamino)phenyl]-4,5-dihydro-5-methyl-
- CAS:
- 52240-42-3
- MF:
- C13H17N3O
- Structure:
- Chemical Name:
- Benzoic acid, 4-[[4-(aminocarbonyl)-1-piperidinyl]methyl]-
- CAS:
- 938143-02-3
- MF:
- C14H18N2O3
- Chemical Name:
- 2,4-bis(1-(2,3-dimethylphenyl)ethyl)-1H-imidazole
- Chemical Name:
- 2-((4R,6S)-6-((2-((4R,6S)-6-(hydroxymethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetoxy)methyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid
- Structure:
- Chemical Name:
- Crisaborole intermediate
- CAS:
- 1187230-70-1
- MF:
- C14H14BNO3
- Structure:
- Chemical Name:
- Glycine, (2R)-N-[(4-ethyl-2,3-dioxo-1-piperazinyl)carbonyl]-2-phenylglycyl-2-[(2S,4S)-4-carboxy-5,5-dimethyl-2-thiazolidinyl]-, (2R)-
- CAS:
- 1449784-97-7
- MF:
- C23H29N5O8S
- Structure:
- Chemical Name:
- 6-Quinolinecarboxamide, 4-[(2-chloro-4-hydroxyphenyl)amino]-7-methoxy-
- CAS:
- 2380197-89-5
- MF:
- C17H14ClN3O3
- Structure:
- Chemical Name:
- Voriconazole Impurity 19
- CAS:
- 321589-01-9
- MF:
- C26H28F3N5O4S
- Chemical Name:
- Salbutamol Impurity 38
- Chemical Name:
- Gadobutrol Impurity 4 (Gd-DOTA)
- Chemical Name:
- Losartan Impurity 3
- Chemical Name:
- Peramivir Impurity 21
- Structure:
- Chemical Name:
- Dapagliflozin Impurity 165
- CAS:
- 342043-51-0
- MF:
- C18H18O4
- Structure:
- Chemical Name:
- 3'-Desethoxy Drotaverine Hydrochloride
- CAS:
- 85475-87-2
- MF:
- C22H28ClNO4
- Structure:
- Chemical Name:
- (S)-dimethyl 2-(4-(4-oxobutyl)benzamido)pentanedioate
- CAS:
- 1081974-98-2
- MF:
- C18H23NO6
- Chemical Name:
- Peramivir Impurity 38
- Chemical Name:
- 2-O-cinnamoyl-beta-D-glucose
- Chemical Name:
- (3S)-3-((S)-1-oxo-3a,4,5,6-tetrahydro-1H-benzo[de]isoquinolin-2(3H)-yl)quinuclidine 1-oxide
- Chemical Name:
- 2-(4-hydroxy-1-methyl-7-phenoxy-5,6,7,8-tetrahydroisoquinoline-3-carboxamido)acetic acid
- Structure:
- Chemical Name:
- 6-HYDROXYLAMINOURACIL
- CAS:
- 20555-88-8
- MF:
- C4H5N3O2
- Structure:
- Chemical Name:
- Dapagliflozin
- CAS:
- 639852-30-5
- MF:
- C19H44O5Si4
- Chemical Name:
- Cabozantinib impurity 52
- Chemical Name:
- Canagliflozin Impurity 71
- Structure:
- Chemical Name:
- N-((4-(5-methyl-2-phenyloxazol-4-yl)phenyl)sulfonyl)propionamide
- CAS:
- 2242749-02-4
- MF:
- C19H18N2O4S
- Chemical Name:
- Dapoxetine impurity 67
- Structure:
- Chemical Name:
- 1-Pyrrolidineacetic acid, α-ethyl-2-oxo-4-propyl-, methyl ester, (4R)-
- CAS:
- 930123-52-7
- MF:
- C12H21NO3
- Chemical Name:
- Traxipide impurity
- Structure:
- Chemical Name:
- Benzeneacetic acid, 4-[2-[4-[1-(2-ethoxyethyl)-1H-benzimidazol-2-yl]-1-piperidinyl]ethyl]-α,α-dimethyl-, methyl ester
- CAS:
- 1181267-38-8
- MF:
- C29H39N3O3
- Structure:
- Chemical Name:
- Benzenemethanol, 4-[2-(1-methylethoxy)ethoxy]-
- CAS:
- 1039828-27-7
- MF:
- C12H18O3
- Structure:
- Chemical Name:
- Brivaracetam Impurity 7 HCl
- CAS:
- 357338-46-6
- MF:
- C13H27ClN2O3
- Structure:
- Chemical Name:
- Bisacodyl Impurity 1
- CAS:
- 13004-51-8
- MF:
- C18H15NO2
- Chemical Name:
- Vecuronium Bromide ImpurityACDEFGHJKL
- Structure:
- Chemical Name:
- Butanedioic acid, 2-[[2-methyl-1-(phenylmethyl)-1H-imidazol-5-yl]methylene]-, 1-ethyl ester, (2E)-
- CAS:
- 1640981-02-7
- MF:
- C18H20N2O4
- Structure:
- Chemical Name:
- INDEX NAME NOT YET ASSIGNED
- CAS:
- 2452300-94-4
- MF:
- C21H25ClO8
- Structure:
- Chemical Name:
- 1-Butanone, 1-(4-fluorophenyl)-4-[(6bS,10aS)-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:
- 1576240-15-7
- MF:
- C24H28FN3O
- Structure:
- Chemical Name:
- 1-Pyrrolidineacetamide, α-ethyl-4-(1-methylethyl)-2-oxo-, (αS,4S)-
- CAS:
- 357334-83-9
- MF:
- C11H20N2O2
- Chemical Name:
- impurity 42
- Chemical Name:
- 2,2'-(4,10-bis((2S,3R)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,7-diyl)diacetic acid
- Structure:
- Chemical Name:
- Loratadine Impurity 2
- CAS:
- 167891-69-2
- MF:
- C22H25ClN2O2
- Structure:
- Chemical Name:
- Eliglustat (1S,2S)-Isomer (Hemitartrate)
- CAS:
- 1092472-70-2
- MF:
- C23H36N2O4
- Structure:
- Chemical Name:
- 3-Azetidineacetic acid, 1-(ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]-
- CAS:
- 2271228-52-3
- MF:
- C16H18N6O4S
- Structure:
- Chemical Name:
- Cyclopentanecarboxylic acid, 3-[(1S)-1-amino-2-ethylbutyl]-4-[(aminoiminomethyl)amino]-2-hydroxy-, (1S,2S,3S,4R)-
- CAS:
- 2412376-06-6
- MF:
- C13H26N4O3
- Chemical Name:
- Peramivir Impurity 49
- CAS:
- 2758048-81-4
- Structure:
- Chemical Name:
- 6-HYDROXY ONDANSETRON
- CAS:
- 110708-17-3
- MF:
- C18H19N3O2
- Structure:
- Chemical Name:
- Trelagliptin Impurity SJ
- CAS:
- 2087874-94-8
- MF:
- C40H42F2N10O6
- Structure:
- Chemical Name:
- CLOTRIMAZOLE IMP. A (PHARMEUROPA): (2-CHLOROPHENYL)DIPHENYLMETHANOL
- CAS:
- 66774-02-5
- MF:
- C19H15ClO
- Structure:
- Chemical Name:
- PREDNICARBATE RELATED COMPOUND A (20 MG) (1,2-DIHYDROPREDNICARBATE)
- CAS:
- 671225-26-6
- MF:
- C27H38O8
- Structure:
- Chemical Name:
- OPEN RING AZTREONAM
- CAS:
- 87500-74-1
- MF:
- C13H19N5O9S2
- Structure:
- Chemical Name:
- Methyl 2-Acetyl-3-(3-nitrophenyl)-5-oxo-hexanoate
- CAS:
- 2469555-30-2
- MF:
- C15H17NO6
- Structure:
- Chemical Name:
- CLONIDINE RELATED COMPOUND A (25 MG) (ACET-YLCLONIDINE)
- CAS:
- 54707-71-0
- MF:
- C11H11Cl2N3O
- Structure:
- Chemical Name:
- Kaempferol-3-rhamnoglucoside-7-glucoside
- CAS:
- 34336-18-0
- MF:
- C33H40O20
- Structure:
- Chemical Name:
- Mupirocin iMpurity 2
- MF:
- C26H44O9
- Structure:
- Chemical Name:
- Cytarabine Impurity 10
- CAS:
- 32830-01-6
- MF:
- C9H11N3O4
- Chemical Name:
- Ceftriaxone Sodium impurity 5
- Chemical Name:
- Sugammadex sodium Org48302 Impurity
- Structure:
- Chemical Name:
- 176761-00-5
- CAS:
- 176761-00-5
- MF:
- C17H15FN2O5
- Structure:
- Chemical Name:
- Triphenylmethanol (Zidovudine impurity)
- MF:
- C19H16O
- Structure:
- Chemical Name:
- Benzenesulfonamide, 2-(5-methyl-3-phenyl-4-isoxazolyl)-
- CAS:
- 2304623-35-4
- MF:
- C16H14N2O3S
- Structure:
- Chemical Name:
- Amylmetacresol EP impurity A
- CAS:
- 876473-73-3
- MF:
- C12H18O
- Structure:
- Chemical Name:
- 5-methyl-2-(2-methylbutyl)phenol
- MF:
- C12H18O
- Chemical Name:
- N-(4-methyl-3-((5-(pyridin-3-yl)
- Chemical Name:
- 7-methyl-3,4-dihydropyrimido
- Structure:
- Chemical Name:
- 4'-hydroxy-3'-nitro-[1,1'-biphenyl]-3-carboxylic acid
- CAS:
- 1097777-60-0
- MF:
- C13H9NO5
- Chemical Name:
- Dapagliflozin Impurity (MW: 425Da)
- Chemical Name:
- Sugammadex Monochloro Impurity
- Chemical Name:
- Oseltamivir Impurity (MW:468Da)
- Chemical Name:
- Levothyroxine – Impurity 5
- Chemical Name:
- Ibuprofen IPA impurity
- Structure:
- Chemical Name:
- methyl 2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4- (phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan-4- yl)acetate
- CAS:
- 1353049-81-6
- MF:
- C37H41FN2O5
- Chemical Name:
- Cilastatin EP Impurity G
- Structure:
- Chemical Name:
- Rosuvastatin Impurity 122
- CAS:
- 135999-58-5
- MF:
- C6H7ClO3
- Chemical Name:
- Anastrozole Impurity IV
- Chemical Name:
- NA
- Chemical Name:
- NA
- Chemical Name:
- Tinidazole Impurity B
- Structure:
- Chemical Name:
- Juncusol 7-O-glucoside
- CAS:
- 175094-15-2
- MF:
- C24H28O7
- Structure:
- Chemical Name:
- 4-Allyl-2,6-dimethoxyphenyl glucoside
- CAS:
- 100187-70-0
- MF:
- C17H24O8
- Structure:
- Chemical Name:
- Apremilast Impurity 19
- CAS:
- 2201974-01-6
- MF:
- C22H24N2O7S
- Structure:
- Chemical Name:
- Nimodipine Metabolite 3
- CAS:
- 82219-48-5
- MF:
- C20H22N2O7
- Structure:
- Chemical Name:
- Osimertinib Impurity M
- CAS:
- 1975982-94-5
- MF:
- C28H33N7O3
- Structure:
- Chemical Name:
- N-DEMETHYLROXITHROMYCIN
- CAS:
- 118267-18-8
- MF:
- C40H74N2O15
- Chemical Name:
- SULPIRIDE IMPURITY A
- Structure:
- Chemical Name:
- Androst-2-en-17-one, (5β)-
- CAS:
- 82467-84-3
- MF:
- C19H28O
- Structure:
- Chemical Name:
- (2Z)-2,3-Dehydroxy Atorvastatin (>90% Z)
- CAS:
- 1191901-60-6
- MF:
- C33H33FN2O4
- Structure:
- Chemical Name:
- (6α,11β)-11,21-Dihydroxy-6-methyl-pregna-1,4-diene-3,20-dione
- CAS:
- 103744-18-9
- MF:
- C22H30O4
- Chemical Name:
- 2,5-Thiazolylmethyl Diacarbonate
- CAS:
- 144142-33-6
- MF:
- C28H30N4O5S2
- Structure:
- Chemical Name:
- 4-(2-Chloroethyl)-N-methoxy-N,α,α-trimethyl-benzeneacetamide
- CAS:
- 1638785-17-7
- MF:
- C14H20ClNO2
- Chemical Name:
- Cefuroxime Impurity A Double-Bond Shift Impurity
- Structure:
- Chemical Name:
- 4-(difluoromethoxy)-N1-((3,4-dimethoxypyridin-2-yl)methyl)benzene-1,2-diamine
- CAS:
- 2641896-99-1
- MF:
- C15H17F2N3O3