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.
- Chemical Name:Aprepitant impurity 1
- CAS:
- MF:
- Structure:
- Chemical Name:Benzonitrile, 4-[3-[(acetyloxy)methyl]-4-bromophenoxy]-
- CAS:2227126-09-0
- MF:C16H12BrNO3
- Structure:
- Chemical Name:3-Pyridineacrylonitrile, α-(m-chlorophenyl)-β-hydroxy- (8CI)
- CAS:18206-80-9
- MF:C14H9ClN2O
- Chemical Name:Pharmacopoeia experiment
- CAS:
- MF:
- Structure:
- Chemical Name:Androsta-3,16-dien-17-ol, acetate, (5α)- (9CI)
- CAS:103088-58-0
- MF:C21H30O2
- Structure:
- Chemical Name:1-Naphthalenamine, 1,2,3,4-tetrahydro-N-methyl-4-phenyl-, (1S,4S)-
- CAS:91797-61-4
- MF:C17H19N
- Structure:
- Chemical Name:2-Pyridineethanamine, N-methyl-N-nitroso-
- CAS:32635-81-7
- MF:C8H11N3O
- Chemical Name:Peramivir Impurity 45
- CAS:
- MF:
- Structure:
- Chemical Name:Pentanamide, 5-(diphenylphosphinyl)-N-ethyl-
- CAS:2512198-63-7
- MF:C19H24NO2P
- Structure:
- Chemical Name:1H-Pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxaline-8(7H)-carboxylic acid, 2,3,6b,9,10,10a-hexahydro-, ethyl ester, (6bR,10aS)-
- CAS:313369-17-4
- MF:C16H21N3O2
- Structure:
- Chemical Name:Ergoline-8-methanol, 10-hydroxy-1,6-dimethyl-, 8-(5-bromo-3-pyridinecarboxylate), (8β)-
- CAS:57935-66-7
- MF:C23H24BrN3O3
- Structure:
- Chemical Name:Ethanone, 2-chloro-1-[3-nitro-4-(phenylmethoxy)phenyl]-
- CAS:871266-45-4
- MF:C15H12ClNO4
- Structure:
- Chemical Name:Benzeneethanamine, N-[2-(3,4-dimethoxyphenyl)ethyl]-3,4-dimethoxy-
- CAS:24997-88-4
- MF:C20H27NO4
- Structure:
- Chemical Name:1H-Pyrazolo[3,4-c]pyridine-3-carboxamide, 4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-6-(4-nitrophenyl)-7-oxo-
- CAS:1642569-42-3
- MF:C20H17N5O5
- Structure:
- Chemical Name:1H-Pyrazolo[3,4-c]pyridine-3-carboxamide, 4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-6-(4-nitrophenyl)-7-oxo-
- CAS:1642569-42-3
- MF:C20H17N5O5
- Structure:
- Chemical Name:DIGOXIGENIN-TETRA-DIGITOXOSIDE
- CAS:31539-05-6
- MF:C47H74O17
- Structure:
- Chemical Name:2-Piperazine-4-amino-6,7-dimethoxyquinazoline
- CAS:60547-97-9
- MF:C14H19N5O2
- Chemical Name:Dapagliflozin Impurity (MW:423Da)
- CAS:
- MF:
- Chemical Name:Ramipril - Isomer Impurity 1
- CAS:
- MF:
- Chemical Name:Aripiprazole peroxide degradation Impurity (MW:480Da)
- CAS:
- MF:
- Chemical Name:Fosinopril Sodium Impurity A (Fosinoprilat)
- CAS:
- MF:
- Chemical Name:Dapoxetine Impurity 40
- CAS:
- MF:
- Chemical Name:Doxofylline Impurity 15
- CAS:
- MF:
- Chemical Name:Iohexol Impurity 10
- CAS:
- MF:
- Chemical Name:Salbutamol Impurity 40
- CAS:
- MF:
- Chemical Name:Benzylpenicillin EP(CP) Impurity F
- CAS:
- MF:
- Structure:
- Chemical Name:(3R,5R)-7-(2-(2-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid
- CAS:2243639-98-5
- MF:C33H37CaFN2O5
- Chemical Name:Flucloxacillin sodium EP Impurity A
- CAS:
- MF:
- Structure:
- Chemical Name:Nilotinib Impurity 28
- CAS:1807607-72-2
- MF:C28H20F3N7O3
- Structure:
- Chemical Name:(7R,8R)-Dihydrodehydrodiconiferyl alcohol 9-O-β-D-glucoside
- CAS:351346-10-6
- MF:C26H34O11
- Chemical Name:Atorvastatin Impurity E Intermediate
- CAS:
- MF:
- Chemical Name:Ceftazidime Double Mother Nucleus Impurity
- CAS:
- MF:
- Chemical Name:Cefuroxime Sodium Trans Impurity I,(E)-Cefuroxime Sodium Impurity I
- CAS:
- MF:
- Chemical Name:Faropenem Degradation Impurity B
- CAS:
- MF:
- Chemical Name:2-chloro-1-(5-isopropoxy-5H-chromeno[2,3-b]pyridin-7-yl)propan-1-one
- CAS:
- MF:
- Chemical Name:Peramivir Impurity 43
- CAS:
- MF:
- Structure:
- Chemical Name:N-(4-BROMOBUTYL)-7-(4-BROMOBUTOXY)-QUINOLINE-2(1H)-ONE
- CAS:1076199-56-8
- MF:C17H21Br2NO2
- Structure:
- Chemical Name:7-methoxy-3,4-dihydro-1-naphthalenylacetonitrile
- CAS:861960-34-1
- MF:C13H13NO
- Structure:
- Chemical Name:METHYL 2-[(2,5-DICHLOROBENZOYL)AMINO]ACETATE
- CAS:338965-44-9
- MF:C10H9Cl2NO3
- Structure:
- Chemical Name:4-(DIPHENYLMETHYL)-1-PIPERAZINEETHANOL DIHYDROCHLORIDE
- CAS:108983-83-1
- MF:C19H26Cl2N2O
- Structure:
- Chemical Name:N-ACETYL-4-BENZOQUINONE IMINE
- CAS:50700-49-7
- MF:C8H7NO2
- Chemical Name:Afatinib impurity 82
- CAS:
- MF:
- Chemical Name:Afatinib impurity 82
- CAS:
- MF:
- Chemical Name:Sugammadex sodium Impurity 51
- CAS:
- MF:
- Chemical Name:Sugammadex sodium Impurity 42
- CAS:
- MF:
- Structure:
- Chemical Name:Org49095
- CAS:2412952-95-3
- MF:C71H111NaO48S8
- Chemical Name:Clopidogrel Impurity 55
- CAS:
- MF:
- Chemical Name:Cabozantinib impurity 43
- CAS:
- MF:
- Chemical Name:Cabozantinib impurity 75
- CAS:
- MF:
- Chemical Name:Cabozantinib impurity 73
- CAS:
- MF:
- Chemical Name:Canagliflozin Impurity 69
- CAS:
- MF:
- Chemical Name:Dapoxetine impurity 65
- CAS:
- MF:
- Chemical Name:Dapoxetine impurity 59
- CAS:
- MF:
- Structure:
- Chemical Name:3-Oxo Atorvastatin tert-Butyl Ester
- CAS:134394-98-2
- MF:C37H41FN2O5
- Structure:
- Chemical Name:(1S,2S,3R,5S)-3-(7-(((1R,2S)-2-(4-fluorophenyl)cyclopropyl)amino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
- CAS:
- MF:C23H29FN6O4S
- Structure:
- Chemical Name:(5-Ethyl-1H-imidazol-4-yl)methanol
- CAS:38603-74-6
- MF:C6H10N2O
- Structure:
- Chemical Name:(Z)-1-(6-methylpyridin-3-yl)-2-(4-(methylsulfonyl)phenyl)ethanone oxime
- CAS:1810761-43-3
- MF:C15H16N2O3S
- Structure:
- Chemical Name:tert-butyl 2-((4R,6S)-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate
- CAS:
- MF:C14H27NO4
- Chemical Name:Apixaban Impurity A
- CAS:
- MF:
- Structure:
- Chemical Name:ethylidene phthalide
- CAS:61658-90-0
- MF:C10H8O2
- Structure:
- Chemical Name:6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl) -7-methyl-7,9-dihydro-8H-purin-8-one
- CAS:1361569-18-7
- MF:C19H15FN8O
- Structure:
- Chemical Name:5-(TRIFLUOROMETHYL)-3-P-TOLYL-1H-PYRAZOLE
- CAS:219986-64-8
- MF:C11H9F3N2
- Structure:
- Chemical Name:Lucidin 3-O-glucoside
- CAS:22255-29-4
- MF:C21H20O10
- Structure:
- Chemical Name:5-Methyl-3-phenylisoxazole-4-carboxylic acid
- CAS:1136-45-4
- MF:C11H9NO3
- Chemical Name:Bendamustine Impurity 26
- CAS:
- MF:
- Chemical Name:Canagliflozin Impurity 26
- CAS:
- MF:
- Structure:
- Chemical Name:Edoxaban Impurity 37
- CAS:2081883-50-1
- MF:C14H27N3O3
- Chemical Name:Imatinib Impurity 10
- CAS:
- MF:
- Structure:
- Chemical Name:Levofloxacin Impurity 19
- CAS:
- MF:C18H20FN3O4
- Structure:
- Chemical Name:Olanzapine Impurity K
- CAS:
- MF:C17H20N4S
- Chemical Name:Ticagrelor Related Compound 55
- CAS:
- MF:
- Chemical Name:Ticagrelor Related Compound 73
- CAS:
- MF:
- Chemical Name:Vildagliptin Impurity 10
- CAS:
- MF:
- Chemical Name:Nintedanib Impurity 24
- CAS:
- MF:
- Structure:
- Chemical Name:2-(((3,4-dimethoxypyridin-2-yl)methyl)thio)-1H-benzo[d] imidazol-5-ol
- CAS:1166386-02-2
- MF:C15H15N3O3S
- Structure:
- Chemical Name:N-((2-(5-methyl-4-phenylisoxazol-3-yl)phenyl)sulfonyl)propionamide
- CAS:2304623-38-7
- MF:C19H18N2O4S
- Chemical Name:Cefminox Impurity 1
- CAS:
- MF:
- Structure:
- Chemical Name:Amlodipine Impurity 25
- CAS:
- MF:C26H31ClN2O8S
- Chemical Name:Axitinib Impurity 13
- CAS:
- MF:
- Chemical Name:Axitinib Impurity 18
- CAS:
- MF:
- Structure:
- Chemical Name:(6R,9S)-3-Oxo-α-ionol glucoside
- CAS:159813-37-3
- MF:C19H30O7
- Chemical Name:T-IRR
- CAS:
- MF:
- Structure:
- Chemical Name:Escitalopram Acid Impurity
- CAS:1133881-04-5
- MF:C20H22FNO3
- Structure:
- Chemical Name:1,3,6,10,14-Hexadecapentaene, 3,7,11,15-tetramethyl-, (3E,6E,10E)-
- CAS:77898-97-6
- MF:C20H32
- Structure:
- Chemical Name:BROMOCRIPTINE IMPURITY A
- CAS:
- MF:C32H40BrN5O5
- Structure:
- Chemical Name:LORATADINE IMPURITY F
- CAS:
- MF:C22H23ClN2O2
- Chemical Name:ZIDOVUDINE IMPURITY A
- CAS:
- MF:
- Structure:
- Chemical Name:Propanoic acid, 2-[[(Z)-[1-(2-amino-4-thiazolyl)-2-[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]amino]-2-oxoethylidene]amino]oxy]-2-methyl-, 1-(1,1-dimethylethyl) ester
- CAS:330944-50-8
- MF:C17H25N5O8S2
- Structure:
- Chemical Name:Apixaban Impurity 16
- CAS:2203740-09-2
- MF:C26H29N5O5
- Structure:
- Chemical Name:Canagliflozin Peroxide Impurity
- CAS:2247196-28-5
- MF:C24H25FO7S
- Structure:
- Chemical Name:(αR)-α-Methyl-N-[3-[3-(trifluoromethyl)phenyl]propyl]-2-naphthalenemethanamine Hydrochloride
- CAS:2200269-28-7
- MF:C22H23ClF3N
- Structure:
- Chemical Name:2-(4-Fluorophenyl)-δ-hydroxy-5-(1-methylethyl)-β-oxo-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic Acid 1,1-Dimethylethyl Ester
- CAS:947262-20-6
- MF:C37H41FN2O5
- Structure:
- Chemical Name:Oxacillin Impurity 1
- CAS:36231-30-8
- MF:C19H19N3O6S
- Chemical Name:Brivaracetam Impurity 33
- CAS:
- MF:
- Structure:
- Chemical Name:Arformoterol Impurity 24
- CAS:477552-93-5
- MF:C19H24N2O3
- Structure:
- Chemical Name:Pregabalin Impurity 99
- CAS:949890-75-9
- MF:C16H23NO4
- Structure:
- Chemical Name:Roxatidine Impurity 9
- CAS:87327-60-4
- MF:C4H6O4
- Chemical Name:Regofenib impurity K
- CAS:
- MF:
- Chemical Name:Chlorpheniramine Impurity 4
- CAS:
- MF: